Valproate and the Pregnancy Prevention Programme

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We are grateful to the authors for putting the spotlight on the valproate Pregnancy Prevention Programme (PPP).¹

It is important to recall the very serious teratogenic effects of valproate. In addition to a 10% risk of major congenital malformations, 30–40% of children exposed in utero will have serious and persistent developmental disorders that impact their quality of life and their ability to lead independent lives. It is therefore vitally important that all reasonable steps are taken to eliminate this risk as far as humanly possible, commensurate with appropriate clinical care of the mother. We continue to be told by some mothers that they were not warned about the risks.

The valproate PPP was implemented in 2018 because of evidence that previous action in 2015 had not had the required impact. Despite repeated communications on the risk since 2015, there were approximately 250 pregnancies exposed to valproate in 2017.

If a patient is considered not to be at risk of pregnancy, they are not required to comply with the requirements of the PPP. We have updated the Annual Risk Acknowledgement Form to include a section to be completed when a specialist prescriber considers that the PPP is not required. If the PPP is needed, the choice of contraception needs to take into account the circumstances of the individual.

We understand that prescribers and patients may have to make individual decisions about treatment that may not be in line with the product licence, to meet the needs of an individual patient. As an off-label prescription, the prescriber would need to take responsibility for, and record the reasons for, that decision.

Implementation of the valproate PPP, which aims to rapidly reduce and eventually eliminate pregnancies exposed to valproate, will take concerted action across the healthcare system. We are closely monitoring the impact, and we will continue to work with the clinical community and a wide range of other stakeholders to identify and respond to barriers to implementation.