RE: Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use. Docket No. FDA-2022-N-2673 - I. Safety of Naloxone Hydrochloride
10 January 2023
The nation needs full market saturation of naloxone to address the scope and severity of the opioid epidemic effectively. [...] Need for Community Saturation of Naloxone Hydrochloride Community saturation refers to the idea that there is enough naloxone in a community to ensure that lack of access does not result in overdose death.6 Although the exact amount of naloxone needed to reach saturation is difficult to calculate and differs based on the community, most places have not reached community saturation.7 One study usin. [...] No Evidence that Naloxone Hydrochloride Leads to More Drug Use Stigma regarding nonprescription opioid use is often related to a belief that greater access to naloxone will cause people to perceive opioid use as less risky or encourage people who use opioids to use greater Stigma of Opioid Use Disorder?”, Journal of Pharmacy Practice (May 3, 2022). [...] Studies have found that among the general public, as well as more vulnerable subpopulations, naloxone access does not decrease the risk perception of heroin use.23 Similarly, there is no evidence that people who use opioids engage in riskier substance use because of the availability of naloxone.24 Finally, there is also no evidence that overdose frequency increases due to naloxone availability.25. [...] Since cost is one of the primary barriers to naloxone access, it also is important to consider how allowing nonprescription sales will impact insurance coverage and overall cost.26 With major medical organizations, such as the American Medical Association and the American Pharmacists Association, endorsing nonprescription naloxone access, it is clear that medical professionals see a need for expan.