Contribution of the community pharmacist workforce to primary care through the lens of medicines classification: comparison of Aotearoa New Zealand and Australia

Introduction

Pharmacists contribute to primary care in multiple ways, with the foundation of their contributions being to facilitate safe access to medicines and optimise outcomes from their use.¹ Primary care globally faces significant challenges with multi-morbidity in ageing populations causing increased health care demand and complexity.² Policy documents in both Australia and Aotearoa New Zealand (NZ) articulate a need to make better use of the full scope of pharmacists’ skills and knowledge.^3,4 The COVID-19 pandemic has further emphasised that maintenance of an efficient and functioning health system relies on the available workforce being used to its maximum capability.⁵

Australia and NZ have similar public health systems and legal frameworks that are designed to ensure safe access to medicines for the public by classifying them into different categories.^6–8 Both countries have a prescription medicine category which includes some controlled drugs (known to have dependency/abuse potential) and three non-prescription medicine categories. The non-prescription categories are:

General sale medicines may be sold from any retail outlet. Pharmacy-only medicines may only be sold from a licenced pharmacy. Pharmacist-only medicines may only be supplied by a pharmacist from a licenced pharmacy. Pharmacist-only medicines may also require a more detailed record of the sale (all in NZ and pseudoephedrine in Australia) and must be stored in a way that members of the public are not able to self-select, for example, behind a pharmacy counter or barrier. Sometimes medicines may have multiple classifications with a maximum quantity, strength or particular indication associated with the level of availability.^6,9

Both Australia and NZ have committees enshrined in legislation to advise their respective Governments on medicine classification. In Australia, the Advisory Committee on Medicines Scheduling (ACMS) makes recommendations to the Delegate of the Secretary to the Department of Health and Aged Care.⁶ In NZ, the Medicines Classification Committee (MCC) makes recommendations to the Minister of Health.¹⁰

The pharmacist-only classification helps to improve public access to medicines that enable self-care while ensuring there is supervision by a health professional who can identify or confirm the need for the medicine and provide tailored information and advice. However, pharmacist-only medicines are not usually funded by the health system in either country which can lead to questions about socioeconomic factors affecting access to these medicines and the potential to exacerbate health inequities.¹¹

Several classes of medicines have moved from prescription-only to pharmacist-only over the years, increasing public access in both countries.¹² Research comparing this type of reclassification between Australia and NZ covering the period up until 2013 concluded that NZ was more progressive in their use of the pharmacist-only category.⁸ A decade has since passed with no further evaluation of alignment in this area between the two closely related countries. Pharmacists in Australia consider it important to improve the availability of effective therapeutic options for the management of minor ailments.¹³ Given ongoing pressure on primary care and with significant health system structural changes progressing in NZ, including new therapeutic products legislation, it is timely to re-examine this area.^14,15

The aim of this paper was to explore the key differences in medicines (excluding vaccines) currently classified for pharmacist-only non-prescription supply in the two countries in relation to the implications for optimal use of the primary care workforce. Ethical approval was not required for this analysis as data was drawn from medicines-related legislation, health policy and professional body documents in both countries, all of which are in the public domain.

Methods

Medicines (excluding vaccines) classified to allow sale by a pharmacist (only) in Australia or NZ as of 1 February 2024 were identified, providing a sampling frame to enable comparisons to be made between the two countries. An initial table was created by a NZ research pharmacist, listing medicines allowed to be supplied by pharmacists without a prescription in NZ and their associated classification statements.⁷ The medicines were listed alphabetically and the classification along with any specific terms of the classification (age restriction, number of units, dosage forms) were included. A column was added for Australia and populated by an Australian research pharmacist using data extracted from Schedule 3 of the Standard for the Uniform Scheduling of Medicines and Poisons (also known as The Poisons Standard).⁶ Once the Australian data was incorporated, the NZ classification of any additional items identified from the Australian data were added to the table.

Based on consensus among the research team that included pharmacists (two from Australia and two from New Zealand) and a general practitioner (GP), notable differences were extracted for further qualitative consideration. Extraction was based on consideration of how medicine classification and access may contribute to extending the role of pharmacists in primary care within the different jurisdictions, and the implications for policy around primary care and the optimal use of medicines. Extracted medicines were grouped by therapeutic area and where necessary for context (eg whether an application for reclassification in either of the countries had been declined and why), additional detail was sought from Therapeutic Good Administration (TGA) publications (Australia), MCC meeting minutes (NZ), professional and government websites and other policy documents.^16,17

Results

The full comparative list of medicines available via a pharmacist without a prescription (pharmacist-only) in Australia and NZ is available in Supplementary File S1. While there is broad consistency overall, key differences were identified between the two countries in three therapeutic areas: respiratory, infection and sexual and reproductive health. The findings in each area are outlined briefly below with the classification details presented in Table 1.

