Healthy Skepticism Library item: 6130

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, Sirio C, Smitherman T, Fedutes-Henderson B, Skledar S, Weber RJ, Zgheib N, Branch R.
Designing a strategy to promote safe, innovative off-label use of medications.
Am J Med Qual 2006 Jul-Aug 01; 21:(4):255-61
http://ajm.sagepub.com/cgi/reprint/21/4/255

Abstract:

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors’ strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

Keywords:
Drug Labeling*/standards Humans Medication Errors/prevention & control Organizational Case Studies Pennsylvania Pharmaceutical Preparations* Program Development Quality Control Safety Management/organization & administration*