Posted by Faye Marks, Solicitor
How new funding from the Bill and Melinda Gates Foundation will help ground-breaking research into medication during pregnancy
Faye Marks looks at new research which is aiming to make medicines safe for pregnant women, which has just received a sizeable grant from the Bill and Melinda Gates Foundation.
The Medicines and Healthcare products Regulatory Agency (MHRA) – the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe – has announced ground-breaking research to support the safer use of medicine during pregnancy.
The MHRA’s research will be supported by a generous $360,000 grant (approximately £292,000) over the next two years from the Bill and Melinda Gates Foundation, the world’s largest private charitable organisation founded by Bill Gates, principle founder of Microsoft Corporation and his wife, philanthropist and former general manager at Microsoft, Melinda Gates.
The research funded by this grant could impact the health of pregnant women around the world, and aims to help predict the need for adjusting the dose of medicines during each trimester of pregnancy. This will ensure effective use, which is vitally important for the health of both mother and baby.
Why this research?
Worldwide data in the area of medication for pregnant women is limited, as pregnant women are not generally included in clinical trials or studies of medicines, unless the medicine studied is already considered to be safe for use during pregnancy. This is due to the increased risk of miscarriage, birth defects, learning difficulties or other problems in the baby, associated with some types of medication.
Pregnant or breastfeeding women are generally recommended to avoid the use of medicines. However, in reality most women are prescribed at least one medication during pregnancy, such as antibiotics to treat minor infections or analgesia for pain relief. For some pregnant women, particularly those with conditions such as diabetes, epilepsy or heart conditions, medicine use during pregnancy may be necessary for the health of the mother and her ability to carry a pregnancy safely. Often these medicines have not been tested for safety during pregnancy. Also, pregnancy is associated with many anatomical, biochemical and physiological changes that can affect how the body reacts to medication.
Currently, unless a medicine is approved for use in pregnancy, doctors and healthcare providers do not currently have information regarding the best dose to administer pregnant women or whether the dose needs to be adjusted during the different stages of pregnancy. Pregnant women are therefore usually given the usual adult dose. In some cases this can result in the patient receiving either a dose that is not strong enough to treat their condition effectively or even a dose that that is harmful to the patient or the pregnancy.
What do they hope to find?
In this research, MHRA specialists will use prediction models to develop recommended medicine dosages for pregnant women in the UK. This includes evaluating existing models— known as physiologically based pharmacokinetic (PBPK) models and simulations to develop a full picture for all stages of pregnancy.
The MHRA will also provide training for healthcare professionals on how to use the models, and there will be a dedicated web portal.
This web portal will host MHRA research on the effects of physiological changes which occur during pregnancy, and their impact on medicine exposure. The results of model predictions will also be available here, allowing the opportunity for different research groups to upload and share their modelling, turbo-charging developments in this area.
Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA said:
“Patient safety is our highest priority and we are determined to support innovation in this important area, which helps improve the quality of health for pregnant women in the UK and internationally.
“This work provides a valuable launch pad for new developments into, and improved understanding of how pregnancy affects medicine levels. That’s why we are encouraging healthcare professionals, research groups and those looking to supply medicines during pregnancy, to make full use of the prediction models, data and resources we will provide.”
Trevor Mundel, President of Global Health, Bill & Melinda Gates Foundation said:
“We’re excited to play a part in the work that MHRA is doing around maternal health. We hope the innovative use of computer-aided modelling will help make medicine use safer and more effective for pregnant women around the world. We are dedicated to improving the quality of people’s lives and look forward to the outcome of new developments in this area.”
I find the news of this new research and technology incredibly exciting. Clinical trials are generally unfeasible for vulnerable patient groups such as children and pregnant women. If a pregnant woman requires medication due to a severe or life threatening condition, often doctors have no choice to prescribe medication after weighing up the risks to the pregnant mother of not taking the medication and the risks to her unborn baby.
We are all aware of the risks that some medicines can pose to unborn babies. Many people today are still living with the terrible legacy of the thalidomide scandal in the 1960s and 70s. More recently, we have learnt of the dangers associated with epilepsy medication Sodium Valproate, which has been found to cause developmental disorders in up to four in ten babies and birth defects in one in 10 babies.
This emerging technology, which will improve drug safety for mothers and babies, without the need for clinical trials, can only be a good thing!
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