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April 11, 2017

National Shortages of Generic Sterile Injectable Drugs: Norepinephrine as a Case Study of Potential Harm

Author Affiliations
  • 1Center for Pharmaceutical Policy and Prescribing (CP3), Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
  • 2Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • 3Associate Editor, JAMA
JAMA. 2017;317(14):1415-1417. doi:10.1001/jama.2017.2826

For decades, US physicians could assume that any approved drug they prescribed would be available. However, since the turn of the 21st century, the United States now regularly experiences national drug shortages, defined by the US Food and Drug Administration (FDA) as situations in which the “total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.”1 The most challenging year so far was 2011, with 251 drug shortages, of which 73% were generic sterile injectable drugs, including many medications required to treat sepsis, cancer, and other life-threatening conditions.2 One of these drugs was norepinephrine, recommended in international guidelines as the primary vasopressor for treatment of septic shock.3 In this issue of JAMA, Vail and colleagues4 report a study examining whether the 2011 norepinephrine shortage was associated with changes in care and outcome.