October 25, 2018

This past week, as part of the U.S. Food and Drug Administration’s (FDA) goal of reducing serious adverse outcomes resulting from inappropriate prescribing and misuse and abuse of opioid analgesics, while maintaining patient access to pain medications, the FDA approved its final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).[1] This new strategy expands the number of products previously covered as well as the target audience to be reached through educational activity.  The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a REMS from manufacturers where, due to certain risks associated with a drug or a class of drugs, a strategy is required to ensure that the benefits of the drug(s) or biological product(s) outweigh those risks. The new opioid REMS focuses on effectively communicating the serious risks associated with opioid pain medications to both patients as well as to health care professionals.

Expanded Application to Immediate-Release (IR) Opioid Analgesics

Importantly, while extended-release and long-acting opioid analgesics have been subject to a REMS since 2012, and all transmucosal immediate-release fentanyl prescription medicines have been subject to a REMS since December 2011, this new strategy now also applies to immediate-release (IR) opioid analgesics (used primarily in outpatient settings). This increases the scope of products reached from 62 to 347 – and IR drugs currently represent 90 percent of all opioid pain medications prescribed for outpatient use.

More Clarity on REMS Educational Content and Reach

To assure educational content quality and impact, the FDA has also approved an Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint).[2] The Blueprint provides that REMS educational content must include comprehensive information about appropriate pain management. Of note, this includes information about alternative therapies to opioids as well as new Patient Counseling Guides designed to help providers engage with and counsel patients. The formerly-required medication guides for patients and caregivers will continue to be a mainstay of the strategy.

To help ensure that proper products are selected for patients in pain, and that they are used with appropriate clinical oversight, manufacturers must make training available not only to prescribers- but to all health care providers involved in pain treatment. This expanded population will now include, for example, nurses, nurse practitioners and pharmacists. It is expected that continuing education training under the modified REMS will be available to health care providers by March 2019.

Improved Labeling Features

As part of this strategy, the FDA will be approving new safety labeling changes for opioid products used in the outpatient setting. This new product labeling will inform health care providers about the availability of and access to educational materials and resources in the “Boxed Warning” and “Warnings and Precautions” sections of labeling. Providers will be “strongly encouraged” to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; 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. Although there is no requirement that providers avail themselves of the training now being offered as a prerequisite to prescribing opioids, the FDA has indicated that it will continue to consider whether such a mandate is warranted. To develop educational materials to meet new FDA requirements, pharmaceutical manufacturers have been providing unrestricted grants to accredited continuing education providers. FDA has indicated that it intends to require an opioid class post market packaging change to help limit distributed pill count and facilitate REMS rollout. The anticipated FDA packaging change mandate for the opioid class will likely focus on designs that will best accommodate these new labeling features.

If you have any questions about the final Opioid Analgesic REMS or anticipated FDA packaging mandates, please contact a member of Hancock Daniel’s Life Sciences team.



The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.




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