(B-276) Paternal Linkage in the PHARMO Data Network: Assessing the Impact of Paternal Drug Exposure on Child Health Outcomes

Background: Emerging evidence suggests that paternal drug exposure can affect child outcomes, for example for immunosuppressive agents or antiepileptics such as valproate. Understanding the impact of paternal health and treatment pathways on offspring is crucial for developing comprehensive public health policies and preventive healthcare measures.

Objectives: The study objective was to assess the feasibility of linking paternal electronic health records to their offspring in the PHARMO Data Network enabling research on paternal treatment pathways and child health outcomes.

Methods: The study used the PHARMO Data Network, including records from the Netherlands Perinatal Registry (Perined), to link paternal electronic health records to their offspring. This included pregnancy records from 2000-2022 as well as outpatient pharmacy records. Deterministic record linkage methods were employed to ensure accurate matching. Variables used to assess feasibility of linkage included date of birth, sex of the child, zip code, surname soundex, residential code, insurance details and general practitioner. Demographics of the resulting linked cohort were compared against national reference data.

Results: This feasibility assessment indicates that paternal linkage could be established within the PHARMO Data Network. Of the 4,017,556 pregnancies identified in Perined, at father was linked for approximately 5% (N = 184,860) of the children born from these pregnancies. The selected linkage variables used were date of birth, sex of the child, zip code and residential code. For these pregnancies, both paternal drug exposure as well as child outcomes could be studied on the short-term (e.g., birth defects) and long-term (e.g., neurodevelopmental disorders). Results were representative of national figures in terms of paternal age distribution and difference between mother and father.

Conclusions: This study demonstrates the feasibility of paternal linkage within the PHARMO Data Network, providing a foundation for further research on the impact of paternal drug exposure on child outcomes. The established linkage methodology offers significant opportunities for conducting regulatory safety studies and assessing potential risks associated with paternal medication use. Planned studies, such as ADEPT (“The utilisation of antiepileptics in men and women of childbearing age, and pregnant women in Europe”, EU PAS number: EUPAS1000000212), will evaluate the validity and broader applications of this linkage, which will further enhance insights and inform future public health strategies.