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FDA Expands Indication for Amivantamab in Lung Cancer
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Treating Family: Ethicist Discusses Whether It’s Appropriate
This transcript has been edited for clarity.
There’s a very interesting story in the medical press. A few years ago, a plastic surgeon named Edmond Cabbabe was preparing to do a follow-up cosmetic procedure on his wife at Mercy Hospital South, which is a big hospital in the St. Louis, Missouri, area.
He put her on the operating schedule, and he had done that when he had performed the original operation on her. On the day of the surgery, he got a call from the hospital saying the procedure was canceled. They said that the hospital’s policy, maybe a new one, would not allow doctors to operate on family members.
This physician was a past president of the Missouri State Medical Association. I think he was also on the board or president of the American Medical Association (AMA) Foundation. This was a physician not only in a skilled area where he felt confident he could take care of his wife, but also someone who was prominent in medical politics and medical policy.
The AMA forever has had a policy that says don’t treat relatives. This physician basically said, I think that policy is too restrictive, too cautious, and it doesn’t make much sense to continue to say that you can’t treat family and friends.
By implication, he was saying, I know exactly what I’m doing in my field and I know exactly what I’m doing with her procedure. I should have a right to perform it. I think I do a great job and I’d be best for her.
If you look at medical boards, every once in a while in some state, someone is brought up on a charge of doing different things with family members and saying that they’re going to get censured. They don’t usually lose their license, but they get a reprimand or get told that is just not ethical to do.
I think, in the long run, the policy about not treating your family and friends makes sense. The problem is, as is well known from the social sciences and psychology, people get biased when they deal with those they care about, love, and hold close to them.
It’s hard for the doctor to be objective when dealing with people that they really like or love. It’s also difficult for patients because they may not want to bring up something or they are uncomfortable talking with a doctor who’s a family member or close friend. They may not want to complain. They may be a little bit embarrassed about things. It just adds an emotional edge, I think, that’s difficult.
All that said, do I know doctors who regularly prescribe, say, an ointment for something that’s itchy or some kind of a pill when allergy season breaks out? I do. Do I think they’re acting in a horribly unethical manner? I don’t.
You need some judgment here. There are absolutely minor things where objectivity, fear, and anxiety are not in play. You’re going to be able to prescribe the routine thing for the routine itch without worrying too much about whether it’s a stranger, a friend, or your daughter.
What sorts of things am I really talking about when I say that minor variability ought to be allowed? It’s one thing when someone has poison ivy and they’re going to need some kind of standard medicine to treat it. A very different area that’s much more dangerous, and one I would avoid, is in the mental health field, and for that matter, the pain field.
It’s tempting to say: “Oh, my relative is just having a bad time. I’ll give her a little bit of antidepressant medicine,” or “They seem to be having pain after an operation or something, and I’m going to give them a little bit of pain meds just to get them through.”
Those areas are flying red flags. It’s easy to abuse and easy for someone to become a user and manipulate a friend or a doctor who’s a relative into getting things that another doctor wouldn’t be giving. I think that’s the space where you’ve got to exercise extreme caution.
Time and again, when those people get called up in front of the boards for treating relatives, it’s in those spaces of mental health, anxiety, and pain control. Again, when you know that there’s a likelihood of abuse, I think that’s the place where the line has to hold. Don’t treat the relative. Don’t treat the friend.
At the end of the day, I wouldn’t change the AMA policy. I think we should keep it in place and morally try to discourage doctors from caring for those they’re close to or they have emotional ties to.
At the same time, as with all ethical situations, there has to be a little bit of wiggle room for those super-minor cases where it just makes sense to say: “You don’t have to go find somebody else to do this. I can prescribe this ointment or this minor thing for you. No one’s objectivity is going to be soured, and you’re not going to feel in any way at risk because I’m going to prescribe this for you.”
Common sense ought to prevail. The default position is don’t do it; however, maybe with a tiny bit of space for what’s minor, what’s routine, and what really does just save people some inconvenience, there I might just give a little.
Dr. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York City, has disclosed relationships with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There’s a very interesting story in the medical press. A few years ago, a plastic surgeon named Edmond Cabbabe was preparing to do a follow-up cosmetic procedure on his wife at Mercy Hospital South, which is a big hospital in the St. Louis, Missouri, area.
