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Impact of Drug Shortages on Patients in the United States: A Case Study of Three Drugs

Publication Date
Office of the Assistant Secretary for Planning and Evaluation and NORC at the University of Chicago

Drug shortages are a persistent problem that can cause substantial disruption in patient treatment regimens and adversely impact a patient’s health. Drug shortages can have severe consequences for patients, including high costs, delayed care, and potential medication errors or unintended side effects when using alternative or unfamiliar drugs.

This report examines three drugs, asparaginase, nelarabine and heparin, used to treat life-threatening conditions and that went into shortage between 2016 and 2020. It presents trends in utilization and cost of the drugs and their alternatives before and after the shortage began. This study was based on analysis of IQVIA Medical Claims (Dx) data for 2016-2020, and the U.S. Food and Drug Administration List of Drug Shortages downloaded in March 2020. The Dx data included pre-adjudicated all-payer claims generated by office-based physicians and specialists. The report presents the trends in the total units administered and cost, as measured by service charge, for each drug. It also presents results for demographic characteristics, such as age, gender, and race/ ethnicity, and explored whether patients switched to substitute drugs during the shortage, dropped the medication, or maintained the drug with a change in the service charge.

Use of the drug in shortage and its substitutes appears to depend not just on the reason of the shortage (increase in demand vs manufacturing delay), but also on the number of manufacturers and substitutes available, and the effectiveness of the alternative drug relative to the drug in shortage. The analysis also showed that the duration of these shortages can be long-lasting, with some shortages lasting almost five years. The results suggest that larger studies that include more drugs and more data are needed to better understand the underlying dynamics and characteristics of shortages and their impacts.

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