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Responses to drug shortages in the United States are broadly heterogeneous

• On average, U.S. shortages are associated with modest decreases in U.S. volume (about 8 percent) and modest increases in U.S. prices (about 7 percent). The volume reduction was relatively larger for shortages included in both the FDA and ASHP databases.
• Few of these U.S.-focused results aligned with measured changes over the same intervals in comparison countries, even when the analysis was limited to shortages with the largest impacts on U.S. markets.

There is limited evidence that U.S. shortages are associated with volume and price changes in other countries

• There was some evidence that U.S. shortages are associated with declines in volume in certain countries, such as France and Australia, but not in other countries. Overall, the geographic scope of most U.S. shortages appears to be domestic, even if there is a small number of shortages that play out on a broader global scale.
• There were occasional and tenuous relationships between U.S. shortage events and changes in outcomes in other countries. Although a small number of "major" U.S. shortages and case studies did appear to play out on a global scale, most shortages in U.S. databases did not.
• Even when the same drugs were in shortage in the United States and in other countries, there was often a considerable temporal gap between shortage events.

Drug shortages, which occur when the supply of drugs does not meet the demand, are a persistent policy and public health concern in the United States and in other countries. Shortages can adversely affect the quality and safety of care provided to patients, and they have implications for morbidity and mortality. Although there is broad international agreement about the importance of mitigating or preventing drug shortages, approaches to defining and tracking them remain fragmented. As a result, the extent to which drug shortages are truly global in nature is often unclear. The authors of this report contribute to the developing literature on the global scope of drug shortages by assessing whether U.S. drug shortages result in (1) measurable changes in U.S. volume, price, and other metrics, and (2) measurable changes in the same outcomes in other countries.

The authors combined information from two U.S. drug shortage databases, one from the Food and Drug Administration (FDA) and the other from the American Society of Health-System Pharmacists (ASHP). The authors also used international prescription drug market data from IQVIA's MIDAS database. They found that most U.S. shortages appear to be domestic in scope. The most-severe U.S. shortages, measured by decreases in volume, only occasionally affected other countries in the same way. Although it is important to keep the global perspective in mind when addressing drug shortages, regulators, other policymakers, and the entire health care system should explore ways to leverage the supply of drugs in other countries in response to U.S. shortages.

• Chapter One

  Introduction

• Chapter Two

  Drug Shortage Conceptual Framework

• Chapter Three

  Data and Empirical Methods

• Chapter Four

  Results

• Chapter Five

  Discussion and Conclusion

• Appendix A

  Overview of Drug Shortage Definitions and Databases

• Appendix B

  Illustrative Drug Shortage Examples

• Appendix C

  Antimicrobial and Immune Globulin Data and Methods

• Appendix D

  Supplemental Results

• Appendix E

  Results for Antimicrobial Drugs

• Appendix F

  Full Results for Immune Globulin Products