National Health (Pharmaceutical Benefits) Electronic National Residential Medication Charts Approval Instrument 2024

PB 136 of 2024

National Health (Pharmaceutical Benefits) Electronic National Residential Medication Charts Approval Instrument 2024

I, Blair Comley, Secretary of the Department of Health of Aged Care make the following instrument.

Dated    11 December 2024

Blair Comley PSM

Contents

1 Name

2 Commencement

3 Authority

4 Definitions

5 Prescribed requirements for electronic medication charts under the Regulations ...2

Schedule 1 — Information Requirements  3

Schedule 2 — System Functionality                     11

Schedule 3 — Copy of an Electronic Medication Chart                   14

1  Name

 (1) This instrument is the National Health (Pharmaceutical Benefits) Electronic National Residential Medication Charts Approval Instrument 2024.

 (2) This instrument may also be cited as PB 136 of 2024.

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.

Note: This table relates only to the provisions of this instrument as originally made.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 section 12A, paragraph 41(5)(b) and subsection 45(9) of the National Health (Pharmaceutical Benefits) Regulations 2017.

4  Definitions

Note: A number of expressions used in this instrument are defined in section 5 of the Regulations, including the following:

(a) authority approval number;

(b) electronic medication chart system.

  In this instrument:

PBS prescriber has the same meaning as in Part VII of the National Health Act 1953.

pharmaceutical benefit has the same meaning as in Part VII of the National Health Act 1953.

pharmaceutical benefits scheme (PBS) has the same meaning as in Part VII of the National Health Act 1953.

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

repatriation pharmaceutical benefit (RPBS) has the same meaning as in Part VII of the National Health Act 1953.

residential care has the same meaning as in the Aged Care Act 1997.

residential care service has the same meaning as in the Aged Care Act 1997.

5  Prescribed requirements for electronic medication charts under the Regulations

1.     Schedule 1 – Information Requirements provides the approved information requirements that must be met in relation to an electronic medication chart. Schedule 1 is only for the purposes of an electronic medication chart that is used for prescribing, supplying and recording the administration of, pharmaceutical benefits to persons receiving treatment in or at a residential care service. The approved information requirements are made under paragraph 41(5)(b) of the Regulations.
2.     Schedule 2 – System Functionality provides the approved electronic medication chart system functionality requirements to facilitate the safe and effective prescribing and supplying of pharmaceutical benefits using electronic medication charts. Schedule 2 is only for the purposes of an electronic chart that is used for prescribing, supplying and recording the administration of, pharmaceutical benefits to persons receiving treatment in or at a residential care service. The approved electronic medication chart system functionality requirements are made under section 12A of the Regulations.  
3.     Schedule 3 – Copy of an Electronic Medication Chart provides the approved information requirements to produce a copy of an electronic medication chart. Schedule 3 is only for the purposes of a chart that is used for prescribing, supplying and recording the administration of, pharmaceutical benefits to persons receiving treatment in or at a residential care service. The approved information requirements to produce a copy of an electronic medication chart are made under subsection 45(9) of the Regulations.

Schedule 1 – Information Requirements

Electronic Medication Chart Information Requirements - PBS/RPBS Electronic Medication Chart prescriptions for persons receiving treatment in or at a residential care service at which the person is receiving residential care.

1.       Residential care service patients

1.                   The information requirements for a patient who is receiving residential care in a residential care service must include the following:
   1.                  the patient's:
      1.           full name; and
      2.          preferred name (if any); and
      3.          date of birth; and
      4.          gender; and
      5.            Unit Record Number (URN) or Medical Record Number (MRN); and
      6.           healthcare identifier; and
      7.        Medicare number; and
   2.                 high resolution photograph of resident; and
   3.                 any number specified on a card, issued by the Commonwealth, as an entitlement number (however described) for the patient; and
   4.                 informed consent to treatment in line with national/state requirements.

