Valproate risk form—Surveying 215 clinicians involving 4775 encounters

Abstract

Objectives: Annual completion of a Valproate Risk Acknowledgement Form (RAF) is mandated in the United Kingdom due to neurodevelopmental risks of in utero valproate exposure. The number of women of childbearing potential taking valproate, the uptake of the RAF within this population and their clinical outcomes is not known or monitored. This study surveyed responses of clinicians administering the RAF to women of childbearing potential taking valproate medications. Materials and Methods: Study design-national online survey distributed to clinical specialists throughout the United Kingdom via their national organizations. Participants-clinicians qualified to counsel and administer the valproate RAF (as defined by the Medicines and Healthcare products Regulatory Agency). Main outcome measures-quantitative and qualitative responses regarding identification, uptake, effects and reactions to the RAF. Trial registration-registered at the Clinical Governance and Audit Committee at Royal Free London NHS Foundation Trust Hospital.Results: 215 respondents covering more than 4775 patient encounters were captured. Most patients continued on valproate, 90% with epilepsy as the indication.Respondents reported that seizure control deteriorated when switched to levetiracetam (33%) and lamotrigine (43%), compared to 7% when continuing valproate (P < .001).Conclusions: 33%-43% of clinicians reported seizure control deterioration in women changed to alternatives to valproate. Informed consent requires women considering a change are given this information. Systematic capture of data automated through online RAFs and linked to patient outcomes is needed. There remains little data on valproate given for indications other than epilepsy.

Risk-benefit assessment of treatment of epileptic women of childbearing age with valproic acid

“…The main limitation of our study is its relatively small sample size. Even so, our results are in line with those of other studies based on larger samples [18][19][20][21][22][23][24][25][26][27][28] and we believe that our sample is representative of day-to-day clinical practice in the epilepsy department of a secondary healthcare centre. Another possible limitation is the relatively short follow-up period: 6 months.…”

A description of sodium valproate, lamotrigine and levetiracetam consumption in the Western Cape public sector

“…27 Furthermore, in a study conducted in the United Kingdom, clinicians were surveyed to monitor the use of risk acknowledgement forms with sodium valproate therapy, one year after the valproate risk acknowledgement form was implemented by the Medicines Healthcare products Regulatory Agency. 28 Lamotrigine followed by levetiracetam was the most frequently prescribed antiepileptic replacing valproate. The risk acknowledgement form for WOCBA without intellectual disability reflected that 43.5% clinicians reported that ‘most’ of their patients continued with valproate, while an additional 25.0% reported that ‘all’ of their patients continued with valproate.…”

Understanding and Responding to Prescribing Patterns of Sodium Valproate-Containing Medicines in Pregnant Women and Women of Childbearing Age in Western Cape, South Africa

“…The reproductive risks of VPA have to be weighed against the need for optimal seizure control. Early reports of the SANAD II study suggest that levetiracetam may be an inferior antiepileptic to VPA [41], while Angus-Leppan and colleagues found that between 33 and 43% of clinicians surveyed in the UK noted deterioration in among women who were switched from VPA to an alternative agent [42]. The risks of inadequate seizure control during pregnancy, both to the woman and the foetus, are significant and include maternal death, sudden unexpected death, small for gestational age, and preterm delivery [43].…”