National Health (Pharmaceutical Benefits) Regulations (Amendment) (Cth)

Statutory Rules 1982 No. 3341

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National Health (Pharmaceutical Benefits) Regulations2(Amendment)

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953 that a drug or medicinal preparation that was not a pharmaceutical benefit under that Act immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of that Act unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

AND WHEREAS the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that each of the following drugs or medicinal preparations be prescribed as a pharmaceutical benefit under section 85 of that Act, namely—

(a)
‘‘INFASOY’’;
(b)
Nifedipine; and
(c)
Ticarcillin Disodium:

AND WHEREAS it is desirable, amongst other things, to prescribe each of those drugs or medicinal preparations as a pharmaceutical benefit under that section:

NOW THEREFORE I, the Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953.

Dated 23 November 1982.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

J. J. CARLTON

Minister of State for Health

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Commencement

1. These Regulations shall come into operation on 1 December 1982.

Schedule 1

2. Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 1.

Schedule 2

3. Schedule 2 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 2.

Schedule 3

4. Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 3.

Schedule 5

5. Schedule 5 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

SCHEDULE 1 Regulation 2

AMENDMENTS OF SCHEDULE 1 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1.	After item 300 insert the following item:
“300A Dichlorphenamide Tablets”.
2.	After item 303 insert the following item:
“303A Dienoestrol Tablets”.
3.	After item 457 insert the following item:
“457A Glycerol Suppositories”.
4.	Omit item 651.
5.	Omit item 670.
6.	Omit item 1079.

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SCHEDULE 2 Regulation 3

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1.	Omit item 66.
2.	Omit item 91.
3.	Omit item 137, substitute the following item:
“137 Hydrocortisone, B.P.	Polymyxin B Sulphate, B.P., with Neomycin Sulphate, B.P., and Hydrocortisone, B.P.”.
4.	After item 146 insert the following item:
“146A ‘INFASOY’	—”.
5.	Omit item 147, substitute the following item:
“147 Insulin Injection, Neutral, B.P.	Insulin Injection, Isophane, B.P., and Insulin Injection, Neutral, B.P.”.
6.	Omit item 148, substitute the following item:
“148 Insulin Injection, Isophane, B.P.	Insulin Injection, Neutral, B.P., and Insulin Injection, Isophane, B.P.”.
7.	After item 167 insert the following item:
“167A Metoclopramide Hydrochloride, B.P.	—”.
8.	Omit item 172, substitute the following item:
“172 Natamycin	—”.
9.	Omit item 173, substitute the following item:
“173 Neomycin Sulphate, B.P.	Bacitracin with Polymyxin B Sulphate, B.P., and Neomycin Sulphate, B.P. Colistin Sulphate, B.P., with Neomycin Sulphate, B.P. Gramicidin with Nystatin, B.P., Triamcinolone Acetonide, B.P., and Neomycin Sulphate B.P. Hydrocortisone Acetate, B.P., with Neomycin Sulphate, B.P. Polymyxin B Sulphate, B.P., with Bacitracin Zinc, B.P., and Neomycin Sulphate, B.P. Polymyxin B Sulphate, B.P., with Gramicidin, and Neomycin Sulphate, B.P. Polymyxin B Sulphate, B.P., with Hydrocortisone, B.P., and Neomycin Sulphate, B.P.”.
10.	Omit item 219.

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SCHEDULE 3 Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1.	Omit item 62.
2.	Omit item 89.
3.	After item 128 insert the following item:
“128A ‘INFASOY’ ”.
4.	Omit item 136.
5.	Omit item 137.
6.	Omit item 138.
7.	Omit item 139.
8.	Omit item 140.
9.	Omit item 141.
10.	After item 180 insert the following item:
“180A Nifedipine”.
11.	Omit item 244.
12.	After item 265 insert the following item:
“265A Ticarcillin Disodium”.

