Evidence-Based Reviews

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

The evolution of illness prevention, diagnosis, and treatment has involved an increased appreciation for the clinical utility of longitudinal assessment. This has included the implementation of screening evaluations for high base rate medical conditions, such as cancer, that involve considerable morbidity and mortality.

Unfortunately, the mental health professions have been slow to embrace this approach. Baseline assessment with psychological/neuropsychological screening tests and more comprehensive test batteries to clarify diagnostic status and facilitate treatment planning is far more the exception than the rule in mental health care. This seems to be the case despite the strong evidence supporting this practice as well as multiple surveys indicating that psychiatrists and other physicians report a high level of satisfaction with the findings and recommendations of psychological/neuropsychological test reports.^1-3

There is a substantial literature that reviews the relative indications and contraindications for initial psychological/neuropsychological test evaluations.^4-7 However, there is a paucity of clinical and evidence-based information regarding criteria for follow-up assessment. Moreover, there are no consensus guidelines to inform decision-making regarding this issue.

In general, good clinical practice for baseline assessment and reexamination should include administration of both psychological and neuropsychological tests. Based on clinical experience, this article addresses the relative indications and contraindications for psychological/neuropsychological test reassessment of adults seen in psychiatric care. It also outlines suggested time frames for such reevaluations, based on the patient’s clinical status and circumstances.

Why are patients not referred for reassessment more often?

There are several reasons patients are not referred for follow-up testing, beginning with the failure, at times, of the psychologist to state in the recommendations section of the test report whether a reassessment is indicated, under what circumstances, and within what time frame. Empirical data is lacking, but predicated on clinical experience, even when a strong and unequivocal recommendation is made for reassessment, only a very small percentage of patients are seen for follow-up evaluation.

There are numerous reasons why this occurs. The patient and/or the psychiatrist may overlook or forget about the recommendation for reassessment, particularly if it was embedded in a lengthy list of recommendations and the suggested time frame for the reassessment was several years away. The patient and the psychiatrist may decide against going forward with a reexamination, for a variety of substantive reasons. The patient might decline, against medical advice, to be retested. The patient may fail to make or keep an appointment for the follow-up reexamination. The patient might leave treatment and become lost to follow-up. The patient might not be able to find an appropriate psychologist. The insurance company may decline to authorize follow-up testing.⁸

Indications for reevaluation

Follow-up testing generally is indicated in the following circumstances:

Patients who are likely to soon improve or worsen. Reassessment is indicated when, based on the initial evaluation, the patient has been identified as having a neuropsychiatric disorder that is likely to improve or worsen over the next year or 2 due to the natural trajectory of the condition and the degree to which it may respond to treatment.

Continue to: Patients who are likely...

Patients who are likely to improve include those with mental status changes referable to ≥1 medical and/or neuropsychiatric factors that are considered at least partially treatable and reversible. Patients who fall within this category include those who have mild to moderately severe head trauma or stroke, have a suspected or known medication- or substance-induced altered mental status, appear to have depression-related cognitive difficulties, or have an initial or recurrent episode of idiopathic psychosis.

Patients whose conditions can be expected to worsen over time include those with a mild neurocognitive disorder or major neuro­cognitive disorder of mild severity that is considered referable to a progressive neurodegenerative illness such as Alzheimer’s disease based on family and personal history, their psychometric test profile, and other factors, including findings from positron emission tomography scanning.

Older patients who were referred primarily due to a strong family history of major neurocognitive disorder but with no clear-cut concerning findings on baseline testing warrant reevaluation in the event of the emergence of significant cognitive and/or psychiatric symptoms and/or a functional decline since the baseline examination.

Patients who have been seen for initial test evaluations prior to interventions such as neuro­surgery (including psychosurgery), electroconvulsive therapy (ECT), transcranial magnetic stimulation, cognitive rehabilitation, etc.

Patients undergoing a substantial transition. Reevaluation is appropriate for a broad range of patients experiencing difficulties when undergoing a significant lifestyle transition or change in level of care. This includes patients considering a return to school or work after a prolonged absence due to neuropsychiatric illness, or for whom there are questions regarding the need for a change in their level of everyday care. The latter includes patients who are returning to home care from assisted living, or transferring from home-based services to assisted living or a skilled nursing facility.

Continue to: What about patients with psychiatric disorders?

What about patients with psychiatric disorders? A “grey area” pertains to reassessment of patients with neuropsychiatric disorders such as schizophrenia and related psychotic disorders, bipolar disorder, major depressive disorder, and obsessive-compulsive disorder. Patients with these conditions often have high rates of cognitive/neuropsychological impairment on baseline testing, even when they appear to be improving from a psychiatric perspective, are reasonably stable, and may even be in remission.^9-12

These deficits are frequently a mix of pre-illness, prodromal, and early-stage illness– related neurocognitive difficulties that, for the most part, remain stable over time. That said, there is emerging evidence of worsening cognitive change over time following a first episode of psychosis for some patients with schizophrenia.¹³

In general, reevaluation should be considered for patients with a family and/or personal history of cognitive/neuropsychological impairment, structural brain abnormalities on neuroimaging, a concerning cognitive/neuropsychological profile, or any other factors that raise the index of suspicion for a possible progressive deteriorative course of illness.^13,14

Patients with personality disorders who have had a baseline psychometric evaluation do not clearly warrant reassessment unless they develop medical and/or psychosocial difficulties that are often linked to problematic personality traits/patterns and that result in significant and persistent mental status changes. For example, reassessment might be indicated for a patient with borderline personality disorder who has new-onset or worsening cognitive and/or psychiatric complaints/symptoms after sustaining a head injury while intoxicated and embroiled in a domestic conflict triggered by anger and fears related to abandonment and separation.

Reevaluation also should be considered when a patient with a personality disorder has had a baseline assessment and subsequently completes an intensive, long-term treatment program that is likely to improve their clinical status. In this context, retesting may help document these gains. Examples of such programs/services include residential psychiatric and/or substance abuse care, object relational/psychodynamically-based psychotherapy, an extended course of dialectical behavioral therapy, or a related coping skills/distress tolerance psychotherapy.

Continue to: Contraindications for reassessment

Contraindications for reassessment

Retesting generally is not indicated in the following circumstances:

Patients with advanced major neurocognitive disorder. Reassessment is not indicated for such patients when there are no new questions regarding diagnosis, prognosis, level of care, and/or related disposition issues.

Patients with transient episodes of poor functioning. For the most part, reassessment is not helpful for patients with well-established diagnoses and treatment plans who, based on their history, experience time-limited, recurrent episodes of poor functioning and then reliably return to their baseline with ongoing psychiatric care. This includes patients with borderline personality disorder and other personality difficulties with histories of transient decompensation in response to psychosocial and psychodynamic triggers.

Patients who do not improve or worsen over time. Reassessment is not indicated when there has been no clear, sustained improvement or worsening of a patient’s clinical status over an extended time, and a protracted change is not anticipated. In this situation, reassessment is unlikely to yield clinically useful information beyond what is already known or meaningfully impact case formulation and treatment planning.

The Table^9-14 summarizes the relative indications and contraindications for psychological/neuropsychological reexamination.

Continue to: Time frames for reassessment

Time frames for retesting vary considerably depending on factors such as diagnostic status, longitudinal course, treatment parameters, and recent/current life circumstances.

While empirical data is lacking regarding this matter, based on clinical experience, reevaluation in 18 to 24 months is generally appropriate for patients with neuro­psychiatric conditions who are likely to gradually improve or slowly worsen over this time. Still, reexamination can be sooner (within 12 to 18 months) for patients who have experienced a more rapid and steep negative change in clinical status than initially anticipated.

For most patients with major mental illness, reexamination in 3 to 5 years is probably a reasonable time interval, barring a poorly understood and clinically significant negative change in functioning that warrants a shorter time frame. This suggested time frame would allow for sufficient time to better gauge improvement, stability, or deterioration in functioning and whether the reason(s) for referral have evolved. On the other hand, this time interval is somewhat arbitrary given the lack of empirical data. Therefore, on a case-by-case basis, it would be helpful for psychiatrists to consult with their patients and preferably with the psychologist who completed the baseline evaluation to determine a reasonable interval between assessments.

For patients who have undergone long-term/intensive treatment, reassessment in 3 or 6 months to as long as 1 year after the patient completes the program should be considered. Patients who undergo medical interventions such as neurosurgery or ECT—which can be associated with short-term, at least partially reversible negative effects on mental status—reassessment usually is most helpful when initiated as one or more screening level examinations for several weeks, followed by a comprehensive psychometric reassessment at the 3- to 6-month mark.

Suggestions for future research

Additional research is needed to ascertain the attitudes and opinions of psychiatrists and other physicians who use psychometric test data regarding how psychologists can most effectively communicate a recommendation for reassessment in their reports and clarify the ways psychiatrists can productively address this issue with their patients. Survey research of this kind should include questions about the frequency with which psychiatrists formally refer patients for retesting, and estimates of the rate of follow-through.

Continue to: It also would be desirable...

It also would be desirable to investigate factors that may facilitate follow-through with recommendations for reassessment, or, conversely, identify reasons that psychiatrists and their patients may decide to forgo reassessment. It would be important to try to obtain information regarding the optimum time frames for such reevaluation, depending on the patient’s circumstances and other variables. Evidence-based data pertaining to these issues would contribute to the development of consensus guidelines and a standard of care for psychological/neuropsychological test reevaluation.

Bottom Line

Only a very small percentage of patients referred for follow-up psychological/ neuropsychological test reevaluation actually undergo reexamination. Such retesting may be most helpful for certain patient populations, such as those who are likely to soon improve or worsen, were referred based on a family history of major cognitive disorder but have no concerning findings on baseline testing, or are undergoing a substantial life transition.

Related Resources

• Thom R, Farrell HM. Neuroimaging in psychiatry: potentials and pitfalls. Current Psychiatry. 2019;18(12):27-28;33-34.
• Papakostas GI. Cognitive symptoms in patients with major depressive disorder and their implications for clinical practice. J Clin Psychiatry. 2014;75(1):8-14.
• American Board of Professional Neuropsychology. https://abn-board.com

The evolution of illness prevention, diagnosis, and treatment has involved an increased appreciation for the clinical utility of longitudinal assessment. This has included the implementation of screening evaluations for high base rate medical conditions, such as cancer, that involve considerable morbidity and mortality.

Unfortunately, the mental health professions have been slow to embrace this approach. Baseline assessment with psychological/neuropsychological screening tests and more comprehensive test batteries to clarify diagnostic status and facilitate treatment planning is far more the exception than the rule in mental health care. This seems to be the case despite the strong evidence supporting this practice as well as multiple surveys indicating that psychiatrists and other physicians report a high level of satisfaction with the findings and recommendations of psychological/neuropsychological test reports.^1-3

There is a substantial literature that reviews the relative indications and contraindications for initial psychological/neuropsychological test evaluations.^4-7 However, there is a paucity of clinical and evidence-based information regarding criteria for follow-up assessment. Moreover, there are no consensus guidelines to inform decision-making regarding this issue.

In general, good clinical practice for baseline assessment and reexamination should include administration of both psychological and neuropsychological tests. Based on clinical experience, this article addresses the relative indications and contraindications for psychological/neuropsychological test reassessment of adults seen in psychiatric care. It also outlines suggested time frames for such reevaluations, based on the patient’s clinical status and circumstances.

Why are patients not referred for reassessment more often?

There are several reasons patients are not referred for follow-up testing, beginning with the failure, at times, of the psychologist to state in the recommendations section of the test report whether a reassessment is indicated, under what circumstances, and within what time frame. Empirical data is lacking, but predicated on clinical experience, even when a strong and unequivocal recommendation is made for reassessment, only a very small percentage of patients are seen for follow-up evaluation.

There are numerous reasons why this occurs. The patient and/or the psychiatrist may overlook or forget about the recommendation for reassessment, particularly if it was embedded in a lengthy list of recommendations and the suggested time frame for the reassessment was several years away. The patient and the psychiatrist may decide against going forward with a reexamination, for a variety of substantive reasons. The patient might decline, against medical advice, to be retested. The patient may fail to make or keep an appointment for the follow-up reexamination. The patient might leave treatment and become lost to follow-up. The patient might not be able to find an appropriate psychologist. The insurance company may decline to authorize follow-up testing.⁸

Indications for reevaluation

Follow-up testing generally is indicated in the following circumstances:

Patients who are likely to soon improve or worsen. Reassessment is indicated when, based on the initial evaluation, the patient has been identified as having a neuropsychiatric disorder that is likely to improve or worsen over the next year or 2 due to the natural trajectory of the condition and the degree to which it may respond to treatment.

Continue to: Patients who are likely...

Patients who are likely to improve include those with mental status changes referable to ≥1 medical and/or neuropsychiatric factors that are considered at least partially treatable and reversible. Patients who fall within this category include those who have mild to moderately severe head trauma or stroke, have a suspected or known medication- or substance-induced altered mental status, appear to have depression-related cognitive difficulties, or have an initial or recurrent episode of idiopathic psychosis.

Patients whose conditions can be expected to worsen over time include those with a mild neurocognitive disorder or major neuro­cognitive disorder of mild severity that is considered referable to a progressive neurodegenerative illness such as Alzheimer’s disease based on family and personal history, their psychometric test profile, and other factors, including findings from positron emission tomography scanning.

Older patients who were referred primarily due to a strong family history of major neurocognitive disorder but with no clear-cut concerning findings on baseline testing warrant reevaluation in the event of the emergence of significant cognitive and/or psychiatric symptoms and/or a functional decline since the baseline examination.

Patients who have been seen for initial test evaluations prior to interventions such as neuro­surgery (including psychosurgery), electroconvulsive therapy (ECT), transcranial magnetic stimulation, cognitive rehabilitation, etc.

Patients undergoing a substantial transition. Reevaluation is appropriate for a broad range of patients experiencing difficulties when undergoing a significant lifestyle transition or change in level of care. This includes patients considering a return to school or work after a prolonged absence due to neuropsychiatric illness, or for whom there are questions regarding the need for a change in their level of everyday care. The latter includes patients who are returning to home care from assisted living, or transferring from home-based services to assisted living or a skilled nursing facility.

Continue to: What about patients with psychiatric disorders?

What about patients with psychiatric disorders? A “grey area” pertains to reassessment of patients with neuropsychiatric disorders such as schizophrenia and related psychotic disorders, bipolar disorder, major depressive disorder, and obsessive-compulsive disorder. Patients with these conditions often have high rates of cognitive/neuropsychological impairment on baseline testing, even when they appear to be improving from a psychiatric perspective, are reasonably stable, and may even be in remission.^9-12

These deficits are frequently a mix of pre-illness, prodromal, and early-stage illness– related neurocognitive difficulties that, for the most part, remain stable over time. That said, there is emerging evidence of worsening cognitive change over time following a first episode of psychosis for some patients with schizophrenia.¹³

In general, reevaluation should be considered for patients with a family and/or personal history of cognitive/neuropsychological impairment, structural brain abnormalities on neuroimaging, a concerning cognitive/neuropsychological profile, or any other factors that raise the index of suspicion for a possible progressive deteriorative course of illness.^13,14

Patients with personality disorders who have had a baseline psychometric evaluation do not clearly warrant reassessment unless they develop medical and/or psychosocial difficulties that are often linked to problematic personality traits/patterns and that result in significant and persistent mental status changes. For example, reassessment might be indicated for a patient with borderline personality disorder who has new-onset or worsening cognitive and/or psychiatric complaints/symptoms after sustaining a head injury while intoxicated and embroiled in a domestic conflict triggered by anger and fears related to abandonment and separation.

Reevaluation also should be considered when a patient with a personality disorder has had a baseline assessment and subsequently completes an intensive, long-term treatment program that is likely to improve their clinical status. In this context, retesting may help document these gains. Examples of such programs/services include residential psychiatric and/or substance abuse care, object relational/psychodynamically-based psychotherapy, an extended course of dialectical behavioral therapy, or a related coping skills/distress tolerance psychotherapy.

Continue to: Contraindications for reassessment

Contraindications for reassessment

Retesting generally is not indicated in the following circumstances:

Patients with advanced major neurocognitive disorder. Reassessment is not indicated for such patients when there are no new questions regarding diagnosis, prognosis, level of care, and/or related disposition issues.

Patients with transient episodes of poor functioning. For the most part, reassessment is not helpful for patients with well-established diagnoses and treatment plans who, based on their history, experience time-limited, recurrent episodes of poor functioning and then reliably return to their baseline with ongoing psychiatric care. This includes patients with borderline personality disorder and other personality difficulties with histories of transient decompensation in response to psychosocial and psychodynamic triggers.

Patients who do not improve or worsen over time. Reassessment is not indicated when there has been no clear, sustained improvement or worsening of a patient’s clinical status over an extended time, and a protracted change is not anticipated. In this situation, reassessment is unlikely to yield clinically useful information beyond what is already known or meaningfully impact case formulation and treatment planning.

The Table^9-14 summarizes the relative indications and contraindications for psychological/neuropsychological reexamination.

Continue to: Time frames for reassessment

Time frames for retesting vary considerably depending on factors such as diagnostic status, longitudinal course, treatment parameters, and recent/current life circumstances.

While empirical data is lacking regarding this matter, based on clinical experience, reevaluation in 18 to 24 months is generally appropriate for patients with neuro­psychiatric conditions who are likely to gradually improve or slowly worsen over this time. Still, reexamination can be sooner (within 12 to 18 months) for patients who have experienced a more rapid and steep negative change in clinical status than initially anticipated.

For most patients with major mental illness, reexamination in 3 to 5 years is probably a reasonable time interval, barring a poorly understood and clinically significant negative change in functioning that warrants a shorter time frame. This suggested time frame would allow for sufficient time to better gauge improvement, stability, or deterioration in functioning and whether the reason(s) for referral have evolved. On the other hand, this time interval is somewhat arbitrary given the lack of empirical data. Therefore, on a case-by-case basis, it would be helpful for psychiatrists to consult with their patients and preferably with the psychologist who completed the baseline evaluation to determine a reasonable interval between assessments.

For patients who have undergone long-term/intensive treatment, reassessment in 3 or 6 months to as long as 1 year after the patient completes the program should be considered. Patients who undergo medical interventions such as neurosurgery or ECT—which can be associated with short-term, at least partially reversible negative effects on mental status—reassessment usually is most helpful when initiated as one or more screening level examinations for several weeks, followed by a comprehensive psychometric reassessment at the 3- to 6-month mark.

Suggestions for future research

Additional research is needed to ascertain the attitudes and opinions of psychiatrists and other physicians who use psychometric test data regarding how psychologists can most effectively communicate a recommendation for reassessment in their reports and clarify the ways psychiatrists can productively address this issue with their patients. Survey research of this kind should include questions about the frequency with which psychiatrists formally refer patients for retesting, and estimates of the rate of follow-through.

Continue to: It also would be desirable...

It also would be desirable to investigate factors that may facilitate follow-through with recommendations for reassessment, or, conversely, identify reasons that psychiatrists and their patients may decide to forgo reassessment. It would be important to try to obtain information regarding the optimum time frames for such reevaluation, depending on the patient’s circumstances and other variables. Evidence-based data pertaining to these issues would contribute to the development of consensus guidelines and a standard of care for psychological/neuropsychological test reevaluation.

Bottom Line

Only a very small percentage of patients referred for follow-up psychological/ neuropsychological test reevaluation actually undergo reexamination. Such retesting may be most helpful for certain patient populations, such as those who are likely to soon improve or worsen, were referred based on a family history of major cognitive disorder but have no concerning findings on baseline testing, or are undergoing a substantial life transition.

Related Resources

• Thom R, Farrell HM. Neuroimaging in psychiatry: potentials and pitfalls. Current Psychiatry. 2019;18(12):27-28;33-34.
• Papakostas GI. Cognitive symptoms in patients with major depressive disorder and their implications for clinical practice. J Clin Psychiatry. 2014;75(1):8-14.
• American Board of Professional Neuropsychology. https://abn-board.com

The evolution of illness prevention, diagnosis, and treatment has involved an increased appreciation for the clinical utility of longitudinal assessment. This has included the implementation of screening evaluations for high base rate medical conditions, such as cancer, that involve considerable morbidity and mortality.

Unfortunately, the mental health professions have been slow to embrace this approach. Baseline assessment with psychological/neuropsychological screening tests and more comprehensive test batteries to clarify diagnostic status and facilitate treatment planning is far more the exception than the rule in mental health care. This seems to be the case despite the strong evidence supporting this practice as well as multiple surveys indicating that psychiatrists and other physicians report a high level of satisfaction with the findings and recommendations of psychological/neuropsychological test reports.^1-3

There is a substantial literature that reviews the relative indications and contraindications for initial psychological/neuropsychological test evaluations.^4-7 However, there is a paucity of clinical and evidence-based information regarding criteria for follow-up assessment. Moreover, there are no consensus guidelines to inform decision-making regarding this issue.

In general, good clinical practice for baseline assessment and reexamination should include administration of both psychological and neuropsychological tests. Based on clinical experience, this article addresses the relative indications and contraindications for psychological/neuropsychological test reassessment of adults seen in psychiatric care. It also outlines suggested time frames for such reevaluations, based on the patient’s clinical status and circumstances.

Why are patients not referred for reassessment more often?

There are several reasons patients are not referred for follow-up testing, beginning with the failure, at times, of the psychologist to state in the recommendations section of the test report whether a reassessment is indicated, under what circumstances, and within what time frame. Empirical data is lacking, but predicated on clinical experience, even when a strong and unequivocal recommendation is made for reassessment, only a very small percentage of patients are seen for follow-up evaluation.

There are numerous reasons why this occurs. The patient and/or the psychiatrist may overlook or forget about the recommendation for reassessment, particularly if it was embedded in a lengthy list of recommendations and the suggested time frame for the reassessment was several years away. The patient and the psychiatrist may decide against going forward with a reexamination, for a variety of substantive reasons. The patient might decline, against medical advice, to be retested. The patient may fail to make or keep an appointment for the follow-up reexamination. The patient might leave treatment and become lost to follow-up. The patient might not be able to find an appropriate psychologist. The insurance company may decline to authorize follow-up testing.⁸

Indications for reevaluation

Follow-up testing generally is indicated in the following circumstances:

Patients who are likely to soon improve or worsen. Reassessment is indicated when, based on the initial evaluation, the patient has been identified as having a neuropsychiatric disorder that is likely to improve or worsen over the next year or 2 due to the natural trajectory of the condition and the degree to which it may respond to treatment.

Continue to: Patients who are likely...

Patients who are likely to improve include those with mental status changes referable to ≥1 medical and/or neuropsychiatric factors that are considered at least partially treatable and reversible. Patients who fall within this category include those who have mild to moderately severe head trauma or stroke, have a suspected or known medication- or substance-induced altered mental status, appear to have depression-related cognitive difficulties, or have an initial or recurrent episode of idiopathic psychosis.

Patients whose conditions can be expected to worsen over time include those with a mild neurocognitive disorder or major neuro­cognitive disorder of mild severity that is considered referable to a progressive neurodegenerative illness such as Alzheimer’s disease based on family and personal history, their psychometric test profile, and other factors, including findings from positron emission tomography scanning.

Older patients who were referred primarily due to a strong family history of major neurocognitive disorder but with no clear-cut concerning findings on baseline testing warrant reevaluation in the event of the emergence of significant cognitive and/or psychiatric symptoms and/or a functional decline since the baseline examination.

Patients who have been seen for initial test evaluations prior to interventions such as neuro­surgery (including psychosurgery), electroconvulsive therapy (ECT), transcranial magnetic stimulation, cognitive rehabilitation, etc.

