Understanding the Dynamics of More Restrictive Medicines Policy: A Case Study of Codeine Up-Scheduling in Australia

Document Type : Original Article

Authors

1 School of Pharmacy, Faculty of Medicine and Health & Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia

2 Menzies Centre for Health Policy, School of Public Health, Faculty of Medicine and Health & Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia

3 Center for Bioethics and Humanities, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

Abstract

Background 
There has been increasing concern over opioid-related harms across the world. In Australia in 2018, codeine-containing products were up-scheduled from over-the-counter access at pharmacies, to requiring a prescription. The drug regulator’s decision to up-schedule was contentious and widely debated, due to the potentially large impact on consumers and healthcare professionals. This study aimed to analyse influences on the codeine up-scheduling policy.

Methods 
This retrospective policy analysis used the Advocacy Coalition Framework to understand how policy actors with shared beliefs formed adversarial coalitions to shape policy. Data were drawn from documents (regulator policy documents, public submissions, news reports, organisational media releases and position statements) and semi-structured interviews with 15 key policy actors. Codes were generated relating to policy processes and actor beliefs; broad themes included the role of health professionals, perceptions of opioids, impact on consumers, and the role of government in healthcare.

Results 
Two coalitions in this policy subsystem were identified: 1) supportive [with respect to the up-scheduling], and 2) opposing. The key evident beliefs of the supportive coalition were that the harms of codeine outweighed the benefits, and that government regulation was the best pathway for protecting consumers. The opposing coalition believed that the benefits  of codeine accessible through pharmacists outweighed any harms, and consumers should manage their health without any more intervention than necessary. The policy decision reflected the influence of the supportive coalition, and this analysis highlighted the importance of their public health framing of the issue, the acceptability of their experts and supporting evidence, and the perceived legitimacy of the up-scheduling process.

Conclusions 
Understanding these coalitions, their beliefs, and how they are translated through existing policy processes and institutions provides insight for those interested in influencing future health policy. Specific lessons include the importance of strategic frames and advocacy, and engagement with formal policy processes.

