When effects cannot be estimated: redefining estimands to understand the effects of naloxone access laws


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Background: All states in the US have enacted at least some naloxone access laws (NALs) in an effort to reduce opioid overdose lethality. Previous evaluations found NALs increased naloxone dispensing but showed mixed results in terms of opioid overdose mortality. One reason for mixed results could be failure to address violations of the positivity assumption caused by the co-occurrence of NAL enactment with enactment of related laws, ultimately resulting in bias, increased variance, and low statistical power. Methods: We reformulated the research question to alleviate some challenges related to law co-occurrence. Because NAL enactment was closely correlated with Good Samaritan Law (GSL) enactment, we bundled NAL with GSL, and estimated the hypothetical associations of enacting NAL/GSL up to 2 years earlier (an amount supported by the observed data) on naloxone dispensation and opioid overdose mortality. Results: We estimated that such a shift in NAL/GSL duration would have been associated with increased naloxone dispensations (0.28 dispensations/100,000 people (95% CI: 0.18-0.38) in 2013 among early NAL/GSL enactors; 47.58 (95% CI: 28.40-66.76) in 2018 among late enactors). We estimated that such a shift would have been associated with increased opioid overdose mortality (1.88 deaths/100,000 people (95% CI: 1.03-2.72) in 2013; 2.06 (95% CI: 0.92-3.21) in 2018). Conclusions: Consistent with prior research, increased duration of NAL/GSL enactment was associated with increased naloxone dispensing. Contrary to expectation, we did not find a protective association with opioid overdose morality, though residual bias due to unobserved confounding and interference likely remain.

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