More awareness needed to prevent harm from an anti-epileptic medicine in pregnancy

Lead researcher: Professor Kathleen Bennett, Royal College of Surgeons in Ireland (RCSI University of Medicine and Health Science)

Graphic for theme 3
The problem

Some medicines can harm the developing baby during pregnancy, so it is important that doctors, pharmacists and other healthcare professionals know the risks. One example is sodium valproate, a medicine used to treat epilepsy and bipolar disorder. In 2018, the Health Products Regulatory Authority (HPRA) in Ireland provided information to healthcare professionals about pregnancy prevention with the use of sodium valproate. But how much awareness and use of this information was there among healthcare professionals in practice?

The project

Working with the HPRA, in 2019, researchers at RCSI University of Medicine and Health Sciences sent an online questionnaire to approximately 3,820 GPs, pharmacists and specialist consultants, to see if they were aware of the risk management measures for women needing to prevent pregnancy when on sodium valproate. The researchers also looked at whether prescription patterns of sodium valproate changed after the HPRA campaign. 

The outcomes
  • The survey had a low response rate (5.8% of the GPs, 10.7% of the pharmacists and 7.6% of the specialists answered the questionnaire), which may limit the generalisability of the findings, that is, the extent to which we can generalise the findings from a sample to an entire population
  • Most who answered the survey knew that sodium valproate can cause harm during pregnancy, but many were unsure of or underestimated how big the risk is
  • Between 2014 and 2019, prescriptions for sodium valproate among women aged 16-44 years in Ireland fell from just under 2000 to just over 1500, particularly among women aged 16-24
  • Healthcare professionals were generally unaware that women who could become pregnant while on sodium valproate needed a review with a specialist every year •  The study findings were made available to the Irish College of General Practitioners, the Pharmaceutical Society of Ireland, the National Medicines Information Centre and medical specialist groups.

Professor Kathleen Bennett, Associate Professor in Biostatistics in the Division of Population Health Sciences, RCSI university of Medicine and Health Science, says:

“We found that there needs to be continued effort and collaboration with doctors and pharmacists about the magnitude of the risks of sodium valproate during pregnancy. The research provides evidence that we need new ways to intervene, and we identified the areas where it is important to focus. For example, we could see that more effort is needed to support awareness among GPs and community pharmacists, in particular, as they would have most regular contact with women.”

'More awareness needed to prevent harm  from an anti-epileptic medicine in pregnancy' is part of a wider collection of success stories across four themes from this year's annual Health Research in Action. Download the full publication

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