EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
NO. PB 4 OF 2005
The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
“Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
Subsection 85(2) of the Act empowers the Minister to declare the drugs and medicinal preparations to which Part VII of the Act applies, and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits.
Subsection 85(2A) provides that the Minister may, in a declaration under subsection 85(2), declare that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A, and specify the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.
Subsection 85(3) provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a drug or medicinal preparation referred to in subsection 85(2). Drugs or medicinal preparations in any other form are not pharmaceutical benefits.
Subsection 85(4) provides that a form of a drug or medicinal preparation as determined by the Minister under subsection 85(3) may be such as to require the addition of a substance or substances to the drug or medicinal preparation so that it will be suitable for administration in a particular manner or at a particular strength.
Subsection 85(6) provides that the Minister may determine, in respect of a drug or medicinal preparation to which Part VII of the Act applies, a brand or brands under which the drug or medicinal preparation may be supplied under that Part VII of the Act, and where such a determination is in force in relation to a drug or medicinal preparation, Part VII of the Act does not apply in relation to the drug or medicinal preparation as marketed under any other brand.
Subsection 85A(1) of the Act provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a pharmaceutical benefit that is or are allowable for the purposes of this Part for prescription by persons included in a class of persons specified in the determination.
Subsection 85A(2) of the Act provides that the Minister may, with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit:
a) determine the maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion, either for all purposes or for particular purposes;
b) determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes; and
c) determine the manner of administration that may, in a prescription, be directed to be used in relation to the pharmaceutical benefit.
Section 88A of the Act provides that, where a pharmaceutical benefit is declared in a declaration made under subsection 85(2) of the Act to be a relevant pharmaceutical benefit for the purposes of that section, the writing of a prescription for the supply of the benefit is authorised under Part VII of the Act only in the circumstances specified in the declaration pursuant to subsection 85(2A) of the Act.
The determinations made under sections 85, 85A and 88 of the Act on 17 November 2004 with effect from 1 December 2004, as amended on 14 December 2004 and 20 December 2004 with effect from 1 January 2005 and 1 February 2005 respectively, are repealed and substituted with these determinations.
These determinations are remade to give effect, as from 1 April 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Advisory Committee. Subparagraph (a) of the definition of “base-priced drug” in paragraph 3 of the determinations has been amended to take account of the removal of the therapeutic group premiums for nizatidine capsule 150 mg and nizatidine capsule 300 mg. Changes to the First, Second and Third Schedules of the determinations are detailed in the attached summary of changes.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
The determinations gives effect to recommendations made by the PBAC. Prior to the making of these determinations significant consultations have been undertaken by the PBAC by means of its consideration of submissions made by applicants for drugs to be listed on the PBS. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
Details of the determinations are set out in the Attachment.
The determinations are a legislative instruments for the purposes of the Legislative Instruments Act 2003.
