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AAP Combats Drug Shortages

The AAP continues to receive regular reports about drug and vaccine shortages, and regularly alerts the Food and Drug Administration (FDA) about these shortages, urging the agency not only to address the immediate shortage but also to find a long-term solution.

GAO Report on Drug Shortages

In accordance with a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), the Government Accountability Office (GAO) is currently preparing a report examining the causes of drug shortages and formulating recommendations to prevent or alleviate shortages. The GAO recently hosted a conference call with AAP leadership to discuss drug shortages. During the call, AAP leaders discussed possible causes of drug shortages, common drugs in shortage, the challenges drug shortages present to clinical pediatric practice, ways pediatricians cope with drug shortages, and recommendations to the FDA to ameliorate or eliminate shortages altogether.

Daunorubicin

In August 2013, Teva Pharmaceuticals announced a shortage of the drug daunorubicin. Daunorubicin is a chemotherapeutic agent and is a first-line treatment for children with acute myeloid leukemia (AML). Teva was the last active supplier of the drug and has not released an expected date to resume full production. Pediatric hematologists-oncologists have reported that their institutions are currently unable to get daunorubicin from their suppliers and some institutions have already had to deny the drug to patients. The AAP has communicated with both the FDA and Congress about this shortage and will continue to advocate for an immediate solution.

TPN Component Shortages

In response to advocacy from the AAP and the Children’s Hospital Association (CHA), early this summer the FDA announced that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients.

Shortages in TPN components, such as sodium and potassium phosphate, have been particularly acute. The shortages are largely the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012. The FDA worked with American Regent in an effort to avoid a shutdown. The company, however, ultimately decided to cease operations temporarily in order to address quality issues that included particulate matter in its injectable products. The FDA continues to work with the company to prioritize the most critical drugs in shortage as it restarts production and to address quality issues to protect patient health.

Reporting a Drug Shortage

Pediatricians are encouraged to report drug shortages directly to the FDA. To report a shortage of a drug product by email, please use drugshortages@fda.hhs.gov or to make a report by phone, please call (888) INFOFDA or (888) 463-6332. To report a shortage of a biological product (including blood, vaccines, tissue, allergenics) by email, please use CBERshortages@fda.hhs.gov or call (301) 827-4239.

Pediatricians may also wish to report a shortage to the American Society of Health-System Pharmacists (ASHP) by completing this form. ASHP maintains an up-to-date website with detailed information about ongoing and past shortages, alternative therapies, and information about when products are expected to be available. 

Learn More
  • AAP comments to FDA Task Force on Drug Shortages (March 2013)
  • AAP Testimony for the Record on drug shortages before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health (February 2012)
  • Written remarks of DeWayne M. Pursely, MD, MPH, FAAP, on drug shortages before FDA's Center for Drug Evaluation and Research Drug Shortage Workshop (September 2011)
  • AAP News 2011 cover story on drug shortages