Australia lags in down-scheduling and misses its benefits

down-scheduling: Natalie Gauld being vaccinated in pharmacy

Australia lags internationally when it comes to down-scheduling medicines; leading New Zealand pharmacist Natalie Gauld explores why, and how the Australian pharmacy landscape could benefit from increasing access to drugs and vaccines.

Australia has fallen a little behind the UK and NZ in down-scheduling medicines from prescription to non-prescription.[1]

Qualitative research has found that a number of factors have impeded down-scheduling in Australia.[2]

The scheduling committee was considered conservative or “risk-averse”. Certain events, such as the orlistat advertising in Teen Idol, mystery shopping finding some pharmacies supplying orlistat to women outside of the BMI criteria for supply, and a toddler’s death from potassium chloride poisoning appeared to contribute to the committee’s stance, and so did changes in the committee members.

For pharmaceutical companies, down-scheduling to S3 was unattractive given they typically could not advertise their brand to the consumer, and generics would immediately enter the market.

They also didn’t like their chances of having a down-scheduling approved.

In the meantime, NZ and the UK have moved forward. There is no evidence of problems from recent prescription to non-prescription switches in either country.

Indeed, a NZ regulator was quoted in the qualitative research mentioned above[2] that with the oseltamivir down-scheduling “pharmacy policed their profession very, very effectively and self-managed their profession very, very effectively, in a way that certainly makes me more confident that other things can go down the same way”.

Research supports this view, showing that pharmacists took the down-scheduling of oseltamivir seriously,[3] and there was no evidence of resistance issues,[4, 5] reduced vaccine uptake, or stockpiling by patients.[4]

Pharmacist administration of influenza vaccines in Australia provides an excellent opportunity to show how well pharmacists can provide new services and work within special criteria to ensure safe supply.

This should provide the ACMS with confidence in pharmacists, enabling further down-scheduling to S3.

Additionally if appropriate advertising will be allowed in Australia, the S3 category would no longer be the “product graveyard” industry currently calls it, encouraging down-scheduling applications. Consumers would then benefit from improved access to a wider range of medicines.

Overseas models provide hope for medicines access in Australia. California has recently enacted legislation permitting pharmacists to supply oral contraceptives and depot progestogen for contraceptives without a prescription.

Given the safety profiles, Australia could also open access to these medicines, particularly given recent Australian research showing a reasonable proportion of women run out of and temporarily discontinue the oral contraceptive.[6]

Australia could also follow other countries in reclassifying medicines for long-term conditions, such as treating psoriasis, erectile dysfunction, irritable bowel, menorrhagia, and incontinence.

Widening access to vaccines as in the US, Canada and NZ would provide a more patient-centred supply.

It is no surprise that a study of 6 million vaccinations in Walmart pharmacies found 39% of consumers under 65 years accessed them at the weekend, and supply peaked over the lunchtime.[7]

Pharmacy is convenient, with extended opening hours, locations in various settings including shopping areas, and low wait times to see a qualified health professional. To maximise uptake of vaccinations we have to increase their convenience.

Internationally in this changing role of the pharmacist, mandatory training is becoming common, for example with vaccines internationally, contraceptives in California, and trimethoprim and sildenafil in NZ.

This ensures everyone supplying the product accesses the same high quality information, and proves their competence. I have no doubt that trimethoprim would not have become available through pharmacist-supply in NZ without this requirement.

A second feature often seen is the need to keep the patient’s doctor informed of supplies, minimising fragmentation of care.

Many new initiatives also require working within a specific protocol or screening tool for supply. This can be highly restrictive, as for trimethoprim in NZ to minimise the risk of bacterial resistance and maximise patient safety.

For those who think this is too demeaning or that as a health professional they should be trusted to work it out, it is time to move on and embrace the opportunities such tools provide.

Working within a screening tool ensures nothing is missed, that there is a record for future supplies to that patient, and provides an assurance to decision makers that pharmacists will provide a safe service.

Checklists are used in aviation for the simple reason of safety. Surgery is safer with checklists.[8] Pharmacy should embrace them, using them as an adjunct to their professional knowledge (which is still very much required), and in doing so gain further opportunities.

