Physicians and other health care professionals seeking to obtain or renew a DEA registration number would be required to complete CME related to responsible opioid prescribing practices under the terms of a plan(www.whitehouse.gov) announced April 19 by the Obama administration.
In addition to required CME, the FDA announced it is requiring manufacturers of long-acting and extended-release opioids to develop a Risk Evaluation and Mitigation Strategy, or REMS(www.fda.gov). The manufacturers will provide educational programs for prescribers, as well as materials health care professionals can use when counseling patients about the drugs.
Although the REMS physician training called for by the FDA will be voluntary, the administration plans to close that loophole with legislation mandating opioid-related CME. In March, Sen. Jay Rockefeller, D-W.Va., introduced a bill, S. 507, that would amend the Controlled Substances Act. Rockefeller's legislation calls for prescribers to complete 16 hours of training every three years on the following topics:
- treatment and management of opioid dependent patients;
- pain management treatment guidelines; and
- early detection of opioid addiction, including screening, intervention and referral for treatment.
The plan announced by the Obama administration was not unexpected. Daniel Ostergaard, M.D., AAFP's vice president for health of the public and interprofessional activities, told AAFP News Now that a group of staff members representing multiple Academy divisions has been working for more than a year in anticipation of potential regulatory actions related to opioids.
"We are poised to work in collaboration with the administration, the FDA, the pharmaceutical industry and others to preserve the ability of family physicians to properly take care of patients with chronic pain, including the use of opioids," he said.
In addition to physician and patient education, the administration's plan calls for increased tracking and monitoring of opioid use, proper disposal through efforts such as increased take-back programs and events, and improved enforcement of statutes aimed at eliminating improper or illegal distribution of these drugs.
Prescription drug abuse has been classified as an epidemic by the CDC. According to the Substance Abuse and Mental Health Services Administration, from 1998 to 2008, there was a 400 percent increase in substance abuse treatment program admissions among people ages 12 and older who reported any pain reliever abuse. A total of 257 million opioid prescriptions were dispensed in 2009, a 48 percent increase compared with figures for 2000, according to the Office of National Drug Control Policy.
More than 700,000 physicians are authorized by the DEA to prescribe extended-release opioids.
"Pain management is a daily issue," said Penny Tenzer, M.D., of Golden Beach, Fla., who is an associate professor and vice chair of the department of family medicine and community health at the University of Miami Miller School of Medicine. "It's something primary care physicians see in their practice on a regular basis. With the proposed regulations and REMS, if physicians want to continue to provide these services -- including prescribing opioid medications -- there will be more required of them."
The FDA said the REMS is intended to educate physicians about the following opioid-related tasks:
- weighing the risks and benefits of opioid therapy;
- choosing patients appropriately;
- managing and monitoring patients;
- counseling patients on the safe use of these drugs; and
- recognizing misuse, abuse and addiction.
It's worth noting that the AAFP developed a monograph -- co-authored by Tenzer -- on the use of opioids in managing chronic pain in anticipation of the FDA's implementation of a REMS last year. The AAFP document, which was mailed with the August 1, 2010, issue of American Family Physician, covers a wide array of topics, including clinical use guidelines, side effects, disposal of unused drugs, new formulations designed to deter abuse, risk factors for abuse and the REMS.
The FDA's recent announcement means the agency is acting against the advice of one of its joint committees, which voted 25-10 against the REMS on July 23, 2010. The FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees rejected the plan because it called for voluntary, rather than mandatory, physician training.
The FDA said at the time that a mandatory program would require a legislative change to give the agency the authority to require training as part of DEA registration.
As for CME, the FDA and a pharmaceutical industry working group will collaborate on guidelines for creating content, but it is unclear who then will develop and administer the CME.
The Academy's Commission on Continuing Professional Development discussed the issue at a January meeting, and sessions devoted to pain management and REMS have been scheduled for AAFP's 2011 Scientific Assembly, which is Sept. 14-17 in Orlando, Fla.
The AAFP also offers CME on pain management through its AAFP Live! and LearningLink programs.
Tenzer said that although some physicians may not be comfortable prescribing opioids, most do so in their practices. It's possible that the additional burden of opioid-specific CME requirements could lead some physicians to stop prescribing the drugs, thus affecting patients' access to these analgesic medications. On the other hand, she said, some physicians may feel more confident in their management of pain with opioids with the additional training and tools that may be provided.
"It would be a shame for this to affect physicians' ongoing care of patients," Tenzer said. "As a family physician, I believe having care provided by your primary care provider -- in a continuity practice -- is the best care there is."
Although licensure-related CME requirements vary from state to state, AAFP members already are required to complete 150 hours of CME every three years to retain their Academy membership, and the 16 hours of opioid-specific content could be included in that total.
"There are always competing priorities for CME," said Tenzer, who also is chief of service for family medicine at the University of Miami Hospital. "As someone who speaks on pain management, I find that people are very interested in this subject. I think it's an area people are already searching for additional information on.
"The question becomes, what will FDA allow to be part of that CME process and how readily available will it be to physicians? The more they make it valuable and accessible, the more receptive physicians will be to it."
That, she said, includes making the CME available in a variety of formats and venues, including live lectures, printed materials and online courses.
Physicians were not specifically singled out in the administration's report, which said most physicians, physician assistants, nurses, nurse practitioners, pharmacists, psychologists and dentists "receive little training on the importance of appropriate prescribing and dispensing of opioids to prevent adverse effects, diversion and addiction."
Educating prescribers about substance abuse is critically important, said the report, because even brief interventions by primary care providers have proven effective in reducing or eliminating substance abuse in people who abuse drugs but are not yet addicted.
The report also calls for required curricula in health professional schools related to opioids and prescription drug abuse. The AAFP already has recommended curriculum for family medicine residents related to chronic pain management and human behavior and mental health.
Tenzer agreed that medical students and residents need more training specific to pain management and opioids.
"Most pain is undertreated," she said. "Being able to treat pain properly is essential for every physician to learn."
The AAFP's Commission on Governmental Advocacy is expected to discuss the administration's plan to reduce opioid abuse following the Family Medicine Congressional Conference, which is scheduled for May 9-10 in Washington, D.C.