According to an FDA report issued in October, 2011, the number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010. From January through October 2011, FDA tracked 220 drug shortages. Of the 127 studied drug shortages in 2010‐11, sterile injectables accounted for the majority (80 percent). The major therapeutic classes of drugs in shortage included oncology drugs (28 percent), antibiotics (13 percent), and electrolyte/nutrition drugs (11 percent).

Effectively addressing a drug shortage is a difficult and complex challenge for the entire healthcare community, in large part because a shortage typically appears with insufficient warning and often requires significant time and resources to manage when a particular therapy is in short supply.

While there are many factors that may result in a product being in short supply, HDMA members play a central role in exchanging and coordinating of information when a shortage occurs. Effective and timely communication across the supply chain is critical for better managing the impact of drug shortages and, most importantly, minimizing their effect on patient care.

HDMA and its members are committed to continuing to work with Congress, federal agencies and all stakeholders to safeguard America’s pharmaceutical supply and support the availability of safe and effective drugs.

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News

• HDMA's John M. Gray Testifies Before Senate Committee - July 25, 2012
• HDMA’s John M. Gray Highlights 2012 Industry Priorities in Jan. 2 Issue of Chain Drug Review - January 2, 2012
• HDMA CEO Perspective: Washington Focuses on Drug Shortages - October 19, 2011

Other Resources

• U.S. Food and Drug Administration (FDA) Drug Shortages Information
• HDMA White Paper on Product Availability: Communications Guidelines for Managing Product Shortages in the Healthcare Supply Chain - April, 2012
• American Society of Health-System Pharmacists (ASHP) Drug Shortages Resource Center
• HDMA Cover Letter and Comments to FDA re: Public Workshop on Addressing Drug Shortages and FDA Review of long-term strategy for Addressing Product Shortages - December 21, 2011
• IMS Institute for Healthcare Informatics report, Drug Shortages: A closer look at products, suppliers and volume volatility - November 2011
• White House fact sheet: “Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S.” - October 31, 2011
• The Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) issued a report: Economic Analysis of the Causes of Drug Shortages - October 31, 2011
• The FDA report, A Review of FDA’s Approach to Medical Product Shortages - October 31, 2011
• FDA Letter to Industry - October 31, 2011
• HDMA Statement on Drug Shortages - September 23, 2011
• Testimony before the House Energy and Commerce Committee Subcommittee on Health, United States House of Representatives, September 23, 2011, John M. Gray, President and CEO, Healthcare Distribution Management Association - September 23, 2011

Issue Contact: Kristen Freitas (Federal Affairs), Anita Ducca (Federal Regulatory Affairs)