You are here

Regulation impact statement: Codeine re-scheduling

Version 1.1, December 2016

20 December 2016

Book pagination

Footnotes

  1. Philip J Wiffen, Roger Knaggs, Sheena Derry, Peter Cole, Tudor Phillips, R Andrew Moore, R Andrew Moore, Cochrane Database of Systematic Reviews, 2016
  2. Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database of Systematic Reviews, 2009
  3. Ahlstrom U, Fahraeus J, Quiding H, Strom C. Multiple Doses of Paracetamol Plus Codeine Taken Immediately After Oral Surgery. Eur J Clin Pharmacol 1985; 693-696.
  4. Iedema J (2011) Cautions with codeine, Australian prescriber 34: 133-135.
  5. Nauta M, Landsmeer M, Koren G et al. Codeine-acetaminophen versus non-steroidal anti-inflammatory drugs in the treatment of post–abdominal surgery pain: a systematic review of randomized trials. Am J Surg 2009; 198:256-261.
  6. http://www.nps.org.au/medicines/respiratory-system...
  7. Opioid prescription in chronic pain conditions: Guidelines for South Australian general practitioners (GPs). These guidelines were produced by Drug & Alcohol Services South Australia, the Flinders Medical Centre Pain Management Unit, and the Royal Adelaide Hospital Pain Management Unit with funding under the Ministerial Council on Drug Strategy Cost Shared Funding Model. 2008. www.dassa.sa.gov.au/goto/ddu, accessed on 21 September 2016.
  8. Therapeutic Guidelines Ltd (eTG July 2016 edition): Analgesic, https://tgldcdp.tg.org.au/viewTopic?topicfile=pain..., accessed on 21 September 2016.
  9. The Poisons Standard states that in the case of codeine, the concentration, strength or quantity is calculated as anhydrous codeine. The concentrations referred to in the Schedules therefore refer to anhydrous codeine. However, codeine is often present in products as codeine phosphate, and the strength listed on packaging usually refers to codeine phosphate, not codeine. Schedule 4 refers to 30 mg or less of codeine. This is equivalent to approximately 39 mg codeine phosphate. Schedule 3 refers to 12 mg or less of codeine. This is equivalent to 15.9 mg codeine phosphate. Schedule 2 refers to 10 mg or less of codeine. This is equivalent to 13 mg codeine phosphate.
  10. Roxburgh A, Hall WD, Burns L, Pilgrim J, Saar E, Nielsen S and L Degenhardt. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust (2015) 203(7).
  11. CA Shaheed, CG Maher and A McLachlan. 'Investigating the efficacy and safety of over-the-counter codeine-containing combination analgesics for pain and codeine based antitussives.'. 21 March 2016. (this report is also referred to as the 'George Institute Report')
  12. CA Shaheed, CG Maher and A McLachlan. 'Investigating the efficacy and safety of over-the-counter codeine-containing combination analgesics for pain and codeine based antitussives.'. 21 March 2016. (this report is also referred to as the 'George Institute Report')
  13. https://ajp.com.au/news/teens-misusing-paracetamol... accessed November 2016
  14. Lund C. et al. A one-year observational study of all hospitalized and fatal acute poisonings in Oslo: Epidemiology intention and follow-up. BMC Public Health 2012; 12: 858.
  15. Cooper SA, Beaver W. A model to describe mild analgesic in oral surgery outpatients. Clin Pharmacol Ther 1976; 20(2)241-250.
  16. 'Some patients take 90 tablets of codeine-ibuprofen per day'. Australian Doctor, 14/11/2016, http://www.australiandoctor.com.au/news/news-insight/.
  17. https://www.tga.gov.au/database-adverse-event-notifications-daen.
  18. Frei MY, Nielsen S, Dobbin MDH, Tobin CL. Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases. Med J Aust 2010;193:294-296
  19. Romach MK, Sproule BA, Sellers EM, Somer G, Busto UE Long-term codeine use is associated with depressive symptoms. J Clin Psychopharmacol 1999; 19: 373-376.
