FDA Recommends Naloxone Prescription for Patients Receiving Opioids or Medications Used to Treat Substance Use Disorder

By: Kristen Andrews Wilson, Aleah M. Schutze

Published: August 18, 2020

In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid reversal medication, to patients who are being treated with opioid pain relievers or medications that treat Substance Use Disorder (“SUD”).  Specifically, the FDA recommends that providers discuss the use of Naloxone with: (1) patients who are prescribed opioid pain relievers in connection with another medication that depresses the central nervous system, such as benzodiazepines; (2) patients who are prescribed medications to treat SUD, particularly if the patient resides in a household with children; and (3) patients who are currently prescribed high doses of opioids, or who have had a previous episode of opioid overdose.

This Drug Safety Communication is an acknowledgement of the challenges faced by providers in treating long-term use opioid patients when those patients have valid pain complaints. State-specific statutes and regulations, as well as provider licensing bodies, may provide further guidance on this topic. Providers should continue to carefully document attempts to find the lowest-effective dose of an opioid pain reliever for their patients and generally utilize conservative treatments. In addition, providers should take appropriate actions to mitigate the risks of opioids such as the use of narcotic contracts, urine drug screens, and pill counts.

If you have any questions regarding the FDA’s Drug Safety Communication, please contact one of the authors of this alert.

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