Authority approval processing for Pharmaceutical Benefits Scheme (PBS) 012-63020000

There are situations where some patients are entitled to receive pharmaceutical benefits but, for various reasons, do not have a Medicare card or whose Medicare number will not be available at the time of consultation or supply. For example, the patient is:

• a newborn infant
• a visitor from a Reciprocal Health Care Agreement (RHCA) country, such as Sweden, who is entitled to access the PBS. See Reciprocal Health Care Agreements (RHCA) eligibility for Medicare and Pharmaceutical Benefits Scheme (PBS) for more information on reciprocal agreements
• an Australian Defence Force (ADF) personnel without a Medicare card

The Process page has more details in Table 4.

The acceptable situations for rejecting an Authority application are:

• the approved prescriber does not state the criteria that meets the restriction
• the patient does not meet the criteria
• answers provided to questions do not qualify patient for an Authority prescription
• the application is considered to be too soon
• someone other than the approved prescriber is requesting the Authority
• the item, form or strength of the Authority prescription is not subsidised under the PBS
• the approved prescriber changes their mind
• the approved prescriber is abusive or demonstrates inappropriate behaviour, and the Service Officer terminates the call
• an incomplete written application

Criteria for increased quantity and repeats

When an approved prescriber requests an Authority for increased quantity and/or repeats and the drug is listed with restrictions, an appropriate restriction/indication must be provided.

Criteria for Authority applications

For online and phone applications, the approved prescriber is required to satisfy Services Australia that the patient meets the restriction criteria listed in the Pharmaceutical Benefits Schedule.

See The Schedule of Pharmaceutical Benefits (the PBS Schedule).

For phone applications, due to the sensitive nature of some diseases or conditions, the restriction criteria can be read to the approved prescriber who can then respond as to whether the patient's disease or condition conforms.

For written applications, the approved prescriber must write the indication for the disease, purpose or condition for which the benefit is required.

Manner of administration

An item may not be supplied as a pharmaceutical benefit if it is to be administered in any other way than indicated in the PBS Schedule (Refer S.85 and S.88). For example, injections can only be used for injection and not for inhalation.

Gender reassignment

Gender reassignment surgery and/or hormone therapy are not pre-requisites for the recognition of a change of gender in Australian Government records, however evidence is required to establish or change the gender details in personal records.

The Resources page contains link to the Gender Guidelines Implementation.

Refer to a Pharmaceutical Adviser if changes have not been recorded on the Medicare system.

The maximum supply for medication is 6 months treatment consisting of approximately one month's supply (subject to pack size) in the quantity and 5 repeats, or where requested by the approved prescriber, the PBS listed maximum quantity and repeats where appropriate.

Some pharmaceutical benefits cannot be approved for more than the PBS listed quantity and repeats regardless of dose. Where applicable, this is stipulated in the restriction and identified in the drug description.

Exception for relevant opioid listings:

• Authority requests extending treatment duration up to one month may be requested through the Online PBS Authorities system or by calling Services Australia
• Authority requests extending treatment duration beyond one month may be requested by a prescriber through the Online PBS Authorities system or in writing (either via post or HPOS form upload) and cannot exceed 3 months' treatment. That is, quantity sufficient for up to 1 month's treatment and up to 2 repeats

Other exceptions include certain HSD S100 items, where more than a 6 month supply may be approved in order to provide the full duration of treatment required.

The quantity is determined by the following parameters:

• requested dose
• number of days therapy requested
• for reconstituted oral liquid medication - the volume
• narcotics limited to treatment duration up to one month may be requested through the Online PBS Authorities system or by calling Services Australia. Treatment duration of up to 3 months may be requested by a prescriber through the Online PBS Authorities system or in writing (either via post or HPOS form upload)
• pack size

To calculate the quantity and repeats that can be approved, see Dosage calculators and charts for Pharmaceutical Benefits Scheme (PBS).

Where the PBS listed maximum quantity and repeats is more than that permitted by the non-opioid dosage chart, prescribers may request and be approved the listed quantity and repeats.

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.

For listings that do not require authority approval for listed quantities and repeats, follow the process for Streamlined listings.

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:

• Handle request for increased quantity and/or repeats for unrestricted, restricted and Authority benefit
• Maximum Supply
• Narcotic dosage chart, Non-narcotic dosage chart and Dosage chart Insulin sections in Dosage calculators and Charts for Pharmaceutical Benefits Scheme (PBS)

If the quantity and repeats are to be reduced:

• approve prescription with changes as per Processing Written Authority requests

If the quantity is required to be increased to fit the pack size:

• if increase in quantity is for up to 3 days' supply, with the exception to medications of abuse and for items that only need a specified course of treatment (for example antibiotics), approve prescription with changes as per Processing Written Authority requests
• if increase in quantity is for greater than 3 days' supply, refer to a Pharmaceutical Adviser (PA) to contact the prescriber to determine if the prescriber feels that an increase in quantity to fit pack size is appropriate for their patient
• if the prescriber has indicated for x number of days or weeks or months, this would indicate it was for a specified course of treatment

Refer to a PA if unsure.