Patients undergoing a substantial transition. Reevaluation is appropriate for a broad range of patients experiencing difficulties when undergoing a significant lifestyle transition or change in level of care. This includes patients considering a return to school or work after a prolonged absence due to neuropsychiatric illness, or for whom there are questions regarding the need for a change in their level of everyday care. The latter includes patients who are returning to home care from assisted living, or transferring from home-based services to assisted living or a skilled nursing facility.

Continue to: What about patients with psychiatric disorders?

What about patients with psychiatric disorders? A “grey area” pertains to reassessment of patients with neuropsychiatric disorders such as schizophrenia and related psychotic disorders, bipolar disorder, major depressive disorder, and obsessive-compulsive disorder. Patients with these conditions often have high rates of cognitive/neuropsychological impairment on baseline testing, even when they appear to be improving from a psychiatric perspective, are reasonably stable, and may even be in remission.^9-12

These deficits are frequently a mix of pre-illness, prodromal, and early-stage illness– related neurocognitive difficulties that, for the most part, remain stable over time. That said, there is emerging evidence of worsening cognitive change over time following a first episode of psychosis for some patients with schizophrenia.¹³

In general, reevaluation should be considered for patients with a family and/or personal history of cognitive/neuropsychological impairment, structural brain abnormalities on neuroimaging, a concerning cognitive/neuropsychological profile, or any other factors that raise the index of suspicion for a possible progressive deteriorative course of illness.^13,14

Patients with personality disorders who have had a baseline psychometric evaluation do not clearly warrant reassessment unless they develop medical and/or psychosocial difficulties that are often linked to problematic personality traits/patterns and that result in significant and persistent mental status changes. For example, reassessment might be indicated for a patient with borderline personality disorder who has new-onset or worsening cognitive and/or psychiatric complaints/symptoms after sustaining a head injury while intoxicated and embroiled in a domestic conflict triggered by anger and fears related to abandonment and separation.

Reevaluation also should be considered when a patient with a personality disorder has had a baseline assessment and subsequently completes an intensive, long-term treatment program that is likely to improve their clinical status. In this context, retesting may help document these gains. Examples of such programs/services include residential psychiatric and/or substance abuse care, object relational/psychodynamically-based psychotherapy, an extended course of dialectical behavioral therapy, or a related coping skills/distress tolerance psychotherapy.

Continue to: Contraindications for reassessment

Contraindications for reassessment

Retesting generally is not indicated in the following circumstances:

Patients with advanced major neurocognitive disorder. Reassessment is not indicated for such patients when there are no new questions regarding diagnosis, prognosis, level of care, and/or related disposition issues.

Patients with transient episodes of poor functioning. For the most part, reassessment is not helpful for patients with well-established diagnoses and treatment plans who, based on their history, experience time-limited, recurrent episodes of poor functioning and then reliably return to their baseline with ongoing psychiatric care. This includes patients with borderline personality disorder and other personality difficulties with histories of transient decompensation in response to psychosocial and psychodynamic triggers.

Patients who do not improve or worsen over time. Reassessment is not indicated when there has been no clear, sustained improvement or worsening of a patient’s clinical status over an extended time, and a protracted change is not anticipated. In this situation, reassessment is unlikely to yield clinically useful information beyond what is already known or meaningfully impact case formulation and treatment planning.

The Table^9-14 summarizes the relative indications and contraindications for psychological/neuropsychological reexamination.

Continue to: Time frames for reassessment

Time frames for retesting vary considerably depending on factors such as diagnostic status, longitudinal course, treatment parameters, and recent/current life circumstances.

While empirical data is lacking regarding this matter, based on clinical experience, reevaluation in 18 to 24 months is generally appropriate for patients with neuro­psychiatric conditions who are likely to gradually improve or slowly worsen over this time. Still, reexamination can be sooner (within 12 to 18 months) for patients who have experienced a more rapid and steep negative change in clinical status than initially anticipated.

For most patients with major mental illness, reexamination in 3 to 5 years is probably a reasonable time interval, barring a poorly understood and clinically significant negative change in functioning that warrants a shorter time frame. This suggested time frame would allow for sufficient time to better gauge improvement, stability, or deterioration in functioning and whether the reason(s) for referral have evolved. On the other hand, this time interval is somewhat arbitrary given the lack of empirical data. Therefore, on a case-by-case basis, it would be helpful for psychiatrists to consult with their patients and preferably with the psychologist who completed the baseline evaluation to determine a reasonable interval between assessments.

For patients who have undergone long-term/intensive treatment, reassessment in 3 or 6 months to as long as 1 year after the patient completes the program should be considered. Patients who undergo medical interventions such as neurosurgery or ECT—which can be associated with short-term, at least partially reversible negative effects on mental status—reassessment usually is most helpful when initiated as one or more screening level examinations for several weeks, followed by a comprehensive psychometric reassessment at the 3- to 6-month mark.

Suggestions for future research

Additional research is needed to ascertain the attitudes and opinions of psychiatrists and other physicians who use psychometric test data regarding how psychologists can most effectively communicate a recommendation for reassessment in their reports and clarify the ways psychiatrists can productively address this issue with their patients. Survey research of this kind should include questions about the frequency with which psychiatrists formally refer patients for retesting, and estimates of the rate of follow-through.

Continue to: It also would be desirable...

It also would be desirable to investigate factors that may facilitate follow-through with recommendations for reassessment, or, conversely, identify reasons that psychiatrists and their patients may decide to forgo reassessment. It would be important to try to obtain information regarding the optimum time frames for such reevaluation, depending on the patient’s circumstances and other variables. Evidence-based data pertaining to these issues would contribute to the development of consensus guidelines and a standard of care for psychological/neuropsychological test reevaluation.

Bottom Line

Only a very small percentage of patients referred for follow-up psychological/ neuropsychological test reevaluation actually undergo reexamination. Such retesting may be most helpful for certain patient populations, such as those who are likely to soon improve or worsen, were referred based on a family history of major cognitive disorder but have no concerning findings on baseline testing, or are undergoing a substantial life transition.

Related Resources

• Thom R, Farrell HM. Neuroimaging in psychiatry: potentials and pitfalls. Current Psychiatry. 2019;18(12):27-28;33-34.
• Papakostas GI. Cognitive symptoms in patients with major depressive disorder and their implications for clinical practice. J Clin Psychiatry. 2014;75(1):8-14.
• American Board of Professional Neuropsychology. https://abn-board.com

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

After more than 600,000 deaths in the United States from the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several safe and effective vaccines against the virus have become available. Vaccines are the most effective preventive measure against COVID-19 and the most promising way to achieve herd immunity to end the current pandemic. However, obstacles to reaching this goal include vaccine skepticism, structural barriers, or simple inertia to get vaccinated. These challenges provide opportunities for psychiatrists to use their medical knowledge and expertise, applying behavior management techniques such as motivational interviewing and nudging to encourage their patients to get vaccinated. In particular, marginalized patients with serious mental illness (SMI), who are subject to disproportionately high rates of COVID-19 infection and more severe outcomes,¹ have much to gain if psychiatrists become involved in the COVID-19 vaccination campaign.

In this article, we define vaccine hesitancy and highlight what makes psychiatrists ideal vaccine ambassadors, given their unique skill set and longitudinal, trust-based connection with their patients. We expand on the particular vulnerabilities of patients with SMI, including structural barriers to vaccination that lead to health disparities and inequity. Finally, building on “The ABCs of successful vaccinations” framework published in Current Psychiatry March 2021,² we outline how psychiatrists can address vaccine misconceptions, employ effective communication strategies to build vaccine confidence, and help patients overcome structural barriers and get the COVID-19 vaccination. While we are currently focused on ending the COVID-19 pandemic, our broader mission as psychiatrists should be to become ambassadors for other vaccinations as well, such as the annual influenza vaccine.

What is vaccine hesitancy?

The World Health Organization (WHO) defines vaccine hesitancy as a “delay in acceptance or refusal of vaccines despite availability of vaccine services.”^3,4 Vaccine hesitancy occurs on a continuum ranging from uncertainty about accepting a vaccine to absolute refusal.^4,5 It involves a complex decision-making process driven by contextual, individual, and social influences, and vaccine-specific issues.⁴ In the “3C” model developed by the WHO Strategic Advisory Group of Experts (SAGE) Working Group, vaccine hesitancy is influenced by confidence (trust in vaccines, in the health care system, and in policy makers), complacency (lower perceived risk), and convenience (availability, affordability, accessibility, language and health literacy, appeal of vaccination program).⁴

In 2019, the WHO named vaccine hesitancy as one of the top 10 global health threats.³ Hesitancy to receive COVID-19 vaccines may be particularly high because of their rapid development. In addition, the tumultuous political environment that often featured inconsistent messaging about the virus, its dangers, and its transmission since the early days of the pandemic created widespread public confusion and doubt as scientific understandings evolved. “Anti-vaxxer” movements that completely rejected vaccine efficacy disseminated misinformation online. Followers of these movements may have such extreme overvalued ideas that any effort to persuade them otherwise with scientific evidence will accomplish very little.^6,7 Therefore, focusing on individuals who are “sitting on the fence” about getting vaccinated can be more productive because they represent a much larger group than those who adamantly refuse vaccines, and they may be more amenable to changing beliefs and behaviors.⁸

The US Census Bureau’s Household Pulse Survey asked, “How likely are you to accept the vaccine?”⁹ As of late June 2021, 11.4% of US adults reported they would “definitely not get a vaccine” or “probably not get a vaccine,” and that number increases to 16.9% when including those who are “unsure,” although there is wide geographical variability.¹⁰

A recent study in Denmark showed that willingness to receive the COVID-19 vaccine was slightly lower among patients with mental illness (84.8%) compared with the general population (89.5%).¹¹ Given the small difference, vaccine hesitancy was not considered to be a major barrier for vaccination among patients with mental illness in Denmark. This is similar to the findings of a pre-pandemic study at a community mental health clinic in the United States involving other vaccinations, which suggested that 84% of patients with SMI perceived vaccinations as safe, effective, and important.¹² In this clinic, identified barriers to vaccinations in general among patients with SMI included lack of awareness and knowledge (42.2%), accessibility (16.3%), personal cost (13.3%), fears about immunization (10.4%), and lack of recommendations by primary care providers (PCPs) (1.5%).¹²

It is critical to distinguish attitude-driven vaccine hesitancy from a lack of education and opportunity to receive a vaccine. Particularly disadvantaged communities may be mislabeled as “vaccine hesitant” when in fact they may not have the ability to be as proactive as other population groups (eg, difficulty scheduling appointments over the Internet).

Continue to: What makes psychiatrists ideal vaccine ambassadors?

What makes psychiatrists ideal vaccine ambassadors?

There are several reasons psychiatrists can be well-positioned to contribute to the success of vaccination campaigns (Table 1). These include their frequent contact with patients and their care teams, the high trust those patients have in them, and their medical expertise and skills in applied behavioral and social science techniques, including motivational interviewing and nudging. Vaccination efforts and outreach are more effective when led by the clinician with whom the patient has the most contact because resolving vaccine hesitancy is not a one-time discussion but requires ongoing communication, persistence, and consistency.¹³ Patients may contact their psychiatrists more frequently than their other clinicians, including PCPs. For this reason, psychiatrists can serve as the gateway to health care, particularly for patients with SMI.¹⁴ In addition, interruptions in nonemergency services caused by the COVID-19 pandemic may affect vaccine delivery because patients may have been unable to see their PCPs regularly during the pandemic.¹⁵

Psychiatrists’ medical expertise and their ability to develop rapport with their patients promote trust-building. Receiving credible information from a trusted source such as a patient’s psychiatrist can be impactful. A recent poll suggested that individual health care clinicians have been consistently identified as the most trusted sources for vaccine information, including for the COVID-19 vaccines.¹⁶ There is also higher trust when there is greater continuity of care both in terms of length of time the patient has known the clinician and the number of consultations,¹⁷ an inherent part of psychiatric practice. In addition, research has shown that patients trust their psychiatrists as much as they trust their general practitioners.¹⁸

Psychiatrists are experts in behavior change, promoting healthy behaviors through motivational interviewing and nudging. They also have experience with managing patients who hold overvalued ideas as well as dealing with uncertainty, given their scientific and medical training.

Motivational interviewing is a patient-centered, collaborative approach widely used by psychiatrists to treat unhealthy behaviors such as substance use. Clinicians elicit and strengthen the patient’s desire and motivation for change while respecting their autonomy. Instead of presenting persuasive facts, the clinician creates a welcoming, nonthreatening, safe environment by engaging patients in open dialogue, reflecting back the patients’ concerns with empathy, helping them realize contradictions in behavior, and supporting self-sufficiency.¹⁹ In a nonpsychiatric setting, studies have shown the effectiveness of motivational interviewing in increasing uptake of human papillomavirus vaccines and of pediatric vaccines.²⁰

Nudging, which comes from behavioral economics and psychology, underscores the importance of structuring a choice architecture in changing the way people make their everyday decisions.²¹ Nudging still gives people a choice and respects autonomy, but it leads patients to more efficient and productive decision-making. Many nudges are based around giving good “default options” because people often do not make efforts to deviate from default options. In addition, social nudges are powerful, giving people a social reference point and normalizing certain behaviors.²¹ Psychiatrists have become skilled in nudging from working with patients with varying levels of insight and cognitive capabilities. That is, they give simple choices, prompts, and frequent feedback to reinforce “good” decisions and to discourage “bad” decisions.

Continue to: Managing overvalued ideas

Managing overvalued ideas. Psychiatrists are also well-versed in having discussions with patients who hold irrational beliefs (psychosis) or overvalued ideas. For example, psychiatrists frequently manage anorexia nervosa and hypochondria, which are rooted in overvalued ideas.⁷ While psychiatrists may not be able to directly confront the overvalued ideas, they can work around such ideas while waiting for more flexible moments. Similarly, managing patients with intense emotional commitment⁷ to commonly held anti-vaccination ideas may not be much different. Psychiatrists can work around resistance until patients may be less strongly attached to those overvalued ideas in instances when other techniques, such as motivational interviewing and nudging, may be more effective.

Managing uncertainty. Psychiatrists are experts in managing “not knowing” and uncertainty. Due to their medical scientific training, they are familiar with the process of science, and how understanding changes through trial and error. In contrast, most patients usually only see the end product (ie, a drug comes to market). Discussions with patients that acknowledge uncertainty and emphasize that changes in what is known are expected and appropriate as scientific knowledge evolves could help preempt skepticism when messages are updated.
 

Why do patients with SMI need more help?

SMI as a high-risk group. Patients with SMI are part of a “tragic” epidemiologic triad of agent-host-environment¹⁵ that places them at remarkably elevated risk for COVID-19 infection and more serious complications and death when infected.¹ After age, a diagnosis of a schizophrenia spectrum disorder is the second largest predictor of mortality from COVID-19, with a 2.7-fold increase in mortality.²² This is how the elements of the triad come together: SARS-Cov-2 is a highly infectious agent affecting individuals who are vulnerable hosts because of their high frequency of medical comorbidities, including cardio­vascular disease, type 2 diabetes, and respiratory tract diseases, which are all risk factors for worse outcomes due to COVID-19.²³ In addition, SMI is associated with socioeconomic risk factors for SARS-Cov-2 infection, including poverty, homelessness, and crowded settings such as jails, group homes, hospitals, and shelters, which constitute ideal environments for high transmission of the virus.

Structural barriers to vaccination. Studies have suggested lower rates of vaccination among people with SMI for various other infectious diseases compared with the general population.¹² For example, in 1 outpatient mental health setting, influenza vaccination rates were 24% to 28%, which was lower than the national vaccination rate of 40.9% for the same influenza season (2010 to 2011).²⁴ More recently, a study in Israel examining the COVID-19 vaccination rate among >25,000 patients with schizophrenia suggested under-vaccination of this cohort. The results showed that the odds of getting the COVID-19 vaccination were significantly lower in the schizophrenia group compared with the general population (odds ratio = 0.80, 95% CI: 0.77 to 0.83).²⁵

Patients with SMI encounter considerable system-level barriers to vaccinations in general, such as reduced access to health care due to cost and a lack of transportation,¹² the digital divide given their reduced access to the internet and computers for information and scheduling,²⁶ and lack of vaccination recommendations from their PCPs.¹² Studies have also shown that patients with SMI often receive suboptimal medical care because of stigmatization and discrimination.²⁷ They also have lower rates of preventive care utilization, seeking medical services only in times of crisis and seeking mental health services more often than physical health care.^28-30

Continue to: Patients with SMI face...

Patients with SMI face additional individual challenges that impede vaccine uptake, such as lack of knowledge and awareness about the virus and vaccinations, general cognitive impairment, low digital literacy skills,³¹ low language literacy and educational attainment, baseline delusions, and negative symptoms such as apathy, avolition, and anhedonia.¹ Thus, even if they overcome the external barriers and obtain vaccine-related information, these patients may experience difficulty in understanding the content and applying this information to their personal circumstances as a result of low health literacy.

How psychiatrists can help

The concept of using mental health care sites and trained clinicians to increase medical disease prevention is not new. The rigorously tested intervention model STIRR (Screen, Test, Immunize, Reduce risk, and Refer) uses co-located nurse practitioners in community mental health centers to provide risk assessment, counseling, and blood testing for hepatitis and HIV, as well as on-site vaccinations for hepatitis to patients dually diagnosed with SMI and substance use disorders.³² Similarly, when a vaccination program was integrated into an outpatient mental health clinic offering various on-site vaccinations, vaccination rates increased by up to 25% over baseline.¹² Such public health approaches of integrating medical care at the site of mental health care, where patients with SMI are most reliably engaged, can be highly cost-effective³³ in terms of reducing disease burden among patients with SMI.

While the psychiatrist may not have the time and resources to directly follow through on all aspects of vaccinations, they can assume leadership and work with the larger team—including therapists and counselors, nurse practitioners, social workers, case managers, care coordinators, or PCPs with whom they regularly collaborate in caring for patients with SMI—to communicate what they have learned about patient hesitancies, share suggestions for future conversations to address these hesitancies, and relay what structural barriers the patient may need assistance to address.

Prioritization of patients with SMI for vaccine eligibility does not directly lead to vaccine uptake. Patients with SMI need extra support from their primary point of health care contact, namely their psychiatrists. Psychiatrists may bring a set of specialized skills uniquely suited to this moment to address vaccine hesitancy and overall lack of vaccine resources and awareness. Freudenreich et al² recently proposed “The ABCs of Successful Vaccinations” framework that psychiatrists can use in their interactions with patients to encourage vaccination by focusing on:

• attitudes towards vaccination
• barriers to vaccination
• completed vaccination series.

Understand attitudes toward vaccination. Decision-making may be an emotional and psychological experience that is informed by thoughts and feelings,³⁴ and psychiatrists are uniquely positioned to tailor messages to individual patients by using motivational interviewing and applying nudging techniques.⁸ Given the large role of the pandemic in everyday life, it would be natural to address vaccine-related concerns in the course of routine rapport-building. Table 2^19,34-38 shows example phrases of COVID-19 vaccine messages that are based on communication strategies that have demonstrated success in health behavior domains (including vaccinations).³⁹

Continue to: First, a strong recommendation...

First, a strong recommendation should be made using the presumptive approach.⁴⁰ If vaccine hesitancy is detected, psychiatrists should next attempt to understand patients’ reasoning with open-ended questions to probe vaccine-related concerns. Motivational interviewing can then be used to target the fence sitters (rather than anti-vaxxers).⁶ Psychiatrists can also communicate with therapists about the need for further follow up on patients’ hesitancies.

When assuring patients of vaccine safety and efficacy, it is helpful to explain the vaccine development process, including FDA approval, extensive clinical trials, monitoring, and the distribution process. Providing clear, transparent, accurate information about the risks and benefits of the vaccines is important, as well as monitoring misinformation and developing convincing counter messages that elicit positive emotions toward the vaccines.⁴¹ Examples of messages to counter common vaccine-related concerns and misinformation are shown in Table 3.^42-44

Know the barriers to vaccination. The role of the psychiatrist is to help patients, particularly those with SMIs, overcome logistical barriers and address hesitancy, which are both essential for vaccine uptake. Psychiatrists can help identify actual barriers (eg, transportation, digital access for information and scheduling) and perceived barriers, improve information access, and help patients obtain self-efficacy to take the actions needed to get vaccinated, particularly by collaborating with and communicating these concerns to other social services (Table 4).⁴¹

Monitor for vaccination series completion. Especially for vaccines that require more than a single dose over time, patients need more reminders, nudges, practical support, and encouragement to complete vaccination. A surprising degree of confusion regarding the timing of protection and benefit from the second COVID-19 injection (for the 2-injection vaccines) was uncovered in a recent survey of >1,000 US adults who had received their vaccinations in February 2021.⁴⁵ Attentive monitoring of vaccination series completion by psychiatrists can thus increase the likelihood that a patient will follow through (Table 4).⁴¹ This can be as simple as asking about completion of the series during appointments, but further aided by communicating to the larger care team (social workers, care managers, care coordinators) when identifying that the patient may need further assistance.

The Figure^2,6,7,19,40 summarizes the steps that psychiatrists can take to help patients get vaccinated by assessing attitudes towards vaccination (vaccine hesitancy), helping to remove barriers to vaccination, and ensuring via patient follow-up that a vaccine series is completed.

Continue to: Active involvement is key

Active involvement is key

The active involvement of psychiatrists in COVID-19 vaccination efforts can protect patients from the virus, reduce health disparities among patients with SMI, and promote herd immunity, helping to end the pandemic. Psychiatry practices can serve as ideal platforms to deliver evidence-based COVID-19 vaccine information and encourage vaccine uptake, particularly for marginalized populations.

Vaccination programs in mental health practices can even be conceptualized as a moral mandate in the spirit of addressing distributive injustice. The population management challenges of individual-level barriers and follow-through could be dramatically reduced—if not nearly eliminated—through policy-level changes that allow vaccinations to be administered in places where patients with SMI are already engaged: that is, “shots in arms” in mental health settings. As noted, some studies have shown that mental health settings can play a key role in other preventive care campaigns, such as the annual influenza and hepatitis vaccinations, and thus the incorporation of preventive care need not be limited to just COVID-19 vaccination efforts.

The COVID-19 pandemic is an opportunity to rethink the role of psychiatrists and psychiatric offices and clinics in preventive health care. The health risks and disparities of patients with SMI require the proactive involvement of psychiatrists at both the level of their individual patients and at the federal and state levels to advocate for policy changes that can benefit these populations. Overall, psychiatrists occupy a special role within the medical establishment that enables them to uniquely advocate for patients with SMI and ensure they are not forgotten during the COVID-19 pandemic.

Bottom Line

Psychiatrists could apply behavior management techniques such as motivational interviewing and nudging to address vaccine hesitancy in their patients and move them to accepting the COVID-19 vaccination. This could be particularly valuable for patients with serious mental illness, who face increased risks from COVID-19 and additional barriers to getting vaccinated.

Related Resources

• American Psychiatric Association. APA coronavirus resources. https://www.psychiatry.org/psychiatrists/covid-19-Coronavirus
• Baddeley M. Behavioural economics: a very short introduction. Oxford University Press; 2017.
• Centers for Disease Control and Prevention. Vaccines for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html
• Chou W, Burgdorf C, Gaysynsky A, et al. COVID-19 vaccination communication: applying behavioral and social science to address vaccine hesitancy and foster vaccine confidence. National Institutes of Health. Published 2020. https://obssr.od.nih.gov/sites/obssr/files/inline-files/OBSSR_VaccineWhitePaper_FINAL_508.pdf
• Miller WR, Rollnick S. Motivational interviewing: helping people change. Guilford Press; 2012.

