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Clinical Relevance of Therapeutic Drug Monitoring During Pregnancy

Epidemiologic surveys have determined that between one third and two thirds of all pregnant women will take at least one medication during pregnancy (1–5). These data demonstrate that drug use during pregnancy is of public concern. Pharmacotherapy during pregnancy usually focuses on the teratogenic safety of the unborn baby. Moreover, although most drug therapy in pregnancy is directed to maternal requirements it is often carried out without considering the important modifications of drug handling by the pregnant woman. Therapeutic drug monitoring during pregnancy aims to better individualize dosing regimens taking into account relevant pregnancyinduced changes in drug disposition. Therefore, to obtain the clinically relevant data from TDM during pregnancy it is imperative to understand the physiologic changes that occur during pregnancy and their influence on drug disposition. The complex physiologic unit of mother, placenta and fetus undergoes considerable dynamic physiologic changes (6–7). These lead to variations in the processes of absorption, distribution and elimination of drugs. Moreover, as previous studies have determined, most drugs easily cross the placenta (8–9), making the fetus an unwanted or even non-benefiting drug recipient. In general, maternal and fetal drug responses during pregnancy are influenced by two main factors: The changes in absorption, distribution and elimination of the drug in the mother which are dictated from pregnancyinduced physiologic changes, and the placental-fetal unit which affects the amount of drug that crosses the placenta, the fraction of drug being metabolized by the placenta and the distribution and elimination of a drug by the fetus. These factors together with characteristics of the specific drug should be taken in consideration when predicting the time course of drug concentration in the fetal-maternal unit.