Valproate pregnancy prevention scheme: what are the barriers to enrolling patients and how do we meet them?

Abstract

Background The UK Medicines Health products Regulation Agency instructs that valproate prescriptions should be restricted in women of childbearing age to those consenting to the Pregnancy Prevention Programme (PPP). We assessed the compliance and barriers to the valproate PPP. Methods We retrospectively audited NHS Grampian's compliance with PPP guidelines among women of childbearing potential prescribed valproate between October 2017 and March 2018. Additionally, we prospectively reviewed new valproate prescriptions from February 2019 to March 2022 and compared this with our retrospective data to assess the effectiveness of our identification process using descriptive statistics. Results We identified 351 women retrospectively and 80 women prospectively. Epilepsy, migraine and psychiatry were the main indications. There was a decline in valproate use over the years, particularly for epilepsy. Initially, only 132 (37.6%) met the PPP requirement, and eventually, 81 (23%) stopped the medication. Despite efforts, 38 (10.8%) had contact with secondary care but still did not meet PPP and 100 (28.5%) had no documentation or referral to secondary care. Patients not meeting PPP lacked capacity, most commonly with severe learning difficulties. Women treated for psychiatric purposes were less likely to meet PPP than other indications. Conclusions A significant proportion of women continue valproate treatment without meeting the PPP requirement. This is linked to their indication for prescription and their comorbidities. Collaborative input from relevant specialities and primary care is required to fully achieve PPP if a national valproate database is to be established.