Keywords


  1. Berterame S, Erthal J, Thomas J, et al. Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study. Lancet. 2016;387(10028):1644-1656. doi:10.1016/S0140-6736(16)00161-6
  2. Roxburgh A, Hall WD, Dobbins T, et al. Trends in heroin and pharmaceutical opioid overdose deaths in Australia. Drug Alcohol Depend. 2017;179:291-298. doi:10.1016/j.drugalcdep.2017.07.018
  3. Lam T, Kuhn L, Hayman J, et al. Recent trends in heroin and pharmaceutical opioid-related harms in Victoria, Australia up to 2018. Addiction. 2020;115(2):261-269. doi:10.1111/add.14784
  4. Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. JAMA Intern Med. 2011;171(7):686-691. doi:10.1001/archinternmed.2011.117
  5. Haegerich TM, Paulozzi LJ, Manns BJ, Jones CM. What we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose. Review. Drug Alcohol Depend. 2014;145:34-47. doi:10.1016/j.drugalcdep.2014.10.001
  6. McAllister WB. Reflections On a Century of International Drug Control. LSE Ideas; 2012:10-16. Governing the Global Drug Wars. https://www.lse.ac.uk/ideas/Assets/Documents/reports/LSE-IDEAS-Governing-the-Global-Drug-Wars.pdf
  7. Therapeutic Goods Administration. Scheduling basics. Accessed July 16, 2021. https://www.tga.gov.au/scheduling-basics
  8. Jones CM, Lurie PG, Throckmorton DC. Effect of US Drug Enforcement Administration's rescheduling of hydrocodone combination analgesic productson opioid analgesic prescribing. Letter. JAMA Intern Med. 2016;176(3):399-402. doi:10.1001/jamainternmed.2015.7799
  9. Seago S, Hayek A, Pruszynski J, Newman MG. Change in prescription habits after federal rescheduling of hydrocodone combination products. Proceedings (Baylor University Medical Center). 2016;29(3):268-270. doi:10.1080/08998280.2016.11929431
  10. Chumpitazi CE, Rees CA, Camp EA, Bernhardt MB. Decreased opioid prescribing in a pediatric emergency department after the rescheduling of hydrocodone. J Emerg Med. 2017;52(4):547-553. doi:10.1016/j.jemermed.2016.08.026
  11. Raji MA, Kuo YF, Adhikari D, Baillargeon J, Goodwin JS. Decline in opioid prescribing after federal rescheduling of hydrocodone products. Pharmacoepidemiol Drug Saf. 2017;doi:10.1002/pds.4376
  12. Therapeutic Guidelines Writing Group. Therapeutic Guidelines: Analgesic. 6 ed. Therapeutic Guidelines Limited; 2012.
  13. Gisev N, Nielsen S, Cama E, Larance B, Bruno R, Degenhardt L. An ecological study of the extent and factors associated with the use of prescription and over-the-counter codeine in Australia. Eur J Clin Pharmacol. 2016;72(4):469-494. doi:10.1007/s00228-015-1995-8
  14. Degenhardt L, Gisev N, Cama E, Nielsen S, Larance B, Bruno R. The extent and correlates of community-based pharmaceutical opioid utilisation in Australia. Pharmacoepidemiol Drug Saf. 2016;25(5):521-538. doi:10.1002/pds.3931
  15. Baldini A, Von Korff M, Lin EH. A Review of Potential Adverse Effects of Long-Term Opioid Therapy: A Practitioner's Guide. Prim Care Companion CNS Disord. 2012;14(3)doi:10.4088/PCC.11m01326
  16. Therapeutic Goods Administration. Codeine rescheduling - information for sponsors. Updated February 24, 2010. Accessed July 16, 2021. https://www.tga.gov.au/codeine-rescheduling-information-sponsors
  17. Therapeutic Goods Administration. FOI disclosure log. Updated September 16, 2021. Accessed October 9, 2021. https://www.tga.gov.au/foi-disclosure-log
  18. Therapeutic Goods Administration. Update on the proposal for the rescheduling of codeine products. Updated December 20, 2016. Accessed July 16, 2021. https://www.tga.gov.au/media-release/update-proposal-rescheduling-codeine-products
  19. Sabatier PA. An advocacy coalition framework of policy change and the role of policy-oriented learning therein. Policy Sci. 1988;21(2):129-168. doi:10.1007/bf00136406
  20. Kübler D. Understanding policy change with the Advocacy Coalition Framework: an application to Swiss drug policy. J Eur Public Policy. 2001;8(4):623-641. doi:10.1080/13501760110064429
  21. Bryant T. Role of knowledge in public health and health promotion policy change. Health Pomot Int. 2002;17(1):89-98. doi:10.1093/heapro/17.1.89
  22. Weible CM, Sabatier PA, Jenkins-Smith HC, Nohrstedt D, Henry AD, de Leon P. A quarter century of the Advocacy Coalition Framework: an introduction to the special issue. Policy Stud J. 2011;39(3):349-360. doi:10.1111/j.1541-0072.2011.00412.x
  23. Therapeutic Goods Administration. Codeine information hub. Updated April 10, 2018. Accessed July 16, 2021. https://www.tga.gov.au/codeine-info-hub
  24. Abdel Shaheed C, Maher CG, McLachlan A. Investigating the efficacy and safety of over-the-counter codeine containing combination analgesics for pain and codeine based antitussives. 2016. https://www.tga.gov.au/sites/default/files/review-efficacy-and-safety-over-counter-codeine-combination-medicines.pdf
  25. Therapeutic Goods Administration. Codeine use in children and ultra-rapid metabolisers. Therapeutic Goods Administration; 2015. Accessed July 16, 2021. https://www.tga.gov.au/sites/default/files/codeine-use-children-and-ultra-rapid-metabolisers.pdf
  26. KPMG. Economic Modelling and Financial Quantification of the Regulatory Impact of Proposed Changes to Codeine Scheduling. KPMG; 2016. https://www.tga.gov.au/sites/default/files/economic-modelling-and-financial-quantification-regulatory-impact-proposed-changes-codeine-scheduling.pdf
