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Valproate medicines: are you acting in compliance with the pregnancy prevention measures?

Tuesday, December 18, 2018

The MHRA have released a drug safety update on the supply of Valproate medicines.

Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not received patient information with their dispensed valproate medicine. All healthcare professionals must continue to identify and review all female patients on valproate, including when it is used outside the licensed indications (off-label use) and provide them with the patient information materials every time they attend their appointments or receive their medicines (including the Patient Information Leaflet at dispensing).

Reminder for pharmacists:

  • always provide the statutory Patient Information Leaflet to female patients with a valproate medicine, even when dispensed in a pharmacy ‘white dispensing box’ (plain carton)
  • remind women of the risks and provide with a Patient Card every time they are dispensed a valproate medicine – situations can change and a one-time conversation is not sufficient
  • check whether women are enrolled in the Pregnancy Prevention Programme and have signed a Risk Acknowledgement Form – if not, dispense the prescription and advise the patient to speak to her GP as soon as possible (including by contacting the GP directly if necessary) for a specialist referral
  • GPhC inspectors will be systematically checking compliance with the Pregnancy Prevention Programme during inspections of registered pharmacies (see GPhC statement)
  • ensure materials are placed in a defined area in the pharmacy and that all staff, including locums, know where they are located and aware of the local policies
  • if you require more copies, contact the Sanofi medical information department without delay on 0845 372 7101 or email 

More information can be found on the Government website or get in touch with Adam in the Policy team.