Applied Evidence

CASE Anthony D, a 61-year-old patient of yours with hypertension and diabetes, is admitted to the hospital with atrial fibrillation and chest pain that radiates to his left arm and hand. On Day 1, he receives aspirin 325 mg and enoxaparin 1 mg/kg; the following day, the patient receives a 600-mg loading dose of clopidogrel prior to catheterization. He undergoes percutaneous coronary intervention and a bare metal stent is placed in his circumflex artery.

The following day, Anthony is ready for discharge and you consider which maintenance drugs to put him on, given that he already takes multiple medications. Is he a candidate for triple therapy?

Triple therapy—the concurrent use of aspirin, a thienopyridine antiplatelet agent, and warfarin—is often prescribed for patients with atrial fibrillation who experience acute coronary syndrome (ACS) or require percutaneous coronary intervention with the placement of a stent (PCI-S). The danger associated with concomitantly treating a patient with 3 agents, each of which has a distinct mechanism that increases bleeding risk, is high, but for carefully selected patients, the benefit may outweigh the risk.

Several studies have evaluated triple therapy and compared it with single or dual therapy (TABLE).^1-5 Due to a lack of robust outcome studies, however, the benefits and risks of triple therapy cannot be directly quantified, nor are they generalizable to all potential candidates for triple therapy. Thus, finding the optimal treatment for secondary prevention of ACS or prevention of stent thrombosis in a patient with atrial fibrillation requires an understanding of the potential consequences of triple therapy—and a thorough assessment of the patient’s risk of reinfarction, stroke, and bleeding complications.^6-9 To make the best treatment decisions and provide adequate support to patients who were started on triple therapy during a recent hospitalization, here’s what you need to know.

TABLE
Triple therapy: What the studies show

First, a review of the components

Aspirin, a key component of triple therapy, is the only nonsteroidal anti-inflammatory drug (NSAID) indicated for primary or secondary prevention of cardiovascular events.^10,11 The reason: Aspirin is more selective for cyclooxygenase-1 (COX-1) than other NSAIDs and irreversibly inhibits COX enzymes.¹¹ The aspirin-induced decrease in thromboxane production leads to a decline in platelet activation and aggregation, which accounts both for aspirin’s beneficial cardiovascular effects and the associated risk of bleeding—aspirin’s most common adverse effect.¹²

Most major bleeds linked to aspirin use involve the gastrointestinal (GI) tract, primarily because of the drug’s direct and indirect effects on the GI mucosa.^11-14 Aspirin’s toxicities are dose related, but its antiplatelet properties do not appear to be.¹⁴

Adding a thienopyridine
Thienopyridine antiplatelet drugs indicated for the secondary prevention of cardiovascular events after ACS or PCI-S include ticlopidine, clopidogrel, and prasugrel.¹⁵ Ticlopidine, the first such agent approved in the United States, is rarely used because of potential neutropenia and thrombotic thrombocytopenia purpura.¹⁶

Clopidogrel, the most commonly used agent for the purpose of secondary prevention, is the only thienopyridine with trial data for triple therapy.¹⁷ Clopidogrel’s antiplatelet effect, however, is highly dependent on specific cytochrome P-450 (CYP) enzymes for conversion to its active metabolite, and can be impaired by genetic variations in CYP 2C19, as well as by medication interactions. This has led to concern about the drug’s efficacy for secondary prevention of ACS.^6,17,18 In 2010, the US Food and Drug Administration (FDA) added a black-box warning for clopidogrel, emphasizing the risk of myocardial infarction (MI), stroke, and cardiovascular death in patients with defective CYP 2C19 activity.¹⁹

Prasugrel, approved by the FDA in 2009,²⁰ is useful for patients who respond poorly to clopidogrel. In fact, inadequate platelet inhibition with clopidogrel has prompted some physicians to choose prasugrel as a component of triple therapy.

While prasugrel may have greater efficacy compared with clopidogrel in preventing reinfarction, it appears to have a higher bleeding rate.^15,17 Because of its bleeding profile, prasugrel is not recommended for patients >75 years unless they are at high risk for MI (prior MI or diabetes), and it is contraindicated for patients with a history of stroke. Caution is needed when prasugrel is prescribed for patients who weigh <132 lb (consider a maintenance dose of 5 mg/d rather than the usual 10 mg/d) or have an increased propensity to bleed.¹⁵

Warfarin provides the anticoagulant component of triple therapy
Until late last year, when dabigatran received FDA approval for use in stroke prevention,²¹ warfarin was the only oral anticoagulant available in the United States. (To learn more about dabigatran, which is not included in this review because of the lack of evidence regarding its use in triple therapy, see “Time to try this warfarin alternative?”.)

Because multiple drug, food, and disease state interactions can interfere with warfarin therapy, frequent monitoring to maintain a target international normalized ratio (INR) is required.^22,23 (See Patient on warfarin? Steer clear of these drugs, in “Avoiding drug interactions: Here’s help,” J Fam Pract. 2010;59: 322-329).

Bridge therapy. Warfarin requires several days to reach its full effect, so anticoagulation with a more immediate-acting medication, such as a low-molecular-weight heparin or fondaparinux, is often used until the INR goal is reached.^22,23 Thus, there are instances in which patients requiring triple therapy are actually receiving 4 drugs that increase bleeding risk.

When (or whether) to consider triple therapy

While triple therapy may be an option for patients with atrial fibrillation and ACS or PCI-S, there is no validated scoring system to aid in treatment decisions.²⁴ As already noted, selecting the optimal therapy requires an individual assessment of the patient’s risk of reinfarction, stent thrombosis, stroke, and bleeding complications.

Risk factors for reinfarction and stent thrombosis are the same ones that increase the risk of ACS initially, and include diabetes mellitus, heart failure, smoking, hyperlipidemia, and hypertension.^10,16 Advanced age; uncontrolled hypertension; chronic conditions such as peripheral vascular disease, anemia, and peptic ulcer disease; and a history of major bleeds are associated with an increased risk of bleeding. ^24,25

In a retrospective trial evaluating independent predictors of major bleeding in patients with atrial fibrillation who underwent PCI-S,¹ the researchers identified several factors that increased the risk of early major bleeding (within 48 hours of stent placement): the use of a glycoprotein IIb/IIIa inhibitor, stenting of ≥3 vessels, or left main artery disease. Factors that significantly increased the risk of major bleeding more than 48 hours after the procedure included triple therapy, an early major bleed, and baseline anemia.¹

Drug combinations: What to consider
In addition to determining whether a patient is a good candidate for triple therapy, it is crucial to consider the choice of drugs. Benefits of prasugrel, compared with clopidogrel, include fewer drug interactions, less resistance to platelet inhibition, more rapid platelet inhibition after an oral loading dose, and higher levels of platelet inhibition during maintenance dosing.^15,17

Improved outcomes are another potential benefit, according to TRITON-Thrombolysis in Myocardial Infarction (TIMI) 38,¹⁷ a large randomized prospective trial comparing the use of prasugrel with clopidogrel in triple therapy. Among study participants, the primary outcome rate—the combined incidence of death from cardiovascular causes, nonfatal MI, and nonfatal stroke—was 9.9% for those on prasugrel vs 12.1% for the clopidogrel group (hazard ratio [HR]=0.81; 95% confidence interval [CI], 0.73-0.90, P<.001).¹⁷ The rate of TIMI major bleeding, however, was higher among those on prasugrel (HR=1.32; 95% CI, 1.03-1.68, P=.03). The evidence suggests that for every 1000 patients treated with prasugrel vs clopidogrel, 24 primary outcomes would be prevented but there would be 10 additional bleeding events.^17,26

CASE Anthony D’s risk for stroke, infarction, and stent thrombosis—based on his history of diabetes and hypertension, atrial fibrillation, and PCI-S—and absence of independent bleeding risk factors make him a good candidate for triple therapy. Because the patient is at high risk, the physician starts him on 2 anticoagulants—warfarin (5 mg at bedtime) and enoxaparin (125 mg every 12 hours)—on the evening of his second day in the hospital. On Day 3, clinicians test Anthony’s prothrombin time/international normalized ratio (PT/INR) and P₂Y₁₂ function assay, which measure 14.9/1.1 and 8% platelet inhibition, respectively.

The patient is discharged on the following medication schedule: enoxaparin 125 mg every 12 hours, to be discontinued after 3 days; warfarin 5 mg daily, prasugrel 10 mg daily, and aspirin 81 mg daily; metoprolol succinate 100 mg daily; lisinopril 10 mg daily; rosuvastatin 10 mg daily; glyburide-metformin 5 mg/500 mg, 2 tablets twice daily; and insulin glargine 20 units at bedtime.

Safety and efficacy: Do the benefits outweigh the risk?
Safety is central to the continuing controversy surrounding the use of triple therapy.^6,9 To date, however, no randomized prospective studies have evaluated its benefits and risks.

Numerous retrospective studies and case series have assessed the risk of bleeding associated with triple therapy.⁶ Several studies compared triple therapy with dual antiplatelet therapy without anticoagulation, and found a several-fold increase in both major and minor bleeding events in the triple therapy group.⁶

Few trials have assessed both the safety and the efficacy of triple therapy, however. One exception is a large retrospective trial, published in 2008.² The researchers found that triple therapy significantly reduced the incidence of major cardiac events (death, acute MI, and target lesion revascularization); all-cause mortality; and major adverse effects (ie, any major cardiovascular event, major bleeding complication, and/or stroke), with no statistically significant increase in major bleeding events compared with patients on antiplatelet therapy without anticoagulation.²

The results of this trial, like those of other studies evaluating triple therapy, were weakened by variance in both the duration of antithrombotic therapy and the drug therapies studied. This limitation was off set, however, by multivariant analysis and well-documented follow-up.² Despite the researchers’ findings, however, the results of other trials (and our knowledge of the mechanisms of action of the drug components) suggest that triple therapy significantly increases bleeding risk. For patients who would likely benefit from it but face an increased bleeding risk, there are ways to mitigate risk.

Prescribing triple therapy, while mitigating the risks
If bleeding is a serious concern in a patient who would benefit from triple therapy, the drug regimen may be adjusted. Options include:

• targeting a lower INR (2.0-2.5 vs the standard 2.0-3.0).⁶ While various trials have found a 2.0 to 3.0 range to reduce the risk of stroke, none has compared it with a lower range to evaluate reduction in bleeding risk.²⁷ One potential benefit of trying to maintain a lower INR is the decrease in deviations into the 3.0 to 4.0 range, which is associated with an increased bleeding risk.²⁸ However, lowering the INR target is not supported by any literature.^1,18
• using low-dose aspirin therapy after PCI-S
• limiting the thienopyridine component of triple therapy to one month after ACS or PCI-S.⁶

When the risks of triple therapy outweigh the benefits because of an exceedingly high bleeding risk, single antiplatelet therapy with warfarin is another option to consider.

CASE [H17012] Anthony D’s discharge instructions called for an 81 mg daily dose of aspirin, as opposed to the 325-mg dose for the first 3 months of triple therapy after stent placement recommended by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for unstable angina/ non-ST segment elevated MI.¹ Although the patient had no independent bleeding risk, his physician selected the lower dose of aspirin to mitigate the increased bleeding risk posed by the use of prasugrel as a component of triple therapy.⁶

Lower aspirin dose. Pharmacodynamic studies support the use of a lower dose of aspirin, finding that serum thromboxane is completely inhibited by a maintenance dose as low as 30 mg/d in healthy individuals and 50 mg/d for those with chronic stable angina.¹⁴ Using low-dose aspirin for the secondary prevention of ACS when triple therapy is indicated is likely to reduce GI toxicities as well as bleeding risk.

Reduce the duration of dual antiplatelet therapy. According to the ACC/AHA guidelines, thienopyridine therapy can be limited to one month in patients who are medically managed or have had a bare metal stent placed if there is concern about the patient’s risk of bleeding.^6,10 Based on the findings of the one study that found triple therapy to be an independent predictor of major bleeds, this approach seems reasonable.¹ It is called into question, however, by another recent trial, which found that patients on dual antiplatelet therapy for one year (vs one month) had a statistically significant improvement in cardiovascular outcomes.¹⁶

Before limiting a patient’s thienopyridine therapy to one month, consider his or her risk of reinfarction. If it is high, continuing the thienopyridine for at least one year is likely to provide the most benefit.

The largest triple therapy trial to date compared the efficacy of triple therapy vs dual therapy (a single antiplatelet agent plus warfarin) in patients with ACS and an indication for warfarin therapy.³ This trial found no statistically significant differences in the combined occurrence of death, stroke, unscheduled PCI, and MI between the 2 treatment groups. (Bleeding risk was not evaluated.) Stroke was significantly increased in the group that received therapy with warfarin and a single antiplatelet agent, with this caveat: The occurrence of stroke was so low overall that no conclusions could be reached from this difference.³

One problem with this trial, and with others evaluating triple therapy, has to do with the lack of consistency, as well as the duration. The warfarin and single antiplatelet group, for example, may have included patients who were receiving only warfarin, aspirin, or clopidogrel by 6 months after initiating treatment.³ Thus, although reinfarction or stent thrombosis after ACS or PCI-S typically occurs within the first few months, any triple therapy trial that lasts less than a year is likely to report skewed results. JFP

CORRESPONDENCE
Haley M. Phillippe, PharmD, BCPS, Auburn University Harrison School of Pharmacy, University of Alabama Birmingham School of Medicine?Huntsville, 301 Governors Drive, Huntsville, AL 35801; mccrahl@auburn.edu

CASE Anthony D, a 61-year-old patient of yours with hypertension and diabetes, is admitted to the hospital with atrial fibrillation and chest pain that radiates to his left arm and hand. On Day 1, he receives aspirin 325 mg and enoxaparin 1 mg/kg; the following day, the patient receives a 600-mg loading dose of clopidogrel prior to catheterization. He undergoes percutaneous coronary intervention and a bare metal stent is placed in his circumflex artery.

The following day, Anthony is ready for discharge and you consider which maintenance drugs to put him on, given that he already takes multiple medications. Is he a candidate for triple therapy?

Triple therapy—the concurrent use of aspirin, a thienopyridine antiplatelet agent, and warfarin—is often prescribed for patients with atrial fibrillation who experience acute coronary syndrome (ACS) or require percutaneous coronary intervention with the placement of a stent (PCI-S). The danger associated with concomitantly treating a patient with 3 agents, each of which has a distinct mechanism that increases bleeding risk, is high, but for carefully selected patients, the benefit may outweigh the risk.

Several studies have evaluated triple therapy and compared it with single or dual therapy (TABLE).^1-5 Due to a lack of robust outcome studies, however, the benefits and risks of triple therapy cannot be directly quantified, nor are they generalizable to all potential candidates for triple therapy. Thus, finding the optimal treatment for secondary prevention of ACS or prevention of stent thrombosis in a patient with atrial fibrillation requires an understanding of the potential consequences of triple therapy—and a thorough assessment of the patient’s risk of reinfarction, stroke, and bleeding complications.^6-9 To make the best treatment decisions and provide adequate support to patients who were started on triple therapy during a recent hospitalization, here’s what you need to know.

TABLE
Triple therapy: What the studies show

First, a review of the components

Aspirin, a key component of triple therapy, is the only nonsteroidal anti-inflammatory drug (NSAID) indicated for primary or secondary prevention of cardiovascular events.^10,11 The reason: Aspirin is more selective for cyclooxygenase-1 (COX-1) than other NSAIDs and irreversibly inhibits COX enzymes.¹¹ The aspirin-induced decrease in thromboxane production leads to a decline in platelet activation and aggregation, which accounts both for aspirin’s beneficial cardiovascular effects and the associated risk of bleeding—aspirin’s most common adverse effect.¹²

Most major bleeds linked to aspirin use involve the gastrointestinal (GI) tract, primarily because of the drug’s direct and indirect effects on the GI mucosa.^11-14 Aspirin’s toxicities are dose related, but its antiplatelet properties do not appear to be.¹⁴

Adding a thienopyridine
Thienopyridine antiplatelet drugs indicated for the secondary prevention of cardiovascular events after ACS or PCI-S include ticlopidine, clopidogrel, and prasugrel.¹⁵ Ticlopidine, the first such agent approved in the United States, is rarely used because of potential neutropenia and thrombotic thrombocytopenia purpura.¹⁶

Clopidogrel, the most commonly used agent for the purpose of secondary prevention, is the only thienopyridine with trial data for triple therapy.¹⁷ Clopidogrel’s antiplatelet effect, however, is highly dependent on specific cytochrome P-450 (CYP) enzymes for conversion to its active metabolite, and can be impaired by genetic variations in CYP 2C19, as well as by medication interactions. This has led to concern about the drug’s efficacy for secondary prevention of ACS.^6,17,18 In 2010, the US Food and Drug Administration (FDA) added a black-box warning for clopidogrel, emphasizing the risk of myocardial infarction (MI), stroke, and cardiovascular death in patients with defective CYP 2C19 activity.¹⁹

Prasugrel, approved by the FDA in 2009,²⁰ is useful for patients who respond poorly to clopidogrel. In fact, inadequate platelet inhibition with clopidogrel has prompted some physicians to choose prasugrel as a component of triple therapy.

While prasugrel may have greater efficacy compared with clopidogrel in preventing reinfarction, it appears to have a higher bleeding rate.^15,17 Because of its bleeding profile, prasugrel is not recommended for patients >75 years unless they are at high risk for MI (prior MI or diabetes), and it is contraindicated for patients with a history of stroke. Caution is needed when prasugrel is prescribed for patients who weigh <132 lb (consider a maintenance dose of 5 mg/d rather than the usual 10 mg/d) or have an increased propensity to bleed.¹⁵

Warfarin provides the anticoagulant component of triple therapy
Until late last year, when dabigatran received FDA approval for use in stroke prevention,²¹ warfarin was the only oral anticoagulant available in the United States. (To learn more about dabigatran, which is not included in this review because of the lack of evidence regarding its use in triple therapy, see “Time to try this warfarin alternative?”.)

Because multiple drug, food, and disease state interactions can interfere with warfarin therapy, frequent monitoring to maintain a target international normalized ratio (INR) is required.^22,23 (See Patient on warfarin? Steer clear of these drugs, in “Avoiding drug interactions: Here’s help,” J Fam Pract. 2010;59: 322-329).

Bridge therapy. Warfarin requires several days to reach its full effect, so anticoagulation with a more immediate-acting medication, such as a low-molecular-weight heparin or fondaparinux, is often used until the INR goal is reached.^22,23 Thus, there are instances in which patients requiring triple therapy are actually receiving 4 drugs that increase bleeding risk.

When (or whether) to consider triple therapy

While triple therapy may be an option for patients with atrial fibrillation and ACS or PCI-S, there is no validated scoring system to aid in treatment decisions.²⁴ As already noted, selecting the optimal therapy requires an individual assessment of the patient’s risk of reinfarction, stent thrombosis, stroke, and bleeding complications.

Risk factors for reinfarction and stent thrombosis are the same ones that increase the risk of ACS initially, and include diabetes mellitus, heart failure, smoking, hyperlipidemia, and hypertension.^10,16 Advanced age; uncontrolled hypertension; chronic conditions such as peripheral vascular disease, anemia, and peptic ulcer disease; and a history of major bleeds are associated with an increased risk of bleeding. ^24,25

In a retrospective trial evaluating independent predictors of major bleeding in patients with atrial fibrillation who underwent PCI-S,¹ the researchers identified several factors that increased the risk of early major bleeding (within 48 hours of stent placement): the use of a glycoprotein IIb/IIIa inhibitor, stenting of ≥3 vessels, or left main artery disease. Factors that significantly increased the risk of major bleeding more than 48 hours after the procedure included triple therapy, an early major bleed, and baseline anemia.¹

Drug combinations: What to consider
In addition to determining whether a patient is a good candidate for triple therapy, it is crucial to consider the choice of drugs. Benefits of prasugrel, compared with clopidogrel, include fewer drug interactions, less resistance to platelet inhibition, more rapid platelet inhibition after an oral loading dose, and higher levels of platelet inhibition during maintenance dosing.^15,17

Improved outcomes are another potential benefit, according to TRITON-Thrombolysis in Myocardial Infarction (TIMI) 38,¹⁷ a large randomized prospective trial comparing the use of prasugrel with clopidogrel in triple therapy. Among study participants, the primary outcome rate—the combined incidence of death from cardiovascular causes, nonfatal MI, and nonfatal stroke—was 9.9% for those on prasugrel vs 12.1% for the clopidogrel group (hazard ratio [HR]=0.81; 95% confidence interval [CI], 0.73-0.90, P<.001).¹⁷ The rate of TIMI major bleeding, however, was higher among those on prasugrel (HR=1.32; 95% CI, 1.03-1.68, P=.03). The evidence suggests that for every 1000 patients treated with prasugrel vs clopidogrel, 24 primary outcomes would be prevented but there would be 10 additional bleeding events.^17,26

CASE Anthony D’s risk for stroke, infarction, and stent thrombosis—based on his history of diabetes and hypertension, atrial fibrillation, and PCI-S—and absence of independent bleeding risk factors make him a good candidate for triple therapy. Because the patient is at high risk, the physician starts him on 2 anticoagulants—warfarin (5 mg at bedtime) and enoxaparin (125 mg every 12 hours)—on the evening of his second day in the hospital. On Day 3, clinicians test Anthony’s prothrombin time/international normalized ratio (PT/INR) and P₂Y₁₂ function assay, which measure 14.9/1.1 and 8% platelet inhibition, respectively.

