OFF-LABEL PRESCRIBING

November 1, 2006

Most psychiatrists and other physicians routinely prescribe medication for off-label use. This article focuses on how to minimize patient harm from off-label therapies and how to protect oneself from legal problems that may arise from off-label prescribing.

Kramer SI, McCall WV. Off-label prescribing: 7 steps for safer, more effective treatment. Curr Psychiatry. 2006;5(4):14-28.

Summary

Most psychiatrists and other physicians routinely prescribe medication for off-label use. This article focuses on how to minimize patient harm from off-label therapies and how to protect oneself from legal problems that may arise from off-label prescribing.

The authors suggest 7 steps that psychiatrists or other health care providers can use to reduce risk to both the patient and themselves when considering prescribing a medication for off-label use. These steps are:

1. Be familiar with evidence-based findings/guidelines.

2. Clarify your rationale for off-label prescription.

3. Obtain second-opinion consultation if indicated.

4. Perform risk-benefit analysis.

5. Obtain informed consent from patient or appropriate surrogate.

6. Document steps 1 through 5 in the patient's record.

7. Monitor for known and unexpected adverse events.

The off-label use of hypnotics, anticonvulsants, and other drugs, as well as the legalities of such prescribing, are also discussed.

Commentary

This is a very helpful account that appropriately reads like a legal "brief" on off-label prescribing--a topic that is of interest to every clinician. The 7 steps for safer, more effective off-label prescribing are intuitive and practical. If followed, these steps will probably protect the clinician in the event of a medicolegal situation.

What is not highlighted is how complex the evolution of medical evidence and practitioner prescribing practices have become. It is difficult for clinicians to stay current with the latest off-label use of a drug for various conditions and symptom management. In addition, as the article states, the adverse effect profile of a medication may differ depending on whether the drug is used as indicated or off-label. When a medication is used to manage conditions or symptoms other than those for which it is indicated, other factors, such as medical comorbidites and drug-drug interactions, may change the risk profile.

With high-profile legal cases against pharmaceutical companies getting more media coverage, there is increasing skepticism among the public about the role that drugs may play in disease management. Considering all these factors, off-label use may be a riskier practice these days.

Peter F. Buckley, MD
Professor and Chairman
Department of Psychiatry
Medical College of Georgia
Augusta