After more than 600,000 deaths in the United States from the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several safe and effective vaccines against the virus have become available. Vaccines are the most effective preventive measure against COVID-19 and the most promising way to achieve herd immunity to end the current pandemic. However, obstacles to reaching this goal include vaccine skepticism, structural barriers, or simple inertia to get vaccinated. These challenges provide opportunities for psychiatrists to use their medical knowledge and expertise, applying behavior management techniques such as motivational interviewing and nudging to encourage their patients to get vaccinated. In particular, marginalized patients with serious mental illness (SMI), who are subject to disproportionately high rates of COVID-19 infection and more severe outcomes,¹ have much to gain if psychiatrists become involved in the COVID-19 vaccination campaign.

In this article, we define vaccine hesitancy and highlight what makes psychiatrists ideal vaccine ambassadors, given their unique skill set and longitudinal, trust-based connection with their patients. We expand on the particular vulnerabilities of patients with SMI, including structural barriers to vaccination that lead to health disparities and inequity. Finally, building on “The ABCs of successful vaccinations” framework published in Current Psychiatry March 2021,² we outline how psychiatrists can address vaccine misconceptions, employ effective communication strategies to build vaccine confidence, and help patients overcome structural barriers and get the COVID-19 vaccination. While we are currently focused on ending the COVID-19 pandemic, our broader mission as psychiatrists should be to become ambassadors for other vaccinations as well, such as the annual influenza vaccine.

What is vaccine hesitancy?

The World Health Organization (WHO) defines vaccine hesitancy as a “delay in acceptance or refusal of vaccines despite availability of vaccine services.”^3,4 Vaccine hesitancy occurs on a continuum ranging from uncertainty about accepting a vaccine to absolute refusal.^4,5 It involves a complex decision-making process driven by contextual, individual, and social influences, and vaccine-specific issues.⁴ In the “3C” model developed by the WHO Strategic Advisory Group of Experts (SAGE) Working Group, vaccine hesitancy is influenced by confidence (trust in vaccines, in the health care system, and in policy makers), complacency (lower perceived risk), and convenience (availability, affordability, accessibility, language and health literacy, appeal of vaccination program).⁴

In 2019, the WHO named vaccine hesitancy as one of the top 10 global health threats.³ Hesitancy to receive COVID-19 vaccines may be particularly high because of their rapid development. In addition, the tumultuous political environment that often featured inconsistent messaging about the virus, its dangers, and its transmission since the early days of the pandemic created widespread public confusion and doubt as scientific understandings evolved. “Anti-vaxxer” movements that completely rejected vaccine efficacy disseminated misinformation online. Followers of these movements may have such extreme overvalued ideas that any effort to persuade them otherwise with scientific evidence will accomplish very little.^6,7 Therefore, focusing on individuals who are “sitting on the fence” about getting vaccinated can be more productive because they represent a much larger group than those who adamantly refuse vaccines, and they may be more amenable to changing beliefs and behaviors.⁸

The US Census Bureau’s Household Pulse Survey asked, “How likely are you to accept the vaccine?”⁹ As of late June 2021, 11.4% of US adults reported they would “definitely not get a vaccine” or “probably not get a vaccine,” and that number increases to 16.9% when including those who are “unsure,” although there is wide geographical variability.¹⁰

A recent study in Denmark showed that willingness to receive the COVID-19 vaccine was slightly lower among patients with mental illness (84.8%) compared with the general population (89.5%).¹¹ Given the small difference, vaccine hesitancy was not considered to be a major barrier for vaccination among patients with mental illness in Denmark. This is similar to the findings of a pre-pandemic study at a community mental health clinic in the United States involving other vaccinations, which suggested that 84% of patients with SMI perceived vaccinations as safe, effective, and important.¹² In this clinic, identified barriers to vaccinations in general among patients with SMI included lack of awareness and knowledge (42.2%), accessibility (16.3%), personal cost (13.3%), fears about immunization (10.4%), and lack of recommendations by primary care providers (PCPs) (1.5%).¹²

It is critical to distinguish attitude-driven vaccine hesitancy from a lack of education and opportunity to receive a vaccine. Particularly disadvantaged communities may be mislabeled as “vaccine hesitant” when in fact they may not have the ability to be as proactive as other population groups (eg, difficulty scheduling appointments over the Internet).

Continue to: What makes psychiatrists ideal vaccine ambassadors?

What makes psychiatrists ideal vaccine ambassadors?

There are several reasons psychiatrists can be well-positioned to contribute to the success of vaccination campaigns (Table 1). These include their frequent contact with patients and their care teams, the high trust those patients have in them, and their medical expertise and skills in applied behavioral and social science techniques, including motivational interviewing and nudging. Vaccination efforts and outreach are more effective when led by the clinician with whom the patient has the most contact because resolving vaccine hesitancy is not a one-time discussion but requires ongoing communication, persistence, and consistency.¹³ Patients may contact their psychiatrists more frequently than their other clinicians, including PCPs. For this reason, psychiatrists can serve as the gateway to health care, particularly for patients with SMI.¹⁴ In addition, interruptions in nonemergency services caused by the COVID-19 pandemic may affect vaccine delivery because patients may have been unable to see their PCPs regularly during the pandemic.¹⁵

Psychiatrists’ medical expertise and their ability to develop rapport with their patients promote trust-building. Receiving credible information from a trusted source such as a patient’s psychiatrist can be impactful. A recent poll suggested that individual health care clinicians have been consistently identified as the most trusted sources for vaccine information, including for the COVID-19 vaccines.¹⁶ There is also higher trust when there is greater continuity of care both in terms of length of time the patient has known the clinician and the number of consultations,¹⁷ an inherent part of psychiatric practice. In addition, research has shown that patients trust their psychiatrists as much as they trust their general practitioners.¹⁸

Psychiatrists are experts in behavior change, promoting healthy behaviors through motivational interviewing and nudging. They also have experience with managing patients who hold overvalued ideas as well as dealing with uncertainty, given their scientific and medical training.

Motivational interviewing is a patient-centered, collaborative approach widely used by psychiatrists to treat unhealthy behaviors such as substance use. Clinicians elicit and strengthen the patient’s desire and motivation for change while respecting their autonomy. Instead of presenting persuasive facts, the clinician creates a welcoming, nonthreatening, safe environment by engaging patients in open dialogue, reflecting back the patients’ concerns with empathy, helping them realize contradictions in behavior, and supporting self-sufficiency.¹⁹ In a nonpsychiatric setting, studies have shown the effectiveness of motivational interviewing in increasing uptake of human papillomavirus vaccines and of pediatric vaccines.²⁰

Nudging, which comes from behavioral economics and psychology, underscores the importance of structuring a choice architecture in changing the way people make their everyday decisions.²¹ Nudging still gives people a choice and respects autonomy, but it leads patients to more efficient and productive decision-making. Many nudges are based around giving good “default options” because people often do not make efforts to deviate from default options. In addition, social nudges are powerful, giving people a social reference point and normalizing certain behaviors.²¹ Psychiatrists have become skilled in nudging from working with patients with varying levels of insight and cognitive capabilities. That is, they give simple choices, prompts, and frequent feedback to reinforce “good” decisions and to discourage “bad” decisions.

Continue to: Managing overvalued ideas

Managing overvalued ideas. Psychiatrists are also well-versed in having discussions with patients who hold irrational beliefs (psychosis) or overvalued ideas. For example, psychiatrists frequently manage anorexia nervosa and hypochondria, which are rooted in overvalued ideas.⁷ While psychiatrists may not be able to directly confront the overvalued ideas, they can work around such ideas while waiting for more flexible moments. Similarly, managing patients with intense emotional commitment⁷ to commonly held anti-vaccination ideas may not be much different. Psychiatrists can work around resistance until patients may be less strongly attached to those overvalued ideas in instances when other techniques, such as motivational interviewing and nudging, may be more effective.

Managing uncertainty. Psychiatrists are experts in managing “not knowing” and uncertainty. Due to their medical scientific training, they are familiar with the process of science, and how understanding changes through trial and error. In contrast, most patients usually only see the end product (ie, a drug comes to market). Discussions with patients that acknowledge uncertainty and emphasize that changes in what is known are expected and appropriate as scientific knowledge evolves could help preempt skepticism when messages are updated.
 

Why do patients with SMI need more help?

SMI as a high-risk group. Patients with SMI are part of a “tragic” epidemiologic triad of agent-host-environment¹⁵ that places them at remarkably elevated risk for COVID-19 infection and more serious complications and death when infected.¹ After age, a diagnosis of a schizophrenia spectrum disorder is the second largest predictor of mortality from COVID-19, with a 2.7-fold increase in mortality.²² This is how the elements of the triad come together: SARS-Cov-2 is a highly infectious agent affecting individuals who are vulnerable hosts because of their high frequency of medical comorbidities, including cardio­vascular disease, type 2 diabetes, and respiratory tract diseases, which are all risk factors for worse outcomes due to COVID-19.²³ In addition, SMI is associated with socioeconomic risk factors for SARS-Cov-2 infection, including poverty, homelessness, and crowded settings such as jails, group homes, hospitals, and shelters, which constitute ideal environments for high transmission of the virus.

Structural barriers to vaccination. Studies have suggested lower rates of vaccination among people with SMI for various other infectious diseases compared with the general population.¹² For example, in 1 outpatient mental health setting, influenza vaccination rates were 24% to 28%, which was lower than the national vaccination rate of 40.9% for the same influenza season (2010 to 2011).²⁴ More recently, a study in Israel examining the COVID-19 vaccination rate among >25,000 patients with schizophrenia suggested under-vaccination of this cohort. The results showed that the odds of getting the COVID-19 vaccination were significantly lower in the schizophrenia group compared with the general population (odds ratio = 0.80, 95% CI: 0.77 to 0.83).²⁵

Patients with SMI encounter considerable system-level barriers to vaccinations in general, such as reduced access to health care due to cost and a lack of transportation,¹² the digital divide given their reduced access to the internet and computers for information and scheduling,²⁶ and lack of vaccination recommendations from their PCPs.¹² Studies have also shown that patients with SMI often receive suboptimal medical care because of stigmatization and discrimination.²⁷ They also have lower rates of preventive care utilization, seeking medical services only in times of crisis and seeking mental health services more often than physical health care.^28-30

Continue to: Patients with SMI face...

Patients with SMI face additional individual challenges that impede vaccine uptake, such as lack of knowledge and awareness about the virus and vaccinations, general cognitive impairment, low digital literacy skills,³¹ low language literacy and educational attainment, baseline delusions, and negative symptoms such as apathy, avolition, and anhedonia.¹ Thus, even if they overcome the external barriers and obtain vaccine-related information, these patients may experience difficulty in understanding the content and applying this information to their personal circumstances as a result of low health literacy.

How psychiatrists can help

The concept of using mental health care sites and trained clinicians to increase medical disease prevention is not new. The rigorously tested intervention model STIRR (Screen, Test, Immunize, Reduce risk, and Refer) uses co-located nurse practitioners in community mental health centers to provide risk assessment, counseling, and blood testing for hepatitis and HIV, as well as on-site vaccinations for hepatitis to patients dually diagnosed with SMI and substance use disorders.³² Similarly, when a vaccination program was integrated into an outpatient mental health clinic offering various on-site vaccinations, vaccination rates increased by up to 25% over baseline.¹² Such public health approaches of integrating medical care at the site of mental health care, where patients with SMI are most reliably engaged, can be highly cost-effective³³ in terms of reducing disease burden among patients with SMI.

While the psychiatrist may not have the time and resources to directly follow through on all aspects of vaccinations, they can assume leadership and work with the larger team—including therapists and counselors, nurse practitioners, social workers, case managers, care coordinators, or PCPs with whom they regularly collaborate in caring for patients with SMI—to communicate what they have learned about patient hesitancies, share suggestions for future conversations to address these hesitancies, and relay what structural barriers the patient may need assistance to address.

Prioritization of patients with SMI for vaccine eligibility does not directly lead to vaccine uptake. Patients with SMI need extra support from their primary point of health care contact, namely their psychiatrists. Psychiatrists may bring a set of specialized skills uniquely suited to this moment to address vaccine hesitancy and overall lack of vaccine resources and awareness. Freudenreich et al² recently proposed “The ABCs of Successful Vaccinations” framework that psychiatrists can use in their interactions with patients to encourage vaccination by focusing on:

• attitudes towards vaccination
• barriers to vaccination
• completed vaccination series.

Understand attitudes toward vaccination. Decision-making may be an emotional and psychological experience that is informed by thoughts and feelings,³⁴ and psychiatrists are uniquely positioned to tailor messages to individual patients by using motivational interviewing and applying nudging techniques.⁸ Given the large role of the pandemic in everyday life, it would be natural to address vaccine-related concerns in the course of routine rapport-building. Table 2^19,34-38 shows example phrases of COVID-19 vaccine messages that are based on communication strategies that have demonstrated success in health behavior domains (including vaccinations).³⁹

Continue to: First, a strong recommendation...

First, a strong recommendation should be made using the presumptive approach.⁴⁰ If vaccine hesitancy is detected, psychiatrists should next attempt to understand patients’ reasoning with open-ended questions to probe vaccine-related concerns. Motivational interviewing can then be used to target the fence sitters (rather than anti-vaxxers).⁶ Psychiatrists can also communicate with therapists about the need for further follow up on patients’ hesitancies.

When assuring patients of vaccine safety and efficacy, it is helpful to explain the vaccine development process, including FDA approval, extensive clinical trials, monitoring, and the distribution process. Providing clear, transparent, accurate information about the risks and benefits of the vaccines is important, as well as monitoring misinformation and developing convincing counter messages that elicit positive emotions toward the vaccines.⁴¹ Examples of messages to counter common vaccine-related concerns and misinformation are shown in Table 3.^42-44

Know the barriers to vaccination. The role of the psychiatrist is to help patients, particularly those with SMIs, overcome logistical barriers and address hesitancy, which are both essential for vaccine uptake. Psychiatrists can help identify actual barriers (eg, transportation, digital access for information and scheduling) and perceived barriers, improve information access, and help patients obtain self-efficacy to take the actions needed to get vaccinated, particularly by collaborating with and communicating these concerns to other social services (Table 4).⁴¹

Monitor for vaccination series completion. Especially for vaccines that require more than a single dose over time, patients need more reminders, nudges, practical support, and encouragement to complete vaccination. A surprising degree of confusion regarding the timing of protection and benefit from the second COVID-19 injection (for the 2-injection vaccines) was uncovered in a recent survey of >1,000 US adults who had received their vaccinations in February 2021.⁴⁵ Attentive monitoring of vaccination series completion by psychiatrists can thus increase the likelihood that a patient will follow through (Table 4).⁴¹ This can be as simple as asking about completion of the series during appointments, but further aided by communicating to the larger care team (social workers, care managers, care coordinators) when identifying that the patient may need further assistance.

The Figure^2,6,7,19,40 summarizes the steps that psychiatrists can take to help patients get vaccinated by assessing attitudes towards vaccination (vaccine hesitancy), helping to remove barriers to vaccination, and ensuring via patient follow-up that a vaccine series is completed.

Continue to: Active involvement is key

Active involvement is key

The active involvement of psychiatrists in COVID-19 vaccination efforts can protect patients from the virus, reduce health disparities among patients with SMI, and promote herd immunity, helping to end the pandemic. Psychiatry practices can serve as ideal platforms to deliver evidence-based COVID-19 vaccine information and encourage vaccine uptake, particularly for marginalized populations.

Vaccination programs in mental health practices can even be conceptualized as a moral mandate in the spirit of addressing distributive injustice. The population management challenges of individual-level barriers and follow-through could be dramatically reduced—if not nearly eliminated—through policy-level changes that allow vaccinations to be administered in places where patients with SMI are already engaged: that is, “shots in arms” in mental health settings. As noted, some studies have shown that mental health settings can play a key role in other preventive care campaigns, such as the annual influenza and hepatitis vaccinations, and thus the incorporation of preventive care need not be limited to just COVID-19 vaccination efforts.

The COVID-19 pandemic is an opportunity to rethink the role of psychiatrists and psychiatric offices and clinics in preventive health care. The health risks and disparities of patients with SMI require the proactive involvement of psychiatrists at both the level of their individual patients and at the federal and state levels to advocate for policy changes that can benefit these populations. Overall, psychiatrists occupy a special role within the medical establishment that enables them to uniquely advocate for patients with SMI and ensure they are not forgotten during the COVID-19 pandemic.

Bottom Line

Psychiatrists could apply behavior management techniques such as motivational interviewing and nudging to address vaccine hesitancy in their patients and move them to accepting the COVID-19 vaccination. This could be particularly valuable for patients with serious mental illness, who face increased risks from COVID-19 and additional barriers to getting vaccinated.

Related Resources

• American Psychiatric Association. APA coronavirus resources. https://www.psychiatry.org/psychiatrists/covid-19-Coronavirus
• Baddeley M. Behavioural economics: a very short introduction. Oxford University Press; 2017.
• Centers for Disease Control and Prevention. Vaccines for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html
• Chou W, Burgdorf C, Gaysynsky A, et al. COVID-19 vaccination communication: applying behavioral and social science to address vaccine hesitancy and foster vaccine confidence. National Institutes of Health. Published 2020. https://obssr.od.nih.gov/sites/obssr/files/inline-files/OBSSR_VaccineWhitePaper_FINAL_508.pdf
• Miller WR, Rollnick S. Motivational interviewing: helping people change. Guilford Press; 2012.

After more than 600,000 deaths in the United States from the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several safe and effective vaccines against the virus have become available. Vaccines are the most effective preventive measure against COVID-19 and the most promising way to achieve herd immunity to end the current pandemic. However, obstacles to reaching this goal include vaccine skepticism, structural barriers, or simple inertia to get vaccinated. These challenges provide opportunities for psychiatrists to use their medical knowledge and expertise, applying behavior management techniques such as motivational interviewing and nudging to encourage their patients to get vaccinated. In particular, marginalized patients with serious mental illness (SMI), who are subject to disproportionately high rates of COVID-19 infection and more severe outcomes,¹ have much to gain if psychiatrists become involved in the COVID-19 vaccination campaign.

In this article, we define vaccine hesitancy and highlight what makes psychiatrists ideal vaccine ambassadors, given their unique skill set and longitudinal, trust-based connection with their patients. We expand on the particular vulnerabilities of patients with SMI, including structural barriers to vaccination that lead to health disparities and inequity. Finally, building on “The ABCs of successful vaccinations” framework published in Current Psychiatry March 2021,² we outline how psychiatrists can address vaccine misconceptions, employ effective communication strategies to build vaccine confidence, and help patients overcome structural barriers and get the COVID-19 vaccination. While we are currently focused on ending the COVID-19 pandemic, our broader mission as psychiatrists should be to become ambassadors for other vaccinations as well, such as the annual influenza vaccine.

What is vaccine hesitancy?

The World Health Organization (WHO) defines vaccine hesitancy as a “delay in acceptance or refusal of vaccines despite availability of vaccine services.”^3,4 Vaccine hesitancy occurs on a continuum ranging from uncertainty about accepting a vaccine to absolute refusal.^4,5 It involves a complex decision-making process driven by contextual, individual, and social influences, and vaccine-specific issues.⁴ In the “3C” model developed by the WHO Strategic Advisory Group of Experts (SAGE) Working Group, vaccine hesitancy is influenced by confidence (trust in vaccines, in the health care system, and in policy makers), complacency (lower perceived risk), and convenience (availability, affordability, accessibility, language and health literacy, appeal of vaccination program).⁴

In 2019, the WHO named vaccine hesitancy as one of the top 10 global health threats.³ Hesitancy to receive COVID-19 vaccines may be particularly high because of their rapid development. In addition, the tumultuous political environment that often featured inconsistent messaging about the virus, its dangers, and its transmission since the early days of the pandemic created widespread public confusion and doubt as scientific understandings evolved. “Anti-vaxxer” movements that completely rejected vaccine efficacy disseminated misinformation online. Followers of these movements may have such extreme overvalued ideas that any effort to persuade them otherwise with scientific evidence will accomplish very little.^6,7 Therefore, focusing on individuals who are “sitting on the fence” about getting vaccinated can be more productive because they represent a much larger group than those who adamantly refuse vaccines, and they may be more amenable to changing beliefs and behaviors.⁸

The US Census Bureau’s Household Pulse Survey asked, “How likely are you to accept the vaccine?”⁹ As of late June 2021, 11.4% of US adults reported they would “definitely not get a vaccine” or “probably not get a vaccine,” and that number increases to 16.9% when including those who are “unsure,” although there is wide geographical variability.¹⁰

A recent study in Denmark showed that willingness to receive the COVID-19 vaccine was slightly lower among patients with mental illness (84.8%) compared with the general population (89.5%).¹¹ Given the small difference, vaccine hesitancy was not considered to be a major barrier for vaccination among patients with mental illness in Denmark. This is similar to the findings of a pre-pandemic study at a community mental health clinic in the United States involving other vaccinations, which suggested that 84% of patients with SMI perceived vaccinations as safe, effective, and important.¹² In this clinic, identified barriers to vaccinations in general among patients with SMI included lack of awareness and knowledge (42.2%), accessibility (16.3%), personal cost (13.3%), fears about immunization (10.4%), and lack of recommendations by primary care providers (PCPs) (1.5%).¹²

It is critical to distinguish attitude-driven vaccine hesitancy from a lack of education and opportunity to receive a vaccine. Particularly disadvantaged communities may be mislabeled as “vaccine hesitant” when in fact they may not have the ability to be as proactive as other population groups (eg, difficulty scheduling appointments over the Internet).

Continue to: What makes psychiatrists ideal vaccine ambassadors?

What makes psychiatrists ideal vaccine ambassadors?

There are several reasons psychiatrists can be well-positioned to contribute to the success of vaccination campaigns (Table 1). These include their frequent contact with patients and their care teams, the high trust those patients have in them, and their medical expertise and skills in applied behavioral and social science techniques, including motivational interviewing and nudging. Vaccination efforts and outreach are more effective when led by the clinician with whom the patient has the most contact because resolving vaccine hesitancy is not a one-time discussion but requires ongoing communication, persistence, and consistency.¹³ Patients may contact their psychiatrists more frequently than their other clinicians, including PCPs. For this reason, psychiatrists can serve as the gateway to health care, particularly for patients with SMI.¹⁴ In addition, interruptions in nonemergency services caused by the COVID-19 pandemic may affect vaccine delivery because patients may have been unable to see their PCPs regularly during the pandemic.¹⁵

Psychiatrists’ medical expertise and their ability to develop rapport with their patients promote trust-building. Receiving credible information from a trusted source such as a patient’s psychiatrist can be impactful. A recent poll suggested that individual health care clinicians have been consistently identified as the most trusted sources for vaccine information, including for the COVID-19 vaccines.¹⁶ There is also higher trust when there is greater continuity of care both in terms of length of time the patient has known the clinician and the number of consultations,¹⁷ an inherent part of psychiatric practice. In addition, research has shown that patients trust their psychiatrists as much as they trust their general practitioners.¹⁸

Psychiatrists are experts in behavior change, promoting healthy behaviors through motivational interviewing and nudging. They also have experience with managing patients who hold overvalued ideas as well as dealing with uncertainty, given their scientific and medical training.

Motivational interviewing is a patient-centered, collaborative approach widely used by psychiatrists to treat unhealthy behaviors such as substance use. Clinicians elicit and strengthen the patient’s desire and motivation for change while respecting their autonomy. Instead of presenting persuasive facts, the clinician creates a welcoming, nonthreatening, safe environment by engaging patients in open dialogue, reflecting back the patients’ concerns with empathy, helping them realize contradictions in behavior, and supporting self-sufficiency.¹⁹ In a nonpsychiatric setting, studies have shown the effectiveness of motivational interviewing in increasing uptake of human papillomavirus vaccines and of pediatric vaccines.²⁰

Nudging, which comes from behavioral economics and psychology, underscores the importance of structuring a choice architecture in changing the way people make their everyday decisions.²¹ Nudging still gives people a choice and respects autonomy, but it leads patients to more efficient and productive decision-making. Many nudges are based around giving good “default options” because people often do not make efforts to deviate from default options. In addition, social nudges are powerful, giving people a social reference point and normalizing certain behaviors.²¹ Psychiatrists have become skilled in nudging from working with patients with varying levels of insight and cognitive capabilities. That is, they give simple choices, prompts, and frequent feedback to reinforce “good” decisions and to discourage “bad” decisions.

