Healthy Skepticism Library item: 6131

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Ansani N, Branch R, Fedutes-Henderson B, Smitherman T, Weber RJ, Skledar S, Zgheib N, Sirio C.
United States medical practice summary: innovative off-label medication use.
Am J Med Qual 2006 Jul-Aug 01; 21:(4):246-54
http://ajm.sagepub.com/cgi/reprint/21/4/246

Abstract:

Data are limited regarding how academic medical centers (AMCs) deal with medication use that represents a departure from product labeling; has reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns; yet is not clinical research (defined as innovative off-label medication use). This report describes national trends in management of innovative off-label medication use. A cross-sectional survey of US AMCs was conducted. Survey questionnaires were directed to drug information centers or pharmacy directors. Of 469 AMCs contacted, 104 responded (22%). Fifty-nine AMCs identified innovative off-label use as a challenge. Only 18 AMCs developed strategies to address this issue: 12 requiring initial reviews and 8 requiring clinical monitoring. Sixty-five AMCs indicated interest in data sharing of clinical outcomes for innovative off-label protocol(s). Innovative off-label medication use is a widely recognized challenge; however, few prospectively active AMC responses exist. The authors suggest development of systematic structured approaches within and across AMCs.

Keywords:
Cross-Sectional Studies Drug Labeling* Drug Therapy/trends* Humans Pharmaceutical Preparations* Pharmaceutical Services Practice Management, Medical United States