In February 2015, the Government Accountability Office (GAO) released a new report: Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved. The report is in response to a request by Senators Chuck Grassley (R-IA) and Sheldon Whitehouse (D-RI), for more information on problems in the process of restricting illicit use of controlled substances, while still managing the availability of certain drugs for medical use, including surgery.
The report revealed that the US Drug Enforcement Agency (DEA) and the US Food and Drug Administration (FDA) should work together more closely to prevent shortages of prescription medications containing controlled substances, and the DEA should improve its process for authorizing quotas of the controlled substances used in these drugs.
ASA has consistently been a leader in the medical community on the drug shortage issue. ASA has participated in three Drug Shortage Summits, worked closely with the FDA and the Administration, and worked with members of Congress on legislative solutions.
ASA President J.P. Abenstein, M.S.E.E., M.D. offered the following remarks in response to the report:
“ASA is pleased GAO has decided to look into this important issue again. This is the second GAO report on the topic of drug shortages, following a 2011 report on Drug Shortages: FDA’s Ability to Respond Should Be Strengthened. Physician anesthesiologists recognize the importance of the quota system as a tool to prevent improper use of controlled substances and addiction but this should not come at the cost of making these drugs unavailable for surgical procedures. ASA appreciated Congress’ interest in addressing this problem and looks forward to working with elected officials for a responsible solution that protects physicians and their patients.”
Anesthesiologists face an unprecedented number of drug shortages. Evidenced by a survey of ASA members in 2011 and 2012, Beverly Philip, M.D., Vice President of Scientific Affairs at ASA discussed shortages in an interview with Medscape Medical News, “We are seeing regular and increasing shortages of these drugs." She also noted the problems associated with a current drug shortage, midazolam, which is used to relax patient before surgery. Read more of the interview here.
Read reports from the Drug Shortages Summits and ASA’s testimony submitted to Congress:
2010 Summary Report
2013 Drug Shortages Summit: Evaluating Long-Term Solutions
2014 Drug Shortages Summit
ASA’ submission to the Senate Finance Committee
ASA’ submission to the Senate Health, Education, Labor and Pension Committee