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PB 59 of 2022 Determinations/Health as made
This instrument expands the list of eligible medicines that can be obtained under Continued Dispensing arrangements and repeals the National Health (Continued Dispensing) Determination 2012 and the National Health (Continued Dispensing – Emergency Measures) Determination 2020.
Administered by: Health and Aged Care
Registered 30 Jun 2022
Tabling HistoryDate
Tabled HR26-Jul-2022
Tabled Senate26-Jul-2022

Commonwealth Coat of Arms of Australia

 

PB 59 of 2022

 

National Health (Continued Dispensing) Determination 2022

I, David Laffan, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 28 June 2022

David Laffan

Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health

 

  

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

1.01....... Name............................................................................................................................. 1

1.02....... Commencement............................................................................................................. 1

1.03....... Authority....................................................................................................................... 1

1.04....... Schedule 2..................................................................................................................... 1

1.05....... Definitions..................................................................................................................... 1

1.06....... Purpose......................................................................................................................... 2

Part 2—Pharmaceutical benefits that may be supplied without a prescription         3

2.01....... Pharmaceutical benefits covered by this instrument....................................................... 3

Part 3—Specified conditions for supplying pharmaceutical benefits without a prescription     4

3.01....... General.......................................................................................................................... 4

3.02....... Condition—unable to obtain prescription...................................................................... 4

3.03....... Condition—previous supply of pharmaceutical benefit................................................. 4

3.04....... Condition—stability of therapy..................................................................................... 4

3.05....... Condition—prior clinical review by PBS prescriber..................................................... 4

3.06....... Condition—prescription for last supply of pharmaceutical benefit................................ 5

3.07....... Condition—no continued dispensing in previous 12 months........................................ 5

3.08....... Condition—declaration for supply of pharmaceutical benefit........................................ 5

3.09....... Condition—maximum quantity of supply..................................................................... 5

3.10....... Condition—preparing and recording information.......................................................... 5

Part 4—Application, savings and transitional provisions                                                        6

4.01....... Application of this instrument....................................................................................... 6

Schedule 1—Pharmaceutical benefits that may be supplied without a prescription  7

1............ Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist            7

Schedule 2—Repeals                                                                                                                                     12

National Health (Continued Dispensing) Determination 2012                                                 12

National Health (Continued Dispensing – Emergency Measures) Determination 2020       12

 


Part 1Preliminary

  

1.01  Name

             (1)  This instrument is the National Health (Continued Dispensing) Determination 2022.

             (2)  This instrument may also be cited as PB 59 of 2022.

1.02  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 July 2022.

1 July 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1.03  Authority

                   This instrument is made under subsection 89A(3) of the National Health Act 1953.

1.04  Schedule 2

                   Each instrument that is specified in Schedule 2 to this instrument is amended or repealed as set out in the applicable items in that Schedule, and any other item in that Schedule has effect according to its terms.

1.05  Definitions

             (1)  In this instrument:

Act means the National Health Act 1953.

electronic prescription has the meaning given by subsection 5(1) of the Regulations.

patient: see subsection 3.01(1).

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

requested supply: see subsection 3.01(1).

             (2)  An expression that is used in this instrument and in Part VII of the Act has the same meaning in this instrument as it has in that Part.

Examples:

(a)    approved pharmacist;

(b)    listed brand;

(c)    PBS prescriber;

(d)    pharmaceutical benefit;

(e)    pharmaceutical item;

(f)    Schedule equivalent.

1.06  Purpose

                   The purpose of this instrument is to determine:

                     (a)  the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription; and

                     (b)  the conditions that must be satisfied when making a supply of those pharmaceutical benefits.

Part 2Pharmaceutical benefits that may be supplied without a prescription

  

2.01  Pharmaceutical benefits covered by this instrument

                   For the purposes of paragraph 89A(3)(a) of the Act, the pharmaceutical benefits covered by an item in the table in Schedule 1 (being the listed drugs specified in the item) are determined to be pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription.

Part 3Specified conditions for supplying pharmaceutical benefits without a prescription

  

3.01  General

             (1)  For the purposes of paragraph 89A(3)(b) of the Act, the conditions specified in this Part are determined to be the conditions that must be satisfied when making a supply (the requested supply) of a pharmaceutical benefit to a person (the patient) requesting the supply without a prescription in accordance with subsection 89A(1) of the Act.

