September 30, 2011 — Sterile injectables such as anesthetics, antibiotics, and cancer medications are at the heart of the nation's drug-shortage crisis, and poor quality largely explains why they are hard to find, an official with the US Food and Drug Administration (FDA) said today.
In 2010, sterile injectables constituted 74% of the 178 drugs deemed to be in short supply by the FDA, said Valerie Jensen, RPh, associate director of the Drug Shortage Program in the FDA's Center for Drug Evaluation and Research, in a Webinar today. So far for 2011 the number of drugs in short supply is about 200, according to Dr. Jensen.
In 2010, product quality and manufacturing issues such as glass and metal particulates, impurities, and bacterial and mold contamination accounted for 54% of sterile injectables in short supply, according to Dr. Jensen. Such problems kept the drugs off the market. Another 21% of the shortages stemmed from manufacturing delays and capacity limits, and 11% was caused by companies choosing to discontinue production.
A number of factors conspire to make many injectables unavailable, Dr. Jensen said. Mergers and acquisitions in the pharmaceutical industry, for example, have reduced the number of companies that make the drugs.
"There's not enough backup capacity," she said. "If one company has a [manufacturing] problem, there may be only one or 2 others making the drug. It's really hard for the other companies to ramp up quickly."
Other companies have dropped older — and generic — sterile injectables from their line-up because of slim profit margins. A vial of propofol, 20 mL, sells for $0.48, for example.
The deepening drug shortage takes an especially heavy toll in oncology, where the lack of anticancer drugs such as cytarabine can become a matter of life or death, experts say. A recent survey by the American Hospital Association showed that drug shortages always or frequently delay patient care at 20% of the nation's hospitals, and patients often receive a less effective medication at 11%.
Physicians Encouraged to Report Shortages
The FDA is not standing by idly in the midst of the drug-shortage crisis, said Dr. Jensen. To be sure, the agency possesses limited authority in this matter.
"We can't tell a manufacturer how much to produce," she said.
Still, the agency is taking steps to address the problem, some of which help drug makers boost production. The agency can expedite review of new manufacturing sites, new suppliers of raw materials, or changes in specifications. It has helped some companies salvage injectables containing particulates by letting them be distributed with filters. In rare cases, Dr. Jensen said, the FDA will allow foreign versions of a scarce product with the same active ingredient into the country.
The FDA is encouraging manufacturers to warn the agency about shortages in the making so it can take steps to prevent them. Dr. Jensen said such early notification allowed the FDA to avoid 38 shortages in 2010 and 99 so far in 2011.
The FDA wants hospitals, physicians, and pharmacists to notify the agency about empty medicine cabinets as well, said Dr. Jensen. Such reports often give the agency its first clue as to what is happening.
Healthcare providers can report a scarce drug to the FDA by email at email@example.com. More information about the drug-shortage crisis is available at the agency's Web site.
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Cite this: Sterile Injectables Account for Most of Drug Shortage - Medscape - Sep 30, 2011.