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Footnotes

November 2016 (Final report)
Last updated
  1. Wholesale pharmaceutical data (IMS) is collated by a commercial organisation (QuintilesIMS) and was provided to KPMG by the Department of Health. See <https://www.imshealth.com/en/about-us/news/top-line-market-data - external site>.
  2. See <https://www.mja.com.au/journal/2015/203/7/trends-and-characteristics-accidental-and-intentional-codeine-overdose-deaths - external site>.
  3. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  4. 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 <www.cochrane.org/evidence - external site>. 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.
  5. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  6. This estimates are derived from IMS data for sales for the 12 months to September 2013, projected to 2017 using an assumed reduction in sales for both of 10% over this period, based on stakeholder advice.
  7. Private prescriptions have been used as the comparator as these products are under the PBS co-pay threshold
  8. Panadeine Forte, for example, has the following active ingredients Paracetamol 500 mg; Codeine phosphate hemihydrate 30 mg
  9. 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 - external site>.
  10. 2015-16 expenditure by MBS group was sourced from Medicare Statistics online: http://medicarestatistics.humanservices.gov.au/statistics/mbs_group.jsp - external site
  11. The Macquarie Centre for the Health Economy, Macquarie University, 'The value of OTC medicines in Australia: March 2014', <http://www - external site.asmi.com.au/media/14036/final_web_copy_asmi_valuestudy_a4.pdf>. The report notes that 'it was funded by the Australian Self Medication Industry and a Macquarie University research grant'.
  12. 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 - external site (pdf,865kb)>.
  13. http://issues.pharmacydaily.com.au/2016/Aug16/pd110816.pdf (pdf,1.8Mb) - external site
  14. It should be noted that, in the SUSMP, references to the concentration, strength or quantity of codeine are calculated for anhydrous codeine (molecular weight: 299.36). However, codeine is commonly present in products as codeine phosphate (molecular weight: 397.4). Weights of codeine referred to in the SUSMP are multiplied by 1.33 to obtain the weight of codeine in codeine phosphate formulations. Codeine weights in this document refer to its presence in codeine phosphate formulations.
  15. See Therapeutic Goods Administration website for more detail: https://www.tga.gov.au/book-page/interim-decisions-matters-referred-expert-advisory-committee-11.
  16. See Therapeutic Goods Administration website for more detail: https://www.tga.gov.au/book-page/part-final-decisions-matters-referred-expert-advisory-committee-11-14.
  17. 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.
  18. The MJA article noted that the study (2000-2013) is limited in '... inferences that can be drawn about the likely impact of reducing OTC codeine availability on the prevalence of codeine-related mortality'. Amanda Roxburgh, Wayne D Hall, Lucinda Burns, Jennifer Pilgrim, Eva Saar, Suzanne Nielsen and Louisa Degenhardt. 'Trends and characteristics of accidental and intentional codeine overdose deaths in Australia', Medical Journal of Australia, 2015, Volume 203, Issue 7, viewed 6 September 2016, <https://www.mja.com.au/journal/2015/203/7/trends-and-characteristics-accidental-and-intentional-codeine-overdose-deaths - external site>.
  19. In the base case, only chronic therapeutic users of low dose codeine medicines 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.
  20. Amanda Roxburgh, Wayne D Hall, Lucinda Burns, Jennifer Pilgrim, Eva Saar, Suzanne Nielsen and Louisa Degenhardt. 'Trends and characteristics of accidental and intentional codeine overdose deaths in Australia', Medical Journal of Australia, 2015, Volume 203, Issue 7, viewed 6 September 2016, <https://www.mja.com.au/journal/2015/203/7/trends-and-characteristics-accidental-and-intentional-codeine-overdose-deaths - external site>.
  21. NPS publication: NSAIDs: minimising the risk <https://www.nps.org.au/__data/assets/pdf_file/0006/17079/N... - external site (pdf,374kb)>.
  22. 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 - external site>. 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.
  23. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  24. 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.
  25. Amanda Roxburgh, Wayne D Hall, Lucinda Burns, Jennifer Pilgrim, Eva Saar, Suzanne Nielsen and Louisa Degenhardt. 'Trends and characteristics of accidental and intentional codeine overdose deaths in Australia', Medical Journal of Australia, 2015, Volume 203, Issue 7, viewed 6 September 2016, < <https://www.mja.com.au/journal/2015/203/7/trends-and-characteristics-accidental-and-intentional-codeine-overdose-deaths - external site>.
  26. 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.
  27. 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.
  28. References to the dosage unit of codeine in this document 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 listings refer to concentrations of codeine phosphate, whereas dosages in the Poisons Standard refer to anhydrous codeine.
  29. TGA, Regulation Impact Statement: General Requirements for labels for medicines, https://ris - external site.govspace.gov.au/files/2016/08/General-requirements-for-labels-for-medicines-RIS.pdf, July 2016.
  30. TGA, Regulation Impact Statement: General Requirements for labels for medicines, https://ris - external site.govspace.gov.au/files/2016/08/General-requirements-for-labels-for-medicines-RIS.pdf, July 2016, p.32.