The patient is discharged on the following medication schedule: enoxaparin 125 mg every 12 hours, to be discontinued after 3 days; warfarin 5 mg daily, prasugrel 10 mg daily, and aspirin 81 mg daily; metoprolol succinate 100 mg daily; lisinopril 10 mg daily; rosuvastatin 10 mg daily; glyburide-metformin 5 mg/500 mg, 2 tablets twice daily; and insulin glargine 20 units at bedtime.

Safety and efficacy: Do the benefits outweigh the risk?
Safety is central to the continuing controversy surrounding the use of triple therapy.^6,9 To date, however, no randomized prospective studies have evaluated its benefits and risks.

Numerous retrospective studies and case series have assessed the risk of bleeding associated with triple therapy.⁶ Several studies compared triple therapy with dual antiplatelet therapy without anticoagulation, and found a several-fold increase in both major and minor bleeding events in the triple therapy group.⁶

Few trials have assessed both the safety and the efficacy of triple therapy, however. One exception is a large retrospective trial, published in 2008.² The researchers found that triple therapy significantly reduced the incidence of major cardiac events (death, acute MI, and target lesion revascularization); all-cause mortality; and major adverse effects (ie, any major cardiovascular event, major bleeding complication, and/or stroke), with no statistically significant increase in major bleeding events compared with patients on antiplatelet therapy without anticoagulation.²

The results of this trial, like those of other studies evaluating triple therapy, were weakened by variance in both the duration of antithrombotic therapy and the drug therapies studied. This limitation was off set, however, by multivariant analysis and well-documented follow-up.² Despite the researchers’ findings, however, the results of other trials (and our knowledge of the mechanisms of action of the drug components) suggest that triple therapy significantly increases bleeding risk. For patients who would likely benefit from it but face an increased bleeding risk, there are ways to mitigate risk.

Prescribing triple therapy, while mitigating the risks
If bleeding is a serious concern in a patient who would benefit from triple therapy, the drug regimen may be adjusted. Options include:

• targeting a lower INR (2.0-2.5 vs the standard 2.0-3.0).⁶ While various trials have found a 2.0 to 3.0 range to reduce the risk of stroke, none has compared it with a lower range to evaluate reduction in bleeding risk.²⁷ One potential benefit of trying to maintain a lower INR is the decrease in deviations into the 3.0 to 4.0 range, which is associated with an increased bleeding risk.²⁸ However, lowering the INR target is not supported by any literature.^1,18
• using low-dose aspirin therapy after PCI-S
• limiting the thienopyridine component of triple therapy to one month after ACS or PCI-S.⁶

When the risks of triple therapy outweigh the benefits because of an exceedingly high bleeding risk, single antiplatelet therapy with warfarin is another option to consider.

CASE [H17012] Anthony D’s discharge instructions called for an 81 mg daily dose of aspirin, as opposed to the 325-mg dose for the first 3 months of triple therapy after stent placement recommended by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for unstable angina/ non-ST segment elevated MI.¹ Although the patient had no independent bleeding risk, his physician selected the lower dose of aspirin to mitigate the increased bleeding risk posed by the use of prasugrel as a component of triple therapy.⁶

Lower aspirin dose. Pharmacodynamic studies support the use of a lower dose of aspirin, finding that serum thromboxane is completely inhibited by a maintenance dose as low as 30 mg/d in healthy individuals and 50 mg/d for those with chronic stable angina.¹⁴ Using low-dose aspirin for the secondary prevention of ACS when triple therapy is indicated is likely to reduce GI toxicities as well as bleeding risk.

Reduce the duration of dual antiplatelet therapy. According to the ACC/AHA guidelines, thienopyridine therapy can be limited to one month in patients who are medically managed or have had a bare metal stent placed if there is concern about the patient’s risk of bleeding.^6,10 Based on the findings of the one study that found triple therapy to be an independent predictor of major bleeds, this approach seems reasonable.¹ It is called into question, however, by another recent trial, which found that patients on dual antiplatelet therapy for one year (vs one month) had a statistically significant improvement in cardiovascular outcomes.¹⁶

Before limiting a patient’s thienopyridine therapy to one month, consider his or her risk of reinfarction. If it is high, continuing the thienopyridine for at least one year is likely to provide the most benefit.

The largest triple therapy trial to date compared the efficacy of triple therapy vs dual therapy (a single antiplatelet agent plus warfarin) in patients with ACS and an indication for warfarin therapy.³ This trial found no statistically significant differences in the combined occurrence of death, stroke, unscheduled PCI, and MI between the 2 treatment groups. (Bleeding risk was not evaluated.) Stroke was significantly increased in the group that received therapy with warfarin and a single antiplatelet agent, with this caveat: The occurrence of stroke was so low overall that no conclusions could be reached from this difference.³

One problem with this trial, and with others evaluating triple therapy, has to do with the lack of consistency, as well as the duration. The warfarin and single antiplatelet group, for example, may have included patients who were receiving only warfarin, aspirin, or clopidogrel by 6 months after initiating treatment.³ Thus, although reinfarction or stent thrombosis after ACS or PCI-S typically occurs within the first few months, any triple therapy trial that lasts less than a year is likely to report skewed results. JFP

CORRESPONDENCE
Haley M. Phillippe, PharmD, BCPS, Auburn University Harrison School of Pharmacy, University of Alabama Birmingham School of Medicine?Huntsville, 301 Governors Drive, Huntsville, AL 35801; mccrahl@auburn.edu

CASE Anthony D, a 61-year-old patient of yours with hypertension and diabetes, is admitted to the hospital with atrial fibrillation and chest pain that radiates to his left arm and hand. On Day 1, he receives aspirin 325 mg and enoxaparin 1 mg/kg; the following day, the patient receives a 600-mg loading dose of clopidogrel prior to catheterization. He undergoes percutaneous coronary intervention and a bare metal stent is placed in his circumflex artery.

The following day, Anthony is ready for discharge and you consider which maintenance drugs to put him on, given that he already takes multiple medications. Is he a candidate for triple therapy?

Triple therapy—the concurrent use of aspirin, a thienopyridine antiplatelet agent, and warfarin—is often prescribed for patients with atrial fibrillation who experience acute coronary syndrome (ACS) or require percutaneous coronary intervention with the placement of a stent (PCI-S). The danger associated with concomitantly treating a patient with 3 agents, each of which has a distinct mechanism that increases bleeding risk, is high, but for carefully selected patients, the benefit may outweigh the risk.

Several studies have evaluated triple therapy and compared it with single or dual therapy (TABLE).^1-5 Due to a lack of robust outcome studies, however, the benefits and risks of triple therapy cannot be directly quantified, nor are they generalizable to all potential candidates for triple therapy. Thus, finding the optimal treatment for secondary prevention of ACS or prevention of stent thrombosis in a patient with atrial fibrillation requires an understanding of the potential consequences of triple therapy—and a thorough assessment of the patient’s risk of reinfarction, stroke, and bleeding complications.^6-9 To make the best treatment decisions and provide adequate support to patients who were started on triple therapy during a recent hospitalization, here’s what you need to know.

TABLE
Triple therapy: What the studies show

First, a review of the components

Aspirin, a key component of triple therapy, is the only nonsteroidal anti-inflammatory drug (NSAID) indicated for primary or secondary prevention of cardiovascular events.^10,11 The reason: Aspirin is more selective for cyclooxygenase-1 (COX-1) than other NSAIDs and irreversibly inhibits COX enzymes.¹¹ The aspirin-induced decrease in thromboxane production leads to a decline in platelet activation and aggregation, which accounts both for aspirin’s beneficial cardiovascular effects and the associated risk of bleeding—aspirin’s most common adverse effect.¹²

Most major bleeds linked to aspirin use involve the gastrointestinal (GI) tract, primarily because of the drug’s direct and indirect effects on the GI mucosa.^11-14 Aspirin’s toxicities are dose related, but its antiplatelet properties do not appear to be.¹⁴

Adding a thienopyridine
Thienopyridine antiplatelet drugs indicated for the secondary prevention of cardiovascular events after ACS or PCI-S include ticlopidine, clopidogrel, and prasugrel.¹⁵ Ticlopidine, the first such agent approved in the United States, is rarely used because of potential neutropenia and thrombotic thrombocytopenia purpura.¹⁶

Clopidogrel, the most commonly used agent for the purpose of secondary prevention, is the only thienopyridine with trial data for triple therapy.¹⁷ Clopidogrel’s antiplatelet effect, however, is highly dependent on specific cytochrome P-450 (CYP) enzymes for conversion to its active metabolite, and can be impaired by genetic variations in CYP 2C19, as well as by medication interactions. This has led to concern about the drug’s efficacy for secondary prevention of ACS.^6,17,18 In 2010, the US Food and Drug Administration (FDA) added a black-box warning for clopidogrel, emphasizing the risk of myocardial infarction (MI), stroke, and cardiovascular death in patients with defective CYP 2C19 activity.¹⁹

Prasugrel, approved by the FDA in 2009,²⁰ is useful for patients who respond poorly to clopidogrel. In fact, inadequate platelet inhibition with clopidogrel has prompted some physicians to choose prasugrel as a component of triple therapy.

While prasugrel may have greater efficacy compared with clopidogrel in preventing reinfarction, it appears to have a higher bleeding rate.^15,17 Because of its bleeding profile, prasugrel is not recommended for patients >75 years unless they are at high risk for MI (prior MI or diabetes), and it is contraindicated for patients with a history of stroke. Caution is needed when prasugrel is prescribed for patients who weigh <132 lb (consider a maintenance dose of 5 mg/d rather than the usual 10 mg/d) or have an increased propensity to bleed.¹⁵

Warfarin provides the anticoagulant component of triple therapy
Until late last year, when dabigatran received FDA approval for use in stroke prevention,²¹ warfarin was the only oral anticoagulant available in the United States. (To learn more about dabigatran, which is not included in this review because of the lack of evidence regarding its use in triple therapy, see “Time to try this warfarin alternative?”.)

Because multiple drug, food, and disease state interactions can interfere with warfarin therapy, frequent monitoring to maintain a target international normalized ratio (INR) is required.^22,23 (See Patient on warfarin? Steer clear of these drugs, in “Avoiding drug interactions: Here’s help,” J Fam Pract. 2010;59: 322-329).

Bridge therapy. Warfarin requires several days to reach its full effect, so anticoagulation with a more immediate-acting medication, such as a low-molecular-weight heparin or fondaparinux, is often used until the INR goal is reached.^22,23 Thus, there are instances in which patients requiring triple therapy are actually receiving 4 drugs that increase bleeding risk.

When (or whether) to consider triple therapy

While triple therapy may be an option for patients with atrial fibrillation and ACS or PCI-S, there is no validated scoring system to aid in treatment decisions.²⁴ As already noted, selecting the optimal therapy requires an individual assessment of the patient’s risk of reinfarction, stent thrombosis, stroke, and bleeding complications.

Risk factors for reinfarction and stent thrombosis are the same ones that increase the risk of ACS initially, and include diabetes mellitus, heart failure, smoking, hyperlipidemia, and hypertension.^10,16 Advanced age; uncontrolled hypertension; chronic conditions such as peripheral vascular disease, anemia, and peptic ulcer disease; and a history of major bleeds are associated with an increased risk of bleeding. ^24,25

In a retrospective trial evaluating independent predictors of major bleeding in patients with atrial fibrillation who underwent PCI-S,¹ the researchers identified several factors that increased the risk of early major bleeding (within 48 hours of stent placement): the use of a glycoprotein IIb/IIIa inhibitor, stenting of ≥3 vessels, or left main artery disease. Factors that significantly increased the risk of major bleeding more than 48 hours after the procedure included triple therapy, an early major bleed, and baseline anemia.¹

Drug combinations: What to consider
In addition to determining whether a patient is a good candidate for triple therapy, it is crucial to consider the choice of drugs. Benefits of prasugrel, compared with clopidogrel, include fewer drug interactions, less resistance to platelet inhibition, more rapid platelet inhibition after an oral loading dose, and higher levels of platelet inhibition during maintenance dosing.^15,17

Improved outcomes are another potential benefit, according to TRITON-Thrombolysis in Myocardial Infarction (TIMI) 38,¹⁷ a large randomized prospective trial comparing the use of prasugrel with clopidogrel in triple therapy. Among study participants, the primary outcome rate—the combined incidence of death from cardiovascular causes, nonfatal MI, and nonfatal stroke—was 9.9% for those on prasugrel vs 12.1% for the clopidogrel group (hazard ratio [HR]=0.81; 95% confidence interval [CI], 0.73-0.90, P<.001).¹⁷ The rate of TIMI major bleeding, however, was higher among those on prasugrel (HR=1.32; 95% CI, 1.03-1.68, P=.03). The evidence suggests that for every 1000 patients treated with prasugrel vs clopidogrel, 24 primary outcomes would be prevented but there would be 10 additional bleeding events.^17,26

CASE Anthony D’s risk for stroke, infarction, and stent thrombosis—based on his history of diabetes and hypertension, atrial fibrillation, and PCI-S—and absence of independent bleeding risk factors make him a good candidate for triple therapy. Because the patient is at high risk, the physician starts him on 2 anticoagulants—warfarin (5 mg at bedtime) and enoxaparin (125 mg every 12 hours)—on the evening of his second day in the hospital. On Day 3, clinicians test Anthony’s prothrombin time/international normalized ratio (PT/INR) and P₂Y₁₂ function assay, which measure 14.9/1.1 and 8% platelet inhibition, respectively.

The patient is discharged on the following medication schedule: enoxaparin 125 mg every 12 hours, to be discontinued after 3 days; warfarin 5 mg daily, prasugrel 10 mg daily, and aspirin 81 mg daily; metoprolol succinate 100 mg daily; lisinopril 10 mg daily; rosuvastatin 10 mg daily; glyburide-metformin 5 mg/500 mg, 2 tablets twice daily; and insulin glargine 20 units at bedtime.

Safety and efficacy: Do the benefits outweigh the risk?
Safety is central to the continuing controversy surrounding the use of triple therapy.^6,9 To date, however, no randomized prospective studies have evaluated its benefits and risks.

Numerous retrospective studies and case series have assessed the risk of bleeding associated with triple therapy.⁶ Several studies compared triple therapy with dual antiplatelet therapy without anticoagulation, and found a several-fold increase in both major and minor bleeding events in the triple therapy group.⁶

Few trials have assessed both the safety and the efficacy of triple therapy, however. One exception is a large retrospective trial, published in 2008.² The researchers found that triple therapy significantly reduced the incidence of major cardiac events (death, acute MI, and target lesion revascularization); all-cause mortality; and major adverse effects (ie, any major cardiovascular event, major bleeding complication, and/or stroke), with no statistically significant increase in major bleeding events compared with patients on antiplatelet therapy without anticoagulation.²

The results of this trial, like those of other studies evaluating triple therapy, were weakened by variance in both the duration of antithrombotic therapy and the drug therapies studied. This limitation was off set, however, by multivariant analysis and well-documented follow-up.² Despite the researchers’ findings, however, the results of other trials (and our knowledge of the mechanisms of action of the drug components) suggest that triple therapy significantly increases bleeding risk. For patients who would likely benefit from it but face an increased bleeding risk, there are ways to mitigate risk.

Prescribing triple therapy, while mitigating the risks
If bleeding is a serious concern in a patient who would benefit from triple therapy, the drug regimen may be adjusted. Options include:

• targeting a lower INR (2.0-2.5 vs the standard 2.0-3.0).⁶ While various trials have found a 2.0 to 3.0 range to reduce the risk of stroke, none has compared it with a lower range to evaluate reduction in bleeding risk.²⁷ One potential benefit of trying to maintain a lower INR is the decrease in deviations into the 3.0 to 4.0 range, which is associated with an increased bleeding risk.²⁸ However, lowering the INR target is not supported by any literature.^1,18
• using low-dose aspirin therapy after PCI-S
• limiting the thienopyridine component of triple therapy to one month after ACS or PCI-S.⁶

When the risks of triple therapy outweigh the benefits because of an exceedingly high bleeding risk, single antiplatelet therapy with warfarin is another option to consider.

CASE [H17012] Anthony D’s discharge instructions called for an 81 mg daily dose of aspirin, as opposed to the 325-mg dose for the first 3 months of triple therapy after stent placement recommended by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for unstable angina/ non-ST segment elevated MI.¹ Although the patient had no independent bleeding risk, his physician selected the lower dose of aspirin to mitigate the increased bleeding risk posed by the use of prasugrel as a component of triple therapy.⁶

Lower aspirin dose. Pharmacodynamic studies support the use of a lower dose of aspirin, finding that serum thromboxane is completely inhibited by a maintenance dose as low as 30 mg/d in healthy individuals and 50 mg/d for those with chronic stable angina.¹⁴ Using low-dose aspirin for the secondary prevention of ACS when triple therapy is indicated is likely to reduce GI toxicities as well as bleeding risk.

Reduce the duration of dual antiplatelet therapy. According to the ACC/AHA guidelines, thienopyridine therapy can be limited to one month in patients who are medically managed or have had a bare metal stent placed if there is concern about the patient’s risk of bleeding.^6,10 Based on the findings of the one study that found triple therapy to be an independent predictor of major bleeds, this approach seems reasonable.¹ It is called into question, however, by another recent trial, which found that patients on dual antiplatelet therapy for one year (vs one month) had a statistically significant improvement in cardiovascular outcomes.¹⁶

Before limiting a patient’s thienopyridine therapy to one month, consider his or her risk of reinfarction. If it is high, continuing the thienopyridine for at least one year is likely to provide the most benefit.

The largest triple therapy trial to date compared the efficacy of triple therapy vs dual therapy (a single antiplatelet agent plus warfarin) in patients with ACS and an indication for warfarin therapy.³ This trial found no statistically significant differences in the combined occurrence of death, stroke, unscheduled PCI, and MI between the 2 treatment groups. (Bleeding risk was not evaluated.) Stroke was significantly increased in the group that received therapy with warfarin and a single antiplatelet agent, with this caveat: The occurrence of stroke was so low overall that no conclusions could be reached from this difference.³

One problem with this trial, and with others evaluating triple therapy, has to do with the lack of consistency, as well as the duration. The warfarin and single antiplatelet group, for example, may have included patients who were receiving only warfarin, aspirin, or clopidogrel by 6 months after initiating treatment.³ Thus, although reinfarction or stent thrombosis after ACS or PCI-S typically occurs within the first few months, any triple therapy trial that lasts less than a year is likely to report skewed results. JFP

CORRESPONDENCE
Haley M. Phillippe, PharmD, BCPS, Auburn University Harrison School of Pharmacy, University of Alabama Birmingham School of Medicine?Huntsville, 301 Governors Drive, Huntsville, AL 35801; mccrahl@auburn.edu

A new certification process for obstetrics in family medicine has begun under the auspices of the American Board of Physician Specialties (ABPS). The new Board of Certification in Family Medicine Obstetrics (BCFMO) is open to family physicians who have completed a fellowship tract or clinical practice tract in obstetrics. Candidates must complete written and oral examinations and proctor-observed surgical competency testing before receiving certification. To date, 25 family physicians have completed the testing process and received certification. In this article, I describe the genesis of this certification and the process that aspiring applicants can expect.

