I, Lisa La Rance, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this special arrangement under subsection 100(1) of the National Health Act 1953.

Dated   26 June 2018

Lisa La Rance

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

1 Name of Special Arrangement

 (1) This Special Arrangement is the National Health (Electronic National Residential Medication Chart Trial) Special Arrangement 2018.

(2)  This Special Arrangement may also be cited as PB 49 of 2018.

2 Commencement

This instrument commences on 6 July 2018.

3 Authority

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

4 Definitions

In this Special Arrangement:

Act means the National Health Act 1953.

approved residential care service is an entity whose name, address and approval number are specified in column 2 of an item in the table in the Schedule to this Special Arrangement. 

 authority approval number has the meaning given by the Regulations.

electronic medication order means an order for a medicine made using an electronic medication order chart. 

electronic medication order chart means a chart within an electronic medication order chart system, for a person, that contains all the standard fields set out in the Schedule to the Medication Chart Form – For PBS/RPBS Medication Chart prescriptions for persons receiving treatment in or at a residential care service at which the person is receiving residential care, as in force immediately before the commencement of this Special Arrangement.

Note: the Medication Chart Form – For PBS/RPBS Medication Chart prescriptions for persons receiving treatment in or at a residential care service at which the person is receiving residential care was made under subsection 19AA(5) of the National Health (Pharmaceutical Benefits) Regulations 1960 and continued in effect by section 99 of the Regulations.

electronic medication order chart system means a software system, owned and operated by a software vendor, that is used for prescribing and recording the administration of medicines to persons receiving residential care at a residential care service.

electronic medication order unique identification number means a number issued to an electronic medication order in an electronic medication order chart system. 

NRMC approved supplier means an approved pharmacist whose name, address and approval number are specified in column 3 of an item in the table in Schedule to this Special Arrangement.

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

residential care has the meaning given by the Aged Care Act 1997.

residential care service has the meaning given by the Aged Care Act 1997.

Rules means the rules under subsection 99AAA(8) and subsection 98AC(4) of the Act.

software vendor means an entity whose name and address are specified in column 4 of an item in the table in the Schedule to this Special Arrangement.

telephone authority required pharmaceutical benefit means a pharmaceutical benefit in respect of which a circumstance mentioned in Part 1 of Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for a circumstance code applying to the pharmaceutical benefit includes ‘Compliance with Telephone Authority Required procedures’.

written authority required pharmaceutical benefit means a pharmaceutical benefit in respect of which a circumstance mentioned in Part 1 of Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for a circumstances code applying to the pharmaceutical benefit includes ‘Compliance with Written Authority Required’ procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’.

Note: A number of expressions used in this Special Arrangement are defined in the Act, including the following:

(a)        Chief Executive Medicare

(b)       CTS claim

(c)        PBS prescriber

(d)       pharmaceutical benefit

(e)       Secretary

5              Pharmaceutical benefits covered by this Special Arrangement  

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

(2)      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.

(3)      This Special Arrangement does not apply to the supply of a pharmaceutical benefit in circumstances in which the supply may only be made under Part VII of the Act in accordance with any other Special Arrangement under section 100 of the Act. 

Note: The Minister can:

(a)        declare under subsection 88(2A) of the Act that a particular drug may only be supplied under special arrangements made under section 100; and

(b)       determine under subsection 88(8)(a) of the Act that a particular pharmaceutical benefit may only be supplied under special arrangements made under section 100; and

(c)        determine under subsection 88(8)(b) of the Act that one or more of the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written are circumstances under which the benefit may only be supplied under special arrangements made under section 100.

6              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 the 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.

7 Prescribing of pharmaceutical benefits

Writing prescriptions by completing an electronic medication order chart

(1)      A PBS prescriber may only prescribe a pharmaceutical benefit under this Special Arrangement by creating an electronic medication order within an electronic medication order chart in accordance with the requirements of section 41 of the Regulations, as modified by this section.  

(2)      A prescription for the supply of a pharmaceutical benefit under this Special Arrangement may only be made:

(a)      for a person receiving residential care at an approved residential care service; and

(b)      using an electronic medication order chart system supplied or made available by the software vendor mentioned in column 4 of the table in the Schedule for that approved residential care service.

Creating electronic medication orders - generally

(3)     Paragraphs 41(2)(c) and 41(2)(g) of the Regulations do not apply to the creation of an electronic medication order within an electronic medication order chart.

