Dispensing valproate for girls and women

Quick reference guide

Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme (PPP) is in place. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a on 24 April 2018 outlining this change. Pharmacists are advised to familiarise themselves with this update, which includes actions for pharmacists, as well as information on the conditions and guidance for the PPP. 

The MHRA published a further on 24 May 2018 which includes new materials to support the pregnancy prevention programme. These include: 

  • – to be given by pharmacists to all female patients who are dispensed valproate medicines to inform them of the risks
  • – to be provided to girls (of any age) and women of childbearing potential (or their parent/caregiver/responsible person) taking any medicine containing valproate
  • – for all prescribers, pharmacists, and other healthcare providers involved in the care of women and girls of childbearing potential using valproate medicines
  • – for the specialist and patient (or their parent/caregiver/responsible person) to sign at initiation and at treatment reviews at least every year. The patient should receive a copy of the form; one copy should be filed in the specialist notes, and one copy sent to the patient’s GP

 

A joint resource has been developed to support pharmacy teams in helping women and girls who have been prescribed valproate medicines. It has been developed in partnership by the pharmacy organisations represented on the MHRA’s Valproate Stakeholder Network, including the Community Pharmacy Patient Safety Group, Community Pharmacy Northern Ireland, Community Pharmacy Scotland, Community Pharmacy Wales, the Londep, the Pharmacy Forum of Northern Ireland and the Pharmaceutical Services Negotiating Committee. 

The resource builds on the MHRA’s national toolkit for all healthcare professionals and enables pharmacists to understand where they can advise and help patients.  It also aligns closely with a clinical audit on valproate safety that the Company Chemists’ Association launched in June 2018.  


Advice for all patients (male and female)

  • Advise patient of the need for regular reviews and monitoring including liver function and full blood count. See the latest version of the BNF for further guidance 
  • Advise patients or their carers of how to recognise the signs and symptoms of blood or liver disorders and pancreatitis, and to seek medical attention if these develop
  • Remind patient to avoid abrupt withdrawal. Do not stop treatment without consulting your doctor – risk of status epilepticus and sudden unexpected death in epilepsy 
  • Patients should be recommended not to drink alcohol whilst taking valproate medicine 
  • Pharmacists should provide driving advice for patients using valproate - see ,  and .

Additional considerations

  • Pharmacists are advised to report any suspected side effects to valproate medicines via the Yellow Card Scheme ()
  • Brand continuity in antiepileptic use: Consider the MHRA guidance Antiepileptics drugs: changing between different manufacturers’ products
  • People using services such as prescription collection and delivery are more likely to have little, if any, personal with the pharmacist. The RPS Repeat medication management, prescription collection and delivery services guidance provides advice on what to do in these scenarios.

 

Where to go for further information

rps resources

external resources

  •  and  - MHRA Drug Safety Updates
  •  - NICE Pathways

 

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