Since 2013, makers of opioids have contributed millions of dollars to a med-ed fund designed to teach proper pain-drug prescribing. Yet, despite 900 courses and 500,000 learners, the effort has largely missed the mark on some core goals, say some of its organizers.

The Food and Drug Administration has long required opioid makers to pool monies into a fund for the creation of independent continuing medical education (CME) courses on safe prescribing. The FDA-mandated program, known as the REMS Program Compliance, or RPC, has been held up as a model of collaboration between the public and private sectors.

But those overseeing the program say they can’t tell for sure whether the years-long effort, designed to educate clinicians in proper pain-drug prescribing, really works. “We can show… that people are learning and they are changing their behavior in practice, but we can’t demonstrate improved outcomes. That’s just because there’s no way in the system to measure it,” said Norm Kahn, M.D., convener of an interprofessional coalition which leads the education initiative. 

As to why we don’t know the real impact on patient care, the manager of one program that has received RPC funding explained, “Assessing patient-level outcomes for a national continuing educational program would be very complicated and expensive.” For one, it’s difficult to get learners to complete follow-up electronic surveys after completing an online CME pain activity, explained the program manager, Ilana Hardesty, of the CME office at Boston University School of Medicine, in response to emailed questions. 

She added that it would likely be “next to impossible” to gain access to their patient-level data before and after the training. And, even assuming one could obtain such data, it would be hard to link the training itself to changes in opioid deaths. 

Preliminary government data recently showed a drop in drug overdose deaths, the first since 1990, a prime cause of which was the dip seen in deaths from prescription opioids between 2012 and 2017. The latter was attributed to more judicious opioid prescribing during the same time period, but many potentially impactful interventions may have played a part.

Those range from reports by the media about opioid risks, published national/state opioid prescribing guidelines, state-mandated prescribing limits, use of prescription drug monitoring programs (PDMPs), expansion of naloxone and medication-assisted treatment for opioid use disorders, not to mention law enforcement efforts to close over-prescribers.  

Often, addiction to pain medication starts with legitimate use, so better education for healthcare providers and more controlled prescribing are thought to be beneficial. 

“The outcomes we’re really trying to accomplish are fewer deaths from prescription opioids,” said Kahn. “And we’re now about six years in a row of fewer deaths. So by putting all of these interventions together, this is actually working. It’s just that, nobody can tell you what the impact is of any one of the interventions.”

Members of the coalition he leads, known as the Conjoint Committee on Continuing Education (CCCE), met last week to discuss the program’s achievements, and shortcomings. Since 2013, some 500,000 clinicians have completed CME activities compliant with an earlier FDA blueprint designed for accredited med-ed providers to use as a basis for developing the education. 

The content originally covered general and product-specific information about extended-release/long-acting opioid analgesics, proper patient selection and guidance on safely starting therapy, as well as on the FDA’s risk evaluation and mitigation strategy (REMS) for these drugs. REMS is a special program the FDA mandates when it determines that safety measures are needed over and above what’s in a product’s approved label. 

Of those prescribers who took a course on extended-release/long-acting opioid analgesics REMS, about half (47%, or 113,692) met the FDA’s definition of a prescriber: Those who said they were registered to prescribe Schedule 2 or 3 drugs and who had written at least one prescription in the last year. Of those FDA-defined prescribers, physicIans, advanced practice nurses and physician assistants made up the largest groups (see chart below).

Since 2013, 108 different med-ed providers have created more than 943 blueprint-compliant activities, 904 of them funded by the RPC firms, according to data the ACCME has collected for the past six years. All of the CME paid for via the pooled fund had to be made available for free or at nominal cost to prescribers, and med-ed providers were required to adhere to the ACCME’s Standards for Commercial Support. 

While the majority of activities were offered in a live format, most learners participated in online offerings (see table below).

When the program started in 2012, there were 18 opioid companies in the RPC. There are now 65, said Kahn, including such names as Allergan, Endo, Janssen, Mylan, Pfizer, Purdue, Sandoz and Teva. The number of grants awarded has risen, as well, from an average of eight in previous years to 14 last year, he added. The company that administers the grants did not respond at press time to a request for the dollar value of the grants awarded, but the amount is easily in the millions, based on the amount of some RFPs seen.

Self-assessment among learners shows the effort is making a difference in “competence” and “performance,” which, according to Kahn, means the education improves learning and changes practice behaviors. That alone is insufficient to measure achievement, however, a point underscored by Kahn and other authors in a paper they published earlier this year recapping the FDA-RPC collaboration. 

“In its assessment of success,” wrote authors in the Journal of CE in the Health Professions (JCEHP), “the RPC needs to also include outcome measures that demonstrate changes in learners’ practice and impact on patient care.”

That was just one of several misses flagged by the authors of the JCEHP paper. Another they termed “recognizing team participation.” The initial target audience for this educational initiative was not designed to extend beyond prescribers. Nurses, pharmacists and others are required by their license to have the training and are, quite frankly, in need of it.

“While it is true that the first REMS (the ER/LA Opioids REMS) focused on prescribers,” observed Hardesty, “educational providers were not limited to teaching only prescribers.” In fact, she pointed out, BU’s activity, called “The SCOPE of Pain,” has always taken a team approach. 

“The education we provide is as relevant for a non-prescribing nurse as it is for a physician,” she noted. “From the beginning we have had a large proportion of nonprescribers attend. With the new Opioid Analgesics REMS, the FDA recognized the need for interprofessional education, and broadened its scope to include all team members.”

Kahn et al. also called for patients to play a bigger role in the development of this educational content. If the goal of CME is to improve patient safety and care, then patient voices need to be heard, they wrote. 

Where does the program go from here? A year ago, a new FDA blueprint was finalized requiring that the education cover a broader range of topics, including immediate-release opioids, as well as alternatives to opioids. 

The blueprint states that clinicians need to consider “all options” for pain management, and to “reserve opioid analgesics for when nonopioid options are inadequate.” It also states that education should be extended to other healthcare professionals who treat pain and monitor such patients, like nurses, pharmacists and others. 

The CCCE, as noted in the JCEHP paper, vowed to put more emphasis on interprofessional education that engages with all members of the health team, including patients, and to expand its stakeholder group, which includes groups like SAMHSA and AHRQ. The collaboration between the FDA and the CE community “is a model,” authors noted, that can be replicated across other challenges in healthcare, like health disparities and chronic illness. 

Still, there is a sense of being haunted by what the effort could have been, had the group worked toward achieving a demonstrative impact on the opioid epidemic. Currently, at least 16 states require continuing education on pain management and/or opioid education for HCPs, Kahn said, and several others require some other kind of continuing education. 

The FDA doesn’t require it, though. “Even though the [RPC] CE is compliant with the FDA’s blueprint…there just isn’t any evidence in the peer-reviewed medical literature or health professional literature that mandatory continuing education achieves the goal [of better outcomes]. Until such time as that evidence is revealed, it’s a little hard to mandate it.”

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