FDA Launches Program to Reduce Drug-Related Injuries
By Brande Nicole Martin
Medscape Medical News
November 5, 2009 — The US Food and Drug Administration (FDA) has launched a new program called the Safe Use Initiative to reduce drug-related injuries from preventable sources of harm, agency officials announced at an FDA press conference yesterday.
"The goal of the Safe Use Initiative is 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," according to an agency news release.
The FDA indicates that as many as 3 billion prescriptions are written each year, and millions of people are injured from medication use. Many injuries are a result of people's limited access to adequate information about a drug, its risks, or the patient's condition. Other injuries occur because of misunderstanding of drug instructions, dosing and dispensing errors, and unintentional or intentional misuse of medications.
"The Institute of Medicine estimates that at least 1.5 million preventable drug-related injuries occur in healthcare settings alone...and it is estimated that up to half of all medication-related injuries could be prevented using currently available knowledge," FDA Commissioner Margaret Hamburg, MD, said at the press conference.
The FDA will collaborate with the healthcare community, including healthcare professionals, patients, pharmacies, insurers, and other federal agencies, to effectively reduce mismanagement of medication and prevent harm from medication.
Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said at the press conference that "this is a paradigm shift for the FDA," explaining that the agency plans to go beyond its traditional role as industry regulator and to serve as "the convener and catalyst" among members of the healthcare system.
"Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications," Dr. Woodcock added in an FDA news release. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use."
Next Steps
As part of the Safe Use Initiative, the FDA plans to take a series of steps in the months ahead.
The agency will seek input from "the healthcare community, patient groups, and all the other stakeholders and what they see as the most serious problems involving unsafe use of medicine and what they think we should tackle and in what way we should tackle these,” Dr. Woodcock said.
The FDA will also hold public meetings and provide other resources for the public to provide feedback on developments related to the new program.
A list of specific problems, interventions, and metrics derived from these discussions will eventually be released.
More information about the Safe Use Initiative is available on the FDA Web site.
