FDA Looking to Impact Preventable Medication Harm

SILVER SPRING, MD—“Patient safety is the primary responsibility of everyone who is involved in the healthcare system.” That is the philosophy that underlies FDA’s Safe Use Initiative and what Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, told the attendees of a two-day workshop last month. The workshop, held here at FDA’s White Oak Campus, brought together healthcare stakeholders to learn about what the Initiative is doing and find ways that they can contribute to the effort. FDA launched its Safe Use initiative a year ago with the goal of using its resources to help reduce preventable harm in the prescribing, dispending, and using of regulated medications.

Woodcock kicked off the workshop by putting FDA’s role in the process in perspective, explaining that, if the purpose of the agency is one of ensuring drug safety, that purpose does not end after the drug gets into the hands of patients. “Drugs are only safe if they’re used right. If they aren’t used correctly, they will cause harm. We’re here to take more steps to prevent that kind of harm,” Woodcock declared. “Patient safety is the primary responsibility of everyone who is involved in the healthcare system.”

Through a series of listening sessions held over the last year with healthcare stakeholders—pharmacists, nurses, physicians, consumers, and industry representatives—FDA has identified specific areas of concern dealing with preventable harm on which the initiative will focus
its efforts.

One of the largest areas of concern is drug management in older adults and the elderly, Woodcock explained. “With Medicare being involved in this, we now have access to new sources of data on what older adults are taking. A patient comes in with a 15-minute medication list, and you’re lucky to find time to just fill those medications [much less] figure out what kind of reactions there might be.”

Data from prospective studies on ER admissions of patients over 65 suggest that close to 9% were due to
adverse drug reactions, with the most important factor being the number of different drugs being taken.

Another area that FDA is focusing on is misuse of injectable medicines, including people taking vials intended for single use and using them multiple times, and sometimes on multiple patients. “There have been instances where thousands of people may have been exposed to infectious agents because of this practice,” Woodcock said. “It’s extremely wrong, but because of the economics of healthcare, they may have been motivated to do this.”

Another problem is “not treating these vials with respect,” she added. “It must be maintained sterile. You cannot open it up and let it sit around. We’re seeing instances of infection because of these inappropriate practices.”

FDA is currently working on improving labeling practices to discourage this kind of behavior, but Woodcock admitted that is not enough to stop the problem. “No matter what we do at the agency, people can still have unsafe injection practices out in the community,” she said.

The agency is also working on strengthening regulations dealing with long-acting, high potency opioids. “Prescription opioid abuse has become the most harmful kind of drug abuse in the United States,” Woodcock said. “But these [regulatory actions] will be most useful when they’re coordinated with actions by other stakeholders.”

FDA is also concerned with problems with prescribing of drugs during the handoff of patients from a hospital to the ambulatory care environment, drug security in the home as it concerns children and teen’s access to medications, and dosing in pregnant women.

“Again and again we’ve been told about a pregnant woman who is prescribed a medication only to find there’s no information on dosing,” Woodcock told the workshop attendees. “And we think we can, with you, identify more appropriate projects to take on and really move the dial on patient safety in the next year.”

FDA intends to compile a publically available report summarizing ideas brought up during the workshop. According to Woodcock, FDA hopes to make substantive progress on its different Safe Use Initiative programs over the next year.

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