Several key medicines for pregnant women are in short supply in Australia due to a “perfect storm” of manufacturing and distribution issues, experts warn.
The only drugs registered as safe for pregnancy are old and less profitable for pharmaceutical companies that have halted distribution amid manufacturing disruptions since the pandemic began.
An editorial published in the Medical Journal of Australia on Monday called on the government to create a body responsible for registering, importing and manufacturing critical medicines for use during pregnancy, independent of need to obtain a profit.
Shortages particularly affect medication for high blood pressure. The commonly used labetalol has been extremely difficult to obtain since late 2023, and the immediate release nifedipine, also used to stop early labour, and oxprenolol have been withdrawn from the Australian market entirely on commercial grounds.
The lead author of the editorial, Associate Professor Stefan Kane, the director of maternity services at Melbourne’s Royal Women’s Hospital, said the problem could be traced to the “systematic exclusion” of pregnant women from clinical trials of new drugs.
“As a result of these reasonable concerns about the potential impact of medication on pregnant women – which largely stems from the thalidomide disaster – we almost went too far the other way, and now we’re just excluding them from trials, so we’re stuck with no new agents,” Kane said.
Without research on the effectiveness of drugs on pregnant women, medications used were old, off-patent and often prescribed off-label.
The editorial highlighted the example that, in contrast to the more than 50 drugs for high blood pressure available to the non-pregnant population, Australian guidelines for the treatment of the condition during pregnancy identify only six, all over the age of 30.
The authors warned that the situation denies pregnant women pharmacotherapeutic advances enjoyed by other groups, such as drugs with fewer side effects, and leaves them relying on older, cheaper drugs that are more vulnerable to supply disruptions.
Australia has a sponsor-driven registration and regulation scheme for medications. This means that pharmaceutical companies must pay to be allowed to sell their drugs, making new drugs on patent with larger profit margins more worthwhile than older, off-patent drugs with narrower margins.
“When logistics flowed easily and factories had fewer restrictions … pre-pandemic, it wasn’t too much of a problem,” Kane said.
But since then, Kane said, certain manufacturers have “just stopped making certain drugs” “because the factory and the distribution process they feel can be used for more profitable ventures”.
This “perfect storm” of factors put lives at risk, Kane said. While large metropolitan hospitals can still access medicines through the special access scheme – albeit with extra pressure on hospital pharmacies – smaller regional and remote hospitals do not have the same access, he said. The scheme is also not available for drugs used off-label during pregnancy.
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Kane saw the issue in general as “yet another example of systematic disadvantage faced by women in general, but pregnant women in particular”.
“There is certainly the potential here for harm to occur,” he said.
“The reason we are lucky in Australia that very, very few women die from pre-eclampsia – high blood pressure during pregnancy – is because of effective treatment of blood pressure. It is a critical component of their care.”
The authors said that Australia needed another way to ensure supply of these medicines, independent of the need to make a profit – in addition to other solutions, including supporting local manufacturing of critical medicines, and safe inclusion of pregnant women in clinical research.
The co-author Prof Amanda Henry, program head of Women Health in Australia for the George Institute for Global Health and board member for the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, said: “It is time to reframe the system so that it considers the risks of including these women in trials AND factors in the inequality proportionally considered. and risks of NOT including it.”
Prof Barbara Mintzes, who specializes in the study of pharmaceutical policy at the University of Sydney and was not an author of the editorial, said the editorial “raises important concerns about the need for better evidence to support drug treatments in pregnancy, and also better systems in place to make sure that pregnant women have access to the necessary medicines”.
“The authors are critical of excluding pregnant women from clinical trials testing new drugs,” Mintzes said. “However, including a few pregnant women in a trial will not really solve the current problem.
“We need dedicated trials in pregnancy for treatments that are commonly used ‘off-label’ in pregnancy but have never been properly tested for effectiveness.”