Discussion

The pharmacist-only classification allows controlled public access to a range of medicines for the general communities of both countries. Although there is broad similarity in the items with this classification in Australia and NZ, there are several key differences. Overall, based on classification, NZ is less restrictive than Australia meaning New Zealanders generally have increased access to medicines via a pharmacist in two key therapeutic areas: sexual and reproductive health and infection. This finding is consistent with previous research covering the period until 2013.³⁷ It confirms that over the past decade NZ has continued to be more progressive than Australia using medicine classification to enable the pharmacist workforce to support care in the community by expanding the number of medicines they can supply without a prescription.

Rather than full down-classification of prescription-only medicines, this greater openness has often been facilitated through adaption of the prescription medicine category by adding exception criteria, such as specific training. This enables the incorporation of additional eligibility or referral criteria to support the optimal use of these medicines. A similar approach was facilitated in Australia in 2019 with the addition of Appendix M to the Poisons Standard which provides for Schedule 3 pharmacist-only medicines to be given additional requirements including patient eligibility criteria, pharmacist training, record-keeping and information sharing.³⁸ To date, there are no medicines listed in Appendix M.⁶ A multitude of factors affect medicines reclassification and reasons that have been cited for the differences in progressiveness between the two countries include greater opposition from other health professional bodies, complexity of the reclassification application process and risk averseness of the medicines scheduling committee in Australia.^8,13 It may also be that the health system focus on responding to the COVID-19 pandemic affected uptake of this new mechanism. The emergence of alternative arrangements at state level for provision of antibiotics in the management of UTIs by community pharmacists suggests that challenges of reclassification at a national level have led to other methods being sought to improve access for the public and enhance the use of the community pharmacist workforce in the provision of primary care in Australia.^22,23,39 This approach is leading to variation in medicine availability for Australians depending on which state they are in.

Most medicines that have been reclassified to enable pharmacist supply in either country to date are for conditions that benefit from timely access to treatment such as infection, bronchospasm and emergency contraception. Several factors contribute to ready patient access to pharmacists, including not requiring an appointment and the long opening hours of many pharmacies. The most recent example of a progressive reclassification decision in NZ with timely access as a factor was for the COVID-19 antivirals Paxlovid™ and molnupiravir. The need to increase access was cited by the NZ Minister of Health as the impetus for this rapid reclassification.⁴⁰ We are only aware of pharmacist-initiated supply of COVID-19 antivirals being instigated in two other jurisdictions – parts of Canada and the United States (US).^41,42 The Food and Drug Administration extended their Emergency Use Authorisation for Paxlovid™ so it could be prescribed by state-licensed pharmacists in the US, but only if they had access to sufficient information to assess renal and hepatic function, and sufficient information about an individual’s regular medicines to assess for potential drug interactions.⁴¹ They did not enable this for molnupiravir. In Canada, a small number of provinces enabled pharmacist prescribing of Paxlovid™.⁴²

The COVID-19 antiviral reclassification in NZ was implemented under Section 106 of the Medicines Act 1981 which allows the Minister of Health to declare a classification by Gazette publication without the usual MCC processes. This clause has been used previously to support the role of pharmacists in the vaccination response to the measles outbreak in 2019.⁴³ This pathway means the Government can rapidly act on policy intention when required.

There are several unique components to the model of care associated with the COVID-19 antiviral reclassification in NZ that are relevant to pharmacist-initiated supply of medicines and pharmacist contribution to primary care. This was the first time that pharmacy in NZ had been funded at a national level for a primary care consultation. Local funding arrangements for some consultations existed in a small number of the geographic areas in NZ (eg ECP consultations for certain patient groups in the Bay of Plenty⁴⁴); otherwise, the patient may be charged a consultation fee (in addition to the cost of the medicine) at the discretion of the pharmacy. Funding for consultation has been included in the Australian trials or pilots underway for pharmacist UTI management but this is not the case in the states where pharmacist supply is already fully implemented.^25,26 Funded consultations help to reduce barriers to access, especially where alternative options are not associated with cost to the patient, eg hospital emergency departments in both countries. Considering the wider context, however, paying for a pharmacist consultation may be less expensive than a GP consultation in many cases in both countries.

Government funding of the medicine when supply has been initiated by a pharmacist is also unusual. There are only two other examples in NZ of funded ‘direct provision’ – the ECP and nicotine replacement therapy.¹⁶ We are not aware of funding for pharmacist-initiated medicine supply in Australia outside the continuation supply provisions known as Continued Dispensing or the recent state-level trial/pilot programmes.^24–26,45 Consideration of equal funding for medicines, regardless of where they are obtained, is necessary to fully benefit from the increased access afforded by reclassification to enable pharmacist supply.

