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

Statutory Rules 1984 No. 501

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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) “ALFARÉ”;

(b) Bassorin; 

(c) Etretinate;

(d) Miconazole;

(e) Minoxidil;

(f) Naloxone Hydrochloride;

(g) Pilocarpine; and

(h) Sucralfate:

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

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S.R. 39/8 Cat. No. Recommended retail price 60c 11/21.3.1984

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 29 March 1984.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

(Sgd) Neal Blewett

Minister of State for Health

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Commencement

1.These Regulations shall come into operation on 1 April 1984.

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 I TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. After item 4 insert the following item:

“4a Adrenaline Acid Tartrate”.

2. After item 35 insert the following items:

“35aa Amitriptyline Embonate Mixture

35ab Amitriptyline Hydrochloride”.

3. After item 158 insert the following item:

“158a Carbenoxolone Tablets”.

4. Omit item 451.

5. After item 519 insert the following item:

“519a Hydroflumethiazide Tablets”.

6. After item 594 insert the following item:

“594a Levodopa Capsules”.

7. Omit item 683.

8. Omit item 697.

9. Omit item 698.

10. After item 826 insert the following item:

“826a Phthalylsulphathiazole”.

11. Omit item 932.

12. After item 1146 insert the following items:

“1146a Viprynium Mixture

1146b Viprynium Tablets”.

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SCHEDULE 2 Regulation 3

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

1. Omit item 1.
2. Omit item 2.
3. Omit item 4.
4. Omit item 6.
5. After item 8 insert the following item:
“8a ‘ALFARÉ’	—”.
6. Omit item 10, substitute the following item:
“10 Aluminium Hydroxide, Dried, B.P.	Magnesium Trisilicate, B.P., with Magnesium Hydroxide, B.P., and Aluminium Hydroxide, Dried, B.P.”.
7. Omit item 17.
8. After item 28 insert the following item:
“28a Bassorin	Frangula Bark, B.P., with Bassorin”.
9. Omit item 46a, substitute the following item:
“46a Calcium Carbonate, B.P.	Calcium Lactate-Gluconate with Calcium Carbonate, B.P.”.
10. After item 116 insert the following item:
“116a Frangula Bark, B.P.	Bassorin with Frangula Bark, B.P.”.
11. Omit item 161, substitute the following item:
“161 Magnesium Hydroxide, B.P.	Aluminium Hydroxide, Dried, B.P., with Magnesium Trisilicate, B.P., and Magnesium Hydroxide, B.P.
Aluminium Hydroxide Mixture, B.P., with Magnesium Hydroxide, B.P.
Aluminium Hydroxide Mixture, B.P., with Oxethazaine and Magnesium Hydroxide, B.P.”.
12. After item 168 insert the following item:
“168a Miconazole	—”.
13. After item 170 insert the following item:
“170a Nalidixic Acid Mixture, B.P.	—”.
14. After item 194a insert the following item:
“194b Pilocarpine	—”.
15. Omit item 248.	—

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SCHEDULE 3 Regulation 4

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

1. Omit item 1.

2. Omit item 3.

3. Omit item 4.

4. After item 9 insert the following item:

“9a ‘ALFARÉ’”

5. After item 32 insert the following item:

“32a Bassorin”.

6. Omit item 68.

7. Omit item 72.

8. After item 95 insert the following item:

“95a Etretinate”.

9. Omit item 127.

10. Omit item 131.

11. After item 168 insert the following item:

“168a Miconazole”.

12. After item 169 insert the following item:

“169a Minoxidil”.

13. After item 170 insert the following item:

“170a Naloxone Hydrochloride”.

14. Omit item 199, substitute the following item:

“199 Pilocarpine”.

15. Omit item 200, substitute the following item:

“200 Pituitary Gonadotrophin, Human”.

16. After item 240 insert the following item:

“241 Sucralfate”.

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SCHEDULE 4 Regulation 5

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

1. After item 3 insert the following item:
“3a ‘ALFARÉ’	With the written authority of the Permanent Head—
Cystic fibrosis
Enterokinase deficiency
Patients who are intolerant of both milk protein and soya protein
Severe diarrhoea of greater than two weeks duration in infants who have not attained the age of four (4) months”.
2. Omit item 9, substitute the following item:
“9 Azathioprine Tablets, B.P.	With the written authority of the Permanent Head Anaemia, autoimmune haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing azathioprine therapy initiated in a hospital
Crohn’s disease
Dermatomyositis
Granulomatosis. Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Nephrotic syndrome
Organ transplant
Pemphigus
Polyarteritis nodosa
Pyoderma gangrenosum
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis”.
3. After item 11 insert the following item:
“11a Bassorin with Frangula Bark, B.P.	Any disease or condition in a paraplegic or quadriplegic patient
For use by patients who are receiving long-term extensive nursing care in hospitals or nursing homes
For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.
4. Omit item 15, substitute the following item:
“15 (1) Bisacodyl Suppositories, B.P.	Any disease or condition in a paraplegic or quadriplegic patient
(2) Bisacodyl Tablets, B.P.	For use by patients who are receiving long-term extensive nursing care in hospitals or nursing homes
For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.
5. Omit item 16.
6. Omit item 17, substitute the following item:
“17 Bromocriptine Mesylate	With the written authority of the Permanent Head—
Acromegaly, prior to surgery or radiotherapy or where surgery or radiotherapy is inappropriate
Parkinson’s disease where treatment with levodopa is unsatisfactory
Pathological hyperprolactinaemia where appropriate surgery or radiotherapy are not indicated or have already been used with incomplete resolution”.

