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.
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.