Continue to: Managing overvalued ideas

Managing overvalued ideas. Psychiatrists are also well-versed in having discussions with patients who hold irrational beliefs (psychosis) or overvalued ideas. For example, psychiatrists frequently manage anorexia nervosa and hypochondria, which are rooted in overvalued ideas.⁷ While psychiatrists may not be able to directly confront the overvalued ideas, they can work around such ideas while waiting for more flexible moments. Similarly, managing patients with intense emotional commitment⁷ to commonly held anti-vaccination ideas may not be much different. Psychiatrists can work around resistance until patients may be less strongly attached to those overvalued ideas in instances when other techniques, such as motivational interviewing and nudging, may be more effective.

Managing uncertainty. Psychiatrists are experts in managing “not knowing” and uncertainty. Due to their medical scientific training, they are familiar with the process of science, and how understanding changes through trial and error. In contrast, most patients usually only see the end product (ie, a drug comes to market). Discussions with patients that acknowledge uncertainty and emphasize that changes in what is known are expected and appropriate as scientific knowledge evolves could help preempt skepticism when messages are updated.
 

Why do patients with SMI need more help?

SMI as a high-risk group. Patients with SMI are part of a “tragic” epidemiologic triad of agent-host-environment¹⁵ that places them at remarkably elevated risk for COVID-19 infection and more serious complications and death when infected.¹ After age, a diagnosis of a schizophrenia spectrum disorder is the second largest predictor of mortality from COVID-19, with a 2.7-fold increase in mortality.²² This is how the elements of the triad come together: SARS-Cov-2 is a highly infectious agent affecting individuals who are vulnerable hosts because of their high frequency of medical comorbidities, including cardio­vascular disease, type 2 diabetes, and respiratory tract diseases, which are all risk factors for worse outcomes due to COVID-19.²³ In addition, SMI is associated with socioeconomic risk factors for SARS-Cov-2 infection, including poverty, homelessness, and crowded settings such as jails, group homes, hospitals, and shelters, which constitute ideal environments for high transmission of the virus.

Structural barriers to vaccination. Studies have suggested lower rates of vaccination among people with SMI for various other infectious diseases compared with the general population.¹² For example, in 1 outpatient mental health setting, influenza vaccination rates were 24% to 28%, which was lower than the national vaccination rate of 40.9% for the same influenza season (2010 to 2011).²⁴ More recently, a study in Israel examining the COVID-19 vaccination rate among >25,000 patients with schizophrenia suggested under-vaccination of this cohort. The results showed that the odds of getting the COVID-19 vaccination were significantly lower in the schizophrenia group compared with the general population (odds ratio = 0.80, 95% CI: 0.77 to 0.83).²⁵

Patients with SMI encounter considerable system-level barriers to vaccinations in general, such as reduced access to health care due to cost and a lack of transportation,¹² the digital divide given their reduced access to the internet and computers for information and scheduling,²⁶ and lack of vaccination recommendations from their PCPs.¹² Studies have also shown that patients with SMI often receive suboptimal medical care because of stigmatization and discrimination.²⁷ They also have lower rates of preventive care utilization, seeking medical services only in times of crisis and seeking mental health services more often than physical health care.^28-30

Continue to: Patients with SMI face...

Patients with SMI face additional individual challenges that impede vaccine uptake, such as lack of knowledge and awareness about the virus and vaccinations, general cognitive impairment, low digital literacy skills,³¹ low language literacy and educational attainment, baseline delusions, and negative symptoms such as apathy, avolition, and anhedonia.¹ Thus, even if they overcome the external barriers and obtain vaccine-related information, these patients may experience difficulty in understanding the content and applying this information to their personal circumstances as a result of low health literacy.

How psychiatrists can help

The concept of using mental health care sites and trained clinicians to increase medical disease prevention is not new. The rigorously tested intervention model STIRR (Screen, Test, Immunize, Reduce risk, and Refer) uses co-located nurse practitioners in community mental health centers to provide risk assessment, counseling, and blood testing for hepatitis and HIV, as well as on-site vaccinations for hepatitis to patients dually diagnosed with SMI and substance use disorders.³² Similarly, when a vaccination program was integrated into an outpatient mental health clinic offering various on-site vaccinations, vaccination rates increased by up to 25% over baseline.¹² Such public health approaches of integrating medical care at the site of mental health care, where patients with SMI are most reliably engaged, can be highly cost-effective³³ in terms of reducing disease burden among patients with SMI.

While the psychiatrist may not have the time and resources to directly follow through on all aspects of vaccinations, they can assume leadership and work with the larger team—including therapists and counselors, nurse practitioners, social workers, case managers, care coordinators, or PCPs with whom they regularly collaborate in caring for patients with SMI—to communicate what they have learned about patient hesitancies, share suggestions for future conversations to address these hesitancies, and relay what structural barriers the patient may need assistance to address.

Prioritization of patients with SMI for vaccine eligibility does not directly lead to vaccine uptake. Patients with SMI need extra support from their primary point of health care contact, namely their psychiatrists. Psychiatrists may bring a set of specialized skills uniquely suited to this moment to address vaccine hesitancy and overall lack of vaccine resources and awareness. Freudenreich et al² recently proposed “The ABCs of Successful Vaccinations” framework that psychiatrists can use in their interactions with patients to encourage vaccination by focusing on:

• attitudes towards vaccination
• barriers to vaccination
• completed vaccination series.

Understand attitudes toward vaccination. Decision-making may be an emotional and psychological experience that is informed by thoughts and feelings,³⁴ and psychiatrists are uniquely positioned to tailor messages to individual patients by using motivational interviewing and applying nudging techniques.⁸ Given the large role of the pandemic in everyday life, it would be natural to address vaccine-related concerns in the course of routine rapport-building. Table 2^19,34-38 shows example phrases of COVID-19 vaccine messages that are based on communication strategies that have demonstrated success in health behavior domains (including vaccinations).³⁹

Continue to: First, a strong recommendation...

First, a strong recommendation should be made using the presumptive approach.⁴⁰ If vaccine hesitancy is detected, psychiatrists should next attempt to understand patients’ reasoning with open-ended questions to probe vaccine-related concerns. Motivational interviewing can then be used to target the fence sitters (rather than anti-vaxxers).⁶ Psychiatrists can also communicate with therapists about the need for further follow up on patients’ hesitancies.

When assuring patients of vaccine safety and efficacy, it is helpful to explain the vaccine development process, including FDA approval, extensive clinical trials, monitoring, and the distribution process. Providing clear, transparent, accurate information about the risks and benefits of the vaccines is important, as well as monitoring misinformation and developing convincing counter messages that elicit positive emotions toward the vaccines.⁴¹ Examples of messages to counter common vaccine-related concerns and misinformation are shown in Table 3.^42-44

Know the barriers to vaccination. The role of the psychiatrist is to help patients, particularly those with SMIs, overcome logistical barriers and address hesitancy, which are both essential for vaccine uptake. Psychiatrists can help identify actual barriers (eg, transportation, digital access for information and scheduling) and perceived barriers, improve information access, and help patients obtain self-efficacy to take the actions needed to get vaccinated, particularly by collaborating with and communicating these concerns to other social services (Table 4).⁴¹

Monitor for vaccination series completion. Especially for vaccines that require more than a single dose over time, patients need more reminders, nudges, practical support, and encouragement to complete vaccination. A surprising degree of confusion regarding the timing of protection and benefit from the second COVID-19 injection (for the 2-injection vaccines) was uncovered in a recent survey of >1,000 US adults who had received their vaccinations in February 2021.⁴⁵ Attentive monitoring of vaccination series completion by psychiatrists can thus increase the likelihood that a patient will follow through (Table 4).⁴¹ This can be as simple as asking about completion of the series during appointments, but further aided by communicating to the larger care team (social workers, care managers, care coordinators) when identifying that the patient may need further assistance.

The Figure^2,6,7,19,40 summarizes the steps that psychiatrists can take to help patients get vaccinated by assessing attitudes towards vaccination (vaccine hesitancy), helping to remove barriers to vaccination, and ensuring via patient follow-up that a vaccine series is completed.

Continue to: Active involvement is key

Active involvement is key

The active involvement of psychiatrists in COVID-19 vaccination efforts can protect patients from the virus, reduce health disparities among patients with SMI, and promote herd immunity, helping to end the pandemic. Psychiatry practices can serve as ideal platforms to deliver evidence-based COVID-19 vaccine information and encourage vaccine uptake, particularly for marginalized populations.

Vaccination programs in mental health practices can even be conceptualized as a moral mandate in the spirit of addressing distributive injustice. The population management challenges of individual-level barriers and follow-through could be dramatically reduced—if not nearly eliminated—through policy-level changes that allow vaccinations to be administered in places where patients with SMI are already engaged: that is, “shots in arms” in mental health settings. As noted, some studies have shown that mental health settings can play a key role in other preventive care campaigns, such as the annual influenza and hepatitis vaccinations, and thus the incorporation of preventive care need not be limited to just COVID-19 vaccination efforts.

The COVID-19 pandemic is an opportunity to rethink the role of psychiatrists and psychiatric offices and clinics in preventive health care. The health risks and disparities of patients with SMI require the proactive involvement of psychiatrists at both the level of their individual patients and at the federal and state levels to advocate for policy changes that can benefit these populations. Overall, psychiatrists occupy a special role within the medical establishment that enables them to uniquely advocate for patients with SMI and ensure they are not forgotten during the COVID-19 pandemic.

Bottom Line

Psychiatrists could apply behavior management techniques such as motivational interviewing and nudging to address vaccine hesitancy in their patients and move them to accepting the COVID-19 vaccination. This could be particularly valuable for patients with serious mental illness, who face increased risks from COVID-19 and additional barriers to getting vaccinated.

Related Resources

• American Psychiatric Association. APA coronavirus resources. https://www.psychiatry.org/psychiatrists/covid-19-Coronavirus
• Baddeley M. Behavioural economics: a very short introduction. Oxford University Press; 2017.
• Centers for Disease Control and Prevention. Vaccines for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html
• Chou W, Burgdorf C, Gaysynsky A, et al. COVID-19 vaccination communication: applying behavioral and social science to address vaccine hesitancy and foster vaccine confidence. National Institutes of Health. Published 2020. https://obssr.od.nih.gov/sites/obssr/files/inline-files/OBSSR_VaccineWhitePaper_FINAL_508.pdf
• Miller WR, Rollnick S. Motivational interviewing: helping people change. Guilford Press; 2012.

“I did not like those patients… They made me angry and I found myself irritated to experience them as they seemed so distant from myself and from all that is human. This is an astonishing intolerance which brands me a poor psychiatrist.”

Sigmund Freud, Letter to István Hollós (1928)

While Freud was referring to psychotic patients,¹ his evident frustration shows that difficult and challenging patients have vexed even the best of us. All physicians and other clinicians will experience patient encounters that lead to anger or frustration, or even challenge their sense of equanimity and professional identity. In short, difficult and challenging patient interactions are unavoidable, regardless of the physician’s discipline.^2-5 At times, physicians might struggle with demanding, unpleasant, ungrateful, and possibly dangerous patients, while sometimes the struggle is with the patient’s family members. No physician is immune to the problem, which makes it crucial to learn to anticipate and manage difficult patient interactions, skills which are generally not taught in medical schools or residency programs.

One prospective study of clinic patients found that up to 15% of patient encounters are deemed “difficult.”⁶ Common scenarios include patients (or their relatives) who seek certain tests after researching symptoms online, threats of legal or social media action in response to feeling that the physician is not listening to them, demands for a second opinion after disagreeing with the physician’s diagnosis, and mistrust of doctors after presenting with symptoms and not receiving a diagnosis. It is also common to care for patients who focus on negative outcomes or fail to adhere to treatment recommendations. These encounters can make physicians feel stressed out, disrespected, abused, or even fearful if threatened. Some physicians may come to feel they are trapped in a hostile work environment with little support from their supervisors or administrators. Patients often have a complaint office or department to turn to, but there is no equivalent for physicians, who are expected to soldier on regardless.

This article highlights a model that describes poor physician-patient encounters, factors contributing to these issues, how to manage these difficult interactions, and what to do if the relationship cannot be remediated.

Describing the ‘difficult’ patient

In a landmark 1978 paper, Groves⁷ provided one of the first descriptions of “difficult” patients. His colorful observations continue to provide useful insights. Groves emphasized that most medical texts ignore the issue of difficult patients and provide little or no guidance—which is still true 43 years later. He observed that physicians cannot avoid occasional negative feelings toward some patients. Further, Groves suggested that countertransference is often at the root of hateful reactions, a process he defines as “conscious or unconscious unbidden and unwanted hostile or sexual feelings toward the patient.”⁷Table 1⁷ outlines how Groves divided “hateful” patients into several categories, and how physicians might respond to such patients.

A model for understanding difficult patient encounters

Adams and Murray² created a model to help explain interactions with difficult or challenging patients that consists of 3 elements: the patient, the physician, and the system (ie, situation or environment). Hull and Broquet⁸ and Hardavella et al⁹ later adapted the model and described its components (Table 2^2,8,9).

Continue to: When considering...

When considering difficult interactions, it is important to be aware that all 3 components could interact, or merely 1 or 2 could come into play, but all should be explored as possible contributing factors.

Patient factors

The patient’s role in initiating or maintaining a problematic interaction should be explored. While some physicians are tempted to conclude that a personality disorder underlies difficult interactions, research shows a more complex picture. First, not all difficult patients have a psychiatric disorder, let alone a personality disorder. Jackson and Kroenke⁶ reported that among 74 difficult patients in an ambulatory clinic, 29% had a depressive disorder or anxiety disorder, with 11% experiencing 2 or more disorders. Major depressive disorder was present in 8.4% patients, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2%.⁶ These researchers found that difficult patient interactions were associated with the presence of a psychiatric disorder, especially depressive or anxiety disorders, and multiple physical symptoms.

Importantly, difficult patients are not unique to psychiatry, and are found in all medical disciplines and every type of practice situation. Some problematic patients have a substance use disorder, and their difficulty might stem from intoxication, withdrawal, or drug-seeking behaviors. Psychotic disorders can be the source of difficult interactions, typically resulting from the patient’s symptoms (ie, hallucinations, delusions, or bizarre behavior). Physicians tend to be forgiving toward these patients because they understand the extent of the individual’s illness. The same is true for a patient with dementia, who might be disruptive and loud, yet clearly is not in control of their behavior.

Koekkoek et al⁵ reviewed 94 articles that focused on difficult patients seen in mental health settings. Most patients were male (60% to 68%), and most were age 26 to 32 years. Diagnoses of psychotic disorders and personality disorders were the most frequent, while mood and other disorders were less common. In 1 of the studies reviewed, 6% of psychiatric inpatients were considered difficult. Koekkoek et al⁵ proposed that there are 3 groups of difficult patients:

• care avoiders: patients with psychosis who lack insight
• care seekers: patients who are chronically ill who have trouble maintaining a steady relationship with their caregivers
• care claimers: patients who do not require long-term care, but need housing, medication, or a “declaration of incompetence.”

Physician factors

Physicians are frequent contributors to bad interactions with their patients.^2,7,8 They can become angry or defensive because of burnout, stress, or frustration, which might lead them to snap or otherwise respond inappropriately to their patients. Many physicians are overworked, sleep-deprived, or busier than they would prefer. Personal problems can be preoccupying and contribute to a physician being ill-tempered or distracted (eg, marital or family problems). Some physicians are simply poor communicators and might not understand the need to adapt their communication style to their patient, instead using medical jargon the patient does not understand. Ideally, physicians should modify their language to suit the patient’s level of education, degree of medical sophistication, and cultural background.

Continue to: A physician's personality traits...

A physician’s personality traits could clash with those of the patient, particularly if the physician is especially rigid or obsessional. Rather than “going with the flow,” the overly rigid physician might become impatient with patients who fail to understand diagnostic assessments or treatment recommendations. Inefficient physicians might not be able to keep up with the daily schedule, which could fuel impatience and perhaps even lead them to think that the patient is taking too much of their valuable time. Some might not know how to convey empathy, for example when giving bad news (“The tests show you have cancer…”). Others fail to make consistent eye contact with patients without understanding its importance to communication, a problem made worse by the use of electronic medical record systems (EMRs).

Systems issues

Systems issues also contribute to suboptimal physician-patient interactions, and some issues can be attributed to administrative problems. Examples of systems issues include:

• when a patient has difficulty making an appointment and is forced to listen to a confusing menu of choices
• a busy clinic that can only offer a patient an appointment 6 months away
• crowded or noisy waiting rooms
• language barriers for patients whose primary langage is not English. Not having access to an interpreter can exacerbate their frustration
• the use of EMRs is a growing threat to positive physician-patient interactions, yet their influence is often ignored. Widely disliked by physicians,¹⁰ EMRs are required in all but the smallest independent practice settings. Many busy physicians focus their attention on the computer, giving the patient the impression that the physician is not listening to them. Many patients conclude that they are less important than the process.

The consequences of difficult interactions

Following a bad interaction, dissatisfied patients are more likely to leave the clinic or hospital and ignore medical advice. These patients might then show up in crowded emergency departments, which may lead to poor use of health care resources. For physicians, challenging situations sap their emotional energy, cause demoralization, and interfere with their sense of job fulfillment. In extreme cases, such feelings might lead the physician to dislike and even avoid the patient.

How to manage challenging situations

Taking the following steps can help physicians work through challenging situations with their patients.

Diagnose the problem. First, recognize the difficult situation, analyze it, and identify how the patient, the physician, and the system are contributing to a bad physician-patient interaction. Diagnosing the interactional difficulty should precede the diagnosis and management of the patient’s disease. Physicians should acknowledge their own contribution through their attitude or actions. Finally, determine if there are system issues that are contributing to the problem, or if it is the clinic or inpatient setting itself (eg, noisy inpatient unit).

Continue to: Maintain your cool

Maintain your cool. With any difficult interaction, a physician’s first obligation is to remain calm and professional, while modeling appropriate behavior. If the patient is angry or emotionally intense, talking over them or interrupting them only makes the situation worse. Try to see the interaction from the patient’s perspective. Both parties should work together to find a common ground.

Collaborate, respect boundaries, and empathize. One study of a group of 100 family physicians found that having the following 3 skills were essential to successfully managing situations with difficult patients^11,12:

• the ability to collaborate (vs opposition)
• the appropriate use of power (vs misuse of power, or violation of boundaries by either party)
• the ability to empathize, which for most physicians involves understanding and validating the patient’s subjective experiences.

Although a description of the many facets of empathy (cognitive, affective, motivational) is beyond the scope of this article, it is worth pointing out that a patient’s positive perception of their physician’s empathy improves not only patient satisfaction but health outcomes.¹³ The Box describes a difficult patient whose actions changed through the collaboration and empathy of his treatment team.

Box 1

Verbalize the difficulty. It is important to openly discuss the problem. For example, “We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?” This approach names the “elephant in the room” and avoids casting blame. It also creates a sense of shared ownership by externalizing the problem from both the patient and physician. Verbalizing the difficulty can help build trust and pave the way to working together toward a common solution.

Consider other explanations for the patient’s behavior. For example, anger directed at a physician could be due to anxiety about an unrelated matter, such as the patient’s recent job loss or impending divorce. Psychiatrists might understand this behavior better as displacement, which is considered a maladaptive defense mechanism. It is important to listen to the patient and offer empathy, which will help the patient feel supported and build a rapport that can help to resolve the encounter.

Continue to: When helping patients...

When helping patients with multiple issues, which is a common scenario, the physician might start by asking, “What would you like to address today?”¹⁴ Keep a list of the issues so you do not forget the patient’s concerns, and then ask: “What do you think is going on?” Give patients time to verbalize their concerns. Physicians should:

• validate concerns: “I understand where you’re coming from.”
• offer empathy: “I can see how difficult this has been for you.”
• reframe: “Let me make sure I hear you correctly.”
• refocus: “Let’s agree on what we need to do at this visit.”

Find common ground. When the patient and physician have different ideas on diagnosis or treatment, finding common ground is another way to resolve a difficult encounter. Difficulties arise when there appears to be little common ground, which often results from unrealistic expectations. Patients might be seen as “demanding” or “manipulative”’ if they push for a diagnosis or treatment the doctor is not comfortable with. As soon as there is some overlap and common ground, the difficulty rapidly subsides.

Set clear boundaries and limits. Physicians should set limits on what patient behavior might “cross the line.” A “behavioral contract” (or “treatment contract”) can help by setting explicit expectations. For example, showing up late for appointments or inappropriately seeking drugs of abuse (eg, opioids, benzodiazepines) might be identified as violations of the contract. Once the contract is set, the patient should be asked to restate key components. Clarify any confusion or barriers to compliance and define clear expectations. The patient should be informed of potential consequences of contract violations, including termination.

Staff members involved in the patient’s care should agree with the terms of any behavioral contract, and should receive a copy of it. Patients should have “buy in,” meaning that they have had an opportunity to provide input to the contract and have agreed to its elements. Both the physician and patient should sign the document.

When all else fails

When there is a breakdown in rapport that makes it difficult or impossible to continue offering treatment, consider termination. This could be due to threatening or abusive patient behavior, sexual advances, repeated no-shows, treatment noncompliance that jeopardizes patient safety, refusal to follow the treatment plan, or violating the terms of a behavioral contract. In some settings, it might be the failure to pay bills.

Continue to: If a patient is unable to...

If a patient is unable to follow the contract, the physician should explore possible extenuating circumstances. The physician should seek to remedy the problem and involve other team members if possible (eg, case manager, nurse), advising a patient about behaviors that could lead to termination.

If the problem is irremediable, notify the patient in writing, give them time to find another physician, and facilitate the transfer of care.¹⁵ Take steps to prevent the patient from running out of any medications associated with withdrawal or discontinuation syndromes (eg, selective serotonin reuptake inhibitors, benzodiazepines) during the care transition. While there is no requirement regarding the amount of time allowed, at least 30 days is typical.

Bottom Line

Difficult patient interactions are common and unavoidable. Physicians should acknowledge and recognize contributing factors in such encounters—including their own role. When handling such situations, physicians should remain calm and model appropriate behavior. Improving communication, offering empathy, and validating the patient’s concerns can help resolve factors that contribute to poor patient interactions. If efforts to remediate the physician-patient relationship fail, termination may be necessary.

Related Resources

• Koekkoek B, Berno van Meijel CNS, Hutschemaekers G. “Difficult patients” in mental health care: a review. Psychiatr Serv. 2006;57(6):795-802.
• Pereira MR, Figueiredo AF. Challenging patient-doctor interactions in psychiatry – difficult patient syndrome. European Psychiatry. 2017;41(supplement):S719. doi. org/10.1016/j.eurpsy.2017.01.1297

“I did not like those patients… They made me angry and I found myself irritated to experience them as they seemed so distant from myself and from all that is human. This is an astonishing intolerance which brands me a poor psychiatrist.”

Sigmund Freud, Letter to István Hollós (1928)

While Freud was referring to psychotic patients,¹ his evident frustration shows that difficult and challenging patients have vexed even the best of us. All physicians and other clinicians will experience patient encounters that lead to anger or frustration, or even challenge their sense of equanimity and professional identity. In short, difficult and challenging patient interactions are unavoidable, regardless of the physician’s discipline.^2-5 At times, physicians might struggle with demanding, unpleasant, ungrateful, and possibly dangerous patients, while sometimes the struggle is with the patient’s family members. No physician is immune to the problem, which makes it crucial to learn to anticipate and manage difficult patient interactions, skills which are generally not taught in medical schools or residency programs.

