FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use

The Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition. Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication. More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, MD. 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 (CMI), 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.