  20. Dobbin M, Tobin C. Over-the counter (OTC) ibuprofen/codeine analgesics: misuse and harm. Victorian Department of Health, Melbourne. 2008. Available At: https://www.tga.gov.au/sites/default/files/scheduling-submissionpublic-submissions-scheduling-matters-referred-acms-15-august-2015-03.pdf (pdf,8.26Mb)
  21. Mill D, Johnson J, Cook V, Monaghan E and Hotham E (2016), Abstract presented at Australian Professional Society on Alcohol and Other Drugs (APSAD), Sydney Conference. Abstract available here https://www.eiseverywhere.com/file_uploads/a5e36f68887d8c77c1a487a94559925b_20_DeannaMill.pdf (pdf,9kb)
  22. Ferguson L, Clarke I, Fisher A, Legg G, Batey R. Over the counter and into the grave: morbidity and mortality related to NSAIDS with codeine dependence. APSAD Conference 2010. Drug and Alc Rev 2010; 29 (Suppl. 1):2-82.
  23. McDonough MA. Misuse of codeine-containing combination analgesics. Medical Journal of Australia. 2011; 194: 486.
  24. Pilgrim J, Dobbin M, Drummer OH. Fatal misuse of codeine-ibuprofen in Victoria, Australia. Med J Aust 2013; 199(5):329-330.
  25. Zahari A, Ismail R. Review: Influence of cytochrome P450, Family 2, Subfamily D, polypeptide 6 (CYP2D6) polymorphisms on pain sensitivity and clinical response to weak opioid analgesics. Drug Metabolism and Pharmacokinetics 2014; 29: 29.
  26. Yue QY et al. Quantification of the O- and N-demethylated and the glucuronidated metabolites of codeine relative to the debrisoquine metabolic ratio in urine in ultrarapid, rapid, and poor debrisoquine hydroxylators. Ther Drug Monit 1997; 19; 539-542.
  27. While dependence to opioids is predictable and can be managed by medication, addiction is abnormal and is classified as a disease manifesting in uncontrollable cravings and an inability to control drug use despite doing harm to oneself or others.
  28. Rowden AM, Lopez JR. Codeine addiction. Ann Pharmacother 1989; 23:475-477.
  29. Weppner RS. "Cheap Kicks": codeine cough syrup abusers and some of their social characteristics. Int J Addict 1971; 6:647-60.
  30. Busto UE, Sproule BA, Knight K, Romach MK, Sellers EM. Severe dependence on oral opiates. Can J Clin Pharmacol 1998; 5:23-28.
  31. Sproule BAP, Busto UEP, Somer GM, et al. Characteristics of dependent and nondependent regular users of codeine. J Clin Psychopharmacol 1999; 19:367-372.
  32. Dutch MJ. Nurofen Plus misuse: an emerging cause of perforated gastric ulcer. Med J Aust. 2008;188:56-57
  33. Kliner DJ, Pickens R. Indicated preference for drugs of abuse. Int J Addict 1982; 17:543-547.
  34. Nielsen S, Cameron J, Pahoki S. 2010. Over the counter codeine dependence: final report. Available at: http://atdc.org.au/wpcontent/uploads/2011/02/OTC_CODEINE_REPORT.pdf
  35. Robinson G. et al. Misuse of over-the-counter codeine-containing analgesics: dependence and other adverse effects. New Zealand Journal of Medicine 2010; 123: 59.
  36. Nielsen S, Cameron J, Pahoki S. 2010. Over the counter codeine dependence: final report. Available At: http://atdc.org.au/wpcontent/uploads/2011/02/OTC_CODEINE_REPORT.pdf
  37. Foley M et al. The availability of over-the-counter codeine medicines across the European Union. Public Health, 2015, 129: 1465-1470.
  38. Berterame, S. et al. 2016 'Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study.' The Lancet 387 (10028), 1644-1656.
  39. http://www.canadianhealthcarenetwork.ca/pharmacist...
  40. Canadian Institute for Health Information, Canadian Centre on Substance Abuse. Hospitalizations and Emergency Department Visits Due to Opioid Poisoning in Canada. Ottawa, ON: CIHI; 2016.
  41. Howlett, K and Grant, K, 'Opioid poisoning puts more Canadians in hospital each year. Here's what Ottawa plans to do', The Globe and Mail, Posted online on 17 Nov 2016. Accessed on 24/11/2016, http://www.theglobeandmail.com/news/national/how-o....