These determinations were made on 22 March 2005 and commenced on 1 April 2005.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
AE AFT Pharmaceuticals Pty Limited
BF Bellwether Pharma Limited
IT InterPharma Pty Ltd
PX Point of Care Diagnostics Australia Pty Ltd
Deletions
BA Boots Pharmaceuticals A Division of Boots Healthcare Australia Pty Ltd
BT Boots Healthcare Australia Pty Ltd
HS healthsense
FIRST SCHEDULE – PART 1
Items Added
Aprepitant Pack containing 1 capsule 125 mg and 2 capsules 80 mg
Dapsone Tablet 25 mg
Tablet 100 mg
Ferrous Sulfate Oral liquid 30 mg per mL, 250 mL
Fotemustine Powder for injection 208 mg with solvent
Iron Sucrose Concentrate for solution for infusion 2.7 g (equivalent
to 100 mg iron (III)) in 5 mL ampoule
Levodopa with Carbidopa Tablet 50 mg-12.5 mg-200 mg
and Entacapone Tablet 100 mg-25 mg-200 mg
Tablet 150 mg-37.5 mg-200 mg
“Lophlex” Sachets containing oral powder 27.8 g, 30
Metformin Hydrochloride Tablet 500 mg-2.5 mg
with Glibenclamide Tablet 500 mg-5 mg
Modafinil Tablet 100 mg
Pemetrexed Disodium Powder for I.V. infusion equivalent to 500 mg pemetrexed,
Heptahydrate vial
Pimecrolimus Cream 10 mg per g, 15 g
Forms Added
Budesonide with Eformoterol Powder for oral inhalation in breath actuated device
Fumarate Dihydrate 100 micrograms–6 micrograms per dose, 120 doses
Calcium Folinate Injection equivalent to 100 mg folinic acid in 10 mL
Cladribine Injection 10 mg in 5 mL vial
Glucose Indicator—Blood Reagent strips, 51 (Accu-Chek Integra)
Reagent strips, 50 (SensoCard)
Interferon Beta-1a Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single
dose pre-filled syringe
Paracetamol Tablet 665 mg (modified release)
Risperidone Tablet 0.5 mg
Tablet 0.5 mg (orally disintegrating)
Tablet 1 mg (orally disintegrating)
Tablet 2 mg (orally disintegrating)
Oral solution 1 mg per mL, 30 mL
Tetanus Vaccine – Adsorbed Injection 0.5 mL in pre-filled syringe
Timolol Maleate Eye gel equivalent to 1 mg timolol per g, 5 g
Brands Added
Bisacodyl Suppositories 10 mg, 10 (PP)
Carbomer 980 Ocular lubricating gel 2 mg per g, 10 g (CV)
Cyproterone Acetate Tablet 50 mg (HX)
Tablet 100 mg (HX)
Enalapril Maleate Tablet 5 mg (BF)
Tablet 10 mg (BF)
Tablet 20 mg (BF)
Fluoxetine Hydrochloride Capsule equivalent to 20 mg fluoxetine (BF)
Hypromellose with Ocular lubricating gel 3 mg-2 mg per g, 10 g (CV)
Carbomer 980
Irinotecan Hydrochloride I.V. injection 40 mg in 2 mL vial (MX)
Trihydrate I.V. injection 100 mg in 5 mL vial (MX)
Lactulose Solution BP 3.34 g per 5 mL, 500 mL (HX)
Lamotrigine Tablet 5 mg (AF, HX)
Tablet 25 mg (AF, HX)
Tablet 50 mg (AF, HX)
Tablet 100 mg (AF, HX)
Tablet 200 mg (AF, HX)
Lisinopril Tablet 5 mg (BF)
Tablet 10 mg (BF)
Tablet 20 mg (BF)
Metformin Hydrochloride Tablet 1 g (AF)
Nifedipine Tablet 30 mg (controlled release) (AW)
Tablet 60 mg (controlled release) (AW)
Nizatidine Capsule 150 mg (LN)
Capsule 300 mg (LN)
Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL
vial (IT)
Solution concentrate for I.V. infusion 100 mg in 16.7 mL
vial (IT)
Solution concentrate for I.V. infusion 150 mg in 25 mL
vial (IT)
Solution concentrate for I.V. infusion 300 mg in 50 mL
vial (IT)
Simvastatin Tablet 5 mg (AF)
Tablet 10 mg (AF)
Tablet 20 mg (AF)
Tablet 40 mg (AF)
Tablet 80 mg (AF)
