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

Statutory Rules 1981 No. 3451

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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)

  Bromocriptine Mesylate;

• (b)

  Dextran 70;

• (c)

  Dipivefrin Hydrochloride;

• (d)

  Gliclazide;

• (e)

  Mianserin Hydrochloride;

• (f)

  Trimipramine; and

• (g)

  Tri-potassium Di-citrato Bismuthate Complex:

 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 26 November 1981.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

MICHAEL MacKELLAR

Minister of State for Health

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Commencement

 1. These Regulations shall come into operation on 1 December 1981.

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. Omit item 507.

2. After item 639 insert the following item:

“639A

Neostigmine Methylsulphate”.

3. After item 718 insert the following item:

“718A

Pentolinium Injection”.

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SCHEDULE 2 Regulation 3

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

1. After item 82 insert the following item:

“82A Dextran 70

Hypromellose 4500 with Dextran 70”.

2. After item 98 insert the following item:

“98A Dipivefrin Hydrochloride

‑”.

3. Omit item 143, substitute the following item:

“143 Hypromellose 4500

Dextran 70 with Hypromellose 4500”.

4. Omit item 174.

5. Omit item 194.

6. After item 245 insert the following item:

“245A Tri-potassium Di-citrato Bismuthate Complex

–”.

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SCHEDULE 3 Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

 

1. After item 43 insert the following item:

“43A

Bromocriptine Mesylate”.

2. After item 83 insert the following item:

“83A

Dextran 70”.

3. After item 93 insert the following item:

“93A

Dipivefrin Hydrochloride”.

4. After item 113 insert the following item:

“113A

Gliclazide”.

5. After item 178 insert the following item:

“178A

Mianserin Hydrochloride”.

6. Omit item 211.

7. After item 284 insert the following item:

“284A

Trimipramine”.

8. After 285 insert the following item:

“285A

Tri-potassium Di-citrato Bismuthate Complex”.

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SCHEDULE 4 Regulation 5

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS

1. After item 15 insert the following items:

“15A	Bromocriptine Mesylate, Tablets 2.5 mg	With the written authority of the Permanent Head
Pathological hyperprolactinaemia where appropriate surgery or radiotherapy are not indicated or have already been used with incomplete resolution
15B	Bromocriptine Mesylate, Capsules 10 mg	With the written authority of the Permanent Head Acromegaly, prior to surgery or radiotherapy or where surgery or radiotherapy is inappropriate”.

2. Omit item 37, substitute the following item:

“Cholestyramine With the written authority of the Permanent Head Bile salt malabsorption associated with ileal resection or proven ileal disease Pruritus associated with partial biliary obstruction not responding to other therapy Hypercholesterolaemia”.

3. Omit item 39A, substitute the following item:

“39A Clofibrate Capsules, B.P. With the written authority of the Permanent Head Hypertriglyceridaemia Hypercholesterolaemia”

4. After item 43 insert the following item:

“43A Codeine Phosphate, B.P. with Paracetamol, B.P. Tablets 8 mg—500 mg For pensioners only”.

5. Omit item 44, substitute the following item:

“44 Colestipol Hydrochloride With the written authority of the Permanent Head— Hypercholesterolaemia”.

6. Omit item 109.

7. After item 110 insert the following item:

“110A Mianserin Hydrochloride With the written authority of the Permanent Head— Depressive illness in persons with cardiovascular disease”.

8. Omit item 156, substitute the following item:

“156 (1) Sodium Valproate Syrup (2) Sodium Valproate Tablet 200 mg Epilepsy”.

9. After item 156 insert the following item:

“156A Sodium Valproate Tablet 500 mg (enteric coated) With the written authority of the Permanent Head— Epilepsy in patients requiring more than 1 g of sodium valproate daily”.

10. Omit item 160, substitute the following item:

“160 Sulindac With the written authority of the Permanent Head— Chronic rheumatoid arthritis not responding to other non-steroidal anti-inflammatory drugs (disregarding phenylbutazone) Chronic osteoarthritis not responding to other non‑steroidal anti-inflammatory drugs (disregarding phenylbutazone)”.

11. After 176 insert the following item:

“176A

Trimipramine

With the written authority of the Permanent Head— Endogenous depression where there is an inadequate response to not less than 100 mg of  trimipramine daily”.

12. After 177 insert the following item:

“177A Tri-potassium Di-citrato Bismuthate Complex With the written authority of the Permanent Head— Duodenal ulcer confirmed by radiology, endoscopy or surgery Gastric ulcer confirmed by radiology, endoscopy, or surgery”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 November 1981.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1981 No. 52 and see also