  27. NSW Department of Premier and Cabinet. Ministers' diary disclosures - Premier & Cabinet. Accessed July 16, 2021. https://www.dpc.nsw.gov.au/publications/ministers-diary-disclosures/
  28. Cairney P. The Politics of Evidence-Based Policy Making. Palgrave Macmillan; 2016.
  29. Therapeutic Goods Administration. Current list of up-scheduled codeine containing products. Updated June 15, 2018. Accessed July 11, 2022. https://www.tga.gov.au/community-qa/current-list-scheduled-codeine-containing-products
  30. Sznitman SR, Bretteville-Jensen AL. Public opinion and medical cannabis policies: examining the role of underlying beliefs and national medical cannabis policies. Harm Reduct J. 2015;12(1):46. doi:10.1186/s12954-015-0082-x
  31. Bell K, Keane H. Nicotine control: e-cigarettes, smoking and addiction. Int J Drug Policy. 2012;23(3):242-247. doi:10.1016/j.drugpo.2012.01.006
  32. Filippidis FT, Laverty AA, Gerovasili V, Vardavas CI. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control. 2017;26(1):98. doi:10.1136/tobaccocontrol-2015-052771
  33. Dai H, Leventhal AM. Prevalence of e-cigarette use among adults in the United States, 2014–2018. JAMA. 2019;322(18):1824-1827. doi:10.1001/jama.2019.15331
  34. Hammond D, Rynard VL, Reid JL. Changes in prevalence of vaping among youths in the United States, Canada, and England from 2017 to 2019. JAMA Pediatr. 2020;174(8):797-800. doi:10.1001/jamapediatrics.2020.0901
  35. Amin S, Dunn AG, Laranjo L. Exposure to e-cigarette information and advertising in social media and e-cigarette use in Australia: a mixed methods study. Drug Alcohol Depend. 2020;213:108112. doi:10.1016/j.drugalcdep.2020.108112
  36. Smith KE, Ikegwuonu T, Weishaar H, Hilton S. Evidence use in e-cigarettes debates: scientific showdowns in a ‘wild west’ of research. BMC Public Health. 2021;21(1):362. doi:10.1186/s12889-021-10396-6
  37. Erku DA, Kisely S, Morphett K, Steadman KJ, Gartner CE. Framing and scientific uncertainty in nicotine vaping product regulation: an examination of competing narratives among health and medical organisations in the UK, Australia and New Zealand. Int J Drug Policy. 2020;78:102699. doi:10.1016/j.drugpo.2020.102699
  38. Chapman S, Bareham D, Maziak W. The gateway effect of e-cigarettes: reflections on main criticisms. Nicotine Tob Res. 2019;21(5):695-698. doi:10.1093/ntr/nty067
  39. Mossialos E, Courtin E, Naci H, et al. From “retailers” to health care providers: Transforming the role of community pharmacists in chronic disease management. Health Policy. 2015;119(5):628-639. doi:10.1016/j.healthpol.2015.02.007
  40. Schindel TJ, Yuksel N, Breault R, Daniels J, Varnhagen S, Hughes CA. Perceptions of pharmacists' roles in the era of expanding scopes of practice. Res Social Adm Pharm. 2017;13(1):148-161. doi:10.1016/j.sapharm.2016.02.007
  41. Stewart D, Jebara T, Cunningham S, Awaisu A, Pallivalapila A, MacLure K. Future perspectives on nonmedical prescribing. Ther Adv Drug Saf. 2017;8(6):183-197. doi:10.1177/2042098617693546
  42. Zhou M, Desborough J, Parkinson A, Douglas K, McDonald D, Boom K. Barriers to pharmacist prescribing: a scoping review comparing the UK, New Zealand, Canadian and Australian experiences. Int J Pharm Pract. 2019;27(6):479-489. doi:10.1111/ijpp.12557
  43. Therapeutic Goods Administration. Submissions received and TGA response: proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only). Updated July 30, 2019. Accessed July 16, 2021. https://www.tga.gov.au/submissions-received-and-tga-response-proposed-criteria-appendix-m-poisons-standard-support-rescheduling-substances-schedule-4-prescription-only-schedule-3-pharmacist-only
  44. Collins J, McLachlan A, Schneider C, Moles R, Carter S. Making more drugs available ‘over the counter’ would be a win for the public and the health care system. Updated March 27, 2019. Accessed July 16, 2021. https://theconversation.com/making-more-drugs-available-over-the-counter-would-be-a-win-for-the-public-and-the-health-care-system-113453
  45. Bhatia S, Simpson SH, Bungard T. Provincial comparison of pharmacist prescribing in Canada using Alberta's model as the reference point. Can J Hosp Pharm. 2017;70(5):349-357. doi:10.4212/cjhp.v70i5.1696
  46. Jebara T, Cunningham S, MacLure K, et al. A modified-Delphi study of a framework to support the potential implementation of pharmacist prescribing. Res Social Adm Pharm. 2020;16(6):812-818. doi:10.1016/j.sapharm.2019.09.005
  47. Adams AJ, Weaver KK. The continuum of pharmacist prescriptive authority. Ann Pharmacother. 2016;50(9):778-784. doi:10.1177/1060028016653608
  48. Apollonio DE. Political advocacy in pharmacy: challenges and opportunities. Integr Pharm Res Pract. 2014;3:89-95. doi:10.2147/IPRP.S47334
  49. Boechler L, Despins R, Holmes J, et al. Advocacy in pharmacy: changing “what is” into “what should be”. Can Pharm J. 2015;148(3):138-141. doi:10.1177/1715163515577693

Articles in Press, Accepted Manuscript
Available Online from 20 November 2022
  • Receive Date: 19 October 2021
  • Revise Date: 12 July 2022
  • Accept Date: 19 November 2022
  • First Publish Date: 20 November 2022