Commonwealth Coat of Arms of Australia

Statutory Rules 1986 No. 3201

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) Indapamide;

(b) Insulin Neutral, Human (Synthetic);

(c) Insulin Zinc Suspension, Human (Synthetic);

(d) Insulin Zinc Suspension (Crystalline), Human (Synthetic);

(e) Oestrogens—Conjugated;

(f) Piroxicam;

(g) Polygeline; and

(h) Silver Sulphadiazine:

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 29 OCTOBER 1986.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

Neal Blewett

Minister of State for Health

(S.R. 317/86)—Cat. No.            8/20.10.1986


Commencement

1. These Regulations shall come into operation on 1 November 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 4

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

Schedule 5

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

SCHEDULE 1    Regulation 3

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

1. After item 17 insert the following item:

“17a Aloxiprin Tablets”.

2. After item 72 insert the following item:

“72a Ascorbic Acid Tablets”.

3. After item 75 insert the following items:

“75a Aspirin Tablets

75b Aspirin Tablets, Dispersible”.

4. After item 185 insert the following item:

“185a Carbenicillin Sodium”.

5. After item 254 insert the following item:

“254a Chlorpheniramine Tablets”.

6. After item 342 insert the following items:

“342a Dextromoramide Tablets

342b Dextromoramide Tartrate”.

7. After item 381 insert the following item:

“381a Dihydrocodeine Tartrate”.


SCHEDULE 1—continued

8. After item 393 insert the following items:

“393a Diphenhydramine Capsules

393b Diphenhydramine Elixir

393c Diphenylpyraline Hydrochloride”.

9. After item 555 insert the following item:

“555a Guanethidine Tablets”.

10. After item 583 insert the following item:

“583a Hydrogen Peroxide Solution (3 per cent)”.

11. After item 631 insert the following item:

“631a Isoprenaline Hydrochloride”.

12. After item 692 insert the following item:

“692a Magnesium Sulphate, Dried”.

13. After item 706 insert the following item:

“706a Meclozine Tablets”.

14. After item 836 insert the following item:

“836a Oxytetracycline Capsules”.

15. After item 848 insert the following item:

“848a Paracetamol Tablets”.

16. After item 887 insert the following item:

“887a Pheniramine Maleate”.

17. After item 910 insert the following item:

“910a Pholcodine”.

18. Omit item 957.

19. After item 985 insert the following items:

“985a Promethazine Hydrochloride Elixir 985B Promethazine Hydrochloride Tablets”.

20. After item 1028 insert the following item:

“1028a Riboflavine”.

21. After item 1103 insert the following item:

“1 103a Sodium Valproate Tablets”.

22. After item 1115 insert the following item:

“1115a Squill Elixir”.

23. After item 1246 insert the following item:

“1246a Trimeprazine Tablets”.

SCHEDULE 2    Regulation 4

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

1. Omit item 22.

2. Omit item 26.

3. Omit item 41.

4. Omit item 48.

5. After item 58 insert the following item:

“58a Chloroquine Sulphate, B.P. —”.

6. Omit item 67.

7. Omit item 84.

8. Omit item 87.


SCHEDULE 2—continued

9. Omit item 90.

 

10. Omit item 118, substitute the following item:

“118 Frangula Bark, B.P.

Sterculia, B.P., with Frangula Bark, B.P.”.

11. Omit item 122.

 

12. Omit item 129.

 

13. After item 131 insert the following item:

“131a Homatropine Hydrobromide,

 

B.P.

 

14. Omit item 136.

 

15. After item 145 insert the following items:

“145a Insulin Isophane, Human (Synthetic)

Insulin Neutral, Human (Synthetic) and Insulin Isophane, Human (Synthetic)

145b Insulin Neutral, Human (Synthetic)

Insulin Isophane, Human (Synthetic) and Insulin Neutral, Human (Synthetic)”.

16. Omit item 191.

 

17. Omit item 193, substitute the following item:

“193 Paracetamol, B.P.

—”

18. Omit item 197.

 

19. Omit item 201.

 

20. After item 204 insert the following item:

“204a Polygeline

—”.

21. Omit item 207, substitute the following item:

“207 Polyvinyl Alcohol

Povidone, B.P., with Polyvinyl Alcohol”.

22. After item 211 insert the following item:

“211a Povidone, B.P.

Polyvinyl Alcohol with Povidone, B.P.”.

23. Omit item 217.

 

24. Omit item 222, substitute the following item:

“222 Silver Sulphadiazine

—”.

25. After item 228 insert the following item:

“228a Sodium Valproate, B.P.

—”.

26. Omit item 230, substitute the following item:

“230 Sterculia, B.P.

Frangula Bark, B.P., with Sterculia, B.P.”.

     SCHEDULE 3     Regulation 5

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

1. Omit item 28.

2. Omit item 32.

3. Omit item 42.

4. Omit item 53.


SCHEDULE 3—continued

5. Omit item 70.

6. Omit item 79.

7. Omit item 96.

8. Omit item 106.

9. Omit item 113.

10. After item 122 insert the following item:

“122a Indapamide”.

11. Omit item 130.

12. After item 131 insert the following items:

“131a Insulin Neutral, Human (Synthetic)

131b Insulin Zinc Suspension, Human (Synthetic)

131c Insulin Zinc Suspension (Crystalline), Human (Synthetic)”.

13. After item 178 insert the following item:

“178a Oestrogens—Conjugated”.

14. Omit item 191.

15. After item 196 insert the following item:

“196a Piroxicam”.