  42. Razzaghi, E.M., Rahimi, A., Hosseni, M., and Madani, S. 1998-1999, 'Rapid situation assessment (RSA) of drug abuse in Iran (1998-1999)', Prevention Department, State Welfare Organization, Ministry of Health, I.R. of Oran and United Nations International Drug Control Program
  43. Paul, A., 'MDs seeing stream of opioid overdoses', Winnipeg Free Press, Posted on 17/11/2016. Accessed on 24/11/2016: http://www.winnipegfreepress.com/local/mds-seeing-...
  44. Gornall, J, 'Addicted to over-the-counter opium: Few realise codeine headache pills come from the same source as heroin - and evidence reveals more and more are getting hooked, Daily Mail Australia, Posted online 19/09/2016. Accessed 24/11/2016: http://www.dailymail.co.uk/femail/article-2424740/...
  45. A 100-a-day, over-the-counter addiction, Stuff Nation. Posted online 18/09/2016. Accessed 24/11/2016: http://www.stuff.co.nz/stuff-nation/assignments/th...
  46. Defined daily dose use per million people per day, where S-DDD = defined daily doses.
  47. Fitzpatrick, L 2016 'Is codeine too easy to get in Australia? These young addicts think so' Vice. Posted online 5 May 2016. Accessed 25/11/2016: http://www.vice.com/en_au/read/pharmaceutical-opio....
  48. Robertson CG et al. Beware of NSAID abuse: think twice before operating! ANZ J Surg: 2014: 84(6): 495-6.
  49. Australian Institute of Health and Welfare. National opioid pharmacotherapy statistics 2013, Drug treatment series no. 23. Cat. No. HSE 147. Canberra: AIHW: 2014: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx....
  50. Arora S, Roxburgh A, Bruno R, Nielsen S, Burns L. A cross-sectional analysis of over-the-counter codeine use among an Australian sample of people who regularly inject drugs. Drug Alcohol Rev. 2013 Nov; 32(6):574-81.
  51. Page CB, Wilson PA, Foy A, Downes MA, Whyte IM, Isbister GK. Life-threatening hypokalaemia associated with ibuprofen-induced renal tubular acidosis. Med J Aust. 2011 Jun 6;194(11):614.
  52. Ng JL, Morgan DJR, Loh NKM, Gan SK, Coleman PL, Ong GSY, et al. Life-threatening hypokalaemia associated with ibuprofen-induced renal tubular acidosis. Medical J Australia. 2011; 194:313-16.
  53. McDonough MA. Misuse of codeine-containing combination analgesics. Medical Journal of Australia. 2011; 194:486.
  54. Lake H. Ibuprofen belly: a case of small bowel stricture due to non-steroidal anti-inflammatory drug abuse in the setting of codeine dependence. Aust NZ J Psychiatry 2013; 47:1210-11.
  55. Waranilla Drug & Alcohol Services SA (DASSA) admissions data.
  56. Royal Adelaide Hospital admissions data.
  57. Derry SM, Single dose codeine, as a single agent, for acute postoperative pain I adults. Cochrane Database Syst Rev 2009; 14; CD008099.
  58. Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database Syst Rev 2009; 21; CD001547.
  59. Robinson GM, Robinson S, McCarthy P, Cameron C. Misuse of over-the-counter codeine-containing analgesics: dependence and other adverse effects. NZ Med J.2010; 123:59-64.
  60. Sproule, B. A. P., & Busto, U. E. P., Somer, G. M., Romach, M. K. M. D., & Sellers, E. M. M. D. P. (1999). Characteristics of Dependent and Nondependent Regular Users of Codeine. Journal of Clinical Psychopharmacology, 19(4), 367-372.
  61. Romach MK, Sproule BA, Sellers EM, Somer G, Busto UE Long-term codeine use is associated with depressive symptoms. J Clin Psychopharmacol 1999; 19:373-6.
  62. Roussin A, Bouyssi A, Pouché L, Pourcel L, Lapeyre-Mestre M (2013) Misuse and Dependence on Non-Prescription Codeine Analgesics or Sedative H1 Antihistamines by Adults: A Cross-Sectional Investigation in France. PLoS ONE 8(10): e76499. doi:10.1371/journal.pone.0076499.
