National Health (Continued Dispensing Initiative) Determination 2012

1.01 Name of determination

This determination is the National Health (Continued Dispensing) Determination 2012.

This determination commences on 1 July 2012.

(1) In this determination:

Act means the National Health Act 1953.

PSA Guidelines means the document titled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, issued by the Pharmaceutical Society of Australia, as the document exists on 1 July 2012.

requested supply: see subsection 2.01 (1).

(2) In this determination, the following terms have the same meaning as in Part VII of the Act:

 approved pharmacist

 PBS prescriber

 pharmaceutical benefit

 pharmaceutical item.

1.04 Purpose

This determination specifies the pharmaceutical benefits that may be supplied, and the conditions that must be satisfied when those pharmaceutical benefits are supplied, by an approved pharmacist without a current prescription, but on the basis of a previous prescription from a PBS prescriber.

Part 2 Conditions

2.01 General

(1) For paragraph 89A (3) (b) of the Act, this Part sets out the conditions that must be satisfied when making a supply (the requested supply) of a pharmaceutical benefit to a person under subsection 89A (1) of the Act.

(2) An approved pharmacist must consider the PSA Guidelines when:

(a) satisfying the conditions set out in this Part; or

(b) deciding whether those conditions are satisfied.

(3) In this Part:

(a) a reference to the person is a reference to the person who requested the supply of a pharmaceutical benefit under subsection 89A (1) of the Act; and

(b) a reference to the PBS prescriber is a reference to the PBS prescriber who most recently prescribed the supply of the pharmaceutical benefit to the person.

2.02 Not practicable to obtain prescription

A condition is that the approved pharmacist is satisfied that it is not practicable for the person to obtain a prescription for the pharmaceutical benefit from a PBS prescriber before the person needs the supply of the pharmaceutical benefit.

2.03 Previous supply of pharmaceutical benefit

A condition is that the approved pharmacist is satisfied that:

(a) the person has previously been supplied the pharmaceutical benefit on the basis of a prescription from a PBS prescriber; and

(b) the PBS prescriber prescribed the supply of the pharmaceutical benefit for the person in at least one of the circumstances determined for that pharmaceutical benefit under paragraph 85 (7) (b) of the Act.

Note The circumstances determined under paragraph 85 (7) (b) of the Act relate to pharmaceutical benefits that are relevant pharmaceutical benefits under section 88A of the Act.

2.04 Stability of therapy

A condition is that the approved pharmacist is satisfied that the person’s therapy is stable.

2.05 Prior clinical review by PBS prescriber

A condition is that the approved pharmacist is satisfied that:

(a) the person has been taking the pharmaceutical benefit regularly for an uninterrupted period; and

(b) since the start of that period, the PBS prescriber has assessed the person’s condition and decided that there is a need for ongoing treatment with the pharmaceutical benefit.

Note See paragraph 2.01 (3) (b) for references to the PBS prescriber.

2.06 Prescription for last supply of pharmaceutical benefit

A condition is that the approved pharmacist is satisfied that the person had a valid prescription under Part VII of the Act for the last supply of the pharmaceutical benefit to the person before the requested supply.

2.07 No continued dispensing in previous 12 months

A condition is that the approved pharmacist is satisfied that the person was not supplied with the pharmaceutical benefit under subsection 89A (1) of the Act in the 12 months before the requested supply.

2.08 Declaration by person supplied with pharmaceutical benefit

A condition is that the person, or an agent of the person (other than the approved pharmacist), signs a declaration acknowledging that the person is being supplied with the pharmaceutical benefit without the presentation of a valid prescription under Part VII of the Act.

2.09 Maximum quantity of supply

A condition is that the approved pharmacist supplies a maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit determined under paragraph 85A (2) (a) of the Act.

2.10 Preparing and recording information

(1) A condition is that, when the pharmaceutical benefit is supplied, the approved pharmacist:

(a) records the information that the pharmacist used to support his or her decision to supply the pharmaceutical benefit; and

(b) prepares information about the supply that the pharmacist will send to the PBS prescriber.

Note See the PSA Guidelines for guidance about when the information should be sent to the PBS prescriber.

(2) The information that must be recorded and prepared includes the following:

(a) a statement that the pharmaceutical benefit supplied is a pharmaceutical benefit determined under paragraph 89A (3) (a) of the Act;

(b) a statement that the conditions mentioned in sections 2.02 to 2.05 are satisfied;

(c) a statement that the approved pharmacist is satisfied that the pharmaceutical benefit needs to be supplied to the person to facilitate continuity of treatment.

Part 3 Pharmaceutical benefits

3.01 Pharmaceutical benefits

For paragraph 89A (3) (a) of the Act, Schedule 1 sets out the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription for that supply under subsection 89A (1) of the Act.

