PBS arrangements due to discontinuation of Ordine 10 (morphine hydrochloride trihydrate) oral liquids effective 1 March 2024
Page last updated: 1 March 2024
Due to the discontinuation of morphine hydrochloride trihydrate oral liquids (brand: Ordine) from the Australian market, the Department will be temporarily listing an alternative brand, Morphini HCl Streuli oral drops, on the Pharmaceutical Benefits Scheme (PBS), from 1 March 2024:
- Morphine, Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL, Morphini HCl Streuli®, which is presented as oral drops.
The Therapeutic Goods Administration (TGA) has temporarily approved the listing of the Morphini HCl Streuli brand under section 19A of the Therapeutic Goods Act 1989. Section 19A (s19A) of the Therapeutic Goods Act 1989 allows overseas-registered medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply. The Morphini HCl Streuli brand is registered in Switzerland.
The Morphini HCl Streuli brand will be ‘a’-flagged to the Ordine 10 brand for the purposes of substitution at the pharmacy level in the Schedule for General listings, Dental listings and Palliative Care listings.
Notably, the product labelling for Morphini HCl Streuli is in French and German, and it is presented as oral drops, unlike the oral solution form of Ordine 10. 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 with Morphini HCl Streuli.
The strength of the Morphini HCl Streuli brand is similar to that of Ordine 10 which is 10 mg of morphine hydrochloride per 1 mL of the preparation. However, it should be noted that the Morphini HCl Streuli oral drops are packaged in 20 mL bottles, therefore differing in presentation compared to the 200 mL pack size of Ordine 10. Consequently, for General and Dental listings, 10 bottles of Morphini HCl Streuli will be equivalent to one bottle of Ordine 10, and for Palliative Care listings, 20 bottles of Morphini HCl Streuli will correspond to 2 bottles of Ordine 10.
It is acknowledged that this adjustment in pack size may pose distribution, storage and dispensing issues at the pharmacy level.
Changes to PBS Listing effective 1 March 2024:
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Temporary s19A PBS listing of Morphini HCl Streuli morphine hydrochloride 10 mg/mL oral drops (Switzerland) |
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Discontinuation from the Australian market |
PBS listing from 1 March 2024 |
PBS listing substitution notes |
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Morphine, oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL, Ordine 10 |
Morphine, oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A), Morphini HCl Streuli
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In the Schedule for General, Dental and Palliative Care Listings, Morphini HCl Streuli brand is ‘a’-flagged to Ordine 10 brand for the purposes of substitution at the pharmacy level. Morphini HCl Streuli brand is NOT ‘a’-flagged to Ordine 2 and Ordine 5 brand for the purposes of substitution at the pharmacy level. |
Advice for prescribers from 1 March 2024:
- The dosing amount and duration of pain relief are at the discretion of the prescriber, based on their clinical judgement. The s19A product is available in pack size of 20 mL in comparison to the 200 mL of the Ordine 10. Please note that for PBS supply, the maximum prescribed quantity is 10 or 20 bottles of the s19A product. Please carefully consider the supply quantity required by the patient and adjust the prescribed quantity if appropriate.
- Prescriptions for LESS than 10 bottles of s19A product are still eligible for PBS subsidy. Prescribers are encouraged to prescribe the minimum quantity necessary to meet the patient’s needs, to support the quality use of medicines (including safety) and effective stock management of the s19A product.
Advice for dispensing from 1 March 2024:
- The Morphini HCI Streuli oral drops are supplied in 20 mL bottles, with each bottle measuring 35 mm x 85 mm x 33 mm.
- General schedule, Dental schedule and Palliative Care schedule prescriptions written prior to and from 1 March 2024 for morphine hydrochloride trihydrate 10mg/mL can be filled with either Ordine 10, or the Morphini HCl Streuli brand, provided brand substitution is allowed on the prescription and pharmacies have stock.
- Note: Morphini HCl Streuli brand is NOT ‘a’-flagged to Ordine 2 and Ordine 5 brand for the purposes of substitution at the pharmacy level.
- Information regarding maximum quantity packs can be found on the PBS website. Pharmacists should communicate any changes or substitutions to patients at the time of dispensing, ensuring that patients are fully informed and can make decisions about their medication in consultation with their prescriber.
- For authority prescriptions for the 'a' flagged item, approved suppliers may receive a warning message (reason code W162/W163) for substitutions, follow the PBS Online fix instructions.
Please visit the Therapeutic Goods Administration’s s19A approvals database for more information regarding Morphini HCl Streuli morphine hydrochloride 10 mg/mL oral drops (Switzerland) and the shortage of morphine brands.
For information pertaining to PBS listings, including medical and product information for morphine, please visit the relevant PBS webpage.
