EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 96 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88
Summary
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 68 of 2010 which came into effect on
1 August 2010. The amendments provide for additions and changes to the names, forms and brands of listed drugs on the Pharmaceutical Benefits Scheme (PBS) and the conditions for prescribing pharmaceutical benefits. It also determines which pharmaceutical benefits authorised midwives and authorised nurse practitioners are authorised to prescribe. The amendments are set out in the items of Schedule 1 to the instrument.
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 pharmaceutical item is a listed drug in a form determined under subsection 85(3) of the Act and with a manner of administration for that form of the drug determined under subsection 85(5) of the Act. 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 trade name, 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 participating dental practitioner is authorised to write a prescription.
Subsection 88(1D) authorises the Minister to determine the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription. The pharmaceutical benefits identified in Part 1 of Schedule 1 by “[MW]” in the column headed “Listed Drug”, (including where [NP] is also mentioned in that column), or where [MW] is also included in the column headed “Form (strength, type, size, etc)” — the pharmaceutical benefits mentioned for that form or forms of the listed drug, are the pharmaceutical benefits for which an authorised midwife is authorised to write a prescription. The identifier [MW] when included in the column headed “Listed Drug” does not constitute part of the name of the listed drug; nor does [MW] when included with the form of a listed drug constitute part of the form of the pharmaceutical item or pharmaceutical benefit.
Subsection 88(1E) authorises the Minister to determine the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription. The pharmaceutical benefits identified in Schedule 1 or Schedule 2 by “[NP]” in the column headed “Listed Drug”, (including where [MW] is also mentioned in that column), or where [NP] is included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats” — the pharmaceutical benefits mentioned for that form or forms of the listed drug or for that number of repeats for that form of the listed drug, are the pharmaceutical benefits for which an authorised nurse practitioner is authorised to write a prescription. The identifier [NP] ,when included in the columns headed “Listed Drug”, “Form” or “Maximum number of repeats”, does not constitute part of the name of the listed drug; form, or number of repeats for the pharmaceutical item or pharmaceutical benefit.
This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), 88(1A), 88(1D) and 88(1E).
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument commences on 1 November 2010.
Consultations
Consultation regarding implementation of arrangements for midwives and nurse practitioners as PBS prescribers occurred via advisory groups established to advise on specific issues and technical aspects. The advisory groups included practitioners from medical and allied health professions, with experience in midwifery, nursing, general practice, obstetrics, and representatives from registration bodies, state and territory health services, regional and remote health services, Indigenous populations, and consumers. Advice was provided on Medicare eligibility, collaborative arrangements with other health professionals, authorisation as PBS prescribers, and medicines for PBS prescribing.
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 November 2010.
Paragraph 2: provides that Schedules 1 and 2 amend PB 68 of 2010.
Schedule 1: provides for the following amendments:
Preamble paragraphs
The introductory paragraphs to the principal instrument are amended to reflect the changes to allow the prescribing of certain listed drugs and in specific forms and strengths of listed drugs by authorised nurse practitioners and/or authorised midwives.
