National Health (Pharmaceutical Benefits) Regulations 2017 amendments

From Pharmaceutical Benefits Scheme
Department of Health and Aged Care 

The Department of Health and Aged Care has reviewed and remade the following instruments, which are effective from 1 April 2024:

As a result of the review, the National Health (Pharmaceutical Benefits) Regulations 2017 (the regulations) have also been amended.

The main amendments to the regulations are as follows:

Patient Signatures Changes

From 1 April 2024, patients are no longer required to sign and date receipt of a pharmaceutical benefit. Additionally, pharmacists are no longer required to certify why it was not practical to obtain a patient acknowledgement of receipt.

Maximum Quantity or Maximum Repeats

The process for seeking authorisation of increases to maximum quantity or maximum repeats in the new section 30 of the Regulations differs from previous version as follows:

  • The prescriber submits details of a proposed prescription to Services Australia rather than submitting the prescription itself or a copy of the prescription.
  • The section has been simplified to remove administrative detail about the different channels a prescriber can use to submit details of the proposed prescription to Services Australia.
  • As Services Australia will now receive details of proposed prescriptions rather than prescriptions that have already been finalised by the prescriber, provisions requiring the prescriber to alter a prescription where requested by the Minister are now redundant and have been omitted.
  • Prescribers can no longer ask the Minister, in practice Services Australia, to send the prescription on to the patient.

Prescriber Bag Changes

Where there is more than one item in a group in the Prescriber Bag Determination Schedule, prescribers may only order the maximum quantity of an item if they do not already have the maximum quantity on hand for the other items within that group.

Regulation 49

Under regulation 49 (previously referred to as regulation 24), original and repeat supplies of pharmaceutical benefits can be supplied at the one time if a medical practitioner, a midwife or a nurse practitioner is first satisfied that certain conditions apply, then endorses the PBS prescription ‘one supply’ or ‘1 supply’ (the words ‘Regulation 49’, ‘Reg 49’, ‘Section 49’, ‘Regulation 24’ or ‘Reg 24’ are also valid for this purpose).

For further information regarding the legislation changes and examples, refer to the Explanatory Statement to the National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024.

Any questions regarding these Legislative Instruments can be sent to PBS@health.gov.au

Pharmaceutical Benefits Scheme
Department of Health and Aged Care
www.pbs.gov.au

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