About the shortage of Ordine (morphine) oral liquid

Ordine (oral liquid morphine) is used to manage severe pain and difficult or laboured breathing in many care settings, including cancer treatment and end-of-life care.

Resupply of Ordine (morphine) oral liquid

On 29 June 2023, pharmaceutical company Mundipharma advised the TGA that they were discontinuing supply of all Ordine (morphine) oral liquid medicines in Australia. In January 2024, Arrotex Pharmaceuticals took over sponsorship of these products. 

Ordine 1 mg/mL, 2 mg/mL and 5 mg/mL are now available and Arrotex is anticipating the 10 mg/mL strength will return to supply in April 2025. See the table below for details, including information on the availability of approved overseas-registered alternatives. 

We acknowledge the challenges that the delayed resupply of Ordine has caused both health professionals and patients.
 

To address the ongoing shortage of Ordine products, we approved the supply of a substitute overseas-registered oral liquid morphine product under section 19A of the Therapeutic Goods Act 1989. Several strengths of substitute overseas-registered products remain available for pharmacists to order as Ordine is resupplied to the Australian market.

Pharmacists should contact the approval holder for information on supply and to order these products. Unlike registered products, section 19A products may have special ordering procedures and their availability may vary during the approval period due to factors such as shipping timeframes, sourcing permits and customer demand. We acknowledge that switching between alternative products is not ideal, but continuous supply of specific products is not always possible during significant shortages.

• Morphine sulfate 2 mg/mL oral solution (Hikma, USA) – Available to order on request
  • Sponsor: Medsurge Healthcare Pty Ltd (Ph: 1300 788 261)
  • Section 19A approval from 1 December 2023 
  • Pharmaceutical Benefits Scheme (PBS) approval from 1 December 2023 − interchangeable with Ordine 2 mg/mL but due to the differences in strength and pack size, patients prescribed Ordine 5 mg/mL and 10 mg/mL under the palliative care PBS listing will require a new prescription for this substitute product to be subsidised on the PBS (go to the PBS website for more information)
• MORPHINI HCL STREULI morphine hydrochloride 10 mg/mL oral drops (Switzerland) – Available to order on request
  • Sponsor: Medsurge Healthcare Pty Ltd (Ph: 1300 788 261)
  • Section 19A approval from 1 December 2023
  • This product is PBS approved since 1 March 2024 and is interchangeable with Ordine 10 mg/mL (go to the PBS website for more information)
  • This section 19A morphine oral liquid is not labelled in English. Pharmacists should take care when dispensing and storing this medicine. Extra labels in English that include the chemical name, excipients and all warnings and other information on the original label should be provided by the sponsor. Health professionals should refer to the Dear Healthcare Professional letter and the approved English-language package leaflet that should be supplied in a zip-lock bag with the product. An English translation of the Patient Information Leaflet for this product is available at the bottom of this page.
  • Warning information: This section 19A medicine contains alcohol (1.2% v/v). Pharmacists should check the product is suitable for their patients before dispensing.
• RA-MORPH morphine hydrochloride trihydrate 10 mg/mL oral solution (New Zealand) – Available to order
  • Sponsor: Bridgewest Perth Pharma Pty Ltd (Ph: 1800 161 156)
  • Section 19A approval from 23 February 2024

All section 19A approval holders (the sponsors listed above) may apply for their products to be subsidised through the Pharmaceutical Benefits Scheme (PBS). For the products above that have PBS approval, you can find more information on the PBS website. 

Medicine shortages action group 

We convened a medicine shortages action group meeting to discuss management of the situation when the discontinuation of Ordine oral liquids in Australia was announced, and again when the change of ownership from Mundipharma to Arrotex was announced. The group includes representatives from the TGA and the Department of Health and Aged Care; Palliative Care Australia; The Australian and New Zealand Society of Palliative Medicine; The Society of Hospital Pharmacists of Australia; Palliative Care Nurses Australia; Australian Medical Association; Pharmaceutical Society of Australia; the Pharmacy Guild of Australia; the Medical Oncologists Group of Australia; and Paediatric Palliative Care Australia and New Zealand.

The TGA and representatives of the medicine shortages action group developed advice for patients and their carers, prescribers and pharmacists when the Ordine products were discontinued. We have now updated the information to apply until the full resupply of Ordine morphine oral liquid is complete in April 2025.

Information for patients and their carers

Normal supply of all strengths of Ordine is not expected until April 2025. If the strength you need is not available, talk to your pharmacist or the health professional who prescribed it for you about whether you could use a substitute overseas-registered product.

You may be able to take other oral products available in Australia. Talk to the health professional who is caring for you about what’s best in your situation.

Information for prescribers

Talk to your patients who are taking a strength of Ordine oral liquid product that is currently in shortage about an interim treatment option, such as a substitute overseas-registered (section 19A) medicine (see above). 

Please keep the shortages in mind when prescribing for your patients. Check the table above to see when different strengths are expected to return to normal supply.

Please note and reassure your patients that if the strength of the oral liquid morphine they have been taking is currently in shortage, it will be available in April 2025. In the interim, we have approved several overseas-registered morphine oral liquid products (listed above) under section 19A of the Therapeutic Goods Act 1989. Details about these are on our Section 19A approvals database.

If you are switching a patient to an alternative opioid medicine, you should take care when selecting the starting dose and dosage intervals to reduce the risk of dosing errors and patient harm. You may need to refer your patient to a palliative care or pain specialist if you are unfamiliar with this process.

Information for pharmacists

People who were taking a strength of Ordine oral liquid that is currently in shortage may need an alternative treatment option, such as a substitute overseas-registered (section 19A) oral morphine medicine (see above).

We encourage you to only order what you need to allow for fair distribution to patients. 

Please note and reassure patients that if the strength of oral liquid morphine they have been taking is currently in shortage, it will be available in April 2025. We have approved several overseas-registered morphine oral liquid products (listed above) under section 19A of the Therapeutic Goods Act 1989 that can be used in the interim period. You can find information, including sponsor contact details for orders, on our Section 19A approvals database.

Please be aware that some overseas-registered oral liquid morphine products may contain different excipients or formulations to the Ordine liquid product. You should refer to the package leaflet or Dear Healthcare Professional Letter supplied with the product to ensure it is suitable for a patient.

If a prescriber has switched a patient to an alternative opioid medicine, please be alert to the starting dose and dosage intervals stated to reduce the risk of dosing errors and patient harm. Patients may need to be referred to a palliative care or pain specialist in some cases.

Accessing other discontinued oral opioid medicines

Visit the About the shortage and discontinuation of oral opioids for information about other products, with current approvals for substitute overseas-registered medicines.