About the discontinuation of Ordine (morphine) oral liquid

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

The Therapeutic Goods Administration (TGA) has been notified of Mundipharma’s intention to discontinue supply of all Ordine oral liquid medicines in Australia. All Ordine oral liquid supplies are expected to be depleted between November 2023 and May 2024.

We acknowledge the discontinuation of Ordine oral liquid medicines may cause distress for some patients and we also recognise that many health professionals are very concerned about the future management options for pain and breathing issues for some patient groups.  We are managing the discontinuation of Ordine with high priority.

To help manage the discontinuation of Ordine oral liquid for patients and health professionals, we have granted approval for the supply of several overseas registered morphine oral liquid products under section 19A of the Therapeutic Goods Act 1989.

Pharmacists can access the following section 19A medicines from December 2023, when the supply of lower-strength Ordine is expected to be depleted:

• Morphine sulfate 2mg/mL oral solution (Hikma)
  • Sponsor: Medsurge Healthcare Pty Ltd (Ph: 1300 788 261)
  • Approval from 1 December 2023

• Morphine sulfate 10mg/5mL oral solution (Martindale Pharma)
  • Sponsor:  Link Medical Products Pty Ltd (Ph: 1800 181 060)
  • Approval from 1 December 2023
  • Warning information: This section 19A morphine oral liquid contains ethanol (0.4mL per 5mL) and sucrose (2.25g per 5mL). Pharmacists should ensure that the product is suitable for their patients prior to dispensing.

• MORPHINI HCL STREULI morphine hydrochloride 10mg/mL oral drops (Switzerland)
  • Sponsor: Medsurge Healthcare Pty Ltd (Ph: 1300 788 261)
  • Approval from 1 December 2023
  • This section 19A morphine oral liquid is not labelled in English. Pharmacists should take care when dispensing and storing this medicine. Appropriate auxiliary labels should be provided. Health professionals should refer to the Australian PI for dosing information.
  • Warning information: This section 19A medicines contains alcohol (1.2% v/v). Pharmacists should ensure that the product is suitable for their patients prior to dispensing.

Section 19A approval holders (the sponsors listed above) may apply for their products to be subsidised through the Pharmaceutical Benefits Scheme (PBS). If PBS approval is granted, information and PBS item codes will be found on the PBS website.

We recently convened a medicine shortages action group meeting to discuss management of the discontinuation of Ordine oral liquids in Australia. The group included 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; Medical Oncologists Group of Australia; and Paediatric Palliative Care Australia and New Zealand.

The following advice has been developed by the TGA and representatives of the medicine shortages action group.

Information for consumers and their carers

If you or someone you care for takes Ordine (morphine) oral liquid and you have concerns about ongoing treatment with this medicine, we recommend you talk to your prescriber.

While Ordine oral liquids are still available from pharmacies, all remaining supplies are expected to be depleted by late March 2024. You can talk to your pharmacist or prescriber about whether an overseas-registered morphine oral liquid is suitable for you.

There are other oral liquid analgesics available in Australia and your prescriber is best placed to provide advice about ongoing treatment options.

Information for health professionals

Prescribers should identify patients taking Ordine oral liquid and discuss with their patients the implications of this discontinuation on their treatment plan.

At this time, pharmacists can continue to access Ordine from their usual wholesaler. However, supplies are expected to be exhausted by late-March 2024. While stocks remain available, we encourage pharmacists to only order what they need to facilitate equitable distribution and access for patients.

Prescribers, hospitals and pharmacists should consider reserving remaining supplies of Ordine 1mg/mL oral liquid for paediatric and neonatal patients.

To support continued access, we have granted advance approval for the supply of several overseas-registered morphine oral liquid products under section 19A of the Therapeutic Goods Act 1989 (see above). These products will be available from 1 December 2023 and pharmacists can find information, including sponsor contact details, on our section 19A Database.

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

If prescribers decide to switch patients to an alternative opioid medicine, care should be taken when selecting the starting dose and dosage intervals to reduce the risk of dosing errors and patient harm. Some prescribers may need to refer their patients to a palliative care or pain specialist if they are unfamiliar with switching their patients between opioid analgesic medicines.

Access to other discontinued opioid medicines

Several opioid medicines have been recently discontinued from supply in Australia including Dilaudid (hydromorphone) oral liquid and Jurnista (hydromorphone) prolonged-release tablets.

To facilitate continuity of supply and minimise the impact of these discontinuations for health professionals and consumers, we have approved the supply of several overseas-registered hydromorphone oral liquid and tablets products under section 19A of the Therapeutic Goods Act 1989.
 

• Hydromorphone hydrochloride 8mg extended-release tablets (Camber)
  • Sponsor: Medsurge Healthcare (Ph: 1300 788 261).

• Hydromorphone hydrochloride 16mg extended-release tablets (Camber)
  • Sponsor: Medsurge Healthcare (Ph: 1300 788 261).

• Hydromorphone hydrochloride 32mg extended-release tablets (Camber)
  • Sponsor: Medsurge Healthcare (Ph: 1300 788 261).

• HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473mL (Rhodes)
  • Sponsor: Medsurge Healthcare (Ph: 1300 788 261).
  • This product is listed on the Pharmaceutical Benefits Scheme (PBS). For PBS item codes please go to the PBS website.
  • Important: Allergen warning – This section 19A hydromorphone oral liquid contains sodium metabisulfite and should not be used in patients with hypersensitivity to sulphite-containing medications. Sulphites are not declared on the medicine label.

Pharmacists can access these products by phoning the section 19A sponsor.

Information about the section 19A approvals has been published on the Section 19A Database.