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Innovations from 'Down-Under': a Focus on Prescription to Non-Prescription Medicine Reclassification in New Zealand and Australia

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Innovations from 'Down-Under': a Focus on Prescription to Non-Prescription Medicine Reclassification in New Zealand and Australia ORIGINAL ARTICLE SelfCare 2012;3(5):88-107 Advancing the study&understanding of self-care INNOVATIONS FROM ‘DOWN-UNDER’: A FOCUS ON PRESCRIPTION TO NON-PRESCRIPTION MEDICINE RECLASSIFICATION IN NEW ZEALAND AND AUSTRALIA NATALIE GAULD*, FIONA KELLY**, LYNNE EMMERTON†, LINDA BRYANT††, STEPHEN BUETOW‡ * PhD Candidate, Department of General Practice and Primary Health Care, University of Auckland, New Zealand **Honorary Senior Lecturer, School of Pharmacy, University of Auckland, New Zealand †Associate Professor, School of Pharmacy, Curtin Health Innovation Research Institute, Perth, Western Australia †† Honorary Lecturer, Department of General Practice and Primary Health Care, University of Auckland, New Zealand ‡Associate Professor, Department of General Practice and Primary Health Care, University of Auckland, New Zealand ABSTRACT BACKGROUND: Australia and New Zealand (NZ) contribute to the international trend of medicines reclassification from prescription to non-prescription availability (switch). Both countries have been acknowledged as being as advanced or even more so than the United Kingdom (UK) in availability of medicines without prescription, despite not making some of the recent innovative UK switches. OBJECTIVE: To derive a measure of progressiveness in switch; to compare the progressiveness of switch between NZ and Australia; and to compare NZ and Australia switch activity with the UK. METHODS: Records of medicines classification meetings in Australia and NZ from 2000 to 2011 were analysed with respect to all switch considerations (whether approved or not approved). Switches in Australia and NZ were compared with those in the UK. A new measure, ‘innovative switches’, was developed to provide a useful measure of switch progress. RESULTS: Australia demonstrated ‘switch innovation’ in the early 2000s, including the ‘first-in-world’ switch of orlistat, but has slowed down since. Recently NZ has become more innovative than Australia with first- in-world switches of oseltamivir, famciclovir and calcipotriol. Switches driven by sponsors, and also non- sponsors, and exemption to prescription supply have facilitated consumer access to medicines in NZ. However, medicines that were switched in the UK but not Australasia indicate locality-specific barriers. CONCLUSIONS: Australia and NZ have both been progressive with medicines reclassification in the past 12 years, albeit with fewer innovative switches in Australia recently. NZ has become more innovative since 2004 and is now one of the more progressive countries in this trend. Our ‘innovative switch’ framework demonstrates potential for ongoing monitoring of international developments. Key words: Self medication; Nonprescription drugs; Reclassification; Pharmacy; Pharmacist Prescribing; Advisory Committees. ©SELFCARE 2012 Accepted for publication 30 July 2012 88 INNOVATIONS FROM ‘DOWN-UNDER’ INTRODUCTION Australia and New Zealand (NZ) contribute to the international trend for reclassification or down-scheduling of medicines from prescription to non-prescription availability, also known as ‘switch’. Both countries have three levels of non-prescription access1-3. Pharmacist Only Medicines (Schedule 3 or S3 in Australia) require a pharmacist’s involvement in supply, and cannot be directly accessed by consumers. Pharmacy Medicines (Schedule 2 or S2 in Australia) are generally only available from pharmacies and can be self-selected in NZ, and in some Australian jurisdictions. General sales medicines (unscheduled medicines in Australia) can be sold in non- pharmacy outlets such as supermarkets and convenience stores. The Advisory Committee on Medicines Scheduling (ACMS) in Australia, and the Medicines Classification Committee (MCC) in NZ advise the respective Governments on classification of medicines4,5. In Australia, the ACMS also makes recommendations on advertising of Pharmacist Only Medicines. Ultimate authority rests with the Minister of Health’s Delegate (in NZ) or the Secretary of the Department of Health and Ageing’s Delegate (in Australia). The ACMS evolved from the decision-making National Drugs and Poisons Scheduling Committee (NDPSC) in Australia in mid-2010. The committee composition, decision-making process, and matters considered by each committee in making a recommendation vary between Australia and NZ, and are presented as Appendices 1 and 2. Australia and NZ have attempted to harmonise the scheduling of medicines since the late 1990s under Trans-Tasman Harmonisation (TTH)6,7. The intention has been to harmonise to the less- restrictive schedule, while considering public health and safety issues