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FDA Issues Educational Blueprint on Opioid Risk Mitigation

The Food and Drug Administration (FDA) has released a blueprint to guide opioid manufacturers in developing education tools for health care providers.

The blueprint, titled “Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” was released as part of FDA’s updated risk evaluation and mitigation strategy (REMS). Under the REMS, opioid manufacturers must provide education, through accredited continuing education activities, to health care providers — including prescribers, pharmacists, and nurses — who participate in the treatment and monitoring of pain.

Educational tools created using the blueprint will cover a range of topics related to opioids and pain management, including:

  • fundamentals of pain management;
  • assessing patients in pain;
  • identifying risk factors for abuse and addition;
  • integrating opioids into a pain treatment plan;
  • safely managing patients on opioids;
  • counseling patients and caregivers about the safe use of opioids;
  • counseling patients and caregivers about the use of naloxone for overdoses;
  • fundamentals of addiction medicine; and
  • identifying and managing patients with opioid use disorder.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Rachel Schwartz is a former policy associate at America's Essential Hospitals.

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