Improving the accessibility of drugs for pregnant women

Reproductive age women make up a substantial portion of the general population, yet are seldom represented in clinical trials for pharmaceuticals – including ones that cater to common pregnancy-related ailments.

Dr Nisha Khot – Vice President and Board Member of the RANZCOG and a Clinical Director of Obstetrics and Gynaecology at Peninsula Health – believes this should change.

She says existing data around the safety and efficacy of drugs largely stems from historical instances, where women have consumed medications before discovering they were pregnant.

She explains this is a challenge on two counts.

“Firstly, this type of data is not gathered in an empirical way. It doesn’t have the strict research criteria that randomised control trials – which underpin most TGA-approved drugs – have. That is why these medications can only be labelled as ‘probably safe’ for pregnant women.

“Secondly, when manufacturers decide to modify their drugs, they often discontinue earlier varieties – i.e. the only ones that have an approval stamp for use in pregnancy. They can’t mark these newer varieties as pregnancy safe until more of this incidental data is gathered – and that obviously takes many years.”

Under-serving people with pre-eclampsia

Dr Khot says this a particular problem for women who experience pre-eclampsia – a condition affecting 5-8 percent of pregnancies.

Pre-eclampsia requires treatment with general blood pressure medication – but these drugs have not been designed for pregnancy and can only be used ‘off-label’.

“A huge number of women require hypertensives but, despite this, the pharmaceutical market does not adequately cater to them. In total, there are around three or four drugs available for severe hypertension, which we know are probably safe in pregnancy because we have used them for many years. But some of them are still classified as Category C drugs and may cause harmful side-effects for the fetus or neonate.

“Also, they are much older than other drugs available to non-pregnant people. They have been around for 50-60 years– so not the best hypertensives around. Research has moved on a lot since then, and there are now far better varieties that pregnant women don’t have access to.”

What is the best way forward?

Dr Khot believes a few factors may be to blame for this issue.

“It could be that manufacturers simply aren’t aware of the demand for their drugs from pregnant women. Or, it could be that there are a lack of incentives to get them labelled as pregnancy safe,” she said.

Historically, there have also been perceived challenges in testing drugs on women, generally, with hormonal fluctuations considered an ‘extraneous variable’. This has left women woefully underrepresented in clinical trials, placing them at risk of adverse side-effects from TGA-approved drugs.

In light of these challenges, Dr Khot recommends a multi-pronged approach.

“Firstly, we need to build awareness. And secondly, we need to advocate for pregnant women to be included in trials. This would ensure they have equal access to newer drugs coming onto market. Women – and their families – need assurance that any drugs they consume have actually been tested on pregnant women in a proper research setting.”

In the absence of financial incentives for pharmaceutical companies to do this, Dr Khot believes it is up to the government to step in.

“It’s not good enough to say that women are unreliable research subjects, so let’s exclude them. We are 50 percent of the population – and we can’t just be given drugs that were only tested on men.

“If the pharmaceutical industry isn’t adequately incentivised, then government ought to provide those incentives. They have the power to requisition certain drugs when there is a shortage – and there could be grounds to do so in this situation too.”

Gaps in PBS and manufacturer provisions

A related issue affecting women is the gap in PBS and manufacturer provisions. Dr Khot says this means some important women’s healthcare, like non-hormonal IUDs, are not freely available.

“We have hormonal IUDs on the market already and these are PBS listed. However, non-hormonal IUDs – which have been around for longer – are not subsidised, because they are classified as devices. While hormonal IUDs provide very good contraception, they may not be ideal for some women. These women have to pay for their IUD and in my view, this is unacceptable.”

Similarly, manufacture discontinuations of hormone replacement therapy (HRT) patches – in favour of cheaper alternatives – have left women short of vital healthcare during menopause.

“The patches are really effective at helping women manage menopausal symptoms, but they are more expensive to produce than other HRT solutions, so they are now almost impossible to come by. It’s just another example of inequity in healthcare.”

Signs of progress

On a positive note, RANZCOG recently convened a medicines roundtable, with participation from manufacturers TGA, PBS and clinicians, to address these issues.

Dr Khot said all parties agreed they were an ethical priority.

“We had a couple of drug manufacturers in the room and they were very much wanting to make sure that they continued to manufacture drugs that women can access in pregnancy. So that was a really good thing,” she said.

Dr Khot also applauds the efforts of multiple organisations, who are pushing for the greater inclusion of pregnant women in medical research.

However, she said a lot more need to happen before the issue goes away.
“I’m looking forward to discuss this further with the sector,” she said.

Join the debate

Continuing the discussion, Dr Khot will present at the upcoming Obstetric Medico-Legal Congress, hosted by Informa Connect.

This year’s event will be held 16-17 September at the Crown Conference Centre Melbourne.

Register your tickets here.

About Dr Khot

Dr Nisha Khot is the vice-president of Royal Australia and New Zealand College of Obstetricians and Gynaecologists RANZCOG and clinical director of obstetrics and gynaecology at Peninsula Health in metropolitan Melbourne.

She is the co-chair of Living Evidence for Australian Pregnancy and Postnatal Care Guidelines, a cross-disciplinary consortium bringing together leading experts from peak health organisations across Australia to provide continuously updated guidelines in pregnancy and postpartum care.

In addition to RANZCOG, Dr Khot is the Board Chair Multicultural Centre for Women’s Health, a community-based organisation that advocates for health, wellbeing, safety and leadership of migrant and refugee women in Australia.

Dr Khot is a staunch advocate for gender equity and diversity especially in healthcare leadership.