The Scoop on Drug Shortages

Jan 01, 2013

A new feature on the pharma landscape is the shortfall in the supply of many medicines essential to the treatment of major health disorders, including cancer, heart disease, and stroke. The problem has festered largely undetected for years, but is gaining fresh momentum as a consequence of medical need, globalization, changes to manufacturing practice, and the exit of some companies from certain low margin segments of the business. Price controls have even been cited by some analysts as a driver behind the interruption of many maintenance therapies needed to help patients keep their conditions under control. To help readers separate truth from fiction, Pharm Exec asked the Tufts Center for the Study of Drug Development (TCSDD) to summarize new survey research—partly commissioned by a grant from Amgen—that documents the scope of the threat and identifies the structural roots of the shortages. In a larger sense, the study underscores how effective management of the drug supply chain is emerging as something much more than an engineering feat: instead it's a societal obligation, one that the industry is going to be measured on in return for that all-important license to operate. This is particularly evident for the generics side of the business, which accounts for the majority of drug shortages tallied to date. —William Looney, Editor-in-Chief

Drug shortages are a global challenge, not only for treatments in oncology but also anti-infectives and drugs that treat the central nervous system and cardiovascular diseases. Of particular note is the shortage of sterile injectable drugs used to treat cancer-related illnesses, anesthetics for surgery, emergency medical interventions, and electrolytes for intravenous feeding. The numbers behind the story are significant: drug shortages in the United States alone tripled in the brief five-year period between 2005 and 2010.

Although the latest reports by the Food and Drug Administration (FDA) have indicated fewer drug shortages in 2012 compared to 2011, there is nevertheless a tremendous residual effect on stakeholders in the supply chain and, more importantly, on patients. The FDA and other government and regulatory agencies worldwide are focusing on resolving drug shortages. Our research seeks to analyze the characteristics of drug shortages and their impact, with the ultimate aim of assisting regulators and other stakeholders to resolve the problem.

Study protocol

Tufts CSDD developed a two-part methodology that entailed building a database of current drug shortages and conducting interviews with experienced hospital pharmacists to gather firsthand knowledge of how drug shortages are managed and the challenges that they pose. Tufts CSDD staff gathered publicly available data on 240 drug shortages occurring between 2001 and February 2012, from lists maintained by the American Society of Health-System Pharmacists (ASHP) and the FDA. Data on therapeutic area, drug classification, molecule type, disease state, and the overall duration of the shortage for each drug was collected and analyzed. Tufts CSDD research staff coded the root cause of each drug shortage and summarized these causes by major grouping. Drug shortages that were resolved during this study were also included and reviewed for insights. We examined primary and secondary sources of research on this topic to provide context and clarification into the data collection process. Lastly, we assessed the economic cost and effects of drug shortages through interviews with hospital pharmacists.

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