Drug 'safe use' initiative launched

Share this article:
“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.


Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Headliner: Proteus CEO takes an original path

Headliner: Proteus CEO takes an original path

Andrew Thompson, CEO, Proteus Digital Health

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...