The outcome of a two-year inquiry in the UK which investigated how the British Healthcare authorities responded to reports of patient concerns regarding the use of sodium valproate (epilim) in pregnancy has today issued their long awaited report.
The inquiry's report is entitled "First Do No Harm" and makes a series of findings concerning the use of sodium valproate (as well as the hormone pregnancy test Primodos and surgical mesh) in the past. It also makes a number of recommendations to be introduced in the UK to ensure the mistakes of the past are not repeated. The key recommendations in the report are as follows:
- That the UK Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- That a Patient Safety Commissioner is appointed. This person would be patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
- Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
- A Redress Agency for those harmed by medicines and medical devices in future should be established.
- The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
- The regulator of medicines and medical devices in the UK, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
- That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
- That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
- Finally, that the UK Government immediately sets up a task force to implement the Review’s recommendations.
The report also made a series of specific findings regarding the use of Sodium Valprate (Epilim) in the UK :
- Sodium valproate was known to be teratogenic in animals at the time of licensing. Despite this, no long-term follow-up was conducted at that time.
- As concerns emerged about the risk of congenital malformations and neurodevelopmental effects warnings given to patients lagged behind that given to doctors.
- Many women were not given enough information about the risks and benefits of their epilepsy treatment and family planning options to make fully informed decisions.
- It took over 40 years for the healthcare system to put into place measures to ensure that women were fully informed of the risk prior to becoming pregnant.
- The Pregnancy Prevention Programme (PPP) sets out the conditions under which all girls and women of childbearing potential should be treated with valproate. Despite these measures, hundreds of women are still becoming pregnant on valproate while unaware of the risks.
Some additional recommendations concerning families affected by valproate include:
- An apology is due, and support is required for those who have suffered avoidable harm.
- Specialist centres should be established for all families affected by teratogenic medication, to provide integrated medical and social care expertise to enable those affected to access the services they need in one place.
- All women and girls of childbearing potential should be written to, asking them to see their general practitioner or specialist to ensure they are receiving treatment in line with the PPP.
We alongside our colleagues in OACS Ireland are very pleased for our colleagues in the UK who now have more answers as to where the system failed them and are a step closer to justice.
We now need to see an independent inquiry ordered in Ireland so families affected here can receive answers to the many questions they have. In response to today's developments in the UK, we have issued a joint statement with OACS Ireland to the media demanding this inquiry. You can read this statement in the 'News' section of our website.