Douglas Mossman, MD

How to reduce malpractice risk with better documentation.

Tips to make documentation easier, faster, and more satisfying” (Current Psychiatry, February 2008), I discussed documentation techniques at length. Table 3 reprints principles that may be especially helpful in practices that consist primarily of med checks.

Table 3

Keys to better documentation

Acknowledgment

Thanks to James Knoll IV, MD for his helpful input on this article.

How to reduce malpractice risk with better documentation.

Tips to make documentation easier, faster, and more satisfying” (Current Psychiatry, February 2008), I discussed documentation techniques at length. Table 3 reprints principles that may be especially helpful in practices that consist primarily of med checks.

Table 3

Keys to better documentation

Acknowledgment

Thanks to James Knoll IV, MD for his helpful input on this article.

How to reduce malpractice risk with better documentation.

Tips to make documentation easier, faster, and more satisfying” (Current Psychiatry, February 2008), I discussed documentation techniques at length. Table 3 reprints principles that may be especially helpful in practices that consist primarily of med checks.

Table 3

Keys to better documentation

Acknowledgment

Thanks to James Knoll IV, MD for his helpful input on this article.

Dear Drs. Mossman and Weston:
In my psychiatric practice, I sometimes provide pharmacotherapy for patients treated by psychotherapists who practice independently. Am I liable for what these therapists do or don’t do—for example, not contacting me if a patient is suicidal or experiences a medication side effect? How much communication should occur between us? Sometimes—after a patient signs a release—I call the therapist and leave messages, but my calls are not returned. What should I do?—Submitted by “Dr. B”

Pharmacologic advances and altered reimbursement patterns have drastically changed how psychiatrists understand and manage mental problems. Not long ago, insight-oriented psychotherapy was the primary treatment—and often the only one—psychiatrists provided for outpatients. Nowadays, most visits to psychiatrists involve little or no in-depth psychotherapy,¹ and many patients receive “joint treatment”—a psychiatrist performs the diagnostic and medical assessment and prescribes medications where appropriate, and a nonphysician provides other treatment services.

Psychiatrists need to be clear about their responsibilities for patients whom they “share” with other mental health professionals. In this article, we’ll discuss:

• forces that promote split treatment
• types of split-treatment relationships
• how to limit liability risk when you split treatment with an nonphysician mental health practitioner.

Dollars and cents reasons

Since the 1980s, psychiatrists have spent less time with their patients, provided less psychotherapy, and prescribed medications more frequently.² An estimated 70% of outpatient visits to psychiatrists involve no psychotherapy.¹

Market conditions are a major factor in these changes. Cost-containment policies and reduced private insurance payments for psychotherapy visits have incentivized psychiatrists to collaborate with less-well-paid psychotherapists. Combining medication and psychotherapy may be the best and most cost-effective treatment for mentally ill patients, but psychiatrists get paid more for three 15-minute “med checks” than for one 45-minute psychotherapy session.^3-5

Although managed care payment patterns may be “perversely influencing” psychiatry (as one psychiatrist puts it)⁶ other factors contributing to the decline of psychotherapy include:

• new medications with fewer side effects
• aggressive pharmaceutical company promotions of psychotropics
• greater public acceptance of mental illness and its treatment
• an increasingly cohort of psychiatrists trained by teachers and mentors who emphasized biologic therapies.¹

Forms of split treatment

Psychiatrists engage in several types of professional relationships that split the care provided to mentally ill patients (Table 1),⁷ and Dr. B has asked us to focus on one type of split-care relationship: a physician and psychotherapist treat the same patient, ideally collaborating to provide good clinical care.

Split, collaborative care is common throughout medicine. Most of us see medical specialists who treat different illnesses, but each doctor is responsible for the care he or she provides. An allergist knows what orthopedic surgery is, but we don’t expect our allergist to provide follow-up after arthroscopic surgery—and neither does our orthopedist.

The same considerations apply when a psychiatrist’s patient sees an independent nonphysician therapist. The psychiatrist provides the same care that a patient receiving only pharmacotherapy would need. The psychiatrist should not expect the collaborating therapist to monitor the patient’s pharmacotherapy—for example, by checking lab tests or asking about medication side effects—although the therapist is welcome to tell the psychiatrist about pharmacotherapy matters or encourage the patient to do so.

Table 1

Types of split-care relationships

Limiting liability

Psychiatrists who share patients with independent nonphysicians can take several steps to promote better care and limit potential liability.

Delegation. Do not delegate essential aspects of medical care. For example, tell young patients starting antidepressants (and minors’ legal guardians) about the risk of increased suicidal ideation, and provide close monitoring. Although it is acceptable for a patient to tell his or her therapist about worsening suicidal thoughts, instruct the patient to inform you as well.

Check them out. Before agreeing to split care, find out if the potential collaborator is credentialed, and respectfully inquire about his or her training and clinical approaches.⁸ Because unlicensed or uncredentialed therapists might not be held to the same practice standards as physicians and often have little or no malpractice insurance, psychiatrists who work with them may be assuming most of the clinical and legal liability.⁹ If a court is looking for a way to compensate an injured patient, it may hold the psychiatrist accountable for not knowing the therapist’s qualifications, failing to supervise the therapist, or failing to inform the patient of the therapist’s lack of qualifications.^7,10

Establish the collaboration. Psychiatrists have a duty to ensure that their patients receive good care. Split treatment can help patients—who get 2 pairs of eyes monitoring them, plus 2 clinicians’ combined areas of skill—if the clinicians work together satisfactorily. Some psychiatrists recommend using initial consultation forms⁸ or contracts to spell out mutual expectations and establish important components of the relationship (Table 2).^11,12 Other psychiatrists are comfortable with brief discussions with potential collaborators that cover:

• how the clinicians will divide treatment responsibilities
• circumstances when they will communicate
• patient coverage during each other’s vacations
• availability to patients during crises
• types of problems that would prompt the patient to contact the psychiatrist or therapist first.

Table 2

7 C’s of effective collaborative treatment

Be sure to document these discussions as well as written consent for initial and ongoing communication in the patient’s medical record. Major treatment advances or setbacks, nonadherence, or termination of treatment by/with one clinician should prompt contact with the other clinician. Collaborating clinicians should communicate regularly even when treatment is going well, not only when big changes occur.⁸

Back to Dr. B

What should you do if a patient seeks pharmacotherapy and the therapist hasn’t contacted you? First, you probably should speak with your patient about the absence of interclinician communication, explain that it is important, and get the patient’s written permission to initiate contact. After contacting the therapist, you will be in a better position to determine how often you should see the patient and how often you need to share information with the therapist.

If you are uncomfortable sharing care with some or all nonphysician therapists, tell your patients. You might refer prospective patients to psychotherapists with whom you’re comfortable providing collaborative care or to other psychiatrists who accept split relationships.

Ideally, get patients’ written consent to share confidential information before you agree to participate in a shared treatment relationship. If patients refuse, you will not have access to all treatment information. This may adversely affect the quality of care and increase your liability risk.

In some cases, your discomfort with a split-treatment situation may make you decide to decline or terminate the treatment relationship. This is permissible if you give the patient proper notice, suggest other psychiatrists who might see the patient, and remain available for urgent matters for a reasonable time—usually 30 to 60 days—to allow the patient to contact another psychiatrist.¹⁰ When you discuss potential providers, explain that you don’t know these clinicians (if that’s the case) or whether they will agree to treat the patient.¹²

Dear Drs. Mossman and Weston:
In my psychiatric practice, I sometimes provide pharmacotherapy for patients treated by psychotherapists who practice independently. Am I liable for what these therapists do or don’t do—for example, not contacting me if a patient is suicidal or experiences a medication side effect? How much communication should occur between us? Sometimes—after a patient signs a release—I call the therapist and leave messages, but my calls are not returned. What should I do?—Submitted by “Dr. B”

Pharmacologic advances and altered reimbursement patterns have drastically changed how psychiatrists understand and manage mental problems. Not long ago, insight-oriented psychotherapy was the primary treatment—and often the only one—psychiatrists provided for outpatients. Nowadays, most visits to psychiatrists involve little or no in-depth psychotherapy,¹ and many patients receive “joint treatment”—a psychiatrist performs the diagnostic and medical assessment and prescribes medications where appropriate, and a nonphysician provides other treatment services.

Psychiatrists need to be clear about their responsibilities for patients whom they “share” with other mental health professionals. In this article, we’ll discuss:

• forces that promote split treatment
• types of split-treatment relationships
• how to limit liability risk when you split treatment with an nonphysician mental health practitioner.

Dollars and cents reasons

Since the 1980s, psychiatrists have spent less time with their patients, provided less psychotherapy, and prescribed medications more frequently.² An estimated 70% of outpatient visits to psychiatrists involve no psychotherapy.¹

Market conditions are a major factor in these changes. Cost-containment policies and reduced private insurance payments for psychotherapy visits have incentivized psychiatrists to collaborate with less-well-paid psychotherapists. Combining medication and psychotherapy may be the best and most cost-effective treatment for mentally ill patients, but psychiatrists get paid more for three 15-minute “med checks” than for one 45-minute psychotherapy session.^3-5

Although managed care payment patterns may be “perversely influencing” psychiatry (as one psychiatrist puts it)⁶ other factors contributing to the decline of psychotherapy include:

• new medications with fewer side effects
• aggressive pharmaceutical company promotions of psychotropics
• greater public acceptance of mental illness and its treatment
• an increasingly cohort of psychiatrists trained by teachers and mentors who emphasized biologic therapies.¹

Forms of split treatment

Psychiatrists engage in several types of professional relationships that split the care provided to mentally ill patients (Table 1),⁷ and Dr. B has asked us to focus on one type of split-care relationship: a physician and psychotherapist treat the same patient, ideally collaborating to provide good clinical care.

Split, collaborative care is common throughout medicine. Most of us see medical specialists who treat different illnesses, but each doctor is responsible for the care he or she provides. An allergist knows what orthopedic surgery is, but we don’t expect our allergist to provide follow-up after arthroscopic surgery—and neither does our orthopedist.

The same considerations apply when a psychiatrist’s patient sees an independent nonphysician therapist. The psychiatrist provides the same care that a patient receiving only pharmacotherapy would need. The psychiatrist should not expect the collaborating therapist to monitor the patient’s pharmacotherapy—for example, by checking lab tests or asking about medication side effects—although the therapist is welcome to tell the psychiatrist about pharmacotherapy matters or encourage the patient to do so.

Table 1

Types of split-care relationships

Limiting liability

Psychiatrists who share patients with independent nonphysicians can take several steps to promote better care and limit potential liability.

Delegation. Do not delegate essential aspects of medical care. For example, tell young patients starting antidepressants (and minors’ legal guardians) about the risk of increased suicidal ideation, and provide close monitoring. Although it is acceptable for a patient to tell his or her therapist about worsening suicidal thoughts, instruct the patient to inform you as well.