Working to meet a long-standing need

Twenty-five years ago, board certification was admirable, but not essential to practice medicine. Today it is imperative. In family medicine, most physicians completing residency training seek board certification in that specialty. Many of them then pursue training in fellowships, with recognition usually conferred by a certificate of added qualification. Obstetrics has been such an area of specialized clinical focus in family medicine, especially for those serving rural communities.^1,2 And women’s health and routine pregnancy care are an integral part of family medicine and the medical home.³

In 1984, Paul D. Mozley, MD, founded Postgraduate Obstetrics Fellowship Training at the University of Alabama School of Medicine in Tuscaloosa, to address the shortage of obstetric providers in rural and underserved areas and a desire by graduating family medicine residents to obtain additional training in obstetrics. Obstetrics fellowships are usually one year in length and include operative obstetrics with cesarean section and instrumental vaginal delivery, limited gynecologic surgery, and office gynecology.^4,5

Family medicine and obstetrics and gynecology organizations have also been working together to continually improve care for obstetric patients. One example is the formation of a Joint Task Force in 1998 by the American Academy of Family Physicians and the American College of Obstetricians and Gynecologists, which developed core educational guidelines in OB/GYN care for training family medicine residents.⁶ Between 2000 and 2005, parties from both specialties approached a number of national organizations about an examination and certification initiative. Although all organizations were supportive and recognized the need, an examination and certification never materialized.

A like-minded certifying partner emerges
In 2005, I made a formal presentation to the ABPS—one of 3 board-certifying organizations in the United States—proposing a program for examination and board certification of family medicine physicians completing obstetrics fellowships.⁷ In response, the ABPS created a Task Force for the Certification of Family Physicians Practicing Obstetrics, composed of family physicians and obstetrician/gynecologists. The Task Force conducted a nationwide survey of hospitals, hospital credentialing committees, malpractice insurance carriers, obstetrics fellowship programs, and family physicians regarding the importance of examination and certification, a certificate of added qualification, and a separate board of certification for family physicians practicing obstetrics.⁸ The aggregate response overwhelmingly favored board certification.

In 2006, responding to the increasingly clear need, the ABPS created the American Board of Family Practice Obstetrics, which is now known as the BCFMO.

What the BcFMO examination entails
From 2006 to 2008, using major textbooks on obstetrics, the BCFMO selected 873 test items that were placed in a bank for review and comment by all board members. The BCFMO then prepared questions of equal competency as the examination in obstetrics and gynecology. Questions of equal competency to both specialties were deemed important to give the certification process validity. Using the same text sources, the Board prepared additional items in a form usable for oral examination. The final written examination comprises 200 questions; the oral examination has 4 questions.

Surgical competency testing
The BCFMO also includes observed surgical competency as part of the process. Documentation of physician competency is emphasized by The Joint Commission. In this part of the testing, a Board-approved local proctor—a family physician practicing obstetrics, a general surgeon who performs cesarean sections, or an obstetrician/ gynecologist—is asked to observe and evaluate the surgical competency of a candidate for examination.

Credentialing for the examinations

Eligible applicants are those who, within the last 5 years, have satisfactorily completed (verified in writing by the fellowship director) a 12-month full-time Obstetrics or Maternal and Child Care Fellowship recognized by the BCFMO (http://www.abpsus.org/userfiles/files/BFMOFellowship.pdf). Applicants who have not completed an obstetrics fellowship but have been actively engaged in the practice of surgical obstetrics for at least 5 years may present a case list of the previous 2 years. All applicants to either tract must have performed a minimum of 100 vaginal deliveries and a verified case list of 50 cesarean sections within the last 5 years.⁹

Applicants successfully completing the computer-based written examination are required to submit verification of competency in surgical obstetrics described earlier, and then successfully complete the oral examination. The first written examination was administered in May 2009, and the oral examination in September 2009. Subsequent written and oral examinations were administered in 2010.

The next written examination is scheduled for October 2011. Successful completion of the written and oral examinations, surgical proctoring, background check, National Practitioner Data Bank query, and payment of appropriate fees constitute board certification in Family Medicine Obstetrics. Twenty-five family physicians have so far received board certification.

Future of the BCFMO
With its first 2 rounds of examination and certification successfully completed, the BCFMO plans to pursue the following:

• formal ceremony confirming certificate recipients’ diplomat status in the ABPS
• creation of a recertification process
• development of an appeals process
• establishment of an academy, college, or society for fellows
• acceptance by hospitals, malpractice insurance carriers, state medical societies, and licensing commissions
• ABPS accreditation of training programs
• BCFMO membership in the American Medical Association
• BCFMO membership in the Accreditation Council for Graduate Medical Education.

Interested in learning more? Visit http://www.abpsus.org/family-medicine-obstetrics, or call (813) 433-2277.

CORRESPONDENCE
Daniel M. Avery, MD, University of Alabama School of Medicine, Department of Obstetrics and Gynecology, 850 5th Avenue East, Tuscaloosa, AL 35401-7419; davery@cchs.ua.edu

A new certification process for obstetrics in family medicine has begun under the auspices of the American Board of Physician Specialties (ABPS). The new Board of Certification in Family Medicine Obstetrics (BCFMO) is open to family physicians who have completed a fellowship tract or clinical practice tract in obstetrics. Candidates must complete written and oral examinations and proctor-observed surgical competency testing before receiving certification. To date, 25 family physicians have completed the testing process and received certification. In this article, I describe the genesis of this certification and the process that aspiring applicants can expect.

Working to meet a long-standing need

Twenty-five years ago, board certification was admirable, but not essential to practice medicine. Today it is imperative. In family medicine, most physicians completing residency training seek board certification in that specialty. Many of them then pursue training in fellowships, with recognition usually conferred by a certificate of added qualification. Obstetrics has been such an area of specialized clinical focus in family medicine, especially for those serving rural communities.^1,2 And women’s health and routine pregnancy care are an integral part of family medicine and the medical home.³

In 1984, Paul D. Mozley, MD, founded Postgraduate Obstetrics Fellowship Training at the University of Alabama School of Medicine in Tuscaloosa, to address the shortage of obstetric providers in rural and underserved areas and a desire by graduating family medicine residents to obtain additional training in obstetrics. Obstetrics fellowships are usually one year in length and include operative obstetrics with cesarean section and instrumental vaginal delivery, limited gynecologic surgery, and office gynecology.^4,5

Family medicine and obstetrics and gynecology organizations have also been working together to continually improve care for obstetric patients. One example is the formation of a Joint Task Force in 1998 by the American Academy of Family Physicians and the American College of Obstetricians and Gynecologists, which developed core educational guidelines in OB/GYN care for training family medicine residents.⁶ Between 2000 and 2005, parties from both specialties approached a number of national organizations about an examination and certification initiative. Although all organizations were supportive and recognized the need, an examination and certification never materialized.

A like-minded certifying partner emerges
In 2005, I made a formal presentation to the ABPS—one of 3 board-certifying organizations in the United States—proposing a program for examination and board certification of family medicine physicians completing obstetrics fellowships.⁷ In response, the ABPS created a Task Force for the Certification of Family Physicians Practicing Obstetrics, composed of family physicians and obstetrician/gynecologists. The Task Force conducted a nationwide survey of hospitals, hospital credentialing committees, malpractice insurance carriers, obstetrics fellowship programs, and family physicians regarding the importance of examination and certification, a certificate of added qualification, and a separate board of certification for family physicians practicing obstetrics.⁸ The aggregate response overwhelmingly favored board certification.

In 2006, responding to the increasingly clear need, the ABPS created the American Board of Family Practice Obstetrics, which is now known as the BCFMO.

What the BcFMO examination entails
From 2006 to 2008, using major textbooks on obstetrics, the BCFMO selected 873 test items that were placed in a bank for review and comment by all board members. The BCFMO then prepared questions of equal competency as the examination in obstetrics and gynecology. Questions of equal competency to both specialties were deemed important to give the certification process validity. Using the same text sources, the Board prepared additional items in a form usable for oral examination. The final written examination comprises 200 questions; the oral examination has 4 questions.

Surgical competency testing
The BCFMO also includes observed surgical competency as part of the process. Documentation of physician competency is emphasized by The Joint Commission. In this part of the testing, a Board-approved local proctor—a family physician practicing obstetrics, a general surgeon who performs cesarean sections, or an obstetrician/ gynecologist—is asked to observe and evaluate the surgical competency of a candidate for examination.

Credentialing for the examinations

Eligible applicants are those who, within the last 5 years, have satisfactorily completed (verified in writing by the fellowship director) a 12-month full-time Obstetrics or Maternal and Child Care Fellowship recognized by the BCFMO (http://www.abpsus.org/userfiles/files/BFMOFellowship.pdf). Applicants who have not completed an obstetrics fellowship but have been actively engaged in the practice of surgical obstetrics for at least 5 years may present a case list of the previous 2 years. All applicants to either tract must have performed a minimum of 100 vaginal deliveries and a verified case list of 50 cesarean sections within the last 5 years.⁹

Applicants successfully completing the computer-based written examination are required to submit verification of competency in surgical obstetrics described earlier, and then successfully complete the oral examination. The first written examination was administered in May 2009, and the oral examination in September 2009. Subsequent written and oral examinations were administered in 2010.

The next written examination is scheduled for October 2011. Successful completion of the written and oral examinations, surgical proctoring, background check, National Practitioner Data Bank query, and payment of appropriate fees constitute board certification in Family Medicine Obstetrics. Twenty-five family physicians have so far received board certification.

Future of the BCFMO
With its first 2 rounds of examination and certification successfully completed, the BCFMO plans to pursue the following:

• formal ceremony confirming certificate recipients’ diplomat status in the ABPS
• creation of a recertification process
• development of an appeals process
• establishment of an academy, college, or society for fellows
• acceptance by hospitals, malpractice insurance carriers, state medical societies, and licensing commissions
• ABPS accreditation of training programs
• BCFMO membership in the American Medical Association
• BCFMO membership in the Accreditation Council for Graduate Medical Education.

Interested in learning more? Visit http://www.abpsus.org/family-medicine-obstetrics, or call (813) 433-2277.

CORRESPONDENCE
Daniel M. Avery, MD, University of Alabama School of Medicine, Department of Obstetrics and Gynecology, 850 5th Avenue East, Tuscaloosa, AL 35401-7419; davery@cchs.ua.edu

A new certification process for obstetrics in family medicine has begun under the auspices of the American Board of Physician Specialties (ABPS). The new Board of Certification in Family Medicine Obstetrics (BCFMO) is open to family physicians who have completed a fellowship tract or clinical practice tract in obstetrics. Candidates must complete written and oral examinations and proctor-observed surgical competency testing before receiving certification. To date, 25 family physicians have completed the testing process and received certification. In this article, I describe the genesis of this certification and the process that aspiring applicants can expect.

Working to meet a long-standing need

Twenty-five years ago, board certification was admirable, but not essential to practice medicine. Today it is imperative. In family medicine, most physicians completing residency training seek board certification in that specialty. Many of them then pursue training in fellowships, with recognition usually conferred by a certificate of added qualification. Obstetrics has been such an area of specialized clinical focus in family medicine, especially for those serving rural communities.^1,2 And women’s health and routine pregnancy care are an integral part of family medicine and the medical home.³

In 1984, Paul D. Mozley, MD, founded Postgraduate Obstetrics Fellowship Training at the University of Alabama School of Medicine in Tuscaloosa, to address the shortage of obstetric providers in rural and underserved areas and a desire by graduating family medicine residents to obtain additional training in obstetrics. Obstetrics fellowships are usually one year in length and include operative obstetrics with cesarean section and instrumental vaginal delivery, limited gynecologic surgery, and office gynecology.^4,5

Family medicine and obstetrics and gynecology organizations have also been working together to continually improve care for obstetric patients. One example is the formation of a Joint Task Force in 1998 by the American Academy of Family Physicians and the American College of Obstetricians and Gynecologists, which developed core educational guidelines in OB/GYN care for training family medicine residents.⁶ Between 2000 and 2005, parties from both specialties approached a number of national organizations about an examination and certification initiative. Although all organizations were supportive and recognized the need, an examination and certification never materialized.

A like-minded certifying partner emerges
In 2005, I made a formal presentation to the ABPS—one of 3 board-certifying organizations in the United States—proposing a program for examination and board certification of family medicine physicians completing obstetrics fellowships.⁷ In response, the ABPS created a Task Force for the Certification of Family Physicians Practicing Obstetrics, composed of family physicians and obstetrician/gynecologists. The Task Force conducted a nationwide survey of hospitals, hospital credentialing committees, malpractice insurance carriers, obstetrics fellowship programs, and family physicians regarding the importance of examination and certification, a certificate of added qualification, and a separate board of certification for family physicians practicing obstetrics.⁸ The aggregate response overwhelmingly favored board certification.

In 2006, responding to the increasingly clear need, the ABPS created the American Board of Family Practice Obstetrics, which is now known as the BCFMO.

What the BcFMO examination entails
From 2006 to 2008, using major textbooks on obstetrics, the BCFMO selected 873 test items that were placed in a bank for review and comment by all board members. The BCFMO then prepared questions of equal competency as the examination in obstetrics and gynecology. Questions of equal competency to both specialties were deemed important to give the certification process validity. Using the same text sources, the Board prepared additional items in a form usable for oral examination. The final written examination comprises 200 questions; the oral examination has 4 questions.

Surgical competency testing
The BCFMO also includes observed surgical competency as part of the process. Documentation of physician competency is emphasized by The Joint Commission. In this part of the testing, a Board-approved local proctor—a family physician practicing obstetrics, a general surgeon who performs cesarean sections, or an obstetrician/ gynecologist—is asked to observe and evaluate the surgical competency of a candidate for examination.

Credentialing for the examinations

Eligible applicants are those who, within the last 5 years, have satisfactorily completed (verified in writing by the fellowship director) a 12-month full-time Obstetrics or Maternal and Child Care Fellowship recognized by the BCFMO (http://www.abpsus.org/userfiles/files/BFMOFellowship.pdf). Applicants who have not completed an obstetrics fellowship but have been actively engaged in the practice of surgical obstetrics for at least 5 years may present a case list of the previous 2 years. All applicants to either tract must have performed a minimum of 100 vaginal deliveries and a verified case list of 50 cesarean sections within the last 5 years.⁹

Applicants successfully completing the computer-based written examination are required to submit verification of competency in surgical obstetrics described earlier, and then successfully complete the oral examination. The first written examination was administered in May 2009, and the oral examination in September 2009. Subsequent written and oral examinations were administered in 2010.

The next written examination is scheduled for October 2011. Successful completion of the written and oral examinations, surgical proctoring, background check, National Practitioner Data Bank query, and payment of appropriate fees constitute board certification in Family Medicine Obstetrics. Twenty-five family physicians have so far received board certification.

Future of the BCFMO
With its first 2 rounds of examination and certification successfully completed, the BCFMO plans to pursue the following:

• formal ceremony confirming certificate recipients’ diplomat status in the ABPS
• creation of a recertification process
• development of an appeals process
• establishment of an academy, college, or society for fellows
• acceptance by hospitals, malpractice insurance carriers, state medical societies, and licensing commissions
• ABPS accreditation of training programs
• BCFMO membership in the American Medical Association
• BCFMO membership in the Accreditation Council for Graduate Medical Education.

Interested in learning more? Visit http://www.abpsus.org/family-medicine-obstetrics, or call (813) 433-2277.

CORRESPONDENCE
Daniel M. Avery, MD, University of Alabama School of Medicine, Department of Obstetrics and Gynecology, 850 5th Avenue East, Tuscaloosa, AL 35401-7419; davery@cchs.ua.edu

CASE 1 Nonpayment

Susan L, a 53-year-old who’d been a patient of Dr. O’s for the past 6 years, received a bill for a visit that had occurred nearly 2 years earlier. She called the office and told the receptionist that she had never been billed for this visit and didn’t think she should have to pay after such a lengthy delay. When she received a past due notice, Susan called and asked to speak to the physician—and to schedule an appointment. She was told that she could do neither until her account was current.

Eventually, the unpaid bill was sent to a collection agency, and Susan received a letter threatening legal action. In response, she sent a letter of her own—certified, return receipt requested—detailing her reason for not paying and threatening to sue Dr. O for abandonment.*

*Adapted from actual cases, with details changed to protect the privacy of the parties involved.

With the national unemployment rate hovering at a record high, unpaid medical bills may be your most pressing problem—and potential grounds for patient dismissal. Judging from a recent survey in which primary care physicians identified nearly one patient in 5 as “difficult,"¹ it’s unlikely that nonpayment is the only patient conundrum you face.

Indeed, there are many ways a patient can be difficult, including exhibiting habitual hostility, chronic drug-seeking behavior, or consistent noncompliance; breaking appointments at the last minute; or being a no-show. You may wish you could “fire” the worst off enders but be concerned about professional and ethical responsibilities and the legal risk you might face. Ironically, though, struggling to maintain a chronically stressed physician-patient relationship is often riskier than a well-timed termination.²

The key here, however, is the persistent or extreme nature of the difficulty.³ When a dismissal is prompted by a one-time occurrence or lower-level offense, what constitutes a reasonable response is not always clear-cut.

Under what circumstances is it appropriate to end your relationship with a patient? When you do terminate the relationship, what steps can you take to safeguard the patient and avoid charges of abandonment? Here’s a look at these questions—and some answers.

Professional responsibility: How far does it go?

As a physician, you’ve pledged to “do no harm.” And you’ve likely been taught—as it states in the American College of Physicians (ACP) ethics manual—that you have “a moral duty to care for all patients.” ⁴ The American Medical Association’s code of ethics cites a similar standard: the obligation to place patients’ welfare above your own interests.⁵

According to the ACP, the physician-patient relationship should be discontinued only under “exceptional circumstances."⁶ But not everyone agrees, not only on what constitutes “exceptional,” but on whether that is the correct threshold for termination.

A health care attorney writing in American Medical News, for example, takes a more liberal view. It’s time to dismiss, he asserts, when the doctor-patient relationship doesn’t work.⁷ By that standard, virtually any ongoing problem could be construed as evidence of an “irreparable breakdown” of the physician-patient relationship (TABLE).

TABLE
Key reasons to "fire" a patient

We can work it out

Legally, a doctor can dismiss a patient for virtually any reason, or fail to give any explanation at all.² Ethically, dismissal should be your last option, not your first choice.

In a home study course titled “Challenging physician-patient interactions,” the American Academy of Family Physicians (AAFP) advises doctors to be certain they have exhausted every reasonable effort to communicate, set achievable goals, and meet the patient’s needs.³ The steps you take to try to mend a damaged patient relationship, of course, will depend on what caused the rift in the first place. Here are some examples.

Nonpayment. You are not compelled (or expected) to indefinitely continue to treat a patient who’s unable—or unwilling—to pay you, of course. But if he or she is out of work and has fallen on hard times or has a single unpaid bill, discussing the problem and attempting to accommodate the patient’s financial limitations (and establish a realistic payment plan) is a reasonable approach.

Having a billing clerk handle most communications regarding unpaid bills may be a good idea. But when a situation escalates, as in the case of Susan L (CASE 1), foregoing a direct discussion and expecting a subordinate to handle an abrupt patient termination is not (ethically or legally) appropriate.⁷

CASE 2 A drug-seeking patient

Laura K, age 34, had always been a challenging patient. She suffered from a collection of pain-producing maladies, including migraines, fibromyalgia, and low back pain. Controlling her pain required increasing amounts of narcotics, sometimes in doses that exceeded therapeutic recommendations.

Recently she’d begun calling her primary care physician’s office for early refills; more than once, she claimed her prescription had been lost or stolen. When Laura called to report that the oxycodone prescribed 4 days ago had been stolen from her purse and to request a refill, the physician refused to speak with her—and instructed the receptionist to tell her she needed to find another physician.

Laura called several other local physicians, but none was able to see her. She then went to the emergency department. The ED physician evaluated her and offered her a prescription for a mild analgesic, but refused her request for oxycodone.

That night, Laura attempted suicide. Although she survived, she was left with significant neurologic deficits. She sued the physician who had refused to speak to her on a variety of counts of negligence, including a charge of abandonment.

At deposition, experts for the plaintiff testified that refusing to see and evaluate a current patient for her ongoing problems without giving substantial notice constituted abandonment—and was a substantial cause of Laura’s suicide attempt. On the advice of counsel, the physician agreed to a $150,000 settlement.

Drug-seeking. Behavior like that of Laura K (CASE 2), whose requests for narcotics and claims of lost pills or prescriptions occurred with increasing regularity, can’t be ignored. The AAFP course, which states that patients should not be dismissed “on the grounds of drug-seeking behaviors alone,"³ recommends that physicians develop policies for prescribing controlled substances and handling drug-seeking patients. Such a policy—which might include limits on the frequency of renewals and the duration of a single prescription, among other provisions—should be communicated to every patient who seeks opioid analgesics.³ The Federation of State Medical Boards recommends the use of a written agreement, spelling out your responsibilities as well as those of the patient, for individuals at high risk of abuse (http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf).

While the existence of a policy or written contract may not alter the behavior of a drug-seeking patient, it can prevent you from being caught off -guard or reacting as rashly as Laura K’s physician did. Indeed, Laura’s doctor made 2 key missteps: acting without warning, and expecting a receptionist to deliver the dismissal message.