2.      Allergies and Drug Reactions (ADRs)

1.                   The information requirements for allergies and drug reactions includes the following:

(a)                the patient's allergies, including:

1.              drugs or other substances that cause allergic reactions; and
2.            the date, type and description of each allergic reaction or a record of no allergies.

(b)             the patient's adverse drug reactions, including:

1.              drugs or other substances that cause adverse drug reactions; and
2.            the date, type and description of each adverse drug reaction or a record of no adverse drug reactions.

3.      Clinical recordings and monitoring

1.                   The information requirements for clinical recording and monitoring must allow for the recording of the following:

(a)                 weight; and

(b)                 height; and

(c)                 falls risk assessment; and

(d)                 sedation and pain scores.

4.      Residential care services

1.                   The information requirements for a residential care service must include the following details of the residential care service:

(a)                 business name; and

(b)                 business address; and

(c)                 Residential Aged Care Service ID.

5.      Period of validity

5.1               The information requirements for the period of validity of the electronic medication chart must not exceed a period of six months.

5.2               The information requirements for the period of validity of the electronic medication chart must include the following details of the chart:

(a)                 commencement date; and

(b)                 expiry date.

6.      PBS prescriber

6.1               The information requirements for a PBS prescriber must include the following details of the PBS prescriber:

(a)                 full name; and

(b)                 address; and

(c)                 PBS prescriber number; and

(d)                 PBS prescribers Healthcare Provider Identifier - Individual (HPI-I); and

(e)                 PBS Prescribers Healthcare Provider Identifier - Organisation (HPI-O); and

(f)                  contact details sufficient to make contact with the PBS prescriber at any time.

7.      Regularly administered and short-term pharmaceutical benefits

7.1               The information requirements for regularly administered and short-term pharmaceutical benefits must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, in line with Pharmaceutical Benefits Scheme requirements, pharmaceutical dose, form and strength; and

(b)                 the pharmaceutical benefit's:

(i)                  date and time of prescribing; and

(ii)                dose; and

(iii)              route of administration; and

(iv)              frequency of administration; and

(v)                 site of administration (if appropriate); and

(vi)              indication for prescribing; and

(vii)            PBS Authority Approval Number/s if required; and

(c)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(d)                 the start time for administration (if necessary); and

(e)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(f)                  specified duration or indication that medicine is to be supplied for duration of chart; and

(g)                 brand substitution indicator

(h)                 Authority Prescription Number; and

(i)                  Closing the Gap (CTG); and

(j)                  PBS/RPBS; and

(k)                 Streamlined Authority; and

(l)                  additional instructions (if any) to be added by the medical practitioner, expressed as 'Additional Instructions'.

7.2               Information requirements for a regularly administered pharmaceutical benefit must also include a record of each administration of the benefit, including the following:

(a)                 pharmaceutical benefit; and

(b)                 form; and

(c)                 strength; and

(d)                 dose; and

(e)                 route; and

(f)                  date and time; and

(g)                 credentials of nurse administering the pharmaceutical benefit.

7.3               Information requirements for a regularly administered pharmaceutical benefit must also include a record of the administration of the benefit if the benefit has been administered by means of a multi-dose pack with the date and time of administration recorded based on accepted naming conventions such as:

(a)                 breakfast; or

(b)                 lunch; or

(c)                 dinner; or

(d)                 bedtime.

8.      Insulin pharmaceutical benefits (non-Pro Re Nata) (non-PRN)

8.1               The information requirements for a pharmaceutical benefit that is insulin and is not required to be administered PRN (as required) must include the following:

(a)             particulars sufficient to identify the pharmaceutical benefit, in line with Pharmaceutical Benefits Scheme Prescribing requirements, pharmaceutical dose, form, strength and units; and

(b)                 the pharmaceutical benefit's:

(i)                  date and time of prescribing; and

(ii)                route of administration; and

(iii)              time for administration; and

(iv)              PBS Authority Approval Number/s (if required); and

(c)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(d)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(e)                 specified duration or indication that medicine is to be supplied for duration of chart; and

(f)                  Authority Prescription Number; and

(g)                 Closing the Gap (CTG); and

(h)                 PBS/RPBS; and

(i)                  additional instructions (if any) to be added by the medical practitioner, expressed as 'Additional Instructions'; and

(j)                  Blood Glucose Level (BGL) range for administration; and

8.2               Information requirements for a pharmaceutical benefit that is insulin and is not required to be administered PRN (as required) must also include a record of each administration of the benefit including the following:

(a)                 date and time; and

(b)                 units/dose; and

(c)                 Blood Glucose Level recording and charting of:

(i)      date and time; and

(ii)    Blood Glucose Level.