Check them out. Before agreeing to split care, find out if the potential collaborator is credentialed, and respectfully inquire about his or her training and clinical approaches.⁸ Because unlicensed or uncredentialed therapists might not be held to the same practice standards as physicians and often have little or no malpractice insurance, psychiatrists who work with them may be assuming most of the clinical and legal liability.⁹ If a court is looking for a way to compensate an injured patient, it may hold the psychiatrist accountable for not knowing the therapist’s qualifications, failing to supervise the therapist, or failing to inform the patient of the therapist’s lack of qualifications.^7,10

Establish the collaboration. Psychiatrists have a duty to ensure that their patients receive good care. Split treatment can help patients—who get 2 pairs of eyes monitoring them, plus 2 clinicians’ combined areas of skill—if the clinicians work together satisfactorily. Some psychiatrists recommend using initial consultation forms⁸ or contracts to spell out mutual expectations and establish important components of the relationship (Table 2).^11,12 Other psychiatrists are comfortable with brief discussions with potential collaborators that cover:

• how the clinicians will divide treatment responsibilities
• circumstances when they will communicate
• patient coverage during each other’s vacations
• availability to patients during crises
• types of problems that would prompt the patient to contact the psychiatrist or therapist first.

Table 2

7 C’s of effective collaborative treatment

Be sure to document these discussions as well as written consent for initial and ongoing communication in the patient’s medical record. Major treatment advances or setbacks, nonadherence, or termination of treatment by/with one clinician should prompt contact with the other clinician. Collaborating clinicians should communicate regularly even when treatment is going well, not only when big changes occur.⁸

Back to Dr. B

What should you do if a patient seeks pharmacotherapy and the therapist hasn’t contacted you? First, you probably should speak with your patient about the absence of interclinician communication, explain that it is important, and get the patient’s written permission to initiate contact. After contacting the therapist, you will be in a better position to determine how often you should see the patient and how often you need to share information with the therapist.

If you are uncomfortable sharing care with some or all nonphysician therapists, tell your patients. You might refer prospective patients to psychotherapists with whom you’re comfortable providing collaborative care or to other psychiatrists who accept split relationships.

Ideally, get patients’ written consent to share confidential information before you agree to participate in a shared treatment relationship. If patients refuse, you will not have access to all treatment information. This may adversely affect the quality of care and increase your liability risk.

In some cases, your discomfort with a split-treatment situation may make you decide to decline or terminate the treatment relationship. This is permissible if you give the patient proper notice, suggest other psychiatrists who might see the patient, and remain available for urgent matters for a reasonable time—usually 30 to 60 days—to allow the patient to contact another psychiatrist.¹⁰ When you discuss potential providers, explain that you don’t know these clinicians (if that’s the case) or whether they will agree to treat the patient.¹²

Dear Drs. Mossman and Weston:
In my psychiatric practice, I sometimes provide pharmacotherapy for patients treated by psychotherapists who practice independently. Am I liable for what these therapists do or don’t do—for example, not contacting me if a patient is suicidal or experiences a medication side effect? How much communication should occur between us? Sometimes—after a patient signs a release—I call the therapist and leave messages, but my calls are not returned. What should I do?—Submitted by “Dr. B”

Pharmacologic advances and altered reimbursement patterns have drastically changed how psychiatrists understand and manage mental problems. Not long ago, insight-oriented psychotherapy was the primary treatment—and often the only one—psychiatrists provided for outpatients. Nowadays, most visits to psychiatrists involve little or no in-depth psychotherapy,¹ and many patients receive “joint treatment”—a psychiatrist performs the diagnostic and medical assessment and prescribes medications where appropriate, and a nonphysician provides other treatment services.

Psychiatrists need to be clear about their responsibilities for patients whom they “share” with other mental health professionals. In this article, we’ll discuss:

• forces that promote split treatment
• types of split-treatment relationships
• how to limit liability risk when you split treatment with an nonphysician mental health practitioner.

Dollars and cents reasons

Since the 1980s, psychiatrists have spent less time with their patients, provided less psychotherapy, and prescribed medications more frequently.² An estimated 70% of outpatient visits to psychiatrists involve no psychotherapy.¹

Market conditions are a major factor in these changes. Cost-containment policies and reduced private insurance payments for psychotherapy visits have incentivized psychiatrists to collaborate with less-well-paid psychotherapists. Combining medication and psychotherapy may be the best and most cost-effective treatment for mentally ill patients, but psychiatrists get paid more for three 15-minute “med checks” than for one 45-minute psychotherapy session.^3-5

Although managed care payment patterns may be “perversely influencing” psychiatry (as one psychiatrist puts it)⁶ other factors contributing to the decline of psychotherapy include:

• new medications with fewer side effects
• aggressive pharmaceutical company promotions of psychotropics
• greater public acceptance of mental illness and its treatment
• an increasingly cohort of psychiatrists trained by teachers and mentors who emphasized biologic therapies.¹

Forms of split treatment

Psychiatrists engage in several types of professional relationships that split the care provided to mentally ill patients (Table 1),⁷ and Dr. B has asked us to focus on one type of split-care relationship: a physician and psychotherapist treat the same patient, ideally collaborating to provide good clinical care.

Split, collaborative care is common throughout medicine. Most of us see medical specialists who treat different illnesses, but each doctor is responsible for the care he or she provides. An allergist knows what orthopedic surgery is, but we don’t expect our allergist to provide follow-up after arthroscopic surgery—and neither does our orthopedist.

The same considerations apply when a psychiatrist’s patient sees an independent nonphysician therapist. The psychiatrist provides the same care that a patient receiving only pharmacotherapy would need. The psychiatrist should not expect the collaborating therapist to monitor the patient’s pharmacotherapy—for example, by checking lab tests or asking about medication side effects—although the therapist is welcome to tell the psychiatrist about pharmacotherapy matters or encourage the patient to do so.

Table 1

Types of split-care relationships

Limiting liability

Psychiatrists who share patients with independent nonphysicians can take several steps to promote better care and limit potential liability.

Delegation. Do not delegate essential aspects of medical care. For example, tell young patients starting antidepressants (and minors’ legal guardians) about the risk of increased suicidal ideation, and provide close monitoring. Although it is acceptable for a patient to tell his or her therapist about worsening suicidal thoughts, instruct the patient to inform you as well.

Check them out. Before agreeing to split care, find out if the potential collaborator is credentialed, and respectfully inquire about his or her training and clinical approaches.⁸ Because unlicensed or uncredentialed therapists might not be held to the same practice standards as physicians and often have little or no malpractice insurance, psychiatrists who work with them may be assuming most of the clinical and legal liability.⁹ If a court is looking for a way to compensate an injured patient, it may hold the psychiatrist accountable for not knowing the therapist’s qualifications, failing to supervise the therapist, or failing to inform the patient of the therapist’s lack of qualifications.^7,10

Establish the collaboration. Psychiatrists have a duty to ensure that their patients receive good care. Split treatment can help patients—who get 2 pairs of eyes monitoring them, plus 2 clinicians’ combined areas of skill—if the clinicians work together satisfactorily. Some psychiatrists recommend using initial consultation forms⁸ or contracts to spell out mutual expectations and establish important components of the relationship (Table 2).^11,12 Other psychiatrists are comfortable with brief discussions with potential collaborators that cover:

• how the clinicians will divide treatment responsibilities
• circumstances when they will communicate
• patient coverage during each other’s vacations
• availability to patients during crises
• types of problems that would prompt the patient to contact the psychiatrist or therapist first.

Table 2

7 C’s of effective collaborative treatment

Be sure to document these discussions as well as written consent for initial and ongoing communication in the patient’s medical record. Major treatment advances or setbacks, nonadherence, or termination of treatment by/with one clinician should prompt contact with the other clinician. Collaborating clinicians should communicate regularly even when treatment is going well, not only when big changes occur.⁸

Back to Dr. B

What should you do if a patient seeks pharmacotherapy and the therapist hasn’t contacted you? First, you probably should speak with your patient about the absence of interclinician communication, explain that it is important, and get the patient’s written permission to initiate contact. After contacting the therapist, you will be in a better position to determine how often you should see the patient and how often you need to share information with the therapist.

If you are uncomfortable sharing care with some or all nonphysician therapists, tell your patients. You might refer prospective patients to psychotherapists with whom you’re comfortable providing collaborative care or to other psychiatrists who accept split relationships.

Ideally, get patients’ written consent to share confidential information before you agree to participate in a shared treatment relationship. If patients refuse, you will not have access to all treatment information. This may adversely affect the quality of care and increase your liability risk.

In some cases, your discomfort with a split-treatment situation may make you decide to decline or terminate the treatment relationship. This is permissible if you give the patient proper notice, suggest other psychiatrists who might see the patient, and remain available for urgent matters for a reasonable time—usually 30 to 60 days—to allow the patient to contact another psychiatrist.¹⁰ When you discuss potential providers, explain that you don’t know these clinicians (if that’s the case) or whether they will agree to treat the patient.¹²

In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

Dear Dr. Mossman,

A psychiatrist retires from practice and goes into some other line of work—perhaps managing a restaurant. He then has an “affair” with a former patient whom he had not treated for several years. Could the retired psychiatrist’s conduct be the basis of a successful lawsuit?—Submitted by “Dr. D”

Evidence tells us that the retired psychiatrist’s behavior likely could do emotional harm to his former patient. If the former patient suffers some injury, a successful suit could follow—if not on grounds of malpractice, then on other grounds. In this article we’ll see why by looking at:

• rates of doctor-patient sex
• potential harm from doctor-patient sex
• ethical bans on sex with former patients
• possible legal actions.

Sex with patients: Rates and risk

Doctors and patients often develop erotic thoughts about each other.^1,2 But as Sigmund Freud noted almost a century ago, an actual love relationship between a doctor and a psychotherapy patient can cause a “complete defeat for the treatment” and destroy the patient’s chance for recovery.³

More than 5 decades later, surveys of medical professionals supplemented Freud’s observations with data about the frequency and impact of doctor-patient sex. In a 1973 survey, 11% of physicians said they had erotic contact with patients, and 5% reported intercourse.⁴ In a 1986 survey of psychiatrists, 3% of women and 7% of men acknowledged having sexual contact with patients.⁵ In a 1992 study of 10,000 nonpsychiatric physicians, 9% of respondents reported having sex with patients.⁶ Actual rates of doctor-patient sex probably are much higher than reported because physicians may be reluctant to admit to having erotic contact with patients, even in anonymous surveys.⁷ The typical therapist-patient sex scenario involves a male doctor and an adult female patient, but same-sex encounters and sexual contact with minors occur, too.⁸

Sex between a therapist and a patient is likely to cause emotional injury. For example, a 1991 study found that 90% of psychotherapy patients who had sexual involvement with a prior therapist had been harmed by the experience.⁹ Books, articles, and Web sites offer vivid individual accounts of harm patients have suffered ( Table ). Doctors who have sex with patients could face public opprobrium, civil lawsuits, actions against their medical licenses, and prosecution in states that make sex with psychiatric patients a criminal offense.¹⁰

Table

How sexual relationships can harm patients

What about former patients?

