FDA Approves New Safety Measures for Immediate-release Opioid Analgesic Medications

PUBLISHED: Sep 19, 2018
Relevant to: All Healthcare Organizations, Pharmacy

The U.S. Food and Drug Administration (FDA) has approved 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, 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:

  • Training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers. (e.g., training provided through the REMS must be made available to nurses and pharmacists.)
  • Education must cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.
    • New product labeling will contain information about the health care provider education available through the new REMS.

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.

Along with this new REMS action, the FDA has also approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint)., whihc includes updated educational content. The FDA 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.

Follow the link below for additional information. Included with today’s notice is an example policy address opioid education and training for individuals involved in prescribing, dispensing and monitoring opioids.

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