(d)                 credentials of the first nurse authorising and administering the pharmaceutical benefit; and

(e)                 credentials of the second nurse authorising and administering the pharmaceutical benefit.

9.      Insulin PRN (as required) pharmaceutical benefits

9.1               The information requirements for a pharmaceutical benefit that is insulin required to be administered PRN (as required) must include the following:

(a)             particulars sufficient to identify the pharmaceutical benefit, in line with Pharmaceutical Benefits Scheme Prescribing requirements, pharmaceutical dose, form, strength and units; and

(b)                 the pharmaceutical benefit's:

(i)                  date and time of prescribing; and

(ii)                route of administration; and

(c)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(d)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(e)                 specified duration or indication that medicine is to be supplied for duration of chart; and

(f)                  Closing the Gap (CTG); and

(g)                 PBS/RPBS; and

(h)                 the maximum dose in 24 hours; and

9.2               Information requirements for a pharmaceutical benefit that is insulin required to be administered PRN (as required) must also include a record of each administration of the benefit including the following:

(a)                 date and time; and

(b)                 units/dose; and

(c)                 Blood Glucose Level recording and charting of:

(i)                  date and time; and

(ii)                Blood Glucose Level.

(d)                 credentials of the first Nurse authorising and administering the pharmaceutical benefit.

10.  PRN (as required) pharmaceutical benefits

10.1            The information requirements for a pharmaceutical benefit, other than insulin, that is required to be administered PRN (as required) must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, in line with Pharmaceutical Benefits Scheme Prescribing requirements, pharmaceutical dose, form and strength; and

(b)                 the pharmaceutical benefit's:

(i)                  date and time of prescribing; and

(ii)                dose; and

(iii)              route of administration; and

(iv)              frequency of administration; and

(v)                 site of administration (if appropriate); and

(vi)              indication for prescribing; and

(vii)            PBS Authority Approval Number/s if required; and

(c)                 the indication for administration of the pharmaceutical benefit; and

(d)                 maximum individual dose or range; and

(e)                 minimum interval between administrations; and

(f)                  maximum dose in 24 hours; and

(g)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(h)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(i)                  specified duration or indication that medicine is to be supplied for duration of chart; and

(j)                  brand substitution indicator; and

(k)                 Authority Prescription Number; and

(l)                  Closing the Gap (CTG); and

(m)              PBS/RPBS; and

(n)                 Streamlined Authority; and

(o)                 additional instructions (if any) to be added by the medical practitioner, expressed as 'Additional Instructions'.

10.2            Information requirements for a pharmaceutical benefit, other than insulin, that is required to be administered PRN (as required) must also include a record of each administration of the benefit including:

(a)                 pharmaceutical benefit; and

(b)                 form; and

(c)                 strength; and

(d)                 dose administered; and

(e)                 route; and

(f)                  reason for administration of the pharmaceutical benefit; and

(g)                 date and time; and

(h)                 credentials of Nurse administering the pharmaceutical benefit; and

(i)                  outcome or effect of medicine and time observation was made; and

(j)                  credentials of Nurse recording the observation.

