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Background and Aims: Opioid substitution treatment is used in many countries as an effective harm minimization strategy. There is a need for more information about patient safety incidents and the resulting harm relating to this treatment. We aimed to characterize patient safety incidents involving opioid substitution treatment with methadone or buprenorphine in community-based care by: (i) identifying the sources and nature of harm and (ii) describing and interpreting themes to identify priorities to focus future improvement work., Design: Mixed-methods study examining patient safety incident reports involving opioid substitution treatment with either methadone or buprenorphine in community-based care., Setting: Data submitted between 2005 and 2015 from the National Reporting and Learning System (NRLS), a national repository of patient safety incident reports from across England and Wales., Participants: A total of 2284 reports were identified involving patients receiving community-based opioid substitution treatment., Measurements: Incident type, contributory factors, incident outcome and severity of harm. Analysis involved data coding, processing and iterative generation of data summaries using descriptive statistical and thematic analysis., Findings: Most risks of harm from opioid substitution treatment came from failure in one of four processes of care delivery: prescribing opioid substitution (n = 151); supervised dispensing (n = 248); non-supervised dispensing (n = 318); and monitoring and communication (n = 1544). Most incidents resulting in harm involved supervised or non-supervised dispensing (n = 91 of 127, 72%). Staff- (e.g. slips during task execution, not following protocols) and organization-related (e.g. poor working conditions or poor continuity of care between services) contributory factors were identified for more than half of incidents., Conclusions: Risks of harm in delivering opioid substitute treatment in England and Wales appear to arise out of failures in four processes: prescribing opioid substitution, supervised dispensing, non-supervised dispensing and monitoring and communication., (© 2020 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Introduction: Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting., Methods and Analysis: A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12,500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions., Ethics and Dissemination: The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)