FDA Initiative Targets Preventable Harms From Medications

The FDA recently launched its Safe Use Initiative, a program intended to reduce the likelihood of preventable harm from OTC and prescription drug use.

The initiative will examine multiple sources of preventable harm, including unintentional misuse of medications, abuse and attempts at self-harm. The agency is seeking input (2-page PDF; About PDFs) from physicians and other stakeholders to identify drugs and classes of drugs linked to such events.

The FDA said it will collaborate with patients, consumers, caregivers, health care professionals, pharmacists, health care systems, insurers, drug manufacturers and other federal agencies to develop a list of specific problems, interventions for reducing harm from those problems and metrics for judging success in meeting the goal of reducing preventable harm.

"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, in a news release announcing the initiative. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

Woodcock is co-author of a report -- "FDA's Safe Use Initiative - Collaborating to Reduce Preventable Harm from Medicines" -- (28-page PDF; About PDFs) that details the initiative's goals.

In addition, the 2010 Physicians' Desk Reference now available for distribution includes a letter from Woodcock highlighting the Safe Use Initiative and urging physicians to report adverse events to the FDA. A facing page directs physicians to the Health Care Notification Network, an online drug alert service of the newly formed PDR Network that is free to AAFP members.

The Institute of Medicine has estimated that 1.5 million preventable adverse drug events occur each year, at a cost of more than $4 billion. According to the FDA, the amount of preventable harm tied specifically to misuse of OTC medications is unknown.