More drug studies need to include pregnant women, says bulletinBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3812 (Published 14 June 2013) Cite this as: BMJ 2013;346:f3812
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This news item highlights an issue that induced the birth of medicines regulation and pharmacovigilance more than forty years ago: the need for more information on medicines taken during pregnancy. Doctors, midwives and women worldwide are still faced with a paucity of data on which to make important (sometimes life-changing) decisions.
In addition to including pregnant women in clinical drug trials, it is also vital to collect data about the utilisation and safety of medicines in pregnancy in 'real-life' post-marketing use, which may differ from use in a clinical trial setting. For example, an issue in 'real-life' use is inadvertant exposure to medicines during pregnancy - including to medicines not licensed for use in pregnancy.
In New Zealand, the Intensive Medicines Monitoring Programme (IMMP) conducts nationwide observational cohort studies on selected medicines, to monitor utlization and safety of these products in a post marketing setting. Cohorts of patients are established from pharmacy dispensing data and patients are followed up primarily by questionnaires sent to GPs.
In several monitoring studies, the IMMP has performed additional specific follow-up to study exposure to the monitored medicine during pregnancy. A recent example is the IMMP study of the smoking cessation medicine varenicline. In this study, all women of reproductive age in a nationwide varenicline cohort were identified (over 6,000 women) and a pregnancy questionnaire was sent for each of these patients. The questionnaire included questions on exposure to varenicline during pregnancy and if applicable, maternal and fetal outcomes.
This proactive monitoring of medicines to determine fetal exposure and safety outcomes is an important part of pharmacovigilance, but it is not enough to perform this is in one small country alone. More effort is still required to establish international pregnancy registers to collect data on exposure and fetal and maternal outcomes for women who take medicines during pregnancy.
Dr Mira Harrison-Woolrych,
Competing interests: No competing interests