PBS arrangements due to discontinuation of the Ordine brands of morphine hydrochloride trihydrate oral liquids effective 1 December 2023
Page last updated: 1 December 2023
Two new temporarily PBS listings for morphine sulfate will be effective from 1 December 2023. These new products are being listed to address the deletion from the Australian market of morphine hydrochloride trihydrate oral liquids (brand: Ordine).
There will be two brands listed:
- Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL, available in packs of 100 mL and 300 mL bottles, and
- Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL), available in packs of 100 mL and 500 mL bottles.
The Therapeutic Goods Administration (TGA) has temporarily approved the listing of the Martindale Pharma and Hikma medicines as Section 19A products. Section 19A of the Therapeutic Goods Act 1989 allows 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 Martindale Pharma and Hikma brands are overseas registered medicines.
The Martindale Pharma and Hikma brands will be ‘a’-flagged to the Ordine 2 brand for the purposes of substitution at the pharmacy level in the Schedule for General listings. The Palliative Care listings will not be ‘a’-flagged due to the differences in strength and pack sizes, therefore, patients will require new prescriptions.
Changes to PBS Listing effective 1 December 2023:
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Temporary s19A PBS listing of Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL |
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Deletion from the Australian market |
PBS listing from 1 December 2023 |
PBS listing substitution notes |
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Morphine, Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL, Ordine 2 Morphine, Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL, Ordine 5 Morphine, Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL, Ordine 10 |
Morphine Oral solution containing morphine sulfate 10 mg per 5 mL in 100 mL bottle, 1 mL (S19A), Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL
Morphine Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A), Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL |
The 100 mL and 300 mL Martindale brand is ‘a’-flagged to Ordine 2 and Hikma brand for the purposes of substitution at the pharmacy level in the Schedule for General listings. The Palliative Care listings will not be ‘a’-flagged due to differences in strength and pack size; patients will require new prescriptions. 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. |
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Temporary s19A PBS listing of Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL) |
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Deletion from Market |
PBS listing from 1 December 2023 |
PBS listing substitution notes |
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Morphine, Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL, Ordine 2 Morphine, Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL, Ordine 5 Morphine, Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL, Ordine 10 |
Morphine Oral solution containing morphine sulfate 2 mg per mL in 100 mL bottle, 1 mL (S19A), Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)
Morphine Oral solution containing morphine sulfate 2 mg per mL in 500 mL bottle, 1 mL (S19A), Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL) |
The 100 mL and 500 mL Hikma brand is ‘a’-flagged to Ordine 2 and Martindale Pharma brand for the purposes of substitution at the pharmacy level in the Schedule for General listings. The Palliative Care listings will not be ‘a’-flagged due to differences in strength and pack size; patients would require new prescriptions. 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. |
Advice for dispensing from 1 December 2023:
- General schedule prescriptions written prior and from 1 December 2023 for morphine sulfate oral solution 2mg/mL can be filled with either Ordine 2, Martindale Pharma or Hikma brand, provided brand substitution is allowed on the prescription and pharmacies have stock.
- The new Palliative Care listings will not be ‘a’-flagged with the existing Palliative Care listings (Ordine 5, Ordine 10) due to the differences in strength and pack size; patients will require new prescriptions.
- Prescriptions written for morphine oral solution 5mg/mL (Ordine 5) and morphine oral solution 10mg/mL (Ordine 10) cannot be substituted with either Ordine 2, Martindale Pharma or Hikma brands. Patients will require a new prescription.
- 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 webpage for more information regarding Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL and Morphine Sulfate (Hikma) 10 mg/5 mL (2mg/mL) 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.
