After years of gathering and assessing information from multiple stakeholders, including the AAFP, the FDA has given final approval to a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids.
Part of an ongoing federal initiative aimed at combating misuse and abuse of prescription medications, the REMS requires manufacturers of these powerful analgesics to bankroll the development and dissemination of FDA-specified education on ER/LA opioids for prescribers of the drugs, production of relevant patient education materials, and ongoing assessment of the REMS' reach and effectiveness.
According to a July 9 FDA news release(www.fda.gov), "The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain."
- The FDA recently approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids.
- The REMS requires pharmaceutical companies that manufacture and distribute these drugs to provide voluntary prescriber education, as well as patient education materials.
- An FDA blueprint developed with input from stakeholders, including the AAFP, lays out the core messages to be covered in educational offerings for prescribers of ER/LA opioids.
Maintaining patient access to these medications has been a primary focus of the AAFP throughout its longstanding involvement with this issue. In a letter(4 page PDF) about the proposed REMS that was sent last December to FDA Commissioner Margaret Hamburg, M.D., AAFP Board Chair Roland Goertz, M.D., M.B.A., of Waco, Texas, stressed that point, while also acknowledging the threat posed by the nation's burgeoning epidemic of prescription drug abuse.
"A key mission of the AAFP is to protect the health of the public, and we are deeply aware of the serious problem of prescription drug abuse and the resulting deaths," said Goertz. "At the same time, we need to address the ongoing public health requirement to provide adequate pain management."
Goertz went on to say that the Academy is "deeply concerned about the public health consequences of undertreatment of pain, as well as opioid misuse," citing the 2011 Institute of Medicine report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research(www.nationalacademies.org), which called for enlisting various groups to address the issue collectively. "Careful review of the report suggests that many of its recommendations are consistent with AAFP policy, and it clearly describes the need to involve family physicians and other primary care physicians in the care of people with pain."
Furthermore, Goertz added, as both a national CME accreditor and an Accreditation Council for Continuing Medical Education (ACCME)-accredited CME provider, the Academy is committed to ensuring that CME developed under the REMS is in full compliance with the AAFP's CME credit system criteria and the ACCME Standards for Commercial Support.
That's a key point, because the REMS that FDA officials approved is all about education -- both for physicians and other prescribers of ER/LA opioids and for patients. Briefly put, the REMS comprises three primary components:
- Educational programs for clinicians who prescribe opioids. The FDA worked up a "Blueprint for Prescriber Education" that lays out the core messages to be covered in voluntary educational offerings for prescribers of these drugs. Among elements to be included are information on weighing the benefits and risks of opioid therapy; how to choose, manage and monitor patients who use these agents; and how these patients should be counseled in their safe use. Recognizing the potential for or evidence of abuse, misuse or addiction also will be part of the training.
- Updated medication guides and patient counseling documents. These materials will provide patient-friendly guidance on safely using, storing and disposing of ER/LA opioid drugs. Specifically, patients will be instructed to consult their prescribing clinician before changing the dose of their medication; counseled about specific signs of overdose and who to contact in an emergency; and given advice on how to safely store these medications in the home to prevent accidental ingestion.
- Assessment and auditing of prescriber training. The FDA has established certain goals for the percentage of ER/LA opioids prescribers who complete the training, as well as for assessing prescribers' ongoing understanding of relevant risk information. A key part of this assessment will be determining whether the REMS is adversely affecting patients' access to necessary pain medication.
According to the FDA blueprint, it is expected that after completing the CME/CE activities, prescribers will
- understand how to assess patients for possible treatment with ER/LA opioids;
- be familiar with how to initiate therapy, modify dosages and discontinue therapy with these agents;
- be knowledgeable about how to manage ongoing ER/LA opioid therapy;
- know how to counsel patients and caregivers about the safe use of these medications, including how to store and dispose of them; and
- be familiar with general and product-specific information about ER/LA opioids.
The AAFP has an overarching policy that opposes any action that limits patients' access to physician-prescribed pharmaceuticals, as well as any actions by pharmaceutical companies, public or private health insurers, lawmakers, or the FDA or other agencies, that have the effect of limiting the use of any pharmaceutical product by medical specialty.
A second, more specific Academy policy "opposes legislation or executive action that would require mandatory education of family physicians as a condition for prescribing specific drugs, such as opioids."
It's important to note that although the FDA has authority over the pharmaceutical industry, it has no power to regulate physicians or other clinicians and so cannot require prescribers to complete education related to opioids or any other drug.
Furthermore, although physicians are required to register with the DEA to prescribe certain controlled medications, including ER/LA opioids, the DEA currently has no statutory authority to require physicians to complete specific educational activities to prescribe any drug. The upshot is that at this time, the CME/CE called for by the FDA is not mandatory for prescribers.
The AAFP has fought long and hard to keep it that way, denouncing calls for mandatory CME on opioid prescribing that formed the basis of a bill(www.govtrack.us) introduced by Sen. John Rockefeller, D-W.Va., in March 2011, as well as a plan introduced a month later by the Obama administration.
As for the current FDA action, "The AAFP has been working very closely with the FDA, the Accreditation Council on Continuing Medical Education (ACCME) and industry to be sure we get this right to head off the mandatory CME being threatened by Congress and the administration," said Daniel Ostergaard, M.D., AAFP vice president for health of the public and interprofessional activities.
"The work we've done with the FDA, in particular, has helped ensure that this CME is now offered in a voluntary fashion and is paid for by industry."
Kathy Marian, M.Ed., manager of CME standards and outcomes for the AAFP, echoed Ostergaard's sentiments: "The AAFP, as a credit system, plays a key role in ensuring the CME/CE credit system guidelines are respected and that there is alignment in these guidelines that supports REMS CME/CE and ensures compliance with the ACCME Standards for Commercial Support."
Furthermore, she added, "The AAFP, as a provider of CME, provides clear vision of the components of effective learner-centered CME design and assessment."
An FDA question-and-answer Web page(www.fda.gov) on the ER/LA opioids REMS notes that the first CME/CE activities are anticipated to begin by March 2013.
However, the agency noted, "Even before the CE activities conducted under the REMS become available, all prescribers are encouraged to thoroughly discuss the risks and benefits of these products with their patients. A patient counseling document approved with the REMS will be available to assist the prescriber in these discussions."