Drug Shortages Loom Large

In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages (132 of the 178 that occurred in 2010) were sterile injectables, including cancer medications and anesthetics. Nearly all of those drugs are considered medically necessary, meaning they are used to treat or prevent a serious disease or medical condition, and there is no other source or alternative drug available. The human toll of the drug shortages was highlighted in a recent New York Times article, in which patients undergoing cancer treatment were interviewed who were denied or were unsure of the supply of potentially life-saving medications.

According to FDA, there were numerous reasons for the shortages. Valerie Jensen, associate director of CDER’s Drug Shortage Program, says on FDA’s website, “Several different factors are contributing to the current shortage of sterile injectables and other drugs. Some firms decided to discontinue making their products for business reasons, others had problems with their raw materials suppliers, some had quality and manufacturing problems, and some were hit with an increased demand.”

Generic drugs made up a large proportion of the drugs in short supply, particularly older sterile injectables. The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement in response, acknowledging the importance that generics play in the global drug supply, and urging its members to cooperate with regulatory agencies to avoid such shortages. Vice-president of PhRMA, Karl Uhlendorf, said in the statement, “Drug shortages of any kind are a complex problem that requires broad-based solutions from all stakeholders-including innovative biopharmaceutical research companies and generic manufacturers, whose products accounted for nearly 80% of prescriptions filled last year. Regardless of the cause, in order to provide patients with uninterrupted access to medicines, it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines. PhRMA member companies accomplish that by our commitment to maintaining good manufacturing practices and working closely and collaboratively with the FDA, supply chain partners and providers when unexpected-and rare-shortages occur.”

Such shortages can have important public health consequences. For instance, the World Health Organization was forced to delist three vaccines manufactured by Panacea Biotec because of quality issues. According to WHO, “Specifically, deficiencies in the quality management system found at the Lalru site relate to the manufacture of the haemophilus influenzae type b (Hib) and hepatitis B bulks used for the formulation of the DTwP-Hep B-Hib, DTwP-Hep B, and hepatitis B vaccines.” Moreover, Health Canada warned healthcare professionals to expect shortages because it has banned the import of several drugs manufactured at Boehringer-Ingelheim’s contract manufacturing plant Ben Venue, again, because of quality issues.

See related Pharm Tech articles:

“Safety Concerns and Shortages Challenge Pharma” Pharm. Technol. 35 (6) 28–31 (2011).

Senator to Draft Legislation to Mitigate Drug Shortages (ePT)

Drug Shortages Rise, but No Requirement to Report Them (Pharm Tech Talk)