Calls for a new body to oversee medications for use in pregnancy

New research published in The Medical Journal of Australia highlights systemic issues impacting access to safe and effective treatment in pregnancy.

“Australia’s supply and access issues in prescription medicine during pregnancy are significant concerns, and caused by several converging problems,” said lead author Associate Professor Stefan Kane, Director of Maternity Services (Medical) at the Royal Women’s Hospital in Melbourne.

“We urgently need to address these and build a system that puts the health of pregnant women and their babies first.”

Kane and his co-authors say an urgent fix is needed to stem and prevent shortages, and call for the government to create a publicly funded entity dedicated to registering, importing and manufacturing critical medications for use during pregnancy.

This would reduce the current reliance on off-label prescribing and ensure a continuous supply of essential pharmaceutical treatments for conditions including pre-eclampsia (high blood pressure during pregnancy), post-partum haemorrhage (bleeding after delivery) and nausea.

Co-author Professor Amanda Henry, Program Head of Women’s Health in Australia for The George Institute for Global Health and Councillor for the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), said pregnant women are significantly underrepresented in pharmacological clinical trials, primarily due to historical biases creating a reluctance to study the effects of medications in this population.

This exclusion resulted in clinicians having limited evidence on the safety and efficacy of drugs during pregnancy, leading to undertreatment for conditions both related and unrelated to pregnancy, and potential harms from inappropriate dosing or from newer, more effective treatments not being approved for this population.

The authors welcomed the recent statement by the National Health and Medical Research Council (NHMRC) advocating for sex, gender, variations of sex characteristics and sexual orientation to be routinely considered in health and medical research as an important initial step to addressing this imbalance.

“The exclusion of pregnant women and women of reproductive age from clinical trials not only puts them at risk but also denies them the benefits of medical advancements that other populations enjoy,” Henry said.

“It’s time to reframe the system so it proportionately considers the risks of including these women in trials and factors in the inequity and risks of not including them.”

The review highlighted that many essential medications used in pregnancy are old, off-patent or prescribed off-label, making them commercially unattractive for pharmaceutical companies. This leads to regular supply constraints and frequent discontinuation.

Additionally, the article called for reforms in the way regulators assess and categorise medicines to provide more clinically relevant information on safety and efficacy, and to explore novel and safe strategies to include pregnant women in clinical trials.

“We are in a perilous situation where pregnant women are vulnerable to the whims of market forces,” Kane said.

“The lack of incentive for pharmaceutical companies to register and maintain the supply of older, off-patent drugs used in pregnancy is putting lives at risk.”

RANZCOG supported the article’s recommendations and has already called for urgent intervention to prevent worsening shortages.

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