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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