SCHEDULE 4—continued

7. Omit item 22.
8. Omit item 25, substitute the following item:
“25 Captopril	With the written authority of the Permanent Head—
For the continuing treatment of severe refractory cardiac failure where treatment with captopril was initiated in a hospital
For the continuing treatment of severe refractory hypertensive disease where treatment with captopril was initiated in a hospital”.
9. Omit item 27.
10. Omit item 53.
11. Omit item 54, substitute the following item:
“54 ‘DE-LACT INFANT’	Acute gastro-enteritis in infants who have not attained the age of six (6) months
Proven lactose intolerance in infants who have not attained the age of six (6) months”.
12. Omit item 63, substitute the following item:
“63 Dioctyl Sodium Sulphosuccinate with Bisacodyl, B.P.	Any disease or condition in a paraplegic or quadriplegic patient
For use by patients who are receiving long-term extensive nursing care in hospitals or nursing homes
For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.
13. After item 72 insert the following item:
“72a Etretinate	With the written authority of the Permanent Head
Treatment initiated in a hospital of
Darier’s disease
Erythrokeratoderma
Pityriasis rubra pilaris
Severe congenital ichthyosis (lamellar, bullous and sex linked)
Severe intractable psoriasis
Severe palmo-plantar keratoderma”.
14. Omit item 83, substitute the following item:
“83 Glycerol, B.P., Suppositories	Any disease or condition in a paraplegic or quadriplegic patient
For use by patients who are receiving long-term extensive nursing care in hospitals or nursing homes
For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.
15. Omit item 94, substitute the following item:
“94 Labetalol Hydrochloride	Hypertension”.
16. Omit item 107, substitute the following item:
“107 (1) Methotrexate, B.P., 5 mg Injection	With the written authority of the Permanent Head
	Acute leukaemia
(2) Methotrexate Injection, B.P., 5 mg	Breast cancer
	Chorioadenoma destruens
(3) Methotrexate Tablets, B.P.	Continuing methotrexate therapy initiated in a hospital
Gestational choriocarcinoma
Head and neck epidermoid cell carcinoma
Hydatidiform mole
Lung cancer
Lymphoma
Osteogenic sarcoma
Pemphigus
Severe intractable or extensive psoriasis”.

SCHEDULE 4—continued

17. Omit item 108, substitute the following item:
“108 (1) Methotrexate, B.P., 50 mg Injection	With the written authority of the Permanent Head—
	Carcinoma of the breast
(2) Methotrexate Injection, B.P., 50 mg	Continuing methotrexate therapy initiated in a hospital
Head and neck epidermoid cell carcinoma
Lymphoma
Osteogenic sarcoma
Pemphigus”.
18. Omit item 115.
19. After item 118 insert the following item:
“118a Minoxidil	With the written authority of the Permanent Head
For the continuing treatment of severe refractory hypertensive disease where treatment with minoxidil was initiated in a hospital”.
20. After item 120 insert the following item:
“120a (1) Nalidixic Acid Mixture, B.P.	With the written authority of the Permanent Head—
	For use as a urinary antiseptic in patients with neurogenic bladder”.
(2) Nalidixic Acid Tablets, B.P.
21. After item 141a insert the following item:
“141b Pilocarpine	With the written authority of the Permanent Head
Chronic glaucoma when other miotics are not tolerated”.
22. After item 161 insert the following item:
“161a Rifampicin, B.P.	With the written authority of the Permanent Head—
Leprosy in adults
Prophylaxis of meningococcal disease in close contacts and carriers”.
23. After item 169 insert the following item:
“169a Sucralfate	With the written authority of the Permanent Head—
Duodenal ulcer, confirmed by radiology, endoscopy or surgery
Gastric ulcer, confirmed by radiology, endoscopy or surgery”.
24. After item 170 insert the following item:
“170a Sulphasalazine	Crohn’s disease
Ulcerative colitis”.
25. Omit item 173, substitute the following item:
“173 Tamoxifen Citrate, B.P.	With the written authority of the Permanent Head—
Treatment of post-menopausal recurrent or metastatic breast cancer”.

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 March 1984.

2. Statutory Rules 1960 No. 17 as amended by 1960 Nos. 90 and 102; 1961 Nos. 59 and 137; 1962 Nos. 34, 101 and 114; 1963 Nos. 34, 69 and 107; 1964 Nos. 12, 57 and 135; 1965 Nos. 51, 151 and 152; 1966 Nos. 80 and 144; 1967 Nos. 67, 116 and 158; 1968 Nos. 44, 76, 88 and 146; 1969 Nos. 44, 107 and 185; 1970 Nos. 39, 94, 119 and 186; 1971 Nos. 44, 101, 136 and 154; 1972 Nos. 32, 121 and 205; 1973 Nos. 15, 57, 139 and 229; 1974 Nos. 37, 126 and 222; 1975 Nos. 50, 148 and 209; 1976 Nos. 84, 150, 195 and 255; 1977 Nos. 39, 125 and 221; 1978 Nos. 47, 142, 153 and 245; 1979 Nos. 51, 55, 144 and 250; 1980 Nos. 69, 213 and 338; 1981 Nos. 52, 212, 218 and 345; 1982 Nos. 69, 76, 179, 334 and 372; 1983 Nos. 28, 102, 116 and 292.

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