Several regulatory, funding and accreditation changes will land on 1 October 2026.
AP breaks down what pharmacists need to know.
1. Sun sets on medicine label requirements
The labelling requirements that manufacturers and sponsors have long worked under – TGO 91 for prescription and related medicines and TGO 92 for non-prescription medicines – will reach their automatic expiry, or ‘sunset’ on 1 October.
According to the Therapeutic Goods Administration (TGA), ‘this is an opportunity to update and improve labelling requirements to support the safe use of medicines’.
The requirements under the new labelling standards include:
- Allergen declarations: mandatory disclosure of marine molluscs such as mussels, oysters and squid oil. Sulphites, regardless of concentration, will also need to be declared.
- Unit formatting: spelling out ‘microgram’ rather than using ‘µg’ to reduce the risk of the unit being misread as ‘mg’.
The new labelling requirements apply to the container and ‘any other packaging’ only, not the Consumer Medicine Information or Product Information.
But the changes won’t happen overnight. Sponsors have up to 5 years to comply with the new standards. Pharmacists can therefore expect both old and new label formats to appear as existing stock is replaced.
2. New Pharmacy Board guidelines for safe practice
The Pharmacy Board of Australia’s refreshed Guidelines on the safe provision of pharmacy services take effect on 1 October.
Four previously separate guideline documents will now be part of a single framework built around the following domains:
- leadership and management
- informed patient choice
- confidentiality and privacy
- communication in practice.
The guidelines set expectations around access to current, evidence-based resources, appropriate supervision and training, and processes for identifying and responding to near misses, errors and other risks. Pharmacists are also expected to provide patients with information they can understand, support informed decisions, protect privacy and confidentiality, and provide culturally safe care.
Practice scenarios are incorporated in the guidelines to support their use in practice. In one, a pharmacist notices that requests for a dihydrocodeine cough syrup are increasing. The pharmacist manager has been supplying dihydrocodeine, which can be a drug of dependence when misused, to returning patients without adequate consultation.
To identify how to address this issue, the pharmacist refers to PSA’s Professional Practice Standards 2023 (including Standards 4,5 and 6) and the Board’s Guidelines on the safe provision of pharmacy services (including medicines and advice) – obliging pharmacists to raise concerns around inappropriate practice with leaders and managers.
Raising it with the manager gets nowhere, so the pharmacist escalates to the proprietor – who, under the guidelines, must respond to safety concerns and intervene immediately, including by reviewing policies, briefing staff and setting up ongoing monitoring.
3. New accreditation pathway for pharmacies
From 1 October, the Quality and Safety Pharmacy Program (QSPP) will replace the Quality Care Pharmacy Program (QCPP). While QCPP assessed pharmacies against the 2017 version of the Australian Community Pharmacy Standard, QSPP moves to the 2024 update, with the addition of four new Service Categories:
- General Pharmacy Services
- Vaccination and Medicine Administration Services
- Full Scope of Practice Services
- Complex Compounding.
Pharmacists don’t need to apply to transition from QCPP to QSPP. But those with unresolved accreditation issues, outstanding corrective actions or unpaid accreditation fees must address these with their accreditation provider before a QSPP certificate can be issued.
Pharmacies currently accredited under QCPP should receive their QSPP certificate automatically after 1 October.
This change will also be reflected in eligibility criteria for community pharmacies to participate in Community Pharmacy Programs tomorrow.
The Pharmacy Programs Administrator (PPA) will email each pharmacy’s Main Authorised Person a secure online form on 5 October for uploading the QSPP certificate.
Pharmacies that are not QSPP accredited by 1 July 2027 will be unable to provide programs like MedsChecks, dose administration aids and staged supply.
4. Registered nurses gain PBS prescribing rights
From 1 October, eligible designated registered nurse (RN) prescribers can issue Pharmaceutical Benefits Scheme (PBS) scripts.
The reform applies to RNs who:
- hold current general registration,with no conditions relevant to the endorsement
- have completed at least 5,000 hours of clinical experience in the previous 6 years
- have completed a Nursing and Midwifery Board of Australia-approved program of study.
The PBS medicine list is being introduced in tranches, with the Pharmaceutical Benefits Advisory Committee considering which medicines are suitable for designated RN prescribing. This means RNs may be able to prescribe some medicines that are not yet available as PBS-subsidised prescriptions for designated RN prescribers.
Implementation may also vary between jurisdictions and practice settings. In the meantime, pharmacists should be aware that designated RN prescribers will have PBS prescriber numbers from tomorrow. And as with other PBS prescriptions, pharmacists will need to verify the prescriber details and ensure any applicable PBS restriction or authority requirements are met.
5. COVID-19 vaccination moves onto the National Immunisation Program
The COVID-19 Vaccination Program – including the COVID-19 Vaccination in Community Pharmacy (CVCP) Program – ends on 1 October.
COVID-19 vaccination will become normal care within the National Immunisation Program (NIP), with a reduced patient eligibility. Where pharmacists administer the COVID-19 vaccine under the NIP, the administration fee may be claimable via the National Immunisations in Pharmacy (NIPVIP) Program claiming pathway.
As outlined in AP this week (Monday 28 September) funded eligibility will narrow to:
- adults aged 75 and over (two doses a year)
- adults aged 65–74 (one dose a year)
- Aboriginal and Torres Strait Islander adults aged 50–74 (one dose a year)
- adults 18–64 with severe immunocompromise (one dose a year).
Funded access is no longer available to people outside this eligibility criteria and those who aren’t Medicare-eligible.
Outstanding CVCP claims for vaccinations administered before 1 October are due by 31 October. Exceptional Circumstances requests for missed claims must be submitted by 30 November.
Refer to AP for more detail on what’s changing and who’s losing funded access. [/vc_column_text][/vc_column][/vc_row]