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SCHEDULE 4 Regulation 5

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1.	After item 5 insert the following item:
“5A Amoxycillin Trihydrate, B.P., Dispersible Tablets	Infection of the lower urinary tract”.
2.	Omit item 6, substitute the following item:
“6 Ascorbic Acid Tablets, B.P.	Any disease or condition in a pensioner or a dependant of a pensioner”.
3.	Omit item 8, substitute the following item:
“8 Azathioprine Tablets, B.P.	With the written authority of the Permanent Head— Anaemia, autoimmune haemolytic Continuing azathioprine therapy initiated in a hospital Dermatomyositis Granulomatosis, Wegener’s Hepatitis, active, chronic Lupus erythematosus, systemic Nephrotic syndrome Organ transplant Polyarteritis nodosa Pyoderma gangrenosum Scleroderma Thrombocytopenic purpura”.
4.	After item 10 insert the following item:
“10A Beclomethasone Dipropionate, B.P., Capsules, 100 micrograms	With the written authority of the Permanent Head— Chronic intractable asthma requiring maintenance corticosteroids in children under the age of eight (8) years who are unable to use a metered aerosol spray”.
5.	Omit item 15, substitute the following item:
“15 Bleomycin Sulphate	Germ cell neoplasms Lymphoma Squamous cell carcinoma”.
6.	Omit item 20, substitute the following item:
“20 Calciferol Tablets, High-Strength, B.P. Hypocalcaemia	Hypoparathyroidism Osteomalacia following gastrectomy, severe steatorrhoea or renal failure Vitamin D-resistant rickets”.
7.	Omit item 21, substitute the following item:
“21 Calcitriol	With the written authority of the Permanent Head— Hypocalcaemia due to renal disease Hypoparathyroidism”.
8.	Omit item 24, substitute the following items:
“24 Calcium Folinate, Injection “24A Calcium Folinate, Tablets, 15 mg	Antidote to folic acid antagonists With the written authority of the Permanent Head— Antidote to folic acid antagonists”.
9.	Omit item 34, substitute the following item:
“34 Chlorambucil Tablets, B.P.	With the written authority of the Permanent Head— Anaemia, autoimmune, haemolytic Continuing chlorambucil therapy initiated in a hospital Granulomatosis, Wegener’s Leukaemia, chronic lymphatic Lupus erythematosus, systemic Lymphoma Myeloproliferative disorders Polyarteritis nodosa Scleroderma Thrombocytopenic purpura”.
10.	Omit item 47, substitute the following item:
“47 Codeine Phosphate, B.P., with Aspirin, B.P., Soluble Tablets	Any disease or condition in a pensioner or a dependant of a pensioner”.
11.	Omit item 48, substitute the following item:
“48 Codeine Phosphate, B.P., with Aspirin, B.P., Tablets, 30mg-325mg	With the written authority of the Permanent Head— Malignant neoplasia”.
12.	Omit item 49, substitute the following item:
“49 Codeine Phosphate, B.P., with Paracetamol, B.P., Tablets, 8mg-500mg	Any disease or condition in a pensioner or a dependant of a pensioner”.
13.	Omit item 53, substitute the following item:
“53 (1) Cyclophosphamide, B.P. (2) Cyclophosphamide Tablets, B.P.	With the written authority of the Permanent Head— Anaemia, autoimmune haemolytic Continuing cyclophosphamide thereapy initiated in a hospital Dermatomyositis Granulomatosis, Wegener’s Hepatitis, active, chronic Lupus erythematosus, systemic Malignant disease including leukaemia Nephritis Nephrotic syndrome Polyarteritis nodosa Scleroderma Thrombocytopenic purpura”.
14.	After item 55 insert the following item:
“55A Daunorubicin	With the written authority of the Permanent Head— Acute leukaemia”.
15.	Omit item 66.
16.	After item 68 insert the following item:
“68A Doxepin Hydrochloride, B.P. Tablet, 50mg (base)	With the written authority of the Permanent Head— Endogenous depression where there is an inadequate response to not less than 100mg of doxepin daily”.
17.	Omit item 72, substitute the following item:
“72 Ergocalciferol, B.P.	Hypocalcaemia Hypoparathyroidism Osteomalacia following gastrectomy, severe steatorrhoea or renal failure Vitamin D-resistant rickets”.
18.	Omit item 84, substitute the following item:
“84 Glycerol, B.P., Suppositories	Any disease or condition in a paraplegic or quadriplegic patient For use by patients who are receiving long-term intensive nursing care in hospitals or nursing homes For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.
19.	After item 89 insert the following item:
