National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010)

PB 108 of 2010

National Health (Listing of Pharmaceutical Benefits) Instrument 2010

as amended

made under sections 84AF, 85, 85A, 88 and 101 of the

National Health Act 1953

This compilation was prepared on 1 September 2012
taking into account amendments up to PB 60 of 2012

This document has been split into two volumes
Volume 1 contains Sections 1–20 and Schedules 1–3
Volume 2 contains Schedule 4 and the Notes
Each volume has its own Table of Contents

Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra

Contents

 1 Name of Instrument [see Note 1]

 2 Commencement 

 3 Revocation 

 4 Definitions 

 5 Drugs and medicinal preparations to which Part VII applies 

 6 Form 

 7 Manner of administration 

 8 Brand and responsible person 

 9 Authorised prescriber 

 10 Prescription circumstances — Schedule 1 

 11 Authority required procedures 

 12 Authority required procedures — submission of prescription 

 13 Authority required procedures — authorisation 

 14 Streamlined authority code 

 15 Prescription circumstances — Schedule 2 

 16 Maximum quantity — Schedule 1 

 17 Maximum quantity — Schedule 2 

 18 Maximum number of repeats — Schedule 1 

 19 Maximum number of repeats — Schedule 2 

 20 Section 100 only supply 

Schedule 1 Ready-prepared pharmaceutical benefits 

Schedule 2 Extemporaneously-prepared pharmaceutical benefits 

Part 1 Listed drugs that may be used as ingredients in extemporaneously-prepared pharmaceutical benefits             

Part 2 Additives 

Part 3 Maximum quantity and number of repeats 

Schedule 3 Responsible person codes 

1 Name of Instrument [see Note 1]

 (1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Instrument 2010.

 (2) This Instrument may also be cited as PB 108 of 2010.

2 Commencement

  This Instrument commences on 1 December 2010.

3 Revocation

  The following instruments are revoked:

 (a) Declaration under subsections 85 (2) and 85 (2AA) of the National Health Act 1953; Determination under subsection 85 (2A) of the National Health Act 1953 (PB 14 of 2010);

 (b) Determinations under sections 85, 85A and 88 of the National Health Act 1953 (PB 68 of 2010);

 (c) Determination under section 84AF of the National Health Act 1953 (PB 69 of 2010);

 (d) Determination under subsections 85A (1) and (2) and 88 (1C) of the National Health Act 1953 (PB 11 of 2009).

4 Definitions

  In this Instrument:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

Act means the National Health Act 1953.

authorised prescriber for a pharmaceutical benefit, means a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit.

CFC means chlorofluorocarbon.

CFU means colony forming unit.

circumstances code means the letter ‘C’ followed by a number.

electronic communication has the meaning given by subsection 5 (1) of the Electronic Transactions Act 1999.

extemporaneously-prepared pharmaceutical benefit means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit.

General Statement for Lipid-Lowering Drugs means the statement set out in Part 2 of Schedule 4.

GP Management Plan means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need.

I.M. means intramuscular.

I.U. means international unit.

I.V. mean intravenous.

mmol means millimole.

palliative care patient means a patient with an active, progressive, far-advanced disease for whom the prognosis is limited and the focus of care is the quality of life.

PBS means Pharmaceutical Benefits Scheme.

prescriber code means any of the following codes identifying the kind of person mentioned for the code:

 (a) MP — medical practitioner;

 (b) PDP — participating dental practitioner;

 (c) AO — authorised optometrist;

 (d) MW — authorised midwife;

 (e) NP — authorised nurse practitioner.

purposes code means the letter ‘P’ followed by a number.

ready-prepared pharmaceutical benefit means a brand of a pharmaceutical item in relation to which a determination under subsection 85(6) of the Act is in force.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.

Streamlined Authority Code means the words ‘Streamlined Authority Code’ followed by a number.

Team Care Arrangements means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient.

Note   Terms used in this Instrument have the same meaning as in the Act — see section 13 of the Legislative Instruments Act 2003. These terms include:

 Chief Executive Medicare

 pharmaceutical benefit

 pharmaceutical item.

5 Drugs and medicinal preparations to which Part VII applies

 (1) For paragraph 85 (2) (a) of the Act, Part VII of the Act applies to:

 (a) a drug or medicinal preparation mentioned in the column headed ‘Listed Drug’ in:

 (i) Schedule 1; or

 (ii) Part 1 of Schedule 2; and

 (b) a medicinal preparation composed of 1 or more listed drugs mentioned in subparagraph (a) (ii).

 (2) For subparagraph 85(2)(b)(i) of the Act, paragraph 85(2)(b) of the Act applies to a listed drug mentioned in subparagraph (1)(a)(ii).

 (3) For subparagraph 85(2)(b)(ii) of the Act, paragraph 85(2)(b) of the Act applies to an additive mentioned in Part 2 of Schedule 2.

Note   Part VII of the Act applies to medicinal preparations composed of 1 or more listed drugs mentioned in subsection (2) and 1 or more of the additives mentioned in subsection (3) – see paragraph 85(2)(b) of the Act.

