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National Health (Continued Dispensing) Determination 20121

National Health Act 1953

I, Felicity McNeill, First Assistant Secretary, Pharmaceutical Benefits Division of the Department of Health and Ageing, make the following determination under subsection 89A (3) of the National Health Act 1953.

Dated 29 June 2012

Felicity McNeill

Delegate for the Minister for Health

Contents

Part 1Preliminary

1.01Name of determination   3

1.02Commencement   3

1.03Definitions   3

1.04Purpose   3

Part 2Conditions

2.01General   4

2.02Not practicable to obtain prescription   4

2.03Previous supply of pharmaceutical benefit   4

2.04Stability of therapy   4

2.05Prior clinical review by PBS prescriber   5

2.06Prescription for last supply of pharmaceutical benefit   5

2.07No continued dispensing in previous 12 months   5

2.08Declaration by person supplied with pharmaceutical benefit                  5

2.09Maximum quantity of supply   5

2.10Preparing and recording information   5

Part 3Pharmaceutical benefits

3.01Pharmaceutical benefits   7

Schedule 1Pharmaceutical benefits   8

Part 1Oral hormonal contraceptives   8

Part 2Lipid modifying agents   9

Part 1                 Preliminary

1.01        Name of determination

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

1.02        Commencement

This determination commences on 1 July 2012.

1.03        Definitions

(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.

Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See

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