Schedule 1 Pharmaceutical benefits

(section 3.01)

Part 1 Oral hormonal contraceptives

Listed drug	Form	Manner of administration	Brand
Levonorgestrel	Tablets 30 mcg, 28	Oral	Microlut 28
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 150 mcg-30 mcg and 7 inert tablets	Oral	Levlen ED
Levonorgestrel with Ethinyloestradiol	Pack containing 6 tablets 50 mcg-30 mcg, 5 tablets 75 mcg-40 mcg, 10 tablets 125 mcg-30 mcg and 7 inert tablets	Oral	Logynon ED
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 150 mcg-30 mcg and 7 inert tablets	Oral	Microgynon 30 ED
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 125 mcg-50 mcg and 7 inert tablets	Oral	Microgynon 50 ED
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 150 mcg-30 mcg and 7 inert tablets	Oral	Monofeme 28
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 150 mcg-30 mcg and 7 inert tablets	Oral	Nordette 28
Levonorgestrel with Ethinyloestradiol	Pack containing 6 tablets 50 mcg-30 mcg, 5 tablets 75 mcg-40 mcg, 10 tablets 125 mcg-30 mcg and 7 inert tablets	Oral	Trifeme 28
Levonorgestrel with Ethinyloestradiol	Pack containing 6 tablets 50 mcg-30 mcg, 5 tablets 75 mcg-40 mcg, 10 tablets 125 mcg-30 mcg and 7 inert tablets	Oral	Triphasil 28
Levonorgestrel with Ethinyloestradiol	Pack containing 6 tablets 50 mcg-30 mcg, 5 tablets 75 mcg-40 mcg, 10 tablets 125 mcg-30 mcg and 7 inert tablets	Oral	Triquilar ED
Norethisterone	Tablets 350 mcg, 28	Oral	Locilan 28 Day
Norethisterone	Tablets 350 mcg, 28	Oral	Micronor
Norethisterone	Tablets 350 mcg, 28	Oral	Noriday 28 Day
Norethisterone with Ethinyloestradiol	Pack containing 21 tablets 500 mcg-35 mcg and 7 inert tablets	Oral	Brevinor
Norethisterone with Ethinyloestradiol	Pack containing 21 tablets 1 mg‑35 mcg and 7 inert tablets	Oral	Brevinor-1
Norethisterone with Ethinyloestradiol	Pack containing 12 tablets 500 mcg-35 mcg, 9 tablets 1 mg-35 mcg and 7 inert tablets	Oral	Improvil 28 Day
Norethisterone with Ethinyloestradiol	Pack containing 21 tablets 500 mcg-35 mcg and 7 inert tablets	Oral	Norimin 28 Day
Norethisterone with Ethinyloestradiol	Pack containing 21 tablets 1 mg‑35 mcg and 7 inert tablets	Oral	Norimin-1 28 Day
Norethisterone with Mestranol	Pack containing 21 tablets 1 mg‑50 mcg and 7 inert tablets	Oral	Norinyl-1/28

