Pregnant women are having difficulty accessing essential medicines due to a  reliance on off-patent drugs and a lack of trial data into the safety of newer medicines.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) has raised concerns about the lack of available therapies for pregnant women due to the reluctance to include them in clinical trials.

With many of the medicines available to pregnant women typically older drugs that are no longer under patent, pharmaceutical companies have little financial incentive to distribute them in the Australian market – leading to supply shortages.

The combination of these factors has left many pregnant women unable to access new or existing therapies for conditions such as hypertension or syphilis – which is increasing in prevalence, particularly among First Nations Australians.

What are the health implications?

Medicine unavailability for pregnant women is ‘really scary’, particularly when it comes to conditions such as hypertension, with patients having difficulty maintaining control, said credentialed pharmacist and women’s health expert Anna Barwick MPS.

‘The prescribing team identifies a need for treatment and writes a script, but when women go to the pharmacy the find the medicine is out of stock. They might go to a number of other pharmacies and can’t find it,’ she said.

‘When they go back for follow-up with their care team, they then need to be hospitalised to get their blood pressure down quickly.’ 

This takes a toll on both the healthcare system, and women and families.

‘Women often need to be hospitalised for a period of time to get control, and then we still need to source ongoing treatment to keep them well managed,’ said Ms Barwick.

The resulting health impacts can be ‘catastrophic’. ‘[Uncontrolled blood pressure] has a massive impact on the pregnancy, often affecting birth weight, and can cause a number of issues with baby and mum’s health going forward.’

Untreated syphilis in pregnancy can lead to congenital syphilis, which can cause premature birth and stillbirth. If diagnosed and treated early, prognosis is good, however supply of its treatment benzathine benzylpenicillin is a concern.

What do pharmacists need to know about off-label medicine use?

Because of the difficulty accessing medicines in pregnancy, off-label medicine use is often the norm, said Ms Barwick.

‘But there’s no published data that these medicines are safe to use, even though they are used regularly to help support women through their pregnancy,’ she said. 

A prime example of this is the Schedule 3 medicine doxylamine to treat nausea and vomiting.

‘Some of the packaging [for doxylamine] has previously said it’s not safe in pregnancy and breastfeeding, when we know it is a category A medication,’ said Ms Barwick.

When unsure whether an off-label medicine is safe to use in pregnancy, she recommends consulting and/or directing patients towards state/territory-based services such as state-based MotherSafe, which operates in NSW.

‘Women and children’s hospitals often collect data to identify whether medicines are not safe, or if there is any reason when it comes to the mechanism of action that would cause a concern during the pregnancy,’ she said. 

‘That data is then used by MotherSafe to reassure women and health professionals about about what treatments are ok or should be avoided.’

A spokesperson for MotherSafe told Australian Pharmacist that as they don’t know patients’ medical histories, it’s important to refer the patient back for a chat with their prescriber to discuss whether a medicine is appropriate for them.

Checking the Therapeutic Guidelines or other reliable resources is also key. Children’s hospitals are also a reliable source of information, often having treatment guides or consumer-directed information on their website which provides recommendations for safe use of medicines in pregnancy and confidence in off-label use.

Pharmacists can also complete the PSA CPD Not as easy as ABCD or X to understand the issues with the Therapeutic Goods Administration’s (TGA) categorisation system for prescribing medicines in pregnancy, and how to consider whether a medicine is safe to use.

‘Sometimes you might need to consult specialist guidelines, or go back to the prescriber and ask what the reason for treatment is, so you understand and can reinforce that with a patient to encourage adherence,’ said Ms Barwick. 

‘It’s also important to find resources that demonstrate evidence that a medicine is reliable and appropriate, including RANZCOG guidelines, which are likely the most up to date. The SOMANZ Guidelines are also highly useful.’

How can pharmacists keep tabs on stock shortages?

Medicines such as benzathine benzylpenicillin to treat syphilis or clonidine for hypertension are currently in short supply. Pharmacists should utilise the Department of Health and Aged Care’s Medicines shortage reports database to keep up to speed with other medicines that are out of stock, advised Ms Barwick.

‘You can search for particular products and when the next expected supply is,’ she added.

Pharmacists can also pass information about shock shortages to GPs, who can start the patient on another available medicine instead, advised Ms Barwick.

Antenatal pharmacists may be able to source essential medications through the Federal Government’s Special Access Scheme, however this may be more difficult in regional, rural or remote areas.

What else can pharmacists do to help?

During medication reviews, pharmacists can potentially suggest an alternative therapy if they know a medicine will be out of stock. For example, labetalol, nifedipine or methyldopa can be recommended in place of clonidine to treat hypertension, said Ms Barwick.

But it’s important to keep patients abreast of different adverse effect profiles and advise
them what to look out for.

‘A required change in therapy due to out of stock medicine may mean adjustment for the body and resultant adverse effects,’ she said.

‘Often it’s a bit of an adjustment for the body around adverse effects,’ she said.

Supporting pregnant women through point-of-care testing, particularly for blood pressure, is another important role for pharmacists, said Ms Barwick.

‘Pharmacists can [explain] what targets pregnant women should be aiming for to manage their blood pressure,’ she said.

‘We can show them how to use blood pressure machines for testing at home. They can use the notes function on their phone for recording their measurements to pass on to their pregnancy care team in their next appointment.’

Monitoring for preeclampsia is also key for patients at risk (see the AP article Shouldering the load for a detailed explainer on pharmacists’ role in pregnancy monitoring).

Lastly, Ms Barwick thinks pharmacists should support RANZCOG’s call for changing the recommendations for medicines in pregnancy.

‘We know [off-label medicines] clearly work and are safe through exposure during pregnancy over a long period of time,’ she said. ‘Hopefully that will mean medicines are less likely to go out of stock because they are a recognised and approved treatment regimen for pregnant women.’