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Focus on supplying medicines safely: sodium valproate

15 November 2018

This month we are focusing on managing and supplying medicines safely and effectively, which we hope will help pharmacy owners and the pharmacy team continually improve the services they provide to patients and the public.

While the focus of this article is sodium valproate, the principles apply to all medicines.

Managing and identifying the risks associated with pharmacy services including the supply of medicines is essential to improve the outcomes for people using pharmacy services. To do this, it is important that procedures are in place to make sure that medicines are supplied safely. In the case of valproate, it is important that women are made aware of the risks of taking valproate medicines during pregnancy.

Valproate is a treatment for conditions including epilepsy and bipolar disorder. Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Recent guidance from the MHRA states: "Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant."

For women and girls, when they are dispensed valproate, they should expect:

  • to be provided with a Patient Card every time valproate is dispensed
  • for valproate to be dispensed with a copy of the patient information leaflet, and if repackaged, with a warning on the container supplied
  • to be reminded of the risks in pregnancy and the need for highly effective contraception, and a reminder of the need for annual specialist review
  • to be asked if they have received the Patient Guide

Pharmacy professionals play a vital role in delivering care and helping people to maintain and improve their health and wellbeing.  Our standards for pharmacy professionals describe how safe and effective care is delivered through person-centred professionalism and the importance of involving, supporting and enabling people when it comes to their health.

This includes communicating effectively and making sure the person has all the relevant information in a way they can understand it, to make informed decisions and choices. Patient information leaflets and other supporting materials are helpful in providing this information which reinforces conversations already had with the pharmacy professional.

Patient safety is our highest priority and it is essential that pharmacy professionals familiarise themselves with the guidance from the MHRA and the importance of the Valproate Pregnancy Prevention Plan (PPP).

When inspecting pharmacies, our inspectors are looking to see whether our standards are being met, and will systematically check compliance with the PPP for valproate during inspections of registered pharmacies.

Resources     

  1. The MHRA’s guidance and supporting materials on Valproate use by women and girls is available on the .GOV.uk website
  2. The pharmacy organisations represented on the MHRA’s Valproate Stakeholder Network have produced a joint resource for pharmacy teams which builds on the MHRA’s national toolkit for all healthcare professionals,
  3. Information for women and girls taking valproate is available on the Epilepsy Society website and on Mind's website.

Image: The Epilepsy Society

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