Terbinafine Hydrochloride Tablet equivalent to 250 mg terbinafine (AF)
Items Deleted
Diphtheria Antitoxin Injection 10,000 units ampoule
Ferrous Sulfate – Dried with Tablet 250 mg, equivalent to 80 mg ferrous iron-
Folic Acid 300 micrograms (sustained release)
Levamisole Hydrochloride Tablet equivalent to 50 mg levamisole
Tetracycline Hydrochloride Capsule 250 mg
Forms Deleted
Cytarabine Injection 500 mg in 25 mL vial
Desmopressin Acetate Nasal spray (pump pack) 10 micrograms per actuation,
50 actuations, 5 mL
Diphtheria and Tetanus Injection 0.5 mL ampoule. For immunization of adults
Vaccine – Adsorbed and children over the age of 8 years
(Diluted)
Idarubicin Hydrochloride Capsule 25 mg
Naloxone Hydrochloride Injection 40 micrograms in 2 mL ampoule
Sterculia with Frangula Bark Granules 473 mg-83 mg per g, 250 g
Tetanus Vaccine – Adsorbed Injection 0.5 mL ampoule
Brands Deleted
Allopurinol Tablet 300 mg (DP, HS)
Amiodarone Hydrochloride Tablet 200 mg (HS)
Amoxycillin Trihydrate Capsule equivalent to 250 mg amoxycillin (HS)
Capsule equivalent to 500 mg amoxycillin (HS)
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg amoxycillin
Water – Purified BP per 5 mL, 100 mL (HS)
Powder for oral suspension equivalent to 250 mg amoxycillin
per 5 mL, 100 mL (HS)
Atenolol Tablet 50 mg (HS)
Captopril Tablet 12.5 mg (HS)
Tablet 25 mg (HS)
Tablet 50 mg (HS)
Cefaclor Monohydrate Tablet (sustained release) equivalent to 375 mg cefaclor (HS)
Cefaclor Monohydrate with Powder for oral suspension equivalent to 125 mg cefaclor
Water – Purified BP per 5 mL, 100 mL (HS)
Powder for oral suspension equivalent to 250 mg cefaclor
per 5 mL, 75 mL (HS)
Cephalexin Capsule 250 mg (anhydrous) (HS)
Capsule 500 mg (anhydrous) (HS)
Clomipramine Hydrochloride Tablet 25 mg (HS)
Cyclophosphamide with any Injection 1 g (anhydrous), vial (with required solvent) (PH)
determined brand of
sterilised Water for Injections
or other solvent
Danazol Capsule 100 mg (SW)
Capsule 200 mg (SW)
Diclofenac Sodium Tablet 25 mg (enteric coated) (HS)
Tablet 50 mg (enteric coated) (HS)
Diltiazem Hydrochloride Tablet 60 mg (HS)
Capsule 240 mg (controlled delivery) (HS)
Doxycycline Monohydrate Tablet equivalent to 50 mg doxycycline (HS)
Enalapril Maleate Tablet 5 mg (HS)
Tablet 10 mg (HS)
Tablet 20 mg (HS)
Fluoxetine Hydrochloride Capsule equivalent to 20 mg fluoxetine (HS)
Folic Acid Tablet 500 micrograms (SI)
Frusemide Tablet 20 mg (HS)
Tablet 40 mg (HS)
Gliclazide Tablet 80 mg (HS)
Indapamide Hemihydrate Tablet 2.5 mg (HS)
Insulin – Neutral with Injection (human) 50 units-50 units per mL, 10 mL vial (LY)
Insulin – Isophane
Insulin Zinc Suspension Injection (human) 100 units per mL, 10 mL vial (LY)
Insulin Zinc Suspension Injection (human) 100 units per mL, 10 mL vial (LY)
(Crystalline)
Ipratropium Bromide Nebuliser solution 250 micrograms (anhydrous) in
1 mL single dose units, 30 (HS)
Nebuliser solution 500 micrograms (anhydrous) in
1 mL single dose units, 30 (HS)
Isosorbide Mononitrate Tablet 60 mg (sustained release) (HS)
Lisinopril Tablet 5 mg (HS)
Tablet 10 mg (HS)
Tablet 20 mg (HS)
Metformin Hydrochlorde Tablet 500 mg (HS)
Metoprolol Tartrate Tablet 50 mg (HS)
Tablet 100 mg (HS)
Moclobemide Tablet 150 mg (HS)
Tablet 300 mg (HS)
Nifedipine Tablet 20 mg (HS)
Norfloxacin Tablet 400 mg (HS)