Definitions
Paragraph 3 is amended to insert, after “Act”, the following definitions: |
“authorised midwife” has the meaning as given by subsection 84(1) of the Act. |
“authorised nurse practitioner” has the meanings given by subsection 84(1) of the Act. |
and after “palliative care patient” the following definition: |
“participating dental practitioner” has the meaning given by subsection 84(1) of the Act. |
Authorised midwives
The amendment inserts a new heading for authorised midwives and new paragraph 5C to describe the mechanism for identifying in Part 1 of Schedule 1, for the purposes of section 88(1D) of the Act, the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription. Where “[MW]” is included in the column headed “Listed Drug”, including where [NP] is also mentioned in that column – the pharmaceutical benefits mentioned for that listed drug; or where [MW] is also included in the column headed “Form (strength, type, size, etc)” - the pharmaceutical benefits mentioned for that form or forms of the listed drug only; are the pharmaceutical benefits. The [MW] when included in the column headed “Listed Drug” does not constitute part of the name of the listed drug; nor does [MW] when included with the form of a listed drug constitute part of the form of the pharmaceutical item or pharmaceutical benefit. |
Authorised nurse practitioners
The amendment inserts a new heading for authorised nurse practitioners and new paragraph 5D to describe the mechanism for identifying in Schedule 1 or Schedule 2, for the purposes of section 88(1E) of the Act, the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription. Where “[NP]” is included in the column headed “Listed Drug”, including where [MW] is also mentioned in that column - the pharmaceutical benefits mentioned for that listed drug; or in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats” - the pharmaceutical benefits mentioned for that form or forms of the listed drug or for that number of repeats for that form of the listed drug; are the pharmaceutical benefits. The [NP] when included in the columns headed “Listed Drug”, “Form” or “Maximum number of repeats”, does not constitute part of the name of the listed drug; form, or number of repeats for the pharmaceutical item or pharmaceutical benefit. |
Prescription
New paragraph 7A provides that for the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit for which an authorised nurse practitioner is authorised to write a prescription (that is, identified in the Schedule as [NP] , are the maximum quantities and number of repeats that an authorised nurse practitioner may prescribe or direct on one occasion for the purposes mentioned but not for other purposes. |
New subparagraph 8(aa) provides that the manner of administration in Part 1 of Schedule 1 for a pharmaceutical benefit for which an authorised midwife is authorised to write a prescription (that is, identified in the Schedule as [MW] and including where [NP] is also mentioned in the same column), is the only manner in which an authorised midwife may, in a prescription, direct the pharmaceutical benefit to be administered; New subparagraph 8(ab) provides that the manner of administration in Schedule 1 or Schedule 2 for a pharmaceutical benefit for which an authorised nurse practitioner is authorised to write a prescription (that is, identified in the Schedule as [NP] and including where [MW] is also mentioned in the same column), is the only manner in which an authorised nurse practitioner may, in a prescription, direct the pharmaceutical benefit to be administered. |
New paragraph 10A provides that for the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit in Part 1 of Schedule 1 for which an authorised midwife is authorised to write a prescription (that is, identified as [MW] and including where [NP] is mentioned in the same column), may, in one prescription, be directed by an authorised midwife to be repeated is the quantity or number, if any, specified in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit. Where [MW] is also in the column headed “Form (strength, type, size, etc)”, the maximum number of repeats is the number, if any, specified in relation to the pharmaceutical benefit. New paragraph 10B provides that for the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit for which an authorised nurse practitioner is authorised to write a prescription (that is, identified in the Schedule as [NP] and including where [MW] is also mentioned in the same column), may, in one prescription, be directed by an authorised nurse practitioner to be repeated is, for pharmaceutical benefits mentioned in Part 1 of Schedule 1 or 2, specified in the column headed “Maximum number of repeats”. Where pharmaceutical benefits are mentioned in Part 2 of Schedule 1 or 2, and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes”, the maximum number of occasions is the quantity or number, if any, specified in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit. Where [NP] is also in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, the maximum number of repeats is the number, if any, specified in relation to the form of the pharmaceutical benefit or the maximum number specified in that column for the pharmaceutical benefit. |
Subparagraph 11(d) is amended to replace “a medical practitioner” with “a medical practitioner or an authorised nurse practitioner’ and to replace “the medical practitioner”, wherever occurring, with “the medical practitioner or authorised nurse practitioner”. Paragraph 11A is amended to replace “medical practitioner” with “medical practitioner or authorised nurse practitioner”. Paragraph 12 is amended to replace “medical practitioner”, wherever occurring, with “medical practitioner or authorised nurse practitioner”. Subparagraph 12A(a) is amended to replace “medical practitioner, orally or by electronic communication” with “medical practitioner, orally or by electronic communication, or an authorised nurse practitioner, orally” in relation to the means by which Medicare Australia must tell a medical practitioner or an authorised nurse practitioner of the number that is allotted to authorised prescriptions. Subparagraph 12A(b) is amended to replace “medical practitioner” with “medical practitioner or authorised nurse practitioner”. Paragraph 12B is amended to replace “medical practitioner”, wherever occurring, with “medical practitioner or authorised nurse practitioner”. Paragraph 12BA is amended to replace “a medical practitioner” with “a medical practitioner or an authorised nurse practitioner”. |
SCHEDULE 1 ― PART 1
The drugs listed in Schedule 1, Part 1 and specific forms and strengths of listed drugs, which may be prescribed by nurse practitioners and/or midwives are indicated by the use of the initials [NP] or [MW] as applicable.
