Blue FDA logo.

Safe Use Initiative Targets Preventable Harm from Medication Use

The Food and Drug Administration recently announced the Safe Use Initiative, a 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," said FDA Commissioner Margaret A. Hamburg, M.D. "The 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. 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.

"Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications," said Janet Woodcock, M.D., director of the 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 was contained in a report, titled "FDA's Safe Use Initiative - Collaborating to Reduce Preventable Harm from Medicines." The report was released by 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, 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, 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 liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes, and spoons.

That guidance document, titled "Dosage Delivery Devices for OTC Liquid Drug Products,' was posted for advanced viewing in the Nov. 4 edition of the Federal Register.

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 document is an example of steps that can be taken to ensure safer medication use," Woodcock said. "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."

For more information, click here.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - July August 2022

    July / August 2022

    Featuring:

    • CONFINED SPACES
      Specific PPE is Needed for Entry and Exit
    • HAZARD COMMUNICATION
      Three Quick Steps to Better HazCom Training
    • GAS DETECTION
      Building a Chemical Emergency Toolkit
    • RESPIRATORY PROTECTION
      The Last Line of Defense
    View This Issue