The Schedule of Pharmaceutical Benefits (the PBS Schedule) 012-60010010

Under the Australian Government's Pharmaceutical Benefits Scheme (PBS), a comprehensive range of drugs and medicinal preparations may be prescribed by medical practitioners for persons receiving medical treatment.

The Schedule of Pharmaceutical Benefits (commonly referred to as the PBS Schedule) contains information regarding a list of items that are available under the PBS, and the Repatriation Pharmaceutical Benefits Scheme (RPBS). It also contains restrictions and legal requirements regarding the prescribing and dispensing of those items.

The Schedule of Pharmaceutical Benefits is updated each month and published online. Pharmaceutical benefit items may be added or deleted, the level of availability of some items changed, or prices adjusted. The maximum quantity and repeats may also be altered.

The Resources page contains a link to the Schedule of Pharmaceutical Benefits (online and offline versions).

Pharmaceutical Benefits Advisory Committee (PBAC)

The PBAC is responsible for advising the Minister for Health and Aged Care which drugs, together with any restriction, should be listed on the Schedule of Pharmaceutical Benefits.

A drug cannot be listed (or deleted) unless it has been recommended by the PBAC. The Schedule of Pharmaceutical Benefits provides information for doctors (prescribers), pharmacists and Services Australia staff regarding the operation of the Pharmaceutical Benefits Scheme.

PBAC is an independent statutory body comprising 11 members. They include consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists with at least one member from each group. There are 3 additional members chosen by the Minister.

Pharmaceutical Benefits Pricing Authority (PBPA)

The prices of drugs on the Schedule of Pharmaceutical Benefits are agreed by the Minister, on advice from the PBPA.

Pharmaceutical Benefits Remuneration Tribunal (PBRT)

Pharmacists are paid a dispensing fee for each item they dispense. These fees are agreed between the Department of Health and Aged Care and the Pharmacy Guild. The PBRT ratifies the new fees and issues the determination to make them legal.

Department of Health and Aged Care (DoHAC)

DoHAC is responsible for compiling, issuing and maintaining the Schedule of Pharmaceutical Benefits.

Section 1 of the Schedule of Pharmaceutical Benefits contains a reference to the workings of the Pharmaceutical Benefits Scheme (PBS).

The section is divided into:

• The Schedule of Pharmaceutical Benefits - Where to find what - Provides an overview of the contents of the Schedule of Pharmaceutical Benefits
• Prescribing Medicines - Information for Doctors and Dentists - Explains who can prescribe PBS prescriptions. It also includes:
• prescription forms available
• how to write a prescription under PBS, both General and Authority prescriptions
• maximum quantities and repeats
• National Health (Pharmaceutical Benefits) Regulations 2017, section 49 (previously regulation 24)
• urgent cases
• drugs of addiction
• prescriber bag supplies
• Supplying Medicines - What Pharmacists need to know - Explains what a pharmacist needs to know in order to make supply of an item under the PBS. This includes:
• eligible suppliers
• supply procedures
• suspected forgeries
• National Health (Pharmaceutical Benefits) Regulations 2017, section 49 (previously regulations 24)
• repeat authorisations
• Authority prescriptions
• urgent cases
• receipts
• prescriber bag supplies
• Patient Charges
• the type of patient
• establishing Concessional entitlement
• patient contribution
• The Safety Net Scheme - Explains the Safety Net Scheme and covers:
• Safety Net thresholds
• recording prescriptions
• patient record forms
• retrospective entitlement and patient refunds
• applying for Safety Net cards
• issuing Safety Net cards
• Services Australia - Entitlement Checks - Explains the administrative procedures for entitlement checking
• How pharmacists claim reimbursement: Information Required - Introduces the Medicare payment system and outlines the information required from approved pharmacists when claims are being submitted
• How pharmacists claim reimbursement: Documents to be Submitted - What documents are required from a pharmacy to support their claim for payment
• Pricing prescriptions - Includes pricing principles used to price ready prepared and extemporaneously prepared items
• Miscellaneous - Refers to references, standards and legislation relating to the PBS

The Therapeutic index is located after Section 1 of the Schedule of Pharmaceutical Benefits. This index lists drugs in therapeutic groups using the Anatomical Therapeutic Chemical (ATC) classification system.

