Opioid Prescribing Will Be Supervised Within the Year, Say Officials

Allison Gandey

May 10, 2010

May 10, 2010 (Baltimore, Maryland) — The US Food and Drug Administration's (FDA's) controversial opioid risk evaluation and mitigation strategies, known as REMS, are in the final stages of development and could be ready this summer.

The plan will alter the prescribing landscape for opioid therapies and is expected to have important implications for clinicians, the patients who use these drugs, and the companies that make them.

The agency has yet to release details about the new plan, but this weekend Bob Rappaport, MD, from the FDA's Center for Drug Evaluation and Research hinted it will include mandatory education.

Speaking here at the American Pain Society 29th Annual Scientific Meeting, Dr. Rappaport said he is unable to confirm any details but suggested that education will factor prominently.

Dr. Bob Rappaport, FDA

"Physician and patient education would be the most beneficial component," he said. "Clinicians could be educated to maintain prescribing privileges for CII opioids and must be willing to require their patients be engaged in safety messaging."

Drug overdose death rates in the United States are at an all time high. "The numbers have increased approximately 5-fold since 1990, largely because of opioids," Dr. Rappaport said.

According to some reports, there are more deaths from opioid overdoses than with heroin and cocaine combined. In some states, these rates are higher than deaths from automobile accidents. An estimated 60% of hospital costs from overdoses are paid for with public funds.

"This trend is something we cannot accept," said session moderator Lynn Webster, MD, from Lifetree Clinical Research and Pain Clinic in Salt Lake City, Utah.

Dr. Lynn Webster, session moderator

The sentiment is echoed by a public outcry and push by the US Congress prompting these changes. This is the first time REMS will be applied to all opioids, but others are already in place for more than 100 medications, including many cancer drugs.

Even so, many clinicians working with pain patients are justifiably concerned.

Dr. Rappaport, also a neurologist, acknowledges that untreated chronic pain is an enormous public health problem. "We are going to need to find a balance," he said, "between ensuring patients can achieve adequate pain control with access to opioid therapies while taking steps to protect against addiction and death," he said.

"FDA is not going to be able to do this alone," Dr. Rappaport added.

The other big issue is how officials will measure the impact of the new plan. Will the program be considered a success if rates of abuse and misuse decrease? Or will it also take patient access into account? Fewer prescribed opioids would ensure the drugs are off the streets, but this won't address the issue of adequate pain control for the people who need it.

Dr. Rappaport said there will be a push for manufacturers to improve their databases.

"REMS are not for sleeping anymore," David Haddox, MD, from Purdue Pharma, said at the meeting. "If you snooze, you lose."

Dr. Haddox raised concerns about educating physicians and patients in face of the huge number of opioid abusers who are acquiring the drugs outside medical practice. "Nonpatients don't want to be educated," he said. "How can we control these issues in a nonpatient who is consciously seeking this out?"

Dr. David Haddox, Purdue Pharma

Dr. Haddox is part of an international working group of pharmaceutical companies reviewing the issue. His team says that should the FDA require a particular training or certification before dispensing opioids, a system similar to the Drug Enforcement Administration (DEA) registration for buprenorphine might work.

Asked by Medscape Neurology to comment, Seddon Savage, MD, president of the American Pain Society, said she agrees with DEA involvement. "It isn't something we can do immediately and it would require legislative changes, but this is the best long-term solution."

Aaron Gilson, MD, from the University of Wisconsin at Madison, said he is concerned about the unanticipated consequences of the new plan. "I am heartened to hear today there is attention being paid to this."

An FDA advisory committee is scheduled to meet in July. In the meantime, the agency is accepting public input online at http://www.regulations.gov. To submit comments, enter the code FDA-2009-N-0143-1061.

"You might want to type your comments up in Word first and copy and paste," Dr. Gilson added. "That page times out quickly and maybe others can learn from my mistake," he smiled.

Dr. Rappaport works for the FDA. Dr. Haddox is an employee of Purdue Pharma. Dr. Savage has worked on advisory boards for Ameritox, Alpharma, MEDA, and REGISTRAT-MAPI. Dr. Gilson reports financial ties to Cephalon and Purdue Pharma. Dr. Webster reports relationships with Boston Scientific, Cephalon, Elan, Medtronic, Ameritox, Advanced Bionic, Abbott, AstraZeneca, CoMentis, Forest, GlaxoSmithKline, and others.

American Pain Society (APS) 29th Annual Scientific Meeting: Abstract 106. Presented May 8, 2010.


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