Critical Shortages of Obstetric Medicines Endanger Pregnant Women in Australia

In Australia, a drug shortage has arisen due to pharmaceutical companies' lack of testing on women, resulting in the use of off-label and off-patent drugs (Myriam Zilles/Unsplash)

Several shortages of crucial obstetric medicines are putting women’s health at risk. These shortages are highlighting the long-lasting systemic issues in healthcare for women in Australia.

What Is Obstetric Medicine and Why Is It Important?

Obstetric medicine is a subspecialty of medicines. It focuses on the care of women with medical conditions before, during, and after medicine. Obstetric medicine is commonly consulted for the management of several chronic conditions in pregnancy including:

Chronic hypertension
Type 1 diabetes
Type 2 diabetes
Several thyroid disorders
Asthma
Lupus
Inflammatory bowel disease
Epilepsy
Renal disease
Congenital cardiac disease
Acquired cardiac disease
Venous thromboembolism

Consultations may also happen for diseases acquired during pregnancy or postpartum for diseases including:

Gestational hypertension
Preeclampsia
Gestational diabetes
Any type of infection
Palpitations
Cardiomyopathy
Headaches
Obstetric cholestasis

Obstetric care is important to help ensure labor and delivery without complications and in the case that complications occur, that care is administered swiftly and safely.

Many trends reveal that women who begin pregnancy at an older age, have higher BMIs, or have diseases such as hypertension and diabetes are at risk for factors that contribute to worsening pregnancy-related morbidity and mortality rates. Additionally, pregnancy conditions could even be signs of health risks later in life.

Furthermore, obstetrics care is very important for women with high-risk pregnancies. Obstetric medicine specialists have advanced training and experience for managing complicated pregnancies work to address and minimize risks and to ensure the baby remains healthy throughout the pregnancy journey. Some things that can cause a high-risk pregnancy are:

A multiple-baby pregnancy
Being over the age of 35
A pre-existing health condition
An abnormal placental positioning
Obesity
A bleeding or clotting disorder
Rh incompatibility
A history of miscarriage or stillbirth
An unhealthy lifestyle

Overall, obstetric medicine is vital for a healthy and safe pregnancy for women.

What Is Happening in Australia?

Women in Australia have limited access to prescription medicine during pregnancy due to the short supply. Obstetric experts have warned that supplies of several crucial blood pressure and other drugs considered safe for use in pregnancy are running short, which could leave women at risk of serious complications like brain bleeds.

Existing drugs that have been used safely in pregnancy are so scarce that some women who have been prescribed the medication but are unable to get ahold of it are experiencing risky blood pressure. Risky blood pressure has the potential to cause women to suffer strokes or brain hemorrhages.

This shortage of medication has already caused many medical emergencies for women. Medical experts are afraid that this shortage can potentially create a crisis.

Systemic Issues

Many point to this issue as a very clear result of the long-standing systemic issues that are against pregnant women. Drug companies and regulatory authorities all over the world have continuously excluded women who are pregnant from clinical trials of developing drugs. As a result of these women being underrepresented in clinical trials, the likelihood of medications harming pregnant women is very high. Pregnant women are being denied the same pharmacotherapeutic advances that are enjoyed by other populations.

This could also be seen during the development of vaccines and medications for COVID-19. Despite pregnant women having a greater risk of COVID-19-related morbidity and mortality, they were continuously excluded from clinical trials. Consequently, pregnant women were given very few options for treatments for COVID-19.

Medications known to be safe and effective for use in pregnancy tend to be off‐patent and are often used off‐label because pharmaceutical companies have not pursued approval for their use in treating pregnancy-specific conditions.

“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,” says Professor Stefan Kane, Director of Maternity Services at the Royal Women’s Hospital in Melbourne.

Compared to the 50 medications for high blood pressure that are used by the non-pregnant population, there are only six available for pregnant women. Additionally, all of the six medications available for pregnant women are more than 30 years old.

Professor Amanda Henry, Program Head of Women’s Health at The George Institute for Global Health and a Councillor for the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, states that pregnant women are greatly underrepresented in pharmacological clinical trials. She additionally states that this is largely attributed to longstanding biases, which have led to hesitancy in studying the effects of medications on this group.

Call to Action

Experts say a fix is urgently needed to prevent shortages. Experts 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 guarantee a continuous supply of essential pharmaceutical treatments for conditions, including pre-eclampsia (high blood pressure during pregnancy), postpartum hemorrhage (bleeding after delivery), and nausea for women who are pregnant.

Professor Henry says, “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." She adds, “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.”

Additionally, experts call for reforms in the way regulators evaluate and organize medicines to provide more clinically relevant information on safety and efficacy. Experts want to explore novel and safe strategies to include pregnant women in clinical trials.