In the ATC classification system, the drugs are divided into different groups according to their site of action and therapeutic and chemical characteristics. There are 5 levels to this code:

• Level 1 - anatomical main group
• Level 2 - therapeutic main group
• Level 3 - therapeutic sub-group
• Level 4 - chemical/therapeutic sub-group
• Level 5 - chemical substance (generic name of the drug)

Level 1 of the ATC code divides drugs into the following 14 anatomical main groups:

• alimentary tract and metabolism
• blood and blood forming organs
• cardiovascular system
• dermatologicals
• genito urinary system and sex hormones
• systemic hormonal preparations, excluding sex hormones and insulins
• anti-infectives for systemic use
• antineoplastic and immunomodulating agents
• musculo-skeletal system
• nervous system
• antiparasitic products, Insecticides and Repellents
• respiratory system
• sensory organs
• various

Within each classification, there are Therapeutic Main Groups (Level 2) and the Therapeutic Sub-Groups (Level 3).

The page numbers referring to the generic items in Section 2 of the Schedule of Pharmaceutical Benefits are indicated next to these 2 levels in the index.

Section 2 of the Schedule of Pharmaceutical Benefits lists ready prepared items available under the Pharmaceutical Benefits Scheme (PBS).

A ready prepared item is one that is bought by the pharmacist ready-made from the manufacturer. These can be ordered by brand or generic name and can also be ordered as individual units that merely require counting or relabelling, for example, tablets or packed lines that are one box.

The Resources page contains a table detailing the ready prepared items.

Container prices, fees, standard packs and prices for ready prepared pharmaceutical benefits

Most items are packed by the manufacturer in the Pharmaceutical Benefits Scheme (PBS) maximum quantity so that the pharmacist only needs to label the item with the doctor's directions for use. Section 3 of the Schedule of Pharmaceutical Benefits lists items that are not packed in the PBS maximum quantity.

The Resources page contains a table detailing these.

Section 4 of the Schedule of Pharmaceutical Benefits lists information relating to extemporaneously prepared pharmaceutical benefit items.

'Extemporaneous' means 'made for the moment' and these items are actually manufactured by the pharmacist, by mixing a number of ingredients in a specified manner to form one final product, for example mixture. They can be Standard Formula preparations for which a recipe is found in approved reference books, or Non-standard Formula, for which the doctor devises his/her own recipe.

Some items may be extemporaneous because of their short shelf life while others are not manufactured as 'ready prepared' items because there is insufficient demand for them.

For extemporaneous items the pharmacist receives a dispensing fee and an allowance for the cost of the bottle or container in which the item is supplied.

The dispensing fee for an 'extemporaneously prepared' item is greater than that for a 'ready prepared' item due to the increased work required by the pharmacist to make the item.

Extemporaneously prepared items are usually comprised of:

• average price items, where payment is usually made on the basis of an average 10g/mL rate applied to the category of preparation concerned
• standard formula preparations, which are commonly used extemporaneously prepared items

The pricing principles of ingredients, miscellaneous pricing rules, pricing prescriptions where additional ingredients have been added to a specified formula and container rates are detailed in Explanatory Notes, Section 1 of the Schedule of Pharmaceutical Benefits.

The Resources page contains a table detailing the description of these items, and a link to the Schedule of Pharmaceutical Benefits.

The Australian Repatriation system is based primarily on the principle of compensation to veterans and eligible dependants for injury or death related to war service. In certain cases treatment is also provided for accepted injuries or conditions that are not service-related or have occurred as a result of other than war service.

The Repatriation Schedule of Pharmaceutical Benefits contains items that are available to Department of Veterans' Affairs (DVA) beneficiaries under the Repatriation Pharmaceutical Benefits Scheme (RPBS). Items available under the Repatriation Pharmaceutical Benefits Scheme include those listed in both the Schedule of Pharmaceutical Benefits and the Repatriation Schedule of Pharmaceutical Benefits.

DVA determines which items will be listed in the Repatriation Schedule of Pharmaceutical Benefits. A number of items are included that are not medicines but which can normally be purchased from a pharmacy, for example, cotton wool, bandages, etc. as these items may be needed to treat conditions which may relate to war service.

Payments for items supplied under the RPBS are processed by Services Australia on behalf of DVA.

Non-listed items can be supplied to veterans providing prior approval is obtained by the prescriber from the Veterans' Affairs Pharmaceutical Approvals Centre (VAPAC).

Eligibility for entitlements under the Repatriation Pharmaceutical Benefits Scheme are not handled by agency staff but should be referred to DVA.