  63. Dutch MJ. Nurofen Plus misuse: an emerging cause of perforated gastric ulcer. Med J Aust. 2008; 188:56-7.
  64. Evans C, Chalmers-Watson TA, Gearry RB. Combination NSAID-codeine preparations and gastrointestinal toxicity. N Z Med J 2010; 123:92-3.
  65. Medani S, Short S, Wall C. Nurofen Plus toxicity—what should nephrologists be alert to? Rare complications of an increasingly misused medication. NDT Plus. 2010.
  66. Ferguson L, Clarke I, Fisher A, Legg G, Batey R. Over the counter and into the grave: morbidity and mortality related to NSAIDS with codeine dependence. APSAD Conference 2010. Drug and Alc Rev 2010; 29 (Suppl. 1):2-82.
  67. McDonough MA. Misuse of codeine-containing combination analgesics. Medical Journal of Australia. 2011; 194:486.
  68. Robinson G. et al. Misuse of over-the-counter codeine-containing analgesics: dependence and other adverse effects. New Zealand Journal of Medicine 2010; 123: 59.
  69. Also known as 'Academic detailing', this is the process of delivering face-to-face education of prescribers by trained health care professionals, typically pharmacists, physicians, or nurses. The goal of academic detailing is to improve prescribing of targeted drugs to be consistent with medical evidence from randomized controlled trials, which ultimately improves patient care and can reduce health care costs.
  70. Personal communication, D Bayever
  71. Guild calls for codeine monitoring laws. Posted online 23 Nov 2016, Pharma In Focus 23, Issue date 21-27 Nov. http://www.pharmainfocus.com.au/news.asp?newsid=11384
  72. Figures from June 2016 and September 2016 were provided to the TGA by the PGA directly.
  73. More recent November 2016 figures given in a PharmaDispatch article (Pharmacy points to success of codeine monitoring. Posted online 23 Nov 2016 https://pharmadispatch.com/news/pharmacy-points-to-success-of-codeine-monitoring) suggests that this figure has risen to 4 million transactions.
  74. Pharmacy points to success of codeine monitoring. Posted online 23 Nov 2016, PharmaDispatch. No. 16 https://pharmadispatch.com/news/pharmacy-points-to-success-of-codeine-monitoring.
  75. Codeine monitoring 'too hard'. Posted online 11 Nov 2016, Pharma in focus, 7-13 Nov 2016. http://www.pharmainfocus.com.au/Newsprint.asp?newsid=11340
  76. Fitzpatrick, L 2016 'Is codeine too easy to get in Australia? These young addicts think so' Vice. Posted online 5 May 2016. Accessed 25/11/2016: http://www.vice.com/en_au/read/pharmaceutical-opioid-addiction-in-australia.
  77. See Therapeutic Goods Administration website for all publicly available submissions: https://www.tga.gov.au/scheduling-submission/public-submissions-scheduling-matters-referred-acms-15-august-2015
  78. 'Regulatory Burden Measurement Framework' dated February 2016
  79. TGA, Regulation Impact Statement: General Requirements for labels for medicines, https://ris.govspace.gov.au/files/2016/08/General-requirements-for-labels-for-medicines-RIS.pdf, July 2016.
  80. TGA, Regulation Impact Statement: General Requirements for labels for medicines, https://ris.govspace.gov.au/files/2016/08/General-requirements-for-labels-for-medicines-RIS.pdf, July 2016, p.32.
  81. Over 1 month, PGA personal communication, September 2016
  82. Office of Best Practice Regulation, 'Guidance Note: Regulatory Burden Measurement Framework', dated February 2016, p.18
  83. www.open.edu.au/careers/healthcare-medical-pharmaceuticals/pharmacists, Based on average salary of $70,000.
  84. http://www.payscale.com/research/AU/Job=General_Practitioner/Salary (click on 'Show hourly rate' link).
  85. ARTG entries relating to codeine derivatives such as dihydrocodeine and norcodeine have been exclude from Table 4 as the re-scheduling decision relates only to products with codeine as an active ingredient. Similarly, listings for 'export only' products that contain codeine as an active ingredient have also been excluded as these are not regulated in accordance with the Poisons Standard.
  86. Sourced from a 2014 survey of companies and referenced in TGA, Regulation Impact Statement: International Harmonisation of Ingredient Names', v.1, dated November 2015, p.39.
