국내 임신부(난임 임신부 포함) 약물 등록 체계 구축을 위한 제언
Suggestion for Guidelines of Pregnancy Exposure Registry
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초록
About 40% of pregnant women are exposed to one or more kinds of medications including multivitamins during their early pregnancy period. And some of those medications are essential for the mother’s health throughout full time of pregnancy. But most of clinical trial for the medicine cannot include the pregnant women because of its uncertain effect on fetus. In this circumstances, the medication can be researched by retrospective study through establishing pregnancy exposure registries. In this study, we aimed to make evidence of fetal safety and risk of many biopharmaceutical products that can help clinician & pregnant women. It is important to enroll the pregnant women who had medication exposure in her early pregnancy without any selective biases. And It should include enough population size and proper data. In addition, pregnancy outcome including the major & minor anomalies of fetus following the exposure of medications in pregnancy must be evaluated by regulated standard guideline. USA & European Union had already published the registry of pregnant women and it really helpful for safe prescription in pregnant women. So It is strongly suggested that this registry will have a great influence on determining the safety and risk of many medications in Korean pregnant women.
Abstract
About 40% of pregnant women are exposed to one or more kinds of medications including multivitamins during their early pregnancy period. And some of those medications are essential for the mother’s health throughout full time of pregnancy. But most of clinical trial for the medicine cannot include the pregnant women because of its uncertain effect on fetus. In this circumstances, the medication can be researched by retrospective study through establishing pregnancy exposure registries. In this study, we aimed to make evidence of fetal safety and risk of many biopharmaceutical products that can help clinician & pregnant women. It is important to enroll the pregnant women who had medication exposure in her early pregnancy without any selective biases. And It should include enough population size and proper data. In addition, pregnancy outcome including the major & minor anomalies of fetus following the exposure of medications in pregnancy must be evaluated by regulated standard guideline. USA & European Union had already published the registry of pregnant women and it really helpful for safe prescription in pregnant women. So It is strongly suggested that this registry will have a great influence on determining the safety and risk of many medications in Korean pregnant women.
참고문헌 (9)
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- Dolk H, "The prevalence of congenital anomalies in Europe", Adv Exp Med Biol, 686, pp.349~364 (2010)
- Mitchell AA, "Systematic identification of drugs that cause birth defects - a new opportunity", N Engl J Med, 349(26), pp.2556~2559 (2003)