             (2)  In this Part:

                     (a)  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 patient; and

                     (b)  a reference to “the pharmaceutical benefit” in sections 3.03, 3.05, 3.06 and 3.07 includes a reference to a pharmaceutical benefit that is a Schedule equivalent.

3.02  Condition—unable to obtain prescription

                   The approved pharmacist must be satisfied of either or both of the following:

                     (a)  the PBS prescriber is unable to be contacted;

                     (b)  the PBS prescriber is unable to provide an electronic prescription.

3.03  Condition—previous supply of pharmaceutical benefit

                   The approved pharmacist must be satisfied that:

                     (a)  the patient 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 patient 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.

3.04  Condition—stability of therapy

                   The approved pharmacist must be satisfied that the patient’s therapy is stable.

3.05  Condition—prior clinical review by PBS prescriber

                   The approved pharmacist must be satisfied that:

                     (a)  the patient 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 patient’s condition and decided that there is a need for ongoing treatment with the pharmaceutical benefit.

Note:          See paragraph 3.01(2)(a) for references to the PBS prescriber.

3.06  Condition—prescription for last supply of pharmaceutical benefit

                   The approved pharmacist must be satisfied that the patient had a valid prescription under Part VII of the Act for the last supply of the pharmaceutical benefit to the patient before the requested supply.

3.07  Condition—no continued dispensing in previous 12 months

                   The approved pharmacist must be satisfied that the patient was not supplied with the pharmaceutical benefit under subsection 89A(1) of the Act in the 12 months before the requested supply.

3.08  Condition—declaration for supply of pharmaceutical benefit

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

3.09  Condition—maximum quantity of supply

                   The approved pharmacist must supply a maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit determined under paragraph 85A(2)(a) of the Act.

3.10  Condition—preparing and recording information

             (1)  The approved pharmacist must, when the pharmaceutical benefit is supplied:

                     (a)  record the information that the pharmacist used to support the pharmacist’s decision to supply the pharmaceutical benefit; and

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

             (2)  The information that must be recorded and prepared under subsection (1) must include the following:

                     (a)  a statement that the pharmaceutical benefit supplied is a pharmaceutical benefit covered by Schedule 1;

                     (b)  a statement that the conditions mentioned in sections 3.02 to 3.05 are satisfied;

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

Part 4Application, savings and transitional provisions

  

4.01  Application of this instrument

                   Despite the repeal of the National Health (Continued Dispensing – Emergency Measures) Determination 2020, that instrument (the emergency instrument) continues to have effect, on and after 1 July 2022, for the purposes of the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 in relation to a supply of a pharmaceutical benefit made in accordance with the emergency instrument on or before 30 June 2022 as if the repeal had not happened.

Schedule 1Pharmaceutical benefits that may be supplied without a prescription

Note:       See section 3.01.

  

  

1  Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist

 

Item

Listed drug

1

Abacavir

2

Abacavir with lamivudine

3

Abacavir with lamivudine and zidovudine

4

Acarbose

5

Adefovir

6

Alogliptin

7

Alogliptin with metformin

8

Amiloride with hydrochlorothiazide

9

Amlodipine

10

Amlodipine with atorvastatin

11

Amlodipine with valsartan

12

Amlodipine with valsartan and hydrochlorothiazide

13

Atazanavir

14

Atazanavir with cobicistat

15

Atenolol

16

Atorvastatin

17

Beclometasone

18

Beclometasone with Formoterol (eformoterol)

19

Bictegravir with emtricitabine with tenofovir alafenamide

20

Bisoprolol

21

Budesonide

22

Budesonide with Formoterol (eformoterol)

