Towards New Tools for Pharmacoepidemiology

Monitoring the outcomes for patient health of marketed drugs is an important tool to raise alerts and analyze adverse drug reactions. It also has multiple quantitative purposes related to that. It can establish the pharmacogenomics and relevant environmental factors to stratify the population into those who will be benefited and those who are at risk, which is important in repurposing and pricing drugs. In many ways it is an ongoing clinical trial on a vast scale, facilitated by the rise of the digital patient record to capture the essential data. Those and the following considerations have been reviewed by the author elsewhere [1]. Without doubt, the primary challenge for the data analyst per se in pharmacogenomics and pharmacosurveillance is the multiplicity of factors involved in expressing disease and adverse reactions, and that even govern diagnosis and how therapies are prescribed and used, and in drawing actionable inference from it. The multifactorial aspect shows up well in the epidemiological-geographical aspects. Whilst sickle cell anemia is due to a single mutation and originally followed the geographical distribution of malaria very well (since it conferred protection against it), the distribution of mutations of the serotonin transporter gene show little relation to the distribution of anxiety and depression in which anomalies of serotonin are strongly implicated, because anxiety and depression are polygenic diseases and strongly influenced by environment. Even if it did, prescription of appropriate drugs and their outcomes would not be good markers since the distribution of diagnosis of anxiety and depression is confounded by psychological and social factors and shows rather poor correlation with prescription even in highly industrialized welfare states.