The U.S. has a drug shortage problem that refuses to go away. Though the FDA has gotten better at stopping new shortages in recent years, the total number of drugs in short supply remains stubbornly high.
The issue continues to frustrate patients who often have to travel hundreds of miles to secure needed meds. Doctors, meanwhile, are sometimes forced to ration treatments for serious illnesses among patients.
Why the hold-ups? Most experts point to manufacturing delays as the main culprit. Several factors continue to create contamination and then recall troubles such as inadequate equipment maintenance and aging processing plants. Manufacturers can also get stymied by the FDA’s lengthy approval process for new drugs, or dwindling supplies of raw or bulk materials needed to produce certain drugs.
The shrinking number of pharmaceutical companies in the U.S. also means there often isn’t great alternatives for drugs on the market.
But according to a 2011 study, manufacturing problems only accounted for 23 percent of drug shortages, while supply/demand issues were blamed for 13 percent. Around half of shortages were caused by “unknown” factors.
Here’s more on the issue, by the numbers.
265 = Approximate number of drugs in short supply in the U.S. In 2007, just 154 drugs were listed as being in short supply, and in 2012 the number reached 456.
74 percent = Increase in drug shortages over the last five years.
15 = Deaths blamed on drug shortages in 2011. The problem has affected a wide range of medications, from cancer, diabetes and Lyme disease treatments to antibiotics and painkillers.
18 million = Vials of generic ketorolac that were recalled in January due to contamination by crystal particles. Ketorolac, which is widely used in hospitals following surgery, is one of the many drugs in short supply that doctors say they don’t have great substitutes for.
3 = Pharmaceutical companies that were responsible for selling 71 percent of all injectable cancer drugs — which have been impacted by shortages — according to a Government Accountability Office report in 2008.
850,000 = Doses of cancer drug BCG the FDA has asked Merck to produce this year. A mold infestation at a manufacturing facility caused Sanofi to halt its production of BCG for two years, setting off a shortage that has affected thousands of patients. Merck is now rapidly stepping up its BCG production — it manufactured 700,000 doses last year, compared to 350,000 in 2011.
170 = Drugs shortages the FDA says it prevented in 2013. In 2012, the FDA launched new measures to stop shortages including a more rapid process for drug approvals. It also enacted new rules for manufacturers that require advanced notice of impending shortages.
12 = Average number of years it can take for a new drug to be approved in the U.S.
1 in 5,000 = Average number of drugs that survive all U.S. clinical trials and make it from invention to market.
