In a recent letter to the FDA, the AAFP took a strong stance against mandatory "one size fits all" CME for individual physicians as a condition for prescribing opioid analgesic medications.
"The AAFP continues to believe educating physicians is an important tool, but to be impactful, the education must be designed to address needs and gaps of the learners," said the AAFP.
Requiring all physicians or prescribers to complete the same education "regardless of whether a relevant performance gap in this area exists would be a disservice to that physician and their patients since it will result in unnecessary time spent away from patient care."
The July 10 letter(3 page PDF), signed by AAFP Board Chair Wanda Filer, M.D., M.B.A., of York, Pa., came in response to the FDA's request for comments(www.gpo.gov) on its opioid education outreach efforts to date and on possible modifications to that prescriber education program(www.gpo.gov).
- In a recent letter to the FDA, the AAFP took a strong stance against mandatory "one size fits all" CME for prescribing opioid analgesic medications.
- The first part of the AAFP's comment letter focused on testimony provided by the AAFP during public workshops held in May in Washington.
- The AAFP also provided specific recommendations for changes to a document titled "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain."
A Short History
Family physicians may recall that in July 2012, the FDA responded to the burgeoning U.S. opioid abuse and misuse epidemic by approving a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid analgesic medications.
That REMS requires that accredited CME/CE activities specific to opioid medication use be made available to physicians and other health care professionals who prescribe these medications.
Then in May 2016, the FDA convened a meeting(www.fda.gov) to discuss, among other things, whether the REMS unduly hampered patient access to the drugs and whether it minimized the burden to the health care delivery system.
Public Workshop Testimony
Most recently, on May 9-10 of this year, the FDA held public workshops to allow open discussion on a number of opioid-related topics, including the role of health care professional training in improving pain management and the safe use of opioids.
Clif Knight, M.D., AAFP senior vice president of education, testified at the event on behalf of the AAFP.
FDA to Expand REMS Requirements to Short-acting Opioids
FDA Commissioner Scott Gottlieb, M.D., announced on July 10 that the agency has determined that a Risk Evaluation and Mitigation Strategy (REMS) is needed for immediate-release opioid products, in addition to the longer-acting formulations of these drugs.
"To this end, FDA intends to update the existing REMS on extended-release opioid analgesics, and for the first time, extend these same regulatory requirements to the manufacturers of immediate-release opioid analgesic product," said Gottlieb in remarks delivered shortly before an FDA meeting(www.fda.gov) on abuse-deterrent opioid products.
Furthermore, said Gottlieb, the new REMS "will include modifications to the existing blueprint for prescriber education, which describes the content of the education."
Among proposed changes to the blueprint are broadening the information presented on pain management strategies and expanding pain management training requirements to include non-prescriber health care professionals involved in managing patients with pain.
Further details of the planned changes will be rolled out in the coming weeks.
The AAFP began its comment letter by reiterating some of the key points Knight made to highlight Academy efforts to date. For instance, the AAFP noted that it was "cautiously optimistic" that the quantity of prescribed opioids had decreased since 2010.
At the same time, the letter acknowledged that unacceptable levels of misuse and addiction persist and pointed out that family physicians -- who constitute the most utilized medical specialty in the nation -- have a "unique opportunity to be part of the solution."
"Family physicians find themselves at the crux of the issue, balancing care for patients with chronic pain and the challenges of managing the appropriate use of opioids, while always mindful of their misuse and abuse," said the AAFP.
The letter reminded the FDA that the AAFP is
- committed to protecting the health of the public,
- aware of the devastating problem of prescription drug abuse,
- actively engaged in the national discussion on pain management and opioid misuse, and
- supportive of state prescription drug monitoring programs that facilitate the interstate exchange of registry information.
However, the success of monitoring programs depends on accessible, timely and interoperable systems, said the AAFP.
Furthermore, family physicians "already are deeply committed to fine-tuning their ability to prescribe opioids appropriately and effectively." In fact, AAFP members completed more than 141,000 opioid-related CME credits in 2016, said the letter.
The letter also highlighted a 2016 update of an AAFP position paper titled "Chronic Pain Management and Opioid Misuse: A Public Health Concern" that aims to help members treat patients' chronic pain and combat the opioid abuse crisis.
Lastly, the AAFP noted its opposition to "limiting patient access to any physician-prescribed pharmaceutical without cause -- as well as any actions that limit physicians' ability to prescribe these products based on the physician's medical specialty."
FDA Blueprint for Prescriber Education
The AAFP devoted the second portion of its letter to comments specific to the draft document titled "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain,"(www.fda.gov) which proposes revisions to the original "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids." (See sidebar below for more on the revised blueprint.)
In general, the AAFP pronounced the proposed blueprint "overly proscriptive" and suggested that the FDA add educational opportunities on shared decision-making and patient-centric counseling to its recommendations.
"The FDA should focus less on an individualized clinician approach that ignores team-based care, and more on promoting patients as stakeholders in their own care via shared-decision making and collaborative physician-patient management plans," said the AAFP.
"These are fundamental concepts that recognize the importance of primary care, and specifically family medicine, in dealing with the opioid epidemic."
The AAFP urged other, more specific changes, as well. For instance, the letter pointed out that often acute pain does not have a "clear precipitating event," and, thus, diagnostic imaging is not always clinically required. The letter referred the FDA to the AAFP's Choosing Wisely recommendation against imaging for low back pain in the absence of certain "red flags."
The AAFP further suggested the FDA cite evidence-based medical literature regarding screening for endocrine function, as suggested in the proposal's discussion on reviewing adverse events.
In addition, the AAFP called on the agency to "acknowledge that it is impossible for physicians to fully monitor patients in the outpatient setting for extended periods of time," and instead called for language encouraging physicians to "educate patients regarding the signs, symptoms and risks of respiratory depression."
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