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Executives with the American Society of Health-System Pharmacists and other groups are urging Congress to pass federal legislation to ease drug shortages in the United States.
Executives with the American Society of Health-System Pharmacists (ASHP) and other groups are urging Congress to pass federal legislation to ease drug shortages in the United States.
ASHP, along with representatives from the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the American Hospital Association recently met with aides to Sen. Amy Klobuchar (D-Minn.) to discuss the key points that should be included in federal legislations.
Sen. Klobuchar may introduce legislation to help reduce drug shortages by the end of January, according to ASHP. “Senator Klobuchar’s office is interested in working with us as a group on this issue. We told her our desire to move forward as a group and [that we will] try to achieve consensus from all participants in the supply chain, including manufacturers and distributors,” said Cynthia Reilly, BS, PharmD, director of ASHP’s Practice Development Division.
The group suggested several options that could be included in federal legislation, including a requirement for advance notification of supply or production problems by both single-source and multi-source manufacturers; changes to FDA regulations for reporting interruptions in single-source, medically-necessary product supplies prior to planned action at least 12 months in advance; and revision of FDA’s definition of “medically necessary” to allow for inclusion of the impact of medication-use factors.
The above options and several others were discussed by the 4 groups at the Drug Shortages Summit last November. Recommendations from the summit are available at www.ashp.org/drugshortages/summitreport.