Implementing valproate safety measures demonstrate multiple improvements

Context

Since 2018 valproate has been contraindicated in women of childbearing potential unless conditions of the Pregnancy Prevention Programme (PPP) are met. Physical birth defects in 11% of babies, and neurodevelopmental disorders in 30-40% of children are associated with valproate exposure in pregnancy. A National Patient Safety Alert was issued in November 2023 to alert organisations to new regulatory measures for the oversight of prescribing to new patients and existing female patients.

A review was undertaken within an NHS hospital trust involving collaborative working with North West London (NWL) Integrated Care Board, focussing on patients prescribed valproate.

Problem

Data from the Medicine and Pregnancy Registry show pregnancies in England continue to be exposed to valproate. For some patients, their valproate prescription was not provided in the manufacturer’s original pack which contained specific warnings or information to alert them to the risks to unborn babies if valproate is used in pregnancy. Regulatory measures were introduced to prescribing and dispensing valproate to ensure valproate is used only if other treatments are ineffective or not tolerated, and use in women of childbearing potential is in accordance with the PPP.

Intervention

A Trust action plan was developed to review and monitor compliance to new regulations, to ensure full pack dispensing, valproate initiation by two independent specialist prescribers for patients under 55 years, and completion of risk acknowledgement form, with counselling. 

Collaborative working with NWL Medication Safety Officers (MSOs) and the integrated care sector was established through a new valproate integrated quality improvement group. A data analytics platform was used to identify patients prescribed valproate.

Additional safety measures (implemented within 6 months): 

• Correspondence to pharmacy team and specialists informing of new regulatory changes.
• Review and disposal of valproate part-pack medications with full pack dispensing cross-site, with a new alert generated on the dispensing system.
• Trust-wide medication safety bulletin informing staff of valproate safety measures.
• Valproate prescribing updated on the Trust’s electronic system.
• Support and progress monitoring by the Trust medication safety group.

Effects of changes

• Wider awareness of regulatory changes for valproate.
• Robust implementation of a Trust-wide action plan to monitor progress and completion of actions, meeting national requirements.
• Streamlined valproate dispensing process, with provision of risk materials.
• Patients counselled on valproate and associated risks via patient information resources.
• Increased medication safety stewardship on valproate use to improve patient safety.
• Shared learning and initiatives amongst NWL MSOs.
• Optimisation of electronic prescribing and medicines administration system; implemented across NWL Trusts.
• Initial auditing demonstrates improved patient centred care with prescriber engagement.

Conclusions

There is a clear consensus and understanding on risks associated with valproate and regulatory changes on prescribing and dispensing valproate, with ongoing actions. Collaborative working has been pivotal, with shared resources. Pharmacists have a key role in driving valproate safety, particularly the expertise of MSOs.

Additional authors: Sheena Patel & Deirdre Linnard, Chelsea and Westminster Hospital NHS Foundation Trust

The opinions expressed in this article are those of the author. They do not purport to reflect the opinions or views of the UKCPA or its members. We encourage readers to follow links and references to primary research papers and guidance.

Competing interest statement:

The author declares: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.