Supply Disruption Alert: Diazepam RecTubes® 2.5mg Rectal Solution (Wockhardt UK Ltd)

Issue date: 11th October 2021

Alert reference: SDA/2021/013

The Department of Health and Social Care (DHSC) and NHS England and Improvement (NHSE&I) have issued a supply disruption alert for Diazepam RecTubes® 2.5mg Rectal Solution (Wockhardt UK Ltd)

Wockhardt UK Ltd, have discontinued Diazepam RecTubes® 2.5mg Rectal Solution due to manufacturing issues with stocks expected to be exhausted by March 2022.

Diazepam RecTubes® 2.5mg are licensed for use in patients aged 1 year and above for the treatment of epileptic and febrile convulsions, acute severe anxiety and agitation, tetanus and as a sedative in minor surgical and dental procedures or other circumstances where a rapid effect is required but where intravenous injection is not appropriate.

Diazepam RecTubes® 2.5mg are used off-label in children under 1 year old.

Summary

• Diazepam RecTubes® 2.5mg have been discontinued in the UK.
• Remaining supplies are expected to be exhausted by March 2022.
• Diazepam RecTubes® are licensed in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus and as a sedative in minor surgical and dental procedures or in other circumstances where rapid effect is required and where intravenous injection is not appropriate.
• Diazepam RecTubes® 2.5mg are mainly used in the management of status epilepticus and convulsions in neonates (off-label) to deliver doses of 1.25mg- 2.5mg doses and repeated if required.
• Clinicians across healthcare settings should review all patients prescribed Diazepam RecTubes® 2.5mg and relevant local guidelines/ protocols which recommend the use of Diazepam RecTubes® 2.5mg to consider alternative preparations where appropriate.
• Diazepam 5mg/ 2.5mL rectal solution remain available and can support an uplift in demand.
• Alternative parenteral and non-parenteral preparations remain available.

Action

All healthcare professionals in primary and secondary care including Ambulance Services should be aware of the following advice and should:

• not initiate new patients on Diazepam RecTubes® 2.5mg; and
• update patient’s epilepsy passport/ child’s emergency care plans immediately if any changes to treatment are required (see supporting information below).

Secondary care:

Pharmacy teams, specialist clinicians and Medication Safety Officers should;

• ensure local guidance and formularies are reviewed and amended to replace Diazepam RecTubes® 2.5mg with an alternative preparation and provide appropriate education and training to staff where required; and
• ensure patients currently prescribed Diazepam RecTubes® 2.5mg (including those referred from primary care) are reviewed in a timely manner and prescribed an alternative preparation with individualised management plans agreed, enacted, and communicated to the patients GP; and
• parents/carers are counselled appropriately on the new treatment regimen including when to access emergency assistance where required.

Prescribers, GPs and Ambulance services should refer to the supply disruption alert for guidance on the action to be taken details of alternate preparations for consideration for use in neonates .

Enquiries

All other organisations should send enquiries about this notice to the DHSC Medicine Supply Team, quoting reference number SDA/2021/013
Email: DHSCmedicinesupplyteam@dhsc.gov.uk

View the full supply disruption alert here.