These opportunities might include new services and funding of these for high needs communities.

There will be increased time required for these new consultations, some of which may require BP readings for example with oral contraceptives, but in most cases consumers will be happy to pay for that time, given the convenience and service.

A Macquarie University study for the Australian Self Medication Industry found a substantial proportion of consumers want oral contraceptives, erectile dysfunction products, antibiotics for cystitis and triptans for migraines from the pharmacy without prescription.[9]

A further requirement will be privacy. In Ireland pharmacies are required to have a private consultation room, and that has been very enabling.

Concerns about down-scheduling often include insufficient privacy, and if pharmacy is to step up, a private consultation room is important. Consumers will return to a pharmacy where they get a professional private service.

So, how would these new pharmacist-only services work in the discount model of medicine supply seen in Australia?

Pharmacists will need to provide a level of service above what may be currently provided for some pharmacist-only medicines.

Pricing (probably including a consultation fee) will need to reflect this time required.

It is in the profession’s best interest to get these consultations right to open up further opportunities.

In the UK the patient group direction model of supplies through pharmacists of medicines like sildenafil and vaccines are sometimes accompanied by audit and spot checks (mystery shopping). While this would likely provide reassurance for decision-makers, this has not been needed for the new pharmacist-supplies in NZ.

Pharmacy in Australia is proving itself with vaccinations. By extending that model of extra training and professional supply within strict criteria, pharmacists could be better utilised in delivering patient-centred care.

In doing so, pharmacists will certainly help consumers, and open up new and interesting opportunities for themselves.


Dr Natalie Gauld consults on and conducts research in reclassification. She is on the Board of the Pharmaceutical Society of New Zealand, has reclassified medicines in NZ including trimethoprim, vaccines, sildenafil and calcipotriol, and was on the Medicine Classification Committee in NZ (2004-2009). Potential conflicts of interest: in the last three years, Dr Gauld has provided consultancy to Green Cross Health, the Pharmacy Guild of NZ, Pharmacy Retailing, Douglas Pharmaceuticals, Novartis Consumer and Sanofi Aventis. She has received research funding from the Pharmacy Guild, ProPharma, Pharmaceutical Society of NZ and Green Cross Health. ASMI, AESGP and RDD have provided travel funding for her to speak at their conferences.

Image: Natalie Gauld (right) being vaccinated in a pharmacy.


  1. Gauld, N.J., et al., Widening consumer access to medicines through switching medicines to non-prescription: A six country comparison. PLoS ONE, 2014. 9(9): p. e107726.
  2. Gauld, N.J., et al., Widening consumer access to medicines: A comparison of prescription to non-prescription medicine switch in Australia and New Zealand. PLoS ONE, 2015. 10(3): p. e0119011.
  3. Gauld, N., F. Kelly, and J. Shaw, Is non-prescription oseltamivir availability under strict criteria workable? A qualitative study in New Zealand. Journal of Antimicrobial Chemotherapy, 2011. 66(1): p. 201-204.
  4. Gauld, N.J., et al., Five years of non-prescription oseltamivir: effects on resistance, immunization and stock-piling. Journal of Antimicrobial Chemotherapy, 2012. 67: p. 2949-56.
  5. Hall, R.J., et al., Tracking oseltamivir-resistance in New Zealand influenza viruses during a medicine reclassification in 2007, a resistant-virus importation in 2008 and the 2009 pandemic. Western Pacific Surveillance and Response Journal : WPSAR, 2012. 3(4): p. 71-77.
  6. Abukres, S.H., K. Hoti, and J.D. Hughes, Patient attitudes towards a new role for pharmacists: Continued dispensing. Patient Preference and Adherence, 2014. 8: p. 1143-1151.
  7. Goad, J.A., et al., Vaccinations administered during off-clinic hours at a national community pharmacy: Implications for increasing patient access and convenience. Annals of Family Medicine, 2013. 11(5): p. 429-436.
  8. Haynes, A.B., et al., A surgical safety checklist to reduce morbidity and mortality in a global population. New England Journal of Medicine, 2009. 360(5): p. 491-499.
  9. Koslow, S., et al. The value of OTC medicines in Australia. 2014 Mar 2014 11 May 2015]; Available from:



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