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July/August 2011
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As Anti-Infective Shortages Continue, GAO to Study Problem
IDSA provides input on shortages’ impact on patient care and public health

Drug shortages, including those of key antibiotics, continue to cause concerns among health care providers and, increasingly, some policymakers in Washington.

At the request of Congress, the Government Accountability Office (GAO) is now studying the problem. The government watchdog recently sought IDSA’s input on the cause of the shortages, what effects antibiotic shortages have, and how the Food and Drug Administration (FDA) has responded to them. At GAO’s request, IDSA identified the following four critical anti-infective sterile injectable drug shortages since 2009 that have had a significant impact on patient care and public health:

  • amikacin
  • intravenous (IV) trimethoprim-sulfamethoxazole (TMP/SMX)
  • IV acyclovir
  • IV clindamycin

In addition, IDSA shared a list of 16 other relevant anti-infective shortages with GAO.

On Capitol Hill, several lawmakers have called for hearings on the issue. A bill introduced in the House of Representatives in July would require FDA to notify health providers of drug shortages and work with manufacturers to fill supply gaps. Similar legislation was introduced earlier this year in the Senate.

Two recent surveys underscore the scope of the problem. Nearly 100 percent of hospitals surveyed by the American Hospital Association reported a drug shortage in the previous six months, and nearly half reported 21 or more shortages. Among the 820 hospitals in the survey (PDF), 82 percent have had to delay treatment, and more than half were not able to provide a patient with the recommended treatment.

Labor costs associated with managing these shortages translates to an estimated annual impact of $216 million nationally, according to a nationwide survey of 353 pharmacy directors, conducted by the American Society of Health-System Pharmacists (ASHP).

Several IDSA members have contacted the Society about the availability of certain drugs, and members of the Emerging Infections Network (EIN) recently discussed the current shortage of amikacin (see May 2011 IDSA News). IDSA members are urged to report drug shortages directly to FDA and to copy IDSA staff at lmcgorman@idsociety.org.

FDA provides information and e-mail alerts about drug shortages and how physicians can obtain available emergency supplies. ASHP’s website offers information about shortages, including current and resolved shortages, as well as bulletins on drugs that are no longer available.

IDSA continues to work with FDA and Congress to keep the issue on their radar.
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