Note: The exclusion of paragraph 41(2)(g) enables prescriptions using electronic medication orders to be made under the Special Arrangement for pharmaceutical benefits that are referred to in Schedule 8 of the current Poisons Standard (within the meaning of the Therapeutic Goods Act 1989).  PBS prescribers and NRMC approved suppliers remain subject to any restrictions on prescribing or dispensing Schedule 8 drugs in applicable state or territory legislation.

(4)      The PBS prescriber must electronically approve the prescription in the electronic medication order chart system.

Creating electronic medication orders - authority prescriptions

(5)      The electronic medication order must contain each authority approval number (if any) for the prescription. 

(6)      A prescription for the supply of a pharmaceutical benefit made in accordance with this section will be taken, for the purposes of the Regulations (other than section 61) and the Rules, to be a medication chart prescription written in accordance with section 41 of the Regulations.

8 Authority required procedures

(1)      An electronic medication order used to prescribe a pharmaceutical benefit under this Special Arrangement may be authorised under the authority required procedures in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, as modified by this section.

Written authority required procedures - submission of electronic medication order

(2)      Where the pharmaceutical benefit is a written authority required pharmaceutical benefit, the PBS prescriber may submit to the Chief Executive Medicare:

(a)      a copy of the electronic medication order, including the electronic medication order unique identification number; 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.

(3) The details of the prescription submitted in accordance with paragraph (2)(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; and

(e)      contain the electronic medication order unique identification number.

Written authority required procedures - authorisation of electronic medication order 

(4) An electronic medication order submitted in accordance with paragraph (2)(a) may be authorised by the Chief Executive Medicare signing his or her authorisation on the copy of the electronic medication chart order, and:

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

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

(c) the PBS prescriber must enter the authorisation number into the electronic medication order.

(5) An electronic medication order submitted in accordance with paragraph (2)(b) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the PBS prescriber.

(6)      If the Chief Executive Medicare authorises a prescription under subsection (5):

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

(b)      the PBS prescriber must enter that number into the electronic medication order.

9 Supply of pharmaceutical benefits

(1)      An NRMC approved supplier specified in an item in the table in the Schedule to this Special Arrangement may supply a pharmaceutical benefit under this Special Arrangement to a person receiving residential care in the approved residential care service specified in column 2 of that item.

(2)      A pharmaceutical benefit may not be supplied to a person under this Special Arrangement before the prescription for that pharmaceutical benefit is available to the NRMC approved supplier through an electronic residential medication chart system.

(3)      Sections 45, 47 and 51 of the Regulations apply to the supply of a pharmaceutical benefit under this Special Arrangement, with the following modifications:

(a)      a reference to a medication chart prescription is taken to be a reference to an electronic medication order;

(b)      a reference to a supplier or an approved supplier is taken to be a reference to an NMRC approved supplier;

(c)      for section 45:

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

(ii)     a reference to a person receiving treatment in or at a residential aged care facility is taken to be a reference to a person receiving residential care at an approved residential care service; and

(iii)   the NRMC approved supplier, or a person authorised for the purpose by the NRMC approved supplier, must verify in the electronic medication order that the pharmaceutical benefit has been supplied and the date on which it was supplied; and

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

10 Claims for supply of pharmaceutical benefit

(1)      An NRMC approved supplier may make a claim for payment for the supply of a pharmaceutical benefit under this Special Arrangement in accordance with the Rules, as modified by this section.

(2)      Where a claim for payment for the supply of a pharmaceutical benefit of a kind mentioned in subsection (3) is made, for item 23 of the table in Schedule 1 to the Rules the Patient Category details for a patient in the Residential aged care facility patient (medication chart prescription) category are 0 (zero).     

(3)      For subsection (2), the kinds of pharmaceutical benefits are benefits supplied using software made available by Fred IT Group Pty Ltd (ABN 68 109 546 901) and which are:

(a)    written authority required pharmaceutical benefits; 

(b)   telephone authority required pharmaceutical; or

(c)    referred to in Schedule 8 of the current Poisons Standards (within the meaning of the Therapeutic Goods Act 1989).

(4)      If the Chief Executive Medicare notifies the approved supplier in writing that a copy of the electronic medication order is required to be submitted, the approved supplier must submit a copy of the electronic medication order to the Department of Human Services.

Electronic pharmacy records

(5)      For each supply of pharmaceutical benefit based on an electronic medication order in respect of which a claim is made under section 99AAA of the Act by an NRMC approved supplier, the supplier must:

Note: This subsection establishes record keeping requirements that correspond to the requirements contained in section 61 of the Regulations.

SCHEDULE