Duke-Margolis Issues Framework to Address Persistent Drug Shortages

Duke-Margolis Issues Framework to Address Persistent Drug Shortages


September 7, 2023
Advancing Federal Coordination to Address Drug Shortages

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EMBARGOED FOR RELEASE: 12:01 am ET, Thursday, September 7, 2023


Duke-Margolis Issues Framework to Address Persistent Drug Shortages

Recommends Establishing Prevent Drug Shortages Initiative

as Federal Coordinating Entity


Washington, DC—A crisis in the drug supply chain is causing shortages of life-saving and life-sustaining medications in the American health care system. The impact on patients from drug shortages, including increased mortality rates, medication errors, rationing of treatment for cancer patients, and additional hospital costs, is broad and far-reaching. A new Duke-Margolis white paper, “Advancing Federal Coordination to Address Drug Shortages,” details the root causes of drug shortages in the U.S., highlights federal government efforts to prevent and mitigate drug shortages, and identifies opportunities for coordinated public and private actions to achieve more reliable supplies of critical drugs that are too often in shortage. Duke-Margolis’ recommendations and analysis in the white paper were informed by the collective expertise of the members of its new Drug Supply Chain Resilience and Advanced Manufacturing Consortium.


Manufacturing quality issues is the leading direct cause of drug shortages, but gaps in manufacturing quality in turn reflect challenges in purchasing from reliable suppliers. “Drug payment policies and a limited ability of health care organizations to identify and purchase from reliable suppliers means purchasers choose manufacturers largely based on lowest short-term price, which creates adverse market incentives for manufacturers to keep costs down even at the expense of needed investments in supply chain reliability,” said Stephen Colvill, Duke-Margolis assistant research director and lead author of this report. “Generic manufacturers are particularly impacted due to slim profit margins and limited incentives to invest in their supply chains. Collective short-term and sustained action through a new cross-cutting Prevent Drug Shortages Initiative is needed to prevent continued severe impact on patient care from drug shortages.”


While the federal government and some innovative manufacturers and health care organizations have taken notable steps toward reducing the frequency and severity of drug shortages, further actions are needed to make our markets for critical generic drugs more reliable,” said Mark McClellan, director of Duke-Margolis. “Most drugs that experience frequent shortages are relatively inexpensive products so that a set of well-designed, coordinated steps could achieve a reliable supply with only limited incremental manufacturing costs—and substantial health benefits and cost savings from fewer complications for the patients that need them.”


The Duke-Margolis white paper’s overall recommendation notes that “while existing governmental, private sector, and non-profit efforts have made progress toward reducing drug shortages, further strategic planning and coordination are still needed to substantially reduce the risk of shortages of many essential medicines, particularly inexpensive generic medications that are complex to manufacture. Therefore, we propose the establishment of a new coordinating initiative, the Prevent Drug Shortages (PDS) Initiative, with requisite authorities and funding to lead a cross-cutting effort to improve drug supply chain reliability, including measurable reductions in the frequency and severity of shortages of critical drugs, that brings together relevant federal agencies and private-sector entities, establishes SMART goals, identifies accountable parties for implementation, and continuously identifies gaps and improvements.”


About Duke-Margolis


The mission of the Robert J. Margolis, MD, Center for Health Policy at Duke University is to improve health, health equity, and the value of health care through practical, innovative, and evidence-based policy solutions. For more information, visit healthpolicy.duke.edu and follow us on Twitter @DukeMargolis.


Contact:  Patricia Green