ADEA Washington Update

FDA Revises Opioid Analgesic REMS Education Blueprint for Health Care Providers

(HHS, Opioid Abuse, Prescription Drug Abuse, Public Health) Permanent link   All Posts

On Jan. 30, ADEA staff participated in an FDA Opioid Policy Steering Committee meeting. Since May 2017, Commissioner Scott Gottlieb, M.D., has made the opioid epidemic a priority for his agency. The Commissioner stated that FDA would be exploring new ways they could reduce exposure to opioids through prescribers, particularly through their Risk Evaluation and Mitigation Strategy (REMS) authorities.

The Commissioner announced the publication of the FDA’s revised blue print, Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain. The 13-page document contains information on the principles of acute and chronic pain management, nonpharmacologic treatments for pain, and pharmacologic treatments for pain (both nonopioid analgesic and opioid analgesic).

The Opioid Steering Committee is also looking to use REMS authorities to facilitate appropriate prescribing by requiring sponsors to implement a prescriber intervention at the point when the prescriber determines an opioid analgesic prescription is necessary for a patient. For example, a REMS could impact prescribing by requiring that sponsors ensure that prescribers provide specific documentation for a prescription above a specified amount, such as a statement that the quantity prescribed is medically necessary for the patient.

ADEA has been actively working with the White House, agency officials and legislators to address their concerns around prescriber education and training.

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