Diamorphine Supply issue: 5mg and 10mg

Background

There are currently two suppliers of diamorphine injection in the UK; Accord and Wockhardt. Recently Accord’s supplier in Germany have experienced quality issues and CMU/DHSC are working closely with Accord and regulators in the resolution of these issues. Having reviewed current stock levels and manufacturing schedules from Wockhardt, even with the additional volumes they are able to provide, the United Kingdom will experience a complete out of stock situation in June 2018.

Based on historical usage and stock available at wholesalers/awaiting release we are expecting to go out of stock of diamorphine 5mg injection week commencing  4^th June 2018 and diamorphine 10mg injection week commencing 11^th June with a resupply date of week commencing 28^th June 2018.

Nb: Accord regions will go out of stock in the next 7 days and so should switch to ordering from Wockhardt until that stock is exhausted.

These are approximate dates and are dependent on the NHS continuing to purchase in line with historical demand over the coming 2 weeks. Any stock piling by trusts/health boards will lead to an earlier out of stock period and reduce the time that the NHS has to brief clinical colleagues and review prescribing guidance.

National Action

• CMU/DHSC are working closely with Accord to resolve the manufacturing issues they are currently experiencing as soon as possible.
• CMU/DHSC are working with Wockhardt as sole supplier of diamorphine (low strength) to secure increased volumes of diamorphine for the UK market from July.
• We have been working with the manufacturers of morphine injection as an alternative to diamorphine. There are currently 3 licence holders of morphine in the UK; Wockhardt, Hameln and Martindale. Wockhardt are currently not manufacturing morphine.  Hameln have stock sufficient to cover forecasted demand in May and June but very little surplus for increased use. Martindale have increased morphine 10mg injection production and based on the manufacturing schedules and volumes to be released they have sufficient to cover the diamorphine 5mg and 10mg gap in June.
• CMU/DHSC have been working with national clinical leads, pharmacy procurement specialists and UKMI and have produced some clinical guidance to help support this supply issue.  The UKMI memo can be found by following this link.
• Further briefings you may wish to review before engaging with clinical staff include the Patient Safety Alert on high dose morphine and diamorphine
• NHS comms to be shared across clinical networks and into primary care.
• We will continue to work with all stakeholders and provide a further update in June.

Recommended Local Action

• Continue to order all strengths of diamorphine in line with historical demand. Any over ordering will lead to the out of stock period shifting into May or new issues with other strengths.
• Do not use diamorphine 30mg injection to cover shortfall as there are insufficient stocks and a risk of miss-selection of medicine.
• Morphine 10mg injection will be available to cover the diamorphine supply issue in June from Martindale. There is not sufficient stock of morphine 15mg injection to support the diamorphine supply issue. Please only order extra stock of morphine as diamorphine injection becomes unavailable locally and do not stock pile.
• Because Hameln’s morphine 10mg injection is preservative free, this can be used for clinical areas which require a preservative free preparation such as Obstetric regional anaesthesia. Outside of contracted regions please only order Hameln stock for obstetric use and ring fence this stock within your trust. There is insufficient Hameln stock to support all clinical areas in June.
• Review and share UKMI guidance with clinical colleagues. You have a two week lead time to engage with clinical colleagues and review/amend clinical guidelines.
• Please cascade onto any relevant networks, who may find this information useful.
• Please let your regional procurement specialist know of any local issues or if you are considering using an alternative other than morphine.

CMU/DHSC will continue to work with all stakeholders and we will provide further updates when available.