Oestradiol Transdermal patches 5.7 mg, 4 (MM)
Paracetamol Tablet 500 mg (DP)
Paroxetine Hydrochloride Tablet equivalent to 20 mg paroxetine (HS)
Pethidine Hydrochloride Injection 100 mg in 2 mL ampoule (SI)
Piroxicam Dispersible tablet 20 mg (HS)
Capsule 10 mg (HS)
Capsule 20 mg (HS)
Prazosin Hydrochloride Tablet equivalent to 1 mg prazosin (HS)
Tablet equivalent to 5 mg prazosin (HS)
Ranitidine Hydrochloride Tablet equivalent to 300 mg ranitidine (HS)
Salbutamol Sulfate Nebuliser solution equivalent to 5 mg salbutamol in
2.5 mL single dose units, 30 (HS, PU)
Sotalol Hydrochloride Tablet 160 mg (HS)
Sulindac Tablet 200 mg (FR)
Trimethoprim with Tablet 160 mg-800 mg (HS)
Sulfamethoxazole
Alterations of Form
Salcatonin From: Injection 50 I.U. in 1 mL ampoule with 1 mL syringe
with needle and 1 alcohol swab
To: Injection 50 I.U. in 1 mL ampoule
From: Injection 100 I.U. in 1 mL ampoule with 1 mL syringe
with needle and 1 alcohol swab
To: Injection 100 I.U. in 1 mL ampoule
Alterations of Form and Maximum Quantity
Copper Sulfate From: Tablets, diagnostic compound, 24 Max. qty: 3
To: Tablets, diagnostic compound, 36 Max. qty: 2
Glucose and Ketone From: Reagent strips, 100 (Keto-Diastix) Max. qty: 1
Indicator—Urine To: Reagent strips, 50 (Keto-Diastix) Max. qty: 2
Glucose Indicator—Urine From: Reagent strips, 100 (Clinistix) Max. qty: 1
To: Reagent strips, 50 (Clinistix) Max. qty: 2
From: Reagent strips, 100 (Diastix) Max. qty: 1
To: Reagent strips, 50 (Diastix) Max. qty: 2
Alteration of Maximum Repeats
Risperidone Tablet 1 mg From: 5
To: 2
Alteration of Manufacturer’s Code
From To
Acetazolamide Tablet 250 mg WY SI
Benzhexol Hydrochloride Tablet 2 mg WY SI
Tablet 5 mg WY SI
Liothyronine Sodium Tablet 20 micrograms BT SI
Lisinopril Tablet 5 mg AD MK
Tablet 10 mg AD MK
Tablet 20 mg AD MK
Oxycodone Hydrochloride Tablet 5 mg BT SI
Warfarin Sodium Tablet 1 mg BA FM
BT SI
Tablet 2 mg BT SI
Tablet 3 mg BA FM
Tablet 5 mg BA FM
BT SI
FIRST SCHEDULE – PART 2
Items Added
Paracetamol Tablet 500 mg
Risperidone Tablet 1 mg
Tablet 1 mg (orally disintegrating)
Brands Added
Cyproterone Acetate Tablet 50 mg (HX)
Items Deleted
Nizatidine Capsule 150 mg
Capsule 300 mg
Tetracycline Hydrochloride Capsule 250 mg
Forms Deleted
Desmopressin Acetate Nasal spray (pump pack) 10 micrograms per actuation,
50 actuations, 5 mL
Brands Deleted
Aciclovir Tablet 200 mg (HS)
Alteration of Purpose
Aciclovir Tablet 200 mg
Adalimumab Injection 40 mg in 0.8 mL pre-filled syringe
Codeine Phosphate with Tablet 30 mg-500 mg
Paracetamol
Etanercept Injection set containing 4 vials powder for injection 25 mg
and 4 pre-filled syringes solvent 1 mL [addition of
availability for active ankylosing spondylitis]
Famciclovir Tablet 250 mg
Hydromorphone Tablet 2 mg
Hydrochloride Tablet 4 mg
Tablet 8 mg
Oral liquid 1 mg per mL, 473 mL
Methadone Hydrochloride Tablet 10 mg
Injection 10 mg in 1 mL ampoule
Morphine Hydrochloride Oral solution 2 mg per mL, 200 mL
Oral solution 5 mg per mL, 200 mL
Oral solution 10 mg per mL, 200 mL
Morphine Sulfate Tablet 30 mg
Tablet 5 mg (controlled release)
Tablet 10 mg (controlled release)
Tablet 15 mg (controlled release)
Tablet 30 mg (controlled release)
Tablet 60 mg (controlled release)
Tablet 100 mg (controlled release)
Capsule 10 mg (containing sustained release pellets)
