Pharmacoepidemiology safety studies

Drug safety is an important public health focus throughout the life cycle of a compound. The main data streams to monitor and examine drug safety are from randomized clinical trials (RCTs), spontaneous adverse event reports, and pharmacoepidemiologic safety studies. 

Launching the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project to monitor the conduct of multicenter postauthorization safety studies... 

There is little doubt, on the one hand, that case-control studies have a valuable place in pharmacoepidemiology, and therefore in the evaluation of drug safety. There is also little doubt that without minute attention to detail and, possibly, a little luck, the method may be unreliable or even completely misleading. A list of... 

Promotes pharmacoepidemiology, a science that applies epidemiologic approaches to studying the use, effectiveness, value, and safety of pharmaceuticals. 

O Neill, R.T., Biostatistical considerations in pharmacovigilance and pharmacoepidemiology linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies, Stat. Med., 17, 1851, 1998. 

Mackay, F., Dunn, N., Wilton, L., Pearce, G., Freemantle, S., Mann, R. (1997). A comparison of fluvoxamine, fluoxetine, sertraline, and paroxetine examined by observational cohort studies. Pharmacoepidemiology and Drug Safety, 6, 235-246. 

Surveillance studies for both efficacy and safety (adverse effects) pharmacoepidemiology and pharmacovigilance... 

Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. Some of the principles of pharmacoepidemiology are used to gain further insight into the efficacy, and especially the safety, of new drugs once they have passed from the limited exposure in controlled therapeutic pre-... 

A critical examination (4) of a report (5) of several children whose chronic bowel and behavioral abnormalities were linked to measles, mumps, and rubella (MMR) immunization can be used as an example to underline Halsey s comments. Without effective and credible systems for the detection of vaccine-associated adverse events through pharmacovigilance, for distinguishing causal reactions from coincidental reactions by pharmacoepidemiological or other studies, and for risk communication, vaccine safety concerns may confuse the media and the public. 

Ungar W (1997a) The choice of pharmacoeconomic study design during drug development -Part 1. Pharmacoepidemiology and Drug Safety 6 391-397. 

Increasingly, observational research and pharmacoepidemiologic approaches are being applied to tiie assessment of safety risks, which may be difficult, if not impossible, to examine by analyzing spontaneously reported adverse events alone or by conduchng interventional clinical studies. 

Strom (2005, p. 3) defined pharmacoepidemiology