Monitoring Pregnancy Outcomes in PEM
At the time of marketing there is little, if any, data available on the use of medicines during human pregnancy, as clinical trials usually do not include pregnant women. However in ‘real world’ clinical practice, drugs, including newly marketed drugs, may be used by pregnant women.
Because Prescription-Event Monitoring (PEM) is a non-interventional, observational cohort technique (patients are identified from dispensed prescriptions, so there can be no interference with the prescribing doctors decision as to the medicine prescribed), pregnant women are identified in PEM study cohorts. Some women may stop the drug as soon as they realise they are pregnant whilst others may continue treatment with the drug.
For all pregnancies identified in the PEM cohort, a follow up questionnaire is sent to ascertain the outcome of the pregnancy. This allows the stage of pregnancy during which the drug was taken to be determined, the nature of the outcomes, the proportion of babies born with a congenital anomaly and the nature of that anomaly. In addition, length of gestation and birth weight can be ascertained.
Currently, studies are underway to compare pregnancy outcomes between different PEM studies, or with external comparators.