  87. TGA, Regulation Impact Statement: International Harmonisation of Ingredient Names', v.1, dated November 2015, p.39.
  88. Cochrane reviews are systematic reviews of primary research in human healthcare and health policy, and are internationally recognised as the highest standard in evidence-based healthcare resources. See <http://www.cochrane.org/evidence>. Relevant reviews are: Derry S, Moore RA, McQuay HJ. Single dose oral codeine, as a single agent, for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD008099. DOI: 10.1002/14651858.CD008099.pub2. Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) for postoperative pain in adults. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004602. DOI: 10.1002/14651858.CD004602.pub2. Derry CJ, Derry S, Moore RA, McQuay HJ. Single dose oral ibuprofen for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD001548. DOI: 10.1002/14651858.CD001548.pub2. Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001547. DOI: 10.1002/14651858.CD001547.pub2. Derry S, Karlin SM, Moore RA. Single dose oral ibuprofen plus codeine for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2015, Issue 2. Art. No.: CD010107. DOI: 10.1002/14651858.CD010107.pub3. Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD010210. DOI: 10.1002/14651858.CD010210.pub2.
  89. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  90. The Pharmaceutical Benefits Advisory Committee does not declare its valuation of A QALY but it is likely to be in the order of $50,000 per QALY. For a discussion of the theory and practice of choice of valuation of a QALY and the use of a shadow price in cost benefit analysis, see Brita A.K. Pekarsky, The new drug reimbursement game; A regulator's guide to playing and winning, Springer, 2015.
  91. "Do not take more than a few days at a time unless your doctor tells you to." Source: Mersyndol DayStrength Caplets Consumer Medicines Information "Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations." http://www.nps.org.au/medicines/pain-relief/combination-simple-pain-relievers/paracetamol-codeine/mersyndol-daystrength-caplets Accessed August 24th
  92. See, for example, "Codeine addiction a growing problem as Aussies abuse over-the-counter pain medication" Leisa Scott QWeekend The Courier-Mail August 31, 2013 http://www.couriermail.com.au/news/queensland/codeine-addiction-a-growing-problem-as-aussies-abuse-overthecounter-pain-medication/story-fnihsrf2-1226707777107
  93. If a patient is referred to a pain clinic by their GP this attracts a rebate via the MBS (MBS items 2801 2806).
  94. Cadence Economics Pty Ltd, 'Fiscal Impact of Codeine Changes: Report for the Pharmacy Guild of Australia', dated 6 November 2015, viewed 24 August 2016, <http://www.auspharmacist.net.au/images/cad.pdf (pdf,865kb)>.
  95. The Macquarie Centre for the Health Economy, Macquarie University, 'The value of OTC medicines in Australia: March 2014', <http://www.asmi.com.au/media/14036/final_web_copy_asmi_valuestudy_a4.pdf (pdf,1.16Mb)>. The report notes that 'it was funded by the Australian Self Medication Industry and a Macquarie University research grant'.
  96. Cadence Economics Pty Ltd, 'Fiscal Impact of Codeine Changes: Report for the Pharmacy Guild of Australia', dated 6 November 2015, viewed 24 August 2016, <http://www.auspharmacist.net.au/images/cad.pdf (pdf,865kb)>.
  97. In the base case, only chronic therapeutic users of low-dose codeine have been included for the modelling of health benefits. It was raised in peak body consultations that some acute therapeutic users of low-dose codeine (e.g. migraine sufferers) may also benefit from improved therapeutic pathways; however, because this was assessed to be a low proportion of current acute users so this was not modelled in the base case.
  98. Fitzpatrick, L 2016 'Is codeine too easy to get in Australia? These young addicts think so' Vice. Posted online 5 May 2016. Accessed 25/11/2016: http://www.vice.com/en_au/read/pharmaceutical-opioid-addiction-in-australia.
  99. In the base case, only chronic therapeutic users of low-dose codeine have been included for the modelling of health benefits. It was raised in peak body consultations that some acute therapeutic users of low-dose codeine (e.g. migraine sufferers) may also benefit from improved therapeutic pathways; however, because this was assessed to be a low proportion of current acute users so this was not modelled in the base case.
