(P-417) Awareness of Pregnant Women About the Spontaneous Adverse Drug Reaction Reporting System in Bulgaria- a Pilot Study

Background: More than half of pregnant women take prescription or over-the-counter (OTC) medicines during pregnancy, and this use is increasing worldwide. Pregnant women are excluded from clinical trials and there is a lack of information about drug safety and adverse drug reactions (ADRs). Pregnant women’s participation in the spontaneous ADR reporting system might be an important source of safety information.

Objectives: To analyse and assess pregnant women's experience with ADRs and level of knowledge about the ADR reporting system in Bulgaria.

Methods: A cross-sectional, questionnaire-based study was conducted between August 2020 and October 2020. A fourteen-item self-administrated questionnaire was distributed among Bulgarian pregnant women via social media. A total of 165 participants completed the survey. Descriptive statistics were applied to participants’ demographics. Pearson’s chi-square test was used for comparing categorical variables.

Results: Medicines use among Bulgarian pregnant women, who participated in the survey, was high (84.5%). Everyday medicines use was reported by 24.2% of the respondents. More than half of surveyed women (57.6%) considered that OTC medicines and herbal drugs are safe to be used during pregnancy, but only following a consultation with a physician or pharmacist. Of all participants, 15.4% have experienced potential ADRs during pregnancy. For the majority of women in the survey, the primary source of information regarding drug safety during pregnancy was a health care provider (81.8%) followed by product information (e.g., package leaflet) (54.5%) and Internet resources (48.5%). Only 21.2% of pregnant women have been aware of the possibility to report ADRs directly to the Bulgarian Drug Agency and this was significantly associated with the level of education (p=0.001). ADRs reporting rate during pregnancy was 9.1%.

Conclusions: Pregnant women in Bulgaria are not well informed about the functional principles of the national safety surveillance system. Spontaneous ADRs reporting rate by pregnant women is still low. Educational campaigns on drug safety during pregnancy may contribute to more active involvement of pregnant women in medicines safety surveillance.