From 1st June 2020, listings for opioid medicines on the Pharmaceutical Benefits Scheme (PBS) will change. The changes will include the addition of listings for smaller maximum quantities as well as updates to existing restriction criteria and arrangements for increased quantities and repeats. These changes are in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and form part of a range of regulatory measures to address the issue of opioid harm in Australia.
The products contained in Table 1 are currently listed on the PBS and have been identified as appropriate for acute pain. The PBAC has recommended the introduction of PBS listings for smaller quantities of these medications with no repeats. Opioids that are currently restricted for use in chronic pain, pain due to cancer, or palliative care are not included in this proposal to reduce pack sizes.
Table 1. Opioid medications considered for reduced pack sizes on the PBS
|Drug||Presentation||Current PBS maximum quantity||Proposed PBS maximum quantity|
|Codeine||Tablet (codeine phosphate 30mg)||20||10|
|Codeine + paracetamol||Tablet (codeine phosphate 30mg + paracetamol 500mg)||20||10|
|Hydromorphone||Oral liquid (hydromorphone hydrochloride 1mg/mL)||1 x 200mL||*|
|Tablet (hydromorphone hydrochloride 2 mg)||20||10|
|Tablet (hydromorphone hydrochloride 4mg)||20||10|
|Tablet (hydromorphone hydrochloride 8mg)||20||10|
|Morphine||Tablet (morphine sulfate 30mg)||20||10|
|Oxycodone||Capsule (oxycodone hydrochloride 5mg)||20||10|
|Tablet (oxycodone hydrochloride 5mg)||20||10|
|Capsule (oxycodone hydrochloride 10mg)||20||10|
|Oral liquid (oxycodone hydrochloride 1mg/mL)||1 x 250mL||*|
|Tramadol||Capsule (tramadol hydrochloride 50mg)||20||10|
*New PBS listings will not be created for liquid formulations until a smaller pack size is available.
Sponsors of relevant medicines have been given 24 months from January 2020 to register new smaller pack sizes with the Therapeutic Goods Administration (TGA). However, the TGA does not have the authority to compel a sponsor to actually supply smaller pack sizes in Australia.
While prescribers are already able to prescribe less than the maximum quantity for existing PBS items, these new listings are intended to simplify the process prior to smaller packs being available. Long-term opioid therapy will still be available on the PBS for the management of chronic pain. However, larger pack sizes and repeats will require authority approval from 1st June 2020. Prescribers must ensure that patients meet the relevant criteria when prescribing opioids under the new Restricted Benefit and Authority Required PBS listings.
Details on all new and amended restrictions will be available for review on the PBS website from 1st June 2020.
- Pharmaceutical Benefits Advisory Committee. Public Summary Document (PSD) December 2019 PBAC Meeting: TGA Prescription Opioid Regulatory Reforms. Canberra: Department of Health; 2019.
- Pharmaceutical Benefits Scheme. Revised opioids PBS listings for the management of severe disabling pain. Canberra: Department of Health; 2020.