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

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

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

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

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

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

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

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

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

Thank you