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

Statutory Rules 1985 No. 3201

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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 the following drug or medicinal preparation be prescribed as a pharmaceutical benefit under section 85 of that Act, namely, Funnel-Web Spider Antivenom:

AND WHEREAS it is desirable, amongst other things, to prescribe that drug or medicinal preparation 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 28 November 1985.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

Neal Blewett

Minister of State for Health

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Commencement

1. These Regulations shall come into operation on 1 December 1985.

Principal Regulations

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

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(S.R. 322/85)—Cat. No. 11/7.11.1985

Supply of pharmaceutical benefits on prescription

3.Regulation 21 of the Principal Regulations is amended—

(a) by omitting from paragraph (1) (c) “6 months” and substituting “12 months”; and

(b) by omitting from paragraph (2) (e) “6 months” and substituting “12 months”.

Repeat authorizations

4.Regulation 26 of the Principal Regulations is amended by omitting from paragraph (2) (d) “6 months” and substituting “12 months”.

Schedule 1

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

Schedule 2

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

Schedule 3

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

Schedule 5

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

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SCHEDULE 1 Regulation 5

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

1. After item 345 insert the following item:

“345a Dextromoramide Tartrate Injection”.

2. Omit item 887.

3. After item 916 insert the following item:

“916a Phenytoin Tablets”.

4. After item 1003 insert the following item:

“1003a Protriptyline Tablets”.

5. Omit item 1272.

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SCHEDULE 2 Regulation 6

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

1. Omit item 12.
2. Omit item 173, substitute the following item:
“173 Morphine Sulphate, B.P.	Tacrine Hydrochloride with Morphine Sulphate, B.P.”.
3. Omit item 222, substitute the following item:
“222 Senega and Ammonia Mixture	—”.
4. Omit item 254.

SCHEDULE 3 Regulation 7

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

1. After item 98 insert the following item:

“98a Funnel-Web Spider Antivenom”.

2. Omit item 109.

3. Omit item 123, substitute the following item:

“123 Insect Allergen Extract—Paper Wasp Venom”.

4. Omit item 200.

5. Omit item 219, substitute the following item:

“219 Senega and Ammonia Mixture”.

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SCHEDULE 4 Regulation 8

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

1. Omit item 5, substitute the following item:
“5 ‘ALFARÉ’.	With the written authority of the Secretary—
Biliary atresia
Cystic fibrosis
Enterokinase deficiency
Intolerance to both milk protein and soya protein
Severe diarrhoea of greater than two weeks duration in infants under the age of 4 months”.
2. Omit item 10.
3. Omit item 13.
4. Omit item 26, substitute the following item:
“26 (1) Calcium Carbonate, B.P.	Hypocalcaemia
(2) Calcium Carbonate, B.P., with Calcium Lactate-Gluconate	Osteoporosis
	Proven malabsorption”.
5. Omit item 27, substitute the following item:
“27 Calcium Folinate	Antidote to folic acid antagonists”.
6. Omit item 28.
7. Omit item 29, substitute the following item:
“29 Captopril	Moderate or severe hypertension
For the continuing treatment of severe refractory cardiac failure where treatment with captopril was initiated in a hospital”.
8. Omit item 34.
9. Omit item 38.
10. Omit item 43, substitute the following item:
“43 (1) Chlorpromazine Elixir, B.P.	Chorea
(2) Chlorpromazine Injection, B.P.	Hyperactive states of organic or toxic delirium
(3) Chlorpromazine Suppositories, B.P.
	Major psychoses including—
(4) Chlorpromazine Tablets, B.P.	Major organic psychoses including arteriopathic dementia

SCHEDULE 4—continued

Manic depressive disorder—manic phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients under the age of 16 years”.
11. Omit item 48, substitute the following item:
“48 (1) Cloxacillin Capsules, B.P.	Infections due to the presence of penicillin-resistant staphylococci
(2).Cloxacillin Sodium, B.P., with Purified Water, B.P.
	Osteomyelitis”.
12. Omit item 54, substitute the following item:
“54 Dantrolene Sodium	Treatment of chronic spasticity”.
13. Omit item 56, substitute the following item:
“56 Demeclocycline Capsules, B.P.	Syndrome of inappropriate antidiuretic hormone secretion, caused otherwise than by treatment with a drug”.
14. Omit item 60, substitute the following item:
“60 (1) Dextromoramide Tablets, B.P.	Disabling pain associated with proven malignant neoplasia”.
(2) Dextromoramide Tartrate, B.P.
15. Omit item 67.
16. Omit item 73, substitute the following item:
“73 Etretinate	With the written authority of the Secretary—
Treatment initiated in a hospital of—
Chronic disfiguring discoid lupus erythematosus
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”.
17. Omit item 74, substitute the following item:
“74 (1) Flucloxacillin Capsules, B.P.	Infections due to the presence of penicillin-resistant staphylococci
(2) Flucloxacillin Sodium, B.P., with Purified Water, B.P.
	Osteomyelitis”.
18. Omit item 77, substitute the following item:
“77 (1) Fluphenazine Decanoate Injection, B.P.	Chorea
	Hyperactive states of organic or toxic delirium
(2) Fluphenazine Hydrochloride, B.P.
	Major psychoses including—
(3) Fluphenazine Tablets, B.P.	Major organic psychoses including arteriopathic dementia

