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

Statutory Rules

1974 No. 222

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1974.*

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953-1974 that a drug or medicinal preparation that was not a pharmaceutical benefit under the National Health Act 1953-1958 immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of the National Health Act 1953-1974 unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

AND WHEREAS that Committee has recommended to the Minister that the following drugs and medicinal preparations be prescribed as pharmaceutical benefits under section 85 of the National Health Act 1953-1974, namely the drugs and medicinal preparations specified in the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations, as amended by the following Regulations, that had not previously been prescribed as pharmaceutical benefits:

NOW THEREFORE I, THE GOVERNOR-GENERAL of Australia, acting with the advice of the Executive Council, hereby make the following Regulations under the National Health Act 1953-1974.

Dated this twenty-sixth day of November, 1974.

JOHN R. KERR

Governor-General.

By His Excellency’s Command,

M. H. CASS

Minister of State for the Environment and Conservation

 for and on behalf of the Minister of State for Health.

Amendments of the National Health (Pharmaceutical Benefits) Regulations  

Commencement.

1. These Regulations shall come into operation on 1 December 1974.

First Schedule.

2. The First Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 1.

Second Schedule.

3. The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 2.

Third Schedule.

4. The Third Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 3.

* Notified in the Australian Government Gazette on 27 November 1974.

  Statutory Rules 1960, No. 17, as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; 1962, Nos. 34, 101 and 114; 1963, Nos. 34, 69 and 107; 1964, Nos. 12, 57 and 133; 1965, Nos. 51, 151 and 152; 1966, Nos. 80 and 144; 1967, Nos. 67, 116 and 158; 1968, Nos. 44, 76, 88 and 146; 1969, Nos. 44, 107 and 185; 1970, Nos. 39, 94, 119 and 186; 1971, Nos. 44, 101, 136 and 154; 1972, Nos. 32, 121 and 205; 1973, Nos. 15, 57, 139 and 229; and 1974, Nos. 37 and 126.

Fourth Schedule.

5. The Fourth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by inserting, after item 23, the following item:—

“ 23a Linseed Oil ”.

Fifth Schedule.

6. The Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

SCHEDULE 1  Regulation 2

Amendments of the First Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 32.

2. Omit item 39.

3. After item 201 insert the following item:—

“ 201a Fluorescein Sodium ”.

4. After item 266 insert the following item:—

“ 266a Laevulose Injection ”.

5. After item 310 insert the following item:—

“ 310a Methaqualone ”.

6. After item 328 insert the following item:—

“ 328a Metyrapone Capsules ”.

7. After item 392 insert the following item:—

“ 392a Phenoxymethylpenicillin Calcium ”.

8. After item 444 insert the following item:—

“ 444a Quinine Hydrochloride ”.

9. Omit item 447.

10. After item 504 insert the following item:—

“ 504a Tetanus Antitoxin ”.

11. Omit item 538.

12. After item 540 insert the following items:—

“ 540a Viomycin Sulphate

“ 540b Viomycin Sulphate Injection ”.

SCHEDULE 2 Regulation 3

Amendments of the Second Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. After item 11 insert the following item:—
“ 11A	Amoxycillin Trihydrate ...............	Purified Water, B.P., with Amoxycillin Trihydrate ”.
2. Omit item 12, substitute the following item:—
“ 12	Amphotericin ..............................		Tetracycline, B.P.C., with a buffering agent and Amphotericin ”.
3. After item 22 insert the following items:—
“ 22a	Benethamine Penicillin, B.P.C		Procaine Penicillin with Benethamine Penicillin and Benzylpenicillin Sodium
“ 22b	Benzathine Penicillin ..................		Procaine Penicillin with Benzylpenicillin Potassium and Benzathine Penicillin
“ 22c	Benzylpenicillin Sodium ..............		Procaine Penicillin with Benethamine Penicillin, B.P.C., and Benzylpenicillin Sodium
Procaine Penicillin with Benzylpenicillin Sodium
“ 22d	Benzylpenicillin Potassium ..........		Benzathine Penicillin with Procaine Penicillin and Benzylpenicillin Potassium ”.
4. Omit item 80, substitute the following item:—
“ 80	Ethinyloestradiol .........................		Dimethisterone with Ethinyloestradiol
Ethynodiol Diacetate with Ethinyloestradiol
Lynoestrenol with Ethinyloestradiol
Megestrol Acetate with Ethinyloestradiol
Norethisterone Acetate with Ethinyloestradiol
Norgestrel with Ethinyloestradiol ”.

Schedule 2—continued

5. Omit item 119, substitute the following item:—
“ 119	Lynoestrenol ...............................	Ethinyloestradiol with Lynoestrenol
Mestranol with Lynoestrenol
6. Omit item 122, substitute the following item:—
“ 122	Magnesium Chloride ...................	Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride ”.
7. After item 134 insert the following item:—
“ 134a	Naphazoline Hydrochloride	— ”.