He put her on the operating schedule, and he had done that when he had performed the original operation on her. On the day of the surgery, he got a call from the hospital saying the procedure was canceled. They said that the hospital’s policy, maybe a new one, would not allow doctors to operate on family members.
This physician was a past president of the Missouri State Medical Association. I think he was also on the board or president of the American Medical Association (AMA) Foundation. This was a physician not only in a skilled area where he felt confident he could take care of his wife, but also someone who was prominent in medical politics and medical policy.
The AMA forever has had a policy that says don’t treat relatives. This physician basically said, I think that policy is too restrictive, too cautious, and it doesn’t make much sense to continue to say that you can’t treat family and friends.
By implication, he was saying, I know exactly what I’m doing in my field and I know exactly what I’m doing with her procedure. I should have a right to perform it. I think I do a great job and I’d be best for her.
If you look at medical boards, every once in a while in some state, someone is brought up on a charge of doing different things with family members and saying that they’re going to get censured. They don’t usually lose their license, but they get a reprimand or get told that is just not ethical to do.
I think, in the long run, the policy about not treating your family and friends makes sense. The problem is, as is well known from the social sciences and psychology, people get biased when they deal with those they care about, love, and hold close to them.
It’s hard for the doctor to be objective when dealing with people that they really like or love. It’s also difficult for patients because they may not want to bring up something or they are uncomfortable talking with a doctor who’s a family member or close friend. They may not want to complain. They may be a little bit embarrassed about things. It just adds an emotional edge, I think, that’s difficult.
All that said, do I know doctors who regularly prescribe, say, an ointment for something that’s itchy or some kind of a pill when allergy season breaks out? I do. Do I think they’re acting in a horribly unethical manner? I don’t.
You need some judgment here. There are absolutely minor things where objectivity, fear, and anxiety are not in play. You’re going to be able to prescribe the routine thing for the routine itch without worrying too much about whether it’s a stranger, a friend, or your daughter.
What sorts of things am I really talking about when I say that minor variability ought to be allowed? It’s one thing when someone has poison ivy and they’re going to need some kind of standard medicine to treat it. A very different area that’s much more dangerous, and one I would avoid, is in the mental health field, and for that matter, the pain field.
It’s tempting to say: “Oh, my relative is just having a bad time. I’ll give her a little bit of antidepressant medicine,” or “They seem to be having pain after an operation or something, and I’m going to give them a little bit of pain meds just to get them through.”
Those areas are flying red flags. It’s easy to abuse and easy for someone to become a user and manipulate a friend or a doctor who’s a relative into getting things that another doctor wouldn’t be giving. I think that’s the space where you’ve got to exercise extreme caution.
Time and again, when those people get called up in front of the boards for treating relatives, it’s in those spaces of mental health, anxiety, and pain control. Again, when you know that there’s a likelihood of abuse, I think that’s the place where the line has to hold. Don’t treat the relative. Don’t treat the friend.
At the end of the day, I wouldn’t change the AMA policy. I think we should keep it in place and morally try to discourage doctors from caring for those they’re close to or they have emotional ties to.
At the same time, as with all ethical situations, there has to be a little bit of wiggle room for those super-minor cases where it just makes sense to say: “You don’t have to go find somebody else to do this. I can prescribe this ointment or this minor thing for you. No one’s objectivity is going to be soured, and you’re not going to feel in any way at risk because I’m going to prescribe this for you.”
Common sense ought to prevail. The default position is don’t do it; however, maybe with a tiny bit of space for what’s minor, what’s routine, and what really does just save people some inconvenience, there I might just give a little.
Dr. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York City, has disclosed relationships with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There’s a very interesting story in the medical press. A few years ago, a plastic surgeon named Edmond Cabbabe was preparing to do a follow-up cosmetic procedure on his wife at Mercy Hospital South, which is a big hospital in the St. Louis, Missouri, area.
He put her on the operating schedule, and he had done that when he had performed the original operation on her. On the day of the surgery, he got a call from the hospital saying the procedure was canceled. They said that the hospital’s policy, maybe a new one, would not allow doctors to operate on family members.
This physician was a past president of the Missouri State Medical Association. I think he was also on the board or president of the American Medical Association (AMA) Foundation. This was a physician not only in a skilled area where he felt confident he could take care of his wife, but also someone who was prominent in medical politics and medical policy.
