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 priori plausible 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.

• Effectiveness
• overdose deaths
• performance measure
• prevention
• public policy
• Scotland
• take-home naloxone

Acknowledgements

The multi-disciplinary National Naloxone Advisory Group (NNAG), a subgroup of Scotland’s National Forum on Drug Related Deaths which had advocated for naloxone funding, has kept under review the issue of THN-kits in regional communities and by Scottish prisons. To NNAG is owed the credit for timely setting of performance targets and myriad close attention to detail. Scotland’s Drug Policy Unit provides the secretariat for NNAG, whose independent chair is pharmacist, Dr. Carole Hunter.

In August of each year, National Records Scotland notifies Scotland’s Information Services Division about all opiate-related deaths in Scotland in the preceding calendar year. Look-back to the 4-week antecedents (prison-release or hospital-discharge) of the notified opiate-related deaths is conducted by staff of the Information Services Division and the outcomes are reported as Official Statistics.

As requested by SMB, Professor Avril Taylor kindly incorporated additional questions about THN into her 2011/12 and 2013/14 Needle Exchange Surveillance Initiatives (NESI). Full details will be published by the NESI team.

Finally, the authors wish to thank an anonymous referee for excellent editorial suggestions which we have closely followed.

Declaration of interest

The three authors are principal investigators for the pilot N-ALIVE Trial. All authors declare as a competing interest that the three-year results from Scotland’s before/after evaluation may have implications for whether and how randomisation continues in the N-ALIVE Trial.

JS has received project grant support and/or honoraria and/or consultancy payments from Department of Health, NTA (National Treatment Agency), PHE (Public Health England), Home Office, NICE (National Institute for Health and Clinical Excellence), and EMCDDA (European Monitoring Centre for Drugs and Drug Addiction) as well as research grants from (last 3 years) NIHR (National Institute on Health Research), MRC (Medical Research Council) and Pilgrim Trust. JS has worked with WHO (World Health Organization), UNODC (United Nations Office for Drug Control), EMCDDA and with other international government agencies specifically around guidelines for wider pre-provision of naloxone and associated training. JS has also received research grant support and/or payment of honoraria, consultancy payments and/or travelling and/or accommodation and/or conference expenses from pharmaceutical companies (including, in the past 3 years, Martindale, Reckitt-Benckiser, Lundbeck, MundiPharma, Alkermes, Rusan/iGen and also discussions with Fidelity International and Titan) concerning medicinal products potentially applicable in the treatment of addictions and related problems and has argued for the development of more suitable formulations of naloxone. JS works closely with the charity Action on Addiction, and also with the J Paul Getty Charitable Trust (JPGT) and the Pilgrim Trust, and has received grant support from them. Previous close links with charitable funded providers include Lifeline (Manchester), Phoenix House, KCA UK (Kent Council on Addictions), and Clouds (Action on Addiction).

The pilot N-ALIVE Trial is funded by the Medical Research Council (MC_G0800012). SMB is funded by Medical Research Council programme number MC_U105260794. JS is core-funded by his university, King’s College London.