A better approach, from the AAFP’s perspective, is to calmly maintain the limits you’ve set, remind the patient that you want to help, and offer treatment alternatives, such as nonopioid analgesics.³ Discussions in response to drug-seeking behavior, of course, should always be delivered—and documented—by the physician.

Noncompliance. This is a particularly complex problem, as issues of patient autonomy and physician authority are involved. A case study presented in the AAFP home study course describes the thoughts and feelings of a physician who considered dismissing a pediatric patient because the child’s mother refused to allow him to be vaccinated. The physician ultimately decided to continue to treat the child, after determining that the physician-patient relationship could still be beneficial and planning to revisit the vaccination issue with the mother at a later date.³ (Another physician, faced with a similar issue, wrote a New York Times article about his decision to dismiss a young patient. His reasoning? Accepting the mother’s refusal to allow her son to get a tetanus booster would compromise “my conscience and my professional ethics. I couldn’t do that."⁸)

Although it is important to recognize the difference between noncompliance and an individual’s right to refuse recommended treatment,⁹ you, too, may encounter situations in which a patient’s, or parent’s, repeated failure—to follow an agreed-upon therapeutic regimen, perhaps, or adhere to a schedule of visits needed to manage a chronic condition— causes your relationship with the patient to deteriorate to a point where dismissal is warranted. Here, as with other potential causes of dismissal, the patient should be adequately warned, the discussion documented, and action taken only if nothing changes.

Anger. As is the case with drug-seeking, the AAFP course advises physicians to anticipate and develop policies for handling situations in which a patient’s anger escalates and creates a real or perceived threat.³ While this is commonly done in acute care facilities, it is often overlooked in outpatient settings.

Among the issues to address: equipping offices and exam rooms with an emergency call button or intercom, knowing where to position yourself to ensure that you can’t be trapped in a room by a threatening patient, and considering how to respond in a way that defuses—rather than escalates—the anger. Calmly ask the patient what he or she is upset about, listen carefully, and apologize, if appropriate, for your role in the upsetting incident. Then move on to the purpose of the visit, stating, for example, “Now, what brings you in today?” ³

It is crucial to set boundaries (although it’s probably not a good idea to attempt it at the time of the outburst), making it clear, for example, that profanity is not acceptable; directing anger at nurses or other staff members is not permitted; and what the consequences of continued outbursts will be. ³

A single incident that’s grounds for dismissal
Despite the emphasis on resolving problems with patients, there are times when dismissal can and should occur, with little warning and no negotiation. In its home study course, the AAFP describes this as a “sentinel incident"— a single occurrence so egregious that it damages the physician-patient relationship beyond repair.³

A threat of violence or a physical assault itself would rise to that level. Some other examples: a sexual assault or blatant sexual advance, falsifying medical records, and theft or another type of criminal activity carried out in the physician’s office.

When a sentinel incident occurs, the best course is likely to be to forego any attempt at resolution, call the police or your facility’s security officer, and, if appropriate, to immediately prepare to “fire” the patient.

Dismissal without abandonment: Here’s how

In the vast majority of cases, dismissing a patient does not in and of itself constitute patient abandonment. Even if the termination is unduly abrupt, as was the case for Susan (CASE 1) and Laura (CASE 2), it doesn’t constitute abandonment unless the patient is dismissed during a course of treatment and unable to find a physician to provide ongoing care.

Neither was true in Susan’s case, and her threat of a lawsuit based on charges of abandonment never came to fruition. Not so for Laura, who was abruptly terminated during ongoing treatment—and who nonetheless made numerous attempts to find another doctor to care for her, without success. The attorney for Laura’s physician advised that the severe consequences of dismissing without going through the proper channels made a trial defense untenable.

Although most charges of patient abandonment never rise to the level required for a successful lawsuit, attorneys often include it in a litany of charges in an attempt to damage the physician’s credibility with a jury. You can usually avoid that scenario by taking the right steps when you dismiss a patient.

CASE 3 Pregnant patient, rural physician

As part of his rural family medicine practice, Dr. J provided obstetrical care. Dr. J had a partner and they alternated call nights, but his partner did not do OB. Dr. J made it a point, however, to always be on call for his obstetrical patients as they neared delivery. Having no patients imminently due, he took a one-week vacation out of town.

One of his patients went into premature labor and went to the local hospital. Dr. J’s partner was called to attend, but indicated he did not do OB work and advised the emergency physician to call “any obstetrician around.” One obstetrical group covered the region and the on-call physician was at another hospital doing a C-section and requested that the patient be transferred to that hospital for evaluation. After a series of delays, the patient was transferred and delivered a preterm infant who showed signs of neurological injury after a lengthy ICU stay.

The family sued all providers involved on several grounds, including patient abandonment. Plaintiff experts testified that the standard of care would be for Dr. J to be in attendance for such emergencies or, failing that, to provide for adequate coverage of his pregnant patient. They also testified that it was reasonable for the patient to have gone to the local hospital where her delivery was planned and that Dr. J should have arranged for the local OB group to provide emergency coverage. The case concluded with an $800,000 pretrial settlement.

Ensure that dismissal is an option
While we’ve already established that physicians have the legal right to dismiss patients, regardless of the reason, there are instances that make it far more difficult—and legally risky—to do so.

A primary care physician in a rural area is a case in point (CASE 3). If you are the only doctor in the area and the patient has no viable means of getting care from another provider, you may want to reconsider the dismissal. It is far easier to establish that a patient in such an underserved area was abandoned, even— as Dr. J found out—for failing to ensure full coverage during a vacation or leave of absence.

Rural physicians can help prevent charges of abandonment by advising patients of the special call challenges a rural setting presents. Doctors should make sure their patients know what to do if an emergency occurs when the practice is closed or a physician is out of town, and document the discussion in the medical record.

A physician in a staff-model HMO may face similar problems. Unless the HMO has another outpatient clinic in the vicinity, dismissal could leave the patient with no means of receiving affordable health care.

Options in such a case might include asking a colleague at the same clinic to accept a patient whom you would like to dismiss or finding a way to manage the patient’s behavior. If a patient has been excessively angry or threatening in the past, for example, it is often advisable to sit down with the patient (with security nearby) to discuss the parameters of expected behavior and develop a contract for future care. The contract might include a requirement that the patient call in advance so that security can be present when he or she arrives, for example, or that the patient agree to abstain from profanity and threats.

Know the laws in your state. Before you terminate a patient, check with your state medical board or local medical society to make sure your actions will be in compliance with any relevant state rules and regulations.

When you dismiss, cover all bases
Send a letter to the patient by certified mail, return receipt requested, notifying him or her of the dismissal and agreeing to provide emergency care for a reasonable time—typically, 30 days—while the patient seeks another physician. It is advisable, too, to help the patient locate other potential clinicians—by, say, including contact information for your county medical society or the patient’s health insurer’s list of in-network providers, or referring an indigent patient to Medicaid or a sliding scale clinic. It is a good idea to offer to transfer records to the new physician, as well.

It is not mandatory to document the reason for the dismissal in the letter, but some sources recommend that you do so. If you’re uncertain how to proceed, check with legal counsel before you send the letter. (You can find sample dismissal letters at www.ttuhsc.edu/som/clinic/forms/ACForm8.11.A.pdf and in “Terminating a patient: Is it time to part ways?” at http://www.aafp.org/fpm/2005/0900/p34.html.)

The events that led up to the dismissal, however, including any discussions you had with the patient about them, must be documented in the medical record. Put a copy of the letter and the certified mail receipt in the chart, as well. JFP

CORRESPONDENCE John Davenport, MD, JD, 13 Redonda, Irvine, CA 92620; john.y.davenport@kp.org

CASE 1 Nonpayment

Susan L, a 53-year-old who’d been a patient of Dr. O’s for the past 6 years, received a bill for a visit that had occurred nearly 2 years earlier. She called the office and told the receptionist that she had never been billed for this visit and didn’t think she should have to pay after such a lengthy delay. When she received a past due notice, Susan called and asked to speak to the physician—and to schedule an appointment. She was told that she could do neither until her account was current.

Eventually, the unpaid bill was sent to a collection agency, and Susan received a letter threatening legal action. In response, she sent a letter of her own—certified, return receipt requested—detailing her reason for not paying and threatening to sue Dr. O for abandonment.*

*Adapted from actual cases, with details changed to protect the privacy of the parties involved.

With the national unemployment rate hovering at a record high, unpaid medical bills may be your most pressing problem—and potential grounds for patient dismissal. Judging from a recent survey in which primary care physicians identified nearly one patient in 5 as “difficult,"¹ it’s unlikely that nonpayment is the only patient conundrum you face.

Indeed, there are many ways a patient can be difficult, including exhibiting habitual hostility, chronic drug-seeking behavior, or consistent noncompliance; breaking appointments at the last minute; or being a no-show. You may wish you could “fire” the worst off enders but be concerned about professional and ethical responsibilities and the legal risk you might face. Ironically, though, struggling to maintain a chronically stressed physician-patient relationship is often riskier than a well-timed termination.²

The key here, however, is the persistent or extreme nature of the difficulty.³ When a dismissal is prompted by a one-time occurrence or lower-level offense, what constitutes a reasonable response is not always clear-cut.

Under what circumstances is it appropriate to end your relationship with a patient? When you do terminate the relationship, what steps can you take to safeguard the patient and avoid charges of abandonment? Here’s a look at these questions—and some answers.

Professional responsibility: How far does it go?

As a physician, you’ve pledged to “do no harm.” And you’ve likely been taught—as it states in the American College of Physicians (ACP) ethics manual—that you have “a moral duty to care for all patients.” ⁴ The American Medical Association’s code of ethics cites a similar standard: the obligation to place patients’ welfare above your own interests.⁵

According to the ACP, the physician-patient relationship should be discontinued only under “exceptional circumstances."⁶ But not everyone agrees, not only on what constitutes “exceptional,” but on whether that is the correct threshold for termination.

A health care attorney writing in American Medical News, for example, takes a more liberal view. It’s time to dismiss, he asserts, when the doctor-patient relationship doesn’t work.⁷ By that standard, virtually any ongoing problem could be construed as evidence of an “irreparable breakdown” of the physician-patient relationship (TABLE).

TABLE
Key reasons to "fire" a patient

We can work it out

Legally, a doctor can dismiss a patient for virtually any reason, or fail to give any explanation at all.² Ethically, dismissal should be your last option, not your first choice.

In a home study course titled “Challenging physician-patient interactions,” the American Academy of Family Physicians (AAFP) advises doctors to be certain they have exhausted every reasonable effort to communicate, set achievable goals, and meet the patient’s needs.³ The steps you take to try to mend a damaged patient relationship, of course, will depend on what caused the rift in the first place. Here are some examples.

Nonpayment. You are not compelled (or expected) to indefinitely continue to treat a patient who’s unable—or unwilling—to pay you, of course. But if he or she is out of work and has fallen on hard times or has a single unpaid bill, discussing the problem and attempting to accommodate the patient’s financial limitations (and establish a realistic payment plan) is a reasonable approach.

Having a billing clerk handle most communications regarding unpaid bills may be a good idea. But when a situation escalates, as in the case of Susan L (CASE 1), foregoing a direct discussion and expecting a subordinate to handle an abrupt patient termination is not (ethically or legally) appropriate.⁷

CASE 2 A drug-seeking patient

Laura K, age 34, had always been a challenging patient. She suffered from a collection of pain-producing maladies, including migraines, fibromyalgia, and low back pain. Controlling her pain required increasing amounts of narcotics, sometimes in doses that exceeded therapeutic recommendations.

Recently she’d begun calling her primary care physician’s office for early refills; more than once, she claimed her prescription had been lost or stolen. When Laura called to report that the oxycodone prescribed 4 days ago had been stolen from her purse and to request a refill, the physician refused to speak with her—and instructed the receptionist to tell her she needed to find another physician.

Laura called several other local physicians, but none was able to see her. She then went to the emergency department. The ED physician evaluated her and offered her a prescription for a mild analgesic, but refused her request for oxycodone.

That night, Laura attempted suicide. Although she survived, she was left with significant neurologic deficits. She sued the physician who had refused to speak to her on a variety of counts of negligence, including a charge of abandonment.

At deposition, experts for the plaintiff testified that refusing to see and evaluate a current patient for her ongoing problems without giving substantial notice constituted abandonment—and was a substantial cause of Laura’s suicide attempt. On the advice of counsel, the physician agreed to a $150,000 settlement.

Drug-seeking. Behavior like that of Laura K (CASE 2), whose requests for narcotics and claims of lost pills or prescriptions occurred with increasing regularity, can’t be ignored. The AAFP course, which states that patients should not be dismissed “on the grounds of drug-seeking behaviors alone,"³ recommends that physicians develop policies for prescribing controlled substances and handling drug-seeking patients. Such a policy—which might include limits on the frequency of renewals and the duration of a single prescription, among other provisions—should be communicated to every patient who seeks opioid analgesics.³ The Federation of State Medical Boards recommends the use of a written agreement, spelling out your responsibilities as well as those of the patient, for individuals at high risk of abuse (http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf).

While the existence of a policy or written contract may not alter the behavior of a drug-seeking patient, it can prevent you from being caught off -guard or reacting as rashly as Laura K’s physician did. Indeed, Laura’s doctor made 2 key missteps: acting without warning, and expecting a receptionist to deliver the dismissal message.

A better approach, from the AAFP’s perspective, is to calmly maintain the limits you’ve set, remind the patient that you want to help, and offer treatment alternatives, such as nonopioid analgesics.³ Discussions in response to drug-seeking behavior, of course, should always be delivered—and documented—by the physician.

Noncompliance. This is a particularly complex problem, as issues of patient autonomy and physician authority are involved. A case study presented in the AAFP home study course describes the thoughts and feelings of a physician who considered dismissing a pediatric patient because the child’s mother refused to allow him to be vaccinated. The physician ultimately decided to continue to treat the child, after determining that the physician-patient relationship could still be beneficial and planning to revisit the vaccination issue with the mother at a later date.³ (Another physician, faced with a similar issue, wrote a New York Times article about his decision to dismiss a young patient. His reasoning? Accepting the mother’s refusal to allow her son to get a tetanus booster would compromise “my conscience and my professional ethics. I couldn’t do that."⁸)

Although it is important to recognize the difference between noncompliance and an individual’s right to refuse recommended treatment,⁹ you, too, may encounter situations in which a patient’s, or parent’s, repeated failure—to follow an agreed-upon therapeutic regimen, perhaps, or adhere to a schedule of visits needed to manage a chronic condition— causes your relationship with the patient to deteriorate to a point where dismissal is warranted. Here, as with other potential causes of dismissal, the patient should be adequately warned, the discussion documented, and action taken only if nothing changes.

Anger. As is the case with drug-seeking, the AAFP course advises physicians to anticipate and develop policies for handling situations in which a patient’s anger escalates and creates a real or perceived threat.³ While this is commonly done in acute care facilities, it is often overlooked in outpatient settings.

Among the issues to address: equipping offices and exam rooms with an emergency call button or intercom, knowing where to position yourself to ensure that you can’t be trapped in a room by a threatening patient, and considering how to respond in a way that defuses—rather than escalates—the anger. Calmly ask the patient what he or she is upset about, listen carefully, and apologize, if appropriate, for your role in the upsetting incident. Then move on to the purpose of the visit, stating, for example, “Now, what brings you in today?” ³

It is crucial to set boundaries (although it’s probably not a good idea to attempt it at the time of the outburst), making it clear, for example, that profanity is not acceptable; directing anger at nurses or other staff members is not permitted; and what the consequences of continued outbursts will be. ³

A single incident that’s grounds for dismissal
Despite the emphasis on resolving problems with patients, there are times when dismissal can and should occur, with little warning and no negotiation. In its home study course, the AAFP describes this as a “sentinel incident"— a single occurrence so egregious that it damages the physician-patient relationship beyond repair.³

A threat of violence or a physical assault itself would rise to that level. Some other examples: a sexual assault or blatant sexual advance, falsifying medical records, and theft or another type of criminal activity carried out in the physician’s office.

When a sentinel incident occurs, the best course is likely to be to forego any attempt at resolution, call the police or your facility’s security officer, and, if appropriate, to immediately prepare to “fire” the patient.

Dismissal without abandonment: Here’s how

In the vast majority of cases, dismissing a patient does not in and of itself constitute patient abandonment. Even if the termination is unduly abrupt, as was the case for Susan (CASE 1) and Laura (CASE 2), it doesn’t constitute abandonment unless the patient is dismissed during a course of treatment and unable to find a physician to provide ongoing care.

Neither was true in Susan’s case, and her threat of a lawsuit based on charges of abandonment never came to fruition. Not so for Laura, who was abruptly terminated during ongoing treatment—and who nonetheless made numerous attempts to find another doctor to care for her, without success. The attorney for Laura’s physician advised that the severe consequences of dismissing without going through the proper channels made a trial defense untenable.

Although most charges of patient abandonment never rise to the level required for a successful lawsuit, attorneys often include it in a litany of charges in an attempt to damage the physician’s credibility with a jury. You can usually avoid that scenario by taking the right steps when you dismiss a patient.

CASE 3 Pregnant patient, rural physician

As part of his rural family medicine practice, Dr. J provided obstetrical care. Dr. J had a partner and they alternated call nights, but his partner did not do OB. Dr. J made it a point, however, to always be on call for his obstetrical patients as they neared delivery. Having no patients imminently due, he took a one-week vacation out of town.

One of his patients went into premature labor and went to the local hospital. Dr. J’s partner was called to attend, but indicated he did not do OB work and advised the emergency physician to call “any obstetrician around.” One obstetrical group covered the region and the on-call physician was at another hospital doing a C-section and requested that the patient be transferred to that hospital for evaluation. After a series of delays, the patient was transferred and delivered a preterm infant who showed signs of neurological injury after a lengthy ICU stay.

The family sued all providers involved on several grounds, including patient abandonment. Plaintiff experts testified that the standard of care would be for Dr. J to be in attendance for such emergencies or, failing that, to provide for adequate coverage of his pregnant patient. They also testified that it was reasonable for the patient to have gone to the local hospital where her delivery was planned and that Dr. J should have arranged for the local OB group to provide emergency coverage. The case concluded with an $800,000 pretrial settlement.

Ensure that dismissal is an option
While we’ve already established that physicians have the legal right to dismiss patients, regardless of the reason, there are instances that make it far more difficult—and legally risky—to do so.

A primary care physician in a rural area is a case in point (CASE 3). If you are the only doctor in the area and the patient has no viable means of getting care from another provider, you may want to reconsider the dismissal. It is far easier to establish that a patient in such an underserved area was abandoned, even— as Dr. J found out—for failing to ensure full coverage during a vacation or leave of absence.

Rural physicians can help prevent charges of abandonment by advising patients of the special call challenges a rural setting presents. Doctors should make sure their patients know what to do if an emergency occurs when the practice is closed or a physician is out of town, and document the discussion in the medical record.

A physician in a staff-model HMO may face similar problems. Unless the HMO has another outpatient clinic in the vicinity, dismissal could leave the patient with no means of receiving affordable health care.

Options in such a case might include asking a colleague at the same clinic to accept a patient whom you would like to dismiss or finding a way to manage the patient’s behavior. If a patient has been excessively angry or threatening in the past, for example, it is often advisable to sit down with the patient (with security nearby) to discuss the parameters of expected behavior and develop a contract for future care. The contract might include a requirement that the patient call in advance so that security can be present when he or she arrives, for example, or that the patient agree to abstain from profanity and threats.

Know the laws in your state. Before you terminate a patient, check with your state medical board or local medical society to make sure your actions will be in compliance with any relevant state rules and regulations.

When you dismiss, cover all bases
Send a letter to the patient by certified mail, return receipt requested, notifying him or her of the dismissal and agreeing to provide emergency care for a reasonable time—typically, 30 days—while the patient seeks another physician. It is advisable, too, to help the patient locate other potential clinicians—by, say, including contact information for your county medical society or the patient’s health insurer’s list of in-network providers, or referring an indigent patient to Medicaid or a sliding scale clinic. It is a good idea to offer to transfer records to the new physician, as well.

It is not mandatory to document the reason for the dismissal in the letter, but some sources recommend that you do so. If you’re uncertain how to proceed, check with legal counsel before you send the letter. (You can find sample dismissal letters at www.ttuhsc.edu/som/clinic/forms/ACForm8.11.A.pdf and in “Terminating a patient: Is it time to part ways?” at http://www.aafp.org/fpm/2005/0900/p34.html.)