11.  Variable dose pharmaceutical benefits (non-insulin)

11.1            The information requirements for a pharmaceutical benefit, other than insulin, that is required to be administered at a variable dose must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, in line with Pharmaceutical Benefits Scheme Prescribing requirements, pharmaceutical dose, form and strength; and

(b)                 the pharmaceutical benefit's:

(i)                  date and time of prescribing; and

(ii)                dose; and

(iii)              route of administration; and

(iv)              frequency of administration; and

(v)                 site of administration (if appropriate); and

(vi)              Indication for prescribing; and

(vii)            PBS Authority Approval Number/s if required; and

(c)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(d)                 the start time for administration (if necessary); and

(e)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(f)                  specified duration or indication that medicine is to be supplied for duration of chart; and

(g)                 brand substitution indicator; and

(h)                 Authority Prescription Number; and

(i)                  Closing the Gap (CTG); and

(j)                  PBS/RPBS; and

(k)                 Streamlined Authority; and

(l)                  additional instructions (if any) to be added by the medical practitioner, expressed as' Additional Instructions'.

11.2            Information requirements for a pharmaceutical benefit other than insulin, that is required to be administered at a variable dose must also include a record of each administration of the benefit with the following details:

(a)                 pharmaceutical benefit; and

(b)                 form; and

(c)                 strength; and

(d)                 dose; and

(e)                 route; and

(f)                  date and time; and

(g)                 dose administered; and

(h)                 credentials of the first nurse authorising and administering the pharmaceutical benefit; and

(i)                  credentials of the second nurse authorising and administering the pharmaceutical benefit.

12.  Infusion and Transdermal Patch pharmaceutical benefit additional requirements

12.1            The additional information requirements for prescribing of a pharmaceutical benefit that is an infusion or transdermal patch must include additional instructions to be added by the medical practitioner, expressed as 'Additional Instructions' to capture information of the pharmaceutical benefit, such as:

(a)                 infusion instructions; and

(b)                 infusion liquid; and

(c)                 rate/time; and

(d)                 maximum hourly rate; and

(e)                 daily limits.

12.2            The additional information requirements for prescribing of a pharmaceutical benefit that is a Transdermal Patch must include additional instructions to be added by the medical practitioner, expressed as 'Additional Instructions' to capture information of the pharmaceutical benefit, such as:

(a)                 day for application; and

(b)                 instructions for safe removal; and

(c)                 placement of patch; and

(d)                 minimum 'patch free' time.

13.  Schedule 8 (controlled) pharmaceutical benefits additional requirements

13.1            The additional information requirements for prescribing and administration of a Schedule 8 (controlled) pharmaceutical benefit must include the following:

(a)                 credentials of the second nurse authorising and administering the pharmaceutical benefit; and

(b)                 sedation scores; and

(c)                 functional assessment.

14.  Nutritional supplements pharmaceutical benefits

14.1            The information requirements for a pharmaceutical benefit that is a nutritional supplement must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, including the name and strength, expressed as 'nutritional supplement'; and

(b)                 the pharmaceutical benefit's:

(i)                  date of prescribing; and

(ii)                dose; and

(iii)              route of administration; and

(iv)              frequency of administration; and

(v)                 Indication for use (when relevant); and

(c)                 the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and

(d)                 the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and

(e)                 specified duration or indication that medicine is to be supplied for duration of chart; and

(f)                  brand substitution indicator; and

(g)                 Closing the Gap (CTG); and

(h)                 PBS/RPBS; and

(i)                  additional instructions (if any) to be added by the PBS prescriber, expressed as 'Additional Instructions'.

Schedule 2 – System Functionality

Electronic Medication Chart System Functionality - PBS/RPBS Electronic Medication Chart prescriptions for persons receiving treatment in or at a residential care service at which the person is receiving residential care.

1.       Residential care service patients

1.              The system functionality for a patient who is receiving residential care in a residential care service must:
   1.                  alert for consumers with similar-sounding names; and
   2.                  ensure that the resident’s details include all details listed in paragraph 1.1 of Schedule 1 of this instrument, and are visible on all system screens from which medicines are prescribed, reviewed, supplied or administered.

