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

Statutory Rules 1984 No. 1691

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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:

(a) Amiodarone Hydrochloride;

(b) Ranitidine Hydrochloride;

(c) Silver Sulphadiazine with Chlorhexidine Gluconate Cream:

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 July 1984.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

 

(Sgd) Neal Blewett

Minister of State for Health

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S.R. 200/84 Cat. No.  —Recommended retail price 60c  11/19.7.1984

Commencement

1.These Regulations shall come into operation on 1 August 1984.

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. (1) Schedule 5 to the Principal Regulations is amended by omitting “Permanent Head” (wherever occurring) and substituting “Secretary”.

(2) Schedule 5 to the Principal Regulations is further amended as set out in Schedule 4.

 

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SCHEDULE 1 Regulation 3

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

1. After item 39 insert the following item:

“39a Amodiaquine Tablets”.

2. After item 113 insert the following item:

“113a Bismuth Subgallate”.

3. Omit items 284 and 285.

4. Omit item 325.

5. Omit item 338.

6. Omit item 357, substitute the following item:

“357 Diphtheria, Tetanus and Pertussis Vaccine”.

7. Omit item 485.

8. Omit item 623, substitute the following item:

“623 Magnesium Trisilicate Tablets, Compound”.

9. Omit items 946 and 947, substitute the following items:

“946 Senega Liquid Extract

“947 Senega Root”.

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SCHEDULE 2

Regulation 4

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

1. Omit item 42.
2. After item 77 insert the following items:
“77a Dextran 40 Intravenous Infusion, B.P.	Anhydrous Glucose, B.P., with 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.
“77b Dextran 70 Intravenous Infusion, B.P.	Glucose, B.P., with Dextran 70 Intravenous Infusion, B.P.
Sodium Chloride, B.P., with Dextran 70 Intravenous Infusion, B.P.”.
3. Omit item 88, substitute the following item:
“88 Diphenhydramine Hydrochloride, B.P.	Ergotamine Tartrate, B.P., with Caffeine Citrate, B.P.C. 1959, and Diphenhydramine Hydrochloride, B.P.”.
4. Omit item 91.
5. Omit item 123, substitute the following item:
“123 Glucose, Anhydrous, B.P.	Dextran 40 Intravenous Infusion B.P., with Anhydrous Glucose, 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.”.
6. Omit, item 159.
7. Omit item 164.
8. After item 213 insert the following item:
“213a Silver Sulphadiazine with Chlorhexidine Gluconate Cream
9. Omit item 234.

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SCHEDULE 3 Regulation 5

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

1. After item 21 insert the following item:

“21a Amiodarone Hydrochloride”.

2. Omit item 152.

3. Omit item 155.

4. Omit item 214, substitute the following item:

“214 Potassium Chloride, B.P., with Potassium Bicarbonate Effervescent Tablets”.

5. After item 224 insert the following item:

“224a Ranitidine Hydrochloride”.

6. After item 232 insert the following item:

“232a Silver Sulphadiazine with Chlorhexidine Gluconate Cream”.

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SCHEDULE 4

Regulation 6

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

1. After item 6 insert the following item:
“6a Amiodarone Hydrochloride		With the written authority of the Secretary—
For the continuing treatment of severe refractory cardiac arrhythmias where treatment with amiodarone hydrochloride was initiated in a hospital”.
2. Omit item 21, substitute the following item:
“21 Calcium Carbonate, B.P., with Calcium Lactate-Gluconate		With the written authority of the Secretary—
		Hypocalcaemia
Osteoporosis
Proven malabsorption”.
3. Omit item 28, substitute the following item:
“28 Carindacillin Sodium	With the written authority of the Secretary—
Urinary tract infections where positive bacteriological evidence confirms that carindacillin or carbenicillin is the most appropriate therapeutic agent”.
4. Omit items 43 and 43a, substitute the following item:
“43 Cimetidine		With the written authority of the Secretary—
Duodenal ulcer, confirmed by radiology, endoscopy or surgery
Gastric ulcer, confirmed by radiology, endoscopy or surgery
Zollinger-Ellison syndrome, proven by investigation”.
5. Omit item 47, substitute the following item:
“47 Codeine Phosphate, B.P., with Aspirin, B.P., Tablets, 30mg-325mg		With the written authority of the Secretary—
		Disabling pain associated with proven malignant neoplasia”.
6. After item 50 insert the following item:
“50a (1) Cyclophosphamide, B.P.		With the written authority of the Secretary—
(2) Cyclophosphamide Tablets, B.P.		Anaemia, autoimmune, haemolytic
		Arthritis, rheumatoid with vasculitis or visceral complications
Continuing cyclophosphamide therapy initiated in a hospital
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Malignant disease including leukaemia
Nephritis
Nephrotic syndrome
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura”.
7. Omit item 54, substitute the following item:
“54 ‘DE-LACT INFANT’		Acute gastro-enteritis complicated by lactose intolerance in infants who have not attained the age of twelve (12) months
Proven lactose intolerance in infants who have not attained the age of twelve (12) months”.