“89A ‘INFASOY’	With the written authority of the Permanent Head— Cows’ milk allergy in children under the age of two (2) years Galactosaemia Homocystinuria Lactose intolerance”.
20.	Omit item 91.
21.	Omit item 95, substitute the following item:
“95 Labetalol Hydrochloride	Tablets Hyertension which fails to respond adequately to multiple antihypertensive drug therapy”
22.	Omit item 100, substitute the following item:
“100 (1) Medroxyprogesterone Acetate, B.P., Injection, 50 mg in 1 ml (2) Medroxyprogesterone Acetate B.P., Tablets 100 mg	Breast cancer Endometrial cancer Renal cell cancer”.
23.	Omit item 101, substitute the following item:
“101 Medroxyprogesterone Acetate, B.P., Injection, 150 mg in 1 ml	Breast cancer Endometrial cancer Precocious puberty Renal cell cancer”.
24.	Omit item 103, substitute the following item:
“103 Medroxyprogesterone Acetate, B.P., Tablets, 10 mg	Breast cancer Dysfunctional uterine bleeding Endometrial cancer Precocious puberty Renal cell cancer Turner’s syndrome”.
25.	Omit item 104.
26.	Omit item 109, substitute the following items:
“109 (1) Methotrexate, B.P., 5 mg Injection (2) Methotrexate Injection, B.P., 5 mg (3) Methotrexate Tablets, B.P.	With the written authority of the Permanent Head— Acute leukaemia Breast cancer Chorioadenoma destruens Continuing methotrexate therapy initiated in a hospital Gestational choriocarcinoma Head and neck epidermoid cell carcinoma Hydatidiform mole Lung cancer Lymphoma Osteogenic sarcoma Severe intractable or extensive psoriasis
“109A (1) Methotrexate, B.P., 50 mg Injection (2) Methotrexate Injection, B.P., 50 mg	With the written authority of the Permanent Head— Head and neck epidermoid cell carcinoma Lymphoma Osteogenic sarcoma”.
27.	After item 114 insert the following item:
“114A Metoclopramide Hydrochloride, B.P.	With the written authority of the Permanent Head— Gastric retention after gastric surgery Malignant neoplasia (late stage)”.
28.	Omit item 124, substitute the following items:
“124 Nicotinic Acid Tablets, B.P.	Any disease or condition in a pensioner or a dependant of a pensioner
“124A Nifedipine, Capsules, 10 mg	With the written authority of the Permanent Head— Intractable angina not responding to other therapy”.
29.	After item 133 insert the following item:
“133A Papaveretum, Tablets 10 mg	Disabling pain associated with proven malignant neoplasia Disabling pain of short duration not responding to non-narcotic analgesics, the maximum duration of treatment being two weeks”.
30.	Omit item 134, substitute the following item:
“134 (1) Penicillamine, B.P., (2) Penicillamine Capsules, B.P. (3) Penicillamine Tablets, B.P.	With the written authority of the Permanent Head— Acute heavy metal intoxication Cystinosis Cystinuria with calculus formation For the continuing treatment of rheumatoid arthritis where penicillamine therapy was initiated in a hospital Haemoglobinuria, paroxysmal cold Patients with rheumatoid arthritis who are already receiving long-term (greater than 6 months) therapy with penicillamine Wilson’s disease (hepatolenticular degeneration)”.
31.	After item 153 insert the following item:
“153A Procarbazine Hydrochloride	With the written authority of the Permanent Head— Lymphoma Small cell carcinoma of the lung”.
32.	Omit item 160, substitute the following items:
“160 Riboflavine, B.P., Tablets	Any disease or condition in a pensioner or a dependant of a pensioner
“160A Salbutamol Sulphate, B.P., Capsules, 200 micrograms	With the written authority of the Permanent Head— Bronchial asthma in children under the age of eight (8) years who are unable to use a metered aerosol spray”.
33.	Omit item 168.
34.	Omit item 178, substitute the following item:
“178 Thiamine Hydrochloride Tablets, B.P.	Any disease or condition in a pensioner or a dependant of a pensioner”.
35.	Omit item 181, substitute the following item:
“181 Ticarcillin Disodium Injection	With the written authority of the Permanent Head— Infections where positive bacteriological evidence confirms that ticarcillin disodium is the most appropriate therapeutic agent Septicaemia, suspected or proven”.
36.	After item 188 insert the following item:
“188A Trimethoprim, B.P.	Acute urinary tract infections”.

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 November 1982.
2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1982 No. 69 and see also