Part 2 - Prescribing of Benefits
Procedure by Medical Practitioners
Prior Approval
6. (a) The Commission may approve any matters requiring "Prior Approval"; and
(b) Prior Approval must be sought, in advance, in accordance with an Authority Prescription Form.
7. Restrictions apply to the prescribing of certain items. These include:
(a) items - quantities and repeats: those listed in the RPBS Schedule or PBS Schedule;
(b) surgical appliances and other treatment aids: surgical appliances and other treatment aids provided under the Treatment Principles may not be prescribed unless specifically listed in the RPBS Schedule;
(c) admixtures: the following restrictions apply to admixtures:
(i) admixture of two or more ready-prepared items into a single combined form, or the addition of one or more supplementary ingredients to a ready-prepared item, is not recognised as a Pharmaceutical Benefit;
(ii) the extemporaneous prescribing of two or more official formulary preparations in a single combined form, or the addition of one or more supplementary ingredients to an official formulary preparation, is a recognised Pharmaceutical Benefit; and
(iii) where one or more of the components of a preparation specified in subsubparagraph (ii) are non-RPBS Schedule or non-PBS Schedule items, Prior Approval is required for their prescribing;
(d) conformity with standards: no drug or therapeutic substance shall be prescribed unless it conforms with:
(i) the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989; or
(ii) the British Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, the Australian Pharmaceutical Formulary, or a prescribed Pharmacology text of international standing;
(e) basis for prescribing: the prescribing of therapeutic substances other than on the clinical diagnosis of a Medical Practitioner shall be invalid;
(f) approval for therapeutic use: it is invalid to prescribe:
(i) an item that is not approved for therapeutic use in the treatment of human illness by the relevant Commonwealth, State or Territory Government agencies, or
(ii) an item for use if it is not in accordance with the terms and conditions specified by the relevant Government agencies in approving the item as a therapeutic substance;
(g) Prior Approval for non-conforming items: any drug or medicine intended for use other than in conformity with the requirements in subparagraph (d) requires Prior Approval;
(h) PBS Schedule restricted items: the prescribing of PBS Schedule restricted items is to comply with the restrictions relating to the prescribing of such items as indicated in the PBS Schedule unless Prior Approval is obtained to prescribe otherwise;
(j) RPBS Schedule restricted items: the prescribing of RPBS Schedule restricted items under this Part is to comply with the restrictions relating to the prescribing of such items as indicated in the RPBS Schedule unless Prior Approval is obtained to prescribe otherwise;
(k) Prior Approval for non-Schedule items: the prescribing of an item not included in the RPBS Schedule or PBS Schedule requires Prior Approval.
8. The PBS Schedule and RPBS Schedule are the primary references for the prescribing of Pharmaceutical Benefits.
Application of PBS Schedule restrictions and RPBS Schedule restrictions
9. Restrictions specified in the PBS Schedule and RPBS Schedule which limit supply of items to a particular class of person, or are reserved for specified purposes or require an authority to prescribe, apply unless Prior Approval is obtained to prescribe otherwise.
Prescriptions to conform with State or Territory Law
10. For a prescription to be recognised by the Commission it must conform with the provisions of State or Territory law except in so far as that law is inconsistent with this Scheme.
11. Prescriptions are to conform with the conditions which the Department or the Commission from time to time notifies, and are to be:
(a) written by Medical Practitioners on an Authority Prescription Form or Standard Prescription Form as the case requires; or
(b) produced on a computer by a Medical Practitioner approved, under paragraph 19(1)(a) of the National Health (Pharmaceutical Benefits) Regulations, to use computer generated prescriptions, by the Secretary to the Department that administers the National Health Act 1953.
When prescriptions are invalid
12. A prescription is not a valid Pharmaceutical Benefit if the Medical Practitioner:
(a) prescribes a Pharmaceutical Benefit for a person in respect of whom another prescription for the same benefit has been written on the same day by the same Medical Practitioner; or
(b) prescribes, on the one form, a Pharmaceutical Benefit that is a drug of addiction and another Pharmaceutical Benefit, and directs that the supply of either Pharmaceutical Benefit is to be repeated (but, if no repeats of either item are ordered, the prescription may be accepted provided that this is in accordance with the relevant State or Territory law); or
(c) prescribes a narcotic drug for the Medical Practitioner writing the prescription; or
(d) prescribes on a Standard Prescription Form an item not listed in the RPBS Schedule or PBS Schedule; or
(e) prescribes on a Standard Prescription Form a benefit in contravention of any of the restrictions set out in paragraph 6.
Maximum quantity and repeats allowed
13. The quantity and repeats for Scheduled items are to be confined to those specified in the RPBS Schedule or PBS Schedule. However, where inadequate, the Medical Practitioner may seek Prior Approval to prescribe a quantity greater, or a greater number of repeats, than the maximum listed in the RPBS Schedule or PBS Schedule.
Prescribing outside the RPBS Schedule or PBS Schedule
14. If a Medical Practitioner is of the clinical opinion that there are no therapeutic alternatives available in the RPBS Schedule or PBS Schedule for the treatment of an Eligible Person, the Medical Practitioner may seek Prior Approval from the Commission to prescribe an item not contained in those Schedules.
Medical Practitioner subject to this Scheme
15. Where a Medical Practitioner prescribes for an Eligible Person, the Medical Practitioner shall be subject to the terms and conditions of this Scheme and the Explanatory Notes.
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