The events that led up to the dismissal, however, including any discussions you had with the patient about them, must be documented in the medical record. Put a copy of the letter and the certified mail receipt in the chart, as well. JFP

CORRESPONDENCE John Davenport, MD, JD, 13 Redonda, Irvine, CA 92620; john.y.davenport@kp.org

CASE 1 Nonpayment

Susan L, a 53-year-old who’d been a patient of Dr. O’s for the past 6 years, received a bill for a visit that had occurred nearly 2 years earlier. She called the office and told the receptionist that she had never been billed for this visit and didn’t think she should have to pay after such a lengthy delay. When she received a past due notice, Susan called and asked to speak to the physician—and to schedule an appointment. She was told that she could do neither until her account was current.

Eventually, the unpaid bill was sent to a collection agency, and Susan received a letter threatening legal action. In response, she sent a letter of her own—certified, return receipt requested—detailing her reason for not paying and threatening to sue Dr. O for abandonment.*

*Adapted from actual cases, with details changed to protect the privacy of the parties involved.

With the national unemployment rate hovering at a record high, unpaid medical bills may be your most pressing problem—and potential grounds for patient dismissal. Judging from a recent survey in which primary care physicians identified nearly one patient in 5 as “difficult,"¹ it’s unlikely that nonpayment is the only patient conundrum you face.

Indeed, there are many ways a patient can be difficult, including exhibiting habitual hostility, chronic drug-seeking behavior, or consistent noncompliance; breaking appointments at the last minute; or being a no-show. You may wish you could “fire” the worst off enders but be concerned about professional and ethical responsibilities and the legal risk you might face. Ironically, though, struggling to maintain a chronically stressed physician-patient relationship is often riskier than a well-timed termination.²

The key here, however, is the persistent or extreme nature of the difficulty.³ When a dismissal is prompted by a one-time occurrence or lower-level offense, what constitutes a reasonable response is not always clear-cut.

Under what circumstances is it appropriate to end your relationship with a patient? When you do terminate the relationship, what steps can you take to safeguard the patient and avoid charges of abandonment? Here’s a look at these questions—and some answers.

Professional responsibility: How far does it go?

As a physician, you’ve pledged to “do no harm.” And you’ve likely been taught—as it states in the American College of Physicians (ACP) ethics manual—that you have “a moral duty to care for all patients.” ⁴ The American Medical Association’s code of ethics cites a similar standard: the obligation to place patients’ welfare above your own interests.⁵

According to the ACP, the physician-patient relationship should be discontinued only under “exceptional circumstances."⁶ But not everyone agrees, not only on what constitutes “exceptional,” but on whether that is the correct threshold for termination.

A health care attorney writing in American Medical News, for example, takes a more liberal view. It’s time to dismiss, he asserts, when the doctor-patient relationship doesn’t work.⁷ By that standard, virtually any ongoing problem could be construed as evidence of an “irreparable breakdown” of the physician-patient relationship (TABLE).

TABLE
Key reasons to "fire" a patient

We can work it out

Legally, a doctor can dismiss a patient for virtually any reason, or fail to give any explanation at all.² Ethically, dismissal should be your last option, not your first choice.

In a home study course titled “Challenging physician-patient interactions,” the American Academy of Family Physicians (AAFP) advises doctors to be certain they have exhausted every reasonable effort to communicate, set achievable goals, and meet the patient’s needs.³ The steps you take to try to mend a damaged patient relationship, of course, will depend on what caused the rift in the first place. Here are some examples.

Nonpayment. You are not compelled (or expected) to indefinitely continue to treat a patient who’s unable—or unwilling—to pay you, of course. But if he or she is out of work and has fallen on hard times or has a single unpaid bill, discussing the problem and attempting to accommodate the patient’s financial limitations (and establish a realistic payment plan) is a reasonable approach.

Having a billing clerk handle most communications regarding unpaid bills may be a good idea. But when a situation escalates, as in the case of Susan L (CASE 1), foregoing a direct discussion and expecting a subordinate to handle an abrupt patient termination is not (ethically or legally) appropriate.⁷

CASE 2 A drug-seeking patient

Laura K, age 34, had always been a challenging patient. She suffered from a collection of pain-producing maladies, including migraines, fibromyalgia, and low back pain. Controlling her pain required increasing amounts of narcotics, sometimes in doses that exceeded therapeutic recommendations.

Recently she’d begun calling her primary care physician’s office for early refills; more than once, she claimed her prescription had been lost or stolen. When Laura called to report that the oxycodone prescribed 4 days ago had been stolen from her purse and to request a refill, the physician refused to speak with her—and instructed the receptionist to tell her she needed to find another physician.

Laura called several other local physicians, but none was able to see her. She then went to the emergency department. The ED physician evaluated her and offered her a prescription for a mild analgesic, but refused her request for oxycodone.

That night, Laura attempted suicide. Although she survived, she was left with significant neurologic deficits. She sued the physician who had refused to speak to her on a variety of counts of negligence, including a charge of abandonment.

At deposition, experts for the plaintiff testified that refusing to see and evaluate a current patient for her ongoing problems without giving substantial notice constituted abandonment—and was a substantial cause of Laura’s suicide attempt. On the advice of counsel, the physician agreed to a $150,000 settlement.

Drug-seeking. Behavior like that of Laura K (CASE 2), whose requests for narcotics and claims of lost pills or prescriptions occurred with increasing regularity, can’t be ignored. The AAFP course, which states that patients should not be dismissed “on the grounds of drug-seeking behaviors alone,"³ recommends that physicians develop policies for prescribing controlled substances and handling drug-seeking patients. Such a policy—which might include limits on the frequency of renewals and the duration of a single prescription, among other provisions—should be communicated to every patient who seeks opioid analgesics.³ The Federation of State Medical Boards recommends the use of a written agreement, spelling out your responsibilities as well as those of the patient, for individuals at high risk of abuse (http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf).

While the existence of a policy or written contract may not alter the behavior of a drug-seeking patient, it can prevent you from being caught off -guard or reacting as rashly as Laura K’s physician did. Indeed, Laura’s doctor made 2 key missteps: acting without warning, and expecting a receptionist to deliver the dismissal message.

A better approach, from the AAFP’s perspective, is to calmly maintain the limits you’ve set, remind the patient that you want to help, and offer treatment alternatives, such as nonopioid analgesics.³ Discussions in response to drug-seeking behavior, of course, should always be delivered—and documented—by the physician.

Noncompliance. This is a particularly complex problem, as issues of patient autonomy and physician authority are involved. A case study presented in the AAFP home study course describes the thoughts and feelings of a physician who considered dismissing a pediatric patient because the child’s mother refused to allow him to be vaccinated. The physician ultimately decided to continue to treat the child, after determining that the physician-patient relationship could still be beneficial and planning to revisit the vaccination issue with the mother at a later date.³ (Another physician, faced with a similar issue, wrote a New York Times article about his decision to dismiss a young patient. His reasoning? Accepting the mother’s refusal to allow her son to get a tetanus booster would compromise “my conscience and my professional ethics. I couldn’t do that."⁸)

Although it is important to recognize the difference between noncompliance and an individual’s right to refuse recommended treatment,⁹ you, too, may encounter situations in which a patient’s, or parent’s, repeated failure—to follow an agreed-upon therapeutic regimen, perhaps, or adhere to a schedule of visits needed to manage a chronic condition— causes your relationship with the patient to deteriorate to a point where dismissal is warranted. Here, as with other potential causes of dismissal, the patient should be adequately warned, the discussion documented, and action taken only if nothing changes.

Anger. As is the case with drug-seeking, the AAFP course advises physicians to anticipate and develop policies for handling situations in which a patient’s anger escalates and creates a real or perceived threat.³ While this is commonly done in acute care facilities, it is often overlooked in outpatient settings.

Among the issues to address: equipping offices and exam rooms with an emergency call button or intercom, knowing where to position yourself to ensure that you can’t be trapped in a room by a threatening patient, and considering how to respond in a way that defuses—rather than escalates—the anger. Calmly ask the patient what he or she is upset about, listen carefully, and apologize, if appropriate, for your role in the upsetting incident. Then move on to the purpose of the visit, stating, for example, “Now, what brings you in today?” ³

It is crucial to set boundaries (although it’s probably not a good idea to attempt it at the time of the outburst), making it clear, for example, that profanity is not acceptable; directing anger at nurses or other staff members is not permitted; and what the consequences of continued outbursts will be. ³

A single incident that’s grounds for dismissal
Despite the emphasis on resolving problems with patients, there are times when dismissal can and should occur, with little warning and no negotiation. In its home study course, the AAFP describes this as a “sentinel incident"— a single occurrence so egregious that it damages the physician-patient relationship beyond repair.³

A threat of violence or a physical assault itself would rise to that level. Some other examples: a sexual assault or blatant sexual advance, falsifying medical records, and theft or another type of criminal activity carried out in the physician’s office.

When a sentinel incident occurs, the best course is likely to be to forego any attempt at resolution, call the police or your facility’s security officer, and, if appropriate, to immediately prepare to “fire” the patient.

Dismissal without abandonment: Here’s how

In the vast majority of cases, dismissing a patient does not in and of itself constitute patient abandonment. Even if the termination is unduly abrupt, as was the case for Susan (CASE 1) and Laura (CASE 2), it doesn’t constitute abandonment unless the patient is dismissed during a course of treatment and unable to find a physician to provide ongoing care.

Neither was true in Susan’s case, and her threat of a lawsuit based on charges of abandonment never came to fruition. Not so for Laura, who was abruptly terminated during ongoing treatment—and who nonetheless made numerous attempts to find another doctor to care for her, without success. The attorney for Laura’s physician advised that the severe consequences of dismissing without going through the proper channels made a trial defense untenable.

Although most charges of patient abandonment never rise to the level required for a successful lawsuit, attorneys often include it in a litany of charges in an attempt to damage the physician’s credibility with a jury. You can usually avoid that scenario by taking the right steps when you dismiss a patient.

CASE 3 Pregnant patient, rural physician

As part of his rural family medicine practice, Dr. J provided obstetrical care. Dr. J had a partner and they alternated call nights, but his partner did not do OB. Dr. J made it a point, however, to always be on call for his obstetrical patients as they neared delivery. Having no patients imminently due, he took a one-week vacation out of town.

One of his patients went into premature labor and went to the local hospital. Dr. J’s partner was called to attend, but indicated he did not do OB work and advised the emergency physician to call “any obstetrician around.” One obstetrical group covered the region and the on-call physician was at another hospital doing a C-section and requested that the patient be transferred to that hospital for evaluation. After a series of delays, the patient was transferred and delivered a preterm infant who showed signs of neurological injury after a lengthy ICU stay.

The family sued all providers involved on several grounds, including patient abandonment. Plaintiff experts testified that the standard of care would be for Dr. J to be in attendance for such emergencies or, failing that, to provide for adequate coverage of his pregnant patient. They also testified that it was reasonable for the patient to have gone to the local hospital where her delivery was planned and that Dr. J should have arranged for the local OB group to provide emergency coverage. The case concluded with an $800,000 pretrial settlement.

Ensure that dismissal is an option
While we’ve already established that physicians have the legal right to dismiss patients, regardless of the reason, there are instances that make it far more difficult—and legally risky—to do so.

A primary care physician in a rural area is a case in point (CASE 3). If you are the only doctor in the area and the patient has no viable means of getting care from another provider, you may want to reconsider the dismissal. It is far easier to establish that a patient in such an underserved area was abandoned, even— as Dr. J found out—for failing to ensure full coverage during a vacation or leave of absence.

Rural physicians can help prevent charges of abandonment by advising patients of the special call challenges a rural setting presents. Doctors should make sure their patients know what to do if an emergency occurs when the practice is closed or a physician is out of town, and document the discussion in the medical record.

A physician in a staff-model HMO may face similar problems. Unless the HMO has another outpatient clinic in the vicinity, dismissal could leave the patient with no means of receiving affordable health care.

Options in such a case might include asking a colleague at the same clinic to accept a patient whom you would like to dismiss or finding a way to manage the patient’s behavior. If a patient has been excessively angry or threatening in the past, for example, it is often advisable to sit down with the patient (with security nearby) to discuss the parameters of expected behavior and develop a contract for future care. The contract might include a requirement that the patient call in advance so that security can be present when he or she arrives, for example, or that the patient agree to abstain from profanity and threats.

Know the laws in your state. Before you terminate a patient, check with your state medical board or local medical society to make sure your actions will be in compliance with any relevant state rules and regulations.

When you dismiss, cover all bases
Send a letter to the patient by certified mail, return receipt requested, notifying him or her of the dismissal and agreeing to provide emergency care for a reasonable time—typically, 30 days—while the patient seeks another physician. It is advisable, too, to help the patient locate other potential clinicians—by, say, including contact information for your county medical society or the patient’s health insurer’s list of in-network providers, or referring an indigent patient to Medicaid or a sliding scale clinic. It is a good idea to offer to transfer records to the new physician, as well.

It is not mandatory to document the reason for the dismissal in the letter, but some sources recommend that you do so. If you’re uncertain how to proceed, check with legal counsel before you send the letter. (You can find sample dismissal letters at www.ttuhsc.edu/som/clinic/forms/ACForm8.11.A.pdf and in “Terminating a patient: Is it time to part ways?” at http://www.aafp.org/fpm/2005/0900/p34.html.)

The events that led up to the dismissal, however, including any discussions you had with the patient about them, must be documented in the medical record. Put a copy of the letter and the certified mail receipt in the chart, as well. JFP

CORRESPONDENCE John Davenport, MD, JD, 13 Redonda, Irvine, CA 92620; john.y.davenport@kp.org

Even with government incentives, I physicians have been slow to make the leap to electronic medical records (EMR) and full electronic prescribing (e-prescribing). My transition to e-prescribing evolved over about a decade, and I was a satisfied e-prescriber—for a while.

Around 2000, I began writing electronic prescriptions using iScribe for Palm handhelds.¹ The final transition to full e-prescribing required only a WiFi connection in the office for use with my Palm, and hitting Send to submit the prescription to the pharmacy. iScribe was user friendly and fast. It eliminated pharmacy “callbacks, “ provided printed receipts for charting, and maintained a record of each prescription on the Palm, filed under the patient’s name. A full prescription history for each patient archived on the Palm reduced the need to pull charts for medication questions.

A rude surprise

Then iScribe was acquired by another company whose e-prescribing product, in my opinion, lengthened patient encounters because it required several additional steps to complete a prescription. This was unacceptable to me, and returning to handwritten prescriptions was out of the question. I needed a better solution.

I was disinclined to invest in another e-prescribing product whose tenure could end as abruptly as iScribe’s had. To wit: I recently read about another user-friendly, well-supported medical software program that was scooped up by a larger company selling less functional and more expensive products (while charging for a costly conversion of existing records and delivering poorer customer service).² And e-prescribing in general has received mixed reviews.³

I briefly considered designing my own prescription writer. A full-featured writer using a relational database, such as Microsoft Access, would be ideal. But developing it would be daunting without software-specific training. The same would be true for spreadsheet software. Adobe Acrobat or word processors with directories or hyperlinks or search functions didn’t seem appropriate.

A welcome surprise
Microsoft Office 2010 software for PC and Mac platforms now includes OneNote, a program new to me. (Price at Costco for Office Home and Student, September 2010, was $119.) OneNote (in which I have no vested interest) is an “electronic notebook” program—a digital version of the multisubject, tabbed binders we all used in school. The user creates tabs, which appear across the top of the notebook interface. Each tab can accommodate as many pages as the user desires, just as in the sections of a paper notebook (FIGURE 1). In OneNote, each page has a title, and the title appears on the page tab on the right side of the screen (left side is an option). Several layers of subpages are also available for each page, similar to subdirectories in a computerized filing system.

FIGURE 1
Tabbed sections

First tab: Summary sheet of patient “problems”
Since 2005, my practice has been limited to skin disease and it has been my custom to create paper “problem lists” as a handy method of tracking each patient’s malignancy types, dates, and anatomic locations. I decided to make these lists electronic, using OneNote (FIGURE 2). OneNote allows default templates, whereby clicking on New Page creates a fully formatted page. I used the template to create a derm summary sheet tab. Under that, I created an electronic page for each of the practice’s patients with a malignancy.

These patient pages are rapidly accessible with OneNote’s search box. As each additional letter is entered, the search feature narrows the possible matches. Usually, entering the first couple of letters of the last name presents the desired match in the search window. I then click on the patient’s name and hit Print; the summary is produced faster than the time it would take to find the information in an alphabetized paper notebook.

The advantage of an electronic summary sheet is that it can be updated and printed at each visit. Electronic summary sheets can be designed in any format—eg, a main page with Problems, Medications, Medication Allergies, Social History, Family History, etc, and a second page with a Health Maintenance flow sheet, or whatever makes sense for the clinician’s practice.

With OneNote, tables, graphics, and text with various fonts can be placed anywhere on the page, as can elements created with drawing tools. Pages can be any size: 3x5 card, letter, legal, or endless (like a Web page). OneNote supports “copy and paste” and “drag and drop” from other programs, as well as hyperlinks to documents outside OneNote.

The user can easily design a variety of templates for use in each tab, simply by designing a page and designating a template. One template can be set as the default for that tab. For example, when I click New Page in the Summary tab, a new summary form appears in that section. Pages can be deleted, copied, or moved within and between sections, just as in a word processing program.

FIGURE 2
Summary sheet

A second tab for prescriptions
I decided to add a second tab to my notebook: Prescriptions. I designed a prescription template and set that as my default New Page for the prescription section. I created a new page for each of my common prescriptions—eg, doxycycline, minocycline, various topical acne preparations. OneNote’s search function at the top of the pages section is nearly instantaneous and shows all possible matches for a string of characters. Entering “tre” will show all matches with “tretinoin. “ It’s easy, then, to select the preparation of interest, hit Print, and have a printed prescription in seconds. For even greater efficiency, I have created new prescription pages for multiple medications I often use in combination—eg, a morning antimicrobial and an evening retinoid for acne, or compounds such as magic mouthwash (FIGURE 3).

Our office check-in process includes producing printed sticky labels with a patient’s name and address and the current date, which we can affix to things like pictures and pathology slips. So I designed my prescription blank to accommodate such labels. I print prescriptions from my wireless notebook computer to a wireless printer. The nurse affixes a label, I sign the document, and in seconds the patient has a detailed, legible prescription. The only disadvantage with this system is that unlike iScribe, I cannot look up a patient’s prescription history electronically because there is no electronically filed copy saved with the patient’s name. One option would be to enter every patient on a page and put prescriptions as subpages under the patient’s page. But that is more work than I want to do in patient exam rooms during a visit. Instead, I print 2 copies of each prescription, one of which goes into the paper chart.

I populated my Prescriptions tab with my prescription “favorites” before going live. But this can also be done “on the fly. “ You simply enter a new prescription as the need arises. OneNote automatically saves the prescription for future use (unless it’s intentionally deleted).

To produce new prescriptions, I set the Prescription blank as the default template. I click New Page and a blank prescription form appears. So, let’s say that lidocaine gel is not in the prescriber. I search “lido, “ and the ointment and transdermal formulations that have already been entered come up. I click New Page, a blank prescription form appears, and I type the details of the prescription (lidocaine gel 2%, dispense 30 grams, apply 30 to 60 minutes before procedure, refill zero). This prescription is saved automatically and will be available the next time I search “lido. “ Alternatively, an existing prescription can be copied and easily modified, as in copying a “cream” prescription and changing to “ointment” in the copy so both are available for future use.

All sorts of variations are possible: “endocarditis prophylaxis” options could be entered as a list on one prescription form. Before the list is printed, the user could simply check the desired option for that patient. Because OneNote saves all changes automatically, any changes made to the default prescriptions (eg, choosing to give a medication once daily rather than the default of twice daily) are saved automatically. When I make any custom changes, I use the Undo button, which I placed on my Quick Access Toolbar, to easily return to my preferred default status.

FIGURE 3
Prescription page for multiple medications

A third tab for patient education
After the success with the Summary sheets and Prescriptions tabs, I added a Patient Ed tab (FIGURE 4). I use handouts liberally to reinforce discussions, to give directions for medication use (eg, retinoids, imiquimod, fluorouracil, permethrin, prednisone), and to educate patients about diseases (eg, dysplastic nevi, melanoma, scabies). Most of this information resides on my computer, and OneNote allows me to rapidly locate and print the documents. I copy the links to patient education files onto corresponding individual OneNote pages, organized by the handouts’ identifying key words.

For example, for the isotretinoin-inflammatory bowel disease information sheet, I created a page called “Isotretinoin - Inflammatory Bowel Disease” in the Patient Education tab. That page contains a hyperlink to the desired document on my computer. The original document can be updated as new information becomes available, and OneNote will always link to the current version. For less commonly used handouts, I can enter key title words in the search box, click on the appropriate page, and print the document.

