This article applies to organisations in Australia that employ medical practitioners and pharmacists.

National Health (Pharmaceutical Benefits) Amendment (Medication Charts) Regulations 2024 (Cth)

On 2 October 2024, the National Health (Pharmaceutical Benefits) Amendment (Medication Charts) Regulations 2024 (Cth) (the Amending Regulations) amended the National Health (Pharmaceutical Benefits) Regulations 2017 (Cth) (the Regulations).

What’s changed?

The Amending Regulations clarify the requirements for supplying pharmaceutical benefits from electronic charts. To that end the Amending Regulations have introduced:

• new requirements for writing a medication chart prescription for a pharmaceutical benefit (where the prescription is an electronic prescription)
• new requirements about what an approved pharmacist, an approved medical practitioner or an approved hospital authority must see before making a supply from an electronic prescription written in an electronic medication chart
• a new offence for failing to retain electronic prescriptions.

Further Information

Medication chart prescriptions – electronic prescriptions

PBS prescribers should be aware that under newly introduced regulation 41(1)(c) of the Regulations, PBS prescribers must now only write a medication chart prescription for a pharmaceutical benefit (where the prescription is an electronic prescription), if the electronic prescription is written in an electronic medication chart using an electronic medication chart system. An electronic medication chart system means a software system that:

• is used for prescribing, and recording the administration of, pharmaceutical benefits to a person receiving treatment in or at:
  • a residential care service at which the person is receiving residential care; or
  • an approved hospital; and
• is accessible in real time by approved suppliers for the purposes of:
  • viewing electronic prescriptions written in electronic medication charts within the system; and
  • recording the supply information mentioned in regulation 45(2)(d) in such electronic prescriptions; and
• meets any electronic medication chart system functionality requirements approved by the Secretary of the Department of Health and Aged Care.

Making a supply from an electronic prescription written in an electronic medication chart

Newly introduced regulation 45(2)(aa) of the Regulations now sets out new requirements about what an approved supplier (i.e. an approved pharmacist, an approved medical practitioner or an approved hospital authority) must see before making a supply from an electronic prescription written in an electronic medication chart.

The approved supplier is now required to either view the medication chart in the electronic medication chart system, or (in urgent situations) the approved supplier must view a copy of the electronic medication chart that complies with requirements specified in new regulation 45(2A) and the approved supplier must also ensure that the pharmaceutical supply is made in accordance with new regulation 45(2B). Newly introduced regulations 45(2A) and 45(2B) deal with requirements that must be met in order for an approved supplier to supply pharmaceutical benefits based on a copy of an electronic medication chart, for supply in urgent situations. Under these regulations:

• the copy of the electronic medication chart must meet the information requirements specified in writing by the Secretary of the Department of Health and Ageing under new regulation 45(9);
• the copy of the electronic medication chart must contain a time and date stamp to reflect the time and date of generation of the copy;
• the copy of the electronic medication chart can only be used by an approved supplier to make the supply within 72 hours from the date and time the copy is generated (as indicated by the stamp required); and
• only up to a single maximum PBS quantity for the pharmaceutical benefit can be supplied from the copy of the medication chart on the one occasion of supply on the copy.

New offence for failing to retain documents – electronic medication charts

Finally we note that it is now an offence under regulation 61(1A) of the Regulations for an approved supplier to supply a pharmaceutical benefit on the basis of a medication chart prescription (that is an electronic medication chart), where the approved supplier does not keep the electronic prescription written in the electronic medication chart, or a copy of the electronic prescription, on which the approved supplier wrote the details referred to in regulation 45(2)(d) in relation to the electronic prescription, for at least 2 years from the date the pharmaceutical benefit was supplied by the approved supplier. A breach of this new regulation incurs a sanction of 0.2 penalty units (currently $62.60).

What you should do

Organisations should ensure their medical practitioner and pharmacy staff are made aware of the new requirements for supplying pharmaceutical benefits from electronic charts, and to that end, organisations may wish to circulate this article to such staff. Organisations should also implement adequate record keeping mechanisms to ensure that the organisation does not breach the new offence in regulation 61(1A) regarding the retention of electronic medication charts.