As many as 180 medications are in short supply so far this year, according to data from the the Drug Information Service (DIS) at University of Utah Health Care, which has tracked drug shortages for a decade. DIS calls the number of shortages this year “unprecedented.”
Across the United States, life-saving or medically necessary drugs are in short supply, endangering care and increasing the odds of medication mistakes for a broad swath of patients. Health officials say drug shortages pose a growing public health crisis, fueled in large part by financial motives of pharmaceutical companies concerned about falling profits due to competition from low-cost generic products.
According to figures compiled by DIS, there has been a significant increase in the number of drug shortages since 2005, when 74 drug shortages were recorded across the U.S. By 2009, the number had more than doubled to 166. And as of Sept. 10 this year, it had logged 150 new shortages – in addition to 30 drug shortages still unresolved and more being reported every week.
This year, shortages have been reported for commonly used drugs such as morphine for pain relief, propofol for sedation and Bactrim injections for infections. The problem has reached such a peak that four leading groups representing cancer doctors, anesthesiologists, pharmacists and safety advocates have convened an invitation-only meeting in Bethesda, Md., on Nov. 5 and have asked pharmaceutical companies and supply-chain representatives to join them in efforts to solve the shortage problems.
According to Valerie Jensen, associate director of the Food and Drug Administration’s drug shortage program, about 40% of the shortages are caused by manufacturing problems, including safety issues, 20% are caused by firms ceasing production of a drug and another 20% are due to production delays. Shortages also may arise due to raw material shortages, increased demand, site issues and problems with parts such as syringes or vials.
The FDA can’t force drug manufacturers to address the problem because it lacks authority to compel them to continue producing a certain drug, or to require them to make a drug that’s in short supply. Nor are companies required to inform the FDA about impending shortages unless there is no alternative for the drug in question, and even then, there are no sanctions for not informing the FDA.
For FDA information about drug shortages, go here.