Part 2 Lipid modifying agents

Listed drug	Form	Manner of administration	Brand
Atorvastatin	Tablet 10 mg (as calcium)	Oral	APO-Atorvastatin
Atorvastatin	Tablet 20 mg (as calcium)	Oral	APO-Atorvastatin
Atorvastatin	Tablet 40 mg (as calcium)	Oral	APO-Atorvastatin
Atorvastatin	Tablet 80 mg (as calcium)	Oral	APO-Atorvastatin
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Atorvachol
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Atorvachol
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Atorvachol
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Atorvachol
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Atorvastatin GH
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Atorvastatin GH
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Atorvastatin GH
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Atorvastatin GH
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Atorvastatin Pfizer
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Atorvastatin Pfizer
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Atorvastatin Pfizer
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Atorvastatin Pfizer
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Atorvastatin Sandoz
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Atorvastatin Sandoz
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Atorvastatin Sandoz
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Atorvastatin Sandoz
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Chem mart Atorvastatin
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Chem mart Atorvastatin
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Chem mart Atorvastatin
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Chem mart Atorvastatin
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Lipitor
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Lipitor
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Lipitor
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Lipitor
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Lorstat 10
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Lorstat 20
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Lorstat 40
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Lorstat 80
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Terry White Chemists Atorvastatin
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Terry White Chemists Atorvastatin
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Terry White Chemists Atorvastatin
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Terry White Chemists Atorvastatin
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Torvastat 10
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Torvastat 20
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Torvastat 40
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Torvastat 80
Atorvastatin	Tablet 10 mg (as calcium)	Oral	Trovas
Atorvastatin	Tablet 20 mg (as calcium)	Oral	Trovas
Atorvastatin	Tablet 40 mg (as calcium)	Oral	Trovas
Atorvastatin	Tablet 80 mg (as calcium)	Oral	Trovas
Fluvastatin	Capsule 20 mg (as sodium)	Oral	Lescol
Fluvastatin	Capsule 40 mg (as sodium)	Oral	Lescol
Fluvastatin	Tablet (prolonged release) 80 mg (as sodium)	Oral	Lescol XL
Fluvastatin	Capsule 20 mg (as sodium)	Oral	Vastin
Fluvastatin	Capsule 40 mg (as sodium)	Oral	Vastin
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	APO-Pravastatin
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	APO-Pravastatin
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	APO-Pravastatin
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	APO-Pravastatin
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Chem mart Pravastatin
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Chem mart Pravastatin
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Chem mart Pravastatin
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Chem mart Pravastatin
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Cholstat 10
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Cholstat 20
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Cholstat 40
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Cholvastin
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Cholvastin
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	GenRx Pravastatin
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	GenRx Pravastatin
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	GenRx Pravastatin
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Lipostat 10
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Lipostat 20
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Lipostat 40
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Lipostat 80
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pharmacor Pravastat 10
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pharmacor Pravastat 20
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pharmacor Pravastat 40
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravachol
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravachol
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravachol
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravachol
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravastatin Actavis 10
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravastatin Actavis 20
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravastatin Actavis 40
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravastatin-GA 10
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravastatin-GA 20
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravastatin-GA 40
