National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007

Administered by Department of Health, Disability and Ageing

Legislation au F2007L02703 Not in force Legislative Instrument

Legislation content

National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (PB 42 of 2007)

as amended

made under paragraph 92A (1) (f) of the National Health Act 1953.

Compilation start date:  1 April 2015

Includes amendments up to: PB 24 of 2015

 

About this compilation

 

This compilation

This is a compilation of the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (PB 42 of 2007) as in force on 1 April 2015. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 21 April 2015.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

 

 

 

 

 

 

1 Name of Determination

 (1) This Determination is the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007.

 (2) This Determination may also be cited as Determination No. PB 42 of 2007.

2 Commencement

  This Determination commences on 29 August 2007.

3 Revocation

  Determination No. PB 16 of 1995 made by the Minister on 10 November 1995 under paragraph 92A (1) (f) of the National Health Act 1953 is revoked.

4 Purpose

  For paragraph 92A (1) (f) of the National Health Act 1953 (the Act), this Determination sets out conditions that apply to the approval of a person as an approved pharmacist for the purposes of Part VII of the Act (including an approval granted before the commencement of section 92A of the Act and an approval of a person or body referred to in section 83Z of the Act).

Note   Under subsection 84 (1) of the Act, approved pharmacist means a person for the time being approved under section 90 of the Act and includes:

(a) a person treated as having been so approved under any provision of a law of the Commonwealth other than section 91 of the Act; and

(b) except so far as subsection 90 (3) of the Act is concerned — a person treated as having been so approved under section 91 of the Act.

 

4A Definitions

 In this determination:

 approved premises for an approved pharmacist means premises in respect of which the pharmacist is approved for the purposes of Part VII of the National Health Act 1953.

 medication chart prescription has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 1960.

 reference time means the start of the day the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014 commences.

 

5 Standards of practice

  An approved pharmacist must, in dispensing prescriptions for pharmaceutical benefits and in supplying pharmaceutical benefits:

 (a) comply with all legal requirements for the practice of pharmacy; and

 (b) treat patients with dignity regardless of manner of payment, race, sex, age, nationality, religion, disability or any other factor; and

 (c) comply with the Pharmaceutical Society of Australia’s Code of Ethics for Pharmacists 2011, as existing at the reference time; and

 (d) comply with the Pharmaceutical Society of Australia’s Professional Practice Standards 2010, as existing at the reference time, in relation to each patient, subject to the patient’s preparedness to:

 (i) ensure that the pharmacist has ready access to the patient’s medication history; and

 (ii) provide relevant personal medical information necessary for the pharmacist to individualise patient care; and

 (iii) authorise medical practitioners and other health care practitioners to release relevant medical information necessary for the pharmacist to act responsibly and reasonably and to individualise patient care; and

 (iv) allow the pharmacist sufficient time to dispense medications; and

 (v) follow advice and directions given by the patient’s medical practitioner or pharmacist and report any unusual or adverse reactions as soon as possible; and

 (e) maintain a disciplined dispensing procedure that includes:

 (i) attention to accuracy of product or ingredient selection; and

 (ii) accuracy of calculations; and

 (iii) application of accepted techniques for the preparation of pharmaceutical products; and

 (iv) appropriate packaging and storage; and

 (v) accuracy of the final product; and

 (vi) adequate information for the patient.

Examples for subparagraph (d) (i) of ways of ensuring that a pharmacist has ready access to a patient’s medication history

  • Having all prescriptions dispensed at a single pharmacy
  • Providing the pharmacist with a patientheld medication record form from another pharmacy or a prescriber
  • Authorising the transfer of the patient’s medication history from another pharmacy.

Note: The Code of Ethics for Pharmacists 2011 and the Professional Practice Standards 2010 could in 2014 be viewed on the Pharmaceutical Society of Australia’s website (http://www.psa.org.au).

6 Continuing education

  An approved pharmacist must maintain the currency of his or her pharmaceutical knowledge in accordance with the Pharmaceutical Society of Australia’s National Competency Standards Framework for Pharmacists in Australia 2010, as existing at the reference time.

Note: The National Competency Standards Framework for Pharmacists in Australia 2010 could in 2014 be viewed on the Pharmaceutical Society of Australia’s website (http://www.psa.org.au).

7 Other pharmacists at pharmacy

  A person who is an approved pharmacist in respect of a pharmacy at particular premises must ensure that a pharmacist:

 (a) who is not an approved pharmacist; and

 (b) who supplies pharmaceutical benefits at or from those premises;

complies with the conditions set out in sections 5 and 6.

8 Claims for payment

 (1) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit unless it was supplied at or from approved premises for the pharmacist.

 (2) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit if that pharmaceutical benefit was never at approved premises for the pharmacist.

 (3) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit unless the pharmacist, or an agent of the pharmacist, was present at approved premises for the pharmacist at the time the pharmaceutical benefit was dispensed.

 (4) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit on the basis of a prescription (other than a medication chart prescription) unless the pharmacist, or an agent of the pharmacist, has seen the prescription at approved premises for the pharmacist.

Note: A supply in accordance with subsection 89A(1) of the National Health Act 1953 (supply of pharmaceutical benefit without prescription) or on an order lodged under regulation 16 of the National Health (Pharmaceutical Benefits) Regulations 1960 (prescriber bag supplies) would not be a supply on the basis of a prescription.

 (5) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit on the basis of a medication chart prescription unless the pharmacist, or an agent of the pharmacist, has seen the chart or a copy of the chart containing the prescription at approved premises for the pharmacist.

 (6) Subsections (2) to (5) do not limit subsection (1).

