April 16, 2019
ASA Commends FDA for Statement on Opioid Labeling and Tapering Guidance
On April 9, 2019, Douglas Throckmorton, M.D., the Deputy Center Director for Regulatory Programs in Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, released a statement on appropriate, evidence-based opioid tapering and FDA-approved labeling for opioid pain medications. The statement coincided with a Drug Safety Communication released by the FDA, which provides guidance to health care providers on how to properly taper patients physically dependent on opioids. ASA commends the FDA for its action which is consistent with ASA’s guidance on similar state related initiatives.
The FDA highlights the importance of identifying an appropriate balance between reducing the rate of new addiction by decreasing excessive exposure to opioids through appropriate prescribing while allowing access to treatment for patients suffering from serious pain. Prior to issuing the Drug Safety Communication, the FDA had received reports of serious withdrawal symptoms in patients physically dependent on opioid pain medications, following forced tapering, or sudden discontinuation of pain medications. Because these patients may attempt to seek out other sources of opioids to self-medicate their pain or withdrawal symptoms with illicit opioids, the FDA released guidance for healthcare providers and patients, as well as required labeling changes for all opioids analgesic medicines.
The guidance in the Drug Safety Communication advises healthcare providers not to abruptly discontinue opioids in patients who are physically dependent. There is no standard opioid tapering schedule that is suitable for all patients; healthcare professionals should create a patient-specific plan to taper dosages, discuss the plan with the patient and guarantee ongoing monitoring and support.
Earlier this year, the Oregon Health Plan was considering a coverage policy that would force taper patients on opioids with certain pain conditions. ASA provided input expressing concern with the policy and at present, the policy has been suspended and consideration postponed. This is one example where individualized patient care was not considered in policy development. ASA commends the FDA for clarifying appropriate tapering guidelines.
The statement also highlights ongoing efforts of the FDA to confront the opioid crisis. ASA is pleased the FDA is working with the National Academies of Sciences, Engineering, and Medicine (NASEM) to advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain caused by a specific condition or procedure. This aligns with a broader National Academy of Medicine’s initiative which ASA is involved in, the Action Collaborative on Countering the U.S. Opioid Epidemic.
The FDA will soon advance policies to require immediate-release formulations of opioids be available in fixed-quantity packaging, such as blister packs, that contain doses typical of what patients may need for common acute pain conditions and procedures. The FDA is also updating information on proper storage and disposal of opioids. As a member of the AMA Opioid Task Force, ASA has endorsed recommendations to promote safe storage and disposal of medications and also supported legislation with provisions that promote safe storage and disposal.
ASA looks forward to continuing working with the FDA and other agencies to address the opioid crisis.