[Drugs in pregnant women of children with congenital anomalies: a study of sources from the Valencian Community].

OBJECTIVE

To compare the drug use information available from the Congenital Anomalies (CA) Population Based Registry of Valencian Region (RPACCV) and Outpatient drug dispensing database (GAIA) in CA's mothers during the first trimester of pregnancy.

METHOD: Pregnant women who gave birth to children with CA, whether live-born or stillborn, between 2013 and 2021 were identified in the RPACCV, and their dispensed drugs records were obtained from GAIA. Pregnant women and the medicines identified from each source were compared, estimating: the kappa coefficient, the proportion of pregnant women using medicines, and the medicines detected in each source by therapeutic group and by categories of interest. The sociodemographic characteristics of pregnant women using medicines were described.

RESULTS

A total of 6,818 CA's mothers were included. The RPACCV identified fewer users but more supplements and over-the-counter (OTC) medicines, whilst the GAIA study identified more users and more high-risk medicines. Although κ=0.22 indicated a limited degree of agreement, together they estimated that 68% of pregnant women used medicines during the first trimester, 37.6% used supplements, 51.1% used OTC, 17.9% used foetotoxic, 10.8% used high-risk and 54.3% used low-risk medicines.

CONCLUSIONS

Although limitations inherent to this type of database have been identified, the combined use of two population-based sources such as RPAC-CV and GAIA proves highly complementary in identifying drugs of interest and determining the timing of drug use, thereby providing key information for research into drug use and safety during pregnancy and for pregnancy planning in women with associated medical conditions.