FDA Recommends Discussing Naloxone with All Patients Receiving Opioid Prescriptions
July 23, 2020
From 1999 to 2018, nearly 450,000 people died from an overdose involving any opioid, including prescription and illicit opioids. Opioids were involved in 46,802 deaths in 2018. The Food and Drug Administration (FDA) is encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat opioid use disorder (OUD).
FDA recommends discussing naloxone with all patients and/or their caregivers when prescribing opioid analgesics or medicines to treat opioid use disorder (OUD). Assess the potential need for patient or home access to naloxone, both when initiating and renewing treatment with opioid analgesics and medicines to treat OUD.
Discuss naloxone with all patients and caregivers when prescribing opioid analgesics or medications to treat OUD.
Consider prescribing naloxone to patients who:
- Are prescribed medicines to treat OUD.
- Have increased risk of opioid overdose, with or without a prescription for an opioid analgesic or medicine to treat OUD (using benzodiazepines or other CNS depressants with opioids, who have a history of OUD, or who have experienced a previous opioid overdose).
- Have household members at risk for accidental ingestion or opioid overdose.
Provide health education related to opioid safety. Key points include:
- Taking an opioid other than how it is prescribed or with alcohol or certain other medicines or drugs could increase the risk of overdose and how to recognize the signs and symptoms of an overdose.
- Naloxone's effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.
- Utilize the teach back method to ensure proper understanding of how to use of naloxone in the event of an overdose. Advise them to tell their family and friends that they have it, and to keep it in a place where their family and friends can easily access it in an emergency.
- Proper storage and disposal of opioids.
For more information, the full FDA Drug Safety Alert and other resources can be found on the FDA website .
Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).
Instructions for reporting can be found online at the NPTC Pharmacovigilance website.