The US Food and Drug Administration (FDA) has unveiled its long-awaited opioid plan that will change the regulations for long-acting and extended-release opioids. More than a million prescribers are currently registered with the Drug Enforcement Administration (DEA) to distribute opioids. Approximately 700,000 of these prescribe long-acting and extended-release products.
The central component of the new opioid Risk Evaluation and Mitigation Strategy (REMS) is an education program for prescribers. The agency will require drug makers to provide and pay for the plan, although the training is still not mandatory for prescribers.
"REMS juxtaposes pharmaceutical companies and continuing medical education [CME] in a way that hasn't occurred before," Murray Kopelow, MD, chief executive of the Accreditation Council for Continuing Medical Education, told Medscape Medical News. "There will be a prescribed curriculum and companies will be accountable to the FDA."
Despite the changes, Dr. Kopelow says drug makers and CME providers can expect more of the same when it comes to accreditation. "The standards we have set will still be applicable," he emphasized, adding, "We are honored that the government views accredited CME as a strategic asset to public health and safety initiatives."
New education programs will soon be launched for morphone, hydromorphone, morphine, methadone, oxycodone, oxymorphine, transdermal fentanyl, and buprenorphine.
"This is a very favorable and long overdue change," Charles Argoff, MD, a pain expert from the Albany Medical Center in New York, said during an interview. "I see this as an opportunity to improve patient care and safety."
However, like many others, he is concerned the plan stops short of what is required to resolve the issue.
"I'm glad the FDA acted," Dr. Argoff added. "Unfortunately, I don't think this goes far enough to get at the root of the problem. This plan is a step in the right direction, but I see this as just the first of many more steps forward," he said.
"We have been allowing physicians with insufficient training to prescribe medications that can kill people," he said. "I hope the companies involved and the continuing medical education providers take this call to action very seriously and as a real opportunity for change."
Long-acting and extended-release prescription opioids can provide effective pain management for appropriately selected patients when used as directed, the FDA pointed out in an online news release. "However, there are serious risks associated with patients being prescribed these drugs who shouldn't take them or accidental or intentional improper use."
The plan is part of the White House's first national action plan to fight prescription drug abuse announced last week. The Office of National Drug Control Policy, the DEA, and the FDA are banding together to address the problem they say has become "an epidemic."
Drug overdose death rates in the United States are at an all-time high. According to some reports, there are more deaths from opioid overdoses than from heroin and cocaine overdoses combined. In some states, these rates are higher than deaths from automobile crashes. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.
The FDA is now asking the US Congress to pass legislation that would link mandatory physician training to obtaining a DEA number that physicians now need to prescribe controlled substances.
An FDA advisory panel on this issue strongly supported such legislation. As it stands now, the education programs will be mandatory for drug makers but voluntary for prescribers. The FDA will not require any formal prescriber enrollment or real-time verification of training.
Physicians Could Opt Out
The FDA dropped a number of early ideas, such as prescriber accreditation and patient registration programs. Bob Rappaport, MD, from the Office of Drug Evaluation, said last summer that those plans were abandoned because of concerns over how onerous it might be to track close to a million prescribers. Some patients, he said, also complained about possible registration requirements.
The agency presented the watered down approach to an unusually large 35-member panel. The FDA had called on members from multiple committees to weigh in, and they voted overwhelmingly against it. In the 25 to 10 vote rejecting the proposal, committee members said they disliked the idea of optional physician training and the exclusion of immediate release formulations in the plan.
Those casting votes were from the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management advisory committees. Most agreed safety measures for opioids are urgently needed but voiced concern that the current approach does not go far enough to protect the public.
"I voted no," committee chair Jeffrey Kirsch, MD, from the Oregon Health and Science University in Portland, said at the July meeting. "I fully support that REMS is a critical requirement of provider learning, but these initiatives will need to establish definite competencies and assessments."
Dr. Kirsch also pointed out at the meeting that both immediate-release and extended-release formulations "have a huge impact on public health."
In a position statement issued by the American Academy of Pain Medicine, specialists said that any new plan should cover the entire class of opioids.
"Any attempt to regulate only a portion of the opioid class of medications will drive prescribers, users, and misusers of these medications to the other, less stringently regulated, but often abused members of the class of medications," the statement notes. "This will not diminish abuse or misuse and will very likely result in decreased access to appropriate therapy for some legitimate patients."
FDA officials say they will begin with long-acting and extended-release opioids because the amount of opioid contained in these formulations is much greater than the amount contained in immediate-release drugs.
Regulators told reporters attending a news conference they may revisit adding immediate release opioids at a later date.
Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said drug manufacturers will be responsible for tracking how many physicians opt in for the education programs.
Dr. Woodcock said they have already contacted the companies involved. "We all support mandatory training," she added, "but that would require legislative change."
Continuing Medical Education
Herbert Neuman, MD, vice president of medical affairs and chief medical officer at Covidien Pharmaceuticals, said in an interview he believes the FDA is moving the field in the right direction.
Covidien already has extensive REMS experience with their hydromorphone extended-release product Exalgo.
"This was the proper way to approach the problem," Dr. Neuman said, noting that Covidien supports the possibility of legislative change to pave the way to mandatory training. "We already offer continuing medical education as an incentive for physicians, but new DEA requirements would certainly provide further incentive."
Dr. Neuman says the FDA focus on prescribers makes sense, but he'd also welcome the inclusion of pharmacists. "We'd like to expand the focus beyond just the prescriber," he said.
What might these new CME programs look like? Dr. Neuman says he'd like to see a mix of face to face education at major meetings and online offerings. "Ideally, it will be multimodal," he noted.
"We plan to offer education opportunities that will be the least disruptive to daily practice."
Many psychiatrists and addictions specialists are in favor of the FDA plan. The American Psychiatric Association issued a statement saying it supports the move. The American Osteopathic Academy of Addiction Medicine and the American Academy of Addiction Psychiatry have also issued statements of support.
The American Pain Society has not yet weighed in publicly. Its public policy committee is scheduled to meet in May to discuss the issue at the group's annual meeting.
Allison Gandey • Medscape Medical News © 2011 WebMD, LLC