EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 31 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no tradename, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.
This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 89 of 2007 which came into effect on 1 December 2007. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 April 2008, was made on 3 March 2008.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations 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. When recommending the listing of a medicine 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 April 2008.
Paragraph 2: provides that Schedule 1 amends PB 89 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1 – PART 1
Listed Drugs Added
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe |
Paliperidone | Tablet 3 mg (prolonged release) |
| Tablet 6 mg (prolonged release) |
| Tablet 9 mg (prolonged release) |
Forms Added
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL |
| Solution for I.V. infusion 500 mg in 100 mL |
Methylphenidate | Capsule containing methylphenidate hydrochloride 20 mg (modified release) |
| Capsule containing methylphenidate hydrochloride 30 mg (modified release) |
| Capsule containing methylphenidate hydrochloride 40 mg (modified release) |
Phenoxymethylpenicillin | Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL |
Brands Added
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Adronat, APO-Alendronate, Chem mart Alendronate70mg and Terry White Chemists Alendronate70mg) |
Amlodipine | Tablet 5 mg (as besylate) (APO-Amlodipine, Chem mart Amlodipine and Terry White Chemists Amlodipine) |
| Tablet 10 mg (as besylate) (APO-Amlodipine, Chem mart Amlodipine and Terry White Chemists Amlodipine) |
Carvedilol | Tablet 3.125 mg (Dilasig 3.125) |
| Tablet 6.25 mg (Dilasig 6.25) |
| Tablet 12.5 mg (Dilasig 12.5) |
| Tablet 25 mg (Dilasig 25) |
Cefaclor | Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Cefaclor Sandoz) |
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Cefaclor Sandoz) |
Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL (Cefalexin Sandoz) |
| Granules for oral suspension 250 mg per 5 mL, 100 mL (Cefalexin Sandoz) |
Enalapril with Hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg (Enalapril/HCT Sandoz) |
Felodipine | Tablet 5 mg (extended release) (Felodipine XR 5) |
| Tablet 10 mg (extended release) (Felodipine XR 10) |
Flucloxacillin | Powder for injection 500 mg (as sodium) (Flucil) |
Gemfibrozil | Tablet 600 mg (Pharmacor Gemfibrozil 600) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan Sandoz) |
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Sandoz) |
Metronidazole | I.V. infusion 500 mg in 100 mL (Metronidazole Sandoz) |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Pharmacor Salbutamol 2.5, Salbutamol-GA and Salbutamol Sandoz) |
| Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Pharmacor Salbutamol 5, Salbutamol-GA and Salbutamol Sandoz) |
Forms Deleted
Benzathine Penicillin | Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) |
Drotrecogin Alfa (activated) | Powder for I.V. infusion 20 mg |
Oestradiol | Nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL |
Prochlorperazine | Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 |
Brands Deleted
Captopril | Tablet 12.5 mg (Topace) |
| Tablet 25 mg (Topace) |
| Tablet 50 mg (Topace) |
Flucloxacillin | Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL (Floxapen) |
| Powder for injection 500 mg (as sodium) (Flopen) |
| Powder for injection 1 g (as sodium) (Flopen) |
Hypromellose | Eye drops 5 mg per mL, 15 mL (Isopto Tears) |
Alteration of Maximum Quantity
Famciclovir [Tablet 250 mg] From: 21
To: 20
Methotrexate [Tablet 10 mg] From: 50
To: 15
Pemetrexed [Powder for I.V. infusion 500 mg (as disodium heptahydrate)] From: 2
To: 1
Alteration of Maximum number of repeats
Famciclovir [Tablet 250 mg] From: ..
To: 1
Methotrexate [Tablet 10 mg] From: 2
To: 1
Pemetrexed [Powder for I.V. infusion 500 mg (as disodium heptahydrate)] From: 2
To: 3
Terbinafine [Tablet 250 mg (as hydrochloride)] From : 1
To: ..
Alteration of Brand Name:
Flucloxacillin | Powder for injection 1 g (as sodium) From : Aspen Flucil |
| To: Flucil |
SCHEDULE 1 - PART 2
Listed Drug Added
Methotrexate | Tablet 10 mg |
Terbinafine | Tablet 250 mg (as hydrochloride) |
Forms Added
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL |
| Solution for I.V. infusion 500 mg in 100 mL |
Famciclovir | Tablet 250 mg |
Listed Drug Deleted
Pemetrexed | Powder for I.V. infusion 500 mg (as disodium heptahydrate) |
Form Deleted
Benzathine Penicillin | Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) |
SCHEDULE 2 - PART 1
Listed Drug Added
Fentanyl | Lozenges 200 micrograms (as citrate), 3 |
| Lozenges 400 micrograms (as citrate), 3 |
| Lozenges 600 micrograms (as citrate), 3 |
| Lozenges 800 micrograms (as citrate), 3 |
| Lozenges 1200 micrograms (as citrate), 3 |
| Lozenges 1600 micrograms (as citrate), 3 |
SCHEDULE 2 - PART 2
Listed Drug Added
Fentanyl | Lozenges 200 micrograms (as citrate), 3 |
| Lozenges 400 micrograms (as citrate), 3 |
| Lozenges 600 micrograms (as citrate), 3 |
| Lozenges 800 micrograms (as citrate), 3 |
| Lozenges 1200 micrograms (as citrate), 3 |
| Lozenges 1600 micrograms (as citrate), 3 |
SCHEDULE 3 – PART 1
Listed Drug Added
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe |
Forms Added
Phenoxymethylpenicillin | Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL |
Brands Added
Cefaclor | Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Cefaclor Sandoz) |
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Cefaclor Sandoz) |
Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL (Cefalexin Sandoz) |
| Granules for oral suspension 250 mg per 5 mL, 100 mL (Cefalexin Sandoz) |
Flucloxacillin | Powder for injection 500 mg (as sodium) (Flucil) |
Metronidazole | I.V. infusion 500 mg in 100 mL (Metronidazole Sandoz) |
Forms Deleted
Benzathine Penicillin | Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) |
Prochlorperazine | Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 |
Brands Deleted
Flucloxacillin | Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL (Floxapen) |
| Powder for injection 500 mg (as sodium) (Flopen) |
| Powder for injection 1 g (as sodium) (Flopen) |
Alteration of Brand Name:
Flucloxacillin | Powder for injection 1 g (as sodium) From : Aspen Flucil |
| To: Flucil |