This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Ansani, N. Articles by Sirio, C. Search for Related Content PubMed PubMed Citation Articles by Ansani, N. Articles by Sirio, C. Social Bookmarking                         What's this?

United States Medical Practice Summary

Innovative Off-Label Medication Use

Robert Branch, MD

Center for Clinical Pharmacology, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Bethany Fedutes-Henderson, PharmD

clinical manager, medication therapy management service, Rite Aid Pharmacy, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Thomas Smitherman, MD

Division of Cardiology, Department of Internal Medicine, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Robert J. Weber, MS

Department of Pharmacy and Therapeutics, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Susan Skledar, RPh, MPH

Department of Pharmacy and Therapeutics, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Nathalie Zgheib, MD

Center for Clinical Pharmacology, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

Carl Sirio, MD

Department of Critical Care Medicine, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, Pennsylvania.

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.

Key Words: off-label • innovative off-label • drug use • medication use • medication safety

American Journal of Medical Quality, Vol. 21, No. 4, 246-254 (2006)
DOI: 10.1177/1062860606288346


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				R. Dresser and J. Frader Off-label prescribing: a call for heightened professional and government oversight. J. Law Med. Ethics, September 1, 2009; 37(3): 476 - 486. [PDF]