FDA did not give many specifics on how it plans to reduce the misuse of prescription drugs through its newly-launched Safe Use Initiative. But a guidance issued in conjunction with the Nov. 4 launch announcement pertaining to OTC drug dosing suggests the effort could mean significant things for pharma as well.

In the draft guidance, FDA makes dosing device labeling recommendations for liquid OTC products, stating that the failure of a dosing device "to bear markings consistent with the labeled dosage directions" causes the drug to be misbranded.

FDA says its goal is "to implement a small number of interventions during the next 12 months" to implement Safe Use, which is aimed at reducing the likelihood of preventable injury and death caused by medical errors, unintentional exposure to drugs, misuse, abuse or attempts at self-harm.

FDA is still feeling its way toward an agenda for the program, and is at this stage seeking input from the health care community through comments to the public docket on a report about the effort, as well as through a series of public meetings. It is asking stakeholders to weigh in on which problems to prioritize, how FDA should go about it, and ways to evaluate the interventions.

FDA's Janet Woodcock, who directs the Center for Drug Evaluation and Research and will lead the Safe Use Initiative, said some of those problems will be addressed by voluntary means, but others may take a blend of regulatory activities.

Woodcock described the effort, which was first announced last year, as a change of course for the agency (Also see "FDA Faces “Daunting” Mission As It Partners With Doctors For Safe Rx Use" - Pink Sheet, 3 March, 2008.). But though a long time coming, it jives with the current public health focus of FDA under the leadership of Commissioner Margaret Hamburg.

"This is a paradigm shift for FDA, and we recognize this," Woodcock said. "We're going beyond our traditional role as regulator of the industry and reaching out to make sure we're impacting on the real world problems out there in the real world.

"We're willing to serve as a convener and a catalyst to spark creative discussion and effective problem solving amongst all the players in the health care system to make a measurable dent in this problem," she said.

More detailed information on the new program is contained in the report, titled, "FDA's Safe Use Initiative - Collaborating to Reduce Preventable Harm from Medicines." The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information and communicating about the risk of inadvertent overexposure to acetaminophen.

Also highlighted is implementing safeguards against operating room fires, caused by alcohol-based surgical preps being ignited by sparks from medical devices - an incidence that Woodcock said happens about 600 times per year.

"And so the interventions and steps we will take will be really tailored to the nature of the problem we identify," she said. "And what we are going to do is get a series of sub-projects based on stakeholder input and then tackle those problems making sure we can measure whether or not we can make a difference in the occurrence."

The agency estimates that medication misuse or overdose results in four million medical facility visits and over 100,000 hospitalizations each year, and that 1.5 million preventable drug-related injuries occur in health care settings alone.

-Jamie Hammon (j.hammon@elsevier.com)

FDA Launches Safe Use Initiative; Details To Evolve Through Stakeholder Input

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