New FDA Program Targets Medication Misuse, Accidental Overdoses

The FDA has launched a new program called the “Safe Use Initiative,” which agency officials hope will cut down on medication injuries that could have been prevented.

The program will create partnerships with federal agencies, healthcare professionals, hospitals, pharmacies and consumer organizations to identify specific, preventable medication risks and implement plans to mitigate those risks. Preventable medication risks can include medication errors, accidental exposure, intentional misuse or abuse and drug quality problems.

The details of the program were outlined in a report released on Wednesday, called “FDA’s Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.” The agency released the report at the annual Science Writers Symposium in Silver Springs, Maryland.

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The federal drug regulatory agency intends to schedule public meetings to get feedback on the report and the “Safe Use Initiative.” A public docket will also be opened to allow the public to submit comments on the report.

New FDA guidance in association with the initiative has already been released, which targets drug makers who manufacture over-the-counter liquid medications. The guidance aims to standardize dosage delivery devices, like cups, droppers, syringes and spoons, so that dosages are easily understood by consumers. The FDA hopes the new guidance will cut down on accidental overdoses with such medications, particularly acetaminophen problems, which the FDA says results in 55,000 emergency room visits each year, primarily due to medication errors that result in liver damage.

According to the Institute of Medicine and FDA, there are 1.5 million preventable medication injuries in the U.S. each year, which add an additional $4 billion to the cost of healthcare. About 60,000 children are seen in emergency rooms nationwide each year due to accidental drug ingestion.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the program. “All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”


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