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

Statutory Rules

1979 No. 250

REGULATIONS UNDER THE NATIONAL HEALTH ACT

19531

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 drug and medicinal preparation the name of which is specified in Schedule 3 to the following Regulations be prescribed as a pharmaceutical benefit in accordance with section 85 of the National Health Act 1953:

AND WHEREAS it is desirable, amongst other things, to prescribe, for the purposes of section 85 of the National Health Act 1953, each drug and medicinal preparation so recommended by the Pharmaceutical Benefits Advisory Committee:

 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 this twenty-seventh day of November 1979.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

RALPH J. HUNT

Minister of State for Health

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AMENDMENTS OF THE NATIONAL HEALTH

(PHARMACEUTICAL BENEFITS) REGULATIONS2

1Commencement

 These Regulations shall come into operation on 1 December 1979.

2Interpretation

 Regulation 5 of the National Health (Pharmaceutical Benefits) Regulations is amended by inserting after the definition of “approved pharmaceutical chemist” in sub‑regulation (1) the following definitions:

“‘participating dental practitioner’ has the same meaning as in Part VII of the Act;

“‘pharmaceutical benefit’ has the same meaning as in Part VII of the Act;”.

3Heading to Part III

 The heading to Part III of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting “UNDER SECTION 85 OF THE ACT”.

4Pharmaceutical benefits that may be prescribed only for specified persons, diseases, &c.

 Regulation 14 of the National Health (Pharmaceutical Benefits) Regulations is amended–

• (a)

  by omitting sub-regulation (1) and substituting the following sub-regulation:

• “(1)

  Each pharmaceutical benefit the name of which is specified in column 2 of an item in Schedule 5 may be prescribed by a medical practitioner or a participating dental practitioner for supply under Part VII of the Act only–

  • (a)

    where a class of persons is specified in column 3 of that item–for the treatment of a person included in that class of persons;

  • (b)

    where a disease or condition is specified in column 3 of that item–

    • (i)

      if sub-paragraph (ii) does not apply–for the treatment of that disease or condition in relation to any person; or

    • (ii)

      if the disease or condition is specified in relation to a specified class of persons–for the treatment of that disease or condition in relation to a person included in that class of persons;

  • (c)

    where a purpose is specified in column 3 of that item–for that purpose; or

  • (d)

    where a condition is specified in column 3 of that item–subject to that condition.”;

  • (b)

    by inserting in sub-regulation (2) “or a participating dental practitioner” after “medical practitioner”;

  • (c)

    by inserting in sub-regulation (3) “or participating dental practitioner” after “medical practitioner”;

  • (d)

    by inserting in sub-regulation (4) “, or a participating dental practitioner,” after “medical practitioner” (first occurring);

  • (e)

    by inserting in sub-regulation (4) “(if any)” after “determination”;

  • (f)

    by inserting in sub-regulation (4) “in relation to medical practitioners or participating dental practitioners, as the case may be” after “Act”;

  • (g)

    by inserting in sub-regulation (4) “or participating dental practitioner” after “medical practitioner” (last occurring); and

  • (h)

    by omitting sub-regulation (5).

5Heading to Part IV

 The heading to Part IV of the National Health (Pharmaceutical Benefits) Regulations is omitted and the following heading substituted:

“PART IV–SUPPLY OF PHARMACEUTICAL BENEFITS BY MEDICAL PRACTITIONERS”.

6Schedule 1

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

7Schedule 2

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

8Schedule 3

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

9Schedule 5

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

_______________

 SCHEDULE 1 Regulation 6

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

• 1.

  After item 166 insert the following item:

“166A

Demeclocycline Capsules”.

• 2.

  Omit item 232

• 3.

  After item 367 insert the following item:

“367A

Isoprenaline Sulphate”.

_______________

 SCHEDULE 2 Regulation 7

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

• 1.

  Omit item 12.

• 2.

  Omit item 44.

• 3.

  Omit item 51, substitute the following item:

“51 Chloramphenicol, B.P. Polymyxin B Sulphate with Chloramphenicol B.P.”.

• 4.

  Omit item 53.

• 5.

  Omit item 111, substitute the following items:

“110A	Glucose Indicator–Blood	–
“111	Glucose Indicator–Urine	–”.

• 6.

  Omit item 126.

• 7.

  Omit item 127, substitute the following items:

“127	Isopropyl Alcohol B.P.	Butyl Monoester Polymer with Isopropyl Alcohol B.P. Isopropyl Monoester Polymer with Isopropyl Alcohol B.P.
“127A	Isopropyl Monoester Polymer	Isopropyl Alcohol B.P. with Isopropyl Monoester Polymer”.

• 8.

  Omit item 144.

• 9.

  After item 165 insert the following item:

“165A Pectin Kaolin Light B.P. or Light Kaolin (Natural) B.P. with Pectin”.

• 10.

  omit item 208, substitute the following item:

“208 Tacrine Hydrochloride Morphine Hydrochloride with Tacrine Hydrochloride Morphine Sulphate with Tacrine Hydrochloride”.