16. After item 204 insert the following item:

“204a Polygeline”.

17. Omit item 227.

18. Omit item 229.

19. After item 230 insert the following item:

“230a Silver Sulphadiazine”.

SCHEDULE 4   Regulation 6

AMENDMENT OF SCHEDULE 4 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

1. Omit item 16.

SCHEDULE 5   Regulation 7

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

1. Omit item 11.

 

2. Omit item 14.

 

3. Omit item 29.

 

4. Omit item 40, substitute the following item:

 

“40 Cholestyramine

Bile salt malabsorption

 

Hypercholesterolaemia

 

Pruritus associated with partial biliary obstruction not responding to other therapy

 

Severe diarrhoea associated with pelvic irradiation”.


SCHEDULE 5—continued

5. Omit item 42, substitute the following item:

“42 Cimetidine

With the written authority of the Secretary—

 

Duodenal ulcer (including pyloric ulcer), confirmed by X-ray, endoscopy or surgery

 

Gastric ulcer, initial, confirmed by X-ray, endoscopy or surgery

 

Gastric ulcer, recurrent (benign gastric ulcer recurring within 12 months of commencing initial therapy), confirmed by X-ray, endoscopy or surgery

 

Oesophageal stricture, recurrent, due to proven chronic ulcer occurring within gastric epithelium where dilatation has been required

 

Severe ulcerating (erosive) oesophagitis, confirmed by endoscopy

 

Ulcerating (erosive) oesophagitis in scleroderma

 

Zollinger-Ellison syndrome, proven by investigation”.

6. Omit item 45, substitute the following item:

 

“45 Clomiphene Tablets, B.P.

Anovulatory infertility

 

Patients undergoing in-vitro fertilisation”.

7. Omit item 47.

 

8. After item 49 insert the following item:

 

“49a Cyproheptadine Tablets, B.P.

Prevention of migraine”.

9. Omit item 57.

 

10. Omit item 65.

 

11. Omit item 72, substitute the following item:

 

“72 Etretinate

With the written authority of the Secretary—

 

Treatment initiated in a hospital (in-patient or out-patient) of—

 

Darier’s disease

 

Erythrokeratoderma

 

Pityriasis rubra pilaris

 

Severe congenital ichthyosis (lamellar, bullous and sex-linked)

 

Severe intractable psoriasis

 

Severe palmo-plantar

keratoderma

 

For the continuing treatment of a patient who has already received, for more than 6 months, therapy with etretinate for a condition listed above”.


SCHEDULE 5—continued

12. Omit item 74.

 

13. Omit item 82.

 

14. Omit item 91, substitute the following item:

 

“91 (1) Insulin Isophane, Human (Synthetic)

Diabetics exhibiting lipoatrophy, lipohypertrophy, local allergy or immunologic resistance

(2) Insulin Isophane, Human (Synthetic) and Insulin Neutral, Human (Synthetic)

 

 

Newly diagnosed insulin dependent diabetics”.

(3) Insulin Neutral, Human (Synthetic)

 

(4) Insulin Zinc Suspension, Human (Synthetic)

 

(5) Insulin Zinc Suspension (Crystalline), Human (Synthetic)

 

15. After item 106 insert the following item:

 

“106a Methdilazine Hydrochloride

Prevention of migraine”.

16. Omit item 127.

 

17. Omit item 150, substitute the following item:

 

“150 Ranitidine Hydrochloride

With the written authority of the Secretary—

 

Duodenal ulcer (including pyloric ulcer), confirmed by X-ray, endoscopy or surgery

 

Gastric ulcer, initial, confirmed by X-ray, endoscopy or surgery

 

Gastric ulcer, recurrent (benign gastric ulcer recurring within 12 months of commencing initial therapy), confirmed by X-ray, endoscopy or surgery

 

Oesophageal stricture, recurrent, due to proven chronic ulcer occurring within gastric epithelium where dilatation has been required

 

Severe ulcerating (erosive) oesophagitis, confirmed by endoscopy

 

Ulcerating (erosive) oesophagitis in scleroderma

 

Zollinger-Ellison syndrome, proven by investigation”.

18. After item 151 insert the following items:

 

“151a Silver Sulphadiazine, Cream, 1%, 100 g

For prevention and treatment of infection in partial or full skin thickness loss due to burns

 

Stasis ulcers

151b Silver Sulphadiazine, Cream, 1%, 500 g

With the written authority of the Secretary—

 

Treatment, in a hospital, of burns”.


SCHEDULE 5—continued

19. Omit item 152, substitute the following items:

 

“152 Silver Sulphadiazine with Chlorhexidine Gluconate Cream, 1%-0.2%, 100 g

For prevention and treatment of infection in partial or full skin thickness loss due to burns

 

Stasis ulcers

152a Silver Sulphadiazine with Chlorhexidine Gluconate Cream, 1%-0.2%, 500 g

With the written authority of the Secretary—

 

Treatment, in a hospital, of burns”.

20. After item 158 insert the following item:

 

“158a Sterculia, B.P., 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”.

21. Omit item 159.

 

22. Omit item 160.

 

23. Omit item 171, substitute the following item:

“171 Ticarcillin Sodium

Infections where positive bacteriological evidence confirms that ticarcillin sodium is an appropriate therapeutic agent

 

Septicaemia, suspected or proven”.

24. Omit item 180.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 October 1986.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1986 No. 38 and see also Statutory Rules 1986 Nos. 38, and 319.

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