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- W2085459562 abstract "A large hospital's systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described.In 2003 the University of Pittsburgh Medical Center (UPMC)-Presbyterian implemented a policy that created a formal process for the systematic evaluation of formulary requests and drug-utilization patterns indicating or suggesting off-label use. Explicit criteria were developed for differentiating innovative off-label use (i.e., use based on a reasonable rationale yet lacking definitive scientific support in the form of fully published randomized controlled trials) from medication use more appropriately classified as clinical research. The UPMC-Presbyterian policy also outlined a process for the development, implementation, and evaluation of guidelines on innovative off-label use, including the collection of efficacy and safety outcomes. As of October 2012, 31 proposals for off-label medication use had been evaluated by the medical center's pharmacy and therapeutics committee and formulary subcommittee. Thirteen requests resulted in a determination of innovative off-label use and the development of prescribing guidelines, and 10 prompted the extension of an agent's current formulary status; in 6 cases, proposed off-label uses were determined to constitute clinical research. In some instances, innovative off-label medication use generated safety and outcomes data that led to changes in local standards of care. An algorithm to guide decision-making with regard to requests and proposals for off-label medication use is provided.The UPMC-Presbyterian experience indicates that off-label medication use can be effectively managed using evidence-based principles and peer review mechanisms." @default.
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- W2085459562 date "2015-03-15" @default.
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- W2085459562 title "Addressing innovative off-label medication use at an academic medical center" @default.
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- W2085459562 doi "https://doi.org/10.2146/ajhp140306" @default.
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