Pregnancy register for anti-epileptic drugs delivers benefits for women and babies

Epilepsy

By Michael Woodhead

27 Jan 2023

The Australian Register of Antiepileptic Drugs in Pregnancy has helped prevent almost 10,000 adverse pregnancy outcomes over the two decades it has been running, a Monash University study suggests.

Since the register was established in 1999 there have been 9609 fewer stillbirths and birth defects such as spina bifida during the period 2000-2019 compared to the two decades prior to its establishment, according to an analysis published in the journal Neurology (link here)

Lead author Associate Professor Zanfina Ademi said the register was set up as a prospective database to record details of the nature of antiepileptic drug (AED) use in pregnant women and analyse data on the risks to babies exposed to the medications.

Data from the register has been used to educate clinicians about the optimal use of AEDs to balance adverse pregnancy outcomes and seizure control.

Associate Professor Ademi, a health economist at the Monash Centre for Medicine Use and Safety, said the study showed there were about 5500 fewer babies born with defects, and almost 2700 fewer miscarriages due to the register.

“Interestingly, we estimated that the information collected by the register led to a decrease of 1147 stillbirths over the two decades.”

Modelling based on conservative estimates of a 2.5-5% contribution of the APR to the savings in healthcare and societal costs suggested that the registry led to $9 billion in cost savings to society, including future gains due to preventions of morbidity and mortality. The $191 million reduction in healthcare costs meant that every dollar spent on the program resulted in a return of $2,250.

“Following its inception 20+ years ago, the APR has represented excellent value for investment for Australia, being also health-saving and cost-saving from a societal and a healthcare perspective. With the growing number of marketed [anti-seizure medications], the APR is expected to continue to have a major impact in the foreseeable future,” the authors said.

Co-author Professor Terry O’Brien, of the Department of Neurology, Alfred Health, cited the example of spina bifida, one of the most severe foetal malformations associated with anti-seizure medication, generally leads to shorter lifespans, major disability, and places a large human and economic burden on caregivers.

“The more information we can gather through this register, the greater chance we have of helping mothers-to-be with epilepsy have healthy babies in the future,” said Professor O’Brien.

The register costs approximately $250,000 a year to run. Non-profit organisation Epilepsy Action Australia is its major supporter, contributing $100,000 annually.

Over its lifetime, the register has been hosted by various Melbourne institutions including the Royal Melbourne Hospital (where it is currently based), Monash University and St Vincent’s Hospital.

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