FDA Launches Safe Use Initiative For OTC Drugs

FDA has launched Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. Margaret Hamburg, commissioner of FDA and Janet Woodcock, director of center for drug evaluation and research at FDA, have released a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines” giving more detailed information about the new program at FDA’s annual Science Writers Symposium.

As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.

The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.

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

The agency also made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter (OTC) liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.

Mr Hamburg said: “Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries.”

Ms Woodcock said: “Only through coordinated interventions across all sectors of the health care system can substantially reduce preventable injuries from using medications. All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”