Pharmaceutical Benefits Scheme (PBS): Approved Pharmacist and Prescriber Obligations

Statutory basis

The Pharmaceutical Benefits Scheme (PBS) is established within Australian law by Part VII of the National Health Act 1953 (Cth). This Act governs the operation of the PBS, including which medicines are subsidised and how they are made available to patients. The PBS Schedule, which details the medicines eligible for subsidy, is also defined within this legislative framework. Therapeutic Goods Act sponsor obligations may also be relevant.

Specific provisions within the National Health Act 1953 (Cth) outline the roles and responsibilities of those involved in the PBS. Section 84AAA defines essential terms used throughout the Act, while section 90 addresses the approval of pharmacists to supply pharmaceutical benefits. Section 92 details arrangements for the supply of pharmaceutical benefits within hospital settings.

The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in advising the government. The PBAC recommends which medicines should be considered for inclusion on the PBS Schedule, as outlined in section 101 of the Act. Services Australia handles the administration of PBS claiming processes, acting on behalf of the Department of Health and Aged Care.

Patient co-payments and safety net

Patients contribute to the cost of their PBS medicines through a co-payment. As of 1 January 2024, the general patient co-payment is $31.60 per prescription, while concession patients pay $7.70. Prior to 1 January 2023, the general patient co-payment was higher at $42.50, representing a significant reduction. Medicare Benefits Schedule MBS providers may also be involved in patient care.

The PBS Safety Net provides further financial assistance. General patients reach the Safety Net threshold of $1,647.90, while concession patients reach a lower threshold of $277.20. Once these thresholds are reached, subsequent prescriptions are supplied at the concession rate or free of charge. Concession card holders include those with a Pensioner Concession Card, Commonwealth Seniors Health Card, Health Care Card, and DVA cards.

Eligible patients with stable chronic conditions may benefit from 60-day prescribing, introduced from 1 January 2023. This allows for a 60-day supply of certain medicines for the cost of one co-payment.

Approved pharmacies and supply

Only pharmacists approved under section 90, or hospitals approved under section 94, are permitted to dispense PBS medicines and claim reimbursement. Approval to operate as an approved pharmacy is subject to the Pharmacy Location Rules and the Australian Community Pharmacy Authority (ACPA) recommendation under sections 90A-90F. The 8th Community Pharmacy Agreement (8CPA) between the Commonwealth and the Pharmacy Guild of Australia commenced 1 July 2024 and runs to 30 June 2029.

Pharmacists must adhere to PBS rules regarding quantity, repeats, authority required items, and brand substitution under section 103. Authority required items necessitate prescriber authority under section 88, which can be obtained via telephone, electronic (PBS Online) or written means. Medicines and poisons scheduling SUSMP Australia dictates the scheduling of medicines.

When dispensing PBS prescriptions, pharmacists may claim a dispensing fee, mark-up and AHI premium (Administration, Handling and Infrastructure fee) in addition to the patient co-payment.

Prescriber obligations and compliance

Prescribers who are medical practitioners, dentists, optometrists, midwives and nurse practitioners (within scope) are approved under section 84 to prescribe medicines under the Pharmaceutical Benefits Scheme (PBS). The Minister has the power to mandate authority requirements for specific medicines through section 103A, utilising Streamlined Authority and Authority Required processes. Prescribers must adhere to these requirements when issuing prescriptions.

The Pharmaceutical Benefits Scheme Drug Utilisation Sub-Committee (DUSC) actively monitors medicine usage and prescribing patterns. This monitoring informs ongoing evaluation and refinement of PBS policies and guidelines.

Prescribers are subject to the PBS compliance program, which includes audits, debt recovery and Practitioner Review. Section 133 outlines offences related to false or misleading PBS claims, carrying a potential maximum penalty of five years imprisonment.