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ASA Presents Before Hundreds at FDA Drug Shortages Public Workshop

Tuesday, September 27, 2011

Hundreds of people gathered for the Food and Drug Administration (FDA) Workshop on Drug Shortages on Monday, September 27, 2011. ASA Vice President for Scientific Affairs Arnold Berry, M.D., M.P.H., and ASA Director of Practice Management, Quality and Regulatory Affairs Jason Byrd, J.D., participated on panels during the meeting. The public workshop, the first open public interaction on this important issue, was intended for all stakeholders to provide additional information and insights about the causes and impact of drug shortages, and to identify possible strategies for preventing or alleviating drug shortages. Throughout the day, the shortages of anesthesia and oncology drugs were the most often mentioned.

During the morning session, Dr. Arnold Berry presented on a health care providers panel that gave perspectives on drug shortages from the point-of-care perspective. During his presentation, Dr. Berry presented the findings of the ASA Drug Shortages Survey, the impact shortages are having on patients in need of anesthesia services and the additional health care costs resulting from drug shortages.

In the afternoon, Jason Byrd along with Juliana Reed from Hospira presented five recommendations from the Legislative and Regulatory Work Group of the Drug Shortages Summit. The Drug Shortages Summit brought together stakeholders including manufacturers, providers, distributors and other individuals to address the issue of drug shortages.

Immediately thereafter, Dr. Arnold Berry and Jason Byrd participated in a health care professional groups panel discussion on recommendations for addressing the shortages. Dr. Berry reiterated ASA’s support for the recommendations of the Drug Shortages Summit.

The most powerful presentations of the day came from patients who had suffered adverse outcomes as a result of drug shortages. Every stakeholder acknowledged that everything comes down to caring for patients. In addition, presentations were made by other provider groups, distributors, manufacturers and government officials.

Four main consensus ideas were reiterated throughout the day:

Improved Communication – Providers expressed the great concern with the lack of timely and accurate information during a shortage, and a lack of warning that a shortage is imminent. Manufacturers, distributors, and government agencies expressed a desire to increase communication. In particular, the FDA and manufacturers plan to increase the communication concerning potential shortages. Along with better communication, increased collaboration is needed. According to FDA, early notification of a looming shortage can lead to hoarding and an increase in the “gray market,” thus exacerbating the drug shortage.

Additional Resources for FDA – FDA reported at the meeting that four staff members are assigned to the Drug Shortages Program (DSP). The entire medical community throughout the day expressed a desire for FDA to allocate additional staff to the DSP. FDA emphasized that extensive collaboration exists between FDA divisions that assist in drug shortages. ASA publicly acknowledged and thanked the DSP staff for their exceptional work in temporarily importing the European version of propofol to alleviate the propofol shortage; however, the limited number of staff at DSP cannot be expected to keep up with the record number of shortages.

Redundancies in Manufacturing – Additional manufacturing capacity and limiting sole source API could help prevent some future shortages. Currently manufacturers have limited capacity to produce drugs and to modify production lines in response to changes in the market. Numerous manufacturers at the meeting expressed they are in the process of improving current facilities or building new ones, which in turn will increase capacity. While this is a positive step, manufacturers noted that it takes an extended period of time to get a new facility fully functioning.

Reduce the “Gray Market” – When a drug goes into shortage, some individuals or companies acquire the product and attempt to sell it at dramatically inflated prices – sometimes at rates 4000 percent higher than normal price. The dramatically inflated price coupled with the inability to accurately track the product’s history (e.g., whether it was stored properly according to manufacturer specifications) describes what some refer to as the “gray market.” When pharmacies are without a critical life-saving product and patients have a need for that drug, there are pressures to resort to purchasing on the gray market. Some manufacturers have stopped selling products to distributors who have been found to engage in the gray market. Stakeholders agreed that additional steps must be taken to ensure patient safety and decrease costs. Discussion included mechanisms for tracking the drug’s chain of custody, as well as interest in additional study of the gray market and which federal and state agencies have authority of investigating further.

The most positive aspect of the workshop was the public discussion of real solutions and concepts for addressing and preventing future drug shortages. ASA will continue to work with all stakeholders on implementing many of the recommendations presented at the meeting.

Learn more about the agenda of the meeting.

Read the five recommendations from the Drug Shortages Summit.

Download Dr. Arnold Berry's Powerpoint presentation.  

Learn more about the work ASA is doing on drug shortages.  

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