Sex between providers and current patients is opposed by all major healthcare organizations, including the American Psychiatric Association (APA),¹¹ American Medical Association,¹² and American Psychological Association.¹³ The last 2 groups strongly discourage sex with former patients, but the APA’s ethics code states that such activity is always unethical.

The APA’s position reflects 2 general truths of psychiatric practice:

• Psychiatric patients often return for care years after initial treatment has ended. “Former patients” are really “possible future patients.” Improper relationships with former patients disrupt the doctor’s obligation to remain available for future care.
• Even if a patient never returns to treatment, intense feelings about a doctor can last for years. A psychiatrist who engages in sex with a former patient may evoke and manipulate feelings “left over” from therapy.

Psychiatrists therefore “have only one kind of relationship with a patient—that is, a doctor-patient relationship.”¹⁴ Moreover, as Simon and Shuman observe, “[N]o patient [is] strong enough, no pause is long enough, and no love is true enough to justify compromising this boundary.”¹⁵

Legal actions

If a physician no longer practices medicine, can any of his activities—including with a former patient—be malpractice? In fact, sex between practicing doctors and current patients might not always be malpractice. If a psychiatrist gains sexual access to a patient by saying that the sex will be therapeutic, the psychiatrist has perpetrated fraud and this intentional action might not be covered by malpractice insurance.¹⁶

In several cases involving nonpsychiatric physicians,¹⁷ courts have held that consensual doctor-patient sex is not malpractice, though it might represent some other form of wrongdoing. The argument is that sex with a patient is an intentional act that is never a professional service, whereas malpractice by definition arises unintentionally from negligence while rendering professional services. Other courts, however, have held that doctor-patient sex can be malpractice because it breaches the physician’s fiduciary relationship and can constitute an abuse of power.¹⁸

After retirement, physicians still have responsibilities to former patients: to protect records, to respect confidentiality, and to release information upon proper requests. Some fiduciary duties to patients survive the conclusion of treatment, and behavior that breaches those responsibilities can bring legal action.

Psychiatrists should realize that many former patients remain vulnerable because of feelings “left over” from therapy. Therefore, potential civil actions against a retired psychiatrist might include:

A suit for intentional infliction of emotional distress. This tort action requires proving more than mere insults or indignities; it occurs only when someone “by extreme and outrageous conduct intentionally or recklessly causes severe emotional distress to another.”¹⁹ Initiating sex with a former patient is strongly disapproved and meets the legal criterion of having a high probability of causing mental distress.²⁰

A suit for negligent infliction of emotional distress. Modern law permits recourse for negligently inflicted emotional distress when harm occurs in “the course of specified categories of activities, undertakings, or relationships in which the negligent conduct is especially likely to cause emotional disturbance.”²¹

Suits for exploitation. Some jurisdictions allow suits against therapists who have sex with former patients, irrespective of therapists’ license status. For example, Minnesota allows lawsuits for “sexual exploitation” if the former patient’s capacity to consent was impaired by emotional dependence on the psychotherapist.²²

Actions by licensing boards. Many retired practitioners maintain their medical licenses. Retired-but-still-licensed psychiatrists can be subject to professional disciplinary actions.

Dear Dr. Mossman,

A psychiatrist retires from practice and goes into some other line of work—perhaps managing a restaurant. He then has an “affair” with a former patient whom he had not treated for several years. Could the retired psychiatrist’s conduct be the basis of a successful lawsuit?—Submitted by “Dr. D”

Evidence tells us that the retired psychiatrist’s behavior likely could do emotional harm to his former patient. If the former patient suffers some injury, a successful suit could follow—if not on grounds of malpractice, then on other grounds. In this article we’ll see why by looking at:

• rates of doctor-patient sex
• potential harm from doctor-patient sex
• ethical bans on sex with former patients
• possible legal actions.

Sex with patients: Rates and risk

Doctors and patients often develop erotic thoughts about each other.^1,2 But as Sigmund Freud noted almost a century ago, an actual love relationship between a doctor and a psychotherapy patient can cause a “complete defeat for the treatment” and destroy the patient’s chance for recovery.³

More than 5 decades later, surveys of medical professionals supplemented Freud’s observations with data about the frequency and impact of doctor-patient sex. In a 1973 survey, 11% of physicians said they had erotic contact with patients, and 5% reported intercourse.⁴ In a 1986 survey of psychiatrists, 3% of women and 7% of men acknowledged having sexual contact with patients.⁵ In a 1992 study of 10,000 nonpsychiatric physicians, 9% of respondents reported having sex with patients.⁶ Actual rates of doctor-patient sex probably are much higher than reported because physicians may be reluctant to admit to having erotic contact with patients, even in anonymous surveys.⁷ The typical therapist-patient sex scenario involves a male doctor and an adult female patient, but same-sex encounters and sexual contact with minors occur, too.⁸

Sex between a therapist and a patient is likely to cause emotional injury. For example, a 1991 study found that 90% of psychotherapy patients who had sexual involvement with a prior therapist had been harmed by the experience.⁹ Books, articles, and Web sites offer vivid individual accounts of harm patients have suffered ( Table ). Doctors who have sex with patients could face public opprobrium, civil lawsuits, actions against their medical licenses, and prosecution in states that make sex with psychiatric patients a criminal offense.¹⁰

Table

How sexual relationships can harm patients

What about former patients?

Sex between providers and current patients is opposed by all major healthcare organizations, including the American Psychiatric Association (APA),¹¹ American Medical Association,¹² and American Psychological Association.¹³ The last 2 groups strongly discourage sex with former patients, but the APA’s ethics code states that such activity is always unethical.

The APA’s position reflects 2 general truths of psychiatric practice:

• Psychiatric patients often return for care years after initial treatment has ended. “Former patients” are really “possible future patients.” Improper relationships with former patients disrupt the doctor’s obligation to remain available for future care.
• Even if a patient never returns to treatment, intense feelings about a doctor can last for years. A psychiatrist who engages in sex with a former patient may evoke and manipulate feelings “left over” from therapy.

Psychiatrists therefore “have only one kind of relationship with a patient—that is, a doctor-patient relationship.”¹⁴ Moreover, as Simon and Shuman observe, “[N]o patient [is] strong enough, no pause is long enough, and no love is true enough to justify compromising this boundary.”¹⁵

Legal actions

If a physician no longer practices medicine, can any of his activities—including with a former patient—be malpractice? In fact, sex between practicing doctors and current patients might not always be malpractice. If a psychiatrist gains sexual access to a patient by saying that the sex will be therapeutic, the psychiatrist has perpetrated fraud and this intentional action might not be covered by malpractice insurance.¹⁶

In several cases involving nonpsychiatric physicians,¹⁷ courts have held that consensual doctor-patient sex is not malpractice, though it might represent some other form of wrongdoing. The argument is that sex with a patient is an intentional act that is never a professional service, whereas malpractice by definition arises unintentionally from negligence while rendering professional services. Other courts, however, have held that doctor-patient sex can be malpractice because it breaches the physician’s fiduciary relationship and can constitute an abuse of power.¹⁸

After retirement, physicians still have responsibilities to former patients: to protect records, to respect confidentiality, and to release information upon proper requests. Some fiduciary duties to patients survive the conclusion of treatment, and behavior that breaches those responsibilities can bring legal action.

Psychiatrists should realize that many former patients remain vulnerable because of feelings “left over” from therapy. Therefore, potential civil actions against a retired psychiatrist might include:

A suit for intentional infliction of emotional distress. This tort action requires proving more than mere insults or indignities; it occurs only when someone “by extreme and outrageous conduct intentionally or recklessly causes severe emotional distress to another.”¹⁹ Initiating sex with a former patient is strongly disapproved and meets the legal criterion of having a high probability of causing mental distress.²⁰

A suit for negligent infliction of emotional distress. Modern law permits recourse for negligently inflicted emotional distress when harm occurs in “the course of specified categories of activities, undertakings, or relationships in which the negligent conduct is especially likely to cause emotional disturbance.”²¹

Suits for exploitation. Some jurisdictions allow suits against therapists who have sex with former patients, irrespective of therapists’ license status. For example, Minnesota allows lawsuits for “sexual exploitation” if the former patient’s capacity to consent was impaired by emotional dependence on the psychotherapist.²²

Actions by licensing boards. Many retired practitioners maintain their medical licenses. Retired-but-still-licensed psychiatrists can be subject to professional disciplinary actions.

Dear Dr. Mossman,

A psychiatrist retires from practice and goes into some other line of work—perhaps managing a restaurant. He then has an “affair” with a former patient whom he had not treated for several years. Could the retired psychiatrist’s conduct be the basis of a successful lawsuit?—Submitted by “Dr. D”

Evidence tells us that the retired psychiatrist’s behavior likely could do emotional harm to his former patient. If the former patient suffers some injury, a successful suit could follow—if not on grounds of malpractice, then on other grounds. In this article we’ll see why by looking at:

• rates of doctor-patient sex
• potential harm from doctor-patient sex
• ethical bans on sex with former patients
• possible legal actions.

Sex with patients: Rates and risk

Doctors and patients often develop erotic thoughts about each other.^1,2 But as Sigmund Freud noted almost a century ago, an actual love relationship between a doctor and a psychotherapy patient can cause a “complete defeat for the treatment” and destroy the patient’s chance for recovery.³

More than 5 decades later, surveys of medical professionals supplemented Freud’s observations with data about the frequency and impact of doctor-patient sex. In a 1973 survey, 11% of physicians said they had erotic contact with patients, and 5% reported intercourse.⁴ In a 1986 survey of psychiatrists, 3% of women and 7% of men acknowledged having sexual contact with patients.⁵ In a 1992 study of 10,000 nonpsychiatric physicians, 9% of respondents reported having sex with patients.⁶ Actual rates of doctor-patient sex probably are much higher than reported because physicians may be reluctant to admit to having erotic contact with patients, even in anonymous surveys.⁷ The typical therapist-patient sex scenario involves a male doctor and an adult female patient, but same-sex encounters and sexual contact with minors occur, too.⁸

Sex between a therapist and a patient is likely to cause emotional injury. For example, a 1991 study found that 90% of psychotherapy patients who had sexual involvement with a prior therapist had been harmed by the experience.⁹ Books, articles, and Web sites offer vivid individual accounts of harm patients have suffered ( Table ). Doctors who have sex with patients could face public opprobrium, civil lawsuits, actions against their medical licenses, and prosecution in states that make sex with psychiatric patients a criminal offense.¹⁰

Table

How sexual relationships can harm patients

What about former patients?

Sex between providers and current patients is opposed by all major healthcare organizations, including the American Psychiatric Association (APA),¹¹ American Medical Association,¹² and American Psychological Association.¹³ The last 2 groups strongly discourage sex with former patients, but the APA’s ethics code states that such activity is always unethical.

The APA’s position reflects 2 general truths of psychiatric practice:

• Psychiatric patients often return for care years after initial treatment has ended. “Former patients” are really “possible future patients.” Improper relationships with former patients disrupt the doctor’s obligation to remain available for future care.
• Even if a patient never returns to treatment, intense feelings about a doctor can last for years. A psychiatrist who engages in sex with a former patient may evoke and manipulate feelings “left over” from therapy.

