Australia is experiencing a significant shortage of vital medications for pregnant women due to a “perfect storm” of manufacturing and distribution issues, experts say.
The drugs deemed safe for pregnancy are often outdated and less profitable, leading pharmaceutical companies to halt their production amid ongoing disruptions since the pandemic. An editorial in the Medical Journal of Australia published on Monday has urged the government to establish an independent body to oversee the registration, importation, and manufacturing of crucial medications for pregnant women, without the need for profit.
The shortages are particularly severe for medications used to manage high blood pressure. Labetalol, a commonly used drug, has been nearly impossible to find since late 2023. Additionally, immediate-release nifedipine and oxprenolol, which are used to prevent early labor, have been withdrawn from the Australian market due to commercial reasons.
Associate Professor Stefan Kane, director of maternity services at Melbourne’s Royal Women’s Hospital and lead author of the editorial, attributes the problem to the “systematic exclusion” of pregnant women from clinical trials for new drugs. Kane points out that, while concerns about the impact of medications on pregnant women, rooted in historical events like the thalidomide disaster, are valid, the current approach of excluding pregnant women from trials has left them without new, safer options.
Without clinical research on the effects of medications during pregnancy, healthcare providers rely on older, off-patent drugs, many of which are used off-label. The editorial notes that while there are over 50 drugs available for managing high blood pressure in the general population, Australian guidelines for pregnant women include only six, all of which are over 30 years old.
The current system in Australia requires pharmaceutical companies to pay for drug registration and regulation. This profit-driven model favors new, patent-protected drugs over older, less profitable options. Kane highlights that pre-pandemic, this system did not present major issues, but now, manufacturers have shifted their focus to more lucrative ventures, leading to critical drug shortages.
This “perfect storm” of factors is endangering lives, Kane warns. Large metropolitan hospitals still have some access to these medications through a special access scheme, but smaller regional and remote hospitals lack similar resources. Additionally, this scheme does not cover off-label drugs used in pregnancy. Kane views this as yet another instance of systemic disadvantage for women, particularly those who are pregnant.
The editorial calls for an alternative pathway to secure these essential medications, emphasizing the need for local production and inclusion of pregnant women in clinical research.
Prof Amanda Henry, head of Women’s Health at the George Institute for Global Health and a co-author of the editorial, advocates for a system that balances the risks of including pregnant women in trials with the risks of excluding them.
Prof Barbara Mintzes from the University of Sydney, who was not involved in the editorial, supports the call for better evidence and systems to ensure pregnant women have access to necessary medications. She stresses that simply including a few pregnant women in existing trials won’t address the issue. Instead, dedicated trials for treatments used off-label during pregnancy are needed to ensure their effectiveness and safety.
