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FDA Weighs Risk Strategies for Opioids

2009; Elsevier BV; Volume: 10; Issue: 9 Linguagem: Inglês

10.1016/s1526-4114(09)60226-2

2377-066X

JEFF EVANS,

Pain Management and Opioid Use

GAITHERSBURG, 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 individuals 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 John K. Jenkins, MD, 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 be larger than all previous REMS programs, Dr. Craig Landau, chief medical officer for Purdue Pharma LP, said at the meeting. The opioid drugs on the FDA's list are mostly transdermal or extended-release oral formulations, and include brand-name 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. 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. Several speakers also suggested that separate REMS for methadone may be necessary because of the drug's very long half-life and its indication for the treatment of opioid addiction. Ardis D. Hoven, MD, a member of the board of trustees of the American Medical Association, said that the AMA supports the use of incentives to encourage physicians to complete educational requirements. “Mandatory education and certification can only be used as a last resort to keep high-risk products with unique and important benefits on the market [because they] may have several unintended consequences, including physicians opting out of prescribing schedule II controlled substances, with fewer primary care physicians willing to manage patients with chronic pain,” Dr. Hoven said. 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. “REMS are not a bad idea in general,” said William Smucker, MD, CMD, a medical director in Akron, Ohio, in an interview. “They are intended to assure prudent and safe prescribing of medications with potential for abuse and for those medications with a potential for serious adverse effects, and they often focus on appropriate monitoring for these effects.” Dr. Smucker noted that there has been an increase in opioid misuse and overdoses in the community due to drug diversion. “It is possible that long-term care facilities will need to have policies to make sure that practitioners prescribing opioids have appropriate experience or training. It also is possible that all prescribers will be required to assess patients for risk of abuse as part of the prescribing process,” he said. “It is unlikely that long-term care will be exempt from this, but institutional settings already have processes in place that reduce the chance that a patient can misuse a prescribed medication.” Medical directors can take the lead on this, said Dr. Smucker, by working with consultant pharmacists to educate attending physicians and nurses about compliance with the law. “This may involve adapting educational handouts for patients, families, physicians, and staff,” he said. On the other hand, Dr. Smucker said he hoped that REMS won't result in “the creation of a stack of consent forms for all medications with potential adverse effects.” Jeff Evans is a senior writer with Elsevier Global Medical News.