September 18, 2018 — Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
The REMS program requires, for the first time, that training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS.
“Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities. As part of our comprehensive work in this area, we’re taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients. Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications,” said FDA Commissioner Scott Gottlieb, M.D. “Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA. As part of the final action being taken today, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90 percent of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content. The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight. It is expected that continuing education training under the modified REMS will be available to health care providers by March 2019.
Today’s action greatly expands the number of products covered by the REMS. Prior to today, the ER/LA Opioid Analgesic REMS included 62 products. But the modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements. The REMS program continues to include Medication Guides for patients and caregivers to read, new Patient Counseling Guides to assist health care providers with important discussions with patients, and plans for assessing the program’s effectiveness.
The FDA is also approving new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting. For the first time, the FDA is requiring the labeling for those products to include information about the availability of education through the REMS for prescribers and other health care providers who are involved in the treatment and monitoring of patients with pain. The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety.
There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal. The FDA also recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help develop a framework to assist medical professional societies in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed. The agency’s aim is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that prescribers are properly informed about appropriate prescribing recommendations, that providers understand how to identify abuse by individual patients, and know how to get patients with opioid use disorder into treatment. The crisis of opioid addiction is a public health tragedy of enormous proportions. The FDA’s goal is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of opioid analgesics, while maintaining patient access to pain medications.
As part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, the FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing unnecessary and/or inappropriate exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products. The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Posted: September 2018
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