Australia is currently grappling with a concerning shortage of essential obstetric medicines, a crisis that is placing unprecedented pressure on the nation's healthcare system.
A recent report by the Medical Journal of Australia (MJA) disclosed that there is a critical shortage of Obstetric medicine in Australia and the shortage of such essential class of medication has highlighted pregnant women's vulnerability to critical medication supply.
The reports revealed shortages in the supply of labetalol, immediate‐release nifedipine and misoprostol tablets etc. in Australia.
Obstetricians across the country informed medications vital for managing labor complications, controlling hemorrhage, and ensuring the health of both mother and baby are becoming increasingly scarce.
It has been observed that there has been always a lesser focus of pharmaceutical companies and regulatory authorities on drug development studying drug effects and organizing pharmacological drug trials for women during pregnancy.
Authorities reported that there is a narrow spectrum of medications known to be safe and efficacious for use in pregnancy. These medications tend to be old, off‐patent, and — in Australia — are often used off‐label, as sponsoring pharmaceutical companies have not sought to have them registered for treatment of pregnancy‐specific conditions.
For example, in contrast to the more than 50 antihypertensive agents available to the non‐pregnant population, the Hypertension in pregnancy guideline 2023, published by the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) and endorsed by the National Health and Medical Research Council (NHMRC), identifies only six medications with adequate safety and efficacy data in pregnancy for treating gestational high blood pressure, and of these six medications, all are more than 30 years old.
The root causes of this crisis are multi-dimensional, involving global supply chain issues, increased demand, and regulatory hurdles that have compounded the problem.
As pharmaceutical companies struggle to keep up with production and distribution challenges, Australian hospitals are facing difficulties sourcing and stockpiling these vital medicines.
The shortage is creating significant challenges in managing the health of pregnant women. It’s crucial that alternative treatments are used effectively and safely.Dr. Emily Roberts, Obstetrician, St. Vincent's Hospital, Sydney
The government and healthcare authorities are being called upon to implement urgent measures to address the shortage, including enhancing local manufacturing capabilities and exploring alternative supply routes.
Until these solutions are effectively put in place, the healthcare system remains at risk of suffering a crisis, further underscoring the need for immediate and coordinated action to safeguard maternal health.
We are working diligently to resolve these shortages and ensure that pregnant women receive the care they need. Our priority is to provide clear guidance and support to both healthcare providers and patients during this challenging time.Sarah Johnson, Health Minister
The Therapeutic Goods Administration (TGA) “Australia's government authority can also play a vital role for evaluating, assessing and monitoring products that are defined as therapeutic goods and regulate medicines, medical devices and biologicals to help Australians stay healthy and safe”.
https://www.mja.com.au/journal/2024/221/7/pharmaceuticals-pregnancy-multifaceted-challenge-australia
van der Graaf R, van der Zande ISE, den Ruijter HM, et al. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach. Trials 2018; 19: 78.
Society of Obstetric Medicine of Australia and New Zealand. SOMANZ hypertension in pregnancy guideline 2023. https://www.somanz.org/content/uploads/2024/01/SOMANZ_Hypertension_in_Pregnancy_Guideline_2023.pdf
(Input from various media sources)
Rehash/Tushar Pandey/MSM