One prospective study of clinic patients found that up to 15% of patient encounters are deemed “difficult.”⁶ Common scenarios include patients (or their relatives) who seek certain tests after researching symptoms online, threats of legal or social media action in response to feeling that the physician is not listening to them, demands for a second opinion after disagreeing with the physician’s diagnosis, and mistrust of doctors after presenting with symptoms and not receiving a diagnosis. It is also common to care for patients who focus on negative outcomes or fail to adhere to treatment recommendations. These encounters can make physicians feel stressed out, disrespected, abused, or even fearful if threatened. Some physicians may come to feel they are trapped in a hostile work environment with little support from their supervisors or administrators. Patients often have a complaint office or department to turn to, but there is no equivalent for physicians, who are expected to soldier on regardless.

This article highlights a model that describes poor physician-patient encounters, factors contributing to these issues, how to manage these difficult interactions, and what to do if the relationship cannot be remediated.

Describing the ‘difficult’ patient

In a landmark 1978 paper, Groves⁷ provided one of the first descriptions of “difficult” patients. His colorful observations continue to provide useful insights. Groves emphasized that most medical texts ignore the issue of difficult patients and provide little or no guidance—which is still true 43 years later. He observed that physicians cannot avoid occasional negative feelings toward some patients. Further, Groves suggested that countertransference is often at the root of hateful reactions, a process he defines as “conscious or unconscious unbidden and unwanted hostile or sexual feelings toward the patient.”⁷Table 1⁷ outlines how Groves divided “hateful” patients into several categories, and how physicians might respond to such patients.

A model for understanding difficult patient encounters

Adams and Murray² created a model to help explain interactions with difficult or challenging patients that consists of 3 elements: the patient, the physician, and the system (ie, situation or environment). Hull and Broquet⁸ and Hardavella et al⁹ later adapted the model and described its components (Table 2^2,8,9).

Continue to: When considering...

When considering difficult interactions, it is important to be aware that all 3 components could interact, or merely 1 or 2 could come into play, but all should be explored as possible contributing factors.

Patient factors

The patient’s role in initiating or maintaining a problematic interaction should be explored. While some physicians are tempted to conclude that a personality disorder underlies difficult interactions, research shows a more complex picture. First, not all difficult patients have a psychiatric disorder, let alone a personality disorder. Jackson and Kroenke⁶ reported that among 74 difficult patients in an ambulatory clinic, 29% had a depressive disorder or anxiety disorder, with 11% experiencing 2 or more disorders. Major depressive disorder was present in 8.4% patients, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2%.⁶ These researchers found that difficult patient interactions were associated with the presence of a psychiatric disorder, especially depressive or anxiety disorders, and multiple physical symptoms.

Importantly, difficult patients are not unique to psychiatry, and are found in all medical disciplines and every type of practice situation. Some problematic patients have a substance use disorder, and their difficulty might stem from intoxication, withdrawal, or drug-seeking behaviors. Psychotic disorders can be the source of difficult interactions, typically resulting from the patient’s symptoms (ie, hallucinations, delusions, or bizarre behavior). Physicians tend to be forgiving toward these patients because they understand the extent of the individual’s illness. The same is true for a patient with dementia, who might be disruptive and loud, yet clearly is not in control of their behavior.

Koekkoek et al⁵ reviewed 94 articles that focused on difficult patients seen in mental health settings. Most patients were male (60% to 68%), and most were age 26 to 32 years. Diagnoses of psychotic disorders and personality disorders were the most frequent, while mood and other disorders were less common. In 1 of the studies reviewed, 6% of psychiatric inpatients were considered difficult. Koekkoek et al⁵ proposed that there are 3 groups of difficult patients:

• care avoiders: patients with psychosis who lack insight
• care seekers: patients who are chronically ill who have trouble maintaining a steady relationship with their caregivers
• care claimers: patients who do not require long-term care, but need housing, medication, or a “declaration of incompetence.”

Physician factors

Physicians are frequent contributors to bad interactions with their patients.^2,7,8 They can become angry or defensive because of burnout, stress, or frustration, which might lead them to snap or otherwise respond inappropriately to their patients. Many physicians are overworked, sleep-deprived, or busier than they would prefer. Personal problems can be preoccupying and contribute to a physician being ill-tempered or distracted (eg, marital or family problems). Some physicians are simply poor communicators and might not understand the need to adapt their communication style to their patient, instead using medical jargon the patient does not understand. Ideally, physicians should modify their language to suit the patient’s level of education, degree of medical sophistication, and cultural background.

Continue to: A physician's personality traits...

A physician’s personality traits could clash with those of the patient, particularly if the physician is especially rigid or obsessional. Rather than “going with the flow,” the overly rigid physician might become impatient with patients who fail to understand diagnostic assessments or treatment recommendations. Inefficient physicians might not be able to keep up with the daily schedule, which could fuel impatience and perhaps even lead them to think that the patient is taking too much of their valuable time. Some might not know how to convey empathy, for example when giving bad news (“The tests show you have cancer…”). Others fail to make consistent eye contact with patients without understanding its importance to communication, a problem made worse by the use of electronic medical record systems (EMRs).

Systems issues

Systems issues also contribute to suboptimal physician-patient interactions, and some issues can be attributed to administrative problems. Examples of systems issues include:

• when a patient has difficulty making an appointment and is forced to listen to a confusing menu of choices
• a busy clinic that can only offer a patient an appointment 6 months away
• crowded or noisy waiting rooms
• language barriers for patients whose primary langage is not English. Not having access to an interpreter can exacerbate their frustration
• the use of EMRs is a growing threat to positive physician-patient interactions, yet their influence is often ignored. Widely disliked by physicians,¹⁰ EMRs are required in all but the smallest independent practice settings. Many busy physicians focus their attention on the computer, giving the patient the impression that the physician is not listening to them. Many patients conclude that they are less important than the process.

The consequences of difficult interactions

Following a bad interaction, dissatisfied patients are more likely to leave the clinic or hospital and ignore medical advice. These patients might then show up in crowded emergency departments, which may lead to poor use of health care resources. For physicians, challenging situations sap their emotional energy, cause demoralization, and interfere with their sense of job fulfillment. In extreme cases, such feelings might lead the physician to dislike and even avoid the patient.

How to manage challenging situations

Taking the following steps can help physicians work through challenging situations with their patients.

Diagnose the problem. First, recognize the difficult situation, analyze it, and identify how the patient, the physician, and the system are contributing to a bad physician-patient interaction. Diagnosing the interactional difficulty should precede the diagnosis and management of the patient’s disease. Physicians should acknowledge their own contribution through their attitude or actions. Finally, determine if there are system issues that are contributing to the problem, or if it is the clinic or inpatient setting itself (eg, noisy inpatient unit).

Continue to: Maintain your cool

Maintain your cool. With any difficult interaction, a physician’s first obligation is to remain calm and professional, while modeling appropriate behavior. If the patient is angry or emotionally intense, talking over them or interrupting them only makes the situation worse. Try to see the interaction from the patient’s perspective. Both parties should work together to find a common ground.

Collaborate, respect boundaries, and empathize. One study of a group of 100 family physicians found that having the following 3 skills were essential to successfully managing situations with difficult patients^11,12:

• the ability to collaborate (vs opposition)
• the appropriate use of power (vs misuse of power, or violation of boundaries by either party)
• the ability to empathize, which for most physicians involves understanding and validating the patient’s subjective experiences.

Although a description of the many facets of empathy (cognitive, affective, motivational) is beyond the scope of this article, it is worth pointing out that a patient’s positive perception of their physician’s empathy improves not only patient satisfaction but health outcomes.¹³ The Box describes a difficult patient whose actions changed through the collaboration and empathy of his treatment team.

Box 1

Verbalize the difficulty. It is important to openly discuss the problem. For example, “We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?” This approach names the “elephant in the room” and avoids casting blame. It also creates a sense of shared ownership by externalizing the problem from both the patient and physician. Verbalizing the difficulty can help build trust and pave the way to working together toward a common solution.

Consider other explanations for the patient’s behavior. For example, anger directed at a physician could be due to anxiety about an unrelated matter, such as the patient’s recent job loss or impending divorce. Psychiatrists might understand this behavior better as displacement, which is considered a maladaptive defense mechanism. It is important to listen to the patient and offer empathy, which will help the patient feel supported and build a rapport that can help to resolve the encounter.

Continue to: When helping patients...

When helping patients with multiple issues, which is a common scenario, the physician might start by asking, “What would you like to address today?”¹⁴ Keep a list of the issues so you do not forget the patient’s concerns, and then ask: “What do you think is going on?” Give patients time to verbalize their concerns. Physicians should:

• validate concerns: “I understand where you’re coming from.”
• offer empathy: “I can see how difficult this has been for you.”
• reframe: “Let me make sure I hear you correctly.”
• refocus: “Let’s agree on what we need to do at this visit.”

Find common ground. When the patient and physician have different ideas on diagnosis or treatment, finding common ground is another way to resolve a difficult encounter. Difficulties arise when there appears to be little common ground, which often results from unrealistic expectations. Patients might be seen as “demanding” or “manipulative”’ if they push for a diagnosis or treatment the doctor is not comfortable with. As soon as there is some overlap and common ground, the difficulty rapidly subsides.

Set clear boundaries and limits. Physicians should set limits on what patient behavior might “cross the line.” A “behavioral contract” (or “treatment contract”) can help by setting explicit expectations. For example, showing up late for appointments or inappropriately seeking drugs of abuse (eg, opioids, benzodiazepines) might be identified as violations of the contract. Once the contract is set, the patient should be asked to restate key components. Clarify any confusion or barriers to compliance and define clear expectations. The patient should be informed of potential consequences of contract violations, including termination.

Staff members involved in the patient’s care should agree with the terms of any behavioral contract, and should receive a copy of it. Patients should have “buy in,” meaning that they have had an opportunity to provide input to the contract and have agreed to its elements. Both the physician and patient should sign the document.

When all else fails

When there is a breakdown in rapport that makes it difficult or impossible to continue offering treatment, consider termination. This could be due to threatening or abusive patient behavior, sexual advances, repeated no-shows, treatment noncompliance that jeopardizes patient safety, refusal to follow the treatment plan, or violating the terms of a behavioral contract. In some settings, it might be the failure to pay bills.

Continue to: If a patient is unable to...

If a patient is unable to follow the contract, the physician should explore possible extenuating circumstances. The physician should seek to remedy the problem and involve other team members if possible (eg, case manager, nurse), advising a patient about behaviors that could lead to termination.

If the problem is irremediable, notify the patient in writing, give them time to find another physician, and facilitate the transfer of care.¹⁵ Take steps to prevent the patient from running out of any medications associated with withdrawal or discontinuation syndromes (eg, selective serotonin reuptake inhibitors, benzodiazepines) during the care transition. While there is no requirement regarding the amount of time allowed, at least 30 days is typical.

Bottom Line

Difficult patient interactions are common and unavoidable. Physicians should acknowledge and recognize contributing factors in such encounters—including their own role. When handling such situations, physicians should remain calm and model appropriate behavior. Improving communication, offering empathy, and validating the patient’s concerns can help resolve factors that contribute to poor patient interactions. If efforts to remediate the physician-patient relationship fail, termination may be necessary.

Related Resources

• Koekkoek B, Berno van Meijel CNS, Hutschemaekers G. “Difficult patients” in mental health care: a review. Psychiatr Serv. 2006;57(6):795-802.
• Pereira MR, Figueiredo AF. Challenging patient-doctor interactions in psychiatry – difficult patient syndrome. European Psychiatry. 2017;41(supplement):S719. doi. org/10.1016/j.eurpsy.2017.01.1297

“I did not like those patients… They made me angry and I found myself irritated to experience them as they seemed so distant from myself and from all that is human. This is an astonishing intolerance which brands me a poor psychiatrist.”

Sigmund Freud, Letter to István Hollós (1928)

While Freud was referring to psychotic patients,¹ his evident frustration shows that difficult and challenging patients have vexed even the best of us. All physicians and other clinicians will experience patient encounters that lead to anger or frustration, or even challenge their sense of equanimity and professional identity. In short, difficult and challenging patient interactions are unavoidable, regardless of the physician’s discipline.^2-5 At times, physicians might struggle with demanding, unpleasant, ungrateful, and possibly dangerous patients, while sometimes the struggle is with the patient’s family members. No physician is immune to the problem, which makes it crucial to learn to anticipate and manage difficult patient interactions, skills which are generally not taught in medical schools or residency programs.

One prospective study of clinic patients found that up to 15% of patient encounters are deemed “difficult.”⁶ Common scenarios include patients (or their relatives) who seek certain tests after researching symptoms online, threats of legal or social media action in response to feeling that the physician is not listening to them, demands for a second opinion after disagreeing with the physician’s diagnosis, and mistrust of doctors after presenting with symptoms and not receiving a diagnosis. It is also common to care for patients who focus on negative outcomes or fail to adhere to treatment recommendations. These encounters can make physicians feel stressed out, disrespected, abused, or even fearful if threatened. Some physicians may come to feel they are trapped in a hostile work environment with little support from their supervisors or administrators. Patients often have a complaint office or department to turn to, but there is no equivalent for physicians, who are expected to soldier on regardless.

This article highlights a model that describes poor physician-patient encounters, factors contributing to these issues, how to manage these difficult interactions, and what to do if the relationship cannot be remediated.

Describing the ‘difficult’ patient

In a landmark 1978 paper, Groves⁷ provided one of the first descriptions of “difficult” patients. His colorful observations continue to provide useful insights. Groves emphasized that most medical texts ignore the issue of difficult patients and provide little or no guidance—which is still true 43 years later. He observed that physicians cannot avoid occasional negative feelings toward some patients. Further, Groves suggested that countertransference is often at the root of hateful reactions, a process he defines as “conscious or unconscious unbidden and unwanted hostile or sexual feelings toward the patient.”⁷Table 1⁷ outlines how Groves divided “hateful” patients into several categories, and how physicians might respond to such patients.

A model for understanding difficult patient encounters

Adams and Murray² created a model to help explain interactions with difficult or challenging patients that consists of 3 elements: the patient, the physician, and the system (ie, situation or environment). Hull and Broquet⁸ and Hardavella et al⁹ later adapted the model and described its components (Table 2^2,8,9).

Continue to: When considering...

When considering difficult interactions, it is important to be aware that all 3 components could interact, or merely 1 or 2 could come into play, but all should be explored as possible contributing factors.

Patient factors

The patient’s role in initiating or maintaining a problematic interaction should be explored. While some physicians are tempted to conclude that a personality disorder underlies difficult interactions, research shows a more complex picture. First, not all difficult patients have a psychiatric disorder, let alone a personality disorder. Jackson and Kroenke⁶ reported that among 74 difficult patients in an ambulatory clinic, 29% had a depressive disorder or anxiety disorder, with 11% experiencing 2 or more disorders. Major depressive disorder was present in 8.4% patients, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2%.⁶ These researchers found that difficult patient interactions were associated with the presence of a psychiatric disorder, especially depressive or anxiety disorders, and multiple physical symptoms.

Importantly, difficult patients are not unique to psychiatry, and are found in all medical disciplines and every type of practice situation. Some problematic patients have a substance use disorder, and their difficulty might stem from intoxication, withdrawal, or drug-seeking behaviors. Psychotic disorders can be the source of difficult interactions, typically resulting from the patient’s symptoms (ie, hallucinations, delusions, or bizarre behavior). Physicians tend to be forgiving toward these patients because they understand the extent of the individual’s illness. The same is true for a patient with dementia, who might be disruptive and loud, yet clearly is not in control of their behavior.

Koekkoek et al⁵ reviewed 94 articles that focused on difficult patients seen in mental health settings. Most patients were male (60% to 68%), and most were age 26 to 32 years. Diagnoses of psychotic disorders and personality disorders were the most frequent, while mood and other disorders were less common. In 1 of the studies reviewed, 6% of psychiatric inpatients were considered difficult. Koekkoek et al⁵ proposed that there are 3 groups of difficult patients:

• care avoiders: patients with psychosis who lack insight
• care seekers: patients who are chronically ill who have trouble maintaining a steady relationship with their caregivers
• care claimers: patients who do not require long-term care, but need housing, medication, or a “declaration of incompetence.”

Physician factors

Physicians are frequent contributors to bad interactions with their patients.^2,7,8 They can become angry or defensive because of burnout, stress, or frustration, which might lead them to snap or otherwise respond inappropriately to their patients. Many physicians are overworked, sleep-deprived, or busier than they would prefer. Personal problems can be preoccupying and contribute to a physician being ill-tempered or distracted (eg, marital or family problems). Some physicians are simply poor communicators and might not understand the need to adapt their communication style to their patient, instead using medical jargon the patient does not understand. Ideally, physicians should modify their language to suit the patient’s level of education, degree of medical sophistication, and cultural background.

Continue to: A physician's personality traits...

A physician’s personality traits could clash with those of the patient, particularly if the physician is especially rigid or obsessional. Rather than “going with the flow,” the overly rigid physician might become impatient with patients who fail to understand diagnostic assessments or treatment recommendations. Inefficient physicians might not be able to keep up with the daily schedule, which could fuel impatience and perhaps even lead them to think that the patient is taking too much of their valuable time. Some might not know how to convey empathy, for example when giving bad news (“The tests show you have cancer…”). Others fail to make consistent eye contact with patients without understanding its importance to communication, a problem made worse by the use of electronic medical record systems (EMRs).

Systems issues

Systems issues also contribute to suboptimal physician-patient interactions, and some issues can be attributed to administrative problems. Examples of systems issues include:

• when a patient has difficulty making an appointment and is forced to listen to a confusing menu of choices
• a busy clinic that can only offer a patient an appointment 6 months away
• crowded or noisy waiting rooms
• language barriers for patients whose primary langage is not English. Not having access to an interpreter can exacerbate their frustration
• the use of EMRs is a growing threat to positive physician-patient interactions, yet their influence is often ignored. Widely disliked by physicians,¹⁰ EMRs are required in all but the smallest independent practice settings. Many busy physicians focus their attention on the computer, giving the patient the impression that the physician is not listening to them. Many patients conclude that they are less important than the process.

The consequences of difficult interactions

Following a bad interaction, dissatisfied patients are more likely to leave the clinic or hospital and ignore medical advice. These patients might then show up in crowded emergency departments, which may lead to poor use of health care resources. For physicians, challenging situations sap their emotional energy, cause demoralization, and interfere with their sense of job fulfillment. In extreme cases, such feelings might lead the physician to dislike and even avoid the patient.

How to manage challenging situations

Taking the following steps can help physicians work through challenging situations with their patients.

Diagnose the problem. First, recognize the difficult situation, analyze it, and identify how the patient, the physician, and the system are contributing to a bad physician-patient interaction. Diagnosing the interactional difficulty should precede the diagnosis and management of the patient’s disease. Physicians should acknowledge their own contribution through their attitude or actions. Finally, determine if there are system issues that are contributing to the problem, or if it is the clinic or inpatient setting itself (eg, noisy inpatient unit).

Continue to: Maintain your cool

Maintain your cool. With any difficult interaction, a physician’s first obligation is to remain calm and professional, while modeling appropriate behavior. If the patient is angry or emotionally intense, talking over them or interrupting them only makes the situation worse. Try to see the interaction from the patient’s perspective. Both parties should work together to find a common ground.

Collaborate, respect boundaries, and empathize. One study of a group of 100 family physicians found that having the following 3 skills were essential to successfully managing situations with difficult patients^11,12:

• the ability to collaborate (vs opposition)
• the appropriate use of power (vs misuse of power, or violation of boundaries by either party)
• the ability to empathize, which for most physicians involves understanding and validating the patient’s subjective experiences.

Although a description of the many facets of empathy (cognitive, affective, motivational) is beyond the scope of this article, it is worth pointing out that a patient’s positive perception of their physician’s empathy improves not only patient satisfaction but health outcomes.¹³ The Box describes a difficult patient whose actions changed through the collaboration and empathy of his treatment team.

Box 1

Verbalize the difficulty. It is important to openly discuss the problem. For example, “We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?” This approach names the “elephant in the room” and avoids casting blame. It also creates a sense of shared ownership by externalizing the problem from both the patient and physician. Verbalizing the difficulty can help build trust and pave the way to working together toward a common solution.

Consider other explanations for the patient’s behavior. For example, anger directed at a physician could be due to anxiety about an unrelated matter, such as the patient’s recent job loss or impending divorce. Psychiatrists might understand this behavior better as displacement, which is considered a maladaptive defense mechanism. It is important to listen to the patient and offer empathy, which will help the patient feel supported and build a rapport that can help to resolve the encounter.

Continue to: When helping patients...

When helping patients with multiple issues, which is a common scenario, the physician might start by asking, “What would you like to address today?”¹⁴ Keep a list of the issues so you do not forget the patient’s concerns, and then ask: “What do you think is going on?” Give patients time to verbalize their concerns. Physicians should:

• validate concerns: “I understand where you’re coming from.”
• offer empathy: “I can see how difficult this has been for you.”
• reframe: “Let me make sure I hear you correctly.”
• refocus: “Let’s agree on what we need to do at this visit.”

Find common ground. When the patient and physician have different ideas on diagnosis or treatment, finding common ground is another way to resolve a difficult encounter. Difficulties arise when there appears to be little common ground, which often results from unrealistic expectations. Patients might be seen as “demanding” or “manipulative”’ if they push for a diagnosis or treatment the doctor is not comfortable with. As soon as there is some overlap and common ground, the difficulty rapidly subsides.

Set clear boundaries and limits. Physicians should set limits on what patient behavior might “cross the line.” A “behavioral contract” (or “treatment contract”) can help by setting explicit expectations. For example, showing up late for appointments or inappropriately seeking drugs of abuse (eg, opioids, benzodiazepines) might be identified as violations of the contract. Once the contract is set, the patient should be asked to restate key components. Clarify any confusion or barriers to compliance and define clear expectations. The patient should be informed of potential consequences of contract violations, including termination.

Staff members involved in the patient’s care should agree with the terms of any behavioral contract, and should receive a copy of it. Patients should have “buy in,” meaning that they have had an opportunity to provide input to the contract and have agreed to its elements. Both the physician and patient should sign the document.

When all else fails

When there is a breakdown in rapport that makes it difficult or impossible to continue offering treatment, consider termination. This could be due to threatening or abusive patient behavior, sexual advances, repeated no-shows, treatment noncompliance that jeopardizes patient safety, refusal to follow the treatment plan, or violating the terms of a behavioral contract. In some settings, it might be the failure to pay bills.

Continue to: If a patient is unable to...

If a patient is unable to follow the contract, the physician should explore possible extenuating circumstances. The physician should seek to remedy the problem and involve other team members if possible (eg, case manager, nurse), advising a patient about behaviors that could lead to termination.

If the problem is irremediable, notify the patient in writing, give them time to find another physician, and facilitate the transfer of care.¹⁵ Take steps to prevent the patient from running out of any medications associated with withdrawal or discontinuation syndromes (eg, selective serotonin reuptake inhibitors, benzodiazepines) during the care transition. While there is no requirement regarding the amount of time allowed, at least 30 days is typical.

Bottom Line

Difficult patient interactions are common and unavoidable. Physicians should acknowledge and recognize contributing factors in such encounters—including their own role. When handling such situations, physicians should remain calm and model appropriate behavior. Improving communication, offering empathy, and validating the patient’s concerns can help resolve factors that contribute to poor patient interactions. If efforts to remediate the physician-patient relationship fail, termination may be necessary.

