Research Questions Are drug shortages typically global in scope (i.e., affecting all countries simultaneously), or are they typically narrower in geographic scope despite occurring worldwide? Do U.S. drug shortages result in measurable changes in U.S. volume, price, and other metrics? Do U.S. drug shortages result in measurable changes in the same outcomes in other countries?
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.
Key Findings 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.
Recommendations Strategies that leverage supply from countries outside the United States might be a promising approach to address at least some U.S. drug shortages given expected shortage timelines and overlap between available foreign products and U.S. products in shortage. Considering the geographic scope of a shortage seems important to help regulators in individual countries and those with a broader perspective understand which policy tools and strategies have the greatest likelihood of success at mitigating the shortage. The evolution of shortages over time as it relates to geography should be considered, with a focus on how initial signals and effects in some markets might have downstream implications elsewhere. It is important that policymakers and researchers have access to better information about the root or proximal causes of shortages.
Table of Contents 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
Research conducted by RAND Health Care
This research was funded by the U.S. Department of Health and Human Services and carried out within the Payment, Cost, and Coverage Program in RAND Health Care.
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