From 1 October 2020, further revisions will be in place for the listings of many opioids on the PBS General Schedule (Section 85). These changes are in addition to the new and amended listings that were made on 1 June 2020 (see Opioids: New and amended PBS listings).
PBS listings for some opioid formulations have been restructured into three treatment phases to reflect the length of time a patient has been treated with both PBS-subsided and non-PBS subsidised opioids:1
- Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months.
- Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months.
- Continuing PBS treatment after 1 June 2020.
The above changes apply to opioids indicated to manage acute severe pain (full/standard pack sizes of immediate release formulations only) and chronic severe pain (modified release formulations) that have ‘authorities for increased maximum quantities and/or repeats'.2
The prescribing instructions for requests for authorisation for increased quantities and/or repeats for these opioids have also been changed to:1
- allow palliative care nurse practitioners to conduct an annual secondary review for palliative care patients
- exempt palliative care patients from the requirement for a secondary annual review when a secondary review is not possible due to the patient’s clinical condition.
The requirement to provide the date of the review and the name of the medical practitioner consulted has also been removed. However, prescribers will need to ensure this information is kept for compliance purposes.2
Some of the clinical criteria wording of PBS-listed opioids has also had minor changes to make it more succinct, without altering the criteria for prescribing. For example, PBS-listed opioids including those for ‘acute severe pain – half pack sizes’ have new wording, ‘patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics’, that was previously explained in two sentences.1
Why were the changes made?
The PBAC recommended additional changes to prescribing instructions to ensure unimpeded access to PBS-listed opioids for patients requiring palliative care.2
PBS listings were also revised to simplify the process for requesting authority approval from Services Australia and ensure prescribers will not be required to repeat the same information for each authority application. These changes also clarify the requirements for increased quantities and repeats in each scenario.2
What else should health professionals know?
With the exception of ensuring unimpeded access to opioids under the PBS for palliative care patients, these changes do not alter how opioids are to be prescribed under the PBS in clinical practice. Pharmacists will continue to be required to ensure PBS scripts have a valid streamlined authority code or authority approval, where relevant.2
Changes to prescribing information and processes
Active ingredient prescribing
On 31 October 2019, active ingredient prescribing regulations were introduced by the PBS under the National Health Act 1953. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.3
Active ingredient prescribing aims to:3
- ensure the identification of active ingredient names on all PBS prescriptions
- increase patient understanding of the medicines they are taking
- promote the uptake of generic and biosimilar medicines.
Under the regulations, prescribers:3
- are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients).
- can include a brand after the active ingredient on a prescription, if the medicine prescribed is likely to pose a patient safety risk if the brand is not specified or to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.
A transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.
Community level electronic prescriptions
On 31 October 2019, Commonwealth legislation changed to recognise electronic prescriptions as a legal prescription for the purpose of PBS-listed medicine supply. Electronic prescribing is part of a wider government strategy to support safer medicine management and improve the efficiency of the PBS. It will not be mandatory, but provides prescribers and their patients with a safe and secure alternative choice to paper prescriptions.
Electronic prescribing aims to:
- improve efficiency in prescribing and dispensing medications
- remove the need for handling and storing a physical paper prescription
- support digital health services such as telehealth services to ensure continuity of patient care
To support the legislative changes, technical upgrades are currently underway to ensure safe, secure and seamless transmission of information of electronic prescriptions between prescribing and dispensing clinical software and to PBS payment systems.
Once in place, two models will be available to support electronic prescription; Token and Active Script List.
More information about electronic prescriptions is available:
- NPS MedicineWise
- Department of Health
- Australian Digital Health Agency FAQs for prescribers and for pharmacists.
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (October 2020). Canberra: Australian Government Department of Health, 2020 (accessed 1 October 2020).
- Pharmaceutical Benefits Scheme. Revised opioid PBS listings for the management of severe pain. Canberra: Australian Government Department of Health, 2020 (accessed 1 October 2020).
- Australian Government Minister for Health. Explanatory Statement - National health (Pharmaceuticals Benefit) Amendment (Active Ingredient Prescribing) Regulations 2019. Canberra: Australian Government Department of Health, 2019 (accessed 1 October 2020)