National Health Act 1953 Declaration under subsections 85(2), 85(2AA) and 85(2A), Determination under subsection 85(2A) (No. PB 6 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 6 of 2008
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) of the National Health Act 1953
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated 14 December 2007
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 January 2008, immediately after the commencement of PB 1 of 2008.
2 Amendment of PB 88 of 2007
Schedule 1 amends PB 88 of 2007.
Schedule 1 Amendments
[1] After paragraph 4A
insert:
4B. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 2A and the circumstances (if any) specified in column 2 of Schedule 2A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised optometrist.
[2] Paragraph 12
omit:
“Schedule 1A, 2 or 4”
and substitute:
“Schedule 1A, 2, 2A or 4”
[3] Paragraph 14
omit:
“Subject to paragraph 16, the following circumstances are determinedin relation to each relevant pharmaceutical benefit for the purposes of section 88A of the Act:”
and substitute:
“Subject to paragraph 16, the following circumstances are determined in relation to each relevant pharmaceutical benefit for the purposes of section 85(2A)(b) of the Act:”
[4] Subparagraphs 14(a), 14(b) and 14(c)
omit:
“Schedule 1A, 2 or 4”
and substitute:
“Schedule 1A, 2, 2A or 4”
[5] Subparagraph 14(d)
(a) omit:
“column 3 of Schedule 1 or column 2 of Schedule 1A”
and substitute:
“column 3 of Schedule 1 or column 2 of Schedule 1A (in respect of medical practitioners), or in column 2 of Schedule 2A (in respect of authorised optometrists),”
(b) omit:
“medical practitioner”
and substitute:
“medical practitioner or authorised optometrist”
[6] Subparagraphs 14(d)(i), 14(d)(i)(A), 14(d)(ii) and 14(d)(iii), paragraph 14A, and subparagraphs 15(a)(i) and 15(a)(ii)(A)
omit wherever occuring:
“medical practitioner”
and substitute:
“medical practitioner or authorised optometrist”
[7] Subparagraph 15A(a)
omit entire paragraph and substitute:
“the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; or in the case of an authorised optometrist, must tell the optometrist orally the number that has been allotted to the authorised prescription; and”
[8] Subparagraph 15A(b) and paragraph 15B
omit wherever occuring:
“medical practitioner”
and substitute:
“medical practitioner or authorised optometrist”
[9] Schedule 1
omit from Column 3 heading:
“88A”
and substitute:
“85(2A)(b)”
[10] Schedule 1, item dealing with Glucose indicator—Blood
omit from Column 3 both:
discs containing electrode sensors, 10 sensors per disc, 5,
and:
electrode strips, 50 (Ascencia Elite) and
[11] Schedule 1, item dealing with Influenza Vaccine
omit from the columns indicated:
| Persons at special risk of adverse consequences from infections of the lower respiratory tract |
and substitute:
| In respect of the injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe: Children up to 35 months of age at increased risk of adverse consequences from infections of the lower respiratory tract In respect of the injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe: Persons at special risk of adverse consequences from infections of the lower respiratory tract |
[12] Schedule 1, item dealing with Lansoprazole
omit from the columns indicated:
| In respect of the sachet containing granules for oral suspension, 30 mg per sachet: Initial treatment of peptic ulcer Gastro-oesophageal reflux disease Scleroderma oesophagus In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor Gastro-oesophageal reflux disease Scleroderma oesophagus |
and substitute:
| In respect of the sachet containing granules for oral suspension, 30 mg per sachet: Initial treatment of peptic ulcer Gastro-oesophageal reflux disease Scleroderma oesophagus In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor |
[13] Schedule 1, item dealing with Oestradiol
(a) omit from Column 3:
transdermal patches 3.28 mg, 8,
and:
transdermal patches 4.33 mg, 8,
and:
transdermal patches 6.57 mg, 8,
(b) omit from Column 3:
, transdermal patches 1.56 mg, 8 and transdermal patches 8.66 mg, 8:
and substitute:
and transdermal patches 1.56 mg, 8:
[14] Schedule 1, omit item dealing with Thioridazine
[15] Schedule 1, item dealing with Varenicline
insert in Column 3 immediately before the existing circumstances:
| In respect of the box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack: |
and
insert in Column 3 immediately before the paragraph commencing with ‘Completion of short term …’:
| In respect of the tablet 1 mg (as tartrate): In compliance with authority procedures set out in subparagraph 14 (d): |
[16] Schedule 1A
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”
[17] Schedule 2
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”
[18] After Schedule 2
insert:
SCHEDULE 2A - READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY AN AUTHORISED OPTOMETRIST
| Column 1 Listed Drug | Column 2 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act |
| Aciclovir | Herpes simplex keratitis |
| Carbomer 974 | In compliance with authority procedures set out in subparagraph 14 (d): |
| Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
| Carbomer 980 | In respect of the ocular lubricating gel 2 mg per g, 10 g: Severe dry eye syndrome, including Sjogren's syndrome |
| In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30: In compliance with authority procedures set out in subparagraph 14 (d): | |
| Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
| Carmellose | In respect of the eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL: Severe dry eye syndrome, including Sjogren's syndrome |
| In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30, eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d): | |
| Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
| Chloramphenicol | — |
| Cromoglycic Acid | Vernal kerato-conjunctivitis |
| Fluorometholone | — |
| Flurbiprofen | — |
| Hydrocortisone | — |
| Hypromellose | Severe dry eye syndrome, including Sjogren's syndrome |
| Hypromellose with Carbomer 980 | Severe dry eye syndrome, including Sjogren's syndrome |
| Hypromellose with Dextran | In respect of the eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL: Severe dry eye syndrome, including Sjogren's syndrome |
| In respect of the eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d): | |
| Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
| Paraffin | — |
| Polyethylene Glycol 400 with Propylene Glycol | Severe dry eye syndrome, including Sjogren's syndrome |
| Polyvinyl Alcohol | Severe dry eye syndrome, including Sjogren's syndrome |
| Sulfacetamide | — |
[19] Schedule 4
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”
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