Contents lists available at ScienceDirect International Journal of Drug Policy journal homepage: www.elsevier.com/locate/drugpo Research Paper Supply of codeine combination analgesics from Australian pharmacies in the context of voluntary real-time recording and regulatory change: A simulated patient study Jack C. Collins 1 , Joel M. Hillman 1 , Carl R. Schneider, Rebekah J. Moles ⁎ Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia ARTICLE INFO Keywords: Drug policy Codeine Analgesics Opioids Simulated patient Pharmacy Drug monitoring program ABSTRACT Background: In recent years there have been growing concerns regarding non-prescription codeine use in Australia. Efforts to mitigate risks associated with non-prescription codeine, such as addiction and toxicity, have been primarily through two initiatives; regulatory changes restricting their availability, and voluntary live- recording supply of non-prescription codeine combination analgesics (CCAs). This study sought to explore the supply of CCAs in the climate of regulatory change. Methods: Eighty University of Sydney pharmacy students mystery-shopped 34 community pharmacies across metropolitan Sydney, Australia from August 2016 to November 2017, with scripted symptom-based (SBR) or direct product requests (DPR) for a CCA. Questions asked, staff involvement, regulatory compliance, voluntary recording, and product(s) supplied were recorded. Results: Of 158 total visits, a non-prescription CCA was supplied in 101 instances. Sixty-one (60%) of these supplies complied with the legislative requirement for a pharmacist to supply the medicine. Voluntary recording was surmised to have been utilised 13 times (13% CCA supplies). CCAs were supplied less frequently in 2017 DPR scenarios compared to 2016 DPR scenarios (64% vs 86%; p = 0.024), and a greater proportion of 2017 DPR supplies were compliant with the legislative requirement of pharmacist supply (72% vs 46%; p = 0.041). No difference in proportion of sales surmised to have been voluntarily recorded was observed between the years. Interactions involving pharmacists resulted in less frequent supply of codeine than those without (58% vs 82%; p = 0.012). Conclusion: Mandatory legislative regulation of pharmacist supply of non-prescription codeine was more likely to be complied with than voluntary recording. Compliance with pharmacist supply for DPRs appeared to im- prove following the announcement of regulatory change to prescription-only, whereas voluntary recording of supply did not appear to change. Background There is international concern about an ‘opioid epidemic’. Data from the USA shows large increases in opioid-related deaths and per capita consumption over recent decades (Hedegaard, Warner & Minino, 2017; Scholl, Seth, Kariisa, Wilson & Baldwin, 2018; Seth, Scholl, Rudd & Bacon, 2018). Overdoses due to clandestine and illicit opioids, in par- ticular, fentanyl, are the current leading cause of opioid-related deaths, exceeding those due to nonmedical use of prescription opioids. Al- though deaths due to nonmedical use of prescription opioids have stabilised in recent years, likely due to increasing awareness of the opioid crisis and the influence of policy on prescribing patterns, concerns remain regarding appropriate use of prescription opioids (Compton, Jones, Stein & Wargo, 2019; Hedegaard et al., 2017). Similarly, opioid-use issues are being observed in Australia (Gisev et al., 2018) where deaths from opioid overdose vastly outweigh all other overdose deaths (Penington, 2017), and further, the use of, and overdose from, marketed opioids outweigh that of illicit opioids (Blanch, Pearson & Haber, 2014). In the period of 2011–2015, more than twice as many Australians died from opioid analgesics than heroin (Australian Commission on Safety and Quality in Health Care, 2018). In contrast to the USA, the Australian market up until recently had the availability of opioids without a prescription in the form of codeine combination analgesics (CCAs). These non-prescription preparations https://doi.org/10.1016/j.drugpo.2019.10.010 ⁎ Corresponding author. E-mail address: rebekah.moles@sydney.edu.au (R.J. Moles). 1 These authors made equal contributions to this work International Journal of Drug Policy 74 (2019) 216–222 0955-3959/ © 2019 Elsevier B.V. All rights reserved. T