FDA opioid plan directs funding for CME
Organizations that produce CME are expected to see an uptick in funding from the FDA's new safety plan for extended-release and long-acting opioid analgesics. However, education providers are not expecting to apply en masse for grants, and those that do may be hard-pressed to attract physician participants.
The risk evaluation and mitigation strategy (REMS), the agency's first class-wide REMS plan, requires drugmakers to make CME programs available to all DEA-registered prescribers of these drugs at no-to-nominal cost to the learner, based on a blueprint developed by the FDA. The plan affects more than 20 manufacturers and more than 30 products, such as Purdue Pharma's OxyContin, Endo Pharma's Opana ER and Janssen's Nucynta ER.
A group of manufacturers, formed to give input to the REMS, set up a structure for funding educational grants and will support CME providers through a website and call center. A number of ACCME- and state-accredited education providers have expertise in producing pain or addiction content, said Dr. Murray Kopelow, the chief executive of the ACCME (or the Accreditation Council for Continuing Medical Education, a non-governmental, fee-funded group which accredits CME providers and serves to referee the medical education industry).
However, Kopelow pointed to a survey of these groups, taken earlier this year during a talk he co-delivered at the annual meeting of the Alliance for Continuing Education in the Health Professions. It showed 78% plan to do continuing education in support of REMS. Only half of 121 respondents said they will apply for commercially supported CME, most of them for activities designed to familiarize prescribers with how to initiate therapy, modify dose and discontinue use.
Instead, said Kopelow, “The impact of the continuing education will firstly be in the context of the positive health outcomes.”
Indeed, the FDA's education push is intended to help curb mis-prescribing, misuse and abuse of the highly addictive painkillers. In 2009, 15,597 Americans died from overdoses involving opioids, nearly four times as many deaths compared to 1999, according to the Centers for Disease Control and Prevention.
Dr. John Jenkins, director of CDER's Office of New Drugs, said adverse–event reports received by the agency demonstrate that doctors are not well-trained in using the high-dose drugs. “We've seen evidence there is confusion about how to initiate these drugs, which are the proper patients in [whom] these drugs should be utilized, how to transfer one medication to another and how to stop use of the medication.”
But getting physicians up to speed won't be easy. There is no mandatory requirement that prescribers attend the training sessions.
“Unfortunately, there's no carrot or stick for the doctor,” said Tom Sullivan, president of accredited med ed firm Rockpointe, which offers several activities on pain management. “We are working on programs that make sense for the prescriber, but getting [doctors] to commit to three hours of content in a specific area is a challenge.”
The Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011, but legislation has not been forthcoming. The FDA backed off a mandatory plan, even though the agency was urged to adopt one in 2010 by an independent panel.
Nevertheless, said Margaret Hamburg, FDA commissioner, “By the third year of the program, we expect that at least 60% of the currently 320,000 prescribers of long-acting opioids in the country will receive the training. We of course would like to see the number even higher.”
Hamburg said she hopes Congress will make participation compulsory in the future.
Right now, just a handful of states—California, Oregon, Rhode Island and West Virginia—require pain education for licensure.
With the agency challenged on two fronts—spurring a high number of CME programs and a large swath of physicians to attend them—is the commissioner's 60% goal a reasonable one? “I think it's doable,” said Kopelow. “The content is known, and explicitly outlined by the FDA and to some extent many have developed it already.”
Key to scaling up attendance at the CME activities, which must start by March 1, 2013, is to diversify the initiative across provider types and educational formats. For example, in the ACCME system in 2010, state medical society-accredited hospitals accounted for 2.3 million physician participants, and the annual meetings of the large physician membership groups accounted for another roughly 700,000 participants. Medical education and communications companies contribute another roughly 4.5 million physician participants (many through web-based CME), with schools of medicine another 3.3 million.
FDA will track the number of grants given, prescribers trained and other relevant information, with companies reporting the information periodically. Other components of the program include patient education, including a one-page medication guide which pharmacists will hand out with prescriptions.
CME courses will be subject to independent third-party audit to ensure content and message conform to the blueprint and are free of commercial influence (manufacturers are not allowed to be involved in course design or curriculum), and whether the REMS adversely affects patient access to medications. Physicians will also take follow-up surveys to ensure they understand how to safely prescribe the drugs.
The agency is ultimately accountable for the success of the REMS plan. If the agency determines that the program is not meeting its goals, it will reevaluate, said Jenkins.
Despite its challenges, the opioid REMS could pave the way for more class-wide drug safety plans. Said Kopelow, “This could serve as a model for the future.”