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TGA medicine labelling and packaging review

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Consultation

24 May 2012

Appendix 2: Reference list

Cited in the consultation paper

  1. Australian Government 2000, National Medicines Policy, Canberra, Australia.
  2. Australian Commission on Safety and Quality in Health Care 2011, Report on the National Round Table on Safer Naming, Labelling and Packaging of Medicines, ACSQHC, Sydney.
  3. Australian Government 2011, TGA reforms: A blueprint for TGA's future, Canberra, Australia.
  4. Australian Commission on Safety and Quality in Health Care 2011, National Standard for the Application of Tall Man Lettering Project Report, ACSQHC, Sydney.
  5. Australian Government 2010, Best Practice Regulation Handbook, Canberra, Australia.
  6. NPS Better Choices Better Health - Be medicine wise
  7. Murnion BP 2010, Combination analgesics, Australian Prescriber 33:113.
  8. Daly, FFS et al 2008, 'Guidelines for the management of paracetamol poisoning in Australia and New Zealand – explanation and elaboration', MJA 188:296-301.
  9. Budnitz, DS et al 2011, 'Emergency department visits for overdoses of acetaminophen-containing products', Am J Prev Med, 40: 585-592.
  10. Lavonas, EJ et al 2012, 'Comparative risks of non-prescription analgesics: a structured topic review and research priorities', Expert Opin Drug Saf 11:33-44.
  11. Statutory instrument No.2045: The Medicines (Sales or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 1997 London: The Stationery Office, 1997.
  12. Statutory Instrument: S.I, 150 of 2001. Medicinal Products (Control of Paracetamol) Regulations, 2001 Dublin: Stationery Office, 2001.
  13. King, JP et al 2011, 'Developing consumer-centered, nonprescription drug labelling', Am J Prev Med, 40:593-598.
  14. Australian Council for Safety and Quality in Health Care 2002, Second national report on patient safety. Improving medicine safety, Australian Commission on Safety and Quality in Health Care, Sydney.
  15. Shrank, W et al 2007, 'Effect of Content and Format of Prescription Drug Labels on Medication Use', Ann Pharmacother, 41:783-801.
  16. National Patient Safety Agency, 2007. Design for patient safety: A guide to the graphic design of medication packaging, 2nd Edition. NPSA and Helen Hamlyn Centre, London.

