Federal Policymakers Should Urgently and Greatly Expand Naloxone Access

ABSTRACT

Since March 2020, the US federal government has invested tremendous public health effort in COVID-19 responses by expediting the availability of vaccines and have therapeutics. Reduced access to addiction treatment and services combined with fentanyl infiltrating drug supplies resulted in an estimated 100000 fatal overdoses in 2020 alone.1 Although the Centers for Disease Control and Prevention iCDC;has released official health advisories2 and the US Department of Health and Human Services (HHS) has supported widespread implementation of expanded distribution and use of naloxone in high-risk populations, there is not enou ugh naloxone in the hands of those who need it most. The opioid overdose crisis continues to ravage communities;thus, we call for federal policymakers within the US Department of Health and Human Services or the FDA to facilitate OTC approval of at least one formulation of naloxone, with or without manufacturer request or approval. State legislatures that implemented coprescribing mandates have seen substantial increases in naloxone prescribing, engagement of a larger and more diverse set of prescribers, expanded geographic reach, and reductions in opioid-related harm.18-20 In 2018, a panel of experts at the Drug Safety and Risk Management Advisory Committee narrowly voted against a coprescribing mandate, citing concerns for potential risks of drug shortages, diverting naloxone from community programs, rise in health care costs, institutional racism benefiting insured patients, and threats to provider autonomy in identifying patient risk.21 Instead, this committee recommended changing opioid prescription labels to encourage coprescription, which was released as an FDA mandate in July 2020 to opioid drug manufacturers.22 Although it remains unclear if these label changes were widely implemented, they serve as a mere nudge for providers to have discussions with their patients about the importance of naloxone, whereas mandatory coprescribing will facilitate increased distribution ofthis lifesaving medication.