Democratic Senators Propose Law to Address Unprecedented Drug Shortages

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Democratic Senators Propose Law to Address Unprecedented Drug Shortages The problem of prescription drug shortages reported last month isn't getting any better. Luckily, U.S. legislators are taking note, and Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced a bill Monday to address the unprecedented medication shortfalls. Health care groups applauded the bill "as an important first step."

Pharmacists and health care providers have been reporting unprecedented shortages of prescription drugs, including vital medications such as chemotherapies, antibiotics, analgesics (painkillers), anesthetics and more. Such shortages can compromise therapy or delay treatment, putting patients at risk -- sometimes even of death.

The American Society of Health-System Pharmacists currently lists 150 "medically necessary" drugs that are in short supply, double the number from five years ago, the senators noted

"Reports of drug shortages are unabated," says ASHP Director of Federal Legislative Affairs Joseph Hill. "In addition, recent reports have included drugs critical to care that have not previously been reported."

Similarly, says Dr. Michael Link, president elect of the American Society of Clinical Oncology: "The oncology community is experiencing severe and worsening shortages of many critical drug therapies which disrupt important medication regimens and may threaten patients' health."

Bill Would Empower the FDA to Act


No single reason explains the shortages. Issues include scarcity of raw materials, manufacturing problems, FDA enforcement actions and unexpected increases in demand. Also, business decisions by pharmaceutical manufacturers to cut back on the production of less profitable drugs in favor of more profitable ones can lead to shortages.

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Despite the severity of the problem, the Food and Drug Administration has little authority to act. Under current law, it can't even require manufacturers to give it early notification of possible shortages. The senators say their bill, the Preserving Access to Life-Saving Medications Act, which includes several of the recommendations from the drug shortage summit held in November, would provide the FDA with key tools to help address and prevent shortages.

The bill will require manufacturers to give early notification to the FDA of any incidents that would likely result in drug shortages, and would also direct the FDA to provide the public with up-to-date notifications of any shortage situations, and the actions it's taking to address them.

"Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available -- that's not right," said Klobuchar. "This commonsense solution will help set up an early-warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible."

"Critical First Step"

Early notifications would give doctors, pharmacists and nurses time to find potential substitutes and learn about them so that dispensing errors can be minimized, Michael Cohen, president of the Institute for Safe Medication Practices, explained to DailyFinance last month. Dr. Link of ASCO expresses a similar view, saying the early-notification legislation would help oncologists to better anticipate and manage shortages.

"Drug shortages are hurting patients, and we applaud the Senators' efforts," says the ASHP's Hill. "This bill is a critical first step in addressing drug shortages."
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