Referred to during consultation paper preparation

  1. Simkin, S et al 2012, 'What can be done to reduce mortality from paracetamol overdoses? A patient interview study', Q J Med, 105:41-51.
  2. Australian Council for Safety and Quality in Health Care 2002, Second National Report o Patient Safety Improving Medication Safety, Australian Council for Safety and Quality in Health Care, Sydney.
  3. Consumers Health Forum Australia 2011, Community Quality Use of Medicines and Diagnostics Project: Achieving Best Practice in the Packaging and Labelling of Medicines: Report from the National Consumer Workshop, CHF, Canberra.
  4. Consumers Health Forum Australia 2011, Community Quality Use of Medicines and Diagnostics Project: Achieving Best Practice in the Packaging and Labelling of Medicines: A consumer information and discussion paper, CHF, Canberra.
  5. Wilson, KM et al 2010, 'Knowledge gaps and misconceptions about over-the-counter analgesics among adolescents attending a hospital-based clinic', Academic Pediatrics, 10:228-32.
  6. Medicines Partnership of Australia, MPA Considerations of Packaging and Labelling; Principles and Recommendations, Canberra, Australia.
  7. Lalor, D 2011, 'Medicines labelling', Australian Prescriber, 34(5)136-137.
  8. Anacleto, TA et al 2005, 'Medication errors and drug-dispensing systems in a hospital pharmacy', Clinics, 60(4):325-32.
  9. O'Donoghue, N 2012, 'Look-alike sound-alike medicines a recipe for dispensing errors', Pharmacy News, 10 January 2012.
  10. Shrank, W et al 2007, 'Medication safety', Ann Pharmacother, 41:783-801.
  11. Hellier, E et al 2006, 'Considering the impact of medicine label design characteristics on patient safety', Ergonomics, 49:617-630.
  12. Watanabe, RK 1994, 'The ability of the geriatric population to read labels on over-the-counter medication containers', J Am Optom Assoc, 65:32-37.
  13. Emmerton, LM and Rizk, MFS 2012, 'Look-alike sound-alike medicines: risks and 'solutions'', Int J Clin Pharm, 34:4-8.
  14. Morrow, DG et al 1998, 'The influence of list format and category headers on age differences in understanding medication instructions', Experimental Aging Research, 24:231-256.
  15. Vigilante, WJ and Woglater, MS 1997, 'The preferred order of over-the-counter (OTC) pharmaceutical label components', Drug Information Journal, 31:973-988.
  16. Filik, R et al 2010, 'The influence of tall man lettering on drug name confusion', Drug Saf 33(8): 677-687.
  17. McLachlan, AJ 2010, 'Generic medicines literacy- minimising the potential for patient confusion', MJA 192(7):368-9.
  18. Hoffman, JM and Proulx, SM 2003, Medication errors caused by confusion of drug names, Drug Safety, 26(7):445-452.
  19. Gabriele, S 2006, 'The role of typography in differentiating look-alike sound-alike drug names', Healthcare Quarterly, 9:88-95.
  20. Australian Commission on Safety and Quality in Health Care 2011, Evaluating the effect of the Australian List of Tall Man Names, Australian Commission on Safety and Quality in Health Care, Sydney.
  21. King, JP et al 2011, 'Developing consumer-centred non-prescription drug labelling, a study in acetaminophen', Am J Prev Med, 40(6):593-598.
  22. Health Canada 2005, Guidance for Industry Drug name review: look-alike sound-alike health product names, Health Canada Publications, Ontario.
  23. National Patient Safety Agency 2008, Design for patient safety: A guide to labelling and packaging of injectable medicines, NPSA and Helen Hamlyn Centre, London.
  24. Medicines and Healthcare products Regulatory Agency 2003, Best practice guidance on labelling and packaging of medicines, MHRA Guidance Note No 5. MHRA, London.
  25. European Commission 2009, Guideline on the readability of the labelling and package leaflet of medicinal products for human use, Revision 1, Brussels.
  26. European Commission 2001, Title V: Labelling and package leaflet, Official journal of the European Communities 2001/83/EC.
  27. Irish Medicine Board 2007, Guide to invented names of human medicines. Dublin.
  28. European Medicines Agency 2007, Guideline on the acceptability of names for human medicinal products processed through the centralised procedure, CHMP, London.
  29. US FDA 2009, Guidance for Industry Labelling OTC Human Drug Products, CDER, Silver Spring.
  30. Therapeutic Goods Administration 2009, Therapeutic Goods Order No. 69 General requirements for labels for medicines, TGA, Canberra.
  31. Therapeutic Goods Administration 2009, Best practice guideline on prescription medicine labelling, TGA, Canberra.
  32. Therapeutic Goods Administration 2011, 'Coversyl and Coumadin: new packaging to reduce potential for dispensing errors', Australian Prescriber, 34(2):48.
  33. O'Hare, F et al 2009, 'Readability of prescription labels and medication recall in a population of tertiary referral glaucoma patients', Clin Experiment Ophthalmol, 37(9):849-54.
  34. Roughead EE and Semple SJ 2009, 'Medication safety in acute care in Australia: where are we now? Part 1: a review of the extent and causes of medication problems 2002-2008', Aust New Zealand Health Policy, 11;6:18.
  35. Weingart, SN et al 2008, 'Epidemiology of medical error', BMJ, 320(7237):774-7.
  36. Nichols, P et al 2008, 'Learning from error: identifying contributory causes of medication errors in an Australian hospital', MJA, 188(5):276-9.
  37. Beddell, SE et al 2000, 'Discrepancies in the use of medicines; Their Extent and Predictors in an Outpatient Practice', Arch Intern Med 160(14):2129-2134.
  38. Cohen, MR 1995, 'Drug product characteristics that foster drug-use-system errors', Am J Health Syst Pharm, 52:395-399.
  39. Pawasker, MD and Sansgiry, SS et al 2006, 'Over the counter medication labels: problems and needs of the elderly population', J Am Geriatr Soc., 54(12):1955-6.
  40. Formby, FT 2008, 'Medication self-administration by patients: a way to prevent errors', Med J Aust, 189(8):471.
  41. Shrank, WH et al 2007, 'The variability and quality of medication container labels', Arch Intern Med, 167(16):1760-5.

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