Contents
1Name#
(1)This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021.
(2)This instrument may also be cited as PB 84 of 2021.
4Definitions#
Note: The expression premises that is used in this instrument is defined in the Act.
In this instrument:
approved pharmacist has the same meaning as in Part VII of the Act.
listed drug has the same meaning as in Part VII of the Act.
PBS prescriber has the same meaning as in Part VII of the Act.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
5Supply of pharmaceutical benefits by approved pharmacist without prescription#
(1)A pharmaceutical benefit (the substitute benefit) described in column 2 of an item of the table in subsection (8) may be supplied without a prescription to a person by an approved pharmacist, at or from premises in respect of which the pharmacist is approved, if:
(a)a prescription for a pharmaceutical benefit (the prescribed benefit) described in column 1 of the item is presented to the approved pharmacist; and
(b)subsections (2), (3), (4), (5), (6) and (7) apply.
Approved pharmacist cannot supply prescribed benefit
(2)This subsection applies if the approved pharmacist cannot supply the prescribed benefit.
Person cannot obtain prescription for substitute benefit in time
(3)This subsection applies if the approved pharmacist is satisfied that it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit.
Substitution permitted under Therapeutic Goods Act
(4)This subsection applies if the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989.
Person presenting prescription has been informed of cost implications
(5)This subsection applies if the approved pharmacist has informed the person presenting the prescription of:
(a)each substitute benefit that the approved pharmacist can supply instead of the prescribed benefit; and
(b)for each substitute benefit that the approved pharmacist can supply:
(i)the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit to the person for whom the prescribed benefit was prescribed, be permitted by Part VII of the Act to charge that person for that supply; and
(ii)the amount that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit otherwise than under Part VII of the Act to the person for whom the prescribed benefit was prescribed, charge that person for that supply; and
(c)the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the prescribed benefit to the person for whom it was prescribed, be permitted by Part VII of the Act to charge that person for that supply.
Record of information justifying supply of substitute benefit
(6)This subsection applies if the approved pharmacist records the information that the approved pharmacist used to support the decision to supply the substitute benefit, including the following statements:
(a)a statement that the substitute benefit supplied is a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act;
(b)a statement that the conditions in this section are satisfied;
(c)a statement that the approved pharmacist is satisfied that the substitute benefit needs to be supplied because:
(i)the approved pharmacist cannot supply the prescribed benefit; and
(ii)it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit.
Arrangements to inform PBS prescriber of substitution
(7)This subsection applies if the approved pharmacist has in place arrangements for giving, to the PBS prescriber who wrote the prescription for the prescribed benefit, written notice of the supply of the substitute benefit, within 72 hours after that supply.
Table of prescribed and substitute pharmaceutical benefits
(8)For the purposes of subsection (1), the table is as follows.
| Prescribed and substitute pharmaceutical benefits | ||
|---|---|---|
| Item | Column 1Prescribed pharmaceutical benefit | Column 2Substitute pharmaceutical benefit |
| 1. | Listed drug: EstradiolForm: Transdermal patches 390 micrograms, 8Manner of administration: TransdermalBrand: Estradot 25 | Listed drug: EstradiolForm: Transdermal patches 750 micrograms (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 25 |
| 2. | Listed drug: EstradiolForm: Transdermal patches 750 micrograms (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 25 | Listed drug: EstradiolForm: Transdermal patches 390 micrograms, 8Manner of administration: TransdermalBrand: Estradot 25 |
| 3. | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 |
| 4. | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 | Listed drug: EstradiolForm: Transdermal patches 390 micrograms, 8Manner of administration: TransdermalBrand: Estradot 25 |
| 5. | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 | Listed drug: EstradiolForm: Transdermal patches 750 micrograms (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 25 |
| 6. | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 |
| 7. | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 | Listed drug: EstradiolForm: Transdermal patches 390 micrograms, 8Manner of administration: TransdermalBrand: Estradot 25 |
| 8. | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 | Listed drug: EstradiolForm: Transdermal patches 750 micrograms (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 25 |
| 9. | Listed drug: EstradiolForm: Transdermal patches 1.17 mg, 8Manner of administration: TransdermalBrand: Estradot 75 | Listed drug: EstradiolForm: Transdermal patches 585 micrograms, 8Manner of administration: TransdermalBrand: any of the following:(a) Estradot 37.5(b) Estradiol Transdermal System (Sandoz, USA) |
| 10. | Listed drug: EstradiolForm: Transdermal patches 1.56 mg, 8Manner of administration: TransdermalBrand: Estradot 100 | Listed drug: EstradiolForm: Transdermal patches 3 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 100 |
| 11. | Listed drug: EstradiolForm: Transdermal patches 1.56 mg, 8Manner of administration: TransdermalBrand: Estradot 100 | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 |
| 12. | Listed drug: EstradiolForm: Transdermal patches 1.56 mg, 8Manner of administration: TransdermalBrand: Estradot 100 | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 |
| 13. | Listed drug: EstradiolForm: Transdermal patches 3 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 100 | Listed drug: EstradiolForm: Transdermal patches 1.56 mg, 8Manner of administration: TransdermalBrand: any of the following:(a) Estradot 100(b) Estradiol Transdermal System (Sandoz, USA) |
| 14. | Listed drug: EstradiolForm: Transdermal patches 3 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 100 | Listed drug: EstradiolForm: Transdermal patches 780 micrograms, 8Manner of administration: TransdermalBrand: Estradot 50 |
| 15. | Listed drug: EstradiolForm: Transdermal patches 3 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 100 | Listed drug: EstradiolForm: Transdermal patches 1.5 mg (as hemihydrate), 8Manner of administration: TransdermalBrand: Estraderm MX 50 |
| 16. | Listed drug: DapsoneForm: Tablet 25 mgManner of administration: OralBrand: Link Medical Products Pty Ltd | Listed drug: DapsoneForm: Tablet 50 mgManner of administration: OralBrand: Dapsomed |
| 17 | Listed drug: DiltiazemForm: Capsule (controlled delivery) containing diltiazem hydrochloride 360 mgManner of administration: OralBrand: Vasocardol CD | Listed drug: DiltiazemForm: Capsule (controlled delivery) containing diltiazem hydrochloride 180 mgManner of administration: OralBrand: any of the following:a) Cardizem CDb) Vasocardol CD |
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