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Written on 23rd November 2021 by Susan Brown

Every community pharmacy in England has been asked to take part in a national clinical audit about their practise in relation to the anti-epileptic drug, valproate.

The Pharmaceutical Services Negotiating Committee (PSNC), which represents pharmacies in negotiations with the government and the NHS, has agreed with NHSE&I that the 2021/22 national clinical audit’s aim will be to reduce the potential harm caused by taking valproate during pregnancy.

The audit is based on a similar valproate audit carried out in 2019/20 by the pharmacies’ quality watchdog, the Pharmacy Quality Scheme (PQS). The PQS audit found that more needs to be done to ensure that women and girls who are taking valproate are given correct information about the drug and its risks to the baby if it is taken in pregnancy.  Those pharmacies which took part in the PQS audit will be able to re-audit their practise in the 2021/22 national clinical audit. Completion of the national audit is mandatory for all community pharmacies as part of their contract with the NHS.

What is valproate?

Sodium valproate is a drug which is very effective in treating people with epilepsy and bipolar disorder. It is often known by trade names, such as Epilim or Epival.

Whilst valproate is often the best treatment to control a patient’s epilepsy, it is very dangerous if taken by a pregnant woman, as it has a high risk of causing serious injury to her baby. Babies who are exposed to valproate during their mother’s pregnancy have a 10% risk of serious birth defects and up to a 40% risk of developmental disability. These injuries include:

  • minor malformations, such as small fingers or toes;
  • major malformations:
    • to the spine, such as spina bifida;
    • to the face and skull, such as cleft palate;
    • to the limbs;
    • to the organs of the body, such as the heart, kidneys and sexual organs;
  • learning and developmental disability, including:
    • FACS or fetal anti-convulsant syndrome, (fetal valproate syndrome, fetal valproate spectrum disorder);
    • delays in walking and talking;
    • speech and language problems;
    • memory problems;
    • low intelligence for their age;
    • autism spectrum disorder (ASD).

Valproate’s association with birth defects has been known since the 1970s. In those days patients relied on their doctors to consider the risks and benefits when prescribing their medicines and, before 1994, manufacturers were not legally required to include information about the risks in the patient information leaflet which came with the drug. It was another ten years until, in  2004, the NICE guidelines made it clear that doctors must give women and girls accurate information and counselling, based on their needs, so that they could make properly informed decisions about their treatment.

In 2018, further steps were taken to try to reduce the harm caused to babies from exposure to valproate during pregnancy. Doctors were banned from prescribing valproate to women of childbearing age, except where no other drug could effectively manage their epilepsy. Where valproate was the only viable treatment, licensing regulations and guidelines set out strict processes which had to be followed when the drug was prescribed, including warning the woman or girl about the risks of valproate in pregnancy, and mandatory contraception under a pregnancy prevention programme (PPP).

Despite these efforts, women were still being prescribed valproate medication without being warned of the risks or taking steps to ensure they do not become pregnant. In 2020,  IMMDS (Independent Medicines and Medical Devices Safety) Review, chaired by Baroness Julia Cumberlege, produced its report, First Do No Harm, condemning the healthcare system’s treatment of women who were prescribed valproate in pregnancy despite the known risk of severe physical and neurological harm to their babies.  

Why is another valproate audit needed?

According to the PSNC, the recently reported results of the 2019/20 valproate audit show that whilst more patients are now aware of the safety considerations, work still needs to be done to ensure that women are given correct information about valproate and the risk of birth defects.

The audit found that of the 12,068 girls or women of childbearing potential who took part in the audit:

  • 5.6% had not been given advice and information about the potential impact of valproate on an unborn child in line with the 2018 updated guidance;
  • 10.6% did not have a copy of the Patient Guide: what women and girls need to know about valproate’;
  • 11.1% did not have a copy of the Patient Alert Card which gives important warnings about valproate;
  • 36.2% of women did not have highly effective contraception which complied with the Pregnancy Prevention Programme;
  • 26.5% of those without adequate contraception were sent back to their GP or specialist to discuss contraception.

Is compensation available for children injured by valproate?

The government has confirmed that despite the recommendations of the Cumberlege Review, it has no plans to set up a  redress agency to compensate valproate victims. This means that the only way to obtain compensation for a child who was injured by exposure to valproate is by making a medical negligence claim on the basis that their mother received negligent GP or hospital advice and care.

Our experienced medical negligence solicitors are already helping families make claims for children who have suffered physical and neurological disability as a result of negligent exposure to valproate.  Compensation can pay for therapies and medical treatment,  specialist equipment, home adaptations and special educational support, and help with essential care.  

If you are caring for a child with physical or neurological disability and would like to find out more about making a claim, you can talk to one of our solicitors, free and confidentially, by contacting us here.