6 Form

  For subsection 85 (3) of the Act, the column headed ‘Form’ in Schedule 1 lists the form or forms for a listed drug determined for that drug.

7 Manner of administration

 (1) For subsection 85 (5) of the Act, the manner of administration of a form of a listed drug mentioned in Schedule 1 is the manner of administration mentioned for that form of the drug in the column headed ‘Manner of Administration’ in Schedule 1.

 (2) For paragraph 85A (2) (c) of the Act, if a manner of administration is mentioned in Schedule 1 for a form of a listed drug, a person writing a prescription for the supply of a pharmaceutical benefit that has the listed drug in that form must, if including a manner of administration in the prescription, direct that the pharmaceutical benefit be administered in that manner.

 (3) For subsection (2), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

8 Brand and responsible person

 (1) A brand mentioned in the column headed ‘Brand’ in Schedule 1 for a pharmaceutical item is determined for subsection 85 (6) of the Act for that pharmaceutical item.

 (2) For subsection 84AF (1) of the Act, if a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in subsection (3) is the responsible person for the brand of the pharmaceutical item.

 (3) For subsection (2), the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person.

 (4) For subsections (1) and (2), the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

9 Authorised prescriber

 (1) For subsection 88 (1A) of the Act, a participating dental practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials PDP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (2) For subsection 88 (1C) of the Act, an authorised optometrist is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials AO are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (3) For subsection 88 (1D) of the Act, an authorised midwife is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials MW are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (4) For subsection 88 (1E) of the Act, an authorised nurse practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials NP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (5) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note   A medical practitioner may prescribe any pharmaceutical benefit — see subsection 88 (1) of the Act.

10 Prescription circumstances — Schedule 1

 (1) This section applies to a pharmaceutical benefit if at least 1 circumstances code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for the pharmaceutical benefit.

 (2) For paragraph 85 (7) (a) of the Act, the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

 (3) For paragraph 85 (7) (b) of the Act, the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written
are the circumstances mentioned in Part 1 of Schedule 4 for at least 1 of
the circumstances codes mentioned in Schedule 1 for the pharmaceutical benefit.

 (4) For subsection (1), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

11 Authority required procedures

 (1) This section applies to a pharmaceutical benefit if the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include any of the following:

 (a) Compliance with Authority Required procedures;

 (b) Compliance with Written Authority Required procedures;

 (c) Compliance with Telephone Authority Required procedures;

 (d) Compliance with Written or Telephone Authority Required procedures.

 (2) A prescription for the supply of the pharmaceutical benefit must be:

 (a) submitted by the authorised prescriber to the Chief Executive Medicare in accordance with section 12; and

 (b) authorised by the Chief Executive Medicare in accordance with section 13.

12 Authority required procedures — submission of prescription

 (1) The authorised prescriber must:

 (a) deliver or post to the Chief Executive Medicare a prescription for the supply of the pharmaceutical benefit, prepared and signed by the authorised prescriber:

 (i) in a form approved by the Secretary and completed by the authorised prescriber in ink in his or her own handwriting; or

 (ii) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subparagraph (i); or

 (iii) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

 (iv) by a method approved in writing by the Secretary; or

 (b) submit to the Chief Executive Medicare, by telephone, details of a prescription for the supply of the pharmaceutical benefit prepared and signed by the authorised prescriber in accordance with subparagraph (a) (i), (ii), (iii) or (iv); or

 (c) if the authorised prescriber has attempted give details of the prescription to the Chief Executive Medicare in accordance with paragraph (b) but has been unable to do so because the telephone system established by the Chief Executive Medicare for the provision of such authorisations was unavailable — submit the prescription in accordance with the instructions in an emergency telephone message provided to the authorised prescriber by the Chief Executive Medicare; or

 (d) submit to the Chief Executive Medicare, by means of an electronic communication of a kind approved in writing by the Chief Executive Medicare, details of a prescription for the supply of the pharmaceutical benefit prepared and signed by the authorised prescriber in accordance with subparagraph (a) (i), (ii), (iii) or (iv).

 (2) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1) (a).

 (3) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1) (b) or (c).

 (4) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written or Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1) (a), (b) or (c).

 (5) For paragraph (1) (a), a prescription prepared and signed by the authorised prescriber in accordance with subsection (1) is taken to have been submitted by the authorised prescriber if it is submitted by his or her employee.

13 Authority required procedures — authorisation 

 (1)  A prescription submitted in accordance with paragraph 12 (1) (a) may be authorised by the Chief Executive Medicare:

 (a) signing his or her authorisation on the prescription; and

 (b) either:

 (i) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or

 (ii) in any other case:

 (A) returning the authorised prescription to the authorised prescriber; or

 (B) sending it to the person in respect of whom it was prepared.

 (2) A prescription submitted in accordance with paragraph 12 (1) (b) may be authorised by the Chief Executive Medicare telling the authorised prescriber by telephone, at the time the Chief Executive Medicare is given details of the prescription, that the prescription is authorised.

 (3) A prescription submitted in accordance with paragraph 12 (1) (d) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, to the authorised prescriber.