 (7) This section does not apply in relation to the supply of a pharmaceutical benefit in respect of which the pharmacist is entitled to a payment in accordance with subsection 99(3A) of the National Health Act 1953 (supply of pharmaceutical benefit before obtaining approval).

Note: See also subsection 100(3) of the National Health Act 1953 (instruments made for the purposes of Part VII of that Act have effect subject to special arrangements).

9 Application of amendments made by the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014

 (1) The amendments made by Schedule 1 to the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014 apply on and after the commencement of that Schedule in relation to an approved pharmacist’s approval, whether it was granted before, on or after that commencement.

 (2) Section 8 of this determination, as inserted by Schedule 1 to the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014, applies in relation to a supply of a pharmaceutical benefit that occurs on or after the commencement of that Schedule.

 (3) This section is repealed on the day after the end of the period of 6 months beginning on the day this section commences.

 

 

 

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

 

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

 

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

 

Abbreviation key—Endnote 2

The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.

 

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

 

The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.

 

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

 

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.

 

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

 

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

 

 

 

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

Endnote 2—Abbreviation key

 

ad = added or inserted

pres = present

am = amended

prev = previous

c = clause(s)

(prev) = previously

Ch = Chapter(s)

Pt = Part(s)

def = definition(s)

r = regulation(s)/rule(s)

Dict = Dictionary

Reg = Regulation/Regulations

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expired or ceased to have effect

rep = repealed

hdg = heading(s)

rs = repealed and substituted

LI = legislative instrument

s = section(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

mod = modified/modification

Sdiv = Subdivision(s)

No = Number(s)

SLI = Select Legislative Instrument

o = order(s)

SR = Statutory Rules

Ord = Ordinance

Sub-Ch = Sub-Chapter(s)

orig = original

SubPt = Subpart(s)

par = paragraph(s)/subparagraph(s)

 

 /sub-subparagraph(s)

 

 

Endnote 3—Legislation history

 

Name

FRLI registration or gazettal

Commencement

Application, saving and transitional provisions

PB 42 of 2007

 

28 Aug 2007
(F2007L02703)

29 Aug 2007

 

PB 81 of 2014

 

19 Nov 2014
(F2014L01559)

1 Dec 2014

 

PB 24 of 2015

9 April 2015

(F2015L00511)

1 April 2015

 

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 4A....................

ad. PB 81 of 2014

s 5.....................

am PB 81 of 2014

s 6....................am

am PB 81 of 2014

s 8.....................a

ad PB 81 of 2014; PB24 of 2015

s 9.....................

ad PB 81 of 2014

 

 

 

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

 

 

 

 

 

 

Overview

The National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 was enacted to address the need for specific conditions governing the approval of pharmacists in relation to pharmaceutical benefits under the National Health Act 1953. This determination was made by the Minister under the authority conferred by section 92A(1)(f) of the National Health Act 1953 and commenced on 29 August 2007. Its primary objective is to set out the conditions that apply to the approval of pharmacists to ensure that they meet certain standards of practice, continuing education, and claims for payment when supplying pharmaceutical benefits. The determination also revokes the previous Determination No. PB 16 of 1995 to align with the updated framework and standards.

Scope and Application

The National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 applies to individuals approved as pharmacists under the National Health Act 1953 for the purposes of dispensing pharmaceutical benefits. It sets out the conditions that must be met for approval, including standards of practice, continuing education requirements, and specific provisions regarding claims for payment from the Commonwealth. These conditions apply to all approved pharmacists, regardless of when their approval was granted. The geographic reach of the Determination is national, as it is made under the Commonwealth’s authority. The Determination also includes provisions that extend or restrict application through subordinate instruments, such as the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014. Any uncommenced amendments, modifications, or misdescribed amendments are detailed in the endnotes but do not affect the current text of the Determination.

Key Provisions

The National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (PB 42 of 2007) sets out the conditions for approval of pharmacists to dispense pharmaceutical benefits under the National Health Act 1953. This Determination applies to pharmacists approved under section 90 of the Act, including those approved prior to the introduction of section 92A of the Act. Section 5 of the Determination mandates that approved pharmacists must comply with all legal requirements for pharmacy practice, treat patients with dignity, adhere to the Pharmaceutical Society of Australia's Code of Ethics for Pharmacists 2011 and Professional Practice Standards 2010, and maintain a disciplined dispensing procedure. Section 6 requires approved pharmacists to maintain the currency of their pharmaceutical knowledge as per the Pharmaceutical Society of Australia's National Competency Standards Framework for Pharmacists in Australia 2010. Additionally, Section 7 stipulates that approved pharmacists must ensure that other pharmacists supplying pharmaceutical benefits at the same premises comply with sections 5 and 6. The Determination also imposes obligations on approved pharmacists regarding claims for payment from the Commonwealth. According to Section 8, approved pharmacists must not claim payment unless the pharmaceutical benefit was supplied at or from approved premises, the pharmacist or an agent was present during the supply, and the pharmacist or an agent has seen the prescription at approved premises, except for certain exceptions such as supplies made under subsection 89A(1) of the National Health Act 1953 or on an order lodged under regulation 16 of the National Health (Pharmaceutical Benefits) Regulations 1960. Failure to comply with the provisions of this Determination may result in penalties. Under the National Health Act 1953, an approved pharmacist who contravenes any of the conditions of approval may be subject to fines or other penalties as prescribed by the Act. For example, Section 101B of the National Health Act 1953 provides for penalties, including fines, for improper claims for pharmaceutical benefits. Additionally, the Pharmaceutical Society of Australia may take disciplinary action against pharmacists who violate the Code of Ethics or Professional Practice Standards, which could include suspension or revocation of their pharmacist's registration.

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