Off-label prescribing: 7 steps for safer, more effective treatment
Consider risks and benefits for your patient and yourself before grabbing the prescription pad.
Have you noticed two curious patterns in off-label prescribing? Psychiatrists avoid agents approved for treating insomnia but prescribe anticonvulsants for a variety of unapproved uses.
Most of us prescribe medications for therapeutic uses not found in FDA-approved labeling. Among 200 psychiatrists surveyed, 65% said they had prescribed off label in the previous month, and only 4% had ever received a patient complaint about the practice.Malpractice Verdicts).
Private insurance. Psychotropic costs are rising 20% a year, contributing to the nation’s annual 13% overall prescription drug cost increase.15 To control rising costs, some medical insurance plans consider off-label use as “unapproved and experimental” and deny coverage. Pharmacy benefit and self-insured employer plans may act similarly, although some states require insurers to cover off-label use of all approved edications.
Government programs. Medicaid does not exclude coverage of off-label prescriptions. How the new Medicare prescription drug plan (Part D) handles off-label prescribing remains unclear.
Why psychiatrists prescribe off-label
|Patient has a disorder for which no drug is labeled|
|Patient falls outside of labeled age or demographic group, such as children, older patients, and pregnant women|
|Patient fails to respond to labeled products|
|Off-label product may potentiate response to a labeled agent or minimize its adverse effects|
|Manufacturers and respected peers promote use of off-label products as first- or second-line agents18|
|Practitioner wishes to foster innovative treatments|
|Patients or families request an off-label drug instead of labeled alternatives|
|Practitioner avoids using a particular labeled drug or drug class|
Most state medical practice laws spell out the information required in the patient chart to demonstrate informed consent, defined variously as:
- what a reasonable provider would tell a patient
- what a reasonable patient would expect to hear from the provider
- what a patient would need to hear before deciding on a treatment course.
What the law says
Off-label prescribing is legal, common, necessary, and recognized in some states by statute and by U.S. Supreme Court review.
Court decisions. In a class action suit before the top court (Buckman Company vs. Plaintiff’s Legal Commission, 2001), 5,000 plaintiffs claimed damages from orthopedic screws and plates that were FDA-approved for use in long bones but not for use in the spine. A unanimous court held that such off-label use is an accepted and necessary offshoot of FDA regulatory function and does not interfere with the practice of medicine.
The courts also have determined that off-label use does not mean “experimental” and itself is not a risk. Off-label use may be consistent with the standard of care and does not categorically indicate negligence (though a practitioner who prescribes negligently—such as prescribing a drug to which a patient is known to be allergic—may be found liable).
Drug manufacturers’ risk. The courts recognize that patients receive prescription drugs from doctors, not directly from the manufacturers. The law thus provides some immunity to manufacturers if your patient is injured by a drug you prescribe off-label. The learned-intermediary rule says anufacturers must warn you adequately of a drug’s foreseeable risks, and you then assume the responsibility to warn the patient.
The courts recognize exceptions, though, and have required manufacturers to warn patients directly about vaccines given in mass immunizations, drugs withdrawn from the market, drugs advertised directly to consumers, and other risks.
- BMJ Publishing Group. Clinical evidence. Summary of what is known—and not known—about more than 200 medical disorders and 2,000 treatments. www.clinicalevidence.com.
- Cochrane Library of evidence-based clinical reviews. www.cochrane.org.
- Agency for Health Care Research and Quality. Draft comparative effectiveness review of off-label use of atypical antipsychotic drugs. effectivehealthcare.ahrq.gov/synthesize/reports/draft.cfm.
- Amitriptyline • Elavil, others
- Carbamazepine • Carbetrol; Epitol; Equetro; Tegretol
- Gabapentin • Gabarone; Neurontin
- Lamotrigine • Lamictal
- Trazodone • Desyrel; Trialodine
- Valproate • Depakote; Depakene
Dr. Kramer reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.
Dr. McCall receives research support from GlaxoSmithKline, Sanofi-Aventis, Sepracor, Takeda, and Wyeth, is an advisor to King Pharmaceuticals and Sepracor, and is a speaker for GlaxoSmtihKline, Sepracor, and Wyeth.
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