Because the printer is in the hall 2 steps from each exam room, I can do that faster than the nurse can find these documents in our paper system. This is particularly useful if the information on the possible link between isotretinoin and inflammatory bowel disease is missing from our isotretinoin packet.

FIGURE 4
Patient education tab

Many advantages with this new system

With OneNote, I have elements of a mini-electronic record with summary sheets for patients with malignancies, prescription writing, and patient handouts. In addition, I will not lose this system in a corporate buyout or be charged exorbitant fees to transfer records. Tabs can be password protected for security, and all pages under a tab can be saved in Adobe Acrobat, Microsoft Word, and OneNote formats. Those features help assure security and portability. (This system does not, however, qualify users for government incentives, as it lacks certain functions that are available with a true EMR.)

True e-prescribing—which, for me, included entering patient demographics and offered electronic access to my prescribing history for each patient—is usually an intermediary step for those moving toward full EMR implementation. Using OneNote, I carry a laptop/notebook room to room and print a lot of patient information handouts that otherwise would have to be retrieved from elsewhere.

As a trial, I used the OneNote system along with iScribe’s replacement e-prescribing product for several weeks. My OneNote system was faster. Now, only when patients specifically request e-prescriptions do I use the iScribe replacement product, which, after the corporate merger, has been continued at no charge for 2 to 3 years for existing users. (E-prescribing for Medicare patients at least 25 times in 2011 will qualify users for the Medicare incentive bonus.)

Because the “computer” portion of patient encounters usually occurs at the end of the visit, it does not interfere with the patient-physician relationship. Additionally, my average patient has already been “teched” with a digital scale, digital blood pressure cuff, and digital camera, so a computer is probably one of the more familiar pieces in the technoscape.

OneNote has become a powerful ally in my clinical practice. I thought I had everything I needed with Word, Excel, and Acrobat. But I’m glad I opened OneNote out of curiosity. It’s not only helped me to modernize my patient “problem lists, “ but it’s proven to be the solution to my e-prescribing dilemma.

CORRESPONDENCE
Gary N. Fox, MD, Defiance Clinic, 1400 E. 2nd Street, Defiance, OH 43512; foxgary@yahoo.com

Even with government incentives, I physicians have been slow to make the leap to electronic medical records (EMR) and full electronic prescribing (e-prescribing). My transition to e-prescribing evolved over about a decade, and I was a satisfied e-prescriber—for a while.

Around 2000, I began writing electronic prescriptions using iScribe for Palm handhelds.¹ The final transition to full e-prescribing required only a WiFi connection in the office for use with my Palm, and hitting Send to submit the prescription to the pharmacy. iScribe was user friendly and fast. It eliminated pharmacy “callbacks, “ provided printed receipts for charting, and maintained a record of each prescription on the Palm, filed under the patient’s name. A full prescription history for each patient archived on the Palm reduced the need to pull charts for medication questions.

A rude surprise

Then iScribe was acquired by another company whose e-prescribing product, in my opinion, lengthened patient encounters because it required several additional steps to complete a prescription. This was unacceptable to me, and returning to handwritten prescriptions was out of the question. I needed a better solution.

I was disinclined to invest in another e-prescribing product whose tenure could end as abruptly as iScribe’s had. To wit: I recently read about another user-friendly, well-supported medical software program that was scooped up by a larger company selling less functional and more expensive products (while charging for a costly conversion of existing records and delivering poorer customer service).² And e-prescribing in general has received mixed reviews.³

I briefly considered designing my own prescription writer. A full-featured writer using a relational database, such as Microsoft Access, would be ideal. But developing it would be daunting without software-specific training. The same would be true for spreadsheet software. Adobe Acrobat or word processors with directories or hyperlinks or search functions didn’t seem appropriate.

A welcome surprise
Microsoft Office 2010 software for PC and Mac platforms now includes OneNote, a program new to me. (Price at Costco for Office Home and Student, September 2010, was $119.) OneNote (in which I have no vested interest) is an “electronic notebook” program—a digital version of the multisubject, tabbed binders we all used in school. The user creates tabs, which appear across the top of the notebook interface. Each tab can accommodate as many pages as the user desires, just as in the sections of a paper notebook (FIGURE 1). In OneNote, each page has a title, and the title appears on the page tab on the right side of the screen (left side is an option). Several layers of subpages are also available for each page, similar to subdirectories in a computerized filing system.

FIGURE 1
Tabbed sections

First tab: Summary sheet of patient “problems”
Since 2005, my practice has been limited to skin disease and it has been my custom to create paper “problem lists” as a handy method of tracking each patient’s malignancy types, dates, and anatomic locations. I decided to make these lists electronic, using OneNote (FIGURE 2). OneNote allows default templates, whereby clicking on New Page creates a fully formatted page. I used the template to create a derm summary sheet tab. Under that, I created an electronic page for each of the practice’s patients with a malignancy.

These patient pages are rapidly accessible with OneNote’s search box. As each additional letter is entered, the search feature narrows the possible matches. Usually, entering the first couple of letters of the last name presents the desired match in the search window. I then click on the patient’s name and hit Print; the summary is produced faster than the time it would take to find the information in an alphabetized paper notebook.

The advantage of an electronic summary sheet is that it can be updated and printed at each visit. Electronic summary sheets can be designed in any format—eg, a main page with Problems, Medications, Medication Allergies, Social History, Family History, etc, and a second page with a Health Maintenance flow sheet, or whatever makes sense for the clinician’s practice.

With OneNote, tables, graphics, and text with various fonts can be placed anywhere on the page, as can elements created with drawing tools. Pages can be any size: 3x5 card, letter, legal, or endless (like a Web page). OneNote supports “copy and paste” and “drag and drop” from other programs, as well as hyperlinks to documents outside OneNote.

The user can easily design a variety of templates for use in each tab, simply by designing a page and designating a template. One template can be set as the default for that tab. For example, when I click New Page in the Summary tab, a new summary form appears in that section. Pages can be deleted, copied, or moved within and between sections, just as in a word processing program.

FIGURE 2
Summary sheet

A second tab for prescriptions
I decided to add a second tab to my notebook: Prescriptions. I designed a prescription template and set that as my default New Page for the prescription section. I created a new page for each of my common prescriptions—eg, doxycycline, minocycline, various topical acne preparations. OneNote’s search function at the top of the pages section is nearly instantaneous and shows all possible matches for a string of characters. Entering “tre” will show all matches with “tretinoin. “ It’s easy, then, to select the preparation of interest, hit Print, and have a printed prescription in seconds. For even greater efficiency, I have created new prescription pages for multiple medications I often use in combination—eg, a morning antimicrobial and an evening retinoid for acne, or compounds such as magic mouthwash (FIGURE 3).

Our office check-in process includes producing printed sticky labels with a patient’s name and address and the current date, which we can affix to things like pictures and pathology slips. So I designed my prescription blank to accommodate such labels. I print prescriptions from my wireless notebook computer to a wireless printer. The nurse affixes a label, I sign the document, and in seconds the patient has a detailed, legible prescription. The only disadvantage with this system is that unlike iScribe, I cannot look up a patient’s prescription history electronically because there is no electronically filed copy saved with the patient’s name. One option would be to enter every patient on a page and put prescriptions as subpages under the patient’s page. But that is more work than I want to do in patient exam rooms during a visit. Instead, I print 2 copies of each prescription, one of which goes into the paper chart.

I populated my Prescriptions tab with my prescription “favorites” before going live. But this can also be done “on the fly. “ You simply enter a new prescription as the need arises. OneNote automatically saves the prescription for future use (unless it’s intentionally deleted).

To produce new prescriptions, I set the Prescription blank as the default template. I click New Page and a blank prescription form appears. So, let’s say that lidocaine gel is not in the prescriber. I search “lido, “ and the ointment and transdermal formulations that have already been entered come up. I click New Page, a blank prescription form appears, and I type the details of the prescription (lidocaine gel 2%, dispense 30 grams, apply 30 to 60 minutes before procedure, refill zero). This prescription is saved automatically and will be available the next time I search “lido. “ Alternatively, an existing prescription can be copied and easily modified, as in copying a “cream” prescription and changing to “ointment” in the copy so both are available for future use.

All sorts of variations are possible: “endocarditis prophylaxis” options could be entered as a list on one prescription form. Before the list is printed, the user could simply check the desired option for that patient. Because OneNote saves all changes automatically, any changes made to the default prescriptions (eg, choosing to give a medication once daily rather than the default of twice daily) are saved automatically. When I make any custom changes, I use the Undo button, which I placed on my Quick Access Toolbar, to easily return to my preferred default status.

FIGURE 3
Prescription page for multiple medications

A third tab for patient education
After the success with the Summary sheets and Prescriptions tabs, I added a Patient Ed tab (FIGURE 4). I use handouts liberally to reinforce discussions, to give directions for medication use (eg, retinoids, imiquimod, fluorouracil, permethrin, prednisone), and to educate patients about diseases (eg, dysplastic nevi, melanoma, scabies). Most of this information resides on my computer, and OneNote allows me to rapidly locate and print the documents. I copy the links to patient education files onto corresponding individual OneNote pages, organized by the handouts’ identifying key words.

For example, for the isotretinoin-inflammatory bowel disease information sheet, I created a page called “Isotretinoin - Inflammatory Bowel Disease” in the Patient Education tab. That page contains a hyperlink to the desired document on my computer. The original document can be updated as new information becomes available, and OneNote will always link to the current version. For less commonly used handouts, I can enter key title words in the search box, click on the appropriate page, and print the document.

Because the printer is in the hall 2 steps from each exam room, I can do that faster than the nurse can find these documents in our paper system. This is particularly useful if the information on the possible link between isotretinoin and inflammatory bowel disease is missing from our isotretinoin packet.

FIGURE 4
Patient education tab

Many advantages with this new system

With OneNote, I have elements of a mini-electronic record with summary sheets for patients with malignancies, prescription writing, and patient handouts. In addition, I will not lose this system in a corporate buyout or be charged exorbitant fees to transfer records. Tabs can be password protected for security, and all pages under a tab can be saved in Adobe Acrobat, Microsoft Word, and OneNote formats. Those features help assure security and portability. (This system does not, however, qualify users for government incentives, as it lacks certain functions that are available with a true EMR.)

True e-prescribing—which, for me, included entering patient demographics and offered electronic access to my prescribing history for each patient—is usually an intermediary step for those moving toward full EMR implementation. Using OneNote, I carry a laptop/notebook room to room and print a lot of patient information handouts that otherwise would have to be retrieved from elsewhere.

As a trial, I used the OneNote system along with iScribe’s replacement e-prescribing product for several weeks. My OneNote system was faster. Now, only when patients specifically request e-prescriptions do I use the iScribe replacement product, which, after the corporate merger, has been continued at no charge for 2 to 3 years for existing users. (E-prescribing for Medicare patients at least 25 times in 2011 will qualify users for the Medicare incentive bonus.)

Because the “computer” portion of patient encounters usually occurs at the end of the visit, it does not interfere with the patient-physician relationship. Additionally, my average patient has already been “teched” with a digital scale, digital blood pressure cuff, and digital camera, so a computer is probably one of the more familiar pieces in the technoscape.

OneNote has become a powerful ally in my clinical practice. I thought I had everything I needed with Word, Excel, and Acrobat. But I’m glad I opened OneNote out of curiosity. It’s not only helped me to modernize my patient “problem lists, “ but it’s proven to be the solution to my e-prescribing dilemma.

CORRESPONDENCE
Gary N. Fox, MD, Defiance Clinic, 1400 E. 2nd Street, Defiance, OH 43512; foxgary@yahoo.com

Even with government incentives, I physicians have been slow to make the leap to electronic medical records (EMR) and full electronic prescribing (e-prescribing). My transition to e-prescribing evolved over about a decade, and I was a satisfied e-prescriber—for a while.

Around 2000, I began writing electronic prescriptions using iScribe for Palm handhelds.¹ The final transition to full e-prescribing required only a WiFi connection in the office for use with my Palm, and hitting Send to submit the prescription to the pharmacy. iScribe was user friendly and fast. It eliminated pharmacy “callbacks, “ provided printed receipts for charting, and maintained a record of each prescription on the Palm, filed under the patient’s name. A full prescription history for each patient archived on the Palm reduced the need to pull charts for medication questions.

A rude surprise

Then iScribe was acquired by another company whose e-prescribing product, in my opinion, lengthened patient encounters because it required several additional steps to complete a prescription. This was unacceptable to me, and returning to handwritten prescriptions was out of the question. I needed a better solution.

I was disinclined to invest in another e-prescribing product whose tenure could end as abruptly as iScribe’s had. To wit: I recently read about another user-friendly, well-supported medical software program that was scooped up by a larger company selling less functional and more expensive products (while charging for a costly conversion of existing records and delivering poorer customer service).² And e-prescribing in general has received mixed reviews.³

I briefly considered designing my own prescription writer. A full-featured writer using a relational database, such as Microsoft Access, would be ideal. But developing it would be daunting without software-specific training. The same would be true for spreadsheet software. Adobe Acrobat or word processors with directories or hyperlinks or search functions didn’t seem appropriate.

A welcome surprise
Microsoft Office 2010 software for PC and Mac platforms now includes OneNote, a program new to me. (Price at Costco for Office Home and Student, September 2010, was $119.) OneNote (in which I have no vested interest) is an “electronic notebook” program—a digital version of the multisubject, tabbed binders we all used in school. The user creates tabs, which appear across the top of the notebook interface. Each tab can accommodate as many pages as the user desires, just as in the sections of a paper notebook (FIGURE 1). In OneNote, each page has a title, and the title appears on the page tab on the right side of the screen (left side is an option). Several layers of subpages are also available for each page, similar to subdirectories in a computerized filing system.

FIGURE 1
Tabbed sections

First tab: Summary sheet of patient “problems”
Since 2005, my practice has been limited to skin disease and it has been my custom to create paper “problem lists” as a handy method of tracking each patient’s malignancy types, dates, and anatomic locations. I decided to make these lists electronic, using OneNote (FIGURE 2). OneNote allows default templates, whereby clicking on New Page creates a fully formatted page. I used the template to create a derm summary sheet tab. Under that, I created an electronic page for each of the practice’s patients with a malignancy.

These patient pages are rapidly accessible with OneNote’s search box. As each additional letter is entered, the search feature narrows the possible matches. Usually, entering the first couple of letters of the last name presents the desired match in the search window. I then click on the patient’s name and hit Print; the summary is produced faster than the time it would take to find the information in an alphabetized paper notebook.

The advantage of an electronic summary sheet is that it can be updated and printed at each visit. Electronic summary sheets can be designed in any format—eg, a main page with Problems, Medications, Medication Allergies, Social History, Family History, etc, and a second page with a Health Maintenance flow sheet, or whatever makes sense for the clinician’s practice.

With OneNote, tables, graphics, and text with various fonts can be placed anywhere on the page, as can elements created with drawing tools. Pages can be any size: 3x5 card, letter, legal, or endless (like a Web page). OneNote supports “copy and paste” and “drag and drop” from other programs, as well as hyperlinks to documents outside OneNote.

The user can easily design a variety of templates for use in each tab, simply by designing a page and designating a template. One template can be set as the default for that tab. For example, when I click New Page in the Summary tab, a new summary form appears in that section. Pages can be deleted, copied, or moved within and between sections, just as in a word processing program.

FIGURE 2
Summary sheet

A second tab for prescriptions
I decided to add a second tab to my notebook: Prescriptions. I designed a prescription template and set that as my default New Page for the prescription section. I created a new page for each of my common prescriptions—eg, doxycycline, minocycline, various topical acne preparations. OneNote’s search function at the top of the pages section is nearly instantaneous and shows all possible matches for a string of characters. Entering “tre” will show all matches with “tretinoin. “ It’s easy, then, to select the preparation of interest, hit Print, and have a printed prescription in seconds. For even greater efficiency, I have created new prescription pages for multiple medications I often use in combination—eg, a morning antimicrobial and an evening retinoid for acne, or compounds such as magic mouthwash (FIGURE 3).

Our office check-in process includes producing printed sticky labels with a patient’s name and address and the current date, which we can affix to things like pictures and pathology slips. So I designed my prescription blank to accommodate such labels. I print prescriptions from my wireless notebook computer to a wireless printer. The nurse affixes a label, I sign the document, and in seconds the patient has a detailed, legible prescription. The only disadvantage with this system is that unlike iScribe, I cannot look up a patient’s prescription history electronically because there is no electronically filed copy saved with the patient’s name. One option would be to enter every patient on a page and put prescriptions as subpages under the patient’s page. But that is more work than I want to do in patient exam rooms during a visit. Instead, I print 2 copies of each prescription, one of which goes into the paper chart.

I populated my Prescriptions tab with my prescription “favorites” before going live. But this can also be done “on the fly. “ You simply enter a new prescription as the need arises. OneNote automatically saves the prescription for future use (unless it’s intentionally deleted).

To produce new prescriptions, I set the Prescription blank as the default template. I click New Page and a blank prescription form appears. So, let’s say that lidocaine gel is not in the prescriber. I search “lido, “ and the ointment and transdermal formulations that have already been entered come up. I click New Page, a blank prescription form appears, and I type the details of the prescription (lidocaine gel 2%, dispense 30 grams, apply 30 to 60 minutes before procedure, refill zero). This prescription is saved automatically and will be available the next time I search “lido. “ Alternatively, an existing prescription can be copied and easily modified, as in copying a “cream” prescription and changing to “ointment” in the copy so both are available for future use.

All sorts of variations are possible: “endocarditis prophylaxis” options could be entered as a list on one prescription form. Before the list is printed, the user could simply check the desired option for that patient. Because OneNote saves all changes automatically, any changes made to the default prescriptions (eg, choosing to give a medication once daily rather than the default of twice daily) are saved automatically. When I make any custom changes, I use the Undo button, which I placed on my Quick Access Toolbar, to easily return to my preferred default status.

FIGURE 3
Prescription page for multiple medications

A third tab for patient education
After the success with the Summary sheets and Prescriptions tabs, I added a Patient Ed tab (FIGURE 4). I use handouts liberally to reinforce discussions, to give directions for medication use (eg, retinoids, imiquimod, fluorouracil, permethrin, prednisone), and to educate patients about diseases (eg, dysplastic nevi, melanoma, scabies). Most of this information resides on my computer, and OneNote allows me to rapidly locate and print the documents. I copy the links to patient education files onto corresponding individual OneNote pages, organized by the handouts’ identifying key words.

For example, for the isotretinoin-inflammatory bowel disease information sheet, I created a page called “Isotretinoin - Inflammatory Bowel Disease” in the Patient Education tab. That page contains a hyperlink to the desired document on my computer. The original document can be updated as new information becomes available, and OneNote will always link to the current version. For less commonly used handouts, I can enter key title words in the search box, click on the appropriate page, and print the document.

Because the printer is in the hall 2 steps from each exam room, I can do that faster than the nurse can find these documents in our paper system. This is particularly useful if the information on the possible link between isotretinoin and inflammatory bowel disease is missing from our isotretinoin packet.

FIGURE 4
Patient education tab

Many advantages with this new system

With OneNote, I have elements of a mini-electronic record with summary sheets for patients with malignancies, prescription writing, and patient handouts. In addition, I will not lose this system in a corporate buyout or be charged exorbitant fees to transfer records. Tabs can be password protected for security, and all pages under a tab can be saved in Adobe Acrobat, Microsoft Word, and OneNote formats. Those features help assure security and portability. (This system does not, however, qualify users for government incentives, as it lacks certain functions that are available with a true EMR.)

True e-prescribing—which, for me, included entering patient demographics and offered electronic access to my prescribing history for each patient—is usually an intermediary step for those moving toward full EMR implementation. Using OneNote, I carry a laptop/notebook room to room and print a lot of patient information handouts that otherwise would have to be retrieved from elsewhere.

As a trial, I used the OneNote system along with iScribe’s replacement e-prescribing product for several weeks. My OneNote system was faster. Now, only when patients specifically request e-prescriptions do I use the iScribe replacement product, which, after the corporate merger, has been continued at no charge for 2 to 3 years for existing users. (E-prescribing for Medicare patients at least 25 times in 2011 will qualify users for the Medicare incentive bonus.)

Because the “computer” portion of patient encounters usually occurs at the end of the visit, it does not interfere with the patient-physician relationship. Additionally, my average patient has already been “teched” with a digital scale, digital blood pressure cuff, and digital camera, so a computer is probably one of the more familiar pieces in the technoscape.

OneNote has become a powerful ally in my clinical practice. I thought I had everything I needed with Word, Excel, and Acrobat. But I’m glad I opened OneNote out of curiosity. It’s not only helped me to modernize my patient “problem lists, “ but it’s proven to be the solution to my e-prescribing dilemma.