_______________

 SCHEDULE 3 Regulation 8

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

• 1.

  Omit item 23.

• 2.

  After item 138 insert the following item:

“138A Glucose Indicator–Blood”.

• 3.

  After item 177 insert the following item:

“177A Isopropyl Monoester Polymer”.

• 4.

  Omit item 208.

• 5.

  Omit item 311, substitute the following item:

“311 Tacrine Hydrochloride”.

_______________

 SCHEDULE 4 Regulation 9

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

• 1.

  Omit the heading to the Schedule, substitute the following heading:

“PRESCRIBING OF PHARMACEUTICAL BENEFITS SUBJECT TO CONDITIONS AND RESTRICTIONS”.

• 2.

  Omit the heading to column 3, substitute the following heading:

 “Column 3

 Persons for whose treatment,

 diseases or conditions for the

 treatment of which, purposes

 for which, and conditions

 subject to which, the

 pharmaceutical benefit may be

 prescribed for supply under

 Part VII of the Act”.

• 3.

  Omit item 3.

• 4.

  Omit item 4.

• 5.

  Omit item 5.

• 6.

  Omit item 8.

• 7.

  Omit item 11, substitute the following item:

“11 Azathioprine Tablets, B.P Any disease or condition in a patient receiving treatment in or at an approved hospital With the written authority of the Permanent Head– Anaemia, autoimmune haemolytic Arthritis, rheumatoid with vasculitis or visceral complications Continuing azathioprine 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”.

• 8.

  Omit item 24, substitute the following item:

“24 Carbenicillin Sodium Any disease or condition in a patient receiving treatment in or at an approved hospital Infections where positive bacteriological evidence confirms that carbenicillin is the most appropriate therapeutic agent Septicaemia, suspected or proven”.

• 9.

  Omit item 33, substitute the following item:

“33 Chlorambucil Tablets, B.P Any disease or condition in a patient receiving treatment in or at an approved hospital With the written authority of the Permanent Head– Anaemia, 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”.

• 10.

  Omit item 44.

• 11.

  Omit item 51, substitute the following item:

“51 (1) Cyclophosphamide, B.P. (2) Cyclophosphamide Tablets, B.P. Any disease or condition in a patient receiving treatment in or at an approved hospital 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”.

• 12.

  Omit item 66, substitute the following item:

“66 (1) Disopyramide (2) Disopyramide Phosphate Cardiac arrhythmias, when other anti-arrhythmic drug therapy is unsatisfactory”.

• 13.

  Omit item 67.

• 14.

  Omit item 73.

• 15.

  Omit item 89.

• 16.

  Omit item 90, substitute the following item:

“90 (1) Idoxuridine Eye Drops (2) Idoxuridine Eye Ointment Eye infections caused by Herpes Simplex Virus or by Vaccinia Virus”.

• 17.

  After item 93 insert the following item:

"93A Isopropyl Monoester Polymer with Isopropyl Alcohol B.P. Ileostomy or colostomy conditions”.

• 18.

  Omit item 97.

• 19.

  Omit item 99.

• 20.

  Omit item 101.

• 21.

  Omit item 111, substitute the following item:

"111  (1) Methotrexate Injection (2) Methotrexate Tablets Any disease or condition in a patient receiving treatment in or at an approved hospital With the written authority of the Permanent Head– Continuing methotrexate therapy after discharge from a hospital Malignant neoplasia Pemphigus Severe intractable or extensive psoriasis ".

• 22.

  Omit item 117, substitute the following item:

“117 Metoclopramide Hydrochloride 10 mg Tablets With the written authority of the Permanent Head– Gastric retention after gastric surgery”.

• 23.

  Omit item 119.

• 24.

  Omit item 121, substitute the following item:

“121 Morphine Sulphate, B.P. with Tacrine Hydrochloride Tablets Severe intractable pain”.

• 25.

  Omit item 132.

• 26.

  Omit item 133.

• 27.

  Omit item 144.

• 28.

  Omit item 145.

• 29.

  Omit item 147.

• 30.

  Omit item 151, substitute the following item:

“151 Potassium Bicarbonate Effervescent Tablets With the written authority of the Permanent Head– Hyperchloraemic hypokalaemic acidosis”.

• 31.

  Omit item 152.

• 32.

  Omit item 158.

• 33.

  Omit item 159, substitute the following item:

“159 Propranolol Tablets, B.P. 160 mg With the written authority of the Permanent Head– Hypertension where there is an inadequate response to a daily dose of at least 160 mg of propranolol Frequent disabling agina without evidence of cardiac failure where there is an inadequate response to a daily dose of at least 160 mg of propranolol”.

• 34.

  Omit item 167.

• 35.

  Omit item 170, substitute the following item:

“170 Spironolactone Tablets, B.P. With the written authority of the Permanent Head– Primary hyperaldosteronism Secondary hyperaldosteronism”.

• 36.

  Omit item 173.

• 37.

  Omit item 181, substitute the following item:

“181 Timolol Maleate Eye Drops With the written authority of the Permanent Head– Open-angle glaucoma”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 November 1979.

2. Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1979 No. 51 and see also