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SR 1982 No. 76 Regulations as made
These Regulations amend the National Health (Pharmaceutical Benefits) Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR20-Apr-1982
Tabled Senate20-Apr-1982
Gazetted 31 Mar 1982
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1982  No. 761

__________

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 Statutory Rules 1982 No. 69.