8. Omit items 159, 160, 161, 162, 163, 164 and 165.

9. After item 172, insert the following item:—
“ 172a	Phenoxymethylpenicillin (Benzathine or Hydrabamine salt)	— ”.
10. After item 187, insert the following item:—
“ 187a	Procaine Penicillin ......................	Benethamine Penicillin, B.P.C., with Benzylpenicillin Sodium and Procaine Penicillin
Benzathine Penicillin with Benzylpenicillin Potassium and Procaine Penicillin
Benzylpenicillin Sodium with Procaine Penicillin ”.
11. After item 194, insert the following item:—
“ 194a	Salbutamol Sulphate ...................	— ”.
12. After item 198, insert the following item:—
“ 198a	Sodium Carboxymethylcellulose	Gelatin and Pectin with Sodium Carboxymethylcellulose ”.
13. Omit item 200, insert the following item:—
“ 200	Sodium Lactate ...........................	Potassium Chloride with Anhydrous Dextrose and Sodium Lactate ”.
14. After item 235, insert the following item:—
“ 235a	Urea ...........................................	— ”.

SCHEDULE 3  Regulation 4

Amendments of the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. After item 32 insert the following item:—

“ 32a Amoxycillin Trihydrate ”.

2. Omit item 33.

3. After item 35 insert the following items:—

“ 35a Anthrax Antiserum

“ 35b Anthrax Vaccine ”.

4. After item 40 insert the following item:—

“ 40a Benethamine Penicillin, B.P.C.”.

5. After item 116 insert the following item:—

“ 116a Epicillin Sodium ”.

6. After item 120 insert the following item:—

“ 120a Ethanolamine Oleate ”.

7. After item 158 insert the following item:—

“ 158a Hydrallazine Hydrochloride ”.

8. Omit item 171.

9. Omit item 183.

10. After item 209 insert the following item:—

“ 209a Mefruside ”.

11. Omit item 213.

12. After item 227 insert the following item:—

“ 227a Naphazoline Hydrochloride ”.

Schedule 3—continued

13. Omit item 255.

14. After item 300 insert the following items:—

“ 300a Rabies vaccine (Duck type)

“ 300b Rabies vaccine (Serum type) ”.

15. After item 315 insert the following item:—

“ 315a Sodium Carboxymethylcellulose ”.

16. Omit item 360.

SCHEDULE 4  Regulation 6

Amendments of the Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item l, substitute the following item:—
“ 1		Acetylcysteine ............................				Bronchiectasis Cystic fibrosis (mucoviscidosis) ”.
2. Omit item 4, substitute the following item:—
“ 4	ALBUMAID XP .........................					Phenylketonuria ”.
3. Omit items 8, 9 and 10, substitute the following items:—
“ 8				(1) Aminocaproic Acid, B.P. (2) Aminocaproic Acid Injection, B.P.		Treatment in hospital of patients suffering from severe hemorrhage associated with excessive fibrinolysis
“ 9				AMINOGRAN ...........................		Phenylketonuria
“ 9a				(1) Amoxycillin Trihydrate (2) Amoxycillin Trihydrate with Purified Water, B.P.		Infections by susceptible organisms where they cannot be safely and effectively treated with sulphonamides, oral forms of Benzylpenicillin, Phenoxymethylpenicillin or Phenethicillin
Urinary tract infections where sulphonamide treatment has proved ineffective and where positive bacteriological evidence shows the organisms to be sensitive to Amoxycillin or where the patient is sensitive to sulphonamides ”.
4. Omit item 13, substitute the following item:—
“ 13			Azathioprine ...............................		Any disease or condition in a patient receiving treatment in or at an approved hospital
With the written authority of the Director-General—Anaemia, autoimmune haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing azathioprine therapy after discharge from an approved hospital
Crohn’s disease
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Nephritis
Nephrotic syndrome
Organ transplant
Pemphigus vulgaris
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis ”.
5. After item 14 insert the following item:—
“ 14a		Beclomethasone Dipropionate metered aerosol spray				Chronic intractable asthma requiring maintenance corticosteroids ”.

6. Omit items 16 and 17.

Schedule 4—continued

7. Omit items 19, 20, 21 and 22, substitute the following items:—
“ 19	Betamethasone Acetate with Betamethasone Injection	Alopecia areata
Granulomata, dermal
Intra-articular use
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid
Uveitis
“ 20	Bisacodyl Suppositories, B.P.	Any disease or condition in a pensioner
“ 22	(1) Calciferol, B.P. (2) Calciferol Tablets, Strong, B.P.	With the written authority of the Director-General—Hypoparathyroidism
Osteomalacia following gastrectomy, severe steatorrhoea or renal failure
Vitamin D-resistant rickets ”.

