WASHINGTON — The number of drug shortages reported annually has nearly tripled over the last five years, with much-needed drugs such as chemotherapy, anesthetics and electrolytes disproportionately affected.

FDA sometimes can mitigate or even prevent a shortage, but this requires extensive cooperation from manufacturers. In the event of a shortage, the federal government has little or no authority over the type or amount of drug the manufacturers produce. 

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Growing Trend of Drug Shortages

In 2005, 61 drug shortages were reported to FDA. By 2010, that number had grown to 178, with 132 of those involving sterile injectable drugs, despite that these drugs comprise a small percentage of the overall prescription drug market. According to FDA officials, this trend has continued into 2011, which will see an even greater number of drug shortages by year’s end. (Drug shortages have had a detrimental effect on VA healthcare. See sidebar, page xxx.)Testifying at a recent hearing held by the House Energy and Commerce Health Subcommittee, Howard Koh, MD, Assistant Secretary of Health, said, “These injectables include critical products such as oncology drugs, anesthetics, parenteral nutrition drugs and many drugs used in emergency rooms.”

Oncology drugs account for 28% of shortages, followed by antibiotics at 13%. During 2010 and 2011, 118 shortages (93% of the total) involved drugs classified as “medically-necessary,” and 41% were both medically necessary and sole source drugs, Koh said.

There is no single reason a drug shortage occurs, Koh noted. Factors include industry consolidation, issues of quality, manufacturing challenges, changes to inventory and distribution practices, production delays, discontinuation for business reasons, unanticipated increased demand and shortage of raw materials.

As for why generic injectables are so strongly affected, Koh said that it may have to do with the long manufacturing processes for such drugs, many of which now occur at off-shore sites. “There is also the aging of facilities where this work is ongoing,” Koh said.

Quality issues caused by these issues have been quite disturbing, Koh said. “We’re actually tracking products that have been found to have pieces of glass or pieces of metal in sterile products meant to be injected into patients.”

Broader economic troubles also impact the profit margin on manufacturing drugs in general, and the profit margin on generic drugs is relatively narrow, Koh said.