GPs to Review 27,000 Women's Valproate Prescriptions

Nicky Broyd

May 02, 2018

The licence for valproate medicines (Epilim, Depakote, and generic brands) has been changed. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) says valproate can no longer be prescribed to women or girls who could become pregnant unless they are taking contraception. The decision follows a European Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)/European Medicines Agency (EMA) announcement in March.

Valproate is prescribed for epilepsy, bipolar disorder, and migraine. If taken during pregnancy it increases the risk of children being born with birth defects and neurodevelopmental disorders.

Primary Care

It's estimated that in primary care there are 27,000 women of childbearing age receiving prescriptions for valproate in primary care. 
 
Within the coming months GPs have been advised to identify all women and girls in their practice who are taking valproate, check that they are on a Pregnancy Prevention Programme (PPP), and refer them for review with a specialist, unless they have already had a review in the last year.

There will be new alerts on GP computer systems to make sure the prescribing changes are established quickly. NHS Digital has worked with GP software suppliers to provide a function for GPs to identify women and girls who are on valproate.
 
Alerts about the drug will also be shown when it is dispensed by pharmacists, smaller pack sizes will be introduced to encourage monthly prescribing, and there will be a pictogram/warning image on valproate labelling.

Professor Helen Stokes-Lampard, chair of the Royal College of GPs, welcomed the changes. In a media statement she said: "GPs are acutely aware of the risks associated with prescribing sodium valproate to women of childbearing age and we welcome this change in legislation as a logical way forward to help ensure our patients' safety." 

Specialists

Under the new regulatory measures introduced by the MHRA, specialist prescribers are advised that if they want to treat a woman of childbearing age with valproate they must be sure there is no suitable alternative treatment. 

If valproate is considered the only suitable drug, the woman must understand the need to avoid pregnancy, be on effective contraception, and be enrolled in the Pregnancy Prevention Programme, which includes the completion of a signed risk acknowledgement form, and an annual review of treatment. 

In a statement on behalf of the Association of British Neurologists (ABN), Professor Mary Reilly, president, and Professor Sanjay Sisodiya, chair of the ABN Epilepsy Advisory Group, said: "It is vital that all neurologists are aware of the changes to the licensing of valproate. We will disseminate information around the new measures to our membership through our publications, website and bulletins. We will also include links to a variety of resources and organisations, including support groups, and remind our membership about the Epilepsy and Pregnancy Register."

The National Institute for Health and Care Excellence (NICE) is working on a full update of its guideline on epilepsy, concentrating on areas where valproate is currently regarded as the drug of choice and where this conflicts with the new position.
 

Pregnancy Prevention Programme 

As part of the PPP the prescriber must:

  • Make sure the patient understands the risks to a foetus of using valproate during pregnancy 

  • Ensure she understands the need to comply with contraception throughout treatment 

  • Sign a form annually, acknowledging the risk 

Dr Asha Kasliwal, president of the Faculty of Sexual and Reproductive Healthcare (FSRH), said in a statement: "Our 2017 clinical guidance on drug interactions with hormonal contraception recommends that women and girls taking sodium valproate use highly effective methods of contraception to avoid an unplanned pregnancy, both during treatment and for the recommended timeframe after discontinuation.

"Methods of contraception which are considered highly effective in this context include long-acting reversible contraceptives (LARCs) such as the copper IUD, levonorgestrel intrauterine system (LNG-IUS), the progestogen-only implant (IMP), and sterilisation. Women should seek advice from a specialist, who will carry out a pregnancy risk assessment and provide evidence-based advice on the most suitable method for them."

The MHRA stresses that no patient should stop taking valproate without medical advice.

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