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Press Release

ASHP Applauds Introduction of Bipartisan Drug Shortages Legislation

H.R. 2245 Gives FDA New Authority to Prevent Shortages

6/27/2011

Legislation introduced recently by Reps. Diana L. DeGette (D-Colo.) and Thomas J. Rooney (R-Fla.) will take steps to help alleviate the serious public health threat caused by drug shortages, according to officials at the American Society of Health-System Pharmacists (ASHP).

The “Preserving Access to Live Saving Medications Act” (H.R. 2245) gives the Food and Drug Administration (FDA) new tools to help prevent drug shortages, including authority to impose civil monetary penalties of up to $1.8 million.

The bill establishes an early warning system and requires all manufacturers of prescription drugs to report interruptions or problems that would halt or delay supplies of drug products resulting in a shortage to the FDA. The agency will be required to publish information on current and pending shortages and to work with health care providers and patient groups to minimize the impact on patient care.

“The rapid increase in the number of drug shortages in recent years is akin to a public health crisis and is the cause of serious patient harm,” said ASHP President Stan Kent, M.S., FASHP. “We are pleased to see that Congress is working to address this critical issue and will advocate strongly for its passage.”

Similar legislation, S. 296, was introduced by Sens. Amy Klobuchar (D-Minn.) and Robert Casey (D-Pa.) in February.

ASHP has a long history of leading efforts to help the health care community manage issues related to drug shortages. The Society was a co-convener of a summit in November 2010 that brought together stakeholders to develop recommendations for new approaches to prevent patient harm and minimize disruptions in care caused by drug shortages. The report from the Summit is available at www.ashp.org/drugshortages/summitreport.

ASHP, in collaboration with the American Hospital Association and Summit co-conveners, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices, worked closely with DeGette and Rooney as they developed the legislation.

The Society also maintains the Drug Shortages Web Resource Center and published guidelines to help practitioners manage drug product shortages.

For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society's 35,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's Web site, www.ashp.org, or its consumer Web site, www.SafeMedication.com.

 

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