A severe shortage of antenatal drugs is putting pregnant women at risk in Australia, experts warn

The supply of many essential antenatal medicines remains in short supply in Australia, putting pregnant women’s health at risk and highlighting systemic issues affecting reliable access to safe and effective treatment during pregnancy, according to a review new published in Medical Journal of Australia (WORK).

“Australia’s supply and access to prescription drugs during pregnancy is a significant concern, and is caused by a number of conversion problems,” said lead author A/Prof Stefan Kane, Director of Services Maternity (Medical) Royal Women’s Hospital Melbourne. “We need to address these urgently and create a system that puts the health of mothers and their babies first.”

The authors say that urgent reform is needed to prevent and prevent shortages and ask the government to create a publicly funded organization that is committed to registering, importing and manufacturing essential medicines for use during pregnancy. This would reduce the current reliance on off-label prescribing and ensure the continued supply of essential medical treatments for conditions including pre-eclampsia (high blood pressure during pregnancy). pregnancy), postpartum hemorrhage (postpartum bleeding), and nausea.

In addition, the article calls for changes in the way regulators test and classify drugs to provide more accurate information about safety and efficacy, and to explore new and safer strategies for including pregnant women in trials. medicine.

Co-author Prof Amanda Henry, Head of the Women’s Health Program in Australia for The George Institute for Global Health, Professor of Women’s Health in the School of Medicine, UNSW Medicine and Health, and Councilor of Royal Australian and New Zealand College of Obstetricians. and Gynecologists (RANZCOG), says that pregnant women are significantly reduced in clinical trials, mainly due to historical biases that cause reluctance to study the effects of drugs in this population.

This exclusion results in doctors having little evidence about the safety and effectiveness of drugs during pregnancy, which leads to the neglect of pregnancy-related conditions, and the potential risks from them. -improper dosing or new, more effective treatments that are not approved for this population.

The authors acknowledge the recent statement of the National Health and Medical Research Council (NHMRC) which advocates sexuality, gender, diversity of sexual characteristics and attitudes towards sexuality to be considered regularly in research on health and medicine as an important first step in addressing this imbalance.

Professor Henry says: “The exclusion of pregnant women and women of childbearing age from clinical trials not only puts them at risk but also prevents them from reaping the benefits of medical advances that other people enjoy. rejoice.” “It’s time to redesign the system to take into account both the risks of including these women in trials AND the disparities and risks of NOT including them.”

The review highlights that many important medications used during pregnancy are outdated, off-patent, or prescribed off-label. This makes them commercially unattractive for pharmaceutical companies, causing constant supply problems and frequent discontinuations.

“We are in a dangerous situation where pregnant women are vulnerable to market forces,” A/Prof Kane says. “Lack of incentive for pharmaceutical companies to register and maintain supply of old, off-patent medicines used during pregnancy puts life at risk.”

The Royal Australian and New Zealand College of Obstetricians and Gynecologists (RANZCOG, the College) supports the article’s recommendations and has called for urgent intervention to stem the worsening shortage. At the beginning of this year, the college convened a round table that brought together key stakeholders for possible solutions.

“Medication and resource shortages in pregnancy and women’s health are long-term issues that continue to affect patient care. The solutions may not be easy, but we must fully committed to working together to overcome these challenges,” said Dr. Anna Clare, Co-Chair. of the round table.

Perspective essay on WORK serves as a call to action for health care professionals, policy makers, and pharmaceutical companies to collaborate and prioritize the needs of pregnant women. By implementing the recommended policies, Australia can address drug supply issues early and protect the health of expectant mothers and women of childbearing age.