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

Statutory Rules 1982 No.761

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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, namely—

• (a)

  Dantrolene Sodium;

• (b)

  Mexiletine Hydrochloride;

• (c)

  Oxycodone Pectinate; and

• (d)

  Pneumococcal Vaccine, Polyvalent:

 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 25 March 1982.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

MICHAEL MACKELLAR

Minister of State for Health

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Commencement

 1. These Regulations shall come into operation on 1 April 1982.

Schedule 2

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

Schedule 2

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

Schedule 3

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

Schedule 5

 5. Schedule 5 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

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SCHEDULE 1

Regulation 2

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

• 1.

  After item 141 insert the following items:

“141A	Capreomycin Sulphate
“141B	Capreomycin Injection”.

• 2.

  After item 174 insert the following item:

“174A Chlorcyclizine Hydrochloride”.

• 3.

  Omit item 343.

• 4.

  After item 372 insert the following item:

“372A Ferrous Fumarate Tablets”.

• 5.

  After item 452 insert the following item:

“452A Hyaluronidase”.

• 6.

  Omit item 622.

• 7.

  After item 832 insert the following item:

“832A Pyrazinamide Tablets”.

• 8.

  Omit item 884, substitute the following item:

“884 Sodium Aminosalicylate”.

• 9.

  After item 939 insert the following item:

“939A Succinylsulphathiazole”.

• 10.

  After item 941A insert the following item:

“941B Sulphadiazine Injection”.

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SCHEDULE 2

Regulation 3

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

• 1.

  Omit item 45.

• 2.

  Omit item 46, substitute the following item:

“46 Butyl Monoester Polymer Ethanol, B.P., with Butyl Monoester Polymer Isopropyl Alcohol, B.P., with Butyl Monoester Polymer”.

• 3.

  After item 106 insert the following item:

“106A Ethanol, B.P. Butyl Monoester Polymer with Ethanol, B.P.”.

• 4.

  After item 218 insert the following item:

“218A Sodium Valproate —”.

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SCHEDULE 3

Regulation 4

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

• 1.

  Omit item 46.

• 2.

  Omit item 64.

• 3.

  After item 77 insert the following item:

“77A Dantrolene Sodium”.

• 4.

  Omit item 178A, substitute the following items:

“178A	Mexiletine Hydrochloride
“178B	Mianserin Hydrochloride”.

• 5.

  After item 189 insert the following item:

“189A Oxycodone Pectinate”.

• 6.

  After item 215 insert the following item:

“215A Pneumococcal Vaccine, Polyvalent”.

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SCHEDULE 4

Regulation 5

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

• 1.

  Omit item 8, substitute the following item:

“8 Azathioprine Tablets, B.P. With the written authority of the Permanent Head— Anaemia, autoimmune haemolytic Arthritis, rheumatoid with vasculitis or visceral complications Continuing azathoprine therapy after discharge from a hospital Crohn’s disease Dermatomyositis Granulomatosis, Wegener’s Hepatitis, active, chronic Lupus erythematosus, systemic Nephritis Nephrotic syndrome Organ transplant Pemphigus Polyarteritis nodosa Pyoderma gangrenosum Scleroderma Thrombocytopenic purpura Ulcerative colitis”.

• 2.

  Omit item 9, substitute the following item:

“9 Baclofen Spasticity due to multiple sclerosis or spinal cord lesions”.

• 3.

  After item 15B insert the following item:

“15C Butyl Monoester Polymer with Ethanol, B.P. Ileostomy or colostomy conditions”.

• 4.

  Omit item 21, substitute the following item:

“21 Carbenicillin Sodium, B.P. Infections where positive bacteriological evidence confirms that carbenicillin is the most appropriate therapeutic agent Septicaemia, suspected or proven”.

• 5.

  Omit item 23, substitute the following item:

“23 (1) Cephalexin Capsules B.P. (2) Cephalexin, B.P., with Purified Water, B.P. With the written authority of the Permanent Head— Infections where both clinical and bacteriological evidence suggest that’s cephradine is the most appropriate therapeutic agent”.

• 6.

  Omit item 27, substitute the following item:

“27 (1) Cephradine Capsules, B.P. (2) Cephradine with Purified Water, B.P. With the written authority of the Permanent Head— Infections where both clinical and bacteriological evidence suggest that cephalexin is the most appropriate therapeutic agent”.

• 7.

  Omit item 30, substitute the following item:

“30 Chlorambucil Tablets, B.P. With the written authority of the Permanent Head— Anemia, autoimmune, haemolytic Arthritis, rheumatoid with vasculitis or visceral complications Continuing chlorambucil therapy after discharge from a hospital Crohn’s disease Dermatomyositis Granulomatosis, Wegener’s Hepatitis, active, chronic Lupus erythematosus, systemic Malignant disease including leukaemia Nephritis Nephrotic syndrome Polyarteritis nodosa Scleroderma Thrombocytopenic purpura Ulcerative colitis”.

• 8.

