Abstract
BackgroundContinuously high rates of overdose deaths in Sweden led to the decision by the Skåne County to initiate the first regional take-home naloxone program in Sweden. The project aims to study the effect of overdose prevention education and naloxone distribution on overdose mortality in Skåne County. Secondary outcome measures include non-fatal overdoses and overdose-related harm in the general population, as well as cohort-specific effects in study participants regarding overdoses, mortality and retention in naloxone program.MethodsImplementation of a multi-site train-the-trainer cascade model was launched in June 2018. Twenty four facilities, including opioid substitution treatment units, needle exchange programs and in-patient addiction units were included for the first line of start-up, aspiring to reach a majority of individuals at-risk within the first 6 months. Serving as self-sufficient naloxone hubs, these units provide training, naloxone distribution and study recruitment. During 3 years, questionnaires are obtained from initial training, follow up, every sixth month, and upon refill. Estimated sample size is 2000 subjects. Naloxone distribution rates are reported, by each unit, every 6 months. Medical diagnoses, toxicological raw data and data on mortality and cause of death will be collected from national and regional registers, both for included naloxone recipients and for the general population. Data on vital status and treatment needs will be collected from registers of emergency and prehospital care.DiscussionDespite a growing body of literature on naloxone distribution, studies on population effect on mortality are scarce. Most previous studies and reports have been uncontrolled, thus not being able to link naloxone distribution to survival, in relation to a comparison period. As Swedish registers present the opportunity to monitor individuals and entire populations over time, conditions for conducting systematic follow-ups in the Swedish population are good, serving the opportunity to study the impact of large scale overdose prevention education and naloxone distribution and thus fill the knowledge gap.Trial registrationNaloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications, NCT 03570099, registered on 26 June 2018.
Highlights
High rates of overdose deaths in Sweden led to the decision by the Skåne County to initiate the first regional take-home naloxone program in Sweden
Northern Europe and Scandinavia are greatly affected by high rates of opioidrelated overdose deaths, and Sweden has experienced a steady increase during the last decade accounting for the second highest rates in Europe [2, 3]
Over the past two decades, there has been an expansion of overdose prevention education and naloxone distribution (OPEND) programs training bystanders how to intervene during a witnessed opioid overdose
Summary
All NEPs (4, in the cities of Malmö, Lund, Helsingborg and Kristianstad) and OST clinics (18, in the cities of Malmö, Lund, Helsingborg, Kristianstad, Ystad, Ängelholm, Landskrona and Trelleborg) in the region were included in the project and in the research study, conducted by Lund University. With a reduction in number of deaths (per 1000 person years) from 30 to 20 individuals, in regards to the power calculation above, and assuming that only 10% of those receiving naloxone use the dose, 100 (10 × 10) present overdose witnesses are required with access to naloxone for dose to be given in ten cases. Skåne’s County medical and administrative registers for diagnoses and intervention codes indicating a condition of drug poisoning Data for all fatal and non-fatal overdose cases attended by ambulance in the region will be identified (including vital status of cases upon ambulance attendance) from a regional electronic documentation system for prehospital units in the Skåne County, where clinical data from ambulance-attended cases, and treatments given by ambulance staff, are documented This data source covers the full intervention period in the study, but the electronic documentation system was introduced in early 2017, such that the comparison period can include this type of data only since . The intervention period begins 1 July 2019 (with the first analyses conducted for general population data for the 18-month period of 1 July 2019–31 December 2020), based on the assumption that the naloxone distribution will be considered to have reached a satisfactory level from July 2019
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