Summary of the example
Valproate containing medicines are indicated for the treatment of epilepsy, bipolar disorder and migraine headache (unlicensed). Valproate is known to be highly teratogenic and use in pregnancy leads to physical birth defects in 10% and neurodevelopmental disorders in approximately 30 to 40% of children. A number of safety initiatives and alerts have been issued, highlighting risks and implications for patients, healthcare professionals and NHS organisations: MHRA/NHSI February 2016: Important information for healthcare professionals on the risks of valproate in female patients: Safety Toolkit NHSI April 2017: Patient Safety Alert (NHS/PSA/RE/2017/002): Resources to support the safety of girls and women being treated Valproate. These resources and safety alerts from the regulatory authorities had limited impact, with continued exposures in pregnancy to valproate containing medicines (400 pregnancies in 2016). The Trust adopted an approach to implementing PREVENT that ensured multi-professional engagement from the outset. The Trust sees this as a driver of the program’s success locally. We are happy to share our experience to date, policy and resources developed.
Why we think it’s important
Approximately 27,000 women of childbearing potential in the UK take valproate, with 1 in 5 unaware of the risks of taking valproate during pregnancy. Over a quarter had not had a discussion with their healthcare professional about the risks. Anecdotal evidence from the Trust’s Consultant Neurologists attending a recent national Epilepsy symposium highlighted that many organisations are still struggling to set up effective systems to ensure compliance with the valproate PREVENT program. We received several requests to share our work. There is a discrepancy between the number of women of child-bearing age taking valproate and those known for follow-up by the neurologists. This is shown by national data published by the MHRA on numbers of women of child-bearing age in each CCG taking valproate. This demonstrates a need for a co-ordinated approach working with primary care to trace and refer patients for specialist follow up.
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Aims and objectives of the work
BHRUT provides specialist Neurology and Neurosciences services including to a significant proportion of female patients of child bearing age that are taking valproate. In addition, the Trust may admit female patients that are taking valproate for bipolar and other psychiatric illness (initiated by specialist Mental Health services). There are fewer of these patients but they potentially represent a greater risk than the Epilepsy cohort due to the unfamiliarity of doctors and healthcare staff working in these settings with the drug, its risks in pregnancy and the national requirements for safeguarding patients. The aim of this work was to:
- Specify and ensure actions in place to safeguard patients under the Pregnancy Prevention Program (PREVENT).
- Ensure all staff aware of their responsibilities under this program and supported to do so with policy and resources
- Provide information to patients and healthcare professionals about the risks associated with the use of valproate during pregnancy
- Ensure information is at the right level for patients to make informed decisions and that this can be evidenced.
- Monitor and report on our compliance
A multidisciplinary working group of the key clinicians and Healthcare staff that dispense, prescribe, administer or review patients on valproate prescriptions met on 3 occasions (6th, 20th July 2018 and 21st Aug 18) to oversee the actions required of the Trust in respect of the National PREVENT program and the previous NHSI Patient Safety Alert. Multi-professional engagement was obtained over the course of the three meetings [see section 5 of the Policy for list of stakeholders]. The meetings were Chaired by the Assistant Chief Pharmacist, and were co-ordinated by the Trust Compliance Group, which this was essential to obtaining multidisciplinary buy-in. The strategy and key actions for all staff were agreed and implemented over the course of the meetings. A policy to support the strategy was developed and approved at the Medicines Optimisation Group and Trust Policy Ratification Panel. This Policy and all the supporting information on the Valproate National Pregnancy Prevention Program was presented at many Trust clinical safety forums and divisional meetings. A Trust-wide launch was supported by Trust Communications department. Systems were set up to safeguard patients and to monitor compliance with the policy. A monthly report was set up on the Trust Electronic Incident reporting system to monitor compliance with the policy. Guidance to standardise reporting of ‘valproate’ associated clinical incidents was issued.
The following critical changes were implemented as a result of this work:
- New Trust Policy: Prescribing of valproate in line with the valproate Pregnancy Prevention Program (PREVENT) Policy
- As a result of the multi-professional stakeholder engagement, clear referral pathways have been set up for patients to receive the necessary specialist inputs under the PREVENT program
- Joint Obstetric/Neurology clinic
- Antenatal care service
- Perinatal mental health service
- Contraception and family planning advice
- A register of adult and paediatric female patients that are taking valproate established and maintained by the Adult and Children’s Epilepsy Specialist Nurses respectively
- The register is being audited to ensure that patients have received an annual risk-assessment. If not they are being called into dedicated clinics.
- A paediatric-specific annual risk-assessment form was developed and shared with MHRA. Subsequently MHRA revised the risk-assessment form for paediatrics. Adopted into Trust Policy in July 2019 review; additional resources were also incorporated (see below) to support clinicians with more challenging issues in respect of the PREVENT program.
- Trust Safeguarding department is providing the MSO with a monthly report on valproate incidents. This then shared with Divisional Quality and Safety Advisors and the Trust Safe Medicines Practice Group.
Risks/unintended consequences identified:
- Prescribing of valproate for unlicensed indications (e.g. migraine) had a negative risk-benefit balance. It has been decided that valproate prescribing for unlicensed indications will no longer be supported and prescriptions will be challenged by pharmacy.
- MHRA Annual Risk Assessment form was too adult-orientated. A paediatric specific annual risk-assessment form was developed. Subsequently the revised MHRA (March 2019) form was adopted.