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Designing a Strategy to Promote Safe, Innovative Off-Label Use of Medications

Carl Sirio, MD

Critical Care Medicine in Medicine, and Pharmacy & Therapeutics, University of Pittsburgh Schools of Medicine and Pharmacy

Thomas Smitherman, MD

Division of Cardiology, University of Pittsburgh School of Medicine

Bethany Fedutes-Henderson, PharmD

Medication Therapy Management Service, Rite Aid Pharmacy

Susan Skledar, RPh, MPH

Department of Pharmacy & Therapeutics, University of Pittsburgh School of Pharmacy

Robert J. Weber, MS

Department of Pharmacy & Therapeutics, University of Pittsburgh School of Pharmacy

Nathalie Zgheib, MD

Clinical Pharmacology, University of Pittsburgh School of Medicine

Robert Branch, MD

Center for Clinical Pharmacology, University of Pittsburgh School of Medicine

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.

Key Words: off-label • patient safety • formulary • Pharmacy & Therapeutics Committee

American Journal of Medical Quality, Vol. 21, No. 4, 255-261 (2006)
DOI: 10.1177/1062860606289020


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