The AMA forever has had a policy that says don’t treat relatives. This physician basically said, I think that policy is too restrictive, too cautious, and it doesn’t make much sense to continue to say that you can’t treat family and friends.
By implication, he was saying, I know exactly what I’m doing in my field and I know exactly what I’m doing with her procedure. I should have a right to perform it. I think I do a great job and I’d be best for her.
If you look at medical boards, every once in a while in some state, someone is brought up on a charge of doing different things with family members and saying that they’re going to get censured. They don’t usually lose their license, but they get a reprimand or get told that is just not ethical to do.
I think, in the long run, the policy about not treating your family and friends makes sense. The problem is, as is well known from the social sciences and psychology, people get biased when they deal with those they care about, love, and hold close to them.
It’s hard for the doctor to be objective when dealing with people that they really like or love. It’s also difficult for patients because they may not want to bring up something or they are uncomfortable talking with a doctor who’s a family member or close friend. They may not want to complain. They may be a little bit embarrassed about things. It just adds an emotional edge, I think, that’s difficult.
All that said, do I know doctors who regularly prescribe, say, an ointment for something that’s itchy or some kind of a pill when allergy season breaks out? I do. Do I think they’re acting in a horribly unethical manner? I don’t.
You need some judgment here. There are absolutely minor things where objectivity, fear, and anxiety are not in play. You’re going to be able to prescribe the routine thing for the routine itch without worrying too much about whether it’s a stranger, a friend, or your daughter.
What sorts of things am I really talking about when I say that minor variability ought to be allowed? It’s one thing when someone has poison ivy and they’re going to need some kind of standard medicine to treat it. A very different area that’s much more dangerous, and one I would avoid, is in the mental health field, and for that matter, the pain field.
It’s tempting to say: “Oh, my relative is just having a bad time. I’ll give her a little bit of antidepressant medicine,” or “They seem to be having pain after an operation or something, and I’m going to give them a little bit of pain meds just to get them through.”
Those areas are flying red flags. It’s easy to abuse and easy for someone to become a user and manipulate a friend or a doctor who’s a relative into getting things that another doctor wouldn’t be giving. I think that’s the space where you’ve got to exercise extreme caution.
Time and again, when those people get called up in front of the boards for treating relatives, it’s in those spaces of mental health, anxiety, and pain control. Again, when you know that there’s a likelihood of abuse, I think that’s the place where the line has to hold. Don’t treat the relative. Don’t treat the friend.
At the end of the day, I wouldn’t change the AMA policy. I think we should keep it in place and morally try to discourage doctors from caring for those they’re close to or they have emotional ties to.
At the same time, as with all ethical situations, there has to be a little bit of wiggle room for those super-minor cases where it just makes sense to say: “You don’t have to go find somebody else to do this. I can prescribe this ointment or this minor thing for you. No one’s objectivity is going to be soured, and you’re not going to feel in any way at risk because I’m going to prescribe this for you.”
Common sense ought to prevail. The default position is don’t do it; however, maybe with a tiny bit of space for what’s minor, what’s routine, and what really does just save people some inconvenience, there I might just give a little.
Dr. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York City, has disclosed relationships with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
Are You Using the Correct Medication or a Look-Alike?
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Cancer Risk: Are Pesticides the New Smoking?
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Should There Be a Mandatory Retirement Age for Physicians?
This transcript has been edited for clarity.
I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service?
You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement.
There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot.
The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that.
It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.
I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right?
In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.
Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.
In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.
This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.
These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.
They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it.
I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States.
I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area.
For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.
It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.
When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service?
You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement.
There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot.
The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that.
It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.
I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right?
In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.
Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.
In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.
This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.
These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.
They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it.
I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States.
I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area.
For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.
It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.
When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service?
You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement.
There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot.
The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that.
It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.
I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right?
In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.
Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.
In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.
This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.
These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.
They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it.
I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States.
I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area.
For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.
It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.
When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
When You and Your Malpractice Insurer Disagree on Your Case
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
‘Reform School’ for Pharmacy Benefit Managers: How Might Legislation Help Patients?
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
AI-Powered Clinical Documentation Tool Reduces EHR Time for Clinicians
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FDA OKs Subcutaneous Atezolizumab Formulation for Multiple Cancer Indications
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Montana Hospital to Pay $10.8M to Settle False Claims Oncology Suit
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.