Decision-making regarding safe use of medications during pregnancy is challenging for a number of reasons. Pregnant women are generally excluded from clinical trials for ethical concerns about the drug’s impact upon the developing fetus. The lack of rigorous post-marketing studies evaluating birth outcomes associated with in utero exposure to most medications is unfortunate, and limits the ability of physicians and patients to make fully informed decisions about the risks and benefits of medications during pregnancy.
To bridge the gap “Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP)” has been developed. MEPREP is a multi-site collaborative research program developed to enable the conduct of studies of medication use and outcomes in pregnancy.
Collaborators include the:
– HMO Research Network,
– Kaiser Permanent Northern and Southern California, and
MEPREP currently involves more than 20 medication safety researchers and includes data for 1,221,156 children delivered to 933,917 mothers. Current studies include evaluations of the prevalence and patterns of use of specific medications and a validation study of data elements in the administrative and birth certificate data files. MEPREP can support multiple studies by providing information on a large, ethnically and geographically diverse population.
This partnership combines clinical and research expertise and data resources to enable the evaluation of outcomes associated with medication use during pregnancy.
A major focus of MEPREP’s research agenda may include studies of the association between in utero exposure to specific medications and congenital anomalies or other birth outcomes (e.g., preterm birth).
Specific medication classes of interest to program researchers include:
– Anti-infectives (including antivirals),
– Asthma medications,
– Antipsychotics, and
There is a strong hope and high expectations that the linked datasets developed as part of MEPREP allow the analysis of comparable data across multiple sites and improve computer programming efficiency and accuracy. Research conducted through this partnership will provide valuable information for patients and physicians when making decisions about medication during pregnancy.
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