  Omit item 41, substitute the following item:

“41 (1) Cloxacillin Capsules B.P. (2) Cloxacillin Sodium, B.P., with Purified Water, B.P. With the written authority of the Permanent Head— Infections due to the presence of penicillin-resistant staphylococci Osteomyelitis”.

• 9.

  Omit item 43, substitute the following item:

“43 Codeine Phosphate, B.P. with Aspirin, B.P. Tablets 30 mg-325 mg Malignant neoplasia”.

• 10.

  Omit item 47, substitute the following item:

“47 (1) Cyclophosphamide, B.P (2) Cyclophosphamide Tablets, B.P. With the written authority of the Permanent Head‑ Anaemia, autoimmune, haemolytic Arthritis, rheumatoid with vasculitis or visceral complications Continuing cyclophosphamide therapy after discharge from a hospital Crohn’s disease Dermatomyositis Granulomatosis, Wegener’s Hepatitis, active chronic Lupus erythematosus, systemic Malignant disease including leukaemia Nephritis Nephrotic syndrome Pemphigus Polyarteritis nodosa Scleroderma Thrombocytopenic purpura Ulcerative colitis”.

• 11.

  After item 48 insert the following item:

“48A Dantrolene Sodium With the written authority of the Permanent Head— Treatment of chronic spasticity”.

• 12.

  Omit item 51, substitute the following item:

“51 Dexamethasone Sodium Phosphate, B.P., Injection equivalent of Dexamethasone Phosphate 120 mg in 5mL For use in a hospital”.

• 13.

  Omit item 71, insert the following item:

“72 Fusidic Acid With the written authority of the Permanent Head— For use in combination with another antibiotic in the treatment of serious staphylococcal infections confirmed by bacteriological evidence”.

• 14.

  Omit item 75.

• 15.

  Omit item 84 (4), substitute the following item:

“84 (4) Insulin Isophane Injection Specially Purified”.

• 16.

  Omit item 87.

• 17.

  Omit item 94, substitute the following item:

“94 Medroxyprogesterone Acetate, B.P. Injection, 50mg mg in 1mL Malignant neoplasia”.

• 18.

  Omit item 95, substitute the following item:

“95 Medroxyprogesterone Acetate, B.P., Injection, 150 mg in 1 mL Malignant neoplasia Precocious puberty”.

• 19.

  Omit item 100, substitute the following item:

“100 (1) Methadone Injection, B.P. (2) Methadone Tablets, B.P. Disabling pain associated with proven malignant. neoplasia Disabling pain of short duration not responding to non-narcotic analgesics, the maximum duration of treatment being two weeks”.

• 20.

  Omit item 103, insert the following item:

“103 (1) Methotrexate Injections (2) Methotrexate Tablets With the written authority of the Permanent Head— Continuing methotrexate therapy after discharge from a hospital Malignant neoplasia Pemphigus Severe intractable or extensive psoriasis”.

• 21.

  Omit item 110A, substitute the following items:

“110A	Metronidazole, B.P.	With the written authority of the Permanent Head— Treatment in a hospital of acute anaerobic sepsis
“110B	Mexiletine Hydrochloride	Treatment (not prophylaxis) of ventricular arrhythmias
“110C	Mianserin Hydrochloride	With the written authority of the Permanent Head— Depressive illness in persons with cardiovascular disease”.

• 22.

  Omit item 115, substitute the following item:

“115 Neomycin Tablets, B.P. Acute leukaemia during induction of remission with chemotherapy Bowel sterilisation preparatory to major surgery Encephalopathy, hepatic”.

• 23.

  After item 122, insert the following item:

“122A Oxycodone Pectinate Malignant neoplasia”.

• 24.

  Omit item 126, substitute the following item:

“126 Pentazocine Lactate Injection, B.P. Disabling pain associated with proven malignant neoplasia Disabling pain of short duration not responding to non-narcotic analgesics, the maximum duration of treatment being two weeks”.

• 25.

  After item 135, insert the following item:

“135A Pneumococcal Vaccine, Polyvalent Splenectomised persons who have attained the age of two (2) years Persons with Hodgkin’s disease Persons at high risk of pneumococcal infections”.

• 26.

  Omit item 143, substitute the following item:

“143 ‘PREGESTIMIL’ With the written authority of the Permanent Head— Cystic fibrosis Enterokinase deficiency Patients who are intolerant of both milk protein and soya protein Severe diarrhoea of greater than two weeks duration in infants who have not attained the age of four (4) months”.

• 27.

  Omit item 155, insert the following item:

“155 Sodium Fusidate, B.P. With the written authority of the Permanent Head— For use in combination with another antibiotic in the treatment of serious staphylococcal infections confirmed by bacteriological evidence”.

• 28.

  Omit item 160, substitute the following item:

“160 Sulindac Chronic osteoarthritis Chronic rheumatoid arthritis”.

• 29.

  Omit item 180, substitute the following item:

“180 Verapamil Hydrochloride Tablets Angina Cardiac arrhythmias Hypertension”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 March 1982.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1982 No. 69 and see also