Psychiatrists therefore “have only one kind of relationship with a patient—that is, a doctor-patient relationship.”¹⁴ Moreover, as Simon and Shuman observe, “[N]o patient [is] strong enough, no pause is long enough, and no love is true enough to justify compromising this boundary.”¹⁵

Legal actions

If a physician no longer practices medicine, can any of his activities—including with a former patient—be malpractice? In fact, sex between practicing doctors and current patients might not always be malpractice. If a psychiatrist gains sexual access to a patient by saying that the sex will be therapeutic, the psychiatrist has perpetrated fraud and this intentional action might not be covered by malpractice insurance.¹⁶

In several cases involving nonpsychiatric physicians,¹⁷ courts have held that consensual doctor-patient sex is not malpractice, though it might represent some other form of wrongdoing. The argument is that sex with a patient is an intentional act that is never a professional service, whereas malpractice by definition arises unintentionally from negligence while rendering professional services. Other courts, however, have held that doctor-patient sex can be malpractice because it breaches the physician’s fiduciary relationship and can constitute an abuse of power.¹⁸

After retirement, physicians still have responsibilities to former patients: to protect records, to respect confidentiality, and to release information upon proper requests. Some fiduciary duties to patients survive the conclusion of treatment, and behavior that breaches those responsibilities can bring legal action.

Psychiatrists should realize that many former patients remain vulnerable because of feelings “left over” from therapy. Therefore, potential civil actions against a retired psychiatrist might include:

A suit for intentional infliction of emotional distress. This tort action requires proving more than mere insults or indignities; it occurs only when someone “by extreme and outrageous conduct intentionally or recklessly causes severe emotional distress to another.”¹⁹ Initiating sex with a former patient is strongly disapproved and meets the legal criterion of having a high probability of causing mental distress.²⁰

A suit for negligent infliction of emotional distress. Modern law permits recourse for negligently inflicted emotional distress when harm occurs in “the course of specified categories of activities, undertakings, or relationships in which the negligent conduct is especially likely to cause emotional disturbance.”²¹

Suits for exploitation. Some jurisdictions allow suits against therapists who have sex with former patients, irrespective of therapists’ license status. For example, Minnesota allows lawsuits for “sexual exploitation” if the former patient’s capacity to consent was impaired by emotional dependence on the psychotherapist.²²

Actions by licensing boards. Many retired practitioners maintain their medical licenses. Retired-but-still-licensed psychiatrists can be subject to professional disciplinary actions.

Dear Dr. Mossman:

I work at a state mental hospital where all patients are adults who are court-committed, and at least 75% of them smoke. The hospital allows smoking in part of the only outdoor area where patients—smokers and nonsmokers—may go while in our most restrictive treatment phase. Patients come to us after spending at least 2 weeks in nonsmoking facilities where smokers receive nicotine replacement therapy. If patients want to smoke but have no money, in the past our hospital provided “unit cigarettes.”

In my state, a court commitment means the patient lacks the capacity to make decisions about psychiatric care. Of course nicotine is a psychoactive drug. If a patient starts smoking while in our care, would the hospital be liable for health-related expenses the patient may later incur?—Submitted by “Dr. A”

Speaking as one colleague to another about malpractice liability, letting psychiatric patients smoke is not breaching the standard of care toward smoking patients. But you care for nonsmoking patients as well, and other types of liability besides malpractice exist.

Doctors have moral duties for lots of things we can’t be sued for. Dr. A is right to be concerned. To explain, we’ll look at:

• changes in attitudes about smoking
• the link between smoking and mental illness
• smoking bans in psychiatric facilities
• malpractice potential
• other issues Dr. A’s hospital should consider, such as offering patients assistance with smoking cessation.

Changing attitudes about smoking

Thirty years ago, doctors smoked during medical meetings, and smoking on airplanes and in public was commonplace. I worked at an adolescent inpatient unit, and line staff carried lighters. We thought lighting kids’ cigarettes was a legitimate way to establish rapport. Times and attitudes have changed. No hospital condones smoking these days, let alone smoking by minor patients. Since the Surgeon General first declared in 1964 that smoking was hazardous, U.S. adult smoking rates have dropped from 42% to under 20%.¹

In the early 1990s, California issued the first statewide ban on smoking in work-places, including bars and restaurants.² Nearly 3,000 state or local jurisdictions require workplaces and/or commercial establishments to be smoke-free.³ Recently, the legislature in Virginia—a major tobacco-producing state—voted to prohibit smoking in restaurants,⁴ and many other state governments are considering smoking bans. Smoking bans are intended to protect nonsmokers—especially children—from risks of secondhand smoke,⁵ but they also discourage individuals from taking up the habit⁶ and encourage smokers to quit.⁷

Smoking and mental illness

Persons with serious psychiatric disorders have smoking rates 2 to 3 times higher than those of the general population.^8,9 As Dr. A notes, nicotine is a psychoactive drug. Smoking may be a genuine—although ultimately unhealthy—form of self-medication and may have positive psychological effects, such as antidepressant activity for many mentally ill persons.^10,11 The Joint Commission on Accreditation of Healthcare Organizations banned smoking in hospitals in 1992 but made an exception for psychiatric units. Out of sympathy for patients and concern about what could happen when they are deprived of a substance they intensely crave, many psychiatric wards continue to accommodate smokers.¹²

What some institutions have done

An increasing number of psychiatric facilities have instituted or are considering bans on smoking.¹³ The first psychiatric smoking bans were implemented despite fears that patient violence would increase and opposition from hospital employees—a group that often includes smokers. Experience shows that although not all smoking bans are successful or problem-free,¹⁴ they usually cause fewer problems than anticipated. We also know what factors help make smoke-free programs successful (Table).¹⁵

Table

Smoke-free plans that work: How to clear the air

Aggression, seclusion, discharges against medical advice, and “prn” medication use do not increase after smoking bans,^5,16,17 and many patients experience health benefits.¹⁸ After discharge, however, most patients resume tobacco use.^11,19,20

Smoking bans have been opposed on grounds that they abridge psychiatric patients’ rights and are unduly coercive.^21,22 In the United States and United Kingdom, however, legal actions to block smoking bans have not succeeded, and courts have not recognized a fundamental “right to smoke.”^23-25

Is allowing smoking malpractice?

Now that many psychiatric facilities have ended smoking, clinicians may worry—as does Dr. A—that we could incur malpractice liability if we let inpatients smoke. One of my University of Cincinnati law students, Amanda Smith, and I researched this topic and found no case report that said letting psychiatric inpatients smoke violated the standard of care.

This makes sense, because in the malpractice context, a practitioner is judged by what prudent, similarly situated physicians with similar training would do in similar circumstances. Many psychiatric facilities still permit smoking, so letting patients smoke does not breach the standard of care, even if it seems negligent.²⁶

The ill effects of smoking accrue over years, not weeks or months. Almost all patients who smoke in hospitals also have smoked before hospitalization, and most smokers who are barred from smoking while inpatients resume soon after discharge. To succeed, a malpractice lawsuit must show that the defendant’s actions caused damages. A jury might find it hard to conclude that a permissive hospital smoking policy was the primary cause of a long-term smoker’s health problems.

4 other concerns

Nonsmokers’ rights. Arrangements at Dr. A’s hospital expose nonsmokers to secondhand cigarette smoke, which raises the possibility of legal action by nonsmokers. In 1993, the U.S. Supreme Court held that a prison inmate’s heavy exposure to secondhand smoke violated the Eighth Amendment ban on cruel and unusual punishment.²⁷ Involuntary hospitalization is not punishment, but suits such as this might be brought on other grounds, such as violation of patients’ civil rights.²⁸

Competence. In some states, civil commitment requires a finding that the respondent is not competent to make treatment decisions. Can persons who are not competent to make treatment decisions make good decisions about whether to smoke? Shouldn’t the hospital deal with patients’ nicotine dependence more therapeutically—and paternalistically—by providing nicotine replacement and encouraging smoking cessation? Shouldn’t the hospital also discourage patients who don’t smoke from starting?

Protecting patients. Dr. A’s hospital provides cigarettes to patients. Though compassion may be the motive, is the hospital failing to protect its incompetent patients and abetting their self-injurious behavior?

Helping smokers quit. Does the hospital offer treatment to help smokers quit? Although the problems that lead to civil commitment are immediate and serious, addressing long-term health issues is consistent with treating acute psychiatric crises. Many hospitals that permit smoking also encourage participation in smoking-cessation programs. Having these available to patients might make claims that the hospital failed in its duties to care for patients less plausible.

Related resources

• Maryland Hospital Association. Smoke-free hospital campus tool-kit. www.mdhospitals.org/mha/Community_Health_Resources/Smoke_Free_Hospital_Campuses.shtml.
• National Association of State Mental Health Program Directors. Tobacco-free living in psychiatric settings: a best-practices toolkit promoting wellness and recovery. www.nasmhpd.org/general_files/publications/NASMHPD.toolkitfinalupdated90707.pdf.

Dear Dr. Mossman:

I work at a state mental hospital where all patients are adults who are court-committed, and at least 75% of them smoke. The hospital allows smoking in part of the only outdoor area where patients—smokers and nonsmokers—may go while in our most restrictive treatment phase. Patients come to us after spending at least 2 weeks in nonsmoking facilities where smokers receive nicotine replacement therapy. If patients want to smoke but have no money, in the past our hospital provided “unit cigarettes.”

In my state, a court commitment means the patient lacks the capacity to make decisions about psychiatric care. Of course nicotine is a psychoactive drug. If a patient starts smoking while in our care, would the hospital be liable for health-related expenses the patient may later incur?—Submitted by “Dr. A”

Speaking as one colleague to another about malpractice liability, letting psychiatric patients smoke is not breaching the standard of care toward smoking patients. But you care for nonsmoking patients as well, and other types of liability besides malpractice exist.

Doctors have moral duties for lots of things we can’t be sued for. Dr. A is right to be concerned. To explain, we’ll look at:

• changes in attitudes about smoking
• the link between smoking and mental illness
• smoking bans in psychiatric facilities
• malpractice potential
• other issues Dr. A’s hospital should consider, such as offering patients assistance with smoking cessation.

