Combating escalating harms associated with pharmaceutical opioid use in Australia: the POPPY II study protocol

Natasa Gisev; Sallie-Anne Pearson; Timothy Dobbins; David C Currow; Fiona Blyth; Sarah Larney; Adrian Dunlop; Richard P Mattick; Andrew Wilson; Louisa Degenhardt

doi:10.1136/bmjopen-2018-025840

Combating escalating harms associated with pharmaceutical opioid use in Australia: the POPPY II study protocol

BMJ Open. 2018 Dec 4;8(12):e025840. doi: 10.1136/bmjopen-2018-025840.

Authors

Affiliations

¹ National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.
² Centre for Big Data Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.
³ IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
⁴ Concord Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
⁵ School of Medicine and Public Health, Faculty of Health, The University of Newcastle, Newcastle, New South Wales, Australia.
⁶ Drug and Alcohol Clinical Services, Hunter New England, Newcastle, New South Wales, Australia.
⁷ Menzies Centre for Health Policy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

Abstract

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.

Keywords: adverse events; health policy; pain management; public health.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Analgesics, Opioid / adverse effects
Analgesics, Opioid / therapeutic use*
Cohort Studies
Drug Overdose / epidemiology*
Female
Humans
Male
New South Wales / epidemiology
Opioid-Related Disorders / epidemiology*
Pain / drug therapy*
Practice Patterns, Physicians'
Regression Analysis
Research Design

Substances

Analgesics, Opioid