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The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).1 Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.2 The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”3 Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.
Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.1 Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to4:
- adequately assess the patient
- consult the patient’s medical records
- obtain informed consent from the patient
- appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
- monitor for adverse effects and therapeutic effectiveness.
Steps to minimize your risk
When prescribing a medication off-label, the following approaches can help reduce your liability risk:
Conduct a comprehensive clinical assessment. This should include requesting and reviewing your patient’s medical records.
Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.
Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.
Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.4 Allow time for the patient to ask questions about these treatments.
Continue to: Document all steps
Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following4:
- your clinical assessment
- information you gleaned from the patient’s medical records
- your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
- your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
- your clinical rationale for why the off-label medication is in the patient’s best interest.
Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.4 Overall, the goal of documentation should be to support the adequate continuing care of our patients.
1. US Food and Drug Administration. Understanding unapproved use of approved drugs “off label.” https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label. Updated February 5, 2018. Accessed August 6, 2020.
2. Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLoS One. 2018;13(7):e0198363. doi: 10.1371/journal.pone.0198363.
3. McLeer S, Mawhinney J; Council on Healthcare Systems and Financing. Position statement on off-label treatments. American Psychiatric Association. https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-2016-Off-Label-Treatment.pdf. Published July 2016. Accessed August 6, 2020.
4. Funicelli A. What to consider when prescribing off-label. Psychiatric News. 2019;54(14):12.
The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).1 Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.2 The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”3 Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.
Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.1 Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to4:
- adequately assess the patient
- consult the patient’s medical records
- obtain informed consent from the patient
- appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
- monitor for adverse effects and therapeutic effectiveness.
Steps to minimize your risk
When prescribing a medication off-label, the following approaches can help reduce your liability risk:
Conduct a comprehensive clinical assessment. This should include requesting and reviewing your patient’s medical records.
Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.
Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.
Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.4 Allow time for the patient to ask questions about these treatments.
Continue to: Document all steps
Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following4:
- your clinical assessment
- information you gleaned from the patient’s medical records
- your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
- your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
- your clinical rationale for why the off-label medication is in the patient’s best interest.
Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.4 Overall, the goal of documentation should be to support the adequate continuing care of our patients.
The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).1 Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.2 The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”3 Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.
Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.1 Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to4:
- adequately assess the patient
- consult the patient’s medical records
- obtain informed consent from the patient
- appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
- monitor for adverse effects and therapeutic effectiveness.
Steps to minimize your risk
When prescribing a medication off-label, the following approaches can help reduce your liability risk:
Conduct a comprehensive clinical assessment. This should include requesting and reviewing your patient’s medical records.
Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.
Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.
Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.4 Allow time for the patient to ask questions about these treatments.
Continue to: Document all steps
Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following4:
- your clinical assessment
- information you gleaned from the patient’s medical records
- your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
- your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
- your clinical rationale for why the off-label medication is in the patient’s best interest.
Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.4 Overall, the goal of documentation should be to support the adequate continuing care of our patients.
1. US Food and Drug Administration. Understanding unapproved use of approved drugs “off label.” https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label. Updated February 5, 2018. Accessed August 6, 2020.
2. Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLoS One. 2018;13(7):e0198363. doi: 10.1371/journal.pone.0198363.
3. McLeer S, Mawhinney J; Council on Healthcare Systems and Financing. Position statement on off-label treatments. American Psychiatric Association. https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-2016-Off-Label-Treatment.pdf. Published July 2016. Accessed August 6, 2020.
4. Funicelli A. What to consider when prescribing off-label. Psychiatric News. 2019;54(14):12.
1. US Food and Drug Administration. Understanding unapproved use of approved drugs “off label.” https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label. Updated February 5, 2018. Accessed August 6, 2020.
2. Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLoS One. 2018;13(7):e0198363. doi: 10.1371/journal.pone.0198363.
3. McLeer S, Mawhinney J; Council on Healthcare Systems and Financing. Position statement on off-label treatments. American Psychiatric Association. https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-2016-Off-Label-Treatment.pdf. Published July 2016. Accessed August 6, 2020.
4. Funicelli A. What to consider when prescribing off-label. Psychiatric News. 2019;54(14):12.