Changing attitudes about smoking

Thirty years ago, doctors smoked during medical meetings, and smoking on airplanes and in public was commonplace. I worked at an adolescent inpatient unit, and line staff carried lighters. We thought lighting kids’ cigarettes was a legitimate way to establish rapport. Times and attitudes have changed. No hospital condones smoking these days, let alone smoking by minor patients. Since the Surgeon General first declared in 1964 that smoking was hazardous, U.S. adult smoking rates have dropped from 42% to under 20%.¹

In the early 1990s, California issued the first statewide ban on smoking in work-places, including bars and restaurants.² Nearly 3,000 state or local jurisdictions require workplaces and/or commercial establishments to be smoke-free.³ Recently, the legislature in Virginia—a major tobacco-producing state—voted to prohibit smoking in restaurants,⁴ and many other state governments are considering smoking bans. Smoking bans are intended to protect nonsmokers—especially children—from risks of secondhand smoke,⁵ but they also discourage individuals from taking up the habit⁶ and encourage smokers to quit.⁷

Smoking and mental illness

Persons with serious psychiatric disorders have smoking rates 2 to 3 times higher than those of the general population.^8,9 As Dr. A notes, nicotine is a psychoactive drug. Smoking may be a genuine—although ultimately unhealthy—form of self-medication and may have positive psychological effects, such as antidepressant activity for many mentally ill persons.^10,11 The Joint Commission on Accreditation of Healthcare Organizations banned smoking in hospitals in 1992 but made an exception for psychiatric units. Out of sympathy for patients and concern about what could happen when they are deprived of a substance they intensely crave, many psychiatric wards continue to accommodate smokers.¹²

What some institutions have done

An increasing number of psychiatric facilities have instituted or are considering bans on smoking.¹³ The first psychiatric smoking bans were implemented despite fears that patient violence would increase and opposition from hospital employees—a group that often includes smokers. Experience shows that although not all smoking bans are successful or problem-free,¹⁴ they usually cause fewer problems than anticipated. We also know what factors help make smoke-free programs successful (Table).¹⁵

Table

Smoke-free plans that work: How to clear the air

Aggression, seclusion, discharges against medical advice, and “prn” medication use do not increase after smoking bans,^5,16,17 and many patients experience health benefits.¹⁸ After discharge, however, most patients resume tobacco use.^11,19,20

Smoking bans have been opposed on grounds that they abridge psychiatric patients’ rights and are unduly coercive.^21,22 In the United States and United Kingdom, however, legal actions to block smoking bans have not succeeded, and courts have not recognized a fundamental “right to smoke.”^23-25

Is allowing smoking malpractice?

Now that many psychiatric facilities have ended smoking, clinicians may worry—as does Dr. A—that we could incur malpractice liability if we let inpatients smoke. One of my University of Cincinnati law students, Amanda Smith, and I researched this topic and found no case report that said letting psychiatric inpatients smoke violated the standard of care.

This makes sense, because in the malpractice context, a practitioner is judged by what prudent, similarly situated physicians with similar training would do in similar circumstances. Many psychiatric facilities still permit smoking, so letting patients smoke does not breach the standard of care, even if it seems negligent.²⁶

The ill effects of smoking accrue over years, not weeks or months. Almost all patients who smoke in hospitals also have smoked before hospitalization, and most smokers who are barred from smoking while inpatients resume soon after discharge. To succeed, a malpractice lawsuit must show that the defendant’s actions caused damages. A jury might find it hard to conclude that a permissive hospital smoking policy was the primary cause of a long-term smoker’s health problems.

4 other concerns

Nonsmokers’ rights. Arrangements at Dr. A’s hospital expose nonsmokers to secondhand cigarette smoke, which raises the possibility of legal action by nonsmokers. In 1993, the U.S. Supreme Court held that a prison inmate’s heavy exposure to secondhand smoke violated the Eighth Amendment ban on cruel and unusual punishment.²⁷ Involuntary hospitalization is not punishment, but suits such as this might be brought on other grounds, such as violation of patients’ civil rights.²⁸

Competence. In some states, civil commitment requires a finding that the respondent is not competent to make treatment decisions. Can persons who are not competent to make treatment decisions make good decisions about whether to smoke? Shouldn’t the hospital deal with patients’ nicotine dependence more therapeutically—and paternalistically—by providing nicotine replacement and encouraging smoking cessation? Shouldn’t the hospital also discourage patients who don’t smoke from starting?

Protecting patients. Dr. A’s hospital provides cigarettes to patients. Though compassion may be the motive, is the hospital failing to protect its incompetent patients and abetting their self-injurious behavior?

Helping smokers quit. Does the hospital offer treatment to help smokers quit? Although the problems that lead to civil commitment are immediate and serious, addressing long-term health issues is consistent with treating acute psychiatric crises. Many hospitals that permit smoking also encourage participation in smoking-cessation programs. Having these available to patients might make claims that the hospital failed in its duties to care for patients less plausible.

Related resources

• Maryland Hospital Association. Smoke-free hospital campus tool-kit. www.mdhospitals.org/mha/Community_Health_Resources/Smoke_Free_Hospital_Campuses.shtml.
• National Association of State Mental Health Program Directors. Tobacco-free living in psychiatric settings: a best-practices toolkit promoting wellness and recovery. www.nasmhpd.org/general_files/publications/NASMHPD.toolkitfinalupdated90707.pdf.

Dear Dr. Mossman:

I work at a state mental hospital where all patients are adults who are court-committed, and at least 75% of them smoke. The hospital allows smoking in part of the only outdoor area where patients—smokers and nonsmokers—may go while in our most restrictive treatment phase. Patients come to us after spending at least 2 weeks in nonsmoking facilities where smokers receive nicotine replacement therapy. If patients want to smoke but have no money, in the past our hospital provided “unit cigarettes.”

In my state, a court commitment means the patient lacks the capacity to make decisions about psychiatric care. Of course nicotine is a psychoactive drug. If a patient starts smoking while in our care, would the hospital be liable for health-related expenses the patient may later incur?—Submitted by “Dr. A”

Speaking as one colleague to another about malpractice liability, letting psychiatric patients smoke is not breaching the standard of care toward smoking patients. But you care for nonsmoking patients as well, and other types of liability besides malpractice exist.

Doctors have moral duties for lots of things we can’t be sued for. Dr. A is right to be concerned. To explain, we’ll look at:

• changes in attitudes about smoking
• the link between smoking and mental illness
• smoking bans in psychiatric facilities
• malpractice potential
• other issues Dr. A’s hospital should consider, such as offering patients assistance with smoking cessation.

Changing attitudes about smoking

Thirty years ago, doctors smoked during medical meetings, and smoking on airplanes and in public was commonplace. I worked at an adolescent inpatient unit, and line staff carried lighters. We thought lighting kids’ cigarettes was a legitimate way to establish rapport. Times and attitudes have changed. No hospital condones smoking these days, let alone smoking by minor patients. Since the Surgeon General first declared in 1964 that smoking was hazardous, U.S. adult smoking rates have dropped from 42% to under 20%.¹

In the early 1990s, California issued the first statewide ban on smoking in work-places, including bars and restaurants.² Nearly 3,000 state or local jurisdictions require workplaces and/or commercial establishments to be smoke-free.³ Recently, the legislature in Virginia—a major tobacco-producing state—voted to prohibit smoking in restaurants,⁴ and many other state governments are considering smoking bans. Smoking bans are intended to protect nonsmokers—especially children—from risks of secondhand smoke,⁵ but they also discourage individuals from taking up the habit⁶ and encourage smokers to quit.⁷

Smoking and mental illness

Persons with serious psychiatric disorders have smoking rates 2 to 3 times higher than those of the general population.^8,9 As Dr. A notes, nicotine is a psychoactive drug. Smoking may be a genuine—although ultimately unhealthy—form of self-medication and may have positive psychological effects, such as antidepressant activity for many mentally ill persons.^10,11 The Joint Commission on Accreditation of Healthcare Organizations banned smoking in hospitals in 1992 but made an exception for psychiatric units. Out of sympathy for patients and concern about what could happen when they are deprived of a substance they intensely crave, many psychiatric wards continue to accommodate smokers.¹²

What some institutions have done

An increasing number of psychiatric facilities have instituted or are considering bans on smoking.¹³ The first psychiatric smoking bans were implemented despite fears that patient violence would increase and opposition from hospital employees—a group that often includes smokers. Experience shows that although not all smoking bans are successful or problem-free,¹⁴ they usually cause fewer problems than anticipated. We also know what factors help make smoke-free programs successful (Table).¹⁵

Table

Smoke-free plans that work: How to clear the air

Aggression, seclusion, discharges against medical advice, and “prn” medication use do not increase after smoking bans,^5,16,17 and many patients experience health benefits.¹⁸ After discharge, however, most patients resume tobacco use.^11,19,20

Smoking bans have been opposed on grounds that they abridge psychiatric patients’ rights and are unduly coercive.^21,22 In the United States and United Kingdom, however, legal actions to block smoking bans have not succeeded, and courts have not recognized a fundamental “right to smoke.”^23-25

Is allowing smoking malpractice?

Now that many psychiatric facilities have ended smoking, clinicians may worry—as does Dr. A—that we could incur malpractice liability if we let inpatients smoke. One of my University of Cincinnati law students, Amanda Smith, and I researched this topic and found no case report that said letting psychiatric inpatients smoke violated the standard of care.

This makes sense, because in the malpractice context, a practitioner is judged by what prudent, similarly situated physicians with similar training would do in similar circumstances. Many psychiatric facilities still permit smoking, so letting patients smoke does not breach the standard of care, even if it seems negligent.²⁶

The ill effects of smoking accrue over years, not weeks or months. Almost all patients who smoke in hospitals also have smoked before hospitalization, and most smokers who are barred from smoking while inpatients resume soon after discharge. To succeed, a malpractice lawsuit must show that the defendant’s actions caused damages. A jury might find it hard to conclude that a permissive hospital smoking policy was the primary cause of a long-term smoker’s health problems.

4 other concerns

Nonsmokers’ rights. Arrangements at Dr. A’s hospital expose nonsmokers to secondhand cigarette smoke, which raises the possibility of legal action by nonsmokers. In 1993, the U.S. Supreme Court held that a prison inmate’s heavy exposure to secondhand smoke violated the Eighth Amendment ban on cruel and unusual punishment.²⁷ Involuntary hospitalization is not punishment, but suits such as this might be brought on other grounds, such as violation of patients’ civil rights.²⁸

Competence. In some states, civil commitment requires a finding that the respondent is not competent to make treatment decisions. Can persons who are not competent to make treatment decisions make good decisions about whether to smoke? Shouldn’t the hospital deal with patients’ nicotine dependence more therapeutically—and paternalistically—by providing nicotine replacement and encouraging smoking cessation? Shouldn’t the hospital also discourage patients who don’t smoke from starting?

Protecting patients. Dr. A’s hospital provides cigarettes to patients. Though compassion may be the motive, is the hospital failing to protect its incompetent patients and abetting their self-injurious behavior?

Helping smokers quit. Does the hospital offer treatment to help smokers quit? Although the problems that lead to civil commitment are immediate and serious, addressing long-term health issues is consistent with treating acute psychiatric crises. Many hospitals that permit smoking also encourage participation in smoking-cessation programs. Having these available to patients might make claims that the hospital failed in its duties to care for patients less plausible.

Related resources

• Maryland Hospital Association. Smoke-free hospital campus tool-kit. www.mdhospitals.org/mha/Community_Health_Resources/Smoke_Free_Hospital_Campuses.shtml.
• National Association of State Mental Health Program Directors. Tobacco-free living in psychiatric settings: a best-practices toolkit promoting wellness and recovery. www.nasmhpd.org/general_files/publications/NASMHPD.toolkitfinalupdated90707.pdf.