SCHEDULE 4—continued

8. Omit item 58, substitute the following items:
“58 (1) Dextromoramide Tablets, B.P.	Disabling pain associated with proven malignant neoplasia
(2) Dextromoramide Tartrate, B.P.
“58a Diflunisal Tablets, B.P.	Chronic osteoarthritis
Chronic rheumatoid arthritis”.
9. Omit item 65.
10. Omit item 86, substitute the following items:
“86 Hydrocortisone Acetate, B.P., Rectal Foam	Proctitis
	Ulcerative colitis
“86a Hydrocortisone Acetate Injection, B.P.	Alopecia areata
	For local intra-articular or peri-articular infiltration
Granulomata, dermal
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid”.
11. Omit item 96, substitute the following item:
“96 Lincomycin Injection, B.P.	Gram-positive coccal infections where these cannot be safely and effectively treated with penicillin or a derivative of penicillin”.
12. Omit item 102, substitute the following item:
“102 Medroxyprogesterone Acetate, B.P., Tablets, 10 mg		Breast cancer
		Dysfunctional uterine bleeding
Endometrial cancer
Endometriosis
Precocious puberty
Renal cell cancer
Turner’s syndrome”.
13. Omit item 114, substitute the following item:
“114 Metoclopramide Hydrochloride, B.P.			With the written authority of the Secretary—
			Malignant neoplasia (late stage)
Gastric stasis due to gastric surgery, diabetic gastroparesis or scleroderma”.
14. Omit items 130 and 131, substitute the following item:
“130 (1) Oxycodone Hydrochloride				Disabling pain associated with proven malignant neoplasia”.
(2) Oxycodone Pectinate
15. Omit item 151, substitute the following item:
“151 Prednisolone Acetate Injection			For local intra-articular or peri-articular infiltration”.
16. Omit items 161a, 162, 163 and 164, substitute the following items:
“161a Ranitidine Hydrochloride			With the written authority of the Secretary—
Duodenal ulcer, confirmed by radiology, endoscopy or surgery
Gastric ulcer, confirmed by radiology, endoscopy or surgery
Zollinger-Ellison syndrome, proven by investigation
“161b Rifampicin, B.P.			With the written authority of the Secretary—
Leprosy in adults
Prophylaxis of meningococcal disease in close contacts and carriers
“162 Silver Sulphadiazine with Chlorhexidine Gluconate Cream			With the written authority of the Secretary—
			Treatment, in a hospital, of burns
“163 Sodium Cromoglycate, B.P., Eye Drops			With the written authority of the Secretary—
			Vernal kerato-conjunctivitis

SCHEDULE 4—continued

“164 Sodium Cromoglycate, B.P., Nebuliser Solution	Use in a power-operated nebuliser for prophylaxis of asthma in persons who are unable to use the capsule for oral inhalation”.
17	Omit items 166 and 167, substitute the following item:
“166 (1) Sodium Valproate, B.P.	Epilepsy”.
(2) Sodium Valproate Elixir, B.P.
(3) Sodium Valproate Tablets, B.P.
18	Omit item 184, substitute the following item:
“184 Triamcinolone Acetonide, B.P., Injection	Alopecia areata
	For local intra-articular or peri-articular infiltration
Granulomata, dermal
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid
Necrobiosis lipoidica
Psoriasis”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 July 1984.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1984 No. 50 and see also Statutory Rules 1984 No. 50 and 148.

                      

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