  100. This price is based on the following results of a Choice survey in July 2015. 'Supermarket generic paracetamol was a lot cheaper than Panadol, costing from 65c (Aldi) to 70c (Coles and Woolworths) for a pack of 20. In pharmacies, however, a pack of 100 Panamax can be had for less than $2, making this one of the cheapest painkillers you can buy. Nurofen (ibuprofen) was generally cheaper in pharmacies than supermarkets, with the bigger packs making it even more so. However, supermarkets were the cheapest source of generic ibuprofen, at $1.65 (Aldi) to $1.80 (Coles) per pack of 24. In Chemist Warehouse we found 50 Rafen tablets for $2.39, but in other pharmacies, house brands such as Amcal and Chemists Own were more expensive than supermarket generics.' <https://www.choice.com.au/health-and-body/medicines-and-supplements/prescription-medicines/articles/supermarkets-vs-pharmacies-for-otc-medicine>.
  101. The total sales values and units by pack size were used to estimate the wholesale prices of both IMS Schedule 2 and Schedule 3 codeine-based medicines. The retail prices of those codeine-based medicines were captured from the retail market in Australia. The retail mark-up is then estimated by employing both wholesale and retail values of codeine-based medicines
  102. Also known as 'Academic detailing", this is the process of delivering face-to-face education of prescribers by trained healthcare professionals, typically pharmacists, physicians, or nurses. The goal of academic detailing is to improve prescribing of targeted drugs to be consistent with medical evidence from randomized controlled trials, which ultimately improves patient care and can reduce health care costs.
  103. References to the dosage unit of codeine in the Poisons Standard refer to anhydrous codeine. This can be multiplied by 1.33 to convert to codeine phosphate. This is important to note because dosages set out in ARTG entries refer to concentrations of codeine phosphate, whereas dosages in the Poisons Standard refer to anhydrous codeine.
  104. Poisons Standard November 2016. Available at: https://www.legislation.gov.au/Details/F2016L01638
  105. TGA consultation with industry groups.
  106. KPMG has assessed that there will be no rationalisation of ARTG entries if this option is implemented, so all existing entries (46) need to be updated on the ARTG.
  107. Number of existing Schedule 2 entries x multiplier to account for ARTG entries covering for more than one medicine unit.
  108. For more information regarding change applications, see the TGA website at https://www.tga.gov.au/book-page/step-2-determining-your-application-level-and-change-codes
  109. OBPR, Regulatory Burden Measurement (RBM) guidance note, https://www.dpmc.gov.au/sites/default/files/publications/005-Regulatory-Burden-Measurement-Framework.pdf (pdf,161kb), February 2016
  110. NPS Medicinewise, Cough and cold medicines. Published online on 23 August 2012. Accessed on 28 November 2016: http://www.nps.org.au/medicines/respiratory-system/cough-and-cold-medicines
  111. Bolser, D.C. (2006) 'The Cough Suppressant and Pharmacologic Protussive Therapy : ACCP Evidence-Based Clinical Practice Guidelines', Chest Journal, 129 (1 suppl), 238S-249S.
  112. Eccles R, et al. (1992) 'Lack of effect of codeine in the treatment of cough associated with acute upper respiratory tract infection', Journal of Clinical Pharmacy and Therapeutics, 17(3), pp. 175-80.
  113. Freestone C et al. (1997) 'Assessment of the antitussive efficacy of codeine in cough associated with common cold', Journal of Pharmacy and Pharmacology, 49, pp. 1045-9.
  114. Pavesi L, Subburaj S, Porter-Shaw K (2001) 'Application and validation of a computerized cough acquisition system for objective monitoring of acute cough: a meta-analysis; Chest, 120, pp. 1121-1128.
  115. Bolser, D.C and Davenport, P.W (2007) 'Codeine and cough: an ineffective gold standard', Curr Opin Allergy Clin Immunol, 7 (1), pp. 32-36.
