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

Statutory Rules 1986 No. 381

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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 subsection 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) Auranofin;

(b) Doxorubicin Hydrochloride;

(c) Human Menopausal Gonadotrophin; and

(d) Isotretinoin;

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 20 March 1986.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

Susan Ryan

Minister of State for Education for and

on behalf of the

Minister of State for Health

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(S.R. 49/86)—Cat. No.  10/18.3.1986

Commencement

1.These Regulations shall come into operation on 1 April 1986.

Principal Regulations

2.In these Regulations, “Principal Regulations” means the National Health (Pharmaceutical Benefits) Regulations.

Schedule 1

3.Schedule 1 to the Principal Regulations is amended as set out in Schedule 1.

Schedule 2

4.Schedule 2 to the Principal Regulations is amended as set out in Schedule 2.

Schedule 3

5.Schedule 3 to the Principal Regulations is amended as set out in Schedule 3.

Schedule 5

6.Schedule 5 to the Principal Regulations is amended as set out in Schedule 4.

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SCHEDULE 1Regulation 3

AMENDMENTS OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

1. Omit item 276.

2. Omit item 710.

3. Omit item 718.

4. Omit item 719.

5. After item 923 insert the following item:

“923a Physostigmine Salicylate”.

6. Omit item 1199.

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SCHEDULE 2 Regulation 4

AMENDMENTS OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

1. Omit item 54.
2. Omit item 77, substitute the following item:
“77 Dextran 40 Intravenous Infusion, B.P.	Glucose, B.P., with Dextran 40 Intravenous Infusion, B.P.
Sodium Chloride, B.P., with Dextran 40 Intravenous Infusion, B.P.”.

SCHEDULE 2— continued

3. After item 92 insert the following item:
“92a Doxorubicin Hydrochloride—”.
4. Omit item 125, substitute the following item:
“125 Glucose, Anhydrous, B.P.	Sodium Chloride, B.P., Potassium Chloride, B.P., Citric Acid, B.P., Sodium Citrate, B.P., and Anhydrous Glucose, B.P.
Sodium Lactate Compound Intravenous Infusion, B.P., with Anhydrous Glucose, B.P.”.
5. Omit item 202.

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SCHEDULE 3 Regulation 5

AMENDMENTS OF SCHEDULE 3 TO THE PRINCIPAL REGULATIONS

1. After item 25 insert the following item:

“25a Auranofin”.

2. Omit item 83.

3. After item 87 insert the following item:

“87a Doxorubicin Hydrochloride”.

4. After item 113 insert the following item:

“113a Human Menopausal Gonadotrophin”.

5. After item 130 insert the following item:

“130a Isotretinoin”.

6. Omit item 246.

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SCHEDULE 4 Regulation 6

AMENDMENTS OF SCHEDULE 5 TO THE PRINCIPAL REGULATIONS

1. Omit item 22, substitute the following items:
“22 (1) Bromocriptine Mesylate, Capsules, 5 mg (base)	With the written authority of the Secretary—
(2) Bromocriptine Mesylate, Capsules, 10 mg (base)	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 is not indicated or has already been used with incomplete resolution

SCHEDULE 4—continued

22a Bromocriptine Mesylate, Tablets, 2.5 mg (base)	Urgent suppression of physiological lactation
With the written authority of the Secretary—
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 is not indicated or has already been used with incomplete resolution”.
2. Omit item 35.
3. Omit item 40, substitute the following item:
“40 (1) Chloramphenicol Capsules, B.P.	Bacterial meningitis
(2) Chloramphenicol Palmitate Mixture, B.P.	Intracranial bacterial infections
	Intraocular infections
Rickettsioses
(3) Chloramphenicol Sodium Succinate, B.P.	Typhoid
	The treatment of other serious infections in a patient where it is established by appropriate bacteriological testing that chloramphenicol is the only suitable antibiotic listed as a pharmaceutical benefit for use in treating the infection in the patient”.
4. Omit item 44, substitute the following item:
“44 Cholestyramine	Bile salt malabsorption associated with ileal resection or proven ileal disease
Hypercholesterolaemia
Pruritis associated with partial biliary obstruction not responding to other therapy
Severe diarrhoea associated with pelvic irradiation”.
5. After item 47 insert the following item:
“47a Clomiphene Tablets, B.P.	With the written authority of the Secretary—
Anovulatory infertility”.
6. Omit item 50, substitute the following item:
“50 Colestipol Hydrochloride	Hypercholesterolaemia”.
7. Omit item 52.

SCHEDULE 4—continued

8. After item 66 insert the following item:
“67 Doxorubicin Hydrochloride	Acute leukaemia
Breast cancer
Endometrial carcinoma
Ewing’s sarcoma
Gastric cancer
Hepatoma
Intravesicular use in bladder cancer
Lymphoma
Multiple myeloma
Neuroblastoma
Osteosarcoma
Ovarian cancer
Soft tissue sarcoma
Thyroid cancer
Wilms’ tumour”.
9. After item 92 insert the following item:
“92a Isotretinoin	With the written authority of the Secretary—
Severe cystic acne not responsive to other therapy”.
10. Omit item 95.
11. After item 101 insert the following item:
“101a Mefenamic Acid Capsules, B.P.	Dysmenorrhoea
Menorrhagia”.
12. Omit item 164, substitute the following item:
“164 Tamoxifen Citrate Tablets, B.P.	Recurrent or metastatic breast cancer”.
13. Omit item 173.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 27 March 1986.

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; 1984 Nos. 50, 148, 169 and 342; 1985 Nos. 32, 184 and 320.

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