Medicine Supply Notification MSN/2021/004 Voriconazole 200mg powder for solution for infusion Tier 2 - medium impact* Date of issue: 14 January 2021 Summary • Pfizer and Bowmed are currently out of stock of voriconazole 200mg vials. • Bowmed expects resupply w/c 18th January. • Fresenius Kabi remains in stock but cannot support the demands of their non-contracted regions during this period. • Pfizer have sourced an alternative product, packaged for the Saudi Arabian market (English labelled) which can support from w/c 18th January until UK licensed stock is resupplied during the course of February. This stock is unlicensed in the UK. • Specialist importers have indicated that other unlicensed imports can be sourced, lead times vary. Actions Required Trust/Health Board pharmacy procurement teams in Bowmed and Pfizer contracted regions should work with clinical leads and the local Medication Safety Officer (MSO) to ensure the following actions are undertaken where relevant: • review local stock holding of voriconazole 200mg vials against anticipated demand and identify if the organisation will need additional supply to bridge the gap until their supplier is back in stock; • work with their Regional Pharmacy Procurement Specialist (RPPS) to share stock locally, to ensure continuity of care for patients; • consider switching patients to oral voriconazole or using an alternative antifungal agent where clinically appropriate; • if therapeutic switching is not possible/appropriate place orders for imports; and • if Trusts are likely to have multiple unlicensed products in use within the organisation at the same time consideration is given and mitigations put in place to minimise the risk of product confusion and dosing errors. Trust/Health Board pharmacy procurement teams in Fresenius Kabi contracted regions should continue to place orders in line with forecasted demand. *Classification of Tiers can be found at the following link: A Guide to Managing Medicines Supply and Shortages. Page 1 of 3 Supporting Information To help mitigate the shortage, Pfizer has obtained approval from the Medicines and Healthcare products Regulatory Authority (MHRA) to import Pfizer Ltd VFEND (voriconazole) from Saudi Arabia. This stock is unlicensed in the UK. The outer packaging is in English and the PIL is a dual language document in English and Arabic. North West Pharmaceutical Quality Assurance, on behalf of SPS, has performed a national quality assessment, attached to this communication. Pfizer UK has prepared a Dear HCP letter, which will be sent out alongside each order for the Saudi Arabian product. It is also attached to this communication for your information. Ordering Information Unlicensed Saudi Arabian voriconazole (Vfend) 200 mg powder for solution for infusion can be ordered via Alliance: • EAN Code 0 5415 062004074 • Pip Code 8031437 Alternative unlicensed imports The following importer companies have indicated they can source supplies of voriconazole 200mg vials: • Alium Medical • Clinigen • Durbin PLC • Mawdsleys Unlicensed • Smartway • Target • UL Global Pharma • Waymade PLC Quantities available and lead times vary so please contact the companies directly for up to date information. Please note there may be other companies that can also source supplies and that this information is correct at time of issue but is subject to change. Any decision to prescribe an unlicensed medicine must consider the relevant guidance and NHS Trust or local governance procedures. Please see the links below for further information: o Prescribing unlicensed medicines, General Medical Council (GMC); o The supply of unlicensed medicinal products, Medicines and Healthcare products Regulatory Agency (MHRA); and o Professional guidance for the procurement and supply of specials, Royal Pharmaceutical Society (RPS). *Classification of Tiers can be found at the following link: A Guide to Managing Medicines Supply and Shortages. Page 2 of 3 Enquiries Enquiries from NHS Trusts in England should in the first instance be directed to your Regional Pharmacy Procurement Specialist, who will escalate to national teams if required. REGION Full Name Email East Midlands Andi Swain [email protected] East of England James Kent [email protected] London Jackie Eastwood [email protected] North East David Cook [email protected] North West Glenn Harley [email protected] South Central Alison Ashman [email protected] South East Coast Richard Bateman [email protected] South West Danny Palmer [email protected] West Midlands Diptyka Hart [email protected] Yorkshire & Humber David Allwood [email protected] Scotland [email protected] Wales [email protected] Northern Ireland [email protected] All other organisations should send enquiries about this notice to the DHSC Medicine Supply Team quoting reference number MSN/2021/004. Email: [email protected] Communication prepared by pharmacy team at the Commercial Medicines Unit, NHS England & NHS Improvement *Classification of Tiers can be found at the following link: A Guide to Managing Medicines Supply and Shortages. Page 3 of 3 .