Pregnancy medicines shortage sparks concern

Pregnant women are missing out on essential medications, including for hypertension, with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) largely blaming the shortages on a ‘near total lack of trial data’.
 
The peak women’s health body called a roundtable on 2 May with medical groups, including the RACGP, and representatives from the Therapeutic Goods Administration (TGA) and Department of Health and Aged Care to discuss treatments facing supply shortages in Australia, and determine short- and long-term solutions.
 
‘The systemic failure to include pregnant women in therapeutic clinical trials … has resulted in a dearth of newer, potentially more effective agents for common conditions in pregnancy,’ RANZCOG states.
 
While the TGA regulates supply of medicines, it does not directly control supply, and pharmaceutical companies can place strict guidelines on medications’ uses. Many of the medications in shortage are older and off-patent, so pharmaceutical companies cite no profit benefit to increase their availability.
 
RANZCOG has raised concerns that, ‘no matter how well validated and supported by evidence’, off-label indications ‘fly under the radar’, and pharmaceutical companies can decide to remove certain products from the market because ‘better, newer agents are available for the officially registered indications’.
 
Chair of RACGP Specific Interests Antenatal and Postnatal Care, Dr Ka-Kiu Cheung, who represented the RACGP at the RANZCOG National Roundtable, told newsGP this is a ‘timely discussion’ with supply issues cause for growing concern.
 
‘Medications used in pregnancy are often older, off-patent and more established, although used off-label,’ she said.
 
‘As a consequence, they may be supplied at a loss or with little financial incentive by a single sponsor or pharmaceutical company. This makes supply particularly precarious especially as the Australian market is very small in comparison to Europe or the United States.’ 
 
Dr Cheung works as a community GP and within a large maternity hospital on the Gold Coast.
 
She sees how her patients benefit from the services of dedicated antenatal pharmacists who can secure essential medications through the Federal Government’s Special Access Scheme, but says it is ‘unfortunately not the case’ for many smaller maternity centres or remote clinics outside of metropolitan areas.
 
‘Having a medical condition arise in pregnancy is already stressful for patients. Add to this the complication of supply issues and it can make adequate management very difficult,’ she said.
 
‘Patients either need to shop around multiple pharmacies to fill a prescription or they are required to attend the hospital pharmacy to pick up their medication and incur the inconvenience and cost of transport and parking.
 
‘Women birthing outside of major centres are particularly vulnerable and disadvantaged … [the medication shortage] impacts maternity care in rural and remote regions where lack of supply could jeopardise the safe transfer of patients in pre-term labour.
 
‘This is where priority for essential and critical medications and devices should be focused.’
 
Medications impacted by the current shortages that also have limited alternatives in pregnancy are of particular concern, according to Dr Cheung.
 
Examples include immediate-release nifedipine used to treat acute hypertension and tocolysis.
 
Supply of benzathine benzylpenicillin is also a worry. The drug is used for the treatment of syphilis which is on the rise across Australia, and can lead to ‘devastating consequences’ in pregnancy of congenital syphilis, which disproportionately impacts Aboriginal and Torres Strait Islander communities. 
 
Dr Cheung says the alternative treatment of doxycycline is not suitable for use in pregnancy.
 
While there are alternative options for some of the medications in question for use in pregnancy, many are not listed on the PBS so come with higher out-of-pocket costs for patients.
 
Non-subsidised medicines, coupled with a lack of clinical trials available for pregnant women, and off-patent medications were all discussed at Thursday’s RANZCOG Roundtable.
 
Dr Cheung said there is a desire to strengthen the relationships between stakeholders, including the TGA, clinical groups and the pharmaceutical industry.
 
‘This could improve the understanding of enablers and barriers to maintaining supply of essential medications in Australia and research opportunities,’ she said.
 
‘Short- and longer-term actions were prioritised and discussed on securing critical medication and device supply and access in pregnancy. 
 
‘There was a focus on prioritising essential medications with an equity lens for vulnerable populations including our First Nations and rural and remote communities.’ 
 
The discussion comes as the TGA continues to investigate contributing factors for nationwide shortages of a range of medications.
 
The RACGP provided feedback to this process in March, highlighting that TGA shortage warnings should be integrated into general practice clinical information systems, and that the regulator needs to implement a ‘proactive process’ of alerting GPs to expect disruptions.
 
The college says this would ensure GPs have the most up-to-date information to discuss supply issues and to prescribe the best option for their patients, regardless of any medication shortages.
 
RANZCOG Co-Chair of the Roundtable Associate Professor Amanda Henry said the women’s health college is ‘determined to address the root causes’ of pregnancy medicine and device shortages in Australia.
 
‘Solutions may not be simple,’ she said. ‘But we are fully committed to working together with consumers, clinicians and all stakeholders to overcome these challenges.’
 
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