Medicolegal Issues

Why off-label isn’t off base

Author and Disclosure Information

You don’t bring greater liability upon yourself in a malpractice suit just because the case includes your off-label Rx


 

References

This article is adapted from the February 2009 issue of Current Psychiatry, a Quadrant HealthCom Inc. publication.

The author reports no financial relationships relevant to this article.

CASE

A physician speaking with a colleague expressed his anxiety and uncertainty over off-label prescribing:

“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?”

This physician wants to know how he can minimize malpractice risk when prescribing a medication off label. He 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, I hope, help you avoid the medicolegal pitfalls of off-label prescribing.

4 reasons why off-label prescribing can be controversial

Limited testing for safety and effectiveness. Experiences such as the fen-phen (weight loss) controversy1 and estrogens for preventing vascular disease in postmenopausal women2 remind physicians that some untested treatments may do more harm than good.

Commercial influence. Pharmaceutical companies have used advisory boards, consultant meetings, and continuing medical education events to promote unproven off-label indications for drugs.3,4 Many studies that were, ostensibly, designed and proposed by researchers show evidence of so-called ghost authorship by commercial concerns.5

Study bias. Even peer-reviewed, double-blind studies that are published in the medical literature might not sufficiently support off-label prescribing practices because sponsors of such studies can structure them or use statistical analyses to make results look favorable. Former editors of the British Medical Journal and The Lancet have acknowledged that their publications unwittingly served as “an extension of the marketing arm” or “laundering operations” for drug manufacturers.6,7 Even for FDA-approved indications, a selective, positive-result publication bias and nonreporting of negative results may make drugs seem more effective than the full range of studies would justify.8

Legal use of labeling. Although off-label prescribing is accepted medical practice, doctors “may be found negligent if their decision to use a drug off label is sufficiently careless, imprudent, or unprofessional.”9 During a malpractice lawsuit, plaintiff’s counsel could try to use FDA-approved labeling or prescribing information to establish a presumptive standard of care. Such evidence usually is admissible if it is supported by expert testimony. The burden of proof is then placed on the defendant physician to show how an off-label use met the standard of care.10

References

1. Connolly H, Crary J, McGoon M, et al. Vascular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:581-588.

2. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA. 2004;291:1701-1712.

3. Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007;4(9):e286.-

4. Steinman MA, Bero L, Chren M, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145:284-293.

5. Gøtzsche PC, Hróbjartsson A, Johansen H, et al. Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007;4(1):e19.-

6. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005;2(5):e138.-

7. Horton R. The dawn of McScience. New York Rev Books. 2004;51(4):7-9.

8. Turner EH, Matthews A, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358:252-260.

9. Richardson v Miller. 44 SW3d 1 (Tenn Ct App 2000).

10. Henry V. Off-label prescribing. Legal implications. J Leg Med. 1999;20:365-383.

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. An example is sildenafil [Viagra] for women who have antidepressant-induced sexual dysfunction.1

Other examples are prescribing a drug:

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

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