Addressing innovative off-label medication use at an academic medical center
| Autor: | Thomas Smitherman, Shelby Corman, Susan J. Skledar |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Decision Making Alternative medicine Off-label use law.invention Nursing Randomized controlled trial law medicine Humans Practice Patterns Physicians' Formulary Pharmacy and Therapeutics Committee Pharmacy and Therapeutics Pharmacology Academic Medical Centers Medication use Evidence-Based Medicine Formulary Status business.industry Health Policy Off-Label Use medicine.disease Organizational Policy Practice Guidelines as Topic Medical emergency Pharmacy Service Hospital business Algorithms |
| Zdroj: | American Journal of Health-System Pharmacy. 72:469-477 |
| ISSN: | 1535-2900 1079-2082 |
| Popis: | Purpose A large hospital’s systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described. Summary 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. Conclusion The UPMC–Presbyterian experience indicates that off-label medication use can be effectively managed using evidence-based principles and peer review mechanisms. |
| Databáze: | OpenAIRE |
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