Related Resources

• Koekkoek B, Berno van Meijel CNS, Hutschemaekers G. “Difficult patients” in mental health care: a review. Psychiatr Serv. 2006;57(6):795-802.
• Pereira MR, Figueiredo AF. Challenging patient-doctor interactions in psychiatry – difficult patient syndrome. European Psychiatry. 2017;41(supplement):S719. doi. org/10.1016/j.eurpsy.2017.01.1297

Approximately 1 in 5 Americans report childhood sexual abuse.¹ While 50% to 65% of child sexual abuse occurs in the absence of pedophilic interests and is thought to be driven by additional factors such as the availability of an appropriate sexual partner,^2,3 a substantial portion of childhood sexual abuse is perpetrated by individuals with pedophilia.

However, many individuals with pedophilic interests never have sexual contact with a child or the penal system. This non-offending pedophile group reports a greater prevalence of psychiatric symptoms compared with the general population, but given the intense stigmatization of their preferences, they are largely psychiatrically underrecognized and underserved. This article focuses on the unique psychiatric needs of this neglected population. By understanding and addressing the treatment needs of these patients, psychiatrists and other mental health clinicians can serve a pivotal role in decreasing stigma, promoting wellness, and preventing sexual abuse.

Understanding the terminology

DSM-5 defines paraphilia as “any intense and persistent sexual interest other than sexual interest in genital stimulation or preparatory fondling with phenotypically normal, physiologically mature, consenting human partners.”⁴ The addition of the word “disorder” to the paraphilias was introduced in DSM-5 to distinguish between paraphilias that are not of clinical concern and paraphilic disorders that cause distress or impairment to the individual, or whereby satisfaction entails personal harm or risk of harm to others. As outlined in DSM-5, pedophilic disorder refers to at least 6 months of recurrent, intense sexually arousing fantasies, sexual urges, or behaviors involving sexual activity with a prepubescent child.⁴ The individual has either acted on these sexual urges, or the sexual urges or fantasies cause marked distress or interpersonal difficulty. Lastly, the individual must be at least age 16 years and at least 5 years older than the child. Sexual attraction to peri- or postpubescent minors is not considered a psychiatric disorder, but is illegal.

Coined by B4U-ACT (www.b4uact.org), the term minor-attracted person (MAP) refers to individuals with sexual attraction to individuals who are minors or below the legal age of consent. MAP is an umbrella term that includes sexual attraction to prepubescent individuals but also includes sexual attraction to peri- and postpubescent individuals (Table 1). A MAP may or may not meet criteria for pedophilia or pedophilic disorder, based on the age of their sexual interest and whether they have experienced distress or acted on the attraction. Although many individuals with minor attraction identify with the term MAP, not all do. The term has been critiqued for being too inclusive and conflating pedophilia with minor attractions.

It is important to keep in mind that the terms pedophilia and minor attraction are not synonymous with childhood sexual abuser or “child molester” because neither term specifies whether the individual has had sexual contact with a child or legal consequences. The terms offending/non-offending and acting/non-acting are used to specify the presence of sexual contact with a child, and do not convey any clinical information.

Prevalence data

The true prevalence of pedophilia and/or attraction to minors is unknown, and estimates vary considerably. In some studies, 1% to 4% of the general population were thought to have persistent attraction to prepubescent children.^5,6 In a community sample of 8,718 German men, 4.1% reported sexual fantasies involving prepubescent children, 3.2% reported sexual offending against prepubescent children, and 0.1% reported a pedophilic sexual preference.⁵ In a study of 367 adult German men surveyed from the community, 15.5% reported fantasies (9.5% daydream and 6.0% masturbation fantasies) involving prepubescent children.⁷

Stigmatization of minor-attracted persons

Stigmatization is the process of forming negative evaluations of an individual or groups of people based on limited characteristics.^8,9 MAPs are a highly stigmatized group. This stigmatization can be profound, regardless of whether the MAP has had sexual contact with a child. A public survey of nearly 1,000 individuals showed that 39% believed that non-acting MAPs should be incarcerated, and 14% believed that they would be “better off dead.”¹⁰ Societal misconceptions of minor attraction are pervasive and include¹⁰:

• MAP sexual orientation is a choice
• MAPs cannot resist their sexual urges
• all MAPs have offended, or inevitably will
• MAPs will not respond to therapy
• MAPs are fundamentally predatory and immoral.

Continue to: In addition to...

In addition to societal stigma, internalized stigma among MAPs has been documented. Lievesley et al⁹ found that MAPs who engaged in suppression of unwanted thought strategies had higher levels of shame and guilt, low levels of hope, and a propensity to actively avoid children. Similarly, Grady et al¹¹ surveyed 293 MAPs and found prominent themes of viewing themselves as “bad.”

Psychiatric presentations include suicidal ideation

Many MAPs, including non-acting MAPs, internalize this societal stigma, which contributes to a significant mental health burden.¹² A survey of 342 MAP actors and 223 MAP non-actors revealed that one-third of both groups reported chronic suicidal ideation.¹³ In addition, online surveys conducted by B4U-ACT and Virtuous Pedophiles (www.virped.org)—both internet-based organizations dedicated to supporting non-acting MAPs—have provided similar results. In a 2011 B4U-ACT survey, nearly one-half of participants reported suicidal ideation due to their minor attraction, 32% had planned suicide attempts, and 13% had non-fatal suicide attempts. Notably, the age group with the most prevalent suicidal ideation was age 14 to 16 years,¹⁴ which makes minor attraction a prominent risk factor for suicidal ideation among patients seen by child psychiatrists.

A 2019 thematic analysis of 5,210 posts on the Virtuous Pedophiles website showed high rates of addiction, anxiety, depression, self-harm, self-hatred, and suicidal thoughts and behaviors among MAPs.² The majority of posts regarding substance use described such use as a means of dissociation. One post read, “…There are days I cannot bear to be sober … I … drink myself into a coma.” Anxiety themes regarding the ability to have a meaningful relationship with an age-appropriate partner and concerns about being “outed” followed by public persecution were prominent. Posts regarding self-injurious and suicidal behavior were common: “I want to kill myself so badly … I have to mutilate myself as punishment for my attractions. I wish myself dead. I don’t want to be attracted to children; I despise myself for fantasizing about them.”²

A study that analyzed a survey of 152 MAPs sampled from websites such as Virtuous Pedophiles and others showed >50% of respondents had strong feelings of isolation and loneliness, nearly 30% had extreme difficulty with concentration, >40% had significant anger and frustration, and >30% were struggling with feelings of detachment.¹² Notably, the respondents attributed these difficulties to their minor attraction.¹² Table 2^2,12-14 summarizes the findings of studies evaluating psychiatric symptoms in MAPs.

Consider OCD, hypersexuality

It is important to be aware that an attraction to minors may be a symptom of obsessive-compulsive disorder (OCD) or hypersexuality.¹⁵ Pedophilia-themed OCD (POCD) is a manifestation of OCD in which the individual experiences shame, fear, and excessive worry related to sexual attraction to children. Typically, individuals with POCD experience sexual thoughts of children as ego-dystonic, whereas MAPs experience such thoughts as ego-syntonic and arousing.¹⁵ However, much like individuals with POCD, MAPs also experience sexual thoughts of minors as distressing. Initial presentations of POCD may be confused with MAPs or pedophilia because of the overlap of symptoms such as anxiety, shame, distress, or suicidal ideation related to the idea of child sexual interests. The distinguishing feature of POCD is the absence of sexual arousal to children.

Continue to: Clinical presentations of...

Clinical presentations of hypersexuality may include sexual arousal to children. These individuals are distinguished from MAPs or those with pedophilia because they lack a preferred or sustained sexual interest in this group. On the contrary, individuals with hypersexuality present with a diversity of sexual interests explained by their high libido. Some individuals, however, may meet criteria for both hypersexuality and pedophilia. These individuals may pose a higher risk of sexual offending due to the presence of a heightened sexual drive and pedophilic interests, and thereby may require more intensive treatment, such as biologic treatment.

Focus on individualized treatment needs

Understanding the treatment needs of MAPs means understanding the goals of the individual MAP. Improving self-esteem, decreasing social isolation, and managing stigma are common treatment goals among MAPs.¹⁶ Levenson and Grady¹² found that most MAPs identified treatment goals unrelated to sexual interests, such as addressing depression, anxiety, and low self-esteem. A smaller percentage identified sexual frustration related to the absence of healthy sexual outlets. Because many MAPs identify common psychiatric treatment needs, most clinicians should be equipped to foster a nonjudgmental therapeutic alliance to treat these patients. Effective treatment outcomes occur when comorbid psychiatric illnesses are treated as well as addressing the internal stigmatization that many MAPs experience.

Specialized treatment may be indicated for individuals who request treatment specific to sexual interests. This may include safety planning, including developing support systems to decrease the risk around children. For MAPs who have been unsuccessful at managing their sexual interests, pharmacotherapy may be an option. To date, research on pharmacotherapy for pedophilia is largely limited to studies of sexual offenders. Testosterone-lowering medications such as gonadotropin-releasing hormone (GnRH) analogue treatment constitutes the most effective treatment for patients who are not helped by conventional psychotherapeutic interventions.¹⁷ Other psychotropic medications, such as selective serotonin reuptake inhibitors or naltrexone, have not demonstrated efficacy outside of case reports.¹⁷

Addressing barriers to care

MAPs have a strong desire but significant hesitation when seeking mental health treatment.^13,18 Nearly half (47%) of the 154 MAP respondents in the Levenson and Grady¹² survey had never told anyone about their minor attraction. MAPs are understandably hesitant to disclose these thoughts and feelings due to fear of public exposure and intense stigmatization, as well as potential punitive and legal consequences.^18,19 One post from the 2011 B4U-ACT online survey read, “Parents will disown you; teachers will report you; friends will abandon you … people in my situation can’t discuss this without serious risk of persecution and/or harassment.”¹⁴ In this survey, 78% of respondents feared a negative reaction by the professional, 78% feared being reported to law enforcement, and 68% feared being reported to family, an employer, or the community.¹⁴ This hesitancy due to fear of being exposed even extended to accessing self-help books, informational websites, and online forums, even though these sources are strongly desired and perceived as helpful.²⁰

Even if MAPs were to decide to seek help, the lack of specific training and experience among psychiatrists make them unlikely to find it in the medical field.²¹ Furthermore, MAPs who desire help often worry it will be inadequate and they will be misunderstood by their clinicians.²² According to the Levenson and Grady survey,¹² when asked what they would like most from therapy, most MAPs said they would want the treatment to focus on depression, anxiety, and low self-esteem rather than on sexual interest. In the B4U-ACT survey,¹⁴ many respondents identified the need for treatment of issues surrounding their sexual attraction, such as assistance in learning how to live in society with the attraction, dealing with society’s negative response to the attraction, and improving their self-concept in the presence of the extreme shame associated with the attraction. However, many MAPs find that clinicians tend to focus on protecting society from them, rather than on offering general psychiatric treatment or treatment focused on improving their well-being.¹⁸ This inability to locate appropriate services is known to exacerbate depression, suicidality, fear, anxiety, hopelessness, and substance abuse among MAPs.¹⁸ There is also evidence that individuals with minor attraction who are in a negative affective state are more likely to act on their attractions.²³

Continue to: An ethical responsibility

An ethical responsibility. Physicians have a long-recognized responsibility to participate in activities to protect and promote the health of the public. The American Medical Association Code of Medical Ethics includes “justice,” or treating patients fairly and equitably.²⁴ This includes patients who have pedophilic interests. Unfortunately, the stigma associated with individuals who have sexual attraction to children is pervasive in our society, including among medical professionals. The first consideration in treating MAPs is to overcome the stigmatization within our field, to remember that as physicians we took an oath to provide treatment fairly, equitably, and in accordance with the patient’s rights and entitlement.²⁴ This includes listening to MAPs’ treatment needs. Not all MAPs want or need treatment related to their sexual interest. As is the case with all patients, listening to the individual’s chief complaint is paramount. If a patient’s treatment needs are beyond the clinician’s expertise, the patient should be referred to another clinician.

Mandated reporting. MAPs may not engage in psychiatric treatment for fear of being reported to authorities as a result of mandated reporting laws. Although the circumstances under which mandated reporting may be required vary by jurisdiction, they generally include situations in which the health care professional has reasonable cause to believe that a child is suffering from abuse or neglect. A patient’s report of sexual urges and fantasies to have sexual contact with minors is not sufficient for mandated reporting. While professionals vary in their interpretation of mandated reporting laws, sexual thoughts alone do not meet the threshold for mandated reporting. Mandated reporting duties should be discussed when first meeting a patient with minor attraction. For clinicians who are uneasy about such distinctions, either supervision or not working with such patients is the solution.

The importance of providing competent and individualized treatment to MAPs is 2-fold. First, individuals who are experiencing psychiatric symptoms deserve to have access treatment. Second, providing psychiatric treatment to individuals with minor attractions is a step toward preventing child sexual abuse. The Prevention Project Dunkelfeld in Germany used public service announcements to advertise confidential treatment for individuals who had sexual interest in children.²⁵ Many of the participants were interested in mental health treatment unrelated to their sexual interests. Such projects may help us understand the best way to meet the treatment needs of minor-attracted individuals, as well as reduce child sexual abuse. As psychiatrists, we can stop making the problem worse by withholding psychiatric treatment from an important population.

Resources for MAPs and clinicians

Currently, resources for MAPs and clinicians are limited. MAPs can communicate and find support among other MAPs in online forums (see Related Resources). These websites provide online peer support groups and guides for seeking therapy. Information for mental health professionals, including available literature, research projects, clinicians who provide specialized treatment, and a monthly “dialog on therapy” can be found on the B4U-ACT and the Global Prevention Project websites. However, beyond the DSM-5 definitions, psychiatric education and training on this topic is almost entirely lacking.

In light of the information discussed in this article, several important issues remain, including how psychiatrists can best reach this population, and how they can work toward decreasing stigma so they can provide meaningful care. The solutions start with education. Educating psychiatrists about this important population can decrease stigma and facilitate appropriate, compassionate care to these patients, with the result of improving the mental health of people with minor attraction and decreasing the incidence of child sexual abuse.

Continue to: Bottom Line

Minor-attracted persons report a high prevalence of general psychiatric symptoms that often go untreated due to a lack of willing clinicians with appropriate expertise. Providing psychiatric treatment to these patients can improve their mental health and possibly decrease the incidence of individuals who act on their attractions.

Related Resources

• B4U-ACT. www.b4uact.org • The Global Prevention Project. http://theglobalprevention project.org
• Virtuous Pedophiles. www.virped.org

Drug Brand Names

Naltrexone • ReVia

Approximately 1 in 5 Americans report childhood sexual abuse.¹ While 50% to 65% of child sexual abuse occurs in the absence of pedophilic interests and is thought to be driven by additional factors such as the availability of an appropriate sexual partner,^2,3 a substantial portion of childhood sexual abuse is perpetrated by individuals with pedophilia.

However, many individuals with pedophilic interests never have sexual contact with a child or the penal system. This non-offending pedophile group reports a greater prevalence of psychiatric symptoms compared with the general population, but given the intense stigmatization of their preferences, they are largely psychiatrically underrecognized and underserved. This article focuses on the unique psychiatric needs of this neglected population. By understanding and addressing the treatment needs of these patients, psychiatrists and other mental health clinicians can serve a pivotal role in decreasing stigma, promoting wellness, and preventing sexual abuse.

Understanding the terminology

DSM-5 defines paraphilia as “any intense and persistent sexual interest other than sexual interest in genital stimulation or preparatory fondling with phenotypically normal, physiologically mature, consenting human partners.”⁴ The addition of the word “disorder” to the paraphilias was introduced in DSM-5 to distinguish between paraphilias that are not of clinical concern and paraphilic disorders that cause distress or impairment to the individual, or whereby satisfaction entails personal harm or risk of harm to others. As outlined in DSM-5, pedophilic disorder refers to at least 6 months of recurrent, intense sexually arousing fantasies, sexual urges, or behaviors involving sexual activity with a prepubescent child.⁴ The individual has either acted on these sexual urges, or the sexual urges or fantasies cause marked distress or interpersonal difficulty. Lastly, the individual must be at least age 16 years and at least 5 years older than the child. Sexual attraction to peri- or postpubescent minors is not considered a psychiatric disorder, but is illegal.

Coined by B4U-ACT (www.b4uact.org), the term minor-attracted person (MAP) refers to individuals with sexual attraction to individuals who are minors or below the legal age of consent. MAP is an umbrella term that includes sexual attraction to prepubescent individuals but also includes sexual attraction to peri- and postpubescent individuals (Table 1). A MAP may or may not meet criteria for pedophilia or pedophilic disorder, based on the age of their sexual interest and whether they have experienced distress or acted on the attraction. Although many individuals with minor attraction identify with the term MAP, not all do. The term has been critiqued for being too inclusive and conflating pedophilia with minor attractions.

It is important to keep in mind that the terms pedophilia and minor attraction are not synonymous with childhood sexual abuser or “child molester” because neither term specifies whether the individual has had sexual contact with a child or legal consequences. The terms offending/non-offending and acting/non-acting are used to specify the presence of sexual contact with a child, and do not convey any clinical information.

Prevalence data

The true prevalence of pedophilia and/or attraction to minors is unknown, and estimates vary considerably. In some studies, 1% to 4% of the general population were thought to have persistent attraction to prepubescent children.^5,6 In a community sample of 8,718 German men, 4.1% reported sexual fantasies involving prepubescent children, 3.2% reported sexual offending against prepubescent children, and 0.1% reported a pedophilic sexual preference.⁵ In a study of 367 adult German men surveyed from the community, 15.5% reported fantasies (9.5% daydream and 6.0% masturbation fantasies) involving prepubescent children.⁷

Stigmatization of minor-attracted persons

Stigmatization is the process of forming negative evaluations of an individual or groups of people based on limited characteristics.^8,9 MAPs are a highly stigmatized group. This stigmatization can be profound, regardless of whether the MAP has had sexual contact with a child. A public survey of nearly 1,000 individuals showed that 39% believed that non-acting MAPs should be incarcerated, and 14% believed that they would be “better off dead.”¹⁰ Societal misconceptions of minor attraction are pervasive and include¹⁰:

• MAP sexual orientation is a choice
• MAPs cannot resist their sexual urges
• all MAPs have offended, or inevitably will
• MAPs will not respond to therapy
• MAPs are fundamentally predatory and immoral.

Continue to: In addition to...

In addition to societal stigma, internalized stigma among MAPs has been documented. Lievesley et al⁹ found that MAPs who engaged in suppression of unwanted thought strategies had higher levels of shame and guilt, low levels of hope, and a propensity to actively avoid children. Similarly, Grady et al¹¹ surveyed 293 MAPs and found prominent themes of viewing themselves as “bad.”

Psychiatric presentations include suicidal ideation

Many MAPs, including non-acting MAPs, internalize this societal stigma, which contributes to a significant mental health burden.¹² A survey of 342 MAP actors and 223 MAP non-actors revealed that one-third of both groups reported chronic suicidal ideation.¹³ In addition, online surveys conducted by B4U-ACT and Virtuous Pedophiles (www.virped.org)—both internet-based organizations dedicated to supporting non-acting MAPs—have provided similar results. In a 2011 B4U-ACT survey, nearly one-half of participants reported suicidal ideation due to their minor attraction, 32% had planned suicide attempts, and 13% had non-fatal suicide attempts. Notably, the age group with the most prevalent suicidal ideation was age 14 to 16 years,¹⁴ which makes minor attraction a prominent risk factor for suicidal ideation among patients seen by child psychiatrists.

A 2019 thematic analysis of 5,210 posts on the Virtuous Pedophiles website showed high rates of addiction, anxiety, depression, self-harm, self-hatred, and suicidal thoughts and behaviors among MAPs.² The majority of posts regarding substance use described such use as a means of dissociation. One post read, “…There are days I cannot bear to be sober … I … drink myself into a coma.” Anxiety themes regarding the ability to have a meaningful relationship with an age-appropriate partner and concerns about being “outed” followed by public persecution were prominent. Posts regarding self-injurious and suicidal behavior were common: “I want to kill myself so badly … I have to mutilate myself as punishment for my attractions. I wish myself dead. I don’t want to be attracted to children; I despise myself for fantasizing about them.”²

A study that analyzed a survey of 152 MAPs sampled from websites such as Virtuous Pedophiles and others showed >50% of respondents had strong feelings of isolation and loneliness, nearly 30% had extreme difficulty with concentration, >40% had significant anger and frustration, and >30% were struggling with feelings of detachment.¹² Notably, the respondents attributed these difficulties to their minor attraction.¹² Table 2^2,12-14 summarizes the findings of studies evaluating psychiatric symptoms in MAPs.

Consider OCD, hypersexuality

It is important to be aware that an attraction to minors may be a symptom of obsessive-compulsive disorder (OCD) or hypersexuality.¹⁵ Pedophilia-themed OCD (POCD) is a manifestation of OCD in which the individual experiences shame, fear, and excessive worry related to sexual attraction to children. Typically, individuals with POCD experience sexual thoughts of children as ego-dystonic, whereas MAPs experience such thoughts as ego-syntonic and arousing.¹⁵ However, much like individuals with POCD, MAPs also experience sexual thoughts of minors as distressing. Initial presentations of POCD may be confused with MAPs or pedophilia because of the overlap of symptoms such as anxiety, shame, distress, or suicidal ideation related to the idea of child sexual interests. The distinguishing feature of POCD is the absence of sexual arousal to children.

Continue to: Clinical presentations of...

Clinical presentations of hypersexuality may include sexual arousal to children. These individuals are distinguished from MAPs or those with pedophilia because they lack a preferred or sustained sexual interest in this group. On the contrary, individuals with hypersexuality present with a diversity of sexual interests explained by their high libido. Some individuals, however, may meet criteria for both hypersexuality and pedophilia. These individuals may pose a higher risk of sexual offending due to the presence of a heightened sexual drive and pedophilic interests, and thereby may require more intensive treatment, such as biologic treatment.

Focus on individualized treatment needs

Understanding the treatment needs of MAPs means understanding the goals of the individual MAP. Improving self-esteem, decreasing social isolation, and managing stigma are common treatment goals among MAPs.¹⁶ Levenson and Grady¹² found that most MAPs identified treatment goals unrelated to sexual interests, such as addressing depression, anxiety, and low self-esteem. A smaller percentage identified sexual frustration related to the absence of healthy sexual outlets. Because many MAPs identify common psychiatric treatment needs, most clinicians should be equipped to foster a nonjudgmental therapeutic alliance to treat these patients. Effective treatment outcomes occur when comorbid psychiatric illnesses are treated as well as addressing the internal stigmatization that many MAPs experience.

