Sodium valproate prescribing safety in women of childbearing potential

AimsThe purpose of this audit was to identify all women being prescribed Sodium Valproate under the Bassetlaw Local Mental Health Team (LMHT) caseload to see how well latest prescribing guidelines are being met, and help set up a system allowing efficient monitoring of Sodium Valproate prescribing in the future.BackgroundDespite early concerns regarding potential teratogenicity, Sodium Valproate became a widely used anticonvulsant and mood stabiliser and is licensed for use in Epilepsy, Migraine prophylaxis and Bipolar affective disorder. Research evidence now shows its use in pregnancy increases risk of neurodevelopmental disorders to 40%, and serious birth defects to 10%. Despite research finding these risks prescribing practice did not significantly change. To better reflect these findings in clinical practice in 2018 the Pharmacovigilance Risk Assessment Committee recommended Sodium Valproate should not be used in pregnancy unless they have a form of epilepsy unresponsive to other anti-epileptic drugs, and all with childbearing potential should be enrolled in a pregnancy prevention programme (PPP). This was endorsed by UK Medicines and Healthcare Devices Regulatory Agency in April 2018 with launch of the PPP.Standards:Must be offered counselling about risks of valproate to unborn child and importance of effective contraception.Annual specialist Review by a specialist now mandatoryRisk acknowledgement form must be updated at least annually.MethodThe electronic RiO records for all female patients on the Bassetlaw LMHT caseload in the year 2019 were checked to identify those prescribed Valproate. For those prescribed Valproate, evidence of annual risk acknowledgement form, date of last appointment, underlying diagnosis and contraceptive method was checked. This data was stored together on an excel file and used to create a patient list to help allow future monitoring.ResultFrom 594 female patients identified, 27 (4.5%) were prescribed Sodium Valproate. Of these, 14 (52%) had PPP documentation uploaded, 24 (89%) had been reviewed within the last 12 months, and 13 (48%) had no documentation of contraceptive method.ConclusionThis audit helped highlight there is likely a large population of patients not yet on the Pregnancy Prevention Programme. Creating a monitoring system in excel for female patients being prescribed Valproate can help improve adherence to latest guidelines, with a colour coding system to highlight those needing risk acknowledgement forms/appointments within the next three or six months. Educating patients and other healthcare professionals about risks will also help improve prescribing practice and avoid use in pregnancy.

Download Full-text

MHRA bans valproate prescribing for women not in pregnancy prevention programme

BMJ ◽

10.1136/bmj.k1823 ◽

2018 ◽

pp. k1823 ◽

Cited By ~ 5

Author(s):

Gareth Iacobucci

Keyword(s):

Pregnancy Prevention ◽

Prevention Programme ◽

Pregnancy Prevention Programme ◽

In Pregnancy

Download Full-text

A quality improvement (QI) project to ensure females on valproate in a CMHT outpatient clinic, eput are registered on the valproate pregnancy prevention programme

BJPsych Open ◽

10.1192/bjo.2021.502 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S185-S186

Author(s):

Adebayo Emmanuel ◽

Parvathy Pillay ◽

Vyasa Immadisetty

Keyword(s):

Quality Improvement ◽

Compliance Rate ◽

Pregnancy Prevention ◽

Management Team ◽

Prevention Programme ◽

Childbearing Age ◽

Medicines Management ◽

Background Rate ◽

Female Patients ◽

Pregnancy Prevention Programme

AimsRecent MHRA guidelines, state that Valproate medicines must no longer be used in women or girls of childbearing potential due to its highly teratogenic effects unless a Pregnancy Prevention Programme is in place. We carried out a service evaluation to determine if there was any way of identifying such patients with the aim of setting one up if required.BackgroundValproate is highly teratogenic and evidence supports that use in pregnancy leads to physical birth defects in 10 in every 100 babies (compared with a background rate of 2 to 3 in 100) and neurodevelopmental disorders in approximately 30 to 40 in every 100 children born to mothers taking Valproate. Data from a previous inpatient audit identified 35 females of childbearing age and none was on a pregnancy prevention plan. Audits done thereafter confirmed there was no system available for identifying such patients. Availability and accessibility to a synchronised IT system, which alerts when the yearly review is due is consistently identified as a contributory factor.MethodA request via the Medicines management team was sent to the GP surgeries within the catchment area to assist in identifying female patients on their records on Valproate registered on the Pregnancy Prevention Programme.The Plan-Do-Study-Act (PDSA) Quality Improvement (QI) model was used to bring about change. The target set to achieve was a 50% reduction in the prescriptions of Valproate in such patient groups.ResultWe had 10 out of the 50 GP surgeries contacted responded with a list of female patients on Valproate, a total of 25 patients’ altogether. In total, 4 patients out of the 25 were registered on the Pregnancy Prevention Programme and the overall non-compliance rate was 86%. . Factors believed to contribute to the low numbers include a lack of a system for registering women of childbearing age on the pregnancy protection plan and the recent introduction of GDPR regulation.ConclusionThere are ongoing discussions with various stakeholders like the Medicines management team, Pharmacists, electronic records team (IT) and other clinicians regarding inserting an alert in the electronic system that reminds clinicians to register all such women on the Pregnancy Prevention Programme, while automatically creating a yearly reminder for completion of the annual risk acknowledgement form.

Download Full-text