Capsule 20 mg (containing sustained release pellets)
Capsule 30 mg (controlled release)
Capsule 50 mg (containing sustained release pellets)
Capsule 60 mg (controlled release)
Capsule 90 mg (controlled release)
Capsule 100 mg (containing sustained release pellets)
Capsule 120 mg (controlled release)
Sachet containing controlled release granules for oral
suspension, 20 mg per sachet
Sachet containing controlled release granules for oral
suspension, 30 mg per sachet
Sachet containing controlled release granules for oral
suspension, 60 mg per sachet
Sachet containing controlled release granules for oral
suspension, 100 mg per sachet
Oxycodone Hydrochloride Tablet 5 mg
Capsule 5 mg
Capsule 10 mg
Capsule 20 mg
Oral solution 5 mg per 5 mL, 250 mL
Tablet 5 mg (controlled release)
Tablet 10 mg (controlled release)
Tablet 20 mg (controlled release)
Tablet 40 mg (controlled release)
Tablet 80 mg (controlled release)
Oxycodone Pectinate Suppository equivalent to 30 mg oxycodone
Rituximab Solution for I.V. infusion 100 mg in 10 mL vial
Solution for I.V. infusion 500 mg in 50 mL vial
Valaciclovir Hydrochloride Tablet equivalent to 500 mg valaciclovir (max qty 30)
Alteration of Maximum Quantity
From To
Codeine Phosphate with Tablet 30 mg-500 mg 40 60
Paracetamol
Alteration of Manufacturer’s Code
From To
Oxycodone Hydrochloride Tablet 5 mg BT SI
SECOND SCHEDULE – PART 1
Forms added
Paracetamol Tablet 665 mg (modified release)
Brands added
Bisacodyl Suppositories 10 mg, 10 (PP)
Forms deleted
Sterculia with Frangula Bark Granules 473 mg-83 mg per g, 250 g
SECOND SCHEDULE – PART 2
Forms added
Paracetamol Tablet 665 mg (modified release)
Brands added
Bisacodyl Suppositories 10 mg, 10 (PP)
Forms deleted
Sterculia with Frangula Bark Granules 473 mg-83 mg per g, 250 g
THIRD SCHEDULE ‑ PART 1
Forms added
Tetanus Vaccine – Adsorbed Injection 0.5 mL in pre-filled syringe
Items Deleted
Tetracycline Hydrochloride Capsule 250 mg
Forms deleted
Tetanus Vaccine – Adsorbed Injection 0.5 mL ampoule
Brands Deleted
Amoxycillin Trihydrate Capsule equivalent to 250 mg amoxycillin (HS)
Capsule equivalent to 500 mg amoxycillin (HS)
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg amoxycillin
Water – Purified BP per 5 mL, 100 mL (HS)
Powder for oral suspension equivalent to 250 mg amoxycillin
per 5 mL, 100 mL (HS)
Cefaclor Monohydrate Tablet (sustained release) equivalent to 375 mg cefaclor (HS)
Cefaclor Monohydrate with Powder for oral suspension equivalent to 125 mg cefaclor
Water – Purified BP per 5 mL, 100 mL (HS)
Powder for oral suspension equivalent to 250 mg cefaclor
per 5 mL, 75 mL (HS)
Cephalexin Capsule 250 mg (anhydrous) (HS)
Capsule 500 mg (anhydrous) (HS)
Diclofenac Sodium Tablet 25 mg (enteric coated) (HS)
Tablet 50 mg (enteric coated) (HS)
Paracetamol Tablet 500 mg (DP)
Pethidine Hydrochloride Injection 100 mg in 2 mL ampoule (SI)
Piroxicam Dispersible tablet 20 mg (HS)
Capsule 10 mg (HS)
Capsule 20 mg (HS)
Sulindac Tablet 200 mg (FR)
Trimethoprim with Tablet 160 mg-800 mg (HS)
Sulfamethoxazole
Alteration of Manufacturer’s Code
From To
Oxycodone Hydrochloride Tablet 5 mg BT SI
THIRD SCHEDULE ‑ PART 2
Items Added
Paracetamol Tablet 500 mg
ATTACHMENT
Paragraph 1 provides that these determinations commences on 1 April 2005.
