As the opioid epidemic continues unabated, the US Food and Drug Administration will hold a two-day session starting on Tuesday to review whether a program for educating doctors about reducing patient risks is accomplishing its goals. And the meeting comes amid criticism that the FDA program insufficiently emphasizes safe prescribing, rather than using opioids as a last resort for treating pain.
The agency will review what is known as a Risk Evaluation and Management Strategy, a mandated program that drug makers must develop to mitigate improper use of products such as drugs and educate doctors on prescribing. Specifically, the FDA required a REMS for all extended-release, long-acting opioids, which number 30 drugs made by more than 20 companies. These include such well-known painkillers as OxyContin.
The issue will be discussed amid growing angst over concerns about inappropriate prescribing of opioids. More than 18,000 overdose deaths were attributed to the painkiller in 2014, according to the US Centers for Disease Control and Prevention, which recently issued guidelines that recommend doctors prescribe opioids only after other therapies have failed, and rely on the lowest possible doses.
To bolster the hope that REMS programs can thwart abuse of the addictive painkillers, the FDA four years ago finalized a blueprint for continuing medical education, or CME, to instruct physicians about the REMS programs. And drug makers, which helped shape the CME programming, were required to fund CME courses. The purpose of this week’s meeting is to get a much-needed reality check.
So far, the FDA is falling behind in its goals. Through May 2015, about 38,300 prescribers were trained in prescribing risks under these CME programs, but this is less than half of the 80,000 prescribers the agency hoped would have been trained by last year. Moreover, this represents less than 25 percent of the 160,000 prescribers that were to have been trained by this year.
But numbers are not the only issue.
Some physicians say the FDA blueprint is flawed. In their view, the agency should de-emphasize prescribing, rather than tout safe prescribing. “We need CME to help clinicians figure out how to talk about the real risk and benefit trade-offs that come with opioid use, and to help patients understand the benefits aren’t as great as we used to think,” said Dr. Kelly Pfeifer, director of high-value care at the California Health Care Foundation, a nonprofit that focuses on improving access to coverage.
The foundation, she explained, had promoted a program to physicians, but no longer does so over what she called a “mismatch” between what she described as the course content and physician needs.
Such concerns were voiced by Physicians for Responsible Opioid Prescribing when the FDA first proposed its blueprint in 2011. The nonprofit, which advocates for reduced prescribing, noted the blueprint resembles CME industry-funded programs that existed previously and argues that the FDA blueprint may inadvertently benefit drug companies.
But Dr. Daniel Alford, an assistant professor of medicine at Boston University, which runs a large CME program, argued that industry funding is necessary. Called Scope of Pain, the program receives financing from two dozen drug makers, including Purdue Pharma, which sells OxyContin. He also maintained that CME programs offer a balanced view.
“There has to be education about pain management, including when opioids are needed,” he said. “Who will pay for that education? If the federal government was willing to pay for that, I’d rather take (that) money … I’d rather have individual doctors, more than anyone else, (pay for the program). But there aren’t a lot of people looking to spend money on education.”
Opioids, he continued, are “still one tool in the toolbox and help some patients. Opioids are not all bad and not all good. I don’t think we’re in positions to get rid of them. And we’re talking about opioids because that’s what the program is about … I don’t feel that I owe anything to the manufacturers. They were forced to do this.”
Another pain specialist, meanwhile, said concerns might be mitigated if the FDA adopted a stance similar to the CDC.
“The blueprint needs to focus substantially more on avoiding opioids and on the serious safety concerns of addition, overdose, and death. They should align this with the CDC opioid prescribing guidelines and highlight the risk … of the whole class of drugs,” said Dr. Lewis Nelson, an emergency medicine specialist at the New York University Langone Medical Center who sat on the CDC guideline panel.
An FDA spokeswoman wrote us that the agency plans to review whether the FDA blueprint should be revised and/or expanded moving forward, among other things.