Supply issues with all valproate preparations: Epilim and Depakote

25 Feb 2019

Sanofi has confirmed that there may be supply issues involving all valproate preparations (Epilim and Depakote)

Sanofi has published a statement confirming that there may be supply issues with all valproate items – this includes the two brands, Epilim and Depakote; there are a total of 17 different valproate-containing treatments available in different formulations and strengths. This is due to a “temporary disruption in the production of valproate” at a manufacturing site outside of the UK, and that this is “not related to Brexit”. It is expected that the disruption will result in lower than usual stock levels in the supply chain.

Stock availability information
Sanofi has confirmed not all valproate items are out of stock.

The table below lists the latest stock availability for those valproate items that are out of stock – this was checked in the afternoon on Monday 25 February 2019:

Table 1: Valproate items which are out of stock as of 25 February 2019

Valproate brand, formulation and strength Availability information Applicable wholesalers
Depakote tablets 500mg Expected week commencing 11 March 2019 AAH and Phoenix
Epilim gastro-resistant tablets 500mg Expected week ending 1 March 2019 AAH and Phoenix
Epilim Chrono tablets 500mg Expected week ending 1 March 2019 AAH and Phoenix
Epilim Chronosphere sachets 1000mg Expected week commencing 8 April 2019 AAH and Phoenix
Epilim Chronosphere sachets 250mg Expected date currently unknown

Advice for pharmacists and pharmacy teams
Pharmacists and pharmacy teams should follow the steps below when a prescription for a valproate item is received:

  1. Check the prescribed valproate item is in stock
    • If the valproate-containing item is in a tablet formulation, ensure the pack size selected for dispensing/ordering, is for 30 and not 100 – following a request from the Medicines and Healthcare products Regulatory Agency (MHRA), Sanofi has reduced the pack sizes; the 100 pack sizes are now expected to return an out-of-stock message
    • Check the NPA medicine shortages list for further stock availability information
  2. If the prescribed valproate item is not in stock:
    • Contact Sanofi Customer Service team on 01483 505515 to check on ordering codes/stock levels
    • Find out from your local AAH/Phoenix depot which valproate-containing item is in stock
  3. Contact the prescriber to discuss an available alternative valproate-containing item if stock of the prescribed one is unavailable – this is to ensure that the patient can continue taking their medication
    • Valproate is listed by MHRA as category 2 if prescribing for epilepsy – patient’s seizure frequency and treatment history should be taken into account when switching between a particular manufacturer’s product; this is a clinical decision to be made by the prescriber
    • The prescription will need to be amended by the prescriber for the alternative valproate-containing item
  4. Ensure all correspondences are recorded on the patient’s medication record, and if applicable, on the pharmacy’s intervention log
  5. Inform the patient of any changes made to their valproate treatment
    • Medication substituted by the prescriber to an alternate formulation may result in a change to dosing frequency

Always remember to highlight the risk of valproate during pregnancy in females of child-bearing age – the NPA patient safety webpage has links to further information, leaflets and resources.

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk.

Produced by the NPA Pharmacy Services team February 2019.