Paragraph 2 provides that the determinations under sections 85, 85A and 88 of the National Health Act 1953 (the Act) made on 17 November 2004, as amended by the determinations under sections 85, 85A and 88 of the Act made on 14 December 2004 and on 20 December 2004, are repealed.
Paragraph 3 defines the following terms for the purposes of these determinations:
- “Act”;
- “base-priced drug”;
- “CFC”;
- “CFU”;
- “Commission”;
- “electronic communication”;
- “g”;
- “I.M.”;
- “I.V.”;
- “kg”;
- “L”;
- “m”;
- “Managing Director”;
- “mg”;
- “mL”;
- “mm”;
- “mmol”; and
- “Regulations”.
Paragraph 4 provides that, for a drug or medicinal preparation that is declared under subsection 85(2), the forms of that drug or medicinal preparation that are listed in the First and Second Schedules to these determinations are pharmaceutical benefits when prescribed by a medical practitioner.
Paragraph 4A provides that, for a drug or medicinal preparation listed in the Declaration under subsection 85(2), the forms of that drug or medicinal preparation listed in the Fourth Schedule to these determinations (which are composed of one or more of the drugs or medicinal preparations listed in Schedule 4 to that Declaration with or without the addition of one or more of the substances specified in Schedule 5 to that Declaration) are pharmaceutical benefits when prescribed by a medical practitioner.
Paragraph 5 provides that for a drug or medicinal preparation that is declared under subsection 85(2), the forms of that drug or medicinal preparation, that are listed in the Third Schedule to these determinations, are pharmaceutical benefits when prescribed by a participating dental practitioner.
Paragraph 6 provides that, for a particular pharmaceutical benefit specified in Part 2 of the First or Second Schedule to these determinations, a medical practitioner may prescribe the maximum quantity and number of repeats specified in that Part, only for the purposes specified in that Part, in relation to that particular pharmaceutical benefit.
Paragraph 7 provides that, for a particular pharmaceutical benefit specified in Part 2 of the Third Schedule to these determinations, a participating dental practitioner may prescribe the maximum quantity specified in that Part, only for the purposes specified in that Part, in relation to that particular pharmaceutical benefit.
Paragraph 8 provides that:
(a) A medical practitioner may only direct that a pharmaceutical benefit be administered according to the “Manner of Administration” specified for that pharmaceutical benefit in the First or Second Schedule to these determinations; or
(b) A participating dental practitioner may only direct that a pharmaceutical benefit be administered according to the “Manner of Administration” specified for that pharmaceutical benefit in the Third Schedule to these determinations.
Paragraph 9 provides that, in each Schedule to the determinations, the maximum quantity or number of units that may be directed to be supplied for a particular pharmaceutical benefit in one prescription, on any one occasion, is the number listed in the column headed “Maximum quantity” for that pharmaceutical benefit.
