On September 18, 2018, the United States Food and Drug Administration (FDA) approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The new REMS is one of many different strategies at the state and national levels to reduce the risk of abuse, misuse, addiction, overdose, and death due to prescription opioids.
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 that training be made available to all health care providers (HCPs) – not just prescribers – who are involved in the management of patients with pain – this includes nurses and pharmacists. To meet this requirement, drug companies with approved opioid analgesics will provide unrestricted grants to accredited continuing education providers for the development of education courses for HCPs based on the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (Blueprint).
The FDA believes that by educating all HCPs involved in the chain of management of patients with pain, 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. This will also add several layers to ensuring patients are receiving the correct prescription for their pain and problems, and are not using or abusing in ways inconsistent
While there is no mandatory federal requirement that prescribers or other HCPs take the training and no precondition to prescribing or dispensing opioid analgesics to patients, the FDA’s Opioid Policy Steering Committee is regularly considering whether there are circumstances when the FDA should require some form of mandatory education for HCPs, and if so, how the agency would pursue such a goal. The FDA’s goal is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that HCPs are properly informed about appropriate prescribing recommendations, that they understand how to identify abuse by individual patients, and that they know how to get patients with opioid use disorder into treatment.
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.
This action also largely expands the number of products covered by the REMS. Prior to the release of the final guidance, the ER/LA Opioid Analgesic REMS included 62 products. However, the modified Opioid Analgesic REMS now requires that 347 opioid analgesics 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.