title: Take-home naloxone to prevent fatalities from opiate-overdose: Protocol for Scotland's public health policy evaluation, and a new measure to assess impact.
abstract: Aims: Scotland was the first country to adopt take-home naloxone (THN) as a funded public health policy. We summarise the background and rigorous set-up for before/after monitoring to assess the impact on high-risk opiate-fatalities.Methods: Evidence-synthesis of prospectively monitored small-scale THN schemes led to a performance indicator for distribution of THN-kits relative to opiate-related deaths. Next, we explain the primary outcome and statistical power for Scotland's before/after monitoring.Results: Fatality-rate at opiate overdoses witnessed by THN-trainees was 6% (9/153, 95% CI: 2-11%). National THN-schemes should aim to issue 20 times as many THN-kits as there are opiate-related deaths per annum; and at least nine times as many. Primary outcome for evaluating Scotland's THN policy is reduction in the percentage of all opiate-related deaths with prison-release as a 4-week antecedent. Scotland's baseline period is 2006-10, giving a denominator of 1970 opiate-related deaths.A prioriplausible effectiveness was 20-30% reduction, relative to baseline, in the proportion of opiate-related deaths that had prison-release as a 4-week antecedent. A secondary outcome was also defined.Conclusion: If Scotland's THN evaluation shifts the policy ground seismically, our new performance measure may prove useful on how many THN-kits nations should provide annually.
authors.affiliation: MRC Biostatistics Unit , Cambridge , UK.
authors.forename: Sheila M
authors.initials: SM
authors.lastname: Bird
authors.affiliation: MRC Clinical Trials Unit, University College London , London , UK.
authors.forename: Mahesh K B
authors.initials: MK
authors.lastname: Parmar
authors.affiliation: King's College London , London , UK ; National Addiction Centre , London , UK.
authors.forename: John
authors.initials: J
authors.lastname: Strang
keywords: Effectiveness; Scotland; overdose deaths; performance measure; prevention; public policy; take-home naloxone