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravastatin-GA 80
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravastatin generichealth
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravastatin generichealth
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravastatin generichealth
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravastatin generichealth
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravastatin Sandoz
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravastatin Sandoz
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravastatin Sandoz
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravastatin Sandoz
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Pravastatin Winthrop
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Pravastatin Winthrop
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Pravastatin Winthrop
Pravastatin	Tablet containing pravastatin sodium 10 mg	Oral	Terry White Chemists Pravastatin
Pravastatin	Tablet containing pravastatin sodium 20 mg	Oral	Terry White Chemists Pravastatin
Pravastatin	Tablet containing pravastatin sodium 40 mg	Oral	Terry White Chemists Pravastatin
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Terry White Chemists Pravastatin
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Crestor
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Crestor
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Crestor
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Crestor
Simvastatin	Tablet 10 mg	Oral	APO-Simvastatin
Simvastatin	Tablet 20 mg	Oral	APO-Simvastatin
Simvastatin	Tablet 40 mg	Oral	APO-Simvastatin
Simvastatin	Tablet 80 mg	Oral	APO-Simvastatin
Simvastatin	Tablet 10 mg	Oral	Auro-Simvastatin 10
Simvastatin	Tablet 20 mg	Oral	Auro-Simvastatin 20
Simvastatin	Tablet 40 mg	Oral	Auro-Simvastatin 40
Simvastatin	Tablet 80 mg	Oral	Auro-Simvastatin 80
Simvastatin	Tablet 10 mg	Oral	Chem mart Simvastatin
Simvastatin	Tablet 20 mg	Oral	Chem mart Simvastatin
Simvastatin	Tablet 40 mg	Oral	Chem mart Simvastatin
Simvastatin	Tablet 80 mg	Oral	Chem mart Simvastatin
Simvastatin	Tablet 10 mg	Oral	GenRx Simvastatin
Simvastatin	Tablet 20 mg	Oral	GenRx Simvastatin
Simvastatin	Tablet 40 mg	Oral	GenRx Simvastatin
Simvastatin	Tablet 80 mg	Oral	GenRx Simvastatin
Simvastatin	Tablet 10 mg	Oral	Lipex 10
Simvastatin	Tablet 20 mg	Oral	Lipex 20
Simvastatin	Tablet 40 mg	Oral	Lipex 40
Simvastatin	Tablet 80 mg	Oral	Lipex 80
Simvastatin	Tablet 10 mg	Oral	Pharmacor Simvastatin 10
Simvastatin	Tablet 20 mg	Oral	Pharmacor Simvastatin 20
Simvastatin	Tablet 40 mg	Oral	Pharmacor Simvastatin 40
Simvastatin	Tablet 80 mg	Oral	Pharmacor Simvastatin 80
Simvastatin	Tablet 10 mg	Oral	Ransim
Simvastatin	Tablet 20 mg	Oral	Ransim
Simvastatin	Tablet 40 mg	Oral	Ransim
Simvastatin	Tablet 80 mg	Oral	Ransim
Simvastatin	Tablet 10 mg	Oral	Simvacor 10
Simvastatin	Tablet 20 mg	Oral	Simvacor 20
Simvastatin	Tablet 40 mg	Oral	Simvacor 40
Simvastatin	Tablet 80 mg	Oral	Simvacor 80
Simvastatin	Tablet 5 mg	Oral	Simvahexal
Simvastatin	Tablet 10 mg	Oral	Simvahexal
Simvastatin	Tablet 20 mg	Oral	Simvahexal
Simvastatin	Tablet 40 mg	Oral	Simvahexal
Simvastatin	Tablet 10 mg	Oral	Simvar 10
Simvastatin	Tablet 20 mg	Oral	Simvar 20
Simvastatin	Tablet 40 mg	Oral	Simvar 40
Simvastatin	Tablet 80 mg	Oral	Simvar 80
Simvastatin	Tablet 10 mg	Oral	Simvastatin-DP
Simvastatin	Tablet 20 mg	Oral	Simvastatin-DP
Simvastatin	Tablet 40 mg	Oral	Simvastatin-DP
Simvastatin	Tablet 80 mg	Oral	Simvastatin-DP
Simvastatin	Tablet 10 mg	Oral	Simvastatin-GA 10
Simvastatin	Tablet 20 mg	Oral	Simvastatin-GA 20
Simvastatin	Tablet 40 mg	Oral	Simvastatin-GA 40
Simvastatin	Tablet 80 mg	Oral	Simvastatin-GA 80
Simvastatin	Tablet 10 mg	Oral	Simvastatin generichealth
Simvastatin	Tablet 20 mg	Oral	Simvastatin generichealth
Simvastatin	Tablet 40 mg	Oral	Simvastatin generichealth
Simvastatin	Tablet 80 mg	Oral	Simvastatin generichealth
Simvastatin	Tablet 10 mg	Oral	Simvastatin Pfizer
Simvastatin	Tablet 20 mg	Oral	Simvastatin Pfizer
Simvastatin	Tablet 40 mg	Oral	Simvastatin Pfizer
Simvastatin	Tablet 80 mg	Oral	Simvastatin Pfizer
Simvastatin	Tablet 5 mg	Oral	Simvastatin Sandoz
Simvastatin	Tablet 10 mg	Oral	Simvastatin Sandoz
Simvastatin	Tablet 20 mg	Oral	Simvastatin Sandoz
Simvastatin	Tablet 40 mg	Oral	Simvastatin Sandoz
Simvastatin	Tablet 80 mg	Oral	Simvastatin Sandoz
Simvastatin	Tablet 10 mg	Oral	Simvastatin-Spirit 10
Simvastatin	Tablet 20 mg	Oral	Simvastatin-Spirit 20
Simvastatin	Tablet 40 mg	Oral	Simvastatin-Spirit 40
Simvastatin	Tablet 80 mg	Oral	Simvastatin-Spirit 80
Simvastatin	Tablet 10 mg	Oral	Simvastatin Winthrop
Simvastatin	Tablet 20 mg	Oral	Simvastatin Winthrop
Simvastatin	Tablet 40 mg	Oral	Simvastatin Winthrop
Simvastatin	Tablet 80 mg	Oral	Simvastatin Winthrop
Simvastatin	Tablet 10 mg	Oral	Synthon Simvastatin
Simvastatin	Tablet 20 mg	Oral	Synthon Simvastatin
Simvastatin	Tablet 40 mg	Oral	Synthon Simvastatin
Simvastatin	Tablet 80 mg	Oral	Synthon Simvastatin
Simvastatin	Tablet 10 mg	Oral	Terry White Chemists Simvastatin
Simvastatin	Tablet 20 mg	Oral	Terry White Chemists Simvastatin
Simvastatin	Tablet 40 mg	Oral	Terry White Chemists Simvastatin
Simvastatin	Tablet 80 mg	Oral	Terry White Chemists Simvastatin
Simvastatin	Tablet 5 mg	Oral	Zimstat
Simvastatin	Tablet 10 mg	Oral	Zimstat
Simvastatin	Tablet 20 mg	Oral	Zimstat
Simvastatin	Tablet 40 mg	Oral	Zimstat
Simvastatin	Tablet 80 mg	Oral	Zimstat
Simvastatin	Tablet 5 mg	Oral	Zocor
Simvastatin	Tablet 10 mg	Oral	Zocor
Simvastatin	Tablet 20 mg	Oral	Zocor
Simvastatin	Tablet 40 mg	Oral	Zocor
Simvastatin	Tablet 80 mg	Oral	Zocor

Note In this table, mg is an abbreviation for milligram and mcg is an abbreviation for microgram.