CORRESPONDENCE
Gary N. Fox, MD, Defiance Clinic, 1400 E. 2nd Street, Defiance, OH 43512; foxgary@yahoo.com

Congenital permanent hearing loss occurs in about 3 of every 1000 births.¹ Undiagnosed hearing loss can result in speech-language, academic, social, and other developmental delays. Until about 20 years ago, most children with hearing loss were not diagnosed until about 3 years of age.² By that age, opportunities for effective intervention to help these children develop communication skills were often delayed, and many children remained seriously disabled.

In this enlightened age, when newborn hearing screening is nearly universal (92%), the prospects for children with hearing impairments are brighter—but not as bright as they could be.³ That’s because more than half the newborns with positive screens are lost to follow-up.³ Too many remain “lost,” without a diagnosis or access to services, until they show up at school without the language skills they need to keep up, academically or socially, with their classmates.

The medical home can help

The American Academy of Pediatrics (AAP) and the Health Resources Services Administration aggressively promote the concept of the medical home as the best locus for coordinating the care of children with special needs, and the American Academy of Family Physicians (AAFP) has endorsed the medical home concept.^2,4 According to the AAFP’s Joint Statement of Principles, the medical home is responsible for coordinating care across all elements of the health care system and the patient’s community.⁴ Most physicians in a recent survey believed the medical home should be responsible for coordinating services and guiding families in the development of intervention plans for children with hearing loss.⁵ Family physicians who provide a medical home for infants and young children are in an ideal position to ensure that children with hearing loss are not lost to follow-up and that they receive the services they need to lead healthy lives.

What follow-up entails
According to the 2007 Position Paper of the Joint Committee on Infant Hearing, a body composed of representatives from the AAP, the American Academy of Audiology, the American Speech-Language-Hearing Association, and other professional organizations concerned with hearing loss, an effective program to mitigate the impact of hearing loss should follow this timetable⁶:

• By 1 month of age, all infants should receive hearing screening. (Of note: In 2008, the US Preventive Services Task Force issued a B recommendation for universal hearing screening of all newborns.⁷)
• By 3 months of age, hearing loss should be diagnosed.
• Within 1 month of diagnosis, hearing aids should be fitted for infants whose parents choose hearing aids.
• As soon as possible after diagnosis—but no later than 6 months of age—infants with confirmed, permanent hearing loss should receive early intervention services.⁶

Intervention services should include medical and surgical evaluation, evaluation for hearing aids, and then cochlear implants for those with severe-to-profound hearing loss who do not benefit from hearing aids. Communication assessment and therapy should also be considered. The goal of intervention is to help infants with hearing loss develop communication competence, social skills, emotional well-being, and positive self-esteem.⁶

The CLINICAL TOOL provides a detailed overview of the early hearing detection and intervention (EHDI) process outlined by the Joint Committee and a checklist of roles and responsibilities for physicians serving as medical homes for children with hearing loss and their families. Unfortunately, many primary caregivers report that their medical training did not prepare them to guide families through this process.^8-10 This article is intended to provide the additional information caregivers have requested to help them meet these obligations.

CLINICAL TOOL
The early hearing detection and intervention process⁶

Getting an early start: Newborn screening

Ideally, intervention should begin before a child is born. When parents come in for prenatal visits, talk to them about the importance of newborn hearing screening. Tell them to expect that their baby will be screened at the birth hospital or at an outpatient audiology facility, and that this screening should be done by the time the baby is 1 month of age.

Tell parents their baby’s hearing will be tested with automated screening equipment that measures otoacoustic emissions from the baby’s ears or auditory brainstem response (ABR) to sound, both measurements that correlate with a child’s hearing and auditory behavior. Infants in well-baby nurseries can be screened by either technology. Infants in neonatal intensive care units (NICUs) for more than 5 days should be screened with ABR technology, which is better able to pick up neural losses.⁶ NICU babies frequently are at higher risk for neural hearing loss including auditory neuropathy/dyssynchrony, a condition that may account for about 8% of pediatric hearing losses annually.³

Be sure to explain to expectant couples that a positive screen indicates only that a problem may exist. It is not equivalent to a diagnosis of hearing loss, which is usually made by an audiologist.

The medical home’s role. The medical home should make sure that infants who fail an initial or secondary hospital screening and those who were missed or born outside the hospital are referred for outpatient screening. Newborns who fail initial screening should have both ears rescreened before hospital discharge, even if only one ear had failed previously.⁶ Additionally, any infant readmitted to the hospital within the first month of life who has a condition associated with potential hearing loss should be rescreened before discharge, preferably with an ABR.⁶ Risk factors associated with permanent-congenital, delayed-onset, or progressive hearing loss in children are listed in the TABLE.

TABLE
Risk indicators associated with hearing loss in childhood

Reporting screening results
Screening results are useful only if they are transmitted to caregivers and families. Breakdowns in transmission are a persistent problem for the early hearing detection and intervention process.² The process is facilitated when hospitals make sure that all babies and their families are linked to a medical home at the time of discharge.

Hospital personnel should also be responsible for providing screening results to families in a face-to-face meeting. Medical home providers should review screening results again with parents and answer any questions that might have arisen after the initial hospital stay. Screening results should be given to parents in a sensitive manner, and patient education materials should be provided in parents’ native language, written at an appropriate reading level. Because hospital staff may not be trained to do this properly, it is important that medical home providers oversee the process and address any parental concerns.²

Screening results should also be reported by the birth hospital to the state’s EHDI coordinator, part of the national tracking and surveillance system funded by the Centers for Disease Control and Prevention to ensure that all children with hearing loss achieve communication and social skills commensurate with their cognitive abilities. ¹¹ You can find contact information for your state coordinator at www.cdc.gov/ncbddd/ehdi/documents/EHDI_contact.pdf.

Diagnosing hearing loss

When an infant who fails newborn screening testing arrives at the medical home, the urgent next step is to make sure he or she is referred to a pediatric audiologist for a complete audiologic diagnostic evaluation. Advising parents to “wait and see” is not appropriate; researchers have identified that response as a major obstacle to successful follow-up.² The audiologic evaluation should be done by the time the baby is 3 months of age and should be performed by a pediatric audiologist specializing in diagnosis and management of young children with hearing loss.^4-6

Tell parents that, with their approval, the audiologist may fit the baby with hearing aids as early as this visit, as amplification can help even very young infants hear all sounds in the environment, particularly spoken language.

Ongoing monitoring
Family practices serving as medical homes should continue to monitor children who pass their newborn screening but have high-risk factors for delayed-onset hearing loss. Those factors are listed in the TABLE. Refer children at higher risk for an audiologic diagnostic evaluation by 24 to 30 months of age.⁶ Follow-up on parental concerns about infant hearing or speech and monitor infants’ developmental milestones, auditory skills, and middle ear status using the AAP’s pediatric periodicity schedule.⁶ Conduct global developmental screenings at 9, 18, and 24 to 30 months of age, and refer for speech-language-hearing evaluations when appropriate.⁶

The medical home as central referral point

The medical home is a central referral point for the complex needs of children with hearing loss. The physician and all other providers involved in the child’s care should report results of diagnostic evaluations to state EHDI coordinators. The medical home’s continued involvement includes medical clearance for hearing aids, additional consultations, and screenings as necessary to help children receive needed services and keep them from being lost to the system.^5,9

Referral for genetic consultation is important, because about half of all autosomal recessive sensorineural hearing losses that are not part of a syndrome are caused by mutations in the Connexin 26 GJB2 gene.^12,13 Referral to a pediatric ophthalmologist is similarly important, to identify deficits in visual acuity that frequently co-occur with hearing loss, especially in preterm infants.⁶ Results of these consultations can assist the physician in guiding families through the intervention process.

Coordination of care among multiple providers is essential. When a family physician’s practice serves as a medical home for a child with hearing loss, the physician should oversee and coordinate the efforts of all stakeholders in the EHDI process; make referrals to, and receive reports from, all providers involved in diagnosis and treatment; and ensure that relevant information is shared. During all phases of the process, the role of the family physician is to encourage families to comply with professionals’ recommendations and to stress the importance of making and keeping scheduled appointments.

Making plans for intervention
Families with children who have any degree of permanent hearing loss in one or both ears are entitled to early intervention services.⁶ In most states, these services are provided by a multidisciplinary team at no or low cost through a federal grant program. Services can be home- or center-based. They may include, as needed, education for the affected child and family; physical, speech/language, and occupational therapy; and social work and psychotherapy services. The team works with the family to develop an individualized family service plan to document and guide the early intervention process.¹⁴

Families with a hearing-impaired child have a range of options to choose from in their search for an approach that is best for the child and most acceptable to them. Communication options span a continuum from emphasis on sign language as used by the deaf community to a variety of oral-aural approaches designed to lead to spoken language. Parental choices are influenced most heavily by the child’s success with hearing aids. Parents need unbiased, culturally sensitive counseling about all available communication options and hearing technologies, so they can make informed choices for their children.⁶

Answering parents’ questions
To ensure that parents have appropriate expectations for what auditory technology can do for their child, they need to receive information about traditional digital signal processing hearing aids, osseointegrated hearing implant systems (also known as bone-anchored hearing aids), and cochlear implants. They need to know that a trial period will probably be necessary to determine whether hearing aids are appropriate or if cochlear implantation should be considered. Cost of hearing aids and cochlear implants is a serious concern for parents, and for many, it presents a major barrier to obtaining optimal care.²

Many insurance plans cover cochlear implants, but require that children be at least 12 months of age, have bilateral profound sensorineural hearing loss (or severe-to-profound sensorineural hearing loss for those ≥24 months of age), receive minimal benefit from hearing aids, be enrolled in auditory rehabilitative therapy, and possess no medical contraindications.¹⁵ Hearing aids and cochlear implants may also be covered for children enrolled in Medicaid or the State Children’s Health Insurance Program.¹⁶ However, according to a recent evaluation of hearing screening programs nationwide, public and private insurance policies almost never provide adequate coverage for hearing services.²

As parents consider the options, be sure they are aware that some children younger than 12 months of age are receiving cochlear implants (sometimes in both ears), that stimulation of both ears is being recommended at earlier ages, and that it is also common for children to use a hearing aid in one ear and a cochlear implant in the other.^17,18 Distinguishing among hearing loss types and knowing which treatment options are most effective helps physicians counsel families appropriately about making the best decisions for their children. Some physicians have expressed uncertainties about these issues and have requested additional information on this topic.¹⁹ Audiologists can help physicians obtain this information and help them to better counsel families about these options.

CORRESPONDENCE
Carole E. Johnson, PhD, AuD, 1199 Haley Center, Auburn University, Auburn, AL 36849; johns19@auburn.edu

Congenital permanent hearing loss occurs in about 3 of every 1000 births.¹ Undiagnosed hearing loss can result in speech-language, academic, social, and other developmental delays. Until about 20 years ago, most children with hearing loss were not diagnosed until about 3 years of age.² By that age, opportunities for effective intervention to help these children develop communication skills were often delayed, and many children remained seriously disabled.

In this enlightened age, when newborn hearing screening is nearly universal (92%), the prospects for children with hearing impairments are brighter—but not as bright as they could be.³ That’s because more than half the newborns with positive screens are lost to follow-up.³ Too many remain “lost,” without a diagnosis or access to services, until they show up at school without the language skills they need to keep up, academically or socially, with their classmates.

The medical home can help

The American Academy of Pediatrics (AAP) and the Health Resources Services Administration aggressively promote the concept of the medical home as the best locus for coordinating the care of children with special needs, and the American Academy of Family Physicians (AAFP) has endorsed the medical home concept.^2,4 According to the AAFP’s Joint Statement of Principles, the medical home is responsible for coordinating care across all elements of the health care system and the patient’s community.⁴ Most physicians in a recent survey believed the medical home should be responsible for coordinating services and guiding families in the development of intervention plans for children with hearing loss.⁵ Family physicians who provide a medical home for infants and young children are in an ideal position to ensure that children with hearing loss are not lost to follow-up and that they receive the services they need to lead healthy lives.

What follow-up entails
According to the 2007 Position Paper of the Joint Committee on Infant Hearing, a body composed of representatives from the AAP, the American Academy of Audiology, the American Speech-Language-Hearing Association, and other professional organizations concerned with hearing loss, an effective program to mitigate the impact of hearing loss should follow this timetable⁶:

• By 1 month of age, all infants should receive hearing screening. (Of note: In 2008, the US Preventive Services Task Force issued a B recommendation for universal hearing screening of all newborns.⁷)
• By 3 months of age, hearing loss should be diagnosed.
• Within 1 month of diagnosis, hearing aids should be fitted for infants whose parents choose hearing aids.
• As soon as possible after diagnosis—but no later than 6 months of age—infants with confirmed, permanent hearing loss should receive early intervention services.⁶

Intervention services should include medical and surgical evaluation, evaluation for hearing aids, and then cochlear implants for those with severe-to-profound hearing loss who do not benefit from hearing aids. Communication assessment and therapy should also be considered. The goal of intervention is to help infants with hearing loss develop communication competence, social skills, emotional well-being, and positive self-esteem.⁶

The CLINICAL TOOL provides a detailed overview of the early hearing detection and intervention (EHDI) process outlined by the Joint Committee and a checklist of roles and responsibilities for physicians serving as medical homes for children with hearing loss and their families. Unfortunately, many primary caregivers report that their medical training did not prepare them to guide families through this process.^8-10 This article is intended to provide the additional information caregivers have requested to help them meet these obligations.

CLINICAL TOOL
The early hearing detection and intervention process⁶

Getting an early start: Newborn screening

Ideally, intervention should begin before a child is born. When parents come in for prenatal visits, talk to them about the importance of newborn hearing screening. Tell them to expect that their baby will be screened at the birth hospital or at an outpatient audiology facility, and that this screening should be done by the time the baby is 1 month of age.

Tell parents their baby’s hearing will be tested with automated screening equipment that measures otoacoustic emissions from the baby’s ears or auditory brainstem response (ABR) to sound, both measurements that correlate with a child’s hearing and auditory behavior. Infants in well-baby nurseries can be screened by either technology. Infants in neonatal intensive care units (NICUs) for more than 5 days should be screened with ABR technology, which is better able to pick up neural losses.⁶ NICU babies frequently are at higher risk for neural hearing loss including auditory neuropathy/dyssynchrony, a condition that may account for about 8% of pediatric hearing losses annually.³

Be sure to explain to expectant couples that a positive screen indicates only that a problem may exist. It is not equivalent to a diagnosis of hearing loss, which is usually made by an audiologist.

The medical home’s role. The medical home should make sure that infants who fail an initial or secondary hospital screening and those who were missed or born outside the hospital are referred for outpatient screening. Newborns who fail initial screening should have both ears rescreened before hospital discharge, even if only one ear had failed previously.⁶ Additionally, any infant readmitted to the hospital within the first month of life who has a condition associated with potential hearing loss should be rescreened before discharge, preferably with an ABR.⁶ Risk factors associated with permanent-congenital, delayed-onset, or progressive hearing loss in children are listed in the TABLE.

TABLE
Risk indicators associated with hearing loss in childhood

Reporting screening results
Screening results are useful only if they are transmitted to caregivers and families. Breakdowns in transmission are a persistent problem for the early hearing detection and intervention process.² The process is facilitated when hospitals make sure that all babies and their families are linked to a medical home at the time of discharge.

Hospital personnel should also be responsible for providing screening results to families in a face-to-face meeting. Medical home providers should review screening results again with parents and answer any questions that might have arisen after the initial hospital stay. Screening results should be given to parents in a sensitive manner, and patient education materials should be provided in parents’ native language, written at an appropriate reading level. Because hospital staff may not be trained to do this properly, it is important that medical home providers oversee the process and address any parental concerns.²

Screening results should also be reported by the birth hospital to the state’s EHDI coordinator, part of the national tracking and surveillance system funded by the Centers for Disease Control and Prevention to ensure that all children with hearing loss achieve communication and social skills commensurate with their cognitive abilities. ¹¹ You can find contact information for your state coordinator at www.cdc.gov/ncbddd/ehdi/documents/EHDI_contact.pdf.

Diagnosing hearing loss

When an infant who fails newborn screening testing arrives at the medical home, the urgent next step is to make sure he or she is referred to a pediatric audiologist for a complete audiologic diagnostic evaluation. Advising parents to “wait and see” is not appropriate; researchers have identified that response as a major obstacle to successful follow-up.² The audiologic evaluation should be done by the time the baby is 3 months of age and should be performed by a pediatric audiologist specializing in diagnosis and management of young children with hearing loss.^4-6

Tell parents that, with their approval, the audiologist may fit the baby with hearing aids as early as this visit, as amplification can help even very young infants hear all sounds in the environment, particularly spoken language.

Ongoing monitoring
Family practices serving as medical homes should continue to monitor children who pass their newborn screening but have high-risk factors for delayed-onset hearing loss. Those factors are listed in the TABLE. Refer children at higher risk for an audiologic diagnostic evaluation by 24 to 30 months of age.⁶ Follow-up on parental concerns about infant hearing or speech and monitor infants’ developmental milestones, auditory skills, and middle ear status using the AAP’s pediatric periodicity schedule.⁶ Conduct global developmental screenings at 9, 18, and 24 to 30 months of age, and refer for speech-language-hearing evaluations when appropriate.⁶

The medical home as central referral point

The medical home is a central referral point for the complex needs of children with hearing loss. The physician and all other providers involved in the child’s care should report results of diagnostic evaluations to state EHDI coordinators. The medical home’s continued involvement includes medical clearance for hearing aids, additional consultations, and screenings as necessary to help children receive needed services and keep them from being lost to the system.^5,9

Referral for genetic consultation is important, because about half of all autosomal recessive sensorineural hearing losses that are not part of a syndrome are caused by mutations in the Connexin 26 GJB2 gene.^12,13 Referral to a pediatric ophthalmologist is similarly important, to identify deficits in visual acuity that frequently co-occur with hearing loss, especially in preterm infants.⁶ Results of these consultations can assist the physician in guiding families through the intervention process.

Coordination of care among multiple providers is essential. When a family physician’s practice serves as a medical home for a child with hearing loss, the physician should oversee and coordinate the efforts of all stakeholders in the EHDI process; make referrals to, and receive reports from, all providers involved in diagnosis and treatment; and ensure that relevant information is shared. During all phases of the process, the role of the family physician is to encourage families to comply with professionals’ recommendations and to stress the importance of making and keeping scheduled appointments.

Making plans for intervention
Families with children who have any degree of permanent hearing loss in one or both ears are entitled to early intervention services.⁶ In most states, these services are provided by a multidisciplinary team at no or low cost through a federal grant program. Services can be home- or center-based. They may include, as needed, education for the affected child and family; physical, speech/language, and occupational therapy; and social work and psychotherapy services. The team works with the family to develop an individualized family service plan to document and guide the early intervention process.¹⁴

Families with a hearing-impaired child have a range of options to choose from in their search for an approach that is best for the child and most acceptable to them. Communication options span a continuum from emphasis on sign language as used by the deaf community to a variety of oral-aural approaches designed to lead to spoken language. Parental choices are influenced most heavily by the child’s success with hearing aids. Parents need unbiased, culturally sensitive counseling about all available communication options and hearing technologies, so they can make informed choices for their children.⁶

Answering parents’ questions
To ensure that parents have appropriate expectations for what auditory technology can do for their child, they need to receive information about traditional digital signal processing hearing aids, osseointegrated hearing implant systems (also known as bone-anchored hearing aids), and cochlear implants. They need to know that a trial period will probably be necessary to determine whether hearing aids are appropriate or if cochlear implantation should be considered. Cost of hearing aids and cochlear implants is a serious concern for parents, and for many, it presents a major barrier to obtaining optimal care.²

Many insurance plans cover cochlear implants, but require that children be at least 12 months of age, have bilateral profound sensorineural hearing loss (or severe-to-profound sensorineural hearing loss for those ≥24 months of age), receive minimal benefit from hearing aids, be enrolled in auditory rehabilitative therapy, and possess no medical contraindications.¹⁵ Hearing aids and cochlear implants may also be covered for children enrolled in Medicaid or the State Children’s Health Insurance Program.¹⁶ However, according to a recent evaluation of hearing screening programs nationwide, public and private insurance policies almost never provide adequate coverage for hearing services.²

As parents consider the options, be sure they are aware that some children younger than 12 months of age are receiving cochlear implants (sometimes in both ears), that stimulation of both ears is being recommended at earlier ages, and that it is also common for children to use a hearing aid in one ear and a cochlear implant in the other.^17,18 Distinguishing among hearing loss types and knowing which treatment options are most effective helps physicians counsel families appropriately about making the best decisions for their children. Some physicians have expressed uncertainties about these issues and have requested additional information on this topic.¹⁹ Audiologists can help physicians obtain this information and help them to better counsel families about these options.

