Federal Register of Legislation - Australian Government

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PB 52 of 2020 Arrangements as made
This instrument authorises the use of a Chemotherapy Medication Chart (CMC) either in paper or electronic form.
Administered by: Health
Registered 20 Aug 2020
Tabling HistoryDate
Tabled HR24-Aug-2020
Tabled Senate24-Aug-2020

Commonwealth Coat of Arms of Australia

 

PB 52 of 2020

 

National Health (Chemotherapy Prescribing) Special Arrangement 2020

I, Adriana Platona, delegate of the Minister for Health, make the following instrument.

Dated           19 August 2020

Adriana Platona
First Assistant Secretary
Technology Assessment and Access Division
Department of Health

 

 

  

  


1  Name of Special Arrangement

             (1)  This Special Arrangement is the National Health (Chemotherapy Prescribing) Special Arrangement 2020.

             (2)  This Special Arrangement may also be cited as PB 52 of 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

At the same time as the commencement of the National Health (Efficient Funding of Chemotherapy) Amendment (COVID-19 Simplified Prescribing) Special Arrangement 2020.

However, the provisions do not commence at all if that event does not occur.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 100(1) of the National Health Act 1953.

4  Simplified outline of this instrument

This instrument makes a special arrangement to make the supply of certain pharmaceutical benefits to patients who have been prescribed certain pharmaceutical benefits for the purposes of chemotherapy more efficient and convenient.

 

The instrument modifies arrangements for prescribing the supply of pharmaceutical benefits available for general supply, to enable them to be prescribed using a medication chart also used to prescribe the person an infusion or related chemotherapy benefit under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

Note:          Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

 

5  Definitions

(1)    In this Special Arrangement:

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 headed ‘Authorised Prescriber’ for the benefit in Schedule 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

authority prescription has the meaning given by section 5 of the Regulations.

chemotherapy medication chart - see section 8.

chemotherapy medication chart prescription - see section 8.

chemotherapy pharmaceutical benefit has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

electronic chemotherapy medication chart prescription - see section 8.

electronic medication chart system means a software system that is used for prescribing and recording the administration of medicines to persons receiving treatment at or from a public or private hospital.   

eligible private hospital patient has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

eligible public hospital patient has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

infusion has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

medication chart means a chart used for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving treatment in, at or from a hospital, and includes a chart within an electronic medication chart system, whether or not the chart:

(a)    is used for any other purpose; or

(b)   contains any other information.

participating hospital authority has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

related pharmaceutical benefit has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

Note:          Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislation Act 2003.  These terms include:

·      approved hospital authority

·      approved pharmacist

·      approved supplier

·      Chief Executive Medicare

·         pharmaceutical benefit.

(2)    In this Special Arrangement, a reference to the supply of an infusion or a related pharmaceutical benefit refers to supply under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

6  Pharmaceutical benefits covered by this Special Arrangement

             (1)  This Special Arrangement applies to a pharmaceutical benefit that is generally available for supply under Part VII of the Act.

(2)   A pharmaceutical benefit is generally available for supply under Part VII if:

(a)   it does not contain a drug that is subject to a declaration under subsection 85(2A) of the Act; or

(b)   it is not subject to a determination under paragraph 85(8)(a) of the Act; or

(c)   for a pharmaceutical benefit in relation to which a determination under paragraph 85(8)(b) has been made about the circumstances in which the benefit can only be supplied under a special arrangement under section 100 - the supply is not in those circumstances.

(3)   This Special Arrangement does not apply to a pharmaceutical benefit that can only be supplied under Part VII of the Act in accordance with any other Special Arrangement under section 100 of the Act.

7  Application of Part VII of the Act

             (1)  Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

             (2)  A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.

Note:  See subsection 100(3) of the Act.

8  Method of prescribing pharmaceutical benefits   

(1)    An authorised prescriber for a pharmaceutical benefit may only write a prescription for a pharmaceutical benefit under this Special Arrangement (a chemotherapy medication chart prescription):

(a)    for an eligible public hospital patient - by completing a section of a medication chart that also directs the supply of an infusion or a related pharmaceutical benefit to the patient, in accordance with section 41 of the Regulations as modified by this section; or

(b)    for eligible private hospital patient - by completing a section of a medication chart that also directs the supply of an infusion to the patient, in accordance with section 41 of the Regulations as modified by this section.

(2)    A medication chart referred to in subsection (1) (a chemotherapy medication chart) is not required to be in a form approved by the Secretary under subsection 41(5) of the Regulations.

(3)    For a prescription written using a chemotherapy medication chart in an electronic medication chart system (an electronic chemotherapy medication chart prescription):

(a)    paragraph 41(2)(c) of the Regulations does not apply to the completion of a section of the chart; and

(b)    the authorised prescriber must electronically approve the electronic chemotherapy medication chart prescription in the electronic medication chart system; and

(c)    the section of the chemotherapy medication chart must include each authority approval number (if any) for the prescription.