Repatriation schedule structure

The Repatriation Schedule of Pharmaceutical Benefits is set out in the following manner:

• Outline of Repatriation beneficiaries' entitlement cards and eligibility for the RPBS
• RPBS explanatory notes
• Address and telephone number of DVA Pharmaceutical Approvals Centre
• Summary of changes that have occurred since the previous edition of the Schedule of Pharmaceutical Benefits and advance notices of future changes
• Therapeutic Index for RPBS Schedule of Pharmaceutical Benefits
• Section 1 - drugs, medicines and dressings. The layout of items is very similar to that of the Schedule of Pharmaceutical Benefits. Items listed in the Repatriation Schedule of Pharmaceutical Benefits are not subject to brand price, therapeutic or special pharmaceutical benefit premiums. See also: Pricing and fees in Pharmaceutical Benefits Scheme (PBS)
• Section 2 - Standard packs and prices

The Generic or Proprietary index lists items by both generic and proprietary names in alphabetical order.

Where applicable, the manufacturer's code is indicated next to the proprietary name.

The page numbers referring to the generic items in Sections 2 of the Schedule of Pharmaceutical Benefits are also indicated in this index.

The premium column contains the 'price difference' between a higher priced brand and the lowest priced brand when multiple brands of the same item have different prices.

Under the Minimum Pricing Policy, the patients must pay the 'price difference' plus their normal patient contribution.

When a prescription for an item with a brand price premium is written for increased quantities (authority or section 49 (previously regulation 24)) the brand price premium is multiplied by the number of maximum quantities supplied.

Brand substitution by pharmacists without reference to the prescriber is legal for Pharmaceutical Benefits Scheme (PBS) prescriptions where:

• the brands are identified in the Schedule of Pharmaceutical Benefits as being interchangeable
• the doctor has not indicated on the prescription form that substitution is not to occur

The means by which the doctor endorses the prescription to prevent substitution has not been specified in the legislation. Prescription forms that are printed by the agency contain a box to be ticked where brand substitution is not permitted.

The prescriber can write an endorsement or use a stamp on prescription forms to prevent brand substitution. When a stamp is used it cannot obliterate other information on the prescription form and it needs to be initialled by the prescriber to demonstrate that it was in fact the prescriber who endorsed the prescription.

When a pharmacist substitutes a brand with the agreement of the patient, the pharmacist is required to state the brand supplied on the repeat prescription form.

Any 'price difference' paid for a dearer priced brand cannot be recorded for Safety Net purposes.

The letter 'B' and a dollar value in the premium column indicate items in the Schedule of Pharmaceutical Benefits for which a brand price premium applies.

Brand price premiums do not apply to prescriber bag supplies or Repatriation Pharmaceutical Benefits Scheme (RPBS) benefits.

Under the therapeutic group premium arrangements, Commonwealth subsidy on medicines is based on the lowest priced benefit items within identified therapeutic groups. Patients pay the difference for higher priced items. Exemptions on medical grounds are available.

When a prescription for an item with a therapeutic group premium is written for increased quantities (authority section 49 (previously regulation 24)) the therapeutic group premium is multiplied by the number of maximum quantities supplied.

The therapeutic group premium is included under the same column as the brand price premium and is indicated by a 'T' after the dollar amount. Under the minimum pricing policy, the patient must pay the 'Price Difference' plus their normal patient contribution. The only exception to this is when the prescriber has obtained a special authority exemption from the agency.

There is currently one drug group that Therapeutic Premiums apply to but this may vary over time. Current groupings is:

• EPROSARTAN Tevetan brand 400mg and 600mg

Doctors can ask for an exemption from the premiums for their patients by applying for an authority prescription through Services Australia or the Department of Veterans' Affairs.

To receive an exemption the patient must meet 1 of the following criteria:

• transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
• adverse effects occurring with all of the base-priced drugs
• drug interactions occurring with all of the base-priced drugs
• drug interactions expected to occur with all of the base-priced drugs

In these cases:

• the patient does not pay a therapeutic group premium
• the agency reimburses the dispensed price listed in the Schedule of Pharmaceutical Benefits, less any brand price premium, less the patient contribution

Abbreviations are necessary due to the length of some Pharmaceutical Benefits Scheme (PBS) Schedule item/brand names, and or form and strength descriptions as well as space limitations on the system.

The tables list common abbreviations for the descriptions of PBS Schedule items in the PBS System for example at Authority applications, claims processing, National drug reference database (NDRD).

Note: some abbreviations appear duplicated but are applied to the appropriate information, for example 'PR' for prolonged release will be in the items form/strength and 'PR' for prior date will be followed with a date.