Authority required items and processing in the Pharmaceutical Benefits Scheme (PBS) 012-63010000

Approved prescribers can get a PBS authority item from the following options:

• calling Services Australia
• by mail
• uploading using HPOS secure form upload, or
• using the Authorities System (OPA System) for delayed /immediate assessment programs where available

Common reasons for mail and HPOS requests include, the:

• patient has sufficient medication, so the request is not urgent
• approved provider finds it more convenient to use post or the HPOS secure form upload facility
• request is for an item that's mandatory to apply in writing

Staff must process all requests for all PBS items in the Online Pharmaceutical Benefits Scheme (PBS) Authorities System (OPA System).

The assessment of an authority approval request may be delayed because of:

• inclusion of high-cost items
• contraindications or intolerances
• the triggering of Pharmaceutical Benefits Scheme (PBS) Authorities System (OPA system) reason codes

See Processing Delayed Assessment requests in the Pharmaceutical Benefits Scheme (PBS).

The Pharmaceutical Benefits Scheme (PBS) schedule lists a Streamlined Authority code which applies to each restriction criterion for an Authority required (STREAMLINED) item.

The Mainframe system can only be used for approvals by Pharmaceutical Advisers (PAs):

• who are proficient, and
• have Mainframe access

The Mainframe system is only to be used for approvals in the following scenarios:

• processing telephone authority approvals for 'balance of supply', lost/replacement scripts and stock shortages for paediatric Growth Hormone items (PA only)
• special approval entries by PAs from authority provided by PBS Listings (via Health)
• extenuating circumstances

See Mainframe Authority approval processing for Pharmaceutical Advisers (PA).

Approved prescribers must follow state or territory law when prescribing drugs listed as narcotic, specified or restricted medication. Prescribers must notify or receive approval from the appropriate health authority before prescribing these drugs. Approved prescribers are responsible for ensuring they meet their responsibility regarding state or territory legislation.

The prescriber should initially be offered the quantity and/or repeats (as per dosage chart) that the patient is entitled to, based on the requested dose.

However, if the prescriber requests the PBS listed maximum quantity and repeats be approved, it may be granted regardless of dose.

If the opportunity arises, explain to the prescriber that the prescription may be out of date before the patient uses the repeats.

Prescriptions where the quantity and repeats guidelines are not met may need to be considered further.

See Dosage calculators and charts in the Pharmaceutical Benefits Scheme (PBS) for:

• maximum supply and when exemptions apply
• Narcotic dosage chart, Non-narcotic dosage chart and Dosage chart Insulin

If the quantity and repeats are to be reduced:

• approve prescription with changes. See Processing new Authority requests in the Pharmaceutical Benefits Scheme (PBS)

The indication must be consistent with the indication in the Schedule for that item.

If the restriction indicates that increased quantities and/or repeats are not permitted, increased quantity and/or repeats cannot be approved.

For phone Authority applications, prescribers must:

• provide the indication for use of that medication
• answer any relevant questions attached to that PBS restriction

Note: the only exception is unrestricted items.

When the indication and/or information do not meet the PBS restriction requirements, the requirements for subsidy have not been met.

Grant an approval when the prescriber makes a different statement that satisfies the criteria either:

• during the course of the same phone application, or
• after calling back

Extemporaneous items are made by a pharmacist by combining ingredients to make a final product. All ingredients must be listed in the Drug Tariff.

These items are prepared from a specific set of ingredients (located in the Drug Tariff). Some items have extra comments, which outline how the ingredient can be prescribed to qualify as a PBS benefit:

• For use only as a base combined with active ingredients
• For use as an additive only

Prescribers must request an Authority approval for increased quantities and repeats for extemporaneous items.

The maximum quantity and repeats allowed on a non-Authority prescription for each type of extemporaneous preparation is available in Section 4 of the Schedule of Pharmaceutical Benefits.

Points to consider:

• An ingredient listed in the Drug Tariff which has no requirement/qualification attached (for example, for use as a base) may be approved as a sole ingredient or part of a total extemporaneous formula
• Ingredients listed in the Drug Tariff which have a requirement for 'use as additive only' must be used as an additive in the total formula for a PBS prescription. These cannot be approved as 'sole' or 'single' item, for example, olive oil ('use as additive only') cannot be approved solely as 'olive oil' - it must be used as an additive with other PBS listed ingredients
• Ingredients listed in the Drug Tariff which have a requirement for 'use as a base combined with active ingredients' must only be used as the base in a PBS prescription
• The approved prescriber must confirm the selection of the type of preparation they request. For example, cream, ointment or lotion
• The use of a ready-prepared item with one or more extemporaneous drugs listed in the Schedule is not a pharmaceutical benefit
• The approved prescriber may list ingredients by the commonly known name instead of the generic name appearing in the drug tariff

Reconstituted oral liquid products are manufactured in powder form due to the short shelf life in liquid form. Once the product is reconstituted, a new shorter shelf life (often 7, 10 or 14 days) is activated.

Many reconstituted oral liquid products are used for short-term treatments. However, repeats can be issued to cover the course of treatment.

The maximum quantity on reconstituted items is determined by the following parameters:

• Requested dose
• Duration of treatment
• Volume and shelf life of reconstituted preparation