Pharmacovigilance in pregnancy: a feasibility study using population-based data linkage

[Truncated abstract] The thalidomide tragedy of the 1950s serves as a warning that surveillance should be a critical part of monitoring and reporting the use of prescribed medicines in pregnancy. Current knowledge of factors affecting pregnancy outcomes in relation to prescription medicines in Australia is limited. National dispensing data for subsidised prescription medicines have recently been approved for linkage to the population-based health datasets in Western Australia (WA), creating the capacity to monitor how these medicines are used and their impact on pregnancy outcomes. The aims of this thesis are: to quantify, for the first time, the spectrum of medicines dispensed under the national Pharmaceutical Benefits Scheme (PBS) to pregnant women in WA; to describe PBS medicines dispensed to pregnant women in WA, in terms of sociodemographic characteristics of the women, trimester of pregnancy, by medicine classification, and by the Australian categorisation of risk of drug use in pregnancy; to determine whether known or suspected teratogens dispensed during pregnancy can be detected when administrative records of medicines dispensed in pregnancy are record-linked to a birth defects registry; to investigate dispensing patterns and pregnancy outcomes of women dispensed a specific class of medicine, selective serotonin reuptake inhibitors (SSRIs), as a surveillance case study; and, to determine whether linking PBS data with WA’s population-based health administration data such as hospital morbidity, midwives’ records, births, deaths and birth defects, is a useful contributor to the postmarketing surveillance and research of teratogenic effects and other adverse pregnancy outcomes.