SCHEDULE 4—continued

Manic depressive disorder—manic phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness”.
19. Omit item 80, substitute the following item:
“80 Fusidic Acid, B.P.	For use in combination with another antibiotic in the treatment of serious staphylococcal infections confirmed by bacteriological evidence”.
20. Omit item 85, substitute the following item:
“85 (1) Haloperidol, B.P.	Chorea
(2) Haloperidol Tablets, B.P.	Hyperactive states of organic or toxic delirium
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic depressive disorder—manic phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness”.
21. Omit item 93, substitute the following item:
“93 (1) ‘KETOVITE’ Liquid	With the written authority of the Secretary—
(2) ‘KETOVITE’ Tablets
Chronic cholestasis
Galactosaemia
Persistent monosaccharide intolerance
Phenylketonuria
Tyrosinosis (hereditary)
Use in association with a ketogenic diet”.
22. Omit item 98, substitute the following item:
“98 (1) Medroxyprogesterone Acetate, B.P., Injection, 50 mg in 1 mL	Breast cancer
	Endometrial cancer
Renal cell cancer”.
(2) Medroxyprogesterone Acetate, B.P., Injection, 500 mg in 2.5 mL
(3) Medroxyprogesterone Acetate, B.P., Tablets, 100 mg
23. Omit item 104.
24. Omit item 105.
25. Omit item 110, substitute the following item:
“110 Metronidazole, B.P.		Prophylaxis in large bowel surgery
Treatment in a hospital of acute anaerobic sepsis”.
26. Omit item 115, substitute the following item:
“115 (1) Nalidixic Acid Mixture, B.P.		For use as a urinary antiseptic in patients with neurogenic bladder
(2) Nalidixic Acid Tablets, B.P.

SCHEDULE 4—continued

Urinary tract infections where current clinical and bacteriological evidence confirm that nalidixic acid is the most appropriate therapeutic agent”.
27. Omit item 119.
28. Omit item 120.
29. Omit item 129, substitute the following item
“129 (1) Penicillamine, B.P.	Acute heavy metal intoxication
(2) Penicillamine Tablets, B.P.	Cystinosis
Cystinuria with calculus formation
Haemoglobinuria, paroxysmal cold
Severe rheumatoid arthritis
Wilson’s disease (hepatolenticular degeneration)”.
30. Omit item 131, substitute the following item:
“131 Pericyazine	Chorea
Hyperactive states of organic or toxic delirium
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic depressive disorder—manic phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients under the age of 16 years”.
31. After item 131 insert the following item:
“131a Pethidine Tablets, B.P.	With the written authority of the Secretary—
Disabling pain associated with proven malignant neoplasia”.
32. Omit item 132, substitute the following item:
“132 Phenelzine Tablets, B.P.	Depressive illness resistant to treatment with either tricyclic antidepressants or electroconvulsive therapy
Phobic states”.
33. Omit item 142.
34. Omit item 147.
35. Omit item 148, substitute the following item:
“148 Propantheline Tablets, B.P.	Chronic neurogenic incontinence of urine”.
36. Omit item 152, substitute the following item:
“152 Rifampicin, B.P.	Prophylaxis of meningococcal disease in close contacts and carriers
With the written authority of the Secretary—
Leprosy in adults”.
37. After item 153 insert the following item:
“153a Sodium Acid Phosphate, B.P., Compound Effervescent Tablets	With the written authority of the Secretary—
Familial hypophosphataemia

SCHEDULE 4—continued

Hypercalcaemia
Vitamin D-resistant rickets”.
38. Omit item 156, substitute the following item:
“156 Sodium Fusidate, B.P.	For use in combination with another antibiotic in the treatment of serious staphylococcal infections confirmed by bacteriological evidence”.
39. Omit item 167, substitute the following item:
“167 Tetrabenazine	Chorea not adequately controlled by other drug therapy”.
40. Omit item 170, substitute the following item:
“170 (1) Thioridazine Hydrochloride, B.P.	Chorea
	Hyperactive states of organic or toxic delirium
(2) Thioridazine Tablets, B.P.
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic depressive disorder—manic
phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients under the age of 16 years”.
41. Omit item 172, substitute the following item:
“172 Tobramycin Injection, B.P.	Infections where positive bacteriological evidence confirms that tobramycin is the most appropriate antibiotic
Septicaemia, suspected or proven”.
42. Omit item 174, substitute the following item:
“174 Tranexamic Acid Tablets, B.P.	Hereditary angio-oedema”.
43. Omit item 175, substitute the following item:
“175 Tranylcypromine Tablets, B.P.	Depressive illness resistant to treatment with either tricyclic antidepressants or electroconvulsive therapy
Phobic states”.
44. Omit item 177, substitute the following item:
“177 (1) Trifluoperazine Hydrochloride, B.P.	Chorea
	Hyperactive states of organic or toxic delirium
(2) Trifluoperazine Hydrochloride Tablets, B.P.
	Major psychoses including—
	Major organic psychoses including arteriopathic dementia
Manic depressive disorder—manic phase
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients under the age of 16 years”.
45. Omit item 180.

NOTES

1. Notified in the Commonwealth of Australia Gazette on 29 November 1985.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1985 No. 32 and see also Statutory Rules 1985 Nos. 32 and 184.

                                      

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