A mixed-methods analysis of patient safety incidents involving opioid substitution treatment with methadone or buprenorphine in community-based care in England and Wales

Background & 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 resulting harm relating to this treatment. We aimed to characterise 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: 2,284 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=91/127, 72%). Staff- (e.g. slips during task execution, not following protocols) and organisation-related (e.g. poor working conditions or poor continuity of care between services) contributory factors were identified for over 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. Keywords: Opioids, patient safety, health services research