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Formulary decisions for pre-1938 medications
Colleen M Culley1, Beth Ann Carroll, Susan J Skledar
1Drug Use and Disease State Management Program, Department of Pharmacy and Therapeutics, University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA 15213, USA. culleycm@upmc.edu
Summary
This study developed a process for reviewing older drugs to ensure they meet current Food and Drug Administration (FDA) approval standards for safety and efficacy, leading to successful formulary revisions.
Area of Science:
- Pharmaceutical Sciences
- Health Policy and Management
Background:
- The Food and Drug Administration (FDA) initiative requires all marketed drugs to have approved safety and efficacy.
- Many pre-1938 drugs lack formal FDA approval, posing potential safety and efficacy concerns.
Observation:
- A systematic review identified 88 pre-1938 drug formulations. Of these, only 17 had received FDA approval.
- 47 of the reviewed formulations were already on the hospital formulary.
Findings:
- The review recommended retaining or adding 37 formulations to the formulary, while 51 were recommended for nonformulary status.
- Recommendations prioritized products with recent hospital use, lack of alternatives, or FDA approval.
Implications:
- The formulary revision process successfully addressed safety concerns associated with older drug formulations.
- Hospital pharmacy and therapeutics committees accepted recommendations, emphasizing ongoing review of nonapproved formulations.
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