2.       Allergies and Drug Reactions (ADRs)

2.1               The system functionality allergies and adverse reactions for a patient who is receiving residential care in a residential care service must:

(a)                 allow the user to record administration-related ADRs; and

(b)                 ensure that allergies and ADRs are visible on all system screens from which medicines are prescribed, reviewed, supplied or administered.

3.      Period of validity

3.1               The system functionality for the six month period of validity of the electronic medication chart must:

(a)                 alert all users when chart is nearing expiry - at least three weeks before expiry; and

(b)                 not allow for further prescribing, supply or administration of pharmaceutical benefits past the expiry date.

4.      PBS prescriber

4.1               The system functionality for a PBS prescriber must:

(a)                 validate the PBS Prescribers Healthcare Provider Identifier - Individual (HPI-I); and

(b)                 validate the PBS Prescribers Healthcare Provider Identifier - Organisation (HPI-O).

5.      Regularly administered and short-term pharmaceutical benefits

5.1               The system functionality for a regularly administered and short-term pharmaceutical benefit must ensure:

(a)                 that systems do not default to add Brand; and

(b)                 for short-term medicines, that the system must only enable administration for the duration specified by the prescriber.

6.      Insulin pharmaceutical benefits (non-PRN and PRN)

6.1               The system functionality for pharmaceutical benefit that is insulin must not default to add Brand.

7.      PRN (as required) pharmaceutical benefits

7.1               The system functionality for PRN pharmaceutical benefits must ensure that systems must not default to add Brand.

8.      Variable dose pharmaceutical benefits (non-insulin)

8.1               The system functionality for a pharmaceutical benefit, other than insulin, that is required to be administered at a variable dose must:

(a)                 enable prescribing based on:

(i)                  age; and

(ii)                weight; and

(iii)              body surface area; and

(b)                 automatically calculate the dates that dose changes will apply; and

(c)                 record and capture pathology results necessary for variable dosing; and

(d)                 support variable dosing regimens including tapering regimens and dose rounding; and

(e)                 provide support tools and templates to assist variable dose prescribing and calculations; and

(f)                  must not default to add Brand.

9.      Schedule 8 (controlled) pharmaceutical benefits

9.1               The system functionality for a Schedule 8 (controlled drugs) pharmaceutical benefit must:

(a)                 restrict prescribing of pharmaceutical benefit to maximum quantity as per the Regulations; and

(b)                 restrict prescribing and supply of pharmaceutical benefit as per the Regulations are not permitted for duration of medication chart.

10.  Security and Validation

10.1            The Security and Validation system functionality for electronic medication charts must:

(a)                 maintain audit log records of all medication management transactions, including the following:

(i)                  all changes to medicine orders, and the dose and route of the administered medicine; and

(ii)                all changes to annotations; and

(iii)              the date and time of each transaction; and

(iv)              the name, designation and registration number of the user undertaking each transaction; and

(b)                 ensure all medicine orders and changes to them can be audited and attributed to the person(s) who made the changes.

11.  Additional System Functionality

11.1            The additional system functionality requirements for electronic medication charts must include the following:

(a)                 ensure all suppliers (contracted and non-contracted) have access to the full list of medicine orders on the electronic medication chart in real time; and

(b)                 systems must only display current medicines and ceased medicines for the current medication chart duration; and

(c)                 systems must support documentation of a consumer’s self-administration of their medicines; and

(d)                 enable generation of a copy of an electronic medication chart which:

(i)                  meets information requirements as specified by the Secretary; and

(ii)                each page is date and time stamped.

Schedule 3 – Copy of an Electronic Medication Chart

Copy of a Medication Chart Information Requirements to support supply from a copy of a PBS/RPBS Electronic Medication Chart prescription for persons receiving treatment in or at a residential care service at which the person is receiving residential care, in urgent situations.

1.       Residential care service patients

1.                   The copy of a chart requirements for a patient who is receiving residential care in a residential care service must include the patient’s:
   1.                  full name; and
   2.                  date of birth; and
   3.                  healthcare identifier; and
   4.                  Medicare number; and
   5.                  any number specified on a card, issued by the Commonwealth, as an entitlement number (however described) for the patient; and
   6.                   weight.