8. Omit item 25.

9. Omit item 27.

10. Omit items 31 and 32, substitute the following items:—
“ 31	Cephaloridine ............................	Infections where positive bacteriological evidence confirms that Cephaloridine is the most appropriate therapeutic agent
“ 32	Cephalothin Sodium ...................	Infections where positive bacteriological evidence confirms that Cephalothin Sodium is the most appropriate therapeutic agent ”.

11. Omit item 39.

12. Omit items 44 and 45, substitute the following items:—
“ 44	(1) Codeine Phosphate with Aspirin Soluble Tablets	Any disease or condition in a pensioner
(2) Codeine Phosphate with Aspirin Tablets
(3) Codeine Phosphate with Aspirin and Paracetamol Soluble Tablets
(4) Codeine Phosphate with Aspirin and Paracetamol Tablets (12mg–250mg–150 mg tablets, 10mg–250mg–250 mg tablets and 8 mg–250 mg–250 mg tablets)
“ 45	Codeine Phosphate with Aspirin and Paracetamol Tablets 30 mg–225 mg–150 mg	Any disease or condition in a pensioner Malignant neoplasia ”.
13. Omit items 48, 48a, 49, 50 and 51, substitute the following item:—
“ 48	(1) Cyclophosphamide Tablets, B.P.		Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Cyclophosphamide, B.P.		With the written authority of the Director-General—Anaemia, autoimmune, haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing Cyclophosphamide therapy after discharge from an approved hospital
Crohn’s disease
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Malignant disease, including leukaemia
Nephritis
Nephrotic syndrome
Pemphigus vulgaris
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis ”.

14. Omit item 53.

Schedule 4—continued

15. Omit items 56 and 57, substitute the following item:—
“ 56			Dextrose Polymer .....................			Phenylketonuria
Tube feeding of infants with swallowing defects ”.
16. Omit item 60, substitute the following item:—
“ 60		Dihydrotachysterol ....................		With the written authority of the Director-General—Hypoparathyroidism
Osteomalacia following gastrectomy, severe steatorrhoea or renal failure
Vitamin D-resistant rickets ”.
17. Omit items 65, 66 and 67, substitute the following items:—
“ 66	Droperidol ................................				Any disease or condition in a patient receiving treatment in a hospital
“ 67	(1) Epicillin Capsules (2) Epicillin Sodium (3) Epicillin with Purified Water, B.P.				Infections by organisms sensitive to Epicillin where the infection cannot be safely and effectively treated with sulphonamides or with any of the following administered orally—
Benzylpenicillin
Phenoxymethylpenicillin
Phenethicillin
Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Epicillin
Urinary tract infections where the patient is sensitive to sulphonamides ”.
18. Omit items 70, 71, 72 and 73, substitute the following item:—
“ 73	Fluoxymesterone Tablets, B.P.				Carcinoma of the breast
Hypogonadism
With the written authority of the Director-General—Intermittent use for corticosteroid-induced osteoporosis
Proven aplastic anaemias ”.
19. Omit items 76, 77, 78 and 79, substitute the following items:—
“ 77	Framycetin Sulphate Tablets				Acute leukaemia during induction of remission with chemotherapy
Bowel sterilisation preparatory to major surgery
“ 78	Frusemide Tablets, B.P., 20 mg and 40 mg				Fluid retention associated with heart failure, cirrhosis of the liver or nephrotic syndrome
Fluid retention associated with other conditions and not responding to thiazides
“ 79	Frusemide Tablets, B.P., 500 mg				Renal failure ”.

20. Omit item 84.

21. Omit item 90, substitute the following item:—
“ 90	Heparin Calcium .......................	Any disease or condition in a patient receiving treatment in a hospital ”.
22. Omit items 92 and 93, substitute the following item:—
“ 93	Hydrocortisone Sodium Succinate Injection, 500 mg	Any disease or condition in a patient receiving treatment in a hospital ”.

23. Omit items 95, 99, 100, 101, 102 and 104.

24. Omit items 111 and 112, substitute the following item:—
“ 112	Lithium Carbonate Tablets B.P.	Manic depression ”.
25. Omit items 114, 115 and 116, substitute the following items:—
“ 114	Lofenalac .................................	Phenylketonuria
“ 115	Maphenide Acetate ...................	Treatment, in a hospital, of burns ”.

 

Schedule 4—continued

 

26. Omit item 119, substitute the following items:—
“ 119	(1) Medroxyprogesterone Acetate Injections, 50 mg in 1 ml	Malignant neoplasia
Precocious puberty
(2) Medroxyprogesterone Acetate Injections, 150 mg in 1 ml
“ 119a	Medroxyprogesterone Acetate Tablets, 100 mg	Malignant neoplasia
“ 119b	Mefruside .................................	Fluid retention associated with heart failure, cirrhosis of the liver or nephrotic syndrome
Fluid retention associated with other conditions and not responding to thiazides ”.