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Dear Dr. Mossman:

I am an adult psychiatrist practicing in a geographically isolated area. I am working with the family of 10-year-old “Bobby” who is struggling with attention problems. Top notch neuropsychologic testing recommends a stimulant trial, but the local pediatrician is too busy to give Bobby adequate follow-up and attention.

I am an experienced psychopharmacologist but have not prescribed medication to children since residency. My relationship with the family is excellent, and the local pediatrician said that she would supervise me. If I choose to treat Bobby, what are the possible liability issues I should be aware of, and how can I address them?—Submitted by “Dr. F”

Dr. F’s question raises issues that come up whenever patients need treatment for conditions outside the few with which you are highly familiar. Although you can’t be an expert on every aspect of every patient’s treatment, psychiatrists shouldn’t practice outside their area of competence.

Thus, the main liability-related issue that Dr. F should ask herself is, “Can I treat Bobby competently?” Of course, whenever you decide to treat any patient, you should be able to answer “yes” to this question. When thinking about potential liability related to treating Bobby, Dr. F might also ask, “If a lawsuit occurred, how would my treatment of Bobby appear?” This article discusses key issues that arise when general psychiatrists treat children and the steps general psychiatrists can take to show that they are practicing prudently.

Problem: Not enough clinicians

Child and adolescent psychiatrists (CAPs) are in short supply.^1,2 In 2001 the United States had 8.67 CAPs per 100,000 youths and 1.6 CAPs for every 1,000 youths with severe mental disorders.¹ Studies suggest that the United States needs nearly twice that many CAPs.³ The shortage is especially severe in rural areas, but approximately one-half of metropolitan counties with populations of >250,000 have no CAPs.¹ In much of the nation, finding CAPs who are accepting new patients is difficult, and child and adolescent psychiatric treatment often is delivered by pediatricians, family practitioners, psychiatric nurse practitioners, and general adult psychiatrists.

Children’s special medical issues

General psychiatrists know that children aren’t just little adults. CAPs develop skills and thinking styles during their 2 years of subspecialty fellowship training that are quite different from those used by their general psychiatric colleagues.

Communication. Children and adolescents who need psychiatric care often have limited verbal abilities. Working and communicating with these patients requires a different interactive style.

Information sources. CAPs learn to seek and assimilate clinically important information from many settings—especially a child’s home—where their patients interact with others.

Caution. Only a small subset of psychotropic medications that adult psychiatrists prescribe are FDA-approved for use in children (Table 1).⁴ Because we don’t know how psychotropic drugs affect brain development, CAPs sometimes are leery of giving kids the same medications that adult psychiatrists readily prescribe.

Table 1

FDA-approved drugs and dosages for ADHD in children and adults

Different drugs. Some medications commonly taken by children are not often prescribed for adults, although this is changing as attention-deficit/hyperactivity disorder (ADHD) is better recognized in adults.^5,6

Dosages. Dosing psychotropics in adults is fairly standardized, but in children and adolescents dosages vary with age, body weight, and physical maturity.

Adverse effects. The side effects kids experience and the way they report them can differ markedly from adults and will vary with age and developmental maturity. Some issues related to monitoring children—such as appropriate cardiac screening before starting stimulants—are controversial and remain unsettled.^7,8

Consider alternatives

Dr. F may be tempted to treat Bobby because of her preexisting, positive relationship with the child’s family and a laudable desire to help. But Dr. F needs to ask, “Is there really no other workable alternative for Bobby?” Some possibilities include:

• Refer Bobby to a CAP in another community for initiation of treatment. Dr. F or Bobby’s pediatrician might safely continue care once a CAP establishes an effective treatment regimen.
• Find another pediatrician who might have more time to provide the follow-up that Dr. F feels is necessary.
• Decline to treat Bobby. Before doing this, Dr. F should consider what effect this refusal might have on her relationship with the family and the consequences for Bobby if his problems go untreated.
• Consult a CAP from another community, describing the situation and clinical factors in detail without naming or identifying the patient, and then ask, “Is this really the best thing to do?”

From a liability standpoint, this last point may be crucial. If the CAP answers “yes,” Dr. F can document the alternatives she has considered and her consultation and discussion with the CAP colleague as evidence of prudent practice. Dr. F can also document any advice that she has received and her plans to follow it.

If you choose to treat

Presumably, Dr. F would not perform thoracic surgery or provide any treatment that is far outside a general psychiatrist’s competence except under the most dire circumstances. General psychiatrists receive child psychiatry training during residency, and treating children is within their scope of practice. Similarly, most elderly patients are treated by general psychiatrists, rather than graduates of geropsychiatry fellowships. Prescribing medication for Bobby is not grossly different from Dr. F’s other duties, and she might provide services that a pediatrician might not.

Ask yourself 4 questions to determine if you are competent to provide medical treatment outside your usual area of expertise (Table 2). In Bobby’s case, Dr. F can consider these additional questions:

• Am I comfortable doing this? Would I be comfortable with this scenario if Bobby were my child?
• How extensive was my general residency training in child psychiatry?
• How long ago was my last CAP experience?
• Have I treated ADHD in adults, and am I familiar with stimulant medications?
• What kind of supervision could I arrange, such as regular phone consultation with a CAP or pediatrician?
• How helpful are other information sources, such as recent texts, journals, and medical Web sites?
• What is my relationship with the family, and how would treating Bobby affect it?

Table 2

Should you provide treatment? 4 questions to ask yourself

Advantages and benefits

So far, we’ve emphasized cautions, but Dr. F also should remember that she may offer patients services that general psychiatrists provide but that pediatricians might not do routinely. Among the possibilities:

• Performing a diagnostic assessment that incorporates biopsychosocial factors.
• Taking time to foster a strong doctor-patient relationship with the family.
• Reserving time for medication-related psychoeducation.
• Scheduling longer visits to discuss a child’s psychiatric problems and explore solutions.
• Utilizing knowledge of and existing relationships with nonphysician therapists who could provide additional psychotherapy.

Dear Dr. Mossman:

I am an adult psychiatrist practicing in a geographically isolated area. I am working with the family of 10-year-old “Bobby” who is struggling with attention problems. Top notch neuropsychologic testing recommends a stimulant trial, but the local pediatrician is too busy to give Bobby adequate follow-up and attention.

I am an experienced psychopharmacologist but have not prescribed medication to children since residency. My relationship with the family is excellent, and the local pediatrician said that she would supervise me. If I choose to treat Bobby, what are the possible liability issues I should be aware of, and how can I address them?—Submitted by “Dr. F”

Dr. F’s question raises issues that come up whenever patients need treatment for conditions outside the few with which you are highly familiar. Although you can’t be an expert on every aspect of every patient’s treatment, psychiatrists shouldn’t practice outside their area of competence.

Thus, the main liability-related issue that Dr. F should ask herself is, “Can I treat Bobby competently?” Of course, whenever you decide to treat any patient, you should be able to answer “yes” to this question. When thinking about potential liability related to treating Bobby, Dr. F might also ask, “If a lawsuit occurred, how would my treatment of Bobby appear?” This article discusses key issues that arise when general psychiatrists treat children and the steps general psychiatrists can take to show that they are practicing prudently.

Problem: Not enough clinicians

Child and adolescent psychiatrists (CAPs) are in short supply.^1,2 In 2001 the United States had 8.67 CAPs per 100,000 youths and 1.6 CAPs for every 1,000 youths with severe mental disorders.¹ Studies suggest that the United States needs nearly twice that many CAPs.³ The shortage is especially severe in rural areas, but approximately one-half of metropolitan counties with populations of >250,000 have no CAPs.¹ In much of the nation, finding CAPs who are accepting new patients is difficult, and child and adolescent psychiatric treatment often is delivered by pediatricians, family practitioners, psychiatric nurse practitioners, and general adult psychiatrists.

Children’s special medical issues

General psychiatrists know that children aren’t just little adults. CAPs develop skills and thinking styles during their 2 years of subspecialty fellowship training that are quite different from those used by their general psychiatric colleagues.

Communication. Children and adolescents who need psychiatric care often have limited verbal abilities. Working and communicating with these patients requires a different interactive style.

Information sources. CAPs learn to seek and assimilate clinically important information from many settings—especially a child’s home—where their patients interact with others.

Caution. Only a small subset of psychotropic medications that adult psychiatrists prescribe are FDA-approved for use in children (Table 1).⁴ Because we don’t know how psychotropic drugs affect brain development, CAPs sometimes are leery of giving kids the same medications that adult psychiatrists readily prescribe.

Table 1

FDA-approved drugs and dosages for ADHD in children and adults

Different drugs. Some medications commonly taken by children are not often prescribed for adults, although this is changing as attention-deficit/hyperactivity disorder (ADHD) is better recognized in adults.^5,6

Dosages. Dosing psychotropics in adults is fairly standardized, but in children and adolescents dosages vary with age, body weight, and physical maturity.

Adverse effects. The side effects kids experience and the way they report them can differ markedly from adults and will vary with age and developmental maturity. Some issues related to monitoring children—such as appropriate cardiac screening before starting stimulants—are controversial and remain unsettled.^7,8

Consider alternatives

Dr. F may be tempted to treat Bobby because of her preexisting, positive relationship with the child’s family and a laudable desire to help. But Dr. F needs to ask, “Is there really no other workable alternative for Bobby?” Some possibilities include:

• Refer Bobby to a CAP in another community for initiation of treatment. Dr. F or Bobby’s pediatrician might safely continue care once a CAP establishes an effective treatment regimen.
• Find another pediatrician who might have more time to provide the follow-up that Dr. F feels is necessary.
• Decline to treat Bobby. Before doing this, Dr. F should consider what effect this refusal might have on her relationship with the family and the consequences for Bobby if his problems go untreated.
• Consult a CAP from another community, describing the situation and clinical factors in detail without naming or identifying the patient, and then ask, “Is this really the best thing to do?”

From a liability standpoint, this last point may be crucial. If the CAP answers “yes,” Dr. F can document the alternatives she has considered and her consultation and discussion with the CAP colleague as evidence of prudent practice. Dr. F can also document any advice that she has received and her plans to follow it.

If you choose to treat

Presumably, Dr. F would not perform thoracic surgery or provide any treatment that is far outside a general psychiatrist’s competence except under the most dire circumstances. General psychiatrists receive child psychiatry training during residency, and treating children is within their scope of practice. Similarly, most elderly patients are treated by general psychiatrists, rather than graduates of geropsychiatry fellowships. Prescribing medication for Bobby is not grossly different from Dr. F’s other duties, and she might provide services that a pediatrician might not.