23

Candesartan

24

Candesartan with hydrochlorothiazide

25

Captopril

26

Carvedilol

27

Chlortalidone

28

Ciclesonide

29

Cromoglycate

30

Dapagliflozin

31

Dapagliflozin with metformin

32

Darunavir

33

Darunavir with cobicistat

34

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

35

Diltiazem

36

Dolutegravir

37

Dolutegravir with abacavir and lamivudine

38

Dolutegravir with lamivudine

39

Dolutegravir with rilpivirine

40

Dulaglutide

41

Efavirenz

42

Empagliflozin

43

Empagliflozin with linagliptin

44

Empagliflozin with metformin

45

Emtricitabine with rilpivirine with tenofovir alafenamide

46

Emtricitabine with tenofovir alafenamide

47

Enalapril

48

Enalapril with hydrochlorothiazide

49

Enfuvirtide

50

Entecavir

51

Eplerenone

52

Eprosartan

53

Eprosartan with hydrochlorothiazide

54

Ertugliflozin

55

Ertugliflozin with metformin

56

Ertugliflozin with sitagliptin

57

Etacrynic acid

58

Etravirine

59

Exenatide

60

Ezetimibe with atorvastatin

61

Ezetimibe with rosuvastatin

62

Ezetimibe with simvastatin

63

Felodipine

64

Fluticasone furoate

65

Fluticasone furoate with Vilanterol

66

Fluticasone propionate

67

Fluticasone propionate with Formoterol (eformoterol)

68

Fluticasone propionate with Salmeterol

69

Fluvastatin

70

Formoterol (eformoterol)

71

Fosamprenavir

72

Fosinopril

73

Fosinopril with hydrochlorothiazide

74

Furosemide (frusemide)

75

Glibenclamide

76

Gliclazide

77

Glimepiride

78

Glipizide

79

Hydrochlorothiazide

80

Indacaterol

81

Indacaterol with Mometasone

82

Indapamide

83

Insulin aspart

84

Insulin aspart with insulin aspart protamine

85

Insulin degludec with insulin aspart

86

Insulin detemir

87

Insulin glargine

88

Insulin glulisine

89

Insulin isophane human

90

Insulin isophane human with insulin neutral human

91

Insulin lispro

92

Insulin lispro with insulin lispro protamine

93

Insulin neutral human

94

Irbesartan

95

Irbesartan with hydrochlorothiazide

96

Labetalol

97

Lamivudine

98

Lamivudine with zidovudine

99

Lercanidipine

100

Lercanidipine with enalapril

101

Levonorgestrel

102

Levonorgestrel with ethinylestradiol

103

Linagliptin

104

Linagliptin with metformin

105

Lisinopril

106

Lopinavir with ritronavir

107

Losartan

108

Maraviroc

109

Metformin

110

Metformin with glibenclamide

111

Metoprolol succinate

112

Metoprolol tartrate

113

Nebivolol

114

Nedocromil

115

Nevirapine

116

Nifedipine

117

Norethisterone

118

Norethisterone with ethinylestradiol

119

Norethisterone with Mestranol

120

Olmesartan

121

Olmesartan with amlodipine and hydrochlorothiazide

122

Olmesartan with hydrochlorothiazide

123

Olmesartan medoxomil with amlodipine

124

Oxprenolol

125

Perindopril

126

Perindopril with amlodipine

127

Perindopril with indapamide

128

Pindolol

129

Pioglitazone

130

Pravastatin

131

Propranolol

132

Quinapril

133

Quinapril with hydrochlorothiazide

134

Raltegravir

135

Ramipril

136

Ramipril with felodipine

137

Rilpivirine

138

Ritonavir

139

Rosuvastatin

140

Sacubitril with valsartan

141

Salbutamol

142

Salmeterol

143

Saquinavir

144

Saxagliptin

145

Saxagliptin with dapagliflozin

146

Saxagliptin with metformin

147

Semaglutide

148

Simvastatin

149

Sitagliptin

150

Sitagliptin with metformin

151

Spironolactone

152

Telmisartan

153

Telmisartan with amlodipine

154

Telmisartan with hydrochlorothiazide

155

Tenofovir with emtricitabine

156

Tenofovir with emtricitabine and efavirenz

157

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

158

Tenofovir disoproxil

159

Terbutaline

160

Tipranavir

161

Trandolapril

162

Trandolapril with verapamil

163

Valsartan

164

Valsartan with hydrochlorothiazide

165

Verapamil

166

Vildagliptin

167

Vildagliptin with metformin

168

Zidovudine


Schedule 2Repeals

  

National Health (Continued Dispensing) Determination 2012

1  The whole of the instrument

Repeal the instrument.

National Health (Continued Dispensing – Emergency Measures) Determination 2020

2  The whole of the instrument

Repeal the instrument.