About the shortage and discontinuation of oral opioid products

Summary 

• The return-to-supply dates for some strengths of Ordine oral liquid have been further extended. See the table below for more information.
• Oxycodone BNM and Oxynorm (oxycodone hydrochloride) capsule products will continue to be supplied in Australia.
• The supply of some other oral opioid products is still being progressively discontinued.
• Substitute overseas-registered products are available. 
• Patients taking oral opioid products that have been or are being discontinued should consult their prescribing health professional about ongoing treatment options.
• Health professionals should speak with any of their patients currently taking products that are being discontinued and revise their treatment plans, considering the information below.
• Read alerts at our Oral opioids collection page. 
   

As oral opioid medicines are used to manage severe pain and difficult or laboured breathing in many care settings, including cancer treatment and end-of-life care, we understand their importance to the patients who rely on them. We also appreciate that the health professionals who prescribe these medicines for patients with pain and breathing issues are concerned about the availability of suitable alternatives. 

The information that follows describes the supply, shortage or discontinuation status of oral opioid products in Australia and, if it applies, what substitutes are available.

Resupply of oxycodone products  

Pharmaceutical company Boucher & Muir has reversed an earlier decision and will continue to supply Oxycodone BNM capsules in Australia. The 5 mg and 10 mg capsules are now available, but Oxycodone BNM 20 mg will remain in shortage until March 2025.

In October 2023, we advised that pharmaceutical company Mundipharma was discontinuing supply of Oxynorm (oxycodone hydrochloride) capsules in Australia. In June 2024, Mundipharma reversed their earlier decision and will continue to supply Oxynorm capsules. The 5 mg and 20 mg capsules are now available, but the 10 mg strength will remain in shortage until the end of 2024. 

We will update this page as we receive new information.

Resupply of Ordine (morphine) oral liquid

On 29 June 2023, pharmaceutical company Mundipharma advised that they were discontinuing supply of all Ordine (morphine) oral liquid medicines in Australia. In January 2024, Arrotex Pharmaceuticals took over ownership of these products and is anticipating a return to normal supply later in 2024. 

We acknowledge the challenges that the delayed resupply of Ordine is causing both health professionals and patients. The following dates apply for the resupply of the different strengths of morphine oral liquid medicine (currently branded as Ordine but which may be rebranded). The table below also includes information on the availability of approved overseas-registered alternatives to assist with supply until the Australian approved products are available. 

Please visit our About the shortage of Ordine (morphine) oral liquid webpage for more information.

Oral hydromorphone products

Dilaudid hydromorphone 1 mg/mL oral liquid was discontinued in August 2021, but we continue to update the approvals for substitute overseas-registered brands (Hikma and Pharmascience) so that the medicine is available for health professionals to prescribe if needed. 

Jurnista (hydromorphone) prolonged-release tablets were discontinued in April 2023. Alternatives may be available under the Special Access Scheme, which allows prescribers to apply for use of unregistered products for individual patients.

We will update this page as we receive new information about the discontinuations and supply of substitute products.

Discontinued medicines

Mundipharma has also advised us that they will discontinue supply of the following products throughout 2024 and 2025:

• MS Mono (morphine sulfate pentahydrate modified-release capsule) 
• Sevredol (morphine sulfate pentahydrate immediate-release tablet). 

We have approved the supply of an overseas-registered alternative morphine sulfate 10 mg tablet. Anamorph (morphine sulphate 30 mg tablet) also remains available for supply. 

We continue to investigate the need for additional alternative supply options for these products, including the registration and/or supply of new Australian products and access to overseas-registered substitute medicines. We have been meeting with our medicine shortages action group, which includes palliative care specialists, to plan the next steps for patients and healthcare professionals who will be affected by these discontinuations.

You can check for the most up-to-date information about these discontinuations on the Medicine shortage reports database.

Substituting opioid medicines 

The following advice has been developed by the Therapeutic Goods Administration (TGA) and representatives of a medicine shortages action group, which includes palliative care specialists, that has been meeting about the discontinuation of oral opioid medicines since July 2023.

Information for patients and their carers

If you or someone you care for takes an oral opioid product that is being discontinued and you are concerned about ongoing treatment with this medicine, we recommend you talk to the health professional who prescribes it for you.

If there is no stock available at your pharmacy, you can talk to the pharmacist or the health professional who prescribes this medicine for you about whether you could use a substitute overseas-registered product. There are also other oral analgesics available in Australia that you may be able to take. 

Information for prescribers

Talk to your patients who are taking any of the oral opioid products that are being discontinued about an alternative treatment option.

Please note and reassure your patients that we have approved substitute overseas-registered products under section 19A of the Therapeutic Goods Act 1989. You can check the availability details on our Section 19A approvals database. There are also other oral analgesics available in Australia that you may be able to prescribe.

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

Please note and reassure patients and carers that we have approved substitute overseas-registered oral opioid products under section 19A of the Therapeutic Goods Act 1989. You can find information, including sponsor contact details for orders, on our Section 19A approvals database.

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

English translations of the labelling and product information should be provided with substitute overseas-registered medicines if the original labelling and product information is in another language. 

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.