Paragraph 10 provides that the maxiumum number of times that a medical practitioner may direct a prescription for a pharmaceutical benefit to be repeated, if at all, is the quantity or number, if any, specified in that Part under the heading “Maximum number of repeats” for that pharmaceutical benefit.
Paragraph 11 provides, in relation to Part 2 of the First or Second Schedules, that:
(a) where a class of persons is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied to a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”:
(i) if subparagraph (ii) does not apply, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition; or
(ii) if a class of persons is also specified in those purposes, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied for that purpose;
(d) where the column headed “Purposes” specifies that compliance with authority procedures (set out in subparagraph 11(d)) is required, then the medical practitioner must submit the prescription to the Managing Director for supply of the pharmaceutical benefit by:
(i) preparing and signing the prescription:
- in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or
- in a form approved by the Secretary, by means of a computer; or
- in a form prepared by means of a computer and approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or
- by a method approved by the Secretary in writing.
(ii) submitting the prescription by telephone, giving the Managing Director the details of that prescription which has been prepared and signed in accordance with subsubparagaph (i); or
(iii) where the medical practitioner is unable to obtain authorisation from the Managing Director due to failure of telephone systems, submitting the prescription in line with subsubparagraph (ii) and according to the instructions stipulated in an emergency telephone message from the medical practitioner to the Managing Director;
(iv) by submitting the details of the prescription, which has been prepared and signed by the medical practitioner (in accordance with subsubparagraph (i)) to the Managing Director by means of electronic communication (of a kind which has been approved by the Managing Director)
Paragraph 11A provides that, if the prescription has been prepared and signed by the medical practitioner in accordance with subsubparagraph 11(d)(i), that prescription may be submitted by one of that medical practitioner’s employees.
Paragraph 12 provides that, subject to paragraph 12B, where a prescription is submitted under subparagraph 11(d), authorisation may be made:
(a) by the Managing Director signing for the authorisation on the prescription and:
(i) if the Managing Director requires that the medical practitioner must alter the prescription, by returning the prescription to the medical practitioner for alteration before the medical practitioner gives it to the patient; or
(ii) in any other case:
- by returning it to the medical practitioner; or
- by sending it to the person for whom it was prepared; or
(b) orally, at the time the Managing Director is given details of the prescription, if the prescription was submitted in accordance with subsubparagraph 14(d)(ii); or
(c) by the managing director sending the authorisation to the medical practitioner by electronic communication, if the prescription was submitted in accordance with subsubparagraph 11(d)(iv).
Paragraph 12 A provides that, if the Managing Director authorises a prescription orally, in accordance with subparagraph 12(b) or (c):
(a) the Managing Director must tell the medical practitioner, either orally or by electronic communication, the number of the authority prescription; and
(b) the medical practitioner must mark the number on the prescription and retain a copy of the prescription for 1 year from the date of authorisation.
Paragraph 12 B provides that authorisation is deemed to be granted where a medical practitioner has submitted a prescription in accordance with subsubparagraph 14(d)(iii), and where the prescription has been completed in accordance with the instructions stipulated in the emergency telephone message provided by the Managing Director.
Paragraph 13 provides, in relation to Part 2 of the Third Schedule, that:
(a) where a class of persons is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied to a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”:
(i) if subparagraph (ii) does not apply, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition; or
(ii) if a class of persons is also specified in those purposes, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied for that purpose.
Paragraph 14 lists the names of the manufacturers of those brands of pharmaceutical benefits, listed under “Brand” in the First, Second or Third Schedule, to which this determination applies.
The Schedules
The First Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner.
The First Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner.
The Second Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner for patients receiving palliative care.
The Second Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner for patients receiving palliative care.
The Third Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a participating dental practitioner.
The Third Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a participating dental practitioner.
The Fourth Schedule lists the forms, maximum quantity and maximum number or repeats of extemporaneously-prepared pharmaceutical benefits, the ingredients of which are declared in Schedule 4 of the declaration under subsection 85(2) of the Act.