 (4) If the Chief Executive Medicare authorises a prescription under subsection (2) or (3):

 (a) the Chief Executive Medicare must tell the authorised prescriber the number given by the Chief Executive Medicare to the prescription: and

 (b) the authorised prescriber must:

 (i) mark that number on the prescription; and

 (ii) retain a copy of the prescription for 1 year from the date the prescription was authorised.             

 (5) For paragraph (4) (a), the Chief Executive Medicare must tell the authorised prescriber the number:

 (i) if the authorised prescriber is an authorised optometrist — by telephone; and

 (ii) in any other case — by telephone or by electronic communication.

 (6) A prescription submitted in accordance with paragraph 12 (1) (c) is taken to have been authorised by the Chief Executive Medicare if the authorised prescriber completes the prescription in accordance with the instructions given in the emergency telephone message.

14 Streamlined authority code

 (1) This section applies to a pharmaceutical benefit if the circumstances mentioned in Schedule 4 for a circumstances code applying to the pharmaceutical benefit include a Streamlined Authority Code.

 (2) The requirements of section 12 are taken to have been complied with, and the Chief Executive Medicare is taken to have authorised the prescription of the pharmaceutical benefit under section 13, if the authorised prescriber has:

 (a) prepared and signed a prescription for the supply of the pharmaceutical benefit in accordance with subparagraph 12 (1) (a) (i), (ii), (iii) or (iv); and

 (b) written the Streamlined Authority Code on the prescription.

15 Prescription circumstances — Schedule 2

 (1) For paragraph 85 (7) (a) of the Act, a pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A if:

 (a) it is:

 (i) a listed drug mentioned in Part 1 of Schedule 2; or

 (ii) an extemporaneously-prepared pharmaceutical benefit that contains the listed drug; and

 (b) there are circumstances mentioned for the listed drug in the column headed ‘Circumstances’ in Part 1 of Schedule 2.

 (2) For paragraph 85 (7) (b) of the Act, the circumstances in which a prescription for the supply of a pharmaceutical benefit mentioned in subsection (1) may be written are:

 (a) for a listed drug mentioned in subparagraph (1) (a) (i) — the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for the drug; and

 (b) for an extemporaneously-prepared pharmaceutical benefit mentioned in subparagraph (1) (a) (ii) — the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for each listed drug contained in the pharmaceutical benefit.

Note   If an extemporaneously-prepared pharmaceutical benefit contains more than one listed drug, a prescription for the supply of the pharmaceutical benefit may only be written if the circumstances mentioned for each of the listed drugs contained in the pharmaceutical benefit are met.

16 Maximum quantity — Schedule 1

 (1) For paragraph 85A (2) (a) of the Act, the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit mentioned in Schedule 1 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the pharmaceutical benefit and authorised prescriber.

 (2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for a pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

 (3) If no purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’, the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

 (4) For subsection (1) the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

 (5) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

17 Maximum quantity — Schedule 2

 (1) For paragraph 85A (2) (a) of the Act, the maximum quantity or number of units of an extemporaneously-prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

 (2) For subsection (1), the extemporaneously-prepared pharmaceutical benefit is:

 (a) the listed drug mentioned in Part 1 of Schedule 2; or

 (b) an extemporaneously-prepared pharmaceutical benefit that contains the listed drug.

18 Maximum number of repeats — Schedule 1

 (1) For paragraph 85A (2) (b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of a pharmaceutical benefit mentioned in Schedule 1 be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the pharmaceutical benefit and the authorised prescriber.

 (2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for the pharmaceutical benefit, the number of repeats mentioned in the column in Schedule 1 headed ‘Number of Repeats’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

 (3) If no purposes code is mentioned in the column headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

 (4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

19 Maximum number of repeats — Schedule 2

 (1) For paragraph 85A (2) (b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of an extemporaneously-prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 be repeated is the number in the column headed ‘Number of Repeats’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

 (2) For this section, the extemporaneously-prepared pharmaceutical benefit is:

 (a) the listed drug mentioned in Part 1 of Schedule 2; or

 (b) an extemporaneously-prepared pharmaceutical benefit that contains the listed drug.

20 Section 100 only supply

 (1) For subsection 85 (2A) of the Act, if the letter D is mentioned in the column headed ‘Section 100 only’ in Schedule 1 for a listed drug, the drug can only be supplied under special arrangements under section 100 of the Act.

 (2) For paragraph 85 (8) (a) of the Act, if the letters PB are mentioned in the column headed ‘Section 100 only’ in Schedule 1 for a pharmaceutical benefit, the pharmaceutical benefit can only be supplied under special arrangements under section 100 of the Act.

 (3) For paragraph 85 (8) (b) of the Act, if the letter C is mentioned in the column headed ‘Section 100 only’ in Schedule 1 for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can be supplied in the circumstances identified in Part 1 of Schedule 4 for the circumstances code only under special arrangements under section 100 of the Act.

 (4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Schedule 1 Ready-prepared pharmaceutical benefits

(sections 5 to 10, 16, 18 and 20)