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.

中文翻译：

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英格兰和威尔士社区护理中涉及用美沙酮或丁丙诺啡替代阿片类药物治疗的患者安全事件的混合方法分析

背景和目的 阿片类药物替代治疗在许多国家被用作一种有效的危害最小化策略。需要更多关于患者安全事件和与此治疗相关的伤害的信息。我们旨在通过以下方式描述涉及在社区护理中使用美沙酮或丁丙诺啡进行阿片类药物替代治疗的患者安全事件：(i) 确定伤害的来源和性质，以及 (ii) 描述和解释主题以确定优先重点，以关注未来的改进工作. 设计 混合方法研究检查涉及在社区护理中使用美沙酮或丁丙诺啡进行阿片类药物替代治疗的患者安全事件报告。设置 2005 年至 2015 年期间从国家报告和学习系统 (NRLS) 提交的数据，来自英格兰和威尔士的患者安全事件报告的国家存储库。参与者 确定了 2,284 份报告，涉及接受基于社区的阿片类药物替代治疗的患者。测量 事件类型、促成因素、事件结果和伤害的严重程度。分析涉及使用描述性统计和专题分析的数据编码、处理和数据摘要的迭代生成。发现 阿片类药物替代治疗造成伤害的大多数风险来自以下四个护理过程之一的失败：处方阿片类药物替代（n=151）；监督配药（n=248）；非监督配药（n=318）；以及监测和沟通（n=1544）。大多数导致伤害的事件涉及监督或非监督分配（n=91/127，72%）。员工-（例如在任务执行期间的失误，不遵守协议）和组织相关（例如恶劣的工作条件或服务之间的护理连续性差）导致超过一半的事件。结论 在英格兰和威尔士提供阿片类药物替代治疗的危害风险似乎源于以下四个过程的失败：处方阿片类药物替代品、监督配药、非监督配药以及监测和沟通。