Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
- adverse events
- public health
- pain management
- health policy
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Contributors All authors had involvement in developing the original protocol document upon which this manuscript was based. The study idea was conceived by NG, SAP, TD and LD. All authors provided input to the study design and developing the research questions and statistical analysis plan. NG and LD drafted the first iteration of the manuscript. All authors reviewed the manuscript and approved the final draft.
Funding This work is supported by a National Health and Medical Research Council Health (NHMRC) project grant (#1138442). NG, SL and LD are supported by NHMRC research fellowships (#1091878, #1140938 and #1135991). The National Drug and Alcohol Research Centre at UNSW Sydney is supported by funding from the Australian Government under the Substance Misuse Prevention and Service Improvements Grant Fund.
Competing interests The authors declare no direct competing interests relevant to this study protocol. Some of the authors have received investigator-initiated untied educational grants from Reckitt Benckiser/Indivior for studies of buprenorphine-naloxone (LD and RPM), buprenorphine depot (LD and AD), naloxone (SL and LD), the development of an opioid-related behaviour scale (LD and RPM) and a study of opioid substitution therapy uptake among chronic non-cancer pain patients (LD and RPM). Some of the authors have also received investigator-initiated untied educational grants for postmarketing surveillance studies of a tamper-resistant opioid formulation from Mundipharma (LD) and for tapentadol from Seqirus Pty Ltd (LD). No company had any knowledge or involvement in this study. AW is paid by the Australian Commonwealth government as the chair of the Pharmaceutical Benefits Advisory Committee (PBAC). SAP is a member of the Drug Utilisation Sub-Committee (DUSC) of the PBAC.
Patient consent Not required.
Ethics approval The study protocol has received full ethical approval from the Australian Institute of Health and Welfare (AIHW) Ethics Committee (EO2016/4/314), NSW Population and Health Services Research Committee (2017/HRE0208) and the ACT Health Human Research Ethics Committee (ETHLR.18.094).
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
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