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Reclassification of Medicines

Reclassification of Medicines. How New Zealand compares with other countries – March 2012. Why did we do this analysis?. To investigate concerns of risk-averse behaviour by Medsafe in switching classification status of medicines Analysis conducted in December 2011. Sources of Data.

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Reclassification of Medicines

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  1. Reclassification of Medicines How New Zealand compares with other countries – March 2012

  2. Why did we do this analysis? • To investigate concerns of risk-averse behaviour by Medsafe in switching classification status of medicines • Analysis conducted in December 2011

  3. Sources of Data • The Association of the European Self-Medication Industry (AESGP) – January 2011 • Selected Regulatory Authorities schedules of medicines – December 2011 • World Self-Medication Industry (WSMI) website • No changes to the source data as at 28 March 2012

  4. What countries were compared? • Countries with established and comparable regulatory regimes • Countries selected for this analysis: • EU countries: • Belgium, UK, Portugal, Finland, Sweden, Denmark, France, the Netherlands, Ireland, Italy, Austria, Germany, Spain, Greece • Specific Non-EU countries: • Australia, the USA, Canada, Switzerland, Norway, Singapore, Japan

  5. Medicines reviewed • Ingredients were selected by the AEGSP and published in their tables • available at www.wsmi.org/otc.htm • Presumably these are medicines of interest to the AEGSP and WSMI • For this analysis, “Restricted Medicine” category in NZ has been grouped with prescription medicines • Ingredients not registered in NZ have been excluded from the analysis

  6. Findings – OTC in NZ • 155 ingredients listed by the AESGP are OTC in New Zealand • 131 of the 155 OTC medicines in New Zealand are prescription medicines in one or more other countries • Only 24 are OTC in all countries • Most comparable country to NZ is Australia, with only 14 of these ingredients classified as Prescription medicines

  7. Findings – prescription in NZ • 48 ingredients listed by the AESGP are Prescription status in New Zealand • None are OTC in all 21 comparable countries • 7 are also prescription status in all 21 comparable countries • Most switched country is the UK where 18 of the 48 are available OTC • Australia has 6 of the 48 prescription medicines in NZ available OTC

  8. Conclusions • Amongst comparable countries, New Zealand leads in having the largest number of medicines available OTC • 14 more than the next least restrictive country (Australia) • 68 more than the most restrictive (the USA) • Concerns of risk-averse behaviour are not upheld by the evidence

  9. Future consideration • But – the analysis suggests there are suitable candidates that the MCC could consider or review, and this work may serve as a way-marker for identifying such candidates • For example: • 6 Rx medicines in NZ are available OTC in Australia • Bacitracin, clobetasone, dihydrocodeine, flavoxate, fluconazole, butoconazole

  10. Examples • 14 OTC medicines in NZ are Rx in Australia • Why? • 18 Rx medicines in NZ are available OTC in the UK • Clemastine, codeine, pramocaine, domperidone, adenosine, oxybuprocaine, acrivastine, clobetasone, dihydrocodeine, mebeverine, fluconazole, sumatriptan, tranexamic acid, flunisolide, hydroxyzine, tamsulosin, azithromycin, simvastatin

  11. Thank you

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