Drug-safety program for pregnant women should be federally funded, doctors say

Funding a program that provides pregnant and breast-feeding women with evidence-based research on drug safety should be a priority for the Canadian government, say doctors citing the closure of such a service after nearly 35 years.

Motherisk, established at the Hospital for Sick Children in Toronto, provided counselling to women and clinicians, but loss of access to its extensive databases exposed a major public-health void, said Dr. Jonathan Zipursky, lead author of an editorial published Monday in the Canadian Medical Association Journal.

The hospital announced the closure in April as due in part to “years of declining grant funding.”

Zipursky, Erin Russell, an epidemiologist and CMAJ medical editor and associate editor Dr. Nathan Stall say in the editorial that the program’s end calls for the reinvention of Motherisk to keep moms and their babies from harm.

About 20 per cent of expectant moms have chronic issues, they said, adding tens of thousands of women annually relied on Motherisk, which conducted large-scale laboratory and clinical research in reproductive drug safety.

“Over the past 30 years, the prevalence of prescription drug use in pregnancy has increased by nearly 70 per cent,” they said. “More than 90 per cent of pregnant women will use at least one prescription or over-the-counter drug during pregnancy and about half of breast-feeding women will continue to use prescription medications.

“For these women, a failure to provide appropriate access to information on drug safety is irresponsible and dangerous.”

The absence of timely information and expert counselling may result in women continuing to use drugs that could cause preventable harm to their child or more commonly, they may unnecessarily stop taking prescription medication for fear of harming their baby, potentially leaving them with untreated medical or psychiatric conditions into the postpartum period, the authors said.

Funding not the only obstacle 

Aside from a lack of external funding, Motherisk’s closure involved a loss of credibility amid allegations of research misconduct linked to its director, the authors noted, adding a reinvented program would require oversight.

“This could be achieved by affiliation with an established research institute and with federal support to guarantee financial independence from industry.”

The authors called for a “modernized” program involving collaboration among health-care organizations, researchers and clinicians, including family doctors, obstetricians and gynecologists, nurses and midwives, along with counselling services complemented by open access and searchable databases.

“Federal support would also mandate more patient and public involvement to ensure the program is meeting the most relevant needs of Canadians.”

Debby Gilliland, who lives in White Rock, B.C., and is 36 weeks pregnant, said she was confused after getting conflicting advice about an over-the-counter medication from various doctors she has seen at a maternity clinic.

The problem we have is that very few medications are formally tested on women, let alone pregnant women– Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada 

Her first doctor didn’t mention the drug, the name of which Gilliland didn’t want published, the second told her to take it, but the third physician said she would have advised against the medication.

“So I said, ‘Do you want me to stop?’ She said ‘No, don’t stop because you’ve been taking it so just keep taking it,’ ” said Gilliland, who has had high blood pressure during her pregnancy.

Independent advice from a source like Motherisk would have been beneficial because she didn’t want to go to “Dr. Google” for information she couldn’t trust, she said.

“I think that would be a great resource if you are second-guessing what your doctor is saying.”

Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada, said the group is involved in facilitating a new service that would be independently funded and governed, with support from Health Canada.

“The problem we have is that very few medications are formally tested on women, let alone pregnant women,” Blake said.

“There’s a lot that is important for a pregnant woman to know but because that research is not typically done in order for a drug to become available it doesn’t go onto a label. And what a label will typically say is we don’t have information about its safety in pregnancy, which is alarming for a woman who’s on a medication.”

Lack of information on a label does not mean some helpful research doesn’t exist, Blake said, adding that’s why an evidence-based service is important.

She said pregnant and nursing mothers also need information on the use of alcohol and recreational drugs including cannabis, which may be considered safe without evidence to support that.

“The data make us quite concerned that it may be affecting the baby’s brain in ways that have a long-lasting impact. So the need for a resource that people can directly access is bigger than ever.”

Health Canada said in a statement information on specific drugs is available on its website though a spokeswoman did not respond to a question on whether the department would fund a robust service akin to Motherisk.