URGENT Levomepromazine 25mg/ml injection supply issue – information for Primary Care

URGENT Levomepromazine 25mg/ml injection supply issue – information for Primary Care

 

Overview of Supply

  • Sanofi informed NHS England and DHSC on 5th April 2019 that they are going out of stock this week of levomepromazine 25mg/ml injection and new stock is expected to be available from the end of April.
  • The supply issue is due to a quality deviation experienced at their Italian factory and is not linked to EU exit.
  • The only other UK supplier, Wockhardt, have informed us that due to the unexpected increase in demand, they will also go out of stock of levomepromazine injection and their next delivery has been delayed with further stock expected at the end of April.
  • Wockhardt have confirmed the remaining levomepromazine 25mg/mL injection stock which is held at Alliance will be ring-fenced for primary care use only. Stock at Alliance is limited and will not last until the end of April.
  • Existing stocks are likely to be exhausted by end of this week and no new supplies are expected until end of April.
  • GPs, palliative care networks and community pharmacies should consider the following advice and work together during this period to ensure patients can be managed appropriately.

 

Alternative agents

  • UK Medicines Information with support of national clinical specialists have developed the following clinical information to help support the management of patients  who may be affected by this issue.
  • Please follow the link to view this guidance:https://www.sps.nhs.uk/articles/shortage-of-levomepromazine-hydrochloride-25mg-ml-solution-for-injection/
  • All the suppliers of the following medicines have  been made aware of this supply issue and have confirmed they can support an increase in demand should this be required.
  • Haloperidol 5mg/1ml solution for injection ampoules (DrugsRUs)
  • Midazolam 10mg/2ml solution for injection ampoules (Hameln, Accord, Roche)
  • Cyclizine 50mg/ml solution for injection ampoules (Advanz)
  • Metoclopramide 10mg/2ml solution for injection ampoules (Hameln, Ennogen)

 

Management Plan – GPs, Palliative Care Networks and Community Pharmacies to review and action immediately

  1. During the period of shortage, new patients should only be started on levomepromazine if other treatment options have been exhausted. This is to try to avoid disrupting existing treatment regimens where possible whilst acknowledging that for some new patients levomepromazine may be the only option available.
  2. Community pharmacies who require stock for existing patients should order Wockhardt stock from Alliance.
  3. Community pharmacies having difficulty obtaining stock should contact their local secondary care trusts as they have been asked to support primary care and hospices where possible, to understand if they have stock that can be made available to allow the continuation of treatment in existing patients.
  4. Some specialist importers have identified stock they can bring into the UK. Lead times vary between 7-21 days. If community pharmacies are considering ordering unlicensed imports, the community pharmacist will need to inform the prescribing doctor the product being supplied to the patients is an unlicensed product. Please consider placing orders now for 1-2 weeks of stock based on forecasted demand. We are currently aware that Clinigen, Waymade, Alium and Mawdsleys have sourced unlicensed supplies from abroad.
  5. Community pharmacies unable to obtain levomepromazine injection should liaise with the prescriber to discuss using an alternative product as outlined in the memo above.

 

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