(245) Characterization of Pregnancy Data Reported by Health Care Professionals Versus Patients in International Case Safety Reports – A ConcePTION Study

Publication Number: 576

Background: Individual Case Safety Reports (ICSRs) are an important source of information for post-marketing safety data relating to use of medicinal products in pregnancy. Since the introduction of patient reporting, several studies focused on differences and similarities between reports from Health Care Professionals (HCPs) and patients, but to our knowledge none for pregnancy ICSRs specifically.

Objectives: To compare the nature and completeness of ICSRs relating to medicinal product exposure during pregnancy reported by HCPs versus patients as received by the Netherlands Pharmacovigilance Centre Lareb.

Methods: ICSRs submitted before 2022 were selected from the Lareb database when related to medicinal product exposure during pregnancy. The nature of the reports was described according to reporter, year of reporting, seriousness, medicinal product(s), and reported (adverse) reactions. Completeness of pregnancy-related variables was described as the percentage of cases in which the variable had been reported. Completeness was assessed for variables relating to demographics, the reported reaction, the medicinal product(s), the pregnancy, the offspring, and the mother. Aggregate analyses of reports were compared between HCPs and patients using Pearson’s Chi-squared test.

Results: 3478 ICSRs were included, of which 74.3% reported by HCPs. A mean of 1.2 (range 1-10) medicinal products were reported per ICSR, with intrauterine devices with progestogen most commonly reported (7.4% of reports). Spontaneous abortion was the most commonly reported outcome (7.3%). Completeness of the variables varied widely, from infant head circumference (0.45%) to the sex of the child (100%). Variables such as mother's date of birth (HCP 53.5% vs. patient 76.0%, p< 0.001) and drug start date (HCP 45.7% vs. patient 75.1%, p< 0.001) were reported more by patients, while variables such as medical history of the mother (HCP 42.6% vs. patient 29.1%, p< 0.001) were reported more by HCPs.

Conclusions: Patients’ reporting of demographic information and the medicinal product(s) tends to be more complete, whereas HCPs provide more complete information on timing of the exposure and clinical values such as details on the medical history of the mother. Insight into these differences may facilitate improvement of future pregnancy data collection and evaluation.