SILVER SPRING, MD. — Reducing preventable injuries from medication errors, misuse, and abuse is the goal of an initiative being launched by the Food and Drug Administration, agency officials announced at a briefing.
The Safe Use Initiative is intended to “reduce preventable harm by identifying specific, preventable medication risks and developing, implementing, and evaluating cross-sector interventions with partners who are committed to safe medication use,” FDA officials said. In addition to health care professionals, partners will include federal agencies, professional societies, pharmacies, hospitals, and manufacturers, as well as patients, caregivers, and consumers.
Drugs, drug classes, and therapeutic situations associated with preventable harm will be identified as part of the initiative.
In addition, the initiative will use measures of success to evaluate the impact of those interventions, Dr. Margaret Hamburg, FDA Commissioner, said during the briefing. Each year, adverse events from drug use result in more than 4 million visits to emergency rooms, physicians' offices, and outpatient facilities, and 117,000 hospitalizations, she said.
As many as half of all medication injuries—which include dosing errors, mixups during drug administration, and unintentional misuse of the medication—could be prevented with currently available information about the medication, Dr. Hamburg added.
During the briefing, Dr. Janet Woodcock, who will be spear-heading the initiative, distinguished between the events targeted by the initiative and inherent medication risks that are not preventable, such as side effects of chemotherapy. Most preventable injuries are caused by a lack of knowledge about the medication, including by prescribers and patients at the point of care, said Dr. Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Dr. Woodcock said that the agency has discussed the initiative with physicians' and nurses' professional groups, and will seek input from the health care community and the public to determine what they perceive to be the biggest problems. Proposed interventions will be specific to a particular problem, she said. For example, measures could be taken to reduce the number of operating room fires (currently about 600 a year), the risks of inadvertent overexposure to acetaminophen, and contamination from multiple-use medication vials.
Dr. Woodcock and Dr. Hamburg cited the following estimates during the briefing:
▸ The Institute of Medicine estimated that every year 400,000 hospitalized patients have a preventable injury.
▸ The cost of preventable injuries from medications exceeds $4 billion annually, according to the IOM.
▸ An estimated 600,000 emergency department visits per year are caused by unsupervised ingestion of medications among children under age 12.
The agency also announced a new draft guidance document on delivery devices for over-the-counter liquid drug products for companies that manufacture, market, or distribute medications such as elixirs, suspensions, and syrups, which are packaged with calibrated cups, droppers, syringes, or other dosage delivery devices.
The draft guidance addresses “ongoing safety concerns about the serious potential for accidental drug overdoses of OTC liquid drug products that can result from the use of dosage delivery devices with markings that are inconsistent or incompatible with the labeled dosage directions for OTC drug products,” according to the document published in the Federal Register on Nov. 4.
For information on the safety initiative, visit www.fda.gov/Drugs/DrugSafety/ucm187806.htmwww.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf