Morphine oral liquid

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Contributor
He Ako Hiringa
Brand change

** Updated 29 April 2024 **

All RA-Morph oral liquid strengths are now out of stock or expired. Wockhardt 10mg/5ml (2mg/ml) and Oramorph 2mg/ml are available instead.

Oramorph now has Medsafe approval, but Workhardt brand remains a Section 29 medicine.


Key points

  • The RA-Morph (Pfizer) brand of morphine hydrochloride oral liquid 1mg/ml and 10mg/ml are out of stock, and the remaining 2mg/ml and 5mg/ml strengths expired at the end of March.
  • Pharmac expects supply of RA-Morph 1mg/ml to resume by June 2024, with the other RA-Morph strengths expected to be available again later in 2024.
  • To cover this supply gap, quantities of Wockhardt (Orspec Pharma) brand morphine sulphate oral liquid 10mg/5ml (2mg/ml) and Oramorph 2mg/ml have been secured.
  • Although the two alternative brands have a different morphine salt to RA-Morph (sulphate compared to hydrochloride), this has no impact on the equivalent dose of morphine.1
  • The Wockhardt and Oramorph brands are 2mg/ml preparations (labelled as 10mg/5ml), whereas the lower strength RA-Morph oral liquid was 1mg/ml. All products have differing presentations.
  • Although Wockhart and Oramorph brands of morphine liquid are approved and used in the UK, they have not gone through the Medsafe approval process so can only be supplied under Section 29 of the Medicines Act.2
  • Wockhardt and Oramorph brands of morphine oral liquid are available on a Practitioner's Supply Order (PSO) despite Wockhardt brand being an unregistered (Section 29) medicine. Patient details must be provided to the pharmacy retrospectively.
  • Oramorph contains alcohol (ethanol) 10% v/v as a preservative. The alcohol content in 5 ml of Oramorph is equivalent to that in 10ml beer or 4ml wine. The data sheet for Oramorph outlines that this is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable.

Visit the Medicine funding and supply page on the Pharmac website for regular supply updates.


Why the change?

Morphine oral liquid was previously manufactured by Pfizer, in Perth. The factory has been sold to Lumancia, along with the right to make and sell RA-Morph. Lumacina has confirmed that it can resume manufacturing of RA-Morph for the New Zealand market by mid-2024.


How do brands differ?

The strength and presentation of Wockhardt and Oramorph brand morphine oral liquids are 10mg/5ml (2mg/ml). This differs to that of the lowest RA-Morph brand morphine oral liquid, which is 1mg/ml. Hence, the lowest strength Wockhardt and Oramorph brands are double the strength of the lowest RA-Morph brand. Additionally, both Wockhardt and Oramorph are presented as milligrams per five millilitres, whereas RA-Morph is presented as milligrams per one millilitre (see table). These differences mean prescribers must take extra care.

Table: Morphine oral liquid presentation

RA-Morph Wockhardt and Oramorph
Strength 1mg/ml 2mg/ml
Strength presentation Per 1ml (1mg/ml) Per 5ml (10mg/5ml)
Container 200ml plastic bottles 100ml glass bottles
Colour of liquid Colourless to pale yellow Colourless to pale yellow


Prescribing restrictions for Wockhardt brand

The Wockhardt brand of morphine oral liquid 10mg/5ml is not approved by Medsafe so may only be prescribed and supplied under Section 29 of the Medicines Act 19812 after obtaining informed consent from the patient.

Furthermore, RA-Morph 1mg/ml repeat prescriptions cannot be substituted with Wockhardt 10mg/5ml due to Section 29 legislation requirements; a new prescription is needed.


Section 29 considerations

Prescribing requirements

Two key requirements of prescribing morphine oral liquid under Section 29 include:

  1. Wockhardt brand of morphine oral liquid may only be prescribed by a person registered with the Medical Council of New Zealand (ie, a doctor).
  2. Informed consent must be obtained from the patient.

Useful resources with full details of requirements for prescribing under Section 29 and obtaining informed consent can be found below.

  • Use of unapproved medicines and unapproved use of medicines – Medsafe.2
  • Informed Consent: Helping patients make informed decisions about their care – Medical Council of New Zealand , 2021 (PDF).3
  • Unapproved medicines (and informed consent) – Healthify (patient and clinician resources).4

Supply on PSO

Morphine oral liquids are also available on Practitioner’s Supply Order (PSO), which is usually not possible for unregistered medicine, given Section 29 of the Act requires the patient to be known at the time of supply. However, holding an emergency supply of certain medicines may be essential for patient safety.

Section 29 morphine oral liquid can, therefore, be supplied to medical practitioners on a PSO if patient details can be provided to the pharmacy retrospectively. The dispensing pharmacist should ensure the medical practitioner agrees to supply these details retrospectively.


Additional information for pharmacists

Brand switch fee

Please ensure affected individuals, their whānau and caregivers are counselled on the difference in strength of morphine oral liquid that they are receiving, and that they are aware of what dose (in ml) they need to use. As support for this, a brand switch fee is claimable.1

Caution alert stickers

Stickers alerting to the different strength are being developed for pharmacies to stick on bottles of morphine oral liquid. When available, the stickers will be able to be ordered free of charge through the Bluestar portal (registration required).


Patient resources

References

  1. Pharmac. Morphine oral liquid: Supply issue. Last updated 5 March 2024. pharmac.govt.nz/medicine-funding-and-supply/medicine-notices/morphine-oral-liquid-10-mg-supply-issue
  2. Medsafe. Section 29 of the Medicines Act 1981. hmedsafe.govt.nz/profs/RIss/unapp.asp#section29
  3. Medical Council of New Zealand. Informed Consent: Helping patients make informed decisions about their care (pdf). June 2021. mcnz.org.nz/assets/standards/55f15c65af/Statement-on-informed-consent.pdf (Accessed 6 November 2023.)
  4. Healthify Te Puna Waiora. Unapproved medicines and informed consent. healthify.nz/medicines-a-z/u/unapproved-medicines Accessed 7 November 2023.
  5. Medicines & Healthcare Products Regulatory Agency. UK Public Assessment Report for morphine sulfate 10mg/5ml oral solution (Wockhardt UK Limited). mhraproducts4853.blob.core.windows.net/docs/8578f314166782fab88c460abaa5e219a34d70ff (Accessed 7 November 2023).

Acknowledgements

Written by: Gayle Robins, freelance medical writer and regular contributor to He Ako Hiringa resources

Content updates

7 March 2024: Multiple updates to include Oramorph brand availability and supply status of RA-Morph strengths.

25 March 2024: Oramorph supplies delayed.

12 April 2024: Updated to reflect current supply status.

29 April 2024: Updated after Oramorph gained Medsafe approval.