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Abstract

Shortages of drugs, vaccines, and other biologics are a perennial problem of the U.S. health care system. The objectives of this study were to assess the prevalence of these shortages of drugs, vaccines, and other biologics, and to characterize the products in short supply as reported in the United States by several public agencies and private organizations on June 1, 2011. Reported shortages of pharmaceuticals were obtained from the FDA, the CDC, the American Society of Health-System Pharmacists (ASHP), and the Brigham and Women’s Hospital (BWH). A list of approved drugs and licensed vaccines and other biologic products were obtained from the FDA. The units of analyses were the active ingredient(s) and the route of administration. The study included descriptive analyses of the characteristics of products experiencing shortages and an estimation of the prevalence of shortages as the proportion of non-discontinued FDA-approved products that were listed by the FDA in June 1, 2011. The most frequent characteristics of shortages included: reported by ASHP, referred to a drug approved under the NDA/ANDA system, contained only one active ingredient, was a drug administered by injection, required a prescription, was part of one of six main therapeutic classes, and was marketed by three or less companies. The overall prevalence of drug shortages was estimated at 11.0% of all the FDA-approved and marketed drugs, vaccines, and other biologics. Vaccines had the highest prevalence of shortage. The prevalence varied from 9.9% reported by the ASHP to 4.0% reported by public agencies and to 2.0% reported by BWH. Differences in the reporting of shortages can be attributed to variations in defining shortages and how they were characterized within each reporting organization. The highest prevalence rate was found among active ingredients with injection routes of administration (23.1%). Shortages are prevalent in the U.S. health care system. Several definitions of shortage are currently in use in the United States. Additional research is needed to develop a standard definition for a pharmaceutical shortage and to standardize the criteria used to characterize a pharmaceutical shortage.

Keywords

Pharmaceutical supply drug shortages drug discontinuations FDA

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The prevalence of pharmaceutical shortages in the United States

Abstract

Keywords

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