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Weekly UpdatesGAITHERSBURG, MD. -- Top officials from the Food and Drug Administration heard both passionate pleas to take immediate action and measured advice to proceed cautiously in implementing Risk Evaluation and Mitigation Strategies for certain opioid pain medications at a recent public meeting.
More than 80 people representing physicians, pharmacists, industry, and patient and drug reform advocacy groups spoke during the 2-day meeting, providing advice on how to design, implement, and assess Risk Evaluation and Mitigation Strategies (REMS) to stem the rise of adverse events and deaths caused by both medical and nonmedical use of opioid analgesics.
In February, the FDA sent letters to 16 manufacturers of generic and branded extended-release and long-acting opioid transdermal patches, capsules, and tablets that required the products to have REMS. Immediate-release opioids would not be subject to REMS under the current proposal, although some groups represented at the meeting, such as the American Pain Society, called for REMS for all types of opioids.
"We focused on the long-acting and the sustained-release products because that's where we're seeing a lot of problems related to serious adverse events and deaths from overdose and misuse," said Dr. John K. Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.
Even without the inclusion of immediate-release opioid formulations, a REMS program for extended-release and long-acting opioids would dwarf the scale of all other previous REMS programs, including the iPLEDGE program for generic and branded isotretinoin. In 2008, iPLEDGE involved 20,000 prescribers and 1 million prescriptions, whereas 375,000 prescribers wrote 26 million prescriptions for extended-release and long-acting opioids, Dr. Craig Landau, chief medical officer for Purdue Pharma LP, said at the meeting.
Dr. Roy Altman, professor of medicine in the division of rheumatology and immunology at the University of California, Los Angeles, maintained that although the safety and diversion of opioid medications are important concerns, pain is still undertreated in many patients and additional barriers to its treatment will not be helpful.
"In my perspective, the problem has not been the overuse of narcotics; it's been the under-use," he said in an interview. "If you put more restrictions on it, it will continue to be a problem." Dr. Altman did not participate in the meeting.
The opioid drugs on the FDA's list are mostly transdermal or extended-release oral formulations, and include brandname products fentanyl (Duragesic extended-release transdermal system), methadone (Dolophine tablets), oxycodone (OxyContin extended-release tablets), oxymorphone (Opana extended-release tablets), and several extended-release oral morphine products. Generic products include several transdermal fentanyl products, methadone tablets, extended-release morphine, and extended-release oxycodone tablets. The products on the list are being targeted because they are responsible for the greatest proportion of serious adverse events and deaths, according to Dr. Jenkins.
At the meeting, there appeared to be a clear majority viewpoint among those who spoke on various aspects of REMS for opioids. Many speakers were in favor of conducting pilot studies of REMS in certain geographic regions of the country. Many thought that an independent patient registry was unnecessary to track the implementation of REMS, and that the same information could be obtained through existing state prescription drug-monitoring programs.
If it is necessary to certify all physicians and pharmacists who wish to prescribe or dispense opioids, most speakers said the process should be carried out through the existing Drug Enforcement Administration system. Many participants agreed that the training of physicians in appropriate prescribing, and of pharmacists in dispensing, could be carried out within existing continuing-education formats. Patient education about the appropriate use of opioids as well as their risks was unanimously thought to be an important part of REMS, but proposals were not consistent in how or where such education would take place. The FDA was interested in hearing about ways to evaluate the success of the REMS, but speakers offered few specifics on how this could be accomplished.
Several speakers also suggested that separate REMS for methadone may be necessary because of the drug's very long half-life and its unique indication for the treatment of opioid addiction.
Dr. Ardis D. Hoven, a member of the board of trustees of the American Medical Association, said the AMA supports the use of positive incentives to encourage physicians to complete educational requirements, as well as alternative strategies to promote provider education.
A drug industry consortium of 25 companies that manufacture generic and branded opioid medications, which formed after the FDA first required the opioid REMS, supports the use of a patient guide to go with the medications, as well as prescriber and dispenser education, training, and certification, and prescriber-patient agreements with periodic drug screening and information on how to obtain prescription refills, Dr. Landau said.
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