Perhaps it is a bit ironic, but just when new drug approvals by the Food and Drug Administration (FDA) hit a 7-year high, we seem to be battling record numbers of medication shortages.
The irony isn’t lost on U.S. Reps. John Carney (D-DE) and Larry Bucshon (R-IN), who this week introduced the Drug Shortage Prevention Act.
An excerpt from the announcement reads:
The legislation mandates expedited review of drugs vulnerable to the shortage in order to prevent shortages in the first place, and it requires FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The bill also streamlines communications between FDA, manufacturers, distributors, providers, and patients to ensure that all parties have the information they need to act proactively—instead of reactively—to prevent shortages from occurring.
While we await the ultimate fate of the Drug Shortage Prevention Act, it’s important to stay abreast of the current situation.
A recent report by the University of Utah Drug Information Service revealed that 267 medications were subject to shortages in 2011, 56 more than in 2010.
The news could have been worse—the FDA took steps in 2011 to prevent some supply shortfalls by requiring manufacturers to report potential shortages in advance to the FDA. According to the University of Utah, the FDA’s actions may have prevented up to 100 additional shortages.
A recent shortage that gained significant media coverage was the Gaucher disease medication imiglucerase (Cerezyme). Genzyme’s key plant producing this agent was closed for viral decontamination in 2009, and Cerezyme had only been removed from the FDA’s list of medication supply problems in 2010 before being replaced on the list in September 2011.
Of all of the medications listed on the FDA’s Drug Shortage List (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
), it seems sterile injectable products have been hardest hit.
According to an interview with the Associated Press
, Erin Fox, PharmD, Director of the University’s Drug Information Service, the supply issues are caused by the need for manufacturers to shut down key production plants because of quality control problems. Additionally, consolidation of the generic drug industry has resulted in fewer manufacturers producing generic versions of similar products. The revenue generated by these medications may not be enough to retain manufacturers’ interest in expending resources on their production.
Hospitals have been greatly affected by the shortage. Dr. Fox points out that current shortages in sedatives like diazepam, midazolam, lorazepam, often used in surgery, along with shortages of the pain medication fentanyl, have created strain across the numerous departments within hospitals. Metronidazole, the mainstay of treatment for Clostridium difficile
infection, is also on the shortage list.
The number of drugs on the shortage list has increased each of the last 5 years. In 2005, there were 61 drug shortages; in 2010 that number spiked to 178, according to Reps. Carney and Bucshon.
These shortages have disrupted chemotherapy regimens for cancer, surgical care, and infectious disease and pain management. Fortunately, suitable and available alternatives exist for a great many of these at-risk medications. But the bigger problem still looms as we await the fate of the Drug Shortage and Prevention Act.