(4)    A prescription written in accordance with this section is taken to be written in accordance with section 41 of the Regulations and Parts 4 and 5 of the Regulations apply as if a reference to a medication chart prescription includes a reference to a prescription written in accordance with this section.

9  Authority required procedures for electronic chemotherapy medication charts

(1)    If a prescription would be an authority prescription, the authority required procedures set out in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 apply with the modifications set out in this section.

(2)   A reference in those sections to a medication chart prescription includes a reference to a chemotherapy medication chart prescription.  

(3)   An electronic chemotherapy medication chart prescription directing the supply of a written authority required pharmaceutical benefit may be authorised as set out in subsections (4) to (8).

Written authority required procedures - submission of electronic chemotherapy medication chart prescription

(4)    The authorised prescriber may submit to the Chief Executive Medicare:

(a)      a copy of the electronic chemotherapy medication chart prescription; or

(b)     details of the prescription, by means of electronic communication to obtain an electronic authority, in accordance with subsection (3).

Note:    For an authority required prescription for a pharmaceutical benefit that is not a written authority required pharmaceutical benefit, the prescription may be submitted in accordance with the procedures set out in paragraph 12(1)(b), (c) or (d), as appropriate, of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

(5)   The details of the prescription submitted in accordance with paragraph (4)(b) must:

(a)      be given to the Chief Executive Medicare in writing; and

(b)     be given by means of an electronic communication; and

(c)      encrypted when given to the Chief Executive Medicare; and

(d)     be given in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.

Written authority required procedures - authorisation of electronic chemotherapy medication chart prescription 

(6)   An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (4)(a) may be authorised by the Chief Executive Medicare signing his or her authorisation on the copy of the prescription, and:

(a)   if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — indicating this on the copy; and

(b)   returning the copy to the authorised prescriber for alteration; and

(c)   the authorised prescriber must enter the authorisation number into the electronic chemotherapy medication chart prescription.

(7)   An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (4)(b) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.

(8)      If the Chief Executive Medicare authorises a prescription under subsection (7):

(a)      the Chief Executive Medicare must tell the authorised prescriber, by telephone or electronic communication, the approval number that has been allotted to the electronic chemotherapy medication chart prescription; and

(b)     the authorised prescriber must enter that number into the electronic chemotherapy medication chart prescription.

10  Supply of pharmaceuticals under this Special Arrangement

(1)   A pharmaceutical benefit may be supplied under this Special Arrangement by:

(a)         a participating hospital authority to an eligible public hospital patient; or

(b)         an approved hospital authority for a private hospital to an eligible private hospital patient; or

(c)         an approved pharmacist to an eligible public hospital patient or eligible private hospital patient.

(2)   However, a participating hospital authority may not supply a related pharmaceutical benefit under this Special Arrangement.

(3)   Subsections 45(2) to (7) of the Regulations, section 47 and section 49 of the Regulations apply to a supply made under this Special Arrangement with the following modifications:

(a)    a reference to a medication chart prescription is taken to include a reference to a chemotherapy medication chart prescription;

(b)   a reference to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital; and

(c)    for an electronic chemotherapy medication chart prescription:

(i)     paragraph 45(2)(c) does not apply;

(ii)   the participating hospital authority, approved hospital authority for a private hospital or approved pharmacist must verify in the electronic chemotherapy medication chart prescription that the pharmaceutical benefit has been supplied and the date on which it was supplied; and

(iii) for section 51, a reference to writing “immediate supply necessary” on the prescription is taken to be a reference to including those words in the electronic chemotherapy medication chart prescription.

(4)    Section 53 the Regulations does not apply to a supply made under this Special Arrangement.

11  Electronic chemotherapy medication chart prescription records

(1)   If an approved hospital authority or approved pharmacist supplies a pharmaceutical benefit under this Special Arrangement, the supplier must keep the chemotherapy medication chart, or a copy of the chemotherapy medication chart, on which the supplier wrote:

(a)    the details required by subsection 45(2)(c) of the Regulations in relation to the prescription; or

(b)   for an electronic chemotherapy medication chart - the verification required by paragraph 10(3)(c) in relation to the prescription.

(2)   The chemotherapy medication chart or copy of the chemotherapy medication chart must be kept for a period of at least 2 years from the date the pharmaceutical benefit is supplied by the approved hospital authority or approved pharmacist.   

12  Modified application of legislative instruments

(1)   A reference to a medication chart prescription in the National Health (Pharmaceutical Benefit) (Condition of approval for approved pharmacists) Determination 2017 is to be taken as including a reference to a chemotherapy medication chart prescription.  

(2)   In the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act:

(a)      a reference to a medication chart prescription is to be read as including a reference to a chemotherapy medication chart prescription; and

(b)     in item 28A of the table to item 1 of Schedule 1, the reference to a paper-based prescription that is a medication chart prescription is to be read as including a reference to an electronic chemotherapy medication chart prescription.