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ASA President Mark A. Warner, M.D., along with representatives from other provider groups, manufacturers and distributors met with the Department of Health and Human Services' (HHS) Secretary Kathleen Sebelius concerning drug shortages on Friday, September 9, 2011. During the invitation-only face-to-face meeting, Dr. Warner spoke on the impact anesthesia drug shortages are having on patients - a message Sebelius referenced later in the meeting.
Secretary Sebelius along with senior staff from the HHS and the Food and Drug Administration (FDA) expressed a strong commitment to ending drug shortages. To accomplish that goal, this meeting focused on learning the causes behind the spike in the number of drug shortages over the last few years.
ASA has been a leader in the fight to address drug shortages. After working with the FDA to alleviate the shortage of propofol, ASA leadership directed ASA staff to work with other organizations to help identify the root of drug shortages and recommendations to address them. In November 2010, ASA co-convened a national drug shortages summit with representatives from manufacturers, distributors and providers. Since that meeting, ASA has been working with the Legislative and Regulatory Activities Work Group to develop recommendations that would help alleviate and decrease the severity of drug shortages. These recommendations are in the final stages.
In April 2011, ASA conducted a nationwide survey of its members and found that drug shortages are wide spread. This information was used by ASA members while lobbying on Capitol Hill in May during the ASA Legislative Conference. This effort, along with the work of other groups, has lead to increased visibility of the issue on Capitol Hill. Also in May, ASA leadership met with FDA officials on drug shortages and followd up that meeting with a letter to the FDA that included some recommendations for alleviating drug shortages.
In June 2011, staffers from the Government Accountability Office (GAO), who are conducting a study of drug shortages, interviewed ASA President Mark A. Warner, M.D., ASA Vice President of Scientific Affairs Arnold J. Berry, M.D., M.P.H., and ASA staff. The interview provided ASA with an opportunity to outline the impact the drug shortages are having on patients as well as the increased cost to the healthcare system. ASA was able to outline some of the potential causes of the drug shortages as well as recommend some actions that might help alleviate drug shortages. The GAO report is expected to be released this fall.
On September 26, 2011, Dr. Berry will serve on a panel at an FDA workshop on drug shortages. This will provide ASA with an opportunity to express the impact drug shortages are having on anesthesia patients as well as an opportunity to offer recommendations on how to alleviate the shortages.
