Opioid analgesics, such as hydrocodone, oxycodone, and morphine, are powerful pain-reducing medications that have both benefits as well as potentially serious risks. The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks. The Opioid Analgesics REMS, approved on September 18, 2018, is one strategy among multiple national and state efforts to reduce the adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse of opioid analgesics.
The REMS program requires that training be made available to all health care providers (HCPs) who are involved in the management of patients with pain, including nurses and pharmacists. To meet this requirement, drug companies with approved opioid analgesics are providing unrestricted grants to accredited continuing education (CE) providers for the development of accredited CE programsfor HCPs based on the FDA’s Opioid Analgesic REMS Education Blueprint for Healthcare Providers Involved in the Treatment and Monitoring of Patients with Pain.
Although training is not mandatory for HCPs to prescribe or dispense opioid analgesics, the FDA believes that all HCPs involved in the management of patients with pain should be educated about the fundamentals of acute and chronic pain management and the risks and 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.
HCPs are strongly encouraged to use the Patient Counseling Guide to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. HCPs are also strongly encouraged to 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 such as a patient-provider agreement.
Accredited CE programs available under the Opioid Analgesic REMS are offered for free or for a nominal fee and can be found at the following website: https://search.opioidanalgesicrems.com/Guest/GuestPageExternal.aspx
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