National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.
Centre for Big Data Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2018 Dec 4;8(12):e025840. doi: 10.1136/bmjopen-2018-025840.
Opioid prescribing has increased 15-fold in Australia in the past two decades, alongside increases in a range of opioid-related harms such as opioid dependence and overdose. However, despite concerns about increasing opioid use, extramedical use and harms, there is a lack of population-level evidence about the drivers of long-term prescribed opioid use, dependence, overdose and other harms.
We will form a cohort of all adult residents in New South Wales (NSW), Australia, who initiated prescribed opioids from 2002 using Pharmaceutical Benefits Scheme dispensing records. This cohort will be linked to a wide range of other datasets containing information on sociodemographic and clinical characteristics, health service use and adverse outcomes (eg, opioid dependence and non-fatal and fatal overdose). Analyses will initially examine patterns and predictors of prescribed opioid use and then apply regression and survival analysis to quantify the risks and risk factors of adverse outcomes associated with prescribed opioid use.
This study has received full ethical approval from the Australian Institute of Health and Welfare Ethics Committee, the NSW Population and Health Services Research Committee and the ACT Health Human Research Ethics Committee. This will be the largest postmarketing surveillance study of prescribed opioids undertaken in Australia, linking exposure and outcomes and examining risk factors for adverse outcomes of prescribed opioids. As such, this work has important translational promise, with direct relevance to regulatory authorities and agencies worldwide. Project findings will be disseminated at scientific conferences and in peer-reviewed journals. We will also conduct targeted dissemination with policy makers, professional bodies and peak bodies in the pain, medicine and addiction fields through stakeholder workshops and advisory groups. Results will be reported in accordance with the REporting of studies Conducted using Observational Routinely collected Data (RECORD) Statement.
在过去的二十年中，澳大利亚的阿片类药物处方增加了 15 倍，同时阿片类药物相关的一系列危害（如阿片类药物依赖和过量）也有所增加。然而，尽管人们对阿片类药物使用的增加、非医疗用途和危害感到担忧，但缺乏关于长期处方阿片类药物使用、依赖、过量和其他危害的人群水平证据。
我们将建立一个由澳大利亚新南威尔士州（NSW）所有成年居民组成的队列，这些居民从 2002 年开始使用药品福利计划配药记录开始服用处方阿片类药物。该队列将与一系列其他数据集相链接，这些数据集包含社会人口统计学和临床特征、卫生服务利用和不良结局（例如，阿片类药物依赖和非致命性和致命性过量）的信息。分析将首先检查处方阿片类药物使用的模式和预测因素，然后应用回归和生存分析来量化与处方阿片类药物使用相关的不良结局的风险和风险因素。
这项研究已获得澳大利亚健康与福利研究所伦理委员会、新南威尔士州人口与卫生服务研究委员会和澳大利亚首都直辖区卫生人类研究伦理委员会的全面伦理批准。这将是澳大利亚进行的最大规模的处方阿片类药物上市后监测研究，将暴露和结局联系起来，并检查处方阿片类药物不良结局的风险因素。因此，这项工作具有重要的转化前景，对全球监管机构和机构具有直接意义。项目研究结果将在科学会议和同行评议期刊上发表。我们还将通过利益相关者研讨会和咨询小组，与政策制定者、专业机构和疼痛、医学和成瘾领域的最高机构进行有针对性的传播。结果将按照使用观察性常规收集数据进行研究的报告（RECORD）声明进行报告。
