Valproate Pregnancy Prevention Programme

Cat Smith Excerpts

Thursday 21st March 2019 Commons Chamber

[Cat Smith (Lancaster and Fleetwood) (Lab)]

I am raising the issue of the valproate pregnancy prevention programme today as a result of tireless campaigning by my constituent Janet Williams. Along with her friend Emma Murphy, Janet, who is here today, launched the Independent Fetal Anti-Convulsant Trust, or INFACT, in November 2012, and they have almost single-handedly kept the issue of disabilities caused by anticonvulsant medication on the political agenda since then. Despite both living in the north-west of England, they regularly travel to and from London to demand action from drug companies, politicians and civil servants, and they simply will not take no for an answer. Mr Deputy-Speaker, you may know that when a woman from Lancashire gets her teeth into something, she is not going to let go. The campaign for justice and to ensure that no families are similarly affected continues, but the fact that progress has been made in recent years is largely down to Janet and Emma.

It may help if I first provide some background to sodium valproate. The drug, a trade name of which is Epilim, is manufactured by Sanofi, among others, and has been prescribed in the UK since the 1970s. Despite its effectiveness for treating certain types of seizures, research has demonstrated that it carries a higher level of risk to the exposed foetus. Around 27,000 women are currently taking sodium valproate in England and Wales. Scientific data demonstrates that around 10% of children exposed to sodium valproate will be born with a major congenital malformation and their IQ is likely to be lower, with 29% requiring additional educational support and 6% being diagnosed with significant social communication difficulties such as autism.

Estimates of the number of children still being affected by this drug vary. In February 2016, the right hon. Member for North Norfolk (Norman Lamb), the then Minister for Life Sciences, stated that 336 children are exposed to valproate every year. Figures from the Clinical Practice Research Datalink suggest that the figure could in fact be 176. However, even the lower number would imply that 7,000 children have been harmed by valproate since it first came on the market in 1973, with a further 28 a month still exposed to it.

Sodium valproate received its licence to be prescribed in the UK in 1973. The first case reporting the effects of sodium valproate during pregnancy appeared in 1981. By 1987, the damages caused by the drug in pregnancy were recognised throughout the medical professional, being given the title of foetal valproate syndrome in 1995. National Archive documents show that the Committee on Safety of Medicines was aware of the dangers of valproate when taken in pregnancy at the time of licensing, but it decided to inform medical professionals while keeping the women taking the medication in the dark. The patient information leaflet for sodium valproate was only changed to highlight the risks during pregnancy in 2000, and the information was sparse even then.

Women and children have been let down by the pharmaceutical industry and successive Governments over many decades, and I hope that they will one day be compensated for the failures that were allowed to occur. However, I want to focus the remainder of my time on addressing how we can ensure that all women of childbearing age taking sodium valproate today are aware of the risks it poses and are able to make informed decisions about their future.

The valproate toolkit was introduced in March 2016 and gave healthcare professionals the opportunity to inform patients voluntarily of the dangers of taking valproate in pregnancy. Sadly, the toolkit failed to achieve its aims. It took the form of a patient booklet, pharmacy cards that were received on collection of a valproate prescription, a healthcare professional booklet and a checklist for specialists.

INFACT surveyed patients and pharmacists, and the two surveys found that around 85% of patients were not receiving the patient booklet and 90% were not receiving the pharmacy card. In a letter from Sanofi on 27 May 2016, INFACT was informed that the patient booklets were not given to GPs, as had previously been indicated by Ministers, but instead had to be downloaded by GPs from the Sanofi website. In designing the pregnancy prevention programme, what lessons have been learned from the failure of the valproate toolkit?

The pregnancy prevention programme, as a mandatory action, was introduced in April 2018 following the failure of the valproate toolkit, which gave healthcare professionals the opportunity to discuss the dangers of valproate with their patients. It was stated:

“To protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)… Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.”

As with the valproate toolkit, the PPP included a booklet to enable patients to understand the risks and a small, credit card-sized information card for pharmacists to provide on dispensing the drug. However, the PPP was strengthened by the addition of an “acknowledgment of risk” form, which was to be signed by the doctor and the patient on the communicating of the risks. For the pharmacist, there was the addition of ensuring that every dispensed prescription of valproate included the patient information leaflet, the credit card-sized information and warning stickers on the white chemist boxes, all of which had been supplied by Sanofi on the instruction of the MHRA.

To get to this stage, numerous meetings had been held over a five-year period to discuss how the information would be designed to be most instructive both to the healthcare professional and the patient, working through the valproate stakeholder network meetings and the expert working group meetings at the MHRA. Following the failure of the first toolkit, patient groups are understandably on guard to ensure they are aware of problems. Worryingly, over a 10-month period INFACT found that the majority of women were not receiving the new pregnancy prevention programme from their doctor or pharmacist.

From December to February, INFACT collected information through a survey of 74 women, which showed: 80% received the white chemist boxes; 40% never received the patient information leaflet, and 41% received it only some of the time; and 78% had never received the small credit card-sized information, with the majority of them never having had warning stickers on their white chemist boxes. During appointments with healthcare professionals, approximately 40% had never discussed the PPP with their doctor, more than 60% had never been asked to sign the “acknowledgment of risk” form, and 73% had never had alternative medication suggested to them.

Those figures indicate that women continue to be failed by their healthcare professionals and pharmacists on the PPP, even though its legislative status has been recognised, with instructions given by the General Pharmaceutical Council to pharmacists and by the MHRA to healthcare professionals.

In the autumn of 2018 proof of the failure, in the form of videos and photographs, was passed to the MHRA and, in turn, to the enforcement agency for investigation, yet we are still awaiting a response to those investigations. The consequences of these findings are deeply troubling. They indicate that women and girls aged between 15 and 45 may still not be being given an informed choice about their medication. They are not being given any information about alternative medications that may be suitable for them, and they are not being asked to sign the “acknowledgement of risk” form by their GP or specialist. On collection of their valproate prescription, they are not receiving any instruction from the pharmacist, nor are they receiving the small credit card-sized information, the patient information leaflet or any warning stickers on the white boxes.

It is worth reiterating that approximately 27,000 women of child-bearing potential are still prescribed sodium valproate every year; that 70% of them have not been offered a change in their medication since April 2018 and the introduction of the PPP; and that approximately 19,000 women are therefore still at risk of becoming pregnant while being prescribed valproate with no instructions from either their doctor or their pharmacist.

In addition to the risks outlined earlier, INFACT has been made aware that folic acid does not have the desired affect when taking sodium valproate and that the dangers to the foetus are no longer dose-related, making it a possibility that all those exposed to valproate in the womb will be affected by it. I would therefore like to ask the Minister to clarify: what assessments have been done to ensure women prescribed valproate receive the PPP and are offered an alternative medication where possible? What assessments are taking place to calculate how many healthcare professionals, including GPs in surgeries and those in pharmacies, complete the PPP with their valproate patients? And what the enforcement agency intends to do to ensure those failing to comply with the PPP have penalties imposed to ensure they do not continue to do so? Finally, I would like to request that the Minister meet me and representatives from INFACT to discuss how we can make sure the PPP works for women, allowing them to make informed choices about their own health and the health of potential future children.