PrescQIPP

Implementation in primary care of patient safety alert issued by NHS Improvement and the MHRA: Resources to support the safety of girls and women who are being treated with valproate (2018)

Sheffield CCG

Introduction

Valproate use during pregnancy is associated with an increased risk of birth defects and development delay. Consequently, a review was undertaken of girls and women of childbearing potential who were prescribed valproate in primary care to ensure that:

  • The risks of birth defects and developmental disorders when taking valproate during pregnancy had been discussed.
  • Adequate contraception was being prescribed.
  • Patients lacking evidence of both or one of the above were highlighted to GPs for review.

How was the project established? / How is it currently being established?

In January 2015 and February 2016 the MHRA issued communication and resources in relation to valproate prescribing and the risk of abnormal pregnancy outcomes and developmental disorders.

Following on from this in April 2017, an NHS Improvement MHRA patient safety alert (PSA), NHS/PSA/RE/2017/002, was issued due to concerns that actions had not been undertaken by all providers of NHS funded care. The alert asked all organisations, including GP practices, to undertake systematic identification of girls and women who are taking valproate, and ensure the MHRA resources were used to support them to make informed choices.

This was discussed at Sheffield CCG's Medicines Safety Group and an action plan agreed. One of the components of the action plan was that a review of females taking valproate, up to 50 years of age, would be undertaken by the Medicines Management Team (MMT). The review was carried out by the medicines management technicians with support from pharmacists where required. See supporting information 'Action sheet – Valproate in pregnancy' and 'Valproate data collection sheet'.

Link to PSA:
https://improvement.nhs.uk/documents/911/Patient_Safety_Alert_-_Resources_to_support_safe_use_of_valproate.pdf

Who are the main beneficiaries of the project? How would they benefit?

  • Females of childbearing potential who are taking valproate are fully informed of the risks of taking valproate during pregnancy, the need to take adequate contraception and, if planning a pregnancy, the need to discuss this with their doctor.
  • Pre-pubertal girls and/or their carers are aware of the risks of valproate; that a change in treatment may be required when the girl reaches childbearing potential; and the need for effective contraception if they remain on valproate.
  • GPs supported with the implementation of the PSA through identification of patients needing a review. GPs were able to prioritise those needing a referral to secondary care specialist.
  • Assurance for NHS Sheffield CCG, Sheffield Teaching Hospitals, Sheffield Health and Social Care Trust and Sheffield Children's Hospital that action with regards to the PSA had been undertaken in primary care.

What were the main outcomes and / or achievements of the project?

This work supported the safe prescribing of valproate in Sheffield.

A total number of 194 female patients aged up to 50 years of age were identified and their records reviewed.

  • 79 (41%) patients had documented evidence that the risks of birth defects and developmental disorders associated with valproate use in pregnancy have been discussed.
  • 63 patients were found to be on adequate contraception.
  • 119 patients were highlighted to a GP as needing a review for a discussion about the risks of taking valproate during pregnancy and/or adequate contraception.

See full project pack – Sheffield CCG MMT valproate summary

The project facilitated collaborative working across the primary care/secondary interface. Secondary care are not able to readily identify the number of relevant patients prescribed valproate in primary care; some may no longer be under regular review in secondary care. The data collected indicated the potential workload for secondary care specialists.

Despite several communications from the MHRA our review highlighted that a large number (59%) of girls and females of childbearing potential who were taking valproate had no documented evidence that a discussion about the risks associated with its use had been discussed.

Subsequent to the initial data collection, the plan was to follow up the patients highlighted for review to establish what action had been taken by the GP. In the short term, a reminder was sent to the prescribing leads at the practices by a senior MM manager to encourage review of the patients referred to them by the team member.

However, in April 2018 further developments were taken by the regulatory authorities. Following a scientific review of the available evidence relating to the effectiveness of previous regulatory action and consultation with healthcare professionals and patients, the EMA and MHRA strengthened the regulatory position: valproate is now contraindicated in women of child-bearing potential unless they meet the conditions of the Pregnancy Prevention Programme. New materials were introduced to support this programme, including an annual risk acknowledgement form to be signed by the specialist and the patient/carer. This was reinforced by an alert from the Chief Medical Officer to encourage implementation of the new contraindication.

We considered that the work carried out by the team enabled GPs to be in a strong position to implement the new recommendations. Further discussions have been held with secondary care specialists regarding the annual review and shared care arrangements updated. In view of these changes, rather than a follow up review, it was agreed that an audit should be undertaken by the MMT in Jan 2019 to assess the level of compliance with the new measures.

Link to MHRA Drug Safety Alert:

https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met

Link to CMO alert:

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102736