27. Omit items 121, 122 and 123.

28. Omit items 126, 127 and 128, substitute the following items:—
“ 126	(1) Methotrexate Tablets (2) Methotrexate Injection	Any disease or condition in a patient receiving treatment in or at an approved hospital
With the written authority of the Director-General—Continuing Methotrexate therapy after discharge from an approved hospital
Malignant neoplasia
Pemphigus vulgaris
Severe intractable or extensive psoriasis
“ 127	Methylprednisolone Acetate Retention Enema	Ulcerative colitis
Proctitis
“ 128	Methylprednisolone Acetate Injection	Intra-articular use
Intrathecal use ”.
29. Omit items 130, 131 and 132, substitute the following items:—
“ 130	(1) Methyltestosterone Tablets,	Carcinoma of the breast
B.P., 25 mg or 50 mg	Hypogonadism
(2) Methyltestosterone B.P.	Klinefelter’s syndrome (seminiferous tubule dysgenesis)
“ 131	Methysergide Maleate ...............	Carcinoid syndrome
Prevention of disabling migraine when other treatment has failed ”.

30. Omit item 134.

31. Omit item 140, substitute the following item:—
“ 140	Neomycin Tablets, B.P..............	Acute leukaemia during induction of remission with chemotherapy
Bowel sterilisation preparatory to major surgery
Encephalopathy, hepatic
Enteropathogenic E. coli infections in infants ”.

32. Omit items 143, 152, 153, 160, 161 and 162.

33. Omit items 163, 164 and 165, substitute the following items:—
“ 163	Pizotifen Malate ........................		Prevention of migraine
“ 164	(1) “ PK AID I ” (2) “ PK AID II ”		Phenylketonuria
“ 165	Plasma Substitute (Polypeptide)		Any disease or condition in a patient receiving treatment in a hospital
34. Omit items 170 and 171, substitute the following items:—
“ 170	(1) Practolol Injection, B.P.	Dissecting aneurysm (aortic)
(2) Practolol Tablets, B.P.	The treatment of angina in a patient who is frequently disabled by attacks of angina, in whom no evidence of cardiac failure is found
Idiopathic hypertrophic subaortic stenosis
Right ventricular outflow tract obstruction
Serious arrhythmias
Thyrotoxicosis
“ 171	Prednisolone Sodium Phosphate Retention Enema and Suppository	Ulcerative colitis
Proctitis ”.

35. Omit items 179, 183 and 185.

Schedule 4—continued

36. After item 189 insert the following item:—
“ 189a		Sodium Carboxymethylcellulose with Pectin and Gelatin	Ileostomy or colostomy conditions ”.
37. Omit items 196 and 197, substitute the following item:—
“ 196	Streptokinase ............................		Any disease or condition in a patient receiving treatment in a hospital ”.
38. Omit items 199 to 209 (inclusive), substitute the following items:—
“ 199	(1) Testosterone Propionate, B.P., with Testosterone Phenylpropionate, B.P. and Testosterone Isocaproate		Carcinoma of the breast
Hypogonadism
Klinefelter’s syndrome (seminiferous tubule dysgenesis)
(2) Testosterone Propionate, B.P., with Testosterone Phenylpropionate, B.P., Testosterone lsocaproate and Testosterone Decanoate
(3) Testosterone Implants, B.P.
(4) Testosterone Enanthate
(5) Testosterone Propionate Injection, B.P.
“ 200	Tetracosactrin Acetate, B.P.		With the written authority of the Director-General—Children who need long term corticosteroid therapy but who are in danger of growth suppression as a result
Hypsarrhythmia
Multiple sclerosis, acute exacerbation
Status asthmaticus
Treatment of patients who are being withdrawn from long term corticosteroid therapy

“ 201	Tetracosactrin Zinc Injection, B.P.		With the written authority of the Director-General—Children who need long term corticosteroid therapy but who are in danger of growth suppression as a result
Hypsarrhythmia
Multiple sclerosis, acute exacerbation
Status asthmaticus
Treatment of patients who are being withdrawn from long term corticosteroid therapy ”.
39. Omit item 212, substitute the following item:—
“ 212	Thiopropazate Hydrochloride		Chorea
Oral dyskinesia
Phenothiazine-induced choreo-athetosis ”.

40. Omit item 214.

41. Omit item 220, substitute the following item:—
“ 220	Vancomycin Hydrochloride........	Any disease or condition in a patient receiving treatment in a hospital ”.

42. Omit item 222.