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Regulatory Affairs / Drug Approvals News

New FDA Program Targets Drug Dosage Errors

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharmacy / Pharmacist;  Compliance;  Public Health
Article Date: 06 Nov 2009 - 4:00 PST

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Federal Drug Administration Commissioner Margaret A. Hamburg announced a new "Safe Use" program for drugs on Wednesday.

The program sets out "to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs," The Washington Post reports. "The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine. The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine" (Layton, 11/4).

Los Angeles Times: "The FDA called on doctors, other healthcare professionals and consumers to help identify drugs and circumstances that may be particular problems. The agency will hold public hearings to gather information, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research." The FDA has identified several specific issues, including "the overuse of acetaminophen, a pain reliever that can cause liver damage when taken to excess. The drug is the primary ingredient in Tylenol and is included in several other over-the-counter medications, so it can be difficult for consumers to judge how much they've consumed. The FDA also will scrutinize the information provided to patients, such as package inserts, labels and instructions that pharmacists give when dispensing prescriptions" (Zajac, 11/5).

CNN: "In an effort to ensure safer use, the agency also released new guidelines for companies that make or distribute over-the-counter medications that come with dose delivery devices such as droppers, spoons or cups" (Young, 11/4).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.






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