2.      Allergies and Drug Reactions (ADRs)

2.1               The copy of a chart requirements for allergies and drug reactions must be easily readable and clearly visible to a person looking at any page of the medication chart, and must include the following:

(a)                 the patient's allergies, including:

1.                   drugs or other substances that cause allergic reactions; and
2.                 the date, type and description of each allergic reaction; and
3.               the patient's adverse drug reactions, including:
4.               drugs or other substances that cause adverse drug reactions; and
5.                  the date, type and description of each adverse drug reaction.

3.       Residential care services

3.1               The copy of a chart requirements for a residential care service must include the following details of the residential care service:

(a)                 business name; and

(b)                 business address; and

(c)                 Residential Aged Care Service ID.

4.      Current Pharmaceutical Benefits

4.1               The copy of a chart requirements for current pharmaceutical benefits is provided below:

(a)                 The information for a regularly administered pharmaceutical benefit must include:

1.                   particulars sufficient to identify the pharmaceutical benefit, including the name, pharmaceutical dose, form and strength, expressed as 'medicine/form/strength'; and
2.                 date of prescribing; and
3.               dose; and
4.               route of administration; and
5.                  frequency of administration; and
6.               prescriber details to satisfy paragraph 6 of Schedule 1

(b)                 The information for a PRN administered pharmaceutical benefit must include:

1.                   particulars sufficient to identify the pharmaceutical benefit, including the name, pharmaceutical dose, form and strength, expressed as 'medicine/form/strength'; and
2.                 date of prescribing; and
3.               dose; and
4.               maximum dose in 24hr; and
5.                  route of administration; and
6.               frequency of administration; and
7.             prescriber details to satisfy Schedule 1 paragraph 4.

(c)                 The information for a short-term pharmaceutical benefit must include:

1.                   particulars sufficient to identify the pharmaceutical benefit, including the name, pharmaceutical dose, form and strength, expressed as 'medicine/form/strength'; and
2.                 date of prescribing; and
3.               dose; and
4.               route of administration; and
5.                  frequency of administration; and
6.               prescriber details to satisfy paragraph 6 of Schedule 1.

(d)                 The information for a variable dose pharmaceutical benefit must include:

1.                   particulars sufficient to identify the pharmaceutical benefit, including the name, pharmaceutical dose, form and strength, expressed as 'medicine/form/strength'; and
2.                 date of prescribing; and
3.               dose; and
4.               route of administration; and
5.                  frequency of administration; and
6.               prescriber details to satisfy paragraph 6 of Schedule 1.

5.      Recently Ceased Pharmaceutical Benefits

5.1               The copy of a chart requirements for recently ceased pharmaceutical benefits within the current chart duration must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, including the name, pharmaceutical dose, form and strength, expressed as 'medicine/form/strength'; and

(b)                 dose; and

(c)                 route of administration;

(d)                 frequency of administration; and

(e)                 prescriber details to satisfy paragraph 6 of Schedule 1; and

(f)                  date ceased; and

(g)                 reason for cessation (if known).

6.      Pharmaceutical Benefit Administration

6.1               The copy of a chart requirements for all pharmaceutical benefit administration must include the following:

(a)                 commencement date; and

(b)                 cessation date; and

(c)                 administration considerations.

7.      Nutritional Supplements

7.1               The copy of a chart requirements for a pharmaceutical benefit that is a nutritional supplement must include the following:

(a)                 particulars sufficient to identify the pharmaceutical benefit, including the name and strength, expressed as 'nutritional supplement'; and

(b)                 date of prescribing; and

(c)                 dose; and

(d)                 route of administration; and

(e)                 frequency of administration; and

(f)                  prescriber details to satisfy paragraph 6 of Schedule1.

8.      Period of validity

8.1               For the 72-hour period of validity of a copy of an electronic medication chart, each page of the copy must include the following details of the chart:

(a)                 commencement time and date of the copy; and

(b)                 expiry time and date of the copy.