“Reducing preventable harm from prescription and OTC medication use is an FDA priority,” according to FDA commissioner Margaret Hamburg.
Speaking at a press conference called to announce the agency's “Safe Use” initiative, she explained the voluntary program is designed to enlist “stakeholders,” including physicians, pharmacists, hospital/nursing home professionals and other health care workers — in a cooperative effort to help reduce the incidence of preventable harm from medication use.
She indicated that FDA intends to collaborate with these and other stakeholders to identify drugs, and drug classes, that are frequently linked to preventable harms, and to develop a list of specific interventions to reduce the likelihood of problems associated with unintentional misuse of medications, abuse of prescription and OTC products, dosing errors, and even attempts at self-harm. A set of “metrics,” or means for evaluating the impact of the initiative, will also be developed.
Hamburg said a series of meetings will be held to obtain feedback on the list of drugs to be identified as particularly subject to misuse or abuse. She described the Safe Use initiative as a “new paradigm” for FDA, emphasizing its largely voluntary and cooperative nature and stressing FDA's “public health” role, in distinction to the agency's more traditional “regulatory” function.