Determining the impact of opioid policy on intended and unintended harms: a data linkage study

Study identification

• EU PAS number:
  EUPAS104005
• Study ID:
  104006
• Official title and acronym:
  Determining the impact of opioid policy on intended and unintended harms: a data linkage study
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Increasing harms related to prescription opioids over the past decade has led to the introduction of a range of key national and state policy initiatives across Australia. However, similar opioid policies internationally have had mixed outcomes, including unintended adverse consequences. There is little real-world evidence on how these policy levers work in Australia. the current study seeks to examine the impact of introducing a range of opioid-related policies on hospital admissions and emergency department (ED) presentations, in Victoria, Australia. In particular, the study aims to understand the effect of various opioid policy and opioid prescribing changes on: (1) The number and rates of ED presentations and hospital admissions attributed to substance use (i.e opioid and non-opioid related), or mental ill-health (e.g. suicide, self-harm, anxiety, depression), (2) the association between differing opioid dose trajectories and the likelihood of ED presentations and hospital admissions related to substance use and mental ill-health, (3) whether changes in an individual’s opioid prescribing changes the risk related to ED presentations and hospital admissions related to substance use and mental ill-health, after considering other confounding factors, using a case-control design. Interrupted time series (ITS) will be used to examine the impact of opioid policies on a range of harms including the incidence of presentations related to substance use (opioid and non-opioid), and mental ill-health among the primary care cohort. Group-based trajectory modelling and a case-crossover design will be used to further explore the impact of changes in opioid dosage and other covariates on opioid and non-opioid poisonings, and mental ill-health related presentations at the patient-level.
• Study status:
  Planned

Research institutions and networks

Institutions

Monash University

Study timelines

Date when funding contract was signed

Planned:01/01/2021

Study start date

Planned:30/06/2022

Date of final study report

Planned:31/12/2023

Sources of funding

Other

More details on funding

Australian NHMRC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable