Identification of Potential Adverse Drug Reaction Occurring in Neonates and Children Following in Utero Exposure to Maternal Medication

Supervisors: Dr James McLay, Dr Markus Steiner, Professor Jill Pell (University of Glasgow) and Dr Lorna Aucott

Current adverse drug reaction (ADR) reporting systems in the UK rely on spontaneous reporting of possible events via the Yellow and Green Card Schemes. Both schemes suffer from poor reporting, making detection of potential ADRs in numerically small patient populations difficult and prolonged. Furthermore, both schemes are focused on immediate events which have a recognisable temporal association between drug exposure and an event. There is increasing interest in the detection of delayed ADRs which may not become apparent for years after drug use. One area of particular interest is the possible effect on a child following in utero drug exposure to maternal medication, which may induce physiological changes in the fetus that are thought to programme intellectual development and chronic disease in later life. We have previously demonstrated that the electronic linkage of routinely collected, computerised health care data can be used to identify possible pharmacovigilance signals for medication associated adverse events in children and we now intend to extend and adapt this methodology using record linkage of routinely collected National healthcare data, including dispensed medication, hospital admissions and maternal/neonatal data, to investigate the effect of in utero drug exposure on childhood health outcomes.