Specialized treatment may be indicated for individuals who request treatment specific to sexual interests. This may include safety planning, including developing support systems to decrease the risk around children. For MAPs who have been unsuccessful at managing their sexual interests, pharmacotherapy may be an option. To date, research on pharmacotherapy for pedophilia is largely limited to studies of sexual offenders. Testosterone-lowering medications such as gonadotropin-releasing hormone (GnRH) analogue treatment constitutes the most effective treatment for patients who are not helped by conventional psychotherapeutic interventions.¹⁷ Other psychotropic medications, such as selective serotonin reuptake inhibitors or naltrexone, have not demonstrated efficacy outside of case reports.¹⁷

Addressing barriers to care

MAPs have a strong desire but significant hesitation when seeking mental health treatment.^13,18 Nearly half (47%) of the 154 MAP respondents in the Levenson and Grady¹² survey had never told anyone about their minor attraction. MAPs are understandably hesitant to disclose these thoughts and feelings due to fear of public exposure and intense stigmatization, as well as potential punitive and legal consequences.^18,19 One post from the 2011 B4U-ACT online survey read, “Parents will disown you; teachers will report you; friends will abandon you … people in my situation can’t discuss this without serious risk of persecution and/or harassment.”¹⁴ In this survey, 78% of respondents feared a negative reaction by the professional, 78% feared being reported to law enforcement, and 68% feared being reported to family, an employer, or the community.¹⁴ This hesitancy due to fear of being exposed even extended to accessing self-help books, informational websites, and online forums, even though these sources are strongly desired and perceived as helpful.²⁰

Even if MAPs were to decide to seek help, the lack of specific training and experience among psychiatrists make them unlikely to find it in the medical field.²¹ Furthermore, MAPs who desire help often worry it will be inadequate and they will be misunderstood by their clinicians.²² According to the Levenson and Grady survey,¹² when asked what they would like most from therapy, most MAPs said they would want the treatment to focus on depression, anxiety, and low self-esteem rather than on sexual interest. In the B4U-ACT survey,¹⁴ many respondents identified the need for treatment of issues surrounding their sexual attraction, such as assistance in learning how to live in society with the attraction, dealing with society’s negative response to the attraction, and improving their self-concept in the presence of the extreme shame associated with the attraction. However, many MAPs find that clinicians tend to focus on protecting society from them, rather than on offering general psychiatric treatment or treatment focused on improving their well-being.¹⁸ This inability to locate appropriate services is known to exacerbate depression, suicidality, fear, anxiety, hopelessness, and substance abuse among MAPs.¹⁸ There is also evidence that individuals with minor attraction who are in a negative affective state are more likely to act on their attractions.²³

Continue to: An ethical responsibility

An ethical responsibility. Physicians have a long-recognized responsibility to participate in activities to protect and promote the health of the public. The American Medical Association Code of Medical Ethics includes “justice,” or treating patients fairly and equitably.²⁴ This includes patients who have pedophilic interests. Unfortunately, the stigma associated with individuals who have sexual attraction to children is pervasive in our society, including among medical professionals. The first consideration in treating MAPs is to overcome the stigmatization within our field, to remember that as physicians we took an oath to provide treatment fairly, equitably, and in accordance with the patient’s rights and entitlement.²⁴ This includes listening to MAPs’ treatment needs. Not all MAPs want or need treatment related to their sexual interest. As is the case with all patients, listening to the individual’s chief complaint is paramount. If a patient’s treatment needs are beyond the clinician’s expertise, the patient should be referred to another clinician.

Mandated reporting. MAPs may not engage in psychiatric treatment for fear of being reported to authorities as a result of mandated reporting laws. Although the circumstances under which mandated reporting may be required vary by jurisdiction, they generally include situations in which the health care professional has reasonable cause to believe that a child is suffering from abuse or neglect. A patient’s report of sexual urges and fantasies to have sexual contact with minors is not sufficient for mandated reporting. While professionals vary in their interpretation of mandated reporting laws, sexual thoughts alone do not meet the threshold for mandated reporting. Mandated reporting duties should be discussed when first meeting a patient with minor attraction. For clinicians who are uneasy about such distinctions, either supervision or not working with such patients is the solution.

The importance of providing competent and individualized treatment to MAPs is 2-fold. First, individuals who are experiencing psychiatric symptoms deserve to have access treatment. Second, providing psychiatric treatment to individuals with minor attractions is a step toward preventing child sexual abuse. The Prevention Project Dunkelfeld in Germany used public service announcements to advertise confidential treatment for individuals who had sexual interest in children.²⁵ Many of the participants were interested in mental health treatment unrelated to their sexual interests. Such projects may help us understand the best way to meet the treatment needs of minor-attracted individuals, as well as reduce child sexual abuse. As psychiatrists, we can stop making the problem worse by withholding psychiatric treatment from an important population.

Resources for MAPs and clinicians

Currently, resources for MAPs and clinicians are limited. MAPs can communicate and find support among other MAPs in online forums (see Related Resources). These websites provide online peer support groups and guides for seeking therapy. Information for mental health professionals, including available literature, research projects, clinicians who provide specialized treatment, and a monthly “dialog on therapy” can be found on the B4U-ACT and the Global Prevention Project websites. However, beyond the DSM-5 definitions, psychiatric education and training on this topic is almost entirely lacking.

In light of the information discussed in this article, several important issues remain, including how psychiatrists can best reach this population, and how they can work toward decreasing stigma so they can provide meaningful care. The solutions start with education. Educating psychiatrists about this important population can decrease stigma and facilitate appropriate, compassionate care to these patients, with the result of improving the mental health of people with minor attraction and decreasing the incidence of child sexual abuse.

Continue to: Bottom Line

Minor-attracted persons report a high prevalence of general psychiatric symptoms that often go untreated due to a lack of willing clinicians with appropriate expertise. Providing psychiatric treatment to these patients can improve their mental health and possibly decrease the incidence of individuals who act on their attractions.

Related Resources

• B4U-ACT. www.b4uact.org • The Global Prevention Project. http://theglobalprevention project.org
• Virtuous Pedophiles. www.virped.org

Drug Brand Names

Naltrexone • ReVia

Approximately 1 in 5 Americans report childhood sexual abuse.¹ While 50% to 65% of child sexual abuse occurs in the absence of pedophilic interests and is thought to be driven by additional factors such as the availability of an appropriate sexual partner,^2,3 a substantial portion of childhood sexual abuse is perpetrated by individuals with pedophilia.

However, many individuals with pedophilic interests never have sexual contact with a child or the penal system. This non-offending pedophile group reports a greater prevalence of psychiatric symptoms compared with the general population, but given the intense stigmatization of their preferences, they are largely psychiatrically underrecognized and underserved. This article focuses on the unique psychiatric needs of this neglected population. By understanding and addressing the treatment needs of these patients, psychiatrists and other mental health clinicians can serve a pivotal role in decreasing stigma, promoting wellness, and preventing sexual abuse.

Understanding the terminology

DSM-5 defines paraphilia as “any intense and persistent sexual interest other than sexual interest in genital stimulation or preparatory fondling with phenotypically normal, physiologically mature, consenting human partners.”⁴ The addition of the word “disorder” to the paraphilias was introduced in DSM-5 to distinguish between paraphilias that are not of clinical concern and paraphilic disorders that cause distress or impairment to the individual, or whereby satisfaction entails personal harm or risk of harm to others. As outlined in DSM-5, pedophilic disorder refers to at least 6 months of recurrent, intense sexually arousing fantasies, sexual urges, or behaviors involving sexual activity with a prepubescent child.⁴ The individual has either acted on these sexual urges, or the sexual urges or fantasies cause marked distress or interpersonal difficulty. Lastly, the individual must be at least age 16 years and at least 5 years older than the child. Sexual attraction to peri- or postpubescent minors is not considered a psychiatric disorder, but is illegal.

Coined by B4U-ACT (www.b4uact.org), the term minor-attracted person (MAP) refers to individuals with sexual attraction to individuals who are minors or below the legal age of consent. MAP is an umbrella term that includes sexual attraction to prepubescent individuals but also includes sexual attraction to peri- and postpubescent individuals (Table 1). A MAP may or may not meet criteria for pedophilia or pedophilic disorder, based on the age of their sexual interest and whether they have experienced distress or acted on the attraction. Although many individuals with minor attraction identify with the term MAP, not all do. The term has been critiqued for being too inclusive and conflating pedophilia with minor attractions.

It is important to keep in mind that the terms pedophilia and minor attraction are not synonymous with childhood sexual abuser or “child molester” because neither term specifies whether the individual has had sexual contact with a child or legal consequences. The terms offending/non-offending and acting/non-acting are used to specify the presence of sexual contact with a child, and do not convey any clinical information.

Prevalence data

The true prevalence of pedophilia and/or attraction to minors is unknown, and estimates vary considerably. In some studies, 1% to 4% of the general population were thought to have persistent attraction to prepubescent children.^5,6 In a community sample of 8,718 German men, 4.1% reported sexual fantasies involving prepubescent children, 3.2% reported sexual offending against prepubescent children, and 0.1% reported a pedophilic sexual preference.⁵ In a study of 367 adult German men surveyed from the community, 15.5% reported fantasies (9.5% daydream and 6.0% masturbation fantasies) involving prepubescent children.⁷

Stigmatization of minor-attracted persons

Stigmatization is the process of forming negative evaluations of an individual or groups of people based on limited characteristics.^8,9 MAPs are a highly stigmatized group. This stigmatization can be profound, regardless of whether the MAP has had sexual contact with a child. A public survey of nearly 1,000 individuals showed that 39% believed that non-acting MAPs should be incarcerated, and 14% believed that they would be “better off dead.”¹⁰ Societal misconceptions of minor attraction are pervasive and include¹⁰:

• MAP sexual orientation is a choice
• MAPs cannot resist their sexual urges
• all MAPs have offended, or inevitably will
• MAPs will not respond to therapy
• MAPs are fundamentally predatory and immoral.

Continue to: In addition to...

In addition to societal stigma, internalized stigma among MAPs has been documented. Lievesley et al⁹ found that MAPs who engaged in suppression of unwanted thought strategies had higher levels of shame and guilt, low levels of hope, and a propensity to actively avoid children. Similarly, Grady et al¹¹ surveyed 293 MAPs and found prominent themes of viewing themselves as “bad.”

Psychiatric presentations include suicidal ideation

Many MAPs, including non-acting MAPs, internalize this societal stigma, which contributes to a significant mental health burden.¹² A survey of 342 MAP actors and 223 MAP non-actors revealed that one-third of both groups reported chronic suicidal ideation.¹³ In addition, online surveys conducted by B4U-ACT and Virtuous Pedophiles (www.virped.org)—both internet-based organizations dedicated to supporting non-acting MAPs—have provided similar results. In a 2011 B4U-ACT survey, nearly one-half of participants reported suicidal ideation due to their minor attraction, 32% had planned suicide attempts, and 13% had non-fatal suicide attempts. Notably, the age group with the most prevalent suicidal ideation was age 14 to 16 years,¹⁴ which makes minor attraction a prominent risk factor for suicidal ideation among patients seen by child psychiatrists.

A 2019 thematic analysis of 5,210 posts on the Virtuous Pedophiles website showed high rates of addiction, anxiety, depression, self-harm, self-hatred, and suicidal thoughts and behaviors among MAPs.² The majority of posts regarding substance use described such use as a means of dissociation. One post read, “…There are days I cannot bear to be sober … I … drink myself into a coma.” Anxiety themes regarding the ability to have a meaningful relationship with an age-appropriate partner and concerns about being “outed” followed by public persecution were prominent. Posts regarding self-injurious and suicidal behavior were common: “I want to kill myself so badly … I have to mutilate myself as punishment for my attractions. I wish myself dead. I don’t want to be attracted to children; I despise myself for fantasizing about them.”²

A study that analyzed a survey of 152 MAPs sampled from websites such as Virtuous Pedophiles and others showed >50% of respondents had strong feelings of isolation and loneliness, nearly 30% had extreme difficulty with concentration, >40% had significant anger and frustration, and >30% were struggling with feelings of detachment.¹² Notably, the respondents attributed these difficulties to their minor attraction.¹² Table 2^2,12-14 summarizes the findings of studies evaluating psychiatric symptoms in MAPs.

Consider OCD, hypersexuality

It is important to be aware that an attraction to minors may be a symptom of obsessive-compulsive disorder (OCD) or hypersexuality.¹⁵ Pedophilia-themed OCD (POCD) is a manifestation of OCD in which the individual experiences shame, fear, and excessive worry related to sexual attraction to children. Typically, individuals with POCD experience sexual thoughts of children as ego-dystonic, whereas MAPs experience such thoughts as ego-syntonic and arousing.¹⁵ However, much like individuals with POCD, MAPs also experience sexual thoughts of minors as distressing. Initial presentations of POCD may be confused with MAPs or pedophilia because of the overlap of symptoms such as anxiety, shame, distress, or suicidal ideation related to the idea of child sexual interests. The distinguishing feature of POCD is the absence of sexual arousal to children.

Continue to: Clinical presentations of...

Clinical presentations of hypersexuality may include sexual arousal to children. These individuals are distinguished from MAPs or those with pedophilia because they lack a preferred or sustained sexual interest in this group. On the contrary, individuals with hypersexuality present with a diversity of sexual interests explained by their high libido. Some individuals, however, may meet criteria for both hypersexuality and pedophilia. These individuals may pose a higher risk of sexual offending due to the presence of a heightened sexual drive and pedophilic interests, and thereby may require more intensive treatment, such as biologic treatment.

Focus on individualized treatment needs

Understanding the treatment needs of MAPs means understanding the goals of the individual MAP. Improving self-esteem, decreasing social isolation, and managing stigma are common treatment goals among MAPs.¹⁶ Levenson and Grady¹² found that most MAPs identified treatment goals unrelated to sexual interests, such as addressing depression, anxiety, and low self-esteem. A smaller percentage identified sexual frustration related to the absence of healthy sexual outlets. Because many MAPs identify common psychiatric treatment needs, most clinicians should be equipped to foster a nonjudgmental therapeutic alliance to treat these patients. Effective treatment outcomes occur when comorbid psychiatric illnesses are treated as well as addressing the internal stigmatization that many MAPs experience.

Specialized treatment may be indicated for individuals who request treatment specific to sexual interests. This may include safety planning, including developing support systems to decrease the risk around children. For MAPs who have been unsuccessful at managing their sexual interests, pharmacotherapy may be an option. To date, research on pharmacotherapy for pedophilia is largely limited to studies of sexual offenders. Testosterone-lowering medications such as gonadotropin-releasing hormone (GnRH) analogue treatment constitutes the most effective treatment for patients who are not helped by conventional psychotherapeutic interventions.¹⁷ Other psychotropic medications, such as selective serotonin reuptake inhibitors or naltrexone, have not demonstrated efficacy outside of case reports.¹⁷

Addressing barriers to care

MAPs have a strong desire but significant hesitation when seeking mental health treatment.^13,18 Nearly half (47%) of the 154 MAP respondents in the Levenson and Grady¹² survey had never told anyone about their minor attraction. MAPs are understandably hesitant to disclose these thoughts and feelings due to fear of public exposure and intense stigmatization, as well as potential punitive and legal consequences.^18,19 One post from the 2011 B4U-ACT online survey read, “Parents will disown you; teachers will report you; friends will abandon you … people in my situation can’t discuss this without serious risk of persecution and/or harassment.”¹⁴ In this survey, 78% of respondents feared a negative reaction by the professional, 78% feared being reported to law enforcement, and 68% feared being reported to family, an employer, or the community.¹⁴ This hesitancy due to fear of being exposed even extended to accessing self-help books, informational websites, and online forums, even though these sources are strongly desired and perceived as helpful.²⁰

Even if MAPs were to decide to seek help, the lack of specific training and experience among psychiatrists make them unlikely to find it in the medical field.²¹ Furthermore, MAPs who desire help often worry it will be inadequate and they will be misunderstood by their clinicians.²² According to the Levenson and Grady survey,¹² when asked what they would like most from therapy, most MAPs said they would want the treatment to focus on depression, anxiety, and low self-esteem rather than on sexual interest. In the B4U-ACT survey,¹⁴ many respondents identified the need for treatment of issues surrounding their sexual attraction, such as assistance in learning how to live in society with the attraction, dealing with society’s negative response to the attraction, and improving their self-concept in the presence of the extreme shame associated with the attraction. However, many MAPs find that clinicians tend to focus on protecting society from them, rather than on offering general psychiatric treatment or treatment focused on improving their well-being.¹⁸ This inability to locate appropriate services is known to exacerbate depression, suicidality, fear, anxiety, hopelessness, and substance abuse among MAPs.¹⁸ There is also evidence that individuals with minor attraction who are in a negative affective state are more likely to act on their attractions.²³

Continue to: An ethical responsibility

An ethical responsibility. Physicians have a long-recognized responsibility to participate in activities to protect and promote the health of the public. The American Medical Association Code of Medical Ethics includes “justice,” or treating patients fairly and equitably.²⁴ This includes patients who have pedophilic interests. Unfortunately, the stigma associated with individuals who have sexual attraction to children is pervasive in our society, including among medical professionals. The first consideration in treating MAPs is to overcome the stigmatization within our field, to remember that as physicians we took an oath to provide treatment fairly, equitably, and in accordance with the patient’s rights and entitlement.²⁴ This includes listening to MAPs’ treatment needs. Not all MAPs want or need treatment related to their sexual interest. As is the case with all patients, listening to the individual’s chief complaint is paramount. If a patient’s treatment needs are beyond the clinician’s expertise, the patient should be referred to another clinician.

Mandated reporting. MAPs may not engage in psychiatric treatment for fear of being reported to authorities as a result of mandated reporting laws. Although the circumstances under which mandated reporting may be required vary by jurisdiction, they generally include situations in which the health care professional has reasonable cause to believe that a child is suffering from abuse or neglect. A patient’s report of sexual urges and fantasies to have sexual contact with minors is not sufficient for mandated reporting. While professionals vary in their interpretation of mandated reporting laws, sexual thoughts alone do not meet the threshold for mandated reporting. Mandated reporting duties should be discussed when first meeting a patient with minor attraction. For clinicians who are uneasy about such distinctions, either supervision or not working with such patients is the solution.

The importance of providing competent and individualized treatment to MAPs is 2-fold. First, individuals who are experiencing psychiatric symptoms deserve to have access treatment. Second, providing psychiatric treatment to individuals with minor attractions is a step toward preventing child sexual abuse. The Prevention Project Dunkelfeld in Germany used public service announcements to advertise confidential treatment for individuals who had sexual interest in children.²⁵ Many of the participants were interested in mental health treatment unrelated to their sexual interests. Such projects may help us understand the best way to meet the treatment needs of minor-attracted individuals, as well as reduce child sexual abuse. As psychiatrists, we can stop making the problem worse by withholding psychiatric treatment from an important population.

Resources for MAPs and clinicians

Currently, resources for MAPs and clinicians are limited. MAPs can communicate and find support among other MAPs in online forums (see Related Resources). These websites provide online peer support groups and guides for seeking therapy. Information for mental health professionals, including available literature, research projects, clinicians who provide specialized treatment, and a monthly “dialog on therapy” can be found on the B4U-ACT and the Global Prevention Project websites. However, beyond the DSM-5 definitions, psychiatric education and training on this topic is almost entirely lacking.

In light of the information discussed in this article, several important issues remain, including how psychiatrists can best reach this population, and how they can work toward decreasing stigma so they can provide meaningful care. The solutions start with education. Educating psychiatrists about this important population can decrease stigma and facilitate appropriate, compassionate care to these patients, with the result of improving the mental health of people with minor attraction and decreasing the incidence of child sexual abuse.

Continue to: Bottom Line

Minor-attracted persons report a high prevalence of general psychiatric symptoms that often go untreated due to a lack of willing clinicians with appropriate expertise. Providing psychiatric treatment to these patients can improve their mental health and possibly decrease the incidence of individuals who act on their attractions.

Related Resources

• B4U-ACT. www.b4uact.org • The Global Prevention Project. http://theglobalprevention project.org
• Virtuous Pedophiles. www.virped.org

Drug Brand Names

Naltrexone • ReVia

Mr. J, age 30, a Black man with major depressive disorder (MDD), has been your patient for the past year. At the time of his diagnosis, Mr. J received sertraline, 100 mg/d, but had little to no improvement. During the past year, he received trials of citalopram and paroxetine, but they were not effective for his recurrent depressive symptoms and/or resulted in significant adverse effects.

During a recent visit, Mr. J asks you about “the genetic tests that help determine which medications will work.” He mentions that his brother had this testing done and that it had “worked for him,” but offers no other details. You research the different testing panels to see which test you might use. After a brief online review, you identify at least 4 different products, and are not sure which test—if any—you should consider.

During the last few years, there has been a rise in commercial pharmacogenetic testing options, including tests available to clinicians at academic medical centers as well as direct-to-consumer testing (Table). Clinician and patient interest regarding pharmacogenetic testing in practice is often followed by the question, “Which test is best?” Although this is a logical question, providing an answer is multifactorial.^1-3 Because none of the currently available tests have been compared in head-to-head clinical trials, it is nearly impossible to identify the “best” test.

In this article, we focus on the evidence-based principles that clinicians should consider when adopting pharmacogenetic testing in their practice. We discuss which genes are of most interest when prescribing psychotropic medications, the value of decision support tools, cost considerations, and patient education regarding this type of testing.

Which genes and variants should be tested?

The genes relevant to medication treatment outcomes can be broadly classified into those with pharmacokinetic vs pharmacodynamic effects. Pharmacogenes, such as those coding for the drug-metabolizing enzymes cytochrome P450 (CYP) 1A2, CYP2B6, CYP2C19, CYP2C9, CYP2D6, CYP3A4, and UDP-glucuronosyltransferase (UGT)2B1, may alter the rate at which medications are metabolized, thus varying the serum drug concentration across patients. Variants that impact the function of these enzymes are considered pharmacokinetic. Up to 40% of the variance in patients’ response to antidepressants may be due to variations in the pharmacokinetic genes.⁴ Alternatively, pharmacodynamic pharmacogenes impact drug action and therefore may affect the degree of receptor activation at a given drug concentration, overall drug efficacy, and/or the occurrence of medication sensitivity. These pharmacogenes may include:

• brain-derived neurotrophic factor (BDNF)
• catechol-O-methyltransferase (COMT)
• human leukocyte antigens A (HLA-A)
• serotonin receptor subtype 2 (HTR2)
• serotonin receptor subtype 2C (HTR2C)
• opioid receptor mu 1 (OPRM1)
• solute carrier family 6 member 4 (SLC6A4).

In articles previously published in Current Psychiatry, we outlined some of the evidence regarding these pharmacogenes, and resources available to clinicians to support their use of these tests.^1,2

Currently, there is no standardization among commercial pharmacogenetic tests on:

• which genes to test
• which variants specific to a gene need to be included
• how the genetic data is translated to phenotype
• how the phenotype is translated to a treatment recommendation.

Continue to: Due to these factors...

Due to these factors, the FDA has advised clinicians to consult the dosing recommendations provided in a medication’s package insert for information regarding how genetic information should be used in making treatment decisions.²

The value of decision support tools

Researchers have assessed how various manufacturers’ decision support tools (DSTs) (ie, the reports the commercial testing companies send to the clinician who orders the test) agree on genotypes, predicted phenotypes, and medication recommendations.⁴ Overall, this research found varying levels of disagreement in the medication recommendations of the testing panels they studied, which indicates that not all tests are equivalent or interchangeable.⁴ Of the actionable recommendations for antidepressants, 16% were conflicting; the recommendations for fluoxetine and imipramine were most frequently in disagreement.⁴ Similarly, 20% of the actionable antipsychotic advice was conflicting, with the recommendations for aripiprazole and clozapine most frequently in disagreement.⁴ Researchers also reported a situation in which 4 testing panels agreed on the patient’s phenotyping status for CYP2C19, but the dosing recommendations provided for the CYP2C19 substrate, amitriptyline, differed.⁴ Thus, it is understandable why DSTs can result in confusion, and why clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Additionally, while the genes included on these panels vary, these testing panels also may not evaluate the same variants within a specific gene. These differences may impact the patient’s reported phenotypes and medication recommendations across DSTs. For example, the FDA has recommended HLA gene testing prior to prescribing carbamazepine. However, few of the available tests may include the HLA-B*15:02 variant, which has been associated with carbamazepine-induced severe cutaneous reactions in patients of Asian descent, and fewer may include the HLA-A*31:01 variant, for which testing is recommended prior to prescribing carbamazepine in patients of Caucasian descent.⁴ Additionally, some of the CYP enzymes—such as CYP2D6*17 and CYP2C19*3 variants, which may be more common in certain populations of patients who are members of ethnic or racial minority groups—may not be consistently included in the various panels. Thus, before deciding on a specific test, clinicians should understand which gene variants are relevant to their patients with regard to race and ethnicity, and key variants for specific medications. Clinicians should refer to FDA guidance and the Clinical Pharmacogenomics Implementation Consortium (CPIC) guidelines to determine the appropriate interpretations of genetic test results.^1,2

Despite the disagreement in recommendations from the various testing companies, DSTs are useful and have been shown to facilitate implementation of relevant psycho­pharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. A recently published meta-analysis of randomized controlled trials (RCTs) of pharmacogenetic testing found that DSTs improved symptom remission among individuals with MDD by 70%.⁵ This suggests that pharmacogenetic-guided DSTs may provide superior treatment compared with treatment for DSTs were not used. However, the RCTs in this meta-analysis only included patients who had previously failed an antidepressant trial.⁵ Therefore, it is currently unknown at what point in care DSTs should be used, and whether they would be more beneficial if they are used when starting a new therapy, or after several trials have failed.

