Since our last article regarding pain medicine shortages, there has been an update about the supply of oral opiates.
The Therapeutic Goods Administration (TGA) has now approved substitute overseas-registered products under section 19A of the Therapeutic Goods Act 1989. (Section 19A approvals database.)
Three substitute medications for Ordine (morphine) oral liquid have now been approved under Section 19A, and 2 of these 3 are now PBS-listed:
- Morphine sulfate 2 mg/mL oral solution (Hikma, USA)
- Morphine sulfate 10 mg/5mL oral solution (Martindale Pharma, UK)
- MORPHINI HCL STREULI morphine hydrochloride 10 mg/mL oral drops (Switzerland)
In addition, the license to supply liquid oral morphine in Australia has recently been transferred from Mundipharma to Arrotex. It is anticipated that there will be continuity of supply of the Arrotex product from August 2024, with gaps in supply of that product between April and July/August 2024.
More details can be found here: About the discontinuation of Ordine (morphine) oral liquid.
Other oral opioid updates include:
- Dilaudid (hydromorphone) 1 mg/mL oral liquid – discontinued in August 2021 but updated overseas-registered substitutes are available (Hikma and Pharmascience). All relevant details are available on the Section 19A approvals database. Check the PBS listing on the PBS website- external site.
- Jurnista (hydromorphone) prolonged-release tablets – discontinued in April 2023 but overseas-registered Camber brand substitutes for 8 mg, 16 mg and 32 mg prolonged-release tablets are available. All relevant details are available on the Section 19A approvals database
Patients taking oral opioid products that have been or are being discontinued should talk to the health professional who prescribes their medicine about ongoing treatment options.
Health professionals should speak with any of their patients currently taking products that are being discontinued and revise their treatment plan, considering all information available. If you are switching a patient to an alternative opioid medicine, it is advised that you take care when selecting the starting dose and dosage intervals to reduce the risk of dosing errors and patient harm. You may need to seek advice from a pain or relevant specialist within your team.
Please follow the Medicine shortage reports database- external site to find information about shortages of reportable medicines in Australia, including those arising from the discontinuation of products. You can use this page to search for all medicines in shortage and find information about management actions, including supply of overseas alternative medicines.
You can also find substitute products subsidised on the Pharmaceutical Benefits Scheme (PBS), on the following link: PBS website- external site.
TGA consultation: ‘Medicine Shortages in Australia – challenges and opportunities’
Please also note that the Therapeutic Goods Administration (TGA) has announced a consultation on ‘Medicine Shortages in Australia – challenges and opportunities’. We encourage you to take this opportunity to express the nature, extent and urgency of problems you are facing with the disruptions in the supply of critical medications.
Submissions are due 12 March 2024 and can be done on an individual basis, with further information and the consultation paper available here.