Naloxone over the Counter: Increasing Opportunities and Challenges for Health Providers

Background Previous studies on high-risk opioid use have only focused on patients diagnosed with an opioid disorder. This study evaluates the impact of various high-risk prescription opioid use groups on healthcare costs and utilization. Methods This is a retrospective cohort study using QuintilesIMS health plan claims with independent variables from 2012 and outcomes from 2013. We included a population-based sample of 191,405 non-elderly adults with known sex, one or more opioid prescriptions, and continuous enrollment in 2012 and 2013. Three high-risk opioid use groups were identified in 2012 as (1) persons with 100+ morphine milligram equivalents per day for 90+ consecutive days (chronic users); (2) persons with 30+ days of concomitant opioid and benzodiazepine use (concomitant users); and (3) individuals diagnosed with an opioid use disorder. The length of time that a person had been characterized as a high-risk user was measured. Three healthcare costs (total, medical, and pharmacy costs) and four binary utilization indicators (the top 5% total cost users, the top 5% pharmacy cost users, any hospitalization, and any emergency department visit) derived from 2013 were outcomes. We applied a generalized linear model (GLM) with a log-link function and gamma distribution for costs while logistic regression was employed for utilization indicators. We also adopted propensity score weighting to control for the baseline differences between high-risk and non-high-risk opioid users. Results Of individuals with one or more opioid prescription, 1.45% were chronic users, 4.81% were concomitant users, and 0.94% were diagnosed as having an opioid use disorder. After adjustment and propensity score weighting, chronic users had statistically significant higher prospective total (40%), medical (3%), and pharmacy (172%) costs. The increases in total, medical, and pharmacy costs associated with concomitant users were 13%, 7%, and 41%, and 28%, 21% and 63% for users with a diagnosed opioid use disorder. Both total and pharmacy costs increased with the length of time characterized as high-risk users, with the increase being statistically significant. Only concomitant users were associated with a higher odds of hospitalization or emergency department use. Conclusions Individuals with high-risk prescription opioid use have significantly higher healthcare costs and utilization than their counterparts, especially those with chronic high-dose opioid use.

Background The US overdose crisis is driven by fentanyl, heroin, and prescription opioids. One evidence-based policy response has been to broaden naloxone distribution, but how much naloxone a community would need to reduce the incidence of fatal overdose is unclear. We aimed to estimate state-level US naloxone need in 2017 across three main naloxone access points (community-based programmes, provider prescription, and pharmacy-initiated distribution) and by dominant opioid epidemic type (fentanyl, heroin, and prescription opioid). Methods In this modelling study, we developed, parameterised, and applied a mechanistic model of risk of opioid overdose and used it to estimate the expected reduction in opioid overdose mortality after deployment of a given number of two-dose naloxone kits. We performed a literature review and used a modified-Delphi panel to inform parameter definitions. We refined an established model of the population at risk of overdose by incorporating changes in the toxicity of the illicit drug supply and in the naloxone access point, then calibrated the model to 2017 using data obtained from proprietary data sources, state health departments, and national surveys for 12 US states that were representative of each epidemic type. We used counterfactual modelling to project the effect of increased naloxone distribution on the estimated number of opioid overdose deaths averted with naloxone and the number of naloxone kits needed to be available for at least 80% of witnessed opioid overdoses, by US state and access point. Findings Need for naloxone differed by epidemic type, with fentanyl epidemics having the consistently highest probability of naloxone use during witnessed overdose events (range 58–76% across the three modelled states in this category) and prescription opioid-dominated epidemics having the lowest (range 0–20%). Overall, in 2017, community-based and pharmacy-initiated naloxone access points had higher probability of naloxone use in witnessed overdose and higher numbers of deaths averted per 100 000 people in state-specific results with these two access points than with provider-prescribed access only. To achieve a target of naloxone use in 80% of witnessed overdoses, need varied from no additional kits (estimated as sufficient) to 1270 kits needed per 100 000 population across the 12 modelled states annually. In 2017, only Arizona had sufficient kits to meet this target. Interpretation Opioid epidemic type and how naloxone is accessed have large effects on the number of naloxone kits that need to be distributed, the probability of naloxone use, and the number of deaths due to overdose averted. The extent of naloxone distribution, especially through community-based programmes and pharmacy-initiated access points, warrants substantial expansion in nearly every US state. Funding National Institute of Health, National Institute on Drug Abuse.

We aim to determine whether administration of higher doses of naloxone for the treatment of opioid overdose is associated with increased pulmonary complications.