  31. Office of Best Practice Regulation, 'Guidance Note: Regulatory Burden Measurement Framework', dated February 2016, p.18
  32. www.open.edu.au/careers/healthcare-medical-pharmaceuticals/pharmacists - external site, Based on average salary of $70,000.
  33. http://www.payscale.com/research/AU/Job=General_Practitioner/Salary - external site (click on 'Show hourly rate' link).
  34. www.tga.gov.au/publication/required-advisory-statements-medicine-labels-rasml
  35. Number of existing S2 entries x multiplier to account for ARTG entries covering for more than one medicine unit.
  36. OBPR, Regulatory Burden Measurement (RBM) guidance note, https://www.dpmc.gov.au/sites/default/files/publications/0... - external site (pdf,160kb), February 2016
  37. No data was able to be sourced by KPMG 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 medicine use by acute therapeutic users this population grouping is not responsible for the arising health costs from codeine medicines abuse/misuse. In relation to the chronic therapeutic population group, 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.
  38. 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 S2 to S4 requires a separate ARTG entry to avoid understating the regulatory burden.
  39. www.wsmi.org/wp-content/uploads/2015/06/CONSUMER-BEHAVIOUR-FACT-BOOK_MARCH-2015.pdf (pdf,3Mb)
  40. This estimation of time spent by the consumer in obtaining S4 medicines from a pharmacist takes into account that many pharmacies are located adjacent to other shops and that if a wait time of greater than a couple of minutes is indicated for the processing of a script, a consumer is likely to leave the pharmacist to undertake other tasks (e.g. purchase of groceries) and then return when the script has been processed. As the expenditure of this time is no longer directly related to the obtaining of a script it has been excluded from the time calculation to determine the regulatory burden.
  41. 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 S2 to S4 requires a separate ARTG entry to avoid understating the regulatory burden.
  42. The figure was calculated as follows: Currently 22 S3 sponsors. 3 of these sponsors also have S4 products (carry-forward figure is 19). 14 of the remaining S3 sponsors also have S2 drugs (and so are picked-up in Option 4 calculations) which leaves 5 remaining sponsors. If we assume that the 50% of S3 sponsors indicated by industry consultations that are likely to migrate products from S3 to S4 are wholly contained within this group then this leave a maximum of 3 sponsors.
  43. This assessment of time spent by the pharmacist (and their staff) for Option 6 takes into account additional time spent by the pharmacy staff in preparing a label and updating any required dispensing recording systems and for the pharmacist to talk to the consumer to explain any specific usage requirements and any known side effects. This is counterbalanced by the time previously taken by the pharmacist when dispensing S3 codeine medicines to talk to the consumer to determine the appropriateness of the requested product, noting this matter is now largely addressed in the GP/patient consultation
  44. Office of Best Practice Regulation, 'Best Practice Regulation Guidance Note: Value of statistical life', dated December 2014.
  45. Compared to occasional users of low dose combination medicines, a higher risk of adverse events due to paracetamol and/or ibuprofen is expected in consumers who are using combination products for longer periods than recommended and/or with greater frequency than the maximum recommended dose for the combination product. These events, and a reduction in their occurrence, are not quantified as part of the model. This leads to an underestimate of the health benefits that are projected to result from Scenario 4.
  46. 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 - external site (pdf,865kb)>.
  47. If a patient is referred to a pain clinic by their GP this attracts a rebate via the MBS (MBS items 2801 2806).
  48. While 5 repeats is the maximum number of repeats that can be given, GPs have discretion to provide a lower number (or even zero) repeats based on the patient's symptomology and medical history.
  49. The following public domain document included an estimate of the fiscal impact of the proposed rescheduling of codeine. 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 - external site (pdf,865kb)>.
  50. ibid., p. 10.
  51. "Do not take more than a few days at a time unless your doctor tells you to." Source: Mersyndol DayStrength Caplets Consumer Medicine 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 - external site>, accessed 24 August 2016.
  52. 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-add... - external site
  53. The total sales values and units by pack size were used to estimate the wholesale prices of both IMS S2 and S3 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
  54. A conservative assumption was made because KPMG was unable to determine whether the prevalence of low dose dependence is increasing due to the paucity of data.
  55. Amanda Roxburgh, Wayne D Hall, Lucinda Burns, Jennifer Pilgrim, Eva Saar, Suzanne Nielsen and Louisa Degenhardt. 'Trends and characteristics of accidental and intentional codeine overdose deaths in Australia', Medical Journal of Australia, 2015, Volume 203, Issue 7, viewed 6 September 2016, <https://www.mja.com.au/journal/2015/203/7/trends-and-characteristics-accidental-and-intentional-codeine-overdose-deaths - external site>.
  56. In 2015/16 83.4% of all GP/GP VR non-referred attendances were bulkbilled. The economic model incorporates this rate in two ways. First, the data provided by Medicare to estimate the cost of additional consultations was developed using Medicare's estimates of the mix of MBS items and the rate of bulkbilling (for the bulkbilling incentive payment). Second, the model assumes a co-payment is paid by 15% of all patients. http://www.health.gov.au/internet/main/publishing.nsf/Con... - external site
  57. 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.

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