CORRESPONDENCE
Carole E. Johnson, PhD, AuD, 1199 Haley Center, Auburn University, Auburn, AL 36849; johns19@auburn.edu

Congenital permanent hearing loss occurs in about 3 of every 1000 births.¹ Undiagnosed hearing loss can result in speech-language, academic, social, and other developmental delays. Until about 20 years ago, most children with hearing loss were not diagnosed until about 3 years of age.² By that age, opportunities for effective intervention to help these children develop communication skills were often delayed, and many children remained seriously disabled.

In this enlightened age, when newborn hearing screening is nearly universal (92%), the prospects for children with hearing impairments are brighter—but not as bright as they could be.³ That’s because more than half the newborns with positive screens are lost to follow-up.³ Too many remain “lost,” without a diagnosis or access to services, until they show up at school without the language skills they need to keep up, academically or socially, with their classmates.

The medical home can help

The American Academy of Pediatrics (AAP) and the Health Resources Services Administration aggressively promote the concept of the medical home as the best locus for coordinating the care of children with special needs, and the American Academy of Family Physicians (AAFP) has endorsed the medical home concept.^2,4 According to the AAFP’s Joint Statement of Principles, the medical home is responsible for coordinating care across all elements of the health care system and the patient’s community.⁴ Most physicians in a recent survey believed the medical home should be responsible for coordinating services and guiding families in the development of intervention plans for children with hearing loss.⁵ Family physicians who provide a medical home for infants and young children are in an ideal position to ensure that children with hearing loss are not lost to follow-up and that they receive the services they need to lead healthy lives.

What follow-up entails
According to the 2007 Position Paper of the Joint Committee on Infant Hearing, a body composed of representatives from the AAP, the American Academy of Audiology, the American Speech-Language-Hearing Association, and other professional organizations concerned with hearing loss, an effective program to mitigate the impact of hearing loss should follow this timetable⁶:

• By 1 month of age, all infants should receive hearing screening. (Of note: In 2008, the US Preventive Services Task Force issued a B recommendation for universal hearing screening of all newborns.⁷)
• By 3 months of age, hearing loss should be diagnosed.
• Within 1 month of diagnosis, hearing aids should be fitted for infants whose parents choose hearing aids.
• As soon as possible after diagnosis—but no later than 6 months of age—infants with confirmed, permanent hearing loss should receive early intervention services.⁶

Intervention services should include medical and surgical evaluation, evaluation for hearing aids, and then cochlear implants for those with severe-to-profound hearing loss who do not benefit from hearing aids. Communication assessment and therapy should also be considered. The goal of intervention is to help infants with hearing loss develop communication competence, social skills, emotional well-being, and positive self-esteem.⁶

The CLINICAL TOOL provides a detailed overview of the early hearing detection and intervention (EHDI) process outlined by the Joint Committee and a checklist of roles and responsibilities for physicians serving as medical homes for children with hearing loss and their families. Unfortunately, many primary caregivers report that their medical training did not prepare them to guide families through this process.^8-10 This article is intended to provide the additional information caregivers have requested to help them meet these obligations.

CLINICAL TOOL
The early hearing detection and intervention process⁶

Getting an early start: Newborn screening

Ideally, intervention should begin before a child is born. When parents come in for prenatal visits, talk to them about the importance of newborn hearing screening. Tell them to expect that their baby will be screened at the birth hospital or at an outpatient audiology facility, and that this screening should be done by the time the baby is 1 month of age.

Tell parents their baby’s hearing will be tested with automated screening equipment that measures otoacoustic emissions from the baby’s ears or auditory brainstem response (ABR) to sound, both measurements that correlate with a child’s hearing and auditory behavior. Infants in well-baby nurseries can be screened by either technology. Infants in neonatal intensive care units (NICUs) for more than 5 days should be screened with ABR technology, which is better able to pick up neural losses.⁶ NICU babies frequently are at higher risk for neural hearing loss including auditory neuropathy/dyssynchrony, a condition that may account for about 8% of pediatric hearing losses annually.³

Be sure to explain to expectant couples that a positive screen indicates only that a problem may exist. It is not equivalent to a diagnosis of hearing loss, which is usually made by an audiologist.

The medical home’s role. The medical home should make sure that infants who fail an initial or secondary hospital screening and those who were missed or born outside the hospital are referred for outpatient screening. Newborns who fail initial screening should have both ears rescreened before hospital discharge, even if only one ear had failed previously.⁶ Additionally, any infant readmitted to the hospital within the first month of life who has a condition associated with potential hearing loss should be rescreened before discharge, preferably with an ABR.⁶ Risk factors associated with permanent-congenital, delayed-onset, or progressive hearing loss in children are listed in the TABLE.

TABLE
Risk indicators associated with hearing loss in childhood

Reporting screening results
Screening results are useful only if they are transmitted to caregivers and families. Breakdowns in transmission are a persistent problem for the early hearing detection and intervention process.² The process is facilitated when hospitals make sure that all babies and their families are linked to a medical home at the time of discharge.

Hospital personnel should also be responsible for providing screening results to families in a face-to-face meeting. Medical home providers should review screening results again with parents and answer any questions that might have arisen after the initial hospital stay. Screening results should be given to parents in a sensitive manner, and patient education materials should be provided in parents’ native language, written at an appropriate reading level. Because hospital staff may not be trained to do this properly, it is important that medical home providers oversee the process and address any parental concerns.²

Screening results should also be reported by the birth hospital to the state’s EHDI coordinator, part of the national tracking and surveillance system funded by the Centers for Disease Control and Prevention to ensure that all children with hearing loss achieve communication and social skills commensurate with their cognitive abilities. ¹¹ You can find contact information for your state coordinator at www.cdc.gov/ncbddd/ehdi/documents/EHDI_contact.pdf.

Diagnosing hearing loss

When an infant who fails newborn screening testing arrives at the medical home, the urgent next step is to make sure he or she is referred to a pediatric audiologist for a complete audiologic diagnostic evaluation. Advising parents to “wait and see” is not appropriate; researchers have identified that response as a major obstacle to successful follow-up.² The audiologic evaluation should be done by the time the baby is 3 months of age and should be performed by a pediatric audiologist specializing in diagnosis and management of young children with hearing loss.^4-6

Tell parents that, with their approval, the audiologist may fit the baby with hearing aids as early as this visit, as amplification can help even very young infants hear all sounds in the environment, particularly spoken language.

Ongoing monitoring
Family practices serving as medical homes should continue to monitor children who pass their newborn screening but have high-risk factors for delayed-onset hearing loss. Those factors are listed in the TABLE. Refer children at higher risk for an audiologic diagnostic evaluation by 24 to 30 months of age.⁶ Follow-up on parental concerns about infant hearing or speech and monitor infants’ developmental milestones, auditory skills, and middle ear status using the AAP’s pediatric periodicity schedule.⁶ Conduct global developmental screenings at 9, 18, and 24 to 30 months of age, and refer for speech-language-hearing evaluations when appropriate.⁶

The medical home as central referral point

The medical home is a central referral point for the complex needs of children with hearing loss. The physician and all other providers involved in the child’s care should report results of diagnostic evaluations to state EHDI coordinators. The medical home’s continued involvement includes medical clearance for hearing aids, additional consultations, and screenings as necessary to help children receive needed services and keep them from being lost to the system.^5,9

Referral for genetic consultation is important, because about half of all autosomal recessive sensorineural hearing losses that are not part of a syndrome are caused by mutations in the Connexin 26 GJB2 gene.^12,13 Referral to a pediatric ophthalmologist is similarly important, to identify deficits in visual acuity that frequently co-occur with hearing loss, especially in preterm infants.⁶ Results of these consultations can assist the physician in guiding families through the intervention process.

Coordination of care among multiple providers is essential. When a family physician’s practice serves as a medical home for a child with hearing loss, the physician should oversee and coordinate the efforts of all stakeholders in the EHDI process; make referrals to, and receive reports from, all providers involved in diagnosis and treatment; and ensure that relevant information is shared. During all phases of the process, the role of the family physician is to encourage families to comply with professionals’ recommendations and to stress the importance of making and keeping scheduled appointments.

Making plans for intervention
Families with children who have any degree of permanent hearing loss in one or both ears are entitled to early intervention services.⁶ In most states, these services are provided by a multidisciplinary team at no or low cost through a federal grant program. Services can be home- or center-based. They may include, as needed, education for the affected child and family; physical, speech/language, and occupational therapy; and social work and psychotherapy services. The team works with the family to develop an individualized family service plan to document and guide the early intervention process.¹⁴

Families with a hearing-impaired child have a range of options to choose from in their search for an approach that is best for the child and most acceptable to them. Communication options span a continuum from emphasis on sign language as used by the deaf community to a variety of oral-aural approaches designed to lead to spoken language. Parental choices are influenced most heavily by the child’s success with hearing aids. Parents need unbiased, culturally sensitive counseling about all available communication options and hearing technologies, so they can make informed choices for their children.⁶

Answering parents’ questions
To ensure that parents have appropriate expectations for what auditory technology can do for their child, they need to receive information about traditional digital signal processing hearing aids, osseointegrated hearing implant systems (also known as bone-anchored hearing aids), and cochlear implants. They need to know that a trial period will probably be necessary to determine whether hearing aids are appropriate or if cochlear implantation should be considered. Cost of hearing aids and cochlear implants is a serious concern for parents, and for many, it presents a major barrier to obtaining optimal care.²

Many insurance plans cover cochlear implants, but require that children be at least 12 months of age, have bilateral profound sensorineural hearing loss (or severe-to-profound sensorineural hearing loss for those ≥24 months of age), receive minimal benefit from hearing aids, be enrolled in auditory rehabilitative therapy, and possess no medical contraindications.¹⁵ Hearing aids and cochlear implants may also be covered for children enrolled in Medicaid or the State Children’s Health Insurance Program.¹⁶ However, according to a recent evaluation of hearing screening programs nationwide, public and private insurance policies almost never provide adequate coverage for hearing services.²

As parents consider the options, be sure they are aware that some children younger than 12 months of age are receiving cochlear implants (sometimes in both ears), that stimulation of both ears is being recommended at earlier ages, and that it is also common for children to use a hearing aid in one ear and a cochlear implant in the other.^17,18 Distinguishing among hearing loss types and knowing which treatment options are most effective helps physicians counsel families appropriately about making the best decisions for their children. Some physicians have expressed uncertainties about these issues and have requested additional information on this topic.¹⁹ Audiologists can help physicians obtain this information and help them to better counsel families about these options.

CORRESPONDENCE
Carole E. Johnson, PhD, AuD, 1199 Haley Center, Auburn University, Auburn, AL 36849; johns19@auburn.edu

Like most family physicians, you’ve probably prescribed oral contraceptive pills (OCPs) for countless patients. But are you up to date on the intricacies of dosage and hormone formulations, biphasic and triphasic pills, and non-traditional dosing schedules that allow patients to extend the frequency of—or even avoid—scheduled withdrawal bleeds?

Use the 3 patient scenarios that follow to test your knowledge of today’s OCPs and the text and tables that follow to fill in any details you may be missing. We’ll discuss the best approach for each patient at the end of this article.

CASE 1 Mandy, age 33, comes in asking for OCPs. She is newly married and would like to start a family in 2 or 3 years. The patient—a smoker—previously used a transdermal contraceptive patch.

CASE 2 Julie, age 18, recently became sexually active and would like to start taking OCPs. She will be spending much of the coming year abroad, Julie explains, and would really like to take “the pill that keeps you from getting your period. “ Other than acne, which she is treating with a topical benzyl peroxide/ antibiotic combination, Julie has no health problems—and no medical coverage.

CASE 3 Sandra, age 41, has taken OCPs in the past, but was taken off them after she was hit by a car and sustained a pelvic fracture 2 years ago. A mother of 4, Sandra delivered twins 6 weeks ago. She would like to take OCPs again, but wonders whether the hormones would interfere with nursing.

Is your patient a candidate for an OCP?

Before you prescribe OCPs for these women, or for any patient, there are a number of things to consider. First and foremost, does the patient have any contraindications to hormonal contraceptives related to the risk of adverse vascular events?

Absolute contraindications. Oral contraceptives are contraindicated (TABLE 1) in women older than 35 years who smoke and in women who have uncontrolled hypertension, a past history of venous or arterial vascular complications or a family history of thrombosis, diabetes with end-organ damage, migraine headaches with focal neurologic symptoms, or a history of breast cancer or liver disease.^1,2 (A venous thromboembolism [VTE] that occurred in a clinical setting with a clear initiating risk factor—a fractured femur secondary to trauma complicated by a VTE, for example—is not an absolute contraindication to OCP therapy, particularly if it occurred years ago. Such patients may use OCPs if other contraceptive methods are not acceptable.¹)

Relative contraindications. Pregnancy is a relative contraindication, as no prescriber would intentionally give a contraceptive medication to a woman known to be pregnant. It is important to note, though, that no harm has been associated with inadvertent use of OCPs during pregnancy.³

Obesity is also a relative contraindication. There is evidence that obese women (body mass index >30 kg/m²) have a higher failure rate with OCPs compared with women who are not overweight. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal contraception for obese patients due to the reduced efficacy of hormonal contraception and increased risk of VTE based on case-control studies.¹ An obese patient should not, however, be precluded from using OCPs if her only other option is to use a less effective contraceptive.

Lupus was previously considered a relative contraindication, but recent studies did not find any exacerbation of stable lupus with OCPs.⁴

Compliance. In determining whether a patient is a candidate for oral contraceptives, you should also discuss the need for daily compliance, the moderate effectiveness of OCPs (which have a 7% failure rate with typical use⁵), and the importance of refilling the prescription in a timely manner. If the patient indicates that she has trouble following a daily routine, you may want to discuss other contraceptive options.

TABLE 1
Contraindications to oral contraceptives^1,2

Which OCP? A look at the choices

In determining which OCP to prescribe for a particular patient, there are a number of issues to consider:

• What estrogen dosage and progestin formulation should be used for this patient?
• Should the patient be placed on a mono-phasic, biphasic, triphasic, or quadra-phasic pill?
• How frequently does she want to menstruate?
• Has she taken OCPs before, either for primary contraception or for another condition that the pill is frequently prescribed for, such as dysmenorrhea or premenstrual syndrome? If she has taken OCPs, did she experience any significant adverse effects?

Most commonly prescribed OCPs are a combination of an estrogen and progesterone. Progestin-only OCPs are also available, but are used less frequently than combination pills because they must be taken within a smaller window of time each day to maintain their effectiveness.

Pill formulations
Combination OCPs typically contain the estrogen ethinyl estradiol (EE) or its precursor, mestranol, which is metabolized into EE, and one of the 9 progestins available in the United States.^6,7 (An OC approved in May 2010 contains a new estrogen, estradiol valerate [EV], and dienogest, a novel progestin.⁷)

Categorized according to when they were approved or introduced, progestins include:

• norethindrone, norethindrone acetate (first generation)
• norgestrel, levonorgestrel, ethynodiol diacetate (second generation)
• norgestimate, desogestrel (third generation)
• drospirenone, dienogest (other).^6,7

Each progestin differs in its affinity to progesterone, estrogen, and androgen receptors and, therefore, each has a slightly different physiologic effect. The first-generation progestins norethindrone and norethindrone acetate have a shorter half-life compared with those introduced later. While some studies have shown that third-generation progestins have a greater risk of VTE compared with first- and second-generation formulations, others have not found that to be the case. Two recent studies, conducted in the Netherlands and Denmark, did find an increased risk of VTE associated with the third-generation progestin desogestrel.^8,9

Drospirenone, one of the more recently approved progestins, should be used with caution in any patient who may be at increased risk of hyperkalemia because of its spironolac-tone-like effects.¹⁰ Overall, however, there is little evidence to help guide initial OCP selection based on patient characteristics.

Dosing considerations
Estrogen dosages range from 10 to 50 mcg EE (and from 1 to 3 mg EV); progesterone dosage is ≤1 mg, with the exception of dienogest (2-3 mg). (Pills with higher doses of estrogen were available in the 1960s and 1970s, but were phased out because they carried a greater risk of vascular complications.) Your goal should be to select the lowest effective dosage of estrogen to minimize the risk of adverse effects.

There is a tradeoff, however: The lowest dose pills (10-20 mcg EE) have an increased risk of irregular bleeding, although they also have a reduced risk of minor adverse effects (eg, breast tenderness and headache, among other premenstrual symptoms).¹¹ And, for women who are not meticulously compliant, low-dose pills are associated with a greater failure rate compared with OCPs with higher doses of EE.¹⁰

Other than the reduction of premenopausal symptoms, the advantages of pills with a lower dose of estrogen remain largely theoretical. The most serious adverse effects associated with estrogen—deep vein thrombosis (DVT) and pulmonary embolism—may not be significantly different between the lower or higher dose pills, although 2 recent studies found a reduced risk of VTE with lower estrogen doses.^8,9

The original OCPs were monophasic, with each active pill having the same amount of estrogen and progesterone. Biphasic pills generally increase in progesterone dose, typically containing one dose for the first 10 days of the pill pack and an increased dose for the next 11 days.

Triphasic pills, designed to mimic the endogenous fluctuation of estrogen and progesterone during the menstrual cycle, have 3 levels of hormones in the active pills. Typically, the progesterone dose is lowest for the first 7 days and then increases on Day 8 and again on Day 15, while the estrogen dose remains constant. In some triphasic formulations, however, the estrogen dose increases and then is reduced in the last 7 days of active pills. (Natazia, the EV/dienogest OCP approved last year, is quadraphasic, featuring 2 different dosages of EV-only pills and 2 different dosages of estrogen/progestin pills.⁷)

There is no evidence of any advantage of triphasic pills over monophasic pills in terms of effectiveness, bleeding patterns, or discontinuation rates,¹² but there is some evidence that biphasic pills result in more adverse effects.¹³

Frequency of withdrawal bleeds
Traditional OCPs have 21 active pills and 7 days of placebos. Women taking them have a menstrual cycle every 4 weeks during the placebo days. Patients can choose to have less frequent periods or avoid a menstrual cycle altogether either by taking one of the name-brand OCPs designed for extended or continuous dosing (TABLE 2) or by skipping the placebo pills in a traditional OCP regimen and starting the next pill pack immediately after taking the final active pill of the previous pack.

In 2003, a continuous OCP with 30 mcg EE and 0. 015 mg levonorgestrel (Seasonale) was approved. Its pill pack contains 84 mono-phasic active pills, plus 7 days of placebos.¹⁴Patients taking Seasonale—which is now available in generic form¹⁵—have a menstrual bleed every 3 months. A second 84/7-day OCP with a slightly different formulation (Seasonique) was approved in 2006.¹⁶ Patients who follow an 84/7-day regimen have been found to have outcomes that are very similar to those of women using OCPs in the traditional 21/7-day pattern in many respects, including the bleeding pattern, discontinuation rates, and satisfaction reported.¹⁷

In 2007, an OCP featuring 365 active pills and no placebo pills was approved (Lybrel).¹⁸ The dosage of EE (20 mcg) and levonorgestrel (0. 09 mg) remains constant each day of the year, with the intention that women on this regimen go an entire year without menstruating. No increase in adverse effects has been noted with the use of this OCP. Patients report improved symptomatology, but not a significant reduction in bleeding days compared with cyclic oral contraceptives.¹⁹ In fact, a potential downside is the possibility that women on extended or continuous dosing regimens may have more frequent unscheduled bleeding days.

Extended and continuous dosing regimens have benefits for patients with gynecologic conditions responsive to the suppression of menstruation, including endometriosis, dysmenorrhea, and chronic pelvic pain (TABLE 3). In fact, OCPs are often prescribed for these conditions, as well as for acne vul-garis, menorrhagia, premenstrual syndrome, and polycystic ovarian syndrome, as patients taking them have been found to have less difficulty with hormonal withdrawal side effects and no increased risk of adverse events.¹⁹

The only problem with extended or continuous dosing is cost (TABLE 4).²⁰ Brand-name OCPs designed as extended-cycle contraceptives are more expensive than generic pills. Similarly, creating a continuous-dosing cycle with a monthly OCP requires more than 13 pill packs a year, and some insurers will not cover the cost of the additional pills.

Currently, no particular OCP or dosing regimen has any evidence-based advantages or indications regarding contraceptive efficacy or bleeding patterns. Until there is ample evidence to show that a particular frequency of withdrawal bleeds has advantages compared with other regimens, the frequency chosen can be at the patient’s and physician’s discretion.

TABLE 2
Traditional vs nontraditional dosing*³¹