  116. http://www.racgp.org.au/afp/2015/july/self-medication-for-cough-and-%E2%80%A8the-common-cold-information-%E2%80%A8needs-of-consumers/ accessed November 2016
  117. Johnson G and Helman C (2004) Remedy or cure? Lay beliefs about over the counter medicines for coughs and colds, Br J Gen Pract, 54(499):98-102
  118. No data was able to be sourced by the Consultant that would enable the modelling of health benefits arising from smaller pack sizes or additional advisory warnings. While such changes might, conceivably, have some impact on the low-dose codeine use by acute therapeutic users, this population is not responsible for the rising health costs from codeine abuse/misuse. In relation to the chronic therapeutic population, particularly the dependent sub-group, which likely accounts for the majority of the health costs from low-dose codeine abuse/misuse, in the absence of specific data to the contrary, it is assessed that they will modify their buying habits to maintain their codeine use, thereby negating any projected health benefits.
  119. The number of ARTG entries under Option 3 is the same as under Option 2. Although some product portfolio rationalisation is likely to occur (50% of products) there are, generally, multiple medicine units (e.g. different pack sizes) per ARTG entry (a planning figure of 2.5 medicines per ARTG entry for OTC medicines has been used). On this basis, KPMG has assumed that no current sponsors will allow existing ARTG listings to lapse if this option is implemented.
  120. For more information regarding change applications, see the TGA website at https://www.tga.gov.au/book-page/step-2-determining-your-application-level-and-change-codes
  121. In actuality, the two products for each sponsor might be able to be incorporated into a single ARTG entry but we have left this as each product up-scheduled from Schedule 2 to Schedule 4 requires a separate ARTG entry to avoid understating the regulatory burden.
  122. www.wsmi.org/wp-content/uploads/2015/06/CONSUMER-BEHAVIOUR-FACT-BOOK_MARCH-2015.pdf (pdf,3Mb)
  123. http://www.racgp.org.au/afp/2015/july/self-medication-for-cough-and-%E2%80%A8the-common-cold-information-%E2%80%A8needs-of-consumers/ accessed November 2016
  124. Johnson G and Helman C (2004) Remedy or cure? Lay beliefs about over the counter medicines for coughs and colds, Br J Gen Pract, 54(499):98-102
  125. For more information regarding change applications, see the TGA website at https://www.tga.gov.au/book-page/step-2-determining-your-application-level-and-change-codes
  126. In actuality, the two products for each sponsor might be able to be incorporated into a single ARTG entry but we have left this as each product up-scheduled from Schedule 2 to Schedule 4 requires a separate ARTG entry to avoid understating the regulatory burden.
  127. The figure was calculated as follows: Currently 22 Schedule 3 sponsors. 3 of these sponsors also have Schedule 4 products (carry-forward figure is 19). 14 of the remaining Schedule 3 sponsors also have Schedule 2 drugs (and so are picked-up in Option 4 calculations) which leaves 5 remaining sponsors. If we assume that the 50% of Schedule 3 sponsors indicated by industry consultations that are likely to migrate products from Schedule 3 to Schedule 4 are wholly contained within this group, then this leave a maximum of 3 sponsors.
  128. Cochrane reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care resources. See <http://www.cochrane.org/evidence>. Relevant reviews are: Derry S, Moore RA, McQuay HJ. Single dose oral codeine, as a single agent, for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD008099. DOI: 10.1002/14651858.CD008099.pub2. Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) for postoperative pain in adults. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004602. DOI: 10.1002/14651858.CD004602.pub2. Derry CJ, Derry S, Moore RA, McQuay HJ. Single dose oral ibuprofen for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD001548. DOI: 10.1002/14651858.CD001548.pub2. Toms L, Derry S, Moore RA, McQuay HJ. Single dose oral paracetamol (acetaminophen) with codeine for postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001547. DOI: 10.1002/14651858.CD001547.pub2. Derry S, Karlin SM, Moore RA. Single dose oral ibuprofen plus codeine for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2015, Issue 2. Art. No.: CD010107. DOI: 10.1002/14651858.CD010107.pub3. Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD010210. DOI: 10.1002/14651858.CD010210.pub2.
  129. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  130. Roxburgh A, Hall WD, Burns L, Pilgrim J, Saar E, Nielsen S and L Degenhardt. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust (2015) 203(7).
  131. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  132. For more information regarding change applications, see the TGA website at https://www.tga.gov.au/book-page/step-2-determining-your-application-level-and-change-codes
  133. www.tga.gov.au/publication/required-advisory-statements-medicine-labels-rasml
  134. See the TGA website for more information on change applications: https://www.tga.gov.au/book-page/step-2-determining-your-application-level-and-change-codes

Book pagination