The Resources page contains definitions for medication of abuse and helpful hints for the recognition of antibiotics.

Where the Authority application is for opioid listings:

• Authority requests extending treatment duration up to one month may be requested through the Online PBS Authorities system or by calling Services Australia
• Authority requests extending treatment duration beyond one month may be requested by a prescriber through the Online PBS Authorities system or in writing (either via post or HPOS form upload) and cannot exceed 3 months' treatment. That is, quantity sufficient for up to one month's treatment and up to 2 repeats

To calculate the quantity and repeats that can be approved for drugs of addiction, see Dosage calculators and charts for Pharmaceutical Benefits Scheme (PBS).

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. Any remaining portion of these reconstituted items must be discarded after the shelf life.

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

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

• requested dose
• number of days therapy requested
• volume and shelf life of reconstituted preparation

An extemporaneously prepared (EP) item is one that is manufactured by the pharmacist, by incorporating a number of ingredients in a specified manner to form one final product. They can be Standard Formula preparations for which a formula is found in approved reference books, or Non-standard, for which the doctor devises their own formula.

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

Note: increased quantities and repeats are permitted by making an Authority application.

Highly Specialised Drugs (HSD) are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, have additional rules.

See Section 100 in Pharmaceutical Benefits Scheme (PBS).

All ingredients for extemporaneous items must be listed in the Schedule of Pharmaceutical Benefits under Extemporaneously-prepared pharmaceutical benefits - Drug Tariff.

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 ingredient is to be used as the base before approval
• The approved prescriber is to 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.
  The Resources page contains a list of common names for items included in extemporaneously prepared pharmaceutical benefits

Further information

Contact a Pharmaceutical Adviser (PA) for more details or help. See Pharmaceutical Benefits Scheme (PBS) - National Pharmaceutical Adviser (PA) pilot.

If a Service Officer needs to stop processing, an Authority application can be saved (OPA) or pended. The acceptable situations for saving an Authority application are:

• An Authority request has been referred to a Pharmaceutical Adviser or Team Leader for a decision
• A Service Officer is processing a written Authority application and a phone enquiry comes through. In this case, the Service Officer will return to processing the written Authority application at a later stage
• A medical practitioner cannot be contacted to clarify details needed to process an Authority
• A Service Officer is waiting for more information to process an Authority

PBS prescriptions are required to be processed in accordance with relevant Commonwealth law.

See Claim Processing in the New Claim Processing System for Pharmaceutical Benefits Scheme (PBS).

Each state or territory has its own legislation that determines how medical practitioners and authorised optometrists should prescribe certain drugs listed in the Schedule of Pharmaceutical Benefits.

Services Australia does not enforce state law but the Service Officer may be prompted to remind medical practitioners of their responsibility to comply with state laws.

Informing medical practitioners and authorised optometrists

When a medical practitioner or an authorised optometrist is seeking Authority approval under Commonwealth legislation from Services Australia for an item that also requires the practitioner to comply with State legislation, a statement in the Question field may show on the Authority screen that must be acknowledged by the approved prescriber.

This statement only shows for drugs that the Pharmaceutical Benefits Advisory Committee (PBAC) and Department of Health and Aged Care has found necessary to flag in the Schedule and is not applicable for unrestricted dangerous drugs.

This statement informs the medical practitioner or authorised optometrist of their responsibility to comply with state legislation when prescribing drugs. The statement is:

'Please note that this drug may be subject to specific state or territory legislation'.

The Service Officer does not need to record any comments made by the medical practitioner or authorised optometrist.

Archiving Authority information

Authority information is recorded daily and backed up.

Written Authority requests are scanned and recorded on the system and the Medicare/Department of Veterans' Affairs (DVA) copy of the authority is destroyed by secure shredding, as it is no longer archived.

Removing old Authority information

All Authority information contained in Services Australia systems is kept for 24 months. Due to the high volume of Authority applications stored, Authority information older than 24 months is removed to make sure that there is sufficient space for new Authority requests.

Authority information (excluding exemptions) more than 24 months old is permanently deleted on the 4th day of each month.

Exemptions to Authority information removal

Authority information for specific Authority items is kept for longer than 24 months. For example, Complex Authority Required (CAR) medicines. These exemptions are based on PBS restriction requirements.