Oral morphine substitute approved

While Australia awaits a return to normal programming with a new sponsor for Ordine, a Swiss product plugs the gap on the PBS.

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An oral morphine alternative is now available on the PBS following the discontinuation of Ordine 10 oral liquid in Australia.

The TGA announced that Arrotex Pharmaceuticals has taken over sponsorship of the Ordine oral liquid products but until supply resumes it has made Morphini HCl Streuli oral drops available on the PBS.

Morphini contains morphine hydrochloride trihydrate 10mg/ml and can be substituted for Ordine 10 prescriptions at the pharmacy for general, dental and palliative care listings.

The Swiss product is similar in strength to Ordine 10, but it comes in 20ml bottles of drops, rather than the 200ml bottles of liquid that Australians are used to.

So, for dental and general listings, 10 bottles of Morphini replace one bottle of Ordine 10. In palliative care settings, 20 bottles of Morphini replace two bottles of Ordine 10.

The maximum amount that can be prescribed on the PBS is either 10 or 20 bottles. A prescription for fewer than 10 bottles is also covered.

Importantly, the instructions only come in French and German.

“To address potential language barriers, a translated copy of the Summary of Product Characteristics (SmPC), a Dear Patient Letter and a Dear Healthcare Professional letter will be provided in a zip lock bag,” the TGA advises.

Prescriptions can be filled at the pharmacy with either product where brand substitution and stock availability allow.

Temporary substitutions for Ordine 2 and Ordine 5 have also been approved (Morphine sulfate 10mg/5ml oral solution, Martindale Pharma, UK and Morphine sulfate 2mg/ml oral solution, Hikma, USA) but will require new prescriptions.

The discontinuation of the Ordine product was announced last year to great concern from Australian peak health organisations.

Mundipharma, which supplied the drug manufactured by a third party, said “sourcing another manufacturer would not be commercially viable”.

When the announcement was made in July last year, Palliative Care Australia told TMR, “Globally, Australia is the second-largest producer of the raw materials for morphine, yet we are still regularly experiencing supply problems. There is an opportunity here to develop our sovereign capability and manufacture essential medicines right here in Australia.” 

The TGA has advised that the shortage of Ordine was expected to “continue in the short-term” and the new sponsor, Arrotex, expected a return to normal supply in August this year.