and/or jurisdictional needs7. Australia8,9 and NZ8 have been found to be advanced in non-prescription availability of medicines relative to selected developed countries. Using World Self-Medication Industries (WSMI) tables (September 2003), the Gilbert et al.8 review of schedules for 119 medicines found NZ and Australia ahead of the United Kingdom (UK), Canada, France and the United States (US) in numbers of medicines available without prescription. The authors concluded that more medicines tended to be available off-prescription in countries with a pharmacy- only or pharmacist-only category, rather than a single non-prescription category, and that two pharmacy categories may be more enabling than one pharmacy category. However, they noted the limitation of confirming the accuracy of only the Australian classifications. Our check of the WSMI tables updated 19 December 2008 (as per the lead author’s personal communication with the Association of the European Self-Medication Industry (AESGP) on 15 July 2009) found 20 discrepancies for NZ that may have changed findings by Gilbert and others, especially if inaccuracies also occurred for other countries. The US Government Accountability Office (GAO) used the WSMI tables (1 February 2007) to compare classification status across 86 medicines approved in all five selected countries9. Australia and the UK had the most medicines available without prescription (n=63 in each country), followed by the ©SELFCARE 2012 Accepted for publication 30 July 2012 89 INNOVATIONS FROM ‘DOWN-UNDER’ US (n=44), Italy (n=43) and the Netherlands (n=41). As Australia had fewer open-availability (unscheduled) medicines than the US or UK, the GAO considered that the benefits of ‘behind- the-counter’ medicine availability were unclear. Since the GAO checked regulatory information against the WSMI tables (finding discrepancies around medicines approvals), its numbers are probably accurate. However, the WSMI tables treat all drugs as equal and do not necessarily reflect the progress that, for example, the UK has made with innovative switches of medicines such as simvastatin, sumatriptan and azithromycin. Blenkinsopp and Bond, in 2005, identified the UK as the most progressive country in the world in terms of switch, although the reason for their judgement was unclear10. This view was supported by McCreedy from the Medicines and Healthcare products Regulatory Agency in 200911. Using WSMI tables to ascertain advancement may reflect historical classifications and switches rather than current activity. Further, in 2010, Australia was described by the industry group Australian Self-Medication Industry as ‘extremely risk-averse’ in switch12, which is at odds with the findings of Gilbert et al.8 and the USGAO9. Thus, there is a need to derive an appropriate measure of progressiveness or switch innovation, in order to compare this process between countries. The term ‘first-in-class switches’ was used by Soller et al. and showed clearly how limited the US has become in switch activity, with only four such reclassifications since 200013. These authors defined first-in-class switches as ‘uniquely pushing the boundary of OTCness’, wanting to differentiate these switches from the easier follow-on switches, and noting that such switches raise a higher level of concern than the easier ‘me-too’ or ‘follow-on’ switches. Mann agreed, noting the difficulties faced in switching simvastatin in the UK as a first-in-class switch14. In drug development, a first-in-class medicine has a novel mode of action, whereas a follow- on medicine uses an existing mode of action15. However, for reclassification first-in-class switches may not push any boundaries, and follow-on switches could push boundaries. For example, the UK reclassification of topical griseofulvin has a different mechanism of action to the already-switched azoles and polyenes16, but does not push boundaries. A switch of diclofenac, allowing 150mg per day (full dose)16 after the ibuprofen low-dose switch, would probably push boundaries in most countries, yet would be deemed a follow-on switch rather than first-in-class. A non-prescription medicine with a new indication previously untreated in the non-prescription arena can be deemed to push boundaries, for example domperidone, being indicated to treat nausea and vomiting in the UK17. Finally, some medicines have no clear class, such as ketotifen (an antihistamine and mast cell stabiliser) and acetylcysteine (a mucolytic and nutritional)16. In measuring innovation in drug development, Schmid and Smith (2005) used US Food and Drug Administration (FDA) priority reviews (for registering new chemical entities) to measure significant advantage over existing medication18, but regulators do not similarly prioritise non- prescription medicines. Thus, a new measure is needed to show progressiveness or innovation in switch. ©SELFCARE 2012 Accepted for publication 30 July 2012
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