The government has now published its full response to the recommendations of the July 2020 IMMDS Review report, ‘First Do No Harm’, into safety concerns into the use of sodium valproate in pregnancy (and two other controversial treatments).
In a statement to Parliament on 21 July 2021, Nadine Dorries, Minister for Patient Safety, Suicide Prevention and Mental Health, provided an update on the government’s response to the review since her previous statement in January 2021.
Current action to improve patient safety includes work towards MHRA reform, the appointment of a Patient Safety Commissioner, and a renewed focus on safe prescription of valproate for those who can’t avoid it. However, the failure to provide a redress scheme or specialised care centres for those left with physical and neurological disability from in utero exposure to valproate reflects the government’s refusal to take responsibility for the widespread, catastrophic, avoidable harm caused by sodium valproate, or act on key recommendations intended to provide them with help. The position remains that valproate victims’ only means of redress is by making a claim for compensation.
Key points for valproate victims from the government’s latest response to the IMMDS Review
The government described the response to the IMMDS Review’s recommendations (in relation to all three treatments) as ‘an ambitious programme of change’, aimed at improving patient safety by:
- improving the way the system listens to and responds to concerns raised by patients;
- strengthening the evidence base (including data) on which decisions are made; and
- improving the safety of medicines and devices, by reforming regulatory frameworks.
Patient Safety Commissioner
Following legislation and an ongoing consultation, the government confirmed its plan to have the UK’s first Patient Safety Commissioner in place in the first half of 2022. The Patient Safety Commissioner will promote the safety of patients and the views of patients and other members of the public in relation to the safety of medicines and medical devices.
Inequality in the healthcare system
The government says it is determined to address the ‘stark inequality’ in the healthcare system which ‘disproportionately fails to listen to women and keep them safe’, as highlighted by the IMMDS review and other reports. One of the ways it intends to do this is through its work to develop the first ever Women’s Health Strategy for England later this year.
In relation to valproate, the government reiterates that, for some women, valproate is the only drug which effectively controls their epilepsy. Therefore, it does not intend to ban the drug completely. However, work will continue to improve the safety of medicines in pregnancy and to ensure that valproate is only prescribed where it is clinically appropriate, for women and girls for whom there is no alternative medicine. The response refers to the letter which the NHS sent recently to all women of childbearing age who are prescribed valproate, providing important safety reminders in relation to contraception, pregnancy and regular prescribing reviews.
Prescription of the drug and compliance with the Pregnancy Prevention Programme, will be monitored via the new valproate registry, with plans to extend the registry to cover other anti-epileptic drugs across the whole of the UK later this year.
In addition, to ensure that valproate prescriptions are dispensed with information setting out how patients can reduce their risks, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering changes to regulations which will require pharmacists to supply sodium valproate in the manufacturers’ original pack with a patient informational leaflet.
The MHRA is also undergoing reforms to:
- improve how it listens and responds to patients and the public;
- develop a more responsive system for reporting when things go wrong;
- strengthen the evidence to help make timely and robust decisions that protect patient safety.
MHRA has appointed a Chief Safety Officer to lead its implementation of the recommendations from the report and is currently consulting on its draft Patient and Public Involvement Strategy which will be published later this year.
The government made clear that it has no plans to set up an independent taskforce to implement the IMMDS Report’s recommendations. It emphasised that the conclusions and recommendations of independent reviews and inquiries cannot be enforced but are merely passed to government ‘for consideration’.
The government referred to the apology that it issued in July 2020 on behalf of the healthcare system to all the affected families for the time it has taken to listen and respond to their concerns. It recognised that the system hasn’t been listening and that it needs to rebuild patient trust. In order to do so, it set up a Patient Reference Group to challenge, advise and scrutinise the government’s response to the IMMDS Report’s recommendations. The Patient Reference Group’s first report was published alongside the government’s response. Its feedback included that:
- It is not enough to listen to patients. Government needs to act on each of the IMMDS Review recommendations to honour those who have been avoidably harmed and ensure the safety of all future patients.
- The lack of a Redress Agency is ‘a massive failing’. Redress schemes must be actioned urgently to support those who have been harmed. Without redress there won’t be change.
Despite this feedback from the Patient Reference Group, the government expressed its ‘sympathy’ for those who have suffered avoidable harm from valproate, hormone pregnancy tests (HPTs), pelvic mesh but refused to set up a Redress Agency provide them with financial help. It also refused to act on the IMMDS Review’s recommendation to set up specialist centres for those affected by valproate in pregnancy, saying that it will work to improve the current care pathways within existing services for children with neurodevelopmental disorders within the NHS.