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September 23, 1974

Current Medical Practice and the Food and Drug Administration: Some Evidence for the Existing Gap

Author Affiliations

From the departments of medicine (Drs. Mazzullo, Weintraub, and Lasagna), pharmacology, and toxicology, School of Medicine and Dentistry, University of Rochester (NY).

JAMA. 1974;229(13):1744-1748. doi:10.1001/jama.1974.03230510018015

The manner of use of three prescription drugs for hospitalized patients (cephalexin, allopurinol, and propranolol hydrochloride) was compared with the labeling recommendations that are approved by the Food and Drug Administration (FDA). Each drug was prescribed frequently for therapeutic indications not mentioned in the approved labeling (cephalexin in 78.3% of cases, allopurinol in 57.1%, and propranolol in 64.7%). Thus, a gap has developed between current medical practice and FDA-approved recommendations for therapeutic use. We suggest that for cephalexin and allopurinol, the FDA-approved recommendations agreed with the current medical literature, and the prescribing habits of physicians were inappropriate. With propranolol, however, the FDA-approved recommendations were lagging behind both good medical practice and the current medical literature. The implications of these findings are discussed with respect to prescribing habits and drug regulation.

(JAMA 229:1744-1748, 1974)