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

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.