HHS Issues Guidelines on Naloxone Prescribing, FDA Advisory Boards Recommend Increased Naloxone Access

On Wednesday, the U.S. Department of Health and Human Services (HHS) issued guidance for health care providers and patients detailing how naloxone should be prescribed to all patients at risk for opioid-related complications, including overdose. HHS Assistant Secretary for Health and Senior Advisor for Opioid Policy Adm. Brett Giroir announced the updated guidance that reinforces and expands upon previous guidelines by the U.S. Centers for Disease Control and Prevention (CDC).

Under the HHS guidance issued this week, clinicians are recommended to prescribe or co-prescribe naloxone to individuals at risk for opioid overdose, including, but not limited to: individuals who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have other underlying health conditions. By prescribing or co-prescribing naloxone to at risk individuals, patients and loved ones may be better equipped for potential complications of overdose, according to the recommendation. The guidance also encourages clinicians to educate patients and those who may respond to an overdose on when and how to administer naloxone in its variety of forms. Recall, U.S. Surgeon General Jerome Adams in April issued a national public health advisory urging more Americans to keep on hand and learn how to use naloxone to address the nationwide opioid epidemic.

Also of note, two U.S. Food and Drug Administration (FDA) panels narrowly voted to urge the FDA to take steps to make naloxone more widely available. In a joint meeting on Tuesday, the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) recommended that labels on opioids should urge clinicians to co-prescribe naloxone to high-risk patients. The FDA is not required to follow the advisory boards’ recommendations, but the panels do play an important role in the formulation of regulatory and policy matters of the agency. Despite the updated guidance from HHS on prescribing naloxone this week, it remains to be seen if FDA Commissioner Scott Gottlieb will also take the steps to issue further guidance as the advisory boards recommended.