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FDA Unveils Safe Use Initiative to Reduce Harm From Medication Use

On Nov. 4, 2009, the Food and Drug Administration (FDA) announced the Safe Use Initiative, a new program aimed at reducing the likelihood of preventable harm from medication use.

"Too many people suffer unnecessary injuries from avoidable medication misuse, errors, and other problems," says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries."

Millions of people are harmed every year from inappropriate medication use. Some of these injuries occur because of

  • incomplete access to information about a drug, a patient, or the patient’s condition
  • unintentional misuse of medications, medication abuse, and attempts by people to harm themselves with medications
  • taking prescription drugs prescribed for other people. Some medications, such as opioid drugs, can cause harm—even death—in a single dose if taken by someone the medication was not intended for.

A Collaborative Effort

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

More detailed information on the new program is contained in "FDA’s Safe Use Initiative—Collaborating to Reduce Preventable Harm from Medicines," a report that outlines how FDA intends to collaborate with health care professionals and others to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, interventions for reducing harm from these problems, and ways to measure success will be developed.

The report highlights several projects that may benefit from collaborations, including

  • evaluating consumer medication information
  • communicating about the risk of inadvertent overexposure to acetaminophen
  • applying safeguards against surgery fires caused by alcohol-based surgical preparations
  • avoiding contamination of multiple-use medication vials

To further advance the Safe Use Initiative, FDA intends to hold a series of public meetings to gather feedback as the list of problems to be addressed is being developed. FDA will open a public docket to receive comments on the report and on the proposed candidate problems.

Medication Measuring Devices

Along with the Safe Use Initiative, FDA also announced new guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes, and spoons.

Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance is an example of steps that can be taken to ensure safer medication use," says Woodcock. "Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications—the safest and most effective dose—especially for children."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: November 4, 2009

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