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May 26, 2011 (Austin, Texas) — In the first national meeting on pain since the US Food and Drug Administration (FDA) announced its long-awaited opioid plan, specialists came out on the side of the move, but they did so with reservations.

"This is a good first step and a reasonable way to go," Edward Michna, MD, chair of the American Pain Society's Public Policy Committee told Medscape Medical News. However, he said, this is likely just the first of many necessary steps moving forward.

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.

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 last month they may revisit, adding immediate release opioids later.

The American Pain Society has been advocating for a classwide REMS that covers all opioids. "We are concerned that regulating one area will inappropriately drive prescribing," Dr. Michna said.

Lukewarm Reception

The American Academy of Pain Management has raised similar concerns. "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 academy pointed out in a position statement. "This will not diminish abuse or misuse and will very likely result in decreased access to appropriate therapy for some legitimate patients."

Past 30-Day Opioid Abuse in Patients Entering Treatment

During a satellite symposium here at the meeting, Simon Budman, PhD, president and chief executive officer of Inflexxion, showed a chart comparing immediate and extended-release opioid abuse in patients entering treatment. The problem was evident with both formulations. "An effective REMS would reduce overall prescription drug abuse," Dr. Budman said.

The new plan is part of the White House's first national action plan to fight prescription drug abuse announced in April. Agencies 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 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 collisions. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.

Session chair Perry Fine, MD, from the University of Utah in Salt Lake City, said he has observed a shift from policing during the Bush administration to a public health orientation with the Obama approach.

Dr. Fine's home state of Utah has been particularly hard hit by America's prescription drug abuse problem. Unintentional deaths from opioid overdoses rose 500% from the year 2000 to 2007.

According to a Centers for Disease Control and Prevention report, just over 20% of Utah adults had been prescribed an opioid during the past year. The vast majority — 72% — had leftover medication.

Problem in Utah

The state launched a media campaign to educate the public about the dangers of opioid misuse and set up continuing medical education for prescribers.

"We offered 46 presentations attended by 581 physicians," Erin Johnson, MPH, from the Utah Department of Health, said at the meeting. Prescribers were required to complete homework before the presentation and complete a series of surveys.

Polling showed the majority of physicians stopped prescribing long-acting opioids for acute pain after the sessions. Half of participants went on to enroll in a prescription monitoring program. Half also started using lower starting doses and slower escalations of analgesics. About a third to half of physicians implemented guidelines, and the same number of prescribers requested electrocardiograms and sleep studies as needed.

New education programs will soon be launched across the country for morphone, hydromorphone, morphine, methadone, oxycodone, oxymorphine, transdermal fentanyl, and buprenorphine.

"Physicians are overworked and overwhelmed and have a lot of other things to do," Dr. Michna acknowledged. "I hope prescribers will keep an open mind and restrict their aversion to this."

Dr. Michna says he knows opioid abuse is a much greater issue that extends beyond prescribers. "This is just one small component."

In a statement, the society confirmed it is advocating for "a comprehensive approach to address this serious health problem."

In an email to Medscape Medical News, the American Academy of Pain Management said, "We applaud the long-awaited provisions of the FDA's risk evaluation mitigation strategy and coordinated effort to reduce adverse outcomes."

The satellite symposium was sponsored by the Postgraduate Institute for Medicine and Miller Communications, LLC.

American Pain Society (APS) 30th Annual Scientific Meeting: Satellite Symposium. Presented May 19, 2011.

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