Ask yourself 4 questions to determine if you are competent to provide medical treatment outside your usual area of expertise (Table 2). In Bobby’s case, Dr. F can consider these additional questions:

• Am I comfortable doing this? Would I be comfortable with this scenario if Bobby were my child?
• How extensive was my general residency training in child psychiatry?
• How long ago was my last CAP experience?
• Have I treated ADHD in adults, and am I familiar with stimulant medications?
• What kind of supervision could I arrange, such as regular phone consultation with a CAP or pediatrician?
• How helpful are other information sources, such as recent texts, journals, and medical Web sites?
• What is my relationship with the family, and how would treating Bobby affect it?

Table 2

Should you provide treatment? 4 questions to ask yourself

Advantages and benefits

So far, we’ve emphasized cautions, but Dr. F also should remember that she may offer patients services that general psychiatrists provide but that pediatricians might not do routinely. Among the possibilities:

• Performing a diagnostic assessment that incorporates biopsychosocial factors.
• Taking time to foster a strong doctor-patient relationship with the family.
• Reserving time for medication-related psychoeducation.
• Scheduling longer visits to discuss a child’s psychiatric problems and explore solutions.
• Utilizing knowledge of and existing relationships with nonphysician therapists who could provide additional psychotherapy.

Dear Dr. Mossman:

I am an adult psychiatrist practicing in a geographically isolated area. I am working with the family of 10-year-old “Bobby” who is struggling with attention problems. Top notch neuropsychologic testing recommends a stimulant trial, but the local pediatrician is too busy to give Bobby adequate follow-up and attention.

I am an experienced psychopharmacologist but have not prescribed medication to children since residency. My relationship with the family is excellent, and the local pediatrician said that she would supervise me. If I choose to treat Bobby, what are the possible liability issues I should be aware of, and how can I address them?—Submitted by “Dr. F”

Dr. F’s question raises issues that come up whenever patients need treatment for conditions outside the few with which you are highly familiar. Although you can’t be an expert on every aspect of every patient’s treatment, psychiatrists shouldn’t practice outside their area of competence.

Thus, the main liability-related issue that Dr. F should ask herself is, “Can I treat Bobby competently?” Of course, whenever you decide to treat any patient, you should be able to answer “yes” to this question. When thinking about potential liability related to treating Bobby, Dr. F might also ask, “If a lawsuit occurred, how would my treatment of Bobby appear?” This article discusses key issues that arise when general psychiatrists treat children and the steps general psychiatrists can take to show that they are practicing prudently.

Problem: Not enough clinicians

Child and adolescent psychiatrists (CAPs) are in short supply.^1,2 In 2001 the United States had 8.67 CAPs per 100,000 youths and 1.6 CAPs for every 1,000 youths with severe mental disorders.¹ Studies suggest that the United States needs nearly twice that many CAPs.³ The shortage is especially severe in rural areas, but approximately one-half of metropolitan counties with populations of >250,000 have no CAPs.¹ In much of the nation, finding CAPs who are accepting new patients is difficult, and child and adolescent psychiatric treatment often is delivered by pediatricians, family practitioners, psychiatric nurse practitioners, and general adult psychiatrists.

Children’s special medical issues

General psychiatrists know that children aren’t just little adults. CAPs develop skills and thinking styles during their 2 years of subspecialty fellowship training that are quite different from those used by their general psychiatric colleagues.

Communication. Children and adolescents who need psychiatric care often have limited verbal abilities. Working and communicating with these patients requires a different interactive style.

Information sources. CAPs learn to seek and assimilate clinically important information from many settings—especially a child’s home—where their patients interact with others.

Caution. Only a small subset of psychotropic medications that adult psychiatrists prescribe are FDA-approved for use in children (Table 1).⁴ Because we don’t know how psychotropic drugs affect brain development, CAPs sometimes are leery of giving kids the same medications that adult psychiatrists readily prescribe.

Table 1

FDA-approved drugs and dosages for ADHD in children and adults

Different drugs. Some medications commonly taken by children are not often prescribed for adults, although this is changing as attention-deficit/hyperactivity disorder (ADHD) is better recognized in adults.^5,6

Dosages. Dosing psychotropics in adults is fairly standardized, but in children and adolescents dosages vary with age, body weight, and physical maturity.

Adverse effects. The side effects kids experience and the way they report them can differ markedly from adults and will vary with age and developmental maturity. Some issues related to monitoring children—such as appropriate cardiac screening before starting stimulants—are controversial and remain unsettled.^7,8

Consider alternatives

Dr. F may be tempted to treat Bobby because of her preexisting, positive relationship with the child’s family and a laudable desire to help. But Dr. F needs to ask, “Is there really no other workable alternative for Bobby?” Some possibilities include:

• Refer Bobby to a CAP in another community for initiation of treatment. Dr. F or Bobby’s pediatrician might safely continue care once a CAP establishes an effective treatment regimen.
• Find another pediatrician who might have more time to provide the follow-up that Dr. F feels is necessary.
• Decline to treat Bobby. Before doing this, Dr. F should consider what effect this refusal might have on her relationship with the family and the consequences for Bobby if his problems go untreated.
• Consult a CAP from another community, describing the situation and clinical factors in detail without naming or identifying the patient, and then ask, “Is this really the best thing to do?”

From a liability standpoint, this last point may be crucial. If the CAP answers “yes,” Dr. F can document the alternatives she has considered and her consultation and discussion with the CAP colleague as evidence of prudent practice. Dr. F can also document any advice that she has received and her plans to follow it.

If you choose to treat

Presumably, Dr. F would not perform thoracic surgery or provide any treatment that is far outside a general psychiatrist’s competence except under the most dire circumstances. General psychiatrists receive child psychiatry training during residency, and treating children is within their scope of practice. Similarly, most elderly patients are treated by general psychiatrists, rather than graduates of geropsychiatry fellowships. Prescribing medication for Bobby is not grossly different from Dr. F’s other duties, and she might provide services that a pediatrician might not.

Ask yourself 4 questions to determine if you are competent to provide medical treatment outside your usual area of expertise (Table 2). In Bobby’s case, Dr. F can consider these additional questions:

• Am I comfortable doing this? Would I be comfortable with this scenario if Bobby were my child?
• How extensive was my general residency training in child psychiatry?
• How long ago was my last CAP experience?
• Have I treated ADHD in adults, and am I familiar with stimulant medications?
• What kind of supervision could I arrange, such as regular phone consultation with a CAP or pediatrician?
• How helpful are other information sources, such as recent texts, journals, and medical Web sites?
• What is my relationship with the family, and how would treating Bobby affect it?

Table 2

Should you provide treatment? 4 questions to ask yourself

Advantages and benefits

So far, we’ve emphasized cautions, but Dr. F also should remember that she may offer patients services that general psychiatrists provide but that pediatricians might not do routinely. Among the possibilities:

• Performing a diagnostic assessment that incorporates biopsychosocial factors.
• Taking time to foster a strong doctor-patient relationship with the family.
• Reserving time for medication-related psychoeducation.
• Scheduling longer visits to discuss a child’s psychiatric problems and explore solutions.
• Utilizing knowledge of and existing relationships with nonphysician therapists who could provide additional psychotherapy.

Dear Dr. Mossman:

I treat children and adolescents in an acute inpatient setting. Sometimes a child of divorced parents—call him “Johnny”—is admitted to the hospital by one parent—for example the mother—but she doesn’t inform the father. Although the parents have joint custody, Mom doesn’t want me to contact Dad.

I tell Mom that I’d like to get clinical information and consent from Dad, but she refuses, saying, “This will make me look bad, and my ex-husband will try to take emergency custody of Johnny.” My hospital’s legal department says consent from both parents isn’t needed.

These scenarios always leave me feeling upset and confused. I’d appreciate clarification on how to handle these matters.—Submitted by “Dr. K”

Knowing the correct legal answer to a question often doesn’t supply the best clinical solution for your patient. Dr. K received a legally sound response from hospital administrators: a parent who has legal custody may authorize medical treatment for a minor child without first asking or informing the other parent. But Dr. K feels unsatisfied because the hospital didn’t provide what Dr. K sought: a clinically sound answer.

This article reviews custody arrangements and the legal rights they give divorced parents. Also, we will discuss the mother’s concerns and explain why—despite her fears—notifying and involving Johnny’s father can be important, even when it’s not legally required.

Custody and urgent treatment

A minor—defined in most states as a person younger than age 18—legally cannot give consent for medical care except in limited circumstances, such as contraceptive care.^1,2 When a minor undergoes psychiatric hospitalization, physicians usually must obtain consent from the minor’s legal custodian.

Married parents both have legal custody of their children. They also have equal rights to spend time with their children and make major decisions about their welfare, such as authorizing medical care. When parents divorce, these rights must be reassigned in a court-approved divorce decree. Table 1 explains some key terms used to describe custody arrangements after divorce.^2,3

Several decades ago, children—especially those younger age 10—usually remained with their mothers, who received sole legal custody; fathers typically had visitation privileges.⁴ Now, however, most states’ statutes presume that divorced mothers and fathers will have joint legal custody.³

Joint legal custody lets both parents retain their individual legal authority to make decisions on behalf of minor children, although the children may spend most of their time in the physical custody of 1 parent. This means that when urgent medical care is needed—such as a psychiatric hospitalization—1 parent’s consent is sufficient legal authorization for treatment.^1,2

What if a child’s parent claims to have legal custody, but the doctor isn’t sure? A doctor who in good faith relies on a parent’s statement can properly provide urgent treatment without delving into custody arrangements.² In many states, noncustodial parents may authorize treatment in urgent situations—and even some nonurgent ones—if they happen to have physical control of the child when care is needed, such as during a visit.¹

Table 1

Child custody: Key legal terms

Nonurgent treatment

After receiving urgent treatment, psychiatric patients typically need continuing, nonurgent care. Dr. K’s inquiry may be anticipating this scenario. In general, parents with joint custody have an equal right to authorize nonurgent care for their children, and Johnny’s treatment could proceed with only Mom’s consent.¹ However, if Dr. K knows or has reason to think that Johnny’s father would refuse to give consent for ongoing, nonurgent psychiatric care, providing treatment over the father’s objection may be legally questionable. Under some joint legal custody agreements, both parents need to give consent for medical care and receive clinical information about their children.²

Moreover, trying to treat Johnny in the face of Dad’s explicit objection may be clinically unwise. Unfortunately, many couples’ conflicts are not resolved by divorce, and children can become pawns in ongoing postmarital battles. Such situations can exacerbate children’s emotional problems, which is the opposite of what Dr. K hopes to do for Johnny.

What can Dr. K do?

Address a parent’s fears. Few parents are at their levelheaded best when their children need psychiatric hospitalization. To help Mom and Johnny, Dr. K can point out these things:

• Many states, such as Ohio,⁵ give Dad the right to learn about Johnny’s treatment and access to treatment records.
• Sooner or later, Dad will find out about the hospitalization. The next time Johnny visits his father, he’ll probably tell Dad what happened. In a few weeks, Dad may receive insurance paperwork or a bill from the hospital.
• Dad may be far more upset and prone to retaliate if he finds out later and is excluded from Johnny’s treatment than if he is notified immediately and gets to participate in his son’s care.
• Realistically, Dad cannot take Johnny away because Mom has arranged for appropriate medical care. If hospitalization is indicated, Mom’s failure to get treatment for Johnny could be grounds for Dad to claim she’s an unfit parent.

