THE IRISH PHARMACY Union (IPU) has voiced its disappointment at the roll out of a new scheme to reimburse women with the cost of a drug that to help with severe sickness during pregnancy – and have called for a re-think of the amount of red tape involved.  

The drug, known as Cariban, was previously unavailable on the drugs payment scheme or medical card.

As part of a major campaign women impacted by severe vomiting – known as Hyperemesis Gravidarum or HG – called for the State to reimburse expenses for Cariban, which can cost up to €3,000 over the course of a pregnancy. 

HG can profoundly debilitate those who suffer with it. While a majority of women experience regular morning sickness – which can actually occur at any time of the day – during pregnancy, HG is a lot more serious and can often mean multiple hospitalisations.

Budget 2023 set out that funding of €1 million would be set aside to facilitate reimbursement of the drug, with women told they could avail of the drug free-of-charge  from January 2023. 

However, despite promises the scheme would be up and running from the first day of this month, the HSE only informed pharmacists about the scheme and how it will operate on 3 January – three days after the scheme came into operation.

‘Creates further delays for women’

In a statement, the IPU said that while it welcomes funding for Cariban under the Community Drug Schemes is now available, it is unhappy with the roll out of the new plan. The scheme is not straightforward and creates further delays for women, pharmacists say.

“We are concerned and disappointed at how the scheme has been implemented,” said the IPU.

The circular sent to pharmacists this week states that the product will be made available on an individual patient basis for those patients who meet the criteria under Community Drug Schemes (GMS, DPS) from 1 January 2023 but it must be consultant obstetrician initiated.

The letter to pharmacists states that as Cariban not licensed with the Health Products Regulatory Authority (HPRA) in Ireland, that under the Community Drug Schemes, the prescription of the medicine must be consultant initiated.

The HSE states in the letter that whilst the original prescriber is a consultant and specialist in the relevant field, the HSE will subsequently accept a GP prescription further to the initial hospital prescription.

In order to approve reimbursement of Cariban, by exceptional arrangements, the prescribing consultant must complete an initial application form for individual reimbursement. 

Consultant prescription

Following the budget announcement in September, Health Minister Stephen Donnelly said he would inquire as to why an initial prescription from a consultant would be required.

This issue has also been criticised by campaigners, along with GPs, and then-Tánaiste Leo Varadkar, who queried the move last year. 

Cariban has been available in the Coombe, Rotunda and Holles Street maternity hospitals for close to a decade.

A spokesperson for the IPU said: “Requiring patients to get prior approval from a Consultant Obstetrician is difficult in practice and creates needless access inequalities where women do not have access to consultants.

“Pharmacies then need to check if the relevant approval is in place which is not straightforward as there is no central portal on which it can be checked thus creating further delays.

“The unnecessary additional bureaucracy attached to this scheme adds needless administration for all healthcare professionals involved in women’s health at a time when the system is under strain.

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“While the purpose of this scheme was to control the spend on this medication its implementation is questionable given the self-limiting nature of the condition and the cautious approach to medication taking by pregnant women,” they added. 

Members of Donnelly’s own party have also spoken out against the consultant requirement. 

‘Not reasonable’

Mayo TD Lisa Chambers, who has been vocal on the issue of HG during pregnancy previously, told The Journal that it was a really important step in the advancement of women’s healthcare to finally have a reimbursement scheme for Cariban.

“Obviously it is key that women can now access the scheme freely and in a timely manner and this is not happening currently so we must address this. Most women will not see a consultant until 12 weeks, certainly any woman using the public healthcare system won’t, so it’s not reasonable or logical to require a consultant to prescribe the drug when it’s very often needed within the first 12 weeks,” she said. 

“With that in mind, the only sensible solution is to allow GPs to prescribe, otherwise the very women we have been trying to help are being blocked from accessing the reimbursement scheme due to red tape and bureaucracy,” said Chambers. 

The HSE form sent to pharmacists retirates that that Cariban, which is used in all maternity hospitals in Ireland, is an unlicensed medicine and that licensed medicines should be used where possible.

It also asks the prescriber to tick a box stating that the patient has not responded to any “conservative management” of the severe sickness during pregnancy.

Previously, The Journal reported that women have reported being told try a range of solutions to help HG, such as eating Rice Krispies with cold milk.

Health Minister Stephen Donnelly was asked to comment but had not responded by the time of publication.