Life Science Compliance Update

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February 02, 2018

FDA REMS Blueprint on Opioids Finalized

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On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (non-opioid analgesic and opioid analgesic).  This REMS represents a major upgrade from the current ER-LA Opioid REMS and includes all Opioid Manufacturers.

Ever since the Opioid Policy Steering Committee was established the FDA has been working to evaluate different policy efforts to combat the emergency. According to FDA Commissioner Dr. Scott Gottlieb, “At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use.”

The Blueprint aims to educate health care providers on safe opioid practices, as well as current Federal and state regulations, national guidelines, and professional organization and medical society guidelines on treating pain and prescribing opioids.

The Blueprint begins with an overview on pain management, including intelligence behind the need for comprehensive pain education, definitions and mechanisms of pain, and how to assess patients in pain.

From there, it goes on to help providers learn how to create a pain treatment plan, customized to the needs of the individual patient and including the types of therapies planned, the goals of treatment, and an explanation of the patient and prescriber roles and responsibilities. It further notes that if HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat patients with pain, attempts should be made to address these barriers. The overall treatment approach and plan should be well documented in the patient record, including written agreements and informed consent/patient provider agreements that reinforce patient-provider responsibilities and avoid punitive tones.

The section about creating a pain treatment plan includes sections that outline: components of an effective treatment plan, general principles of nonpharmacologic approaches, general principles of pharmacologic analgesic therapy, managing patients on opioid analgesics, and a primer on addiction medicine.

FDA is making the FDA Blueprint, which will be approved as part of the Opioid Analgesic REMS, available on the REMS@FDA Website (www.fda.gov/REMS), where it will remain posted for use by CE providers as they develop the CE materials and activities. A list of the REMS-compliant CE activities supported by unrestricted educational grants from the opioid analgesic companies to accredited CE providers will be made available when the Opioid Analgesics REMS is approved.

Other FDA Actions

On the same day the FDA released the new Blueprint, the Agency also hosted a meeting entitled, “FDA’s Opioid Policy Steering Committee – Prescribing Intervention – Exploring a Strategy for Implementation,” where various stakeholders spoke about the Agency’s Risk Evaluation and Mitigation Strategy (REMS) authority and how to improve safe use of opioid analgesics.

In the Press Announcement that accompanied these moves by the FDA, Commissioner Gottlieb wrote, “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse. If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books. You have a social contract to take voluntary steps to help address public health challenges.”

Gottlieb encouraged stakeholders to participate in this ongoing process by submitting electronic or written comments to the docket until March 16, 2018.

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