(Z) COVID-19 Infection and Medication Use in Pregnancy (CONSIGN) – A Multinational Drug Utilisation Study Using Linked Healthcare Data

Publication Number: 1024

Background: There is a lack of knowledge about medication use among pregnant women with COVID-19. The European Medicines Agency funded the CONSIGN study to assess the impact of COVID-19 on pregnant women and their infants, and the role played by medicines. This drug utilisation study is using linked healthcare data sources from five data access providers (DAP) across Europe.

Objectives: To estimate the prevalence of medicines use for nineteen medication classes (ATC 2nd level) in the outpatient setting among pregnant women with and without COVID-19, by age and trimester of pregnancy in four countries.

Methods: Five DAPs from Italy, Norway, Spain and Wales contributed data from June 2019 up to and including the most recent data available (April 2021). Information on prescribing or dispensing of medicines (ATC 2nd level) in primary care /outpatients was retrieved, plus information on pregnancy, age and COVID-19 status. Pregnancies were divided by trimesters. Only pregnancies ongoing or completed during the pandemic were included. The prevalence of medication use in trimesters with no COVID-19 positive test/diagnosis was compared with that observed in trimesters when a first recorded positive COVID-19 test/diagnosis was received, and subsequent trimesters. Analysis was confined to descriptive statistics.

Results: The study included 115,162 pregnant women, a total of 2022 (1.8%) pregnant women had a recorded COVID-19 positive test. In trimesters with a positive COVID-19 test/diagnosis, antithrombotic agents (B01) were the most commonly dispensed/ prescribed medicines. In Spain and Italy, there was an approximately threefold increase in prevalence of antithrombotic agents dispensing/prescribing compared with trimesters without a COVID-19 diagnosis. Rates of antithrombotic use in the third trimester remained higher for those who contracted COVID-19 in the first or second trimester compared to those without a previous COVID-19 infection (e.g., IACS-Spain: 13.7%, 95% CI: 8.0 - 19.4 vs. 7.4%, 95% CI: 6.8 - 8.0). In contrast, there was no increase in antithrombotic prescribing in Wales.
While there was a tendency towards a higher prevalence of use of corticosteroids and antibacterial agents in trimesters with a COVID-19 diagnosis, few of these increases were statistically significant.

Conclusions: In all except Wales, there was a changing and increased use of antithrombotics in primary care/outpatients amongst pregnant women with COVID-19. This remained elevated in subsequent trimesters. Few other drug classes had such clear, consistent patterns. Further studies are underway to consolidate these results and investigate the consequences of medicines use among pregnant women with COVID-19.