Why both parents are needed

Johnny’s hospital care probably will benefit from Dad’s involvement for several reasons (Table 2).

More information. Child and adolescent psychiatrists agree that in most clinical situations it helps to obtain information from as many sources as possible.^6-9 Johnny’s father might have crucial information relevant to diagnosis or treatment, such as family history details that Mom doesn’t know.

Debiasing. If Johnny spends time living with both parents, Dr. K should know how often symptoms appear in both environments. Dad’s perspective may be vital, but when postdivorce relationships are strained, what parents convey about each other can be biased. Getting information directly from both parents will give Dr. K a more realistic picture of the child’s environment and psychosocial stressors.⁷

Treatment planning. After a psychiatric hospitalization, both parents should be aware of Johnny’s diagnosis and treatment. Johnny may need careful supervision for recurrence of symptoms, such as suicidal or homicidal ideation, that can have life-threatening implications.

Medication management. If Johnny is taking medication, he’ll need to receive it regularly. Missing medication when Johnny is with Dad would reduce effectiveness and in some cases could be dangerous. Both parents also should know about possible side effects so they can provide good monitoring.

Psychotherapy. Often, family therapy is an important element of a child’s recovery and will achieve optimum results only if all family members participate. Also, children need consistency. If a behavioral plan is part of Johnny’s treatment, Mom and Dad will need to agree on the rules and implement them consistently at both homes.

Table 2

Why both parents’ input is valuable

Work with parents

When one divorced parent is reluctant to inform the other about their child’s hospitalization, you can respond empathically to fears and concerns. Despite mental health professionals’ best efforts, psychiatric illness still generates feelings of stigma and shame. Divorced parents often feel guilty about the stress the divorce has brought to their children, and they may consciously or unconsciously blame themselves for their child’s illness. In the midst of an ongoing custody dispute, the parent initiating a psychiatric hospitalization may feel especially vulnerable and reluctant to inform the other parent about what’s happening.

Being attuned to these issues will help you address and normalize a parent’s fears. Parents should know that a court could support their seeking treatment for their children’s illness, and they could be contributing to medical neglect if they do not seek this treatment.

In rare instances, not informing the other parent may be the best clinical decision. In situations involving child abuse or extreme domestic violence, a parent’s learning about the hospitalization could create safety issues. In most instances, however, both Mom and Dad will see their child soon after hospitalization, so one parent cannot hope to conceal a hospitalization for very long. Involving both parents from the outset usually will give the child and his family the best shot at a positive outcome.

Dear Dr. Mossman:

I treat children and adolescents in an acute inpatient setting. Sometimes a child of divorced parents—call him “Johnny”—is admitted to the hospital by one parent—for example the mother—but she doesn’t inform the father. Although the parents have joint custody, Mom doesn’t want me to contact Dad.

I tell Mom that I’d like to get clinical information and consent from Dad, but she refuses, saying, “This will make me look bad, and my ex-husband will try to take emergency custody of Johnny.” My hospital’s legal department says consent from both parents isn’t needed.

These scenarios always leave me feeling upset and confused. I’d appreciate clarification on how to handle these matters.—Submitted by “Dr. K”

Knowing the correct legal answer to a question often doesn’t supply the best clinical solution for your patient. Dr. K received a legally sound response from hospital administrators: a parent who has legal custody may authorize medical treatment for a minor child without first asking or informing the other parent. But Dr. K feels unsatisfied because the hospital didn’t provide what Dr. K sought: a clinically sound answer.

This article reviews custody arrangements and the legal rights they give divorced parents. Also, we will discuss the mother’s concerns and explain why—despite her fears—notifying and involving Johnny’s father can be important, even when it’s not legally required.

Custody and urgent treatment

A minor—defined in most states as a person younger than age 18—legally cannot give consent for medical care except in limited circumstances, such as contraceptive care.^1,2 When a minor undergoes psychiatric hospitalization, physicians usually must obtain consent from the minor’s legal custodian.

Married parents both have legal custody of their children. They also have equal rights to spend time with their children and make major decisions about their welfare, such as authorizing medical care. When parents divorce, these rights must be reassigned in a court-approved divorce decree. Table 1 explains some key terms used to describe custody arrangements after divorce.^2,3

Several decades ago, children—especially those younger age 10—usually remained with their mothers, who received sole legal custody; fathers typically had visitation privileges.⁴ Now, however, most states’ statutes presume that divorced mothers and fathers will have joint legal custody.³

Joint legal custody lets both parents retain their individual legal authority to make decisions on behalf of minor children, although the children may spend most of their time in the physical custody of 1 parent. This means that when urgent medical care is needed—such as a psychiatric hospitalization—1 parent’s consent is sufficient legal authorization for treatment.^1,2

What if a child’s parent claims to have legal custody, but the doctor isn’t sure? A doctor who in good faith relies on a parent’s statement can properly provide urgent treatment without delving into custody arrangements.² In many states, noncustodial parents may authorize treatment in urgent situations—and even some nonurgent ones—if they happen to have physical control of the child when care is needed, such as during a visit.¹

Table 1

Child custody: Key legal terms

Nonurgent treatment

After receiving urgent treatment, psychiatric patients typically need continuing, nonurgent care. Dr. K’s inquiry may be anticipating this scenario. In general, parents with joint custody have an equal right to authorize nonurgent care for their children, and Johnny’s treatment could proceed with only Mom’s consent.¹ However, if Dr. K knows or has reason to think that Johnny’s father would refuse to give consent for ongoing, nonurgent psychiatric care, providing treatment over the father’s objection may be legally questionable. Under some joint legal custody agreements, both parents need to give consent for medical care and receive clinical information about their children.²

Moreover, trying to treat Johnny in the face of Dad’s explicit objection may be clinically unwise. Unfortunately, many couples’ conflicts are not resolved by divorce, and children can become pawns in ongoing postmarital battles. Such situations can exacerbate children’s emotional problems, which is the opposite of what Dr. K hopes to do for Johnny.

What can Dr. K do?

Address a parent’s fears. Few parents are at their levelheaded best when their children need psychiatric hospitalization. To help Mom and Johnny, Dr. K can point out these things:

• Many states, such as Ohio,⁵ give Dad the right to learn about Johnny’s treatment and access to treatment records.
• Sooner or later, Dad will find out about the hospitalization. The next time Johnny visits his father, he’ll probably tell Dad what happened. In a few weeks, Dad may receive insurance paperwork or a bill from the hospital.
• Dad may be far more upset and prone to retaliate if he finds out later and is excluded from Johnny’s treatment than if he is notified immediately and gets to participate in his son’s care.
• Realistically, Dad cannot take Johnny away because Mom has arranged for appropriate medical care. If hospitalization is indicated, Mom’s failure to get treatment for Johnny could be grounds for Dad to claim she’s an unfit parent.

Why both parents are needed

Johnny’s hospital care probably will benefit from Dad’s involvement for several reasons (Table 2).

More information. Child and adolescent psychiatrists agree that in most clinical situations it helps to obtain information from as many sources as possible.^6-9 Johnny’s father might have crucial information relevant to diagnosis or treatment, such as family history details that Mom doesn’t know.

Debiasing. If Johnny spends time living with both parents, Dr. K should know how often symptoms appear in both environments. Dad’s perspective may be vital, but when postdivorce relationships are strained, what parents convey about each other can be biased. Getting information directly from both parents will give Dr. K a more realistic picture of the child’s environment and psychosocial stressors.⁷

Treatment planning. After a psychiatric hospitalization, both parents should be aware of Johnny’s diagnosis and treatment. Johnny may need careful supervision for recurrence of symptoms, such as suicidal or homicidal ideation, that can have life-threatening implications.

Medication management. If Johnny is taking medication, he’ll need to receive it regularly. Missing medication when Johnny is with Dad would reduce effectiveness and in some cases could be dangerous. Both parents also should know about possible side effects so they can provide good monitoring.

Psychotherapy. Often, family therapy is an important element of a child’s recovery and will achieve optimum results only if all family members participate. Also, children need consistency. If a behavioral plan is part of Johnny’s treatment, Mom and Dad will need to agree on the rules and implement them consistently at both homes.

Table 2

Why both parents’ input is valuable

Work with parents

When one divorced parent is reluctant to inform the other about their child’s hospitalization, you can respond empathically to fears and concerns. Despite mental health professionals’ best efforts, psychiatric illness still generates feelings of stigma and shame. Divorced parents often feel guilty about the stress the divorce has brought to their children, and they may consciously or unconsciously blame themselves for their child’s illness. In the midst of an ongoing custody dispute, the parent initiating a psychiatric hospitalization may feel especially vulnerable and reluctant to inform the other parent about what’s happening.

Being attuned to these issues will help you address and normalize a parent’s fears. Parents should know that a court could support their seeking treatment for their children’s illness, and they could be contributing to medical neglect if they do not seek this treatment.

In rare instances, not informing the other parent may be the best clinical decision. In situations involving child abuse or extreme domestic violence, a parent’s learning about the hospitalization could create safety issues. In most instances, however, both Mom and Dad will see their child soon after hospitalization, so one parent cannot hope to conceal a hospitalization for very long. Involving both parents from the outset usually will give the child and his family the best shot at a positive outcome.

Dear Dr. Mossman:

I treat children and adolescents in an acute inpatient setting. Sometimes a child of divorced parents—call him “Johnny”—is admitted to the hospital by one parent—for example the mother—but she doesn’t inform the father. Although the parents have joint custody, Mom doesn’t want me to contact Dad.

I tell Mom that I’d like to get clinical information and consent from Dad, but she refuses, saying, “This will make me look bad, and my ex-husband will try to take emergency custody of Johnny.” My hospital’s legal department says consent from both parents isn’t needed.

These scenarios always leave me feeling upset and confused. I’d appreciate clarification on how to handle these matters.—Submitted by “Dr. K”

Knowing the correct legal answer to a question often doesn’t supply the best clinical solution for your patient. Dr. K received a legally sound response from hospital administrators: a parent who has legal custody may authorize medical treatment for a minor child without first asking or informing the other parent. But Dr. K feels unsatisfied because the hospital didn’t provide what Dr. K sought: a clinically sound answer.

This article reviews custody arrangements and the legal rights they give divorced parents. Also, we will discuss the mother’s concerns and explain why—despite her fears—notifying and involving Johnny’s father can be important, even when it’s not legally required.

Custody and urgent treatment

A minor—defined in most states as a person younger than age 18—legally cannot give consent for medical care except in limited circumstances, such as contraceptive care.^1,2 When a minor undergoes psychiatric hospitalization, physicians usually must obtain consent from the minor’s legal custodian.

Married parents both have legal custody of their children. They also have equal rights to spend time with their children and make major decisions about their welfare, such as authorizing medical care. When parents divorce, these rights must be reassigned in a court-approved divorce decree. Table 1 explains some key terms used to describe custody arrangements after divorce.^2,3