The FDA Recommends Prescribers Discuss Naloxone when Prescribing Opioids

The FDA Recommends Prescribers Discuss Naloxone when Prescribing Opioids

The FDA recommends prescribers discuss naloxone when prescribing opioids or medications to treat opioid use disorder (OUD).  In a recent Drug Safety Communication posted on July 23, 2020, the FDA made the recommendations about naloxone in an effort to reduce the risk of death from opioid overdose.  Do you know what the FDA is recommending?  What steps do you need to take as a prescriber?

From 1999 to 2018, over 400,000 people died from an overdose involving an opioid, including both prescription and illicit drugs.  In a continued effort to increase access to the opioid antagonist naloxone, the FDA is requiring drug manufacturers to add new language to the prescribing information to all opioid pain medications.  This will encourage prescribers to assess a patient’s need for a naloxone prescription as well as discuss its availability.

Naloxone is an opioid antagonist used in the emergency treatment of opioid overdose.  It can be given whenever an opioid overdose is suspected in people of all ages and is unlikely to cause any harm if administered to someone who has not overdosed.  Although healthcare professionals often use naloxone, it can also be administered by non-healthcare professionals such as friends, family members or bystanders.  There are three FDA-approved forms of naloxone: a nasal spray, an injectable, and an auto-injector.  It is available in both brand name and generic versions.

What does the FDA recommend you do as a prescriber?

  • Routinely discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.
  • Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose. Patients receiving medicines to treat OUD have a lower risk of opioid overdose than those with OUD who are not being treated; however, they are still at risk of relapse and opioid overdose.
  • Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental opioid ingestion or opioid overdose.
  • Even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.
  • Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone.
  • Inform patients about their options for obtaining naloxone as permitted by their individual state dispensing and prescribing requirements or guidelines for naloxone.
  • Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.
  • Educate patients and caregivers on proper storage and disposal of opioids.
  • Report adverse events involving naloxone, opioids, or other medications to the FDA MedWatch program.

Although we have largely been focused on the enduring COVID-19 pandemic, the FDA and Commissioner Stephen M. Hahn, M.D. are continuing to prioritize the national opioid crisis.  Education is a great tool in all aspects of patient safety, and the opioid crisis is no exception.  Educating healthcare professionals and patients is a crucial step in enhancing the knowledge about naloxone as a potentially life-saving treatment.  We encourage our clients to have this discussion and develop a process for ongoing education, both internally and externally.  We are experts at medication management and safety so if you have any questions or need additional guidance, please contact us.

The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.


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