FDA forges drug safety initiative
ROCKVILLE, Md. —Responding aggressively to the mounting crisis in medication errors, the Food and Drug Administration has unveiled a major campaign to boost drug safety and oversight.
The effort, dubbed the Safe Use Initiative, will enlist federal agencies, manufacturers, pharmacies and other groups to identify and prevent many of the hundreds of thousands of medication errors that occur each year. Its effect could spur closer coordination among pharmacists and other health stakeholders.
“The FDA seeks to partner…with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health,” the agency announced. One early goal, added its report on the initiative, will be “to identify, using a transparent and collaborative process, specific…drugs, drug classes and/or therapeutic situations” associated with preventable harm.
The new guidelines underscore the agency’s increasing reliance on risk evaluation and mitigation strategies, or REMS, for higher-risk medications, even those already in common use. “The FDA believes that in many cases, interventions to prevent harm may consist of a regulatory…and nonregulatory components, highlighting the need for collaborative action,” the agency reported. “For example, the FDA may require that manufacturers of a specific drug class implement a REMS while the FDA works closely with relevant stakeholders to develop complementary, voluntary, collaborative actions that will improve the medication use process for these medications.”
The FDA will take several steps in coming months to push through the Safe Use Initiative. Among them:
Work with public and private stakeholders to “develop a list of…cases for collaborative analysis and intervention;”
Develop, in partnership with other federal agencies, a map that will show “population-based national estimates of preventable harm from medications, categorized by drug, drug classes and therapeutic conditions;”
Hold public meetings to gather input on which cases to focus its efforts on; and
Work with “interested partners” to select “specific…cases for analysis, intervention proposals and evaluation metrics.”
Over the next year, the agency also will launch “a small number” of patient interventions to test the effectiveness of its drug safety effort. Those interventions will draw on community health resources, almost certainly including pharmacists.
Historically, the agency acknowledged, “the FDA regulation has focused on maintaining drug quality, pre-market evaluation of drug safety and effectiveness, appropriate drug labeling, drug advertising and promotion, and post-market surveillance for unexpected side effects.”
Those methods, however, haven’t kept up with the increasing reach and complexity of drug therapy—or the post-market health problems surrounding some medications in recent years. “Beginning in the early 1990s,” the agency noted, “the FDA determined that these regulatory programs were not sufficient to manage all the risks associated with using medications. To address other types of errors, such as…informational errors…the FDA took on additional activities to further reduce preventable harm during the medication use phases.”
Those new steps included a move to standardize medication labels and medication-use guidelines for patients and health professionals. Nevertheless, the problem of serious drug interactions and adverse events continue to mount. Noted the FDA, “Adverse events…result in more than 4 million visits to…outpatient settings annually, and 117,000 hospitalizations each year.”
Even hospitals report “a high incidence of adverse drug events,” the agency reported, ranging from two to six events for every 100 patients admitted. Many of those events are preventable, the FDA said, with currently available knowledge.