FDA announces labeling changes to reduce risk of death from opioid overdose by increasing access to naloxone

August 3, 2020 · Clinical Connection team

FDA announces labeling changes to reduce risk of death from opioid overdose by increasing access to naloxone

In late July, the U.S. Food and Drug Administration (FDA) announced they are requiring manufacturers of all opioid analgesics and medications to treat opioid use disorder (OUD) to add recommendations about naloxone to the prescribing information and patient Medication Guides.

As part of this effort, the FDA recommends that healthcare professionals consider prescribing naloxone in the following situations:

For all patients prescribed opioid analgesics who:
- Are at increased risk of opioid overdose, including those who are also taking benzodiazepines and other central nervous system (CNS) depressants
- Have a history of OUD, or
- Have experienced a previous opioid overdose
All patients being prescribed medications for OUD
Patients being prescribed methadone and buprenorphine-containing medications for OUD
For patients with household members, children, or close contacts at risk for opioid overdose or accidental ingestion
Other patients at increased risk of opioid overdose even if they are not currently taking an opioid analgesic or medication to treat OUD (e.g., have a current or past diagnosis of OUD or previous opioid overdose)

Impact on workers’ compensation and auto no-fault

As a result of the July 23, 2020 FDA safety communication, we anticipate an upward trend of naloxone products being prescribed for injured claimants. As always, the appropriate medical treatment guidelines should be followed when prescribing opioid analgesics and naloxone. For example, according to ODG, naloxone nasal spray is considered first-line therapy and classified as a “Y” (preferred) drug on the ODG Drug Formulary, whereas naloxone auto-injector is considered second-line therapy and classified as an “N” drug, meaning prior authorization is recommended.

Additionally, state-specific rules and regulations regarding the prescribing of opioid analgesics and co-prescribing of naloxone may vary and should be followed.

At Optum Workers’ Comp and Auto No-fault, naloxone nasal spray and auto-injector are allowed on our standard Global, Auto, First Fill and Injury-based formularies, with maximum fill and cost limits when warranted.

General recommendations for use and availability

Naloxone is an opioid antagonist with no abuse potential and is recommended for complete or partial reversal of opioid overdose induced by natural and synthetic opioids. Some factors that increase risk for opioid overdose include, but are not limited to, history of overdose, history of substance abuse, higher opioid analgesic doses (may vary by treatment guidelines) and concurrent use of benzodiazepines. As a reminder, naloxone cannot reverse overdose effects from medications other than opioid analgesics.

Naloxone is available in three FDA-approved formulations: an injectable, a nasal spray (e.g., Narcan® Nasal Spray) and an auto-injector (e.g., Evzio® auto-injector). The needle-free nasal spray and auto-injector are designed to be administered by a family member or caregiver to an individual with known or suspected opioid overdose. Depending on certain state pharmacy and/or medical guidelines and regulations, naloxone may be available without a prescription. Click here for more information.

For more detailed information on naloxone from the FDA, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration (FDA). News & Events. Newsroom. Press Announcements. FDA News Release. FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone. July 23, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-requiring-labeling-changes-opioid-pain-medicines-opioid-use-disorder-medicines-regarding?utm_campaign=072320_PR_FDA%20Requiring%20Labeling%20Changes%20for%20Opioid%20Pain%2C%20Use%20Disorder%20Medicines&utm_medium=email&utm_source=Eloqua.

2. ODG by MCG Treatment Guidelines and Drug Formulary [database online]. An MCG Health Company. Accessed July 28, 2020.