Cost to the patient is a factor in equity of access and may affect the achievement of equitable outcomes from medicines and services available in community pharmacies. The national level funding for a pharmacist consultation regardless of outcome has similarities with funded common ailments services commissioned in other jurisdictions such as the United Kingdom (UK).^46,47 Little is yet known about whether such services achieve equitable health outcomes.⁴⁸ NZ based researchers have explored Māori experiences of minor ailments care and the pharmacists’ role.⁴⁹ They identified factors considered important for designing services to deliver equitable care, with potential international application. NZ ran a pilot-funded minor ailments service in certain priority areas during winter 2023 based on emergency department capacity and pressure at key hospital locations.⁵⁰ The evaluation is not available at the time of writing although certain areas have opted to continue the service (Northland, Hawkes Bay and the Hutt Valley).⁵¹ In Canada, all provinces have pharmacist prescribing for minor ailments in place, with evidence of improving patient access to timely and cost-effective health care.⁵² A new more formalised ‘pharmacist primary care clinic’ model is emerging in some with quantitative and qualitative evaluation pending.⁵³ Overall, there is limited published literature on clinical and economic outcomes of medicine reclassifications, although what is available is promising in terms of safety and effectiveness.⁵⁴

A key requirement built into the COVID-19 antiviral service enabled by the reclassification of the antivirals in NZ was communication and integration with the wider primary care team. Pharmacists initiating supply have access to a shared electronic portal where they document and communicate the outcome of their consultation to the patient’s GP and others involved in COVID-19 community care.⁵⁵ Although protocols for other pharmacist-only medicines in NZ encourage communication with the patient’s GP, a digital portal to specifically facilitate this is novel. It is unclear whether the particular tool used worked well in practice, yet it indicates a step towards a future where a multidisciplinary approach to primary care is supported and enabled by digital tools helping to connect various providers. Development of this concept is crucial in addressing concerns around the potential for fragmentation when multiple providers are involved in care.⁵⁶

Approaches other than medicines reclassification have been used in various jurisdictions to enable extended use of the pharmacist workforce in primary care. Standing orders¹ underpin the community pharmacy anticoagulant management and gout management services in NZ where pharmacists undertake monitoring and dose adjustment of the prescribed medicines warfarin and allopurinol respectively.^57,58 Other similar examples include Collaborative Practice Agreements in the US⁵⁹ and Patient Group Directions in the UK.⁶⁰

A significant upcoming change in the UK intended to support optimal use of the pharmacy workforce in clinical care is amendment to pharmacy education standards so that all pharmacy graduates will be able to be qualified as independent prescribers on entry to the practice register by 2026.⁶¹ Research will be needed to fully understand the impact of this change on future pharmacist roles and patient access to medicines in primary care.⁶² Digital integration and information sharing with the wider primary care team will be just as important in this model to support coordination and continuity of care.⁶³

Despite timely access for acute conditions or symptoms being a traditional driver of reclassifications, the current findings show some medicines used more chronically, selected oral contraceptives and sildenafil for erectile dysfunction, have been reclassified in NZ to enable supply by a pharmacist. Resupply of oral contraceptives is also emerging in some Australian states.^24,25,36 The NZ COVID-19 antiviral example of digital integration and information sharing within the primary care team lays a foundation for further expansion of this type of service.^64,65 In NZ work is underway on a national digital health record that will provide patients and health providers with access to a range of health information such as prescribed and dispensed medicines, immunisation records, diagnostic test results and summary primary care information.⁶⁶ A digital health record such as this is already in existence in Australia and sharing to it is mandatory in the trials and pilots underway.^24,26,67

This analysis provides a comparison of medicines classified for access via community pharmacists in Australia and NZ as of 1 February 2024 to aid health policymakers and planners considering medicines access and optimal use of the primary care workforce. It shows a continuing trend of NZ making use of medicines classification to enable pharmacist contribution to help meet the growing demand on primary care and highlights the emergence of alternative state level legislative arrangements in Australia. A strength of the analysis is that information has been collated from several credible sources including classification databases, committee meeting notes, government websites, policy documents and published literature. Limitations include that it has been conducted with a cross-sectional lens in a dynamic environment. Several Australian states have pilots or trials underway for community pharmacist management of UTI and resupply of oral contraceptives using mechanisms other than national level reclassification.^24–26 A further pilot on a major expansion of community pharmacist scope of practice is beginning in Queensland.⁶⁸ The legislation regulating therapeutic products in NZ is also in the midst of change which will potentially impact medicines access and supply going forward. Furthermore, the underpinning structure of the whole NZ health system was reformed in 2022, with the implications still unfolding.^14,15

Medicines reclassification has a role in enabling pharmacist contribution to primary care. However, commissioning of services and policy that facilitates integration of pharmacy-provided care within the wider health care environment are also required. Digital tools that support information sharing, collaboration and communication will be key in future models of care.

Supplementary material

Supplementary material is available online.