Consider the cost

The cost and availability of pharmacogenetic testing can be an issue when making treatment decisions, and such testing may not be covered by a patient’s insurance plan. Recently, the Centers for Medicare & Medicaid Services announced that Medicare would cover FDA-approved genomic tests that encompass broad gene panels if the evidence supports their use. Similarly, commercial insurers such as UnitedHealthcare have begun to cover some pharmacogenetic tests.⁶ Medicare or Medicaid plans cover some testing panels’ costs and patients do not incur any out-of-pocket costs; however, some private insurance companies require patients to pay at least a portion of the cost, and many companies offer financial assistance for patients based on income and other factors. Although financial coverage for testing has improved, patients may still face out-of-pocket costs; therefore, clinicians may need to weigh the benefits of pharmacogenetic testing vs its cost.⁷ Clinicians should also determine what timeline best suits their patient’s financial and clinical needs, and test accordingly.

Continue to: Patient education is critical

Although the benefits of using pharmacogenetic testing information when making certain treatment decisions is promising, it is important for both patients and clinicians to understand that test results do not always change therapy. A study on the impact of pharmacogenetic testing on clinical outcomes of patients with MDD found that 79% of patients were already prescribed medications that aligned with recommendations.⁸ Therefore, switching medications based on the test results of a patient who is doing well clinically is not recommended. However, DSTs may help with clinical decisions for ambiguous cases. For example, if a patient has a genotype and/or phenotype that aligns with medication recommendations, the DST might not be able to identify a better medication to use, but may be able to recommend dosing guidance to improve the tolerability of the patient’s current therapy.⁶ It is also important to understand that the results of such testing may have a broader use beyond the initial reason for obtaining testing, such as when prescribing a common blood thinner such as warfarin or clopidogrel. However, for many of the pharmacodynamic genes that are included in these panels, their use beyond the treatment of depression may be limited because outcome studies for pharmacodynamic pharmacogenes may vary based on psychiatric diagnosis. Regardless, it may be beneficial to securely save and store patient test results in a standardized place within the medical record for future use.

CASE CONTINUED

You work with Mr. J to help him understand the benefits and limitations associated with pharmacogenetic testing. Assuming Mr. J is comfortable with the costs of obtaining testing, you contact the testing companies you identified to determine the specific pharmacogene variants included on each of these panels, and which would be the most appropriate given his race. If the decision is made to order the testing, provide Mr. J with a copy of his testing report so that he can use this information should he need any additional pharmacotherapy in the future, and also maintain a copy in his patient records using a standardized location for easy future access. If Mr. J is not comfortable with the costs associated with the testing, find out which medication his brother is currently receiving for treatment; this information may help identify a treatment plan for Mr. J.

Impact on practice

As psychiatry continues to gain experience in using pharmacogenetic testing and DSTs to help guide treatments for depression and other disorders, clinicians need to learn about these tools and how to use an evidence-based approach to best implement them in their practice. Many academic medical centers have developed continuing education programs or consult services to help with this.^9,10 Just as the choice of which medication to use may be based partly on clinician experience, so too may be which pharmacogenetic test to use.

Bottom Line

Pharmacogenetic tests have not been examined in head-to-head clinical trials, which makes it nearly impossible to identify which test is best to use. Although the testing companies’ decision support tools (DSTs) often disagree in their recommendations, research has shown that using DSTs can facilitate implementation of relevant psychopharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. Clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Related Resources

• PGx Gene-specific information tables. www.pharmgkb.org/page/pgxGeneRef
• Clinical Pharmacogenetics Implementation Consortium. https://cpicpgx.org/guidelines/

Drug Brand Names

Aripiprazole • Abilify
Carbamazepine • Tegretol
Citalopram • Celexa
Clopidogrel • Plavix
Clozapine • Clozaril
Fluoxetine • Prozac
Imipramine • Tofranil
Paroxetine • Paxil
Sertraline • Zoloft
Warfarin • Coumadin, Jantoven

Mr. J, age 30, a Black man with major depressive disorder (MDD), has been your patient for the past year. At the time of his diagnosis, Mr. J received sertraline, 100 mg/d, but had little to no improvement. During the past year, he received trials of citalopram and paroxetine, but they were not effective for his recurrent depressive symptoms and/or resulted in significant adverse effects.

During a recent visit, Mr. J asks you about “the genetic tests that help determine which medications will work.” He mentions that his brother had this testing done and that it had “worked for him,” but offers no other details. You research the different testing panels to see which test you might use. After a brief online review, you identify at least 4 different products, and are not sure which test—if any—you should consider.

During the last few years, there has been a rise in commercial pharmacogenetic testing options, including tests available to clinicians at academic medical centers as well as direct-to-consumer testing (Table). Clinician and patient interest regarding pharmacogenetic testing in practice is often followed by the question, “Which test is best?” Although this is a logical question, providing an answer is multifactorial.^1-3 Because none of the currently available tests have been compared in head-to-head clinical trials, it is nearly impossible to identify the “best” test.

In this article, we focus on the evidence-based principles that clinicians should consider when adopting pharmacogenetic testing in their practice. We discuss which genes are of most interest when prescribing psychotropic medications, the value of decision support tools, cost considerations, and patient education regarding this type of testing.

Which genes and variants should be tested?

The genes relevant to medication treatment outcomes can be broadly classified into those with pharmacokinetic vs pharmacodynamic effects. Pharmacogenes, such as those coding for the drug-metabolizing enzymes cytochrome P450 (CYP) 1A2, CYP2B6, CYP2C19, CYP2C9, CYP2D6, CYP3A4, and UDP-glucuronosyltransferase (UGT)2B1, may alter the rate at which medications are metabolized, thus varying the serum drug concentration across patients. Variants that impact the function of these enzymes are considered pharmacokinetic. Up to 40% of the variance in patients’ response to antidepressants may be due to variations in the pharmacokinetic genes.⁴ Alternatively, pharmacodynamic pharmacogenes impact drug action and therefore may affect the degree of receptor activation at a given drug concentration, overall drug efficacy, and/or the occurrence of medication sensitivity. These pharmacogenes may include:

• brain-derived neurotrophic factor (BDNF)
• catechol-O-methyltransferase (COMT)
• human leukocyte antigens A (HLA-A)
• serotonin receptor subtype 2 (HTR2)
• serotonin receptor subtype 2C (HTR2C)
• opioid receptor mu 1 (OPRM1)
• solute carrier family 6 member 4 (SLC6A4).

In articles previously published in Current Psychiatry, we outlined some of the evidence regarding these pharmacogenes, and resources available to clinicians to support their use of these tests.^1,2

Currently, there is no standardization among commercial pharmacogenetic tests on:

• which genes to test
• which variants specific to a gene need to be included
• how the genetic data is translated to phenotype
• how the phenotype is translated to a treatment recommendation.

Continue to: Due to these factors...

Due to these factors, the FDA has advised clinicians to consult the dosing recommendations provided in a medication’s package insert for information regarding how genetic information should be used in making treatment decisions.²

The value of decision support tools

Researchers have assessed how various manufacturers’ decision support tools (DSTs) (ie, the reports the commercial testing companies send to the clinician who orders the test) agree on genotypes, predicted phenotypes, and medication recommendations.⁴ Overall, this research found varying levels of disagreement in the medication recommendations of the testing panels they studied, which indicates that not all tests are equivalent or interchangeable.⁴ Of the actionable recommendations for antidepressants, 16% were conflicting; the recommendations for fluoxetine and imipramine were most frequently in disagreement.⁴ Similarly, 20% of the actionable antipsychotic advice was conflicting, with the recommendations for aripiprazole and clozapine most frequently in disagreement.⁴ Researchers also reported a situation in which 4 testing panels agreed on the patient’s phenotyping status for CYP2C19, but the dosing recommendations provided for the CYP2C19 substrate, amitriptyline, differed.⁴ Thus, it is understandable why DSTs can result in confusion, and why clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Additionally, while the genes included on these panels vary, these testing panels also may not evaluate the same variants within a specific gene. These differences may impact the patient’s reported phenotypes and medication recommendations across DSTs. For example, the FDA has recommended HLA gene testing prior to prescribing carbamazepine. However, few of the available tests may include the HLA-B*15:02 variant, which has been associated with carbamazepine-induced severe cutaneous reactions in patients of Asian descent, and fewer may include the HLA-A*31:01 variant, for which testing is recommended prior to prescribing carbamazepine in patients of Caucasian descent.⁴ Additionally, some of the CYP enzymes—such as CYP2D6*17 and CYP2C19*3 variants, which may be more common in certain populations of patients who are members of ethnic or racial minority groups—may not be consistently included in the various panels. Thus, before deciding on a specific test, clinicians should understand which gene variants are relevant to their patients with regard to race and ethnicity, and key variants for specific medications. Clinicians should refer to FDA guidance and the Clinical Pharmacogenomics Implementation Consortium (CPIC) guidelines to determine the appropriate interpretations of genetic test results.^1,2

Despite the disagreement in recommendations from the various testing companies, DSTs are useful and have been shown to facilitate implementation of relevant psycho­pharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. A recently published meta-analysis of randomized controlled trials (RCTs) of pharmacogenetic testing found that DSTs improved symptom remission among individuals with MDD by 70%.⁵ This suggests that pharmacogenetic-guided DSTs may provide superior treatment compared with treatment for DSTs were not used. However, the RCTs in this meta-analysis only included patients who had previously failed an antidepressant trial.⁵ Therefore, it is currently unknown at what point in care DSTs should be used, and whether they would be more beneficial if they are used when starting a new therapy, or after several trials have failed.

Consider the cost

The cost and availability of pharmacogenetic testing can be an issue when making treatment decisions, and such testing may not be covered by a patient’s insurance plan. Recently, the Centers for Medicare & Medicaid Services announced that Medicare would cover FDA-approved genomic tests that encompass broad gene panels if the evidence supports their use. Similarly, commercial insurers such as UnitedHealthcare have begun to cover some pharmacogenetic tests.⁶ Medicare or Medicaid plans cover some testing panels’ costs and patients do not incur any out-of-pocket costs; however, some private insurance companies require patients to pay at least a portion of the cost, and many companies offer financial assistance for patients based on income and other factors. Although financial coverage for testing has improved, patients may still face out-of-pocket costs; therefore, clinicians may need to weigh the benefits of pharmacogenetic testing vs its cost.⁷ Clinicians should also determine what timeline best suits their patient’s financial and clinical needs, and test accordingly.

Continue to: Patient education is critical

Although the benefits of using pharmacogenetic testing information when making certain treatment decisions is promising, it is important for both patients and clinicians to understand that test results do not always change therapy. A study on the impact of pharmacogenetic testing on clinical outcomes of patients with MDD found that 79% of patients were already prescribed medications that aligned with recommendations.⁸ Therefore, switching medications based on the test results of a patient who is doing well clinically is not recommended. However, DSTs may help with clinical decisions for ambiguous cases. For example, if a patient has a genotype and/or phenotype that aligns with medication recommendations, the DST might not be able to identify a better medication to use, but may be able to recommend dosing guidance to improve the tolerability of the patient’s current therapy.⁶ It is also important to understand that the results of such testing may have a broader use beyond the initial reason for obtaining testing, such as when prescribing a common blood thinner such as warfarin or clopidogrel. However, for many of the pharmacodynamic genes that are included in these panels, their use beyond the treatment of depression may be limited because outcome studies for pharmacodynamic pharmacogenes may vary based on psychiatric diagnosis. Regardless, it may be beneficial to securely save and store patient test results in a standardized place within the medical record for future use.

CASE CONTINUED

You work with Mr. J to help him understand the benefits and limitations associated with pharmacogenetic testing. Assuming Mr. J is comfortable with the costs of obtaining testing, you contact the testing companies you identified to determine the specific pharmacogene variants included on each of these panels, and which would be the most appropriate given his race. If the decision is made to order the testing, provide Mr. J with a copy of his testing report so that he can use this information should he need any additional pharmacotherapy in the future, and also maintain a copy in his patient records using a standardized location for easy future access. If Mr. J is not comfortable with the costs associated with the testing, find out which medication his brother is currently receiving for treatment; this information may help identify a treatment plan for Mr. J.

Impact on practice

As psychiatry continues to gain experience in using pharmacogenetic testing and DSTs to help guide treatments for depression and other disorders, clinicians need to learn about these tools and how to use an evidence-based approach to best implement them in their practice. Many academic medical centers have developed continuing education programs or consult services to help with this.^9,10 Just as the choice of which medication to use may be based partly on clinician experience, so too may be which pharmacogenetic test to use.

Bottom Line

Pharmacogenetic tests have not been examined in head-to-head clinical trials, which makes it nearly impossible to identify which test is best to use. Although the testing companies’ decision support tools (DSTs) often disagree in their recommendations, research has shown that using DSTs can facilitate implementation of relevant psychopharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. Clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Related Resources

• PGx Gene-specific information tables. www.pharmgkb.org/page/pgxGeneRef
• Clinical Pharmacogenetics Implementation Consortium. https://cpicpgx.org/guidelines/

Drug Brand Names

Aripiprazole • Abilify
Carbamazepine • Tegretol
Citalopram • Celexa
Clopidogrel • Plavix
Clozapine • Clozaril
Fluoxetine • Prozac
Imipramine • Tofranil
Paroxetine • Paxil
Sertraline • Zoloft
Warfarin • Coumadin, Jantoven

Mr. J, age 30, a Black man with major depressive disorder (MDD), has been your patient for the past year. At the time of his diagnosis, Mr. J received sertraline, 100 mg/d, but had little to no improvement. During the past year, he received trials of citalopram and paroxetine, but they were not effective for his recurrent depressive symptoms and/or resulted in significant adverse effects.

During a recent visit, Mr. J asks you about “the genetic tests that help determine which medications will work.” He mentions that his brother had this testing done and that it had “worked for him,” but offers no other details. You research the different testing panels to see which test you might use. After a brief online review, you identify at least 4 different products, and are not sure which test—if any—you should consider.

During the last few years, there has been a rise in commercial pharmacogenetic testing options, including tests available to clinicians at academic medical centers as well as direct-to-consumer testing (Table). Clinician and patient interest regarding pharmacogenetic testing in practice is often followed by the question, “Which test is best?” Although this is a logical question, providing an answer is multifactorial.^1-3 Because none of the currently available tests have been compared in head-to-head clinical trials, it is nearly impossible to identify the “best” test.

In this article, we focus on the evidence-based principles that clinicians should consider when adopting pharmacogenetic testing in their practice. We discuss which genes are of most interest when prescribing psychotropic medications, the value of decision support tools, cost considerations, and patient education regarding this type of testing.

Which genes and variants should be tested?

The genes relevant to medication treatment outcomes can be broadly classified into those with pharmacokinetic vs pharmacodynamic effects. Pharmacogenes, such as those coding for the drug-metabolizing enzymes cytochrome P450 (CYP) 1A2, CYP2B6, CYP2C19, CYP2C9, CYP2D6, CYP3A4, and UDP-glucuronosyltransferase (UGT)2B1, may alter the rate at which medications are metabolized, thus varying the serum drug concentration across patients. Variants that impact the function of these enzymes are considered pharmacokinetic. Up to 40% of the variance in patients’ response to antidepressants may be due to variations in the pharmacokinetic genes.⁴ Alternatively, pharmacodynamic pharmacogenes impact drug action and therefore may affect the degree of receptor activation at a given drug concentration, overall drug efficacy, and/or the occurrence of medication sensitivity. These pharmacogenes may include:

• brain-derived neurotrophic factor (BDNF)
• catechol-O-methyltransferase (COMT)
• human leukocyte antigens A (HLA-A)
• serotonin receptor subtype 2 (HTR2)
• serotonin receptor subtype 2C (HTR2C)
• opioid receptor mu 1 (OPRM1)
• solute carrier family 6 member 4 (SLC6A4).

In articles previously published in Current Psychiatry, we outlined some of the evidence regarding these pharmacogenes, and resources available to clinicians to support their use of these tests.^1,2

Currently, there is no standardization among commercial pharmacogenetic tests on:

• which genes to test
• which variants specific to a gene need to be included
• how the genetic data is translated to phenotype
• how the phenotype is translated to a treatment recommendation.

Continue to: Due to these factors...

Due to these factors, the FDA has advised clinicians to consult the dosing recommendations provided in a medication’s package insert for information regarding how genetic information should be used in making treatment decisions.²

The value of decision support tools

Researchers have assessed how various manufacturers’ decision support tools (DSTs) (ie, the reports the commercial testing companies send to the clinician who orders the test) agree on genotypes, predicted phenotypes, and medication recommendations.⁴ Overall, this research found varying levels of disagreement in the medication recommendations of the testing panels they studied, which indicates that not all tests are equivalent or interchangeable.⁴ Of the actionable recommendations for antidepressants, 16% were conflicting; the recommendations for fluoxetine and imipramine were most frequently in disagreement.⁴ Similarly, 20% of the actionable antipsychotic advice was conflicting, with the recommendations for aripiprazole and clozapine most frequently in disagreement.⁴ Researchers also reported a situation in which 4 testing panels agreed on the patient’s phenotyping status for CYP2C19, but the dosing recommendations provided for the CYP2C19 substrate, amitriptyline, differed.⁴ Thus, it is understandable why DSTs can result in confusion, and why clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Additionally, while the genes included on these panels vary, these testing panels also may not evaluate the same variants within a specific gene. These differences may impact the patient’s reported phenotypes and medication recommendations across DSTs. For example, the FDA has recommended HLA gene testing prior to prescribing carbamazepine. However, few of the available tests may include the HLA-B*15:02 variant, which has been associated with carbamazepine-induced severe cutaneous reactions in patients of Asian descent, and fewer may include the HLA-A*31:01 variant, for which testing is recommended prior to prescribing carbamazepine in patients of Caucasian descent.⁴ Additionally, some of the CYP enzymes—such as CYP2D6*17 and CYP2C19*3 variants, which may be more common in certain populations of patients who are members of ethnic or racial minority groups—may not be consistently included in the various panels. Thus, before deciding on a specific test, clinicians should understand which gene variants are relevant to their patients with regard to race and ethnicity, and key variants for specific medications. Clinicians should refer to FDA guidance and the Clinical Pharmacogenomics Implementation Consortium (CPIC) guidelines to determine the appropriate interpretations of genetic test results.^1,2

Despite the disagreement in recommendations from the various testing companies, DSTs are useful and have been shown to facilitate implementation of relevant psycho­pharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. A recently published meta-analysis of randomized controlled trials (RCTs) of pharmacogenetic testing found that DSTs improved symptom remission among individuals with MDD by 70%.⁵ This suggests that pharmacogenetic-guided DSTs may provide superior treatment compared with treatment for DSTs were not used. However, the RCTs in this meta-analysis only included patients who had previously failed an antidepressant trial.⁵ Therefore, it is currently unknown at what point in care DSTs should be used, and whether they would be more beneficial if they are used when starting a new therapy, or after several trials have failed.

Consider the cost

The cost and availability of pharmacogenetic testing can be an issue when making treatment decisions, and such testing may not be covered by a patient’s insurance plan. Recently, the Centers for Medicare & Medicaid Services announced that Medicare would cover FDA-approved genomic tests that encompass broad gene panels if the evidence supports their use. Similarly, commercial insurers such as UnitedHealthcare have begun to cover some pharmacogenetic tests.⁶ Medicare or Medicaid plans cover some testing panels’ costs and patients do not incur any out-of-pocket costs; however, some private insurance companies require patients to pay at least a portion of the cost, and many companies offer financial assistance for patients based on income and other factors. Although financial coverage for testing has improved, patients may still face out-of-pocket costs; therefore, clinicians may need to weigh the benefits of pharmacogenetic testing vs its cost.⁷ Clinicians should also determine what timeline best suits their patient’s financial and clinical needs, and test accordingly.

Continue to: Patient education is critical

Although the benefits of using pharmacogenetic testing information when making certain treatment decisions is promising, it is important for both patients and clinicians to understand that test results do not always change therapy. A study on the impact of pharmacogenetic testing on clinical outcomes of patients with MDD found that 79% of patients were already prescribed medications that aligned with recommendations.⁸ Therefore, switching medications based on the test results of a patient who is doing well clinically is not recommended. However, DSTs may help with clinical decisions for ambiguous cases. For example, if a patient has a genotype and/or phenotype that aligns with medication recommendations, the DST might not be able to identify a better medication to use, but may be able to recommend dosing guidance to improve the tolerability of the patient’s current therapy.⁶ It is also important to understand that the results of such testing may have a broader use beyond the initial reason for obtaining testing, such as when prescribing a common blood thinner such as warfarin or clopidogrel. However, for many of the pharmacodynamic genes that are included in these panels, their use beyond the treatment of depression may be limited because outcome studies for pharmacodynamic pharmacogenes may vary based on psychiatric diagnosis. Regardless, it may be beneficial to securely save and store patient test results in a standardized place within the medical record for future use.

CASE CONTINUED

You work with Mr. J to help him understand the benefits and limitations associated with pharmacogenetic testing. Assuming Mr. J is comfortable with the costs of obtaining testing, you contact the testing companies you identified to determine the specific pharmacogene variants included on each of these panels, and which would be the most appropriate given his race. If the decision is made to order the testing, provide Mr. J with a copy of his testing report so that he can use this information should he need any additional pharmacotherapy in the future, and also maintain a copy in his patient records using a standardized location for easy future access. If Mr. J is not comfortable with the costs associated with the testing, find out which medication his brother is currently receiving for treatment; this information may help identify a treatment plan for Mr. J.

Impact on practice

As psychiatry continues to gain experience in using pharmacogenetic testing and DSTs to help guide treatments for depression and other disorders, clinicians need to learn about these tools and how to use an evidence-based approach to best implement them in their practice. Many academic medical centers have developed continuing education programs or consult services to help with this.^9,10 Just as the choice of which medication to use may be based partly on clinician experience, so too may be which pharmacogenetic test to use.

Bottom Line

Pharmacogenetic tests have not been examined in head-to-head clinical trials, which makes it nearly impossible to identify which test is best to use. Although the testing companies’ decision support tools (DSTs) often disagree in their recommendations, research has shown that using DSTs can facilitate implementation of relevant psychopharmacology dosing guidelines, assist in identifying optimal medication therapy, and improve patient outcomes. Clinicians should use testing panels with recommendations that best align with their individual practices, their patient’s needs, and FDA information.

Related Resources

• PGx Gene-specific information tables. www.pharmgkb.org/page/pgxGeneRef
• Clinical Pharmacogenetics Implementation Consortium. https://cpicpgx.org/guidelines/

Drug Brand Names

Aripiprazole • Abilify
Carbamazepine • Tegretol
Citalopram • Celexa
Clopidogrel • Plavix
Clozapine • Clozaril
Fluoxetine • Prozac
Imipramine • Tofranil
Paroxetine • Paxil
Sertraline • Zoloft
Warfarin • Coumadin, Jantoven