Abstract

BackgroundOn February 1, 2018, Australia rescheduled codeine to a prescription-only medication. Many concerns were associated with this change, including increased financial costs, reduced service accessibility, the potential for poorer pain management, and a decline in physical and mental health if codeine could not be accessed. In the research literature, there is limited knowledge about the long-term consequences of rescheduling pharmaceutical opioids and, as Australia has followed many countries in implementing a restriction on codeine, further study of these consequences is critical.ObjectiveThe goal of this study was to examine the impact of rescheduling codeine from an over-the-counter (OTC) product to a prescription-only medicine on the primary measures of codeine use and dependence in a prospective cohort of people who are frequent consumers of OTC codeine. Secondary measures included pain and self-efficacy, health service use, and mental health.MethodsThe Codeine Cohort study aimed to recruit 300 participants in Australia who regularly (at least a few times per week for the past 6 months) used OTC codeine. Using an online survey, participants were followed up at three time points (February 2018, June 2018, and February 2019) after codeine was rescheduled.ResultsAll four waves of data collection are complete, with the final round of data collection finalized in August 2019. Data analyses are yet to be completed. Information on demographics, codeine use and dependence, physical and mental health, medication use, and health service use will be analyzed using mixed models.ConclusionsResults of this study will provide insight into the effectiveness of regulatory restriction in curtailing nonmedical use of and harms associated with codeine. Additionally, results will explore positive and negative outcomes of codeine rescheduling for individual patients, which informs health professionals who support patients who use codeine and further community education.International Registered Report Identifier (IRRID)DERR1-10.2196/15540

Highlights

  • Codeine is the most commonly used opioid in the world [1]

  • Results of this study will provide insight into the effectiveness of regulatory restriction in curtailing nonmedical use of and harms associated with codeine

  • Results will explore positive and negative outcomes of codeine rescheduling for individual patients, which informs health professionals who support patients who use codeine and further community education

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Summary

Introduction

Background Codeine is the most commonly used opioid in the world [1]. Regulation of its availability varies among countries; in New Zealand, the United Kingdom, most of Canada, and Ireland, codeine is available as an over-the-counter (OTC) preparation and is often combined with paracetamol or a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen [2]. In addition to risk of serious harm, there is limited evidence for the addition of low-dose codeine (16 to 25 mg of codeine per dose) to paracetamol or ibuprofen preparations for improved pain relief [5,6,7,8,9]. International awareness of the misuse of OTC pharmaceuticals containing codeine is growing [13,14,15], and government responses have predominantly focused on upscheduling (increasing prescribing restrictions), improving guidelines and procedures around the supply of low-dose codeine preparations. There is limited knowledge about the long-term consequences of rescheduling pharmaceutical opioids and, as Australia has followed many countries in implementing a restriction on codeine, further study of these consequences is critical

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