Listed Drugs Added
Amlodipine with valsartan and hydrochlorothiazide |
Olmesartan with amlodipine |
Palonosetron |
Listed Drug Deleted
Mexiletine |
Forms Added
Artemether with lumefantrine | Tablet (dispersible) 20 mg-120 mg |
Tacrolimus | Capsule 0.5 mg (once daily prolonged release) Capsule 1 mg (once daily prolonged release) Capsule 5 mg (once daily prolonged release) |
Triptorelin | Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles |
Brands Added
Brimonidine | Eye drops containing brimodine tartrate 1.5 mg per mL, 5 mL (Alphagan P 1.5) |
Enalapril [NP] | Tablet containing enalapril maleate 5 mg (Enalapril Sandoz) Tablet containing enalapril maleate 10 mg (Enalapril Sandoz) Tablet containing enalapril maleate 20 mg (Enalapril Sandoz) |
Famotidine [NP] | Tablet 20 mg (Famotidine Sandoz) |
Fluconazole [NP] | Solution for I.V. infusion 100 mg in 50 mL (Fluconazole-Claris) Solution for I.V. infusion 200 mg in 100 mL (Fluconazole-Claris) |
Lamotrigine [NP] | Tablet 25 mg (APO-Lamotrigine) |
Perindopril [NP] | Tablet containing perindopril erbumine 2 mg (APO- Perindopril) |
Brands Deleted
Aciclovir | Tablet (Lovir) |
Moclobemide | Tablet 300 mg (Maosig) |
Alteration of Maximum Quantity
Hydromorphone | Tablet (modified release)containing hydromorphone hydrochloride 4 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 8 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 16 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 32 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 64 mg From: 10 To: 14 |
SCHEDULE 1 ― PART 2
The drugs listed in Schedule 1, Part 2 and specific forms and strengths of listed drugs, which may be prescribed by authorised nurse practitioners and/or authorised midwives are indicated by the use of the initials [NP] or [MW] as applicable.
Alteration of Purposes
Adalimumab | [additional availability for the treatment of adult patients with a history of juvenile idiopathic arthritis] |
Etanercept | [availability for the treatment of adult patients with a history of juvenile idiopathic arthritis (previously termed chronic juvenile arthritis)] |
Brands Deleted
Aciclovir | Tablet (Lovir) |
Alteration of Maximum Quantity
Hydromorphone | Tablet (modified release)containing hydromorphone hydrochloride 4 mg From: 20 To: 28 Tablet (modified release)containing hydromorphone hydrochloride 8 mg From: 20 To: 28 Tablet (modified release)containing hydromorphone hydrochloride 16 mg From: 20 To: 28 Tablet (modified release)containing hydromorphone hydrochloride 32 mg From: 20 To: 28 Tablet (modified release)containing hydromorphone hydrochloride 64 mg From: 20 To: 28 |
SCHEDULE 3 ― PART 1
Alteration of Maximum Quantity
Hydromorphone | Tablet (modified release)containing hydromorphone hydrochloride 4 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 8 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 16 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 32 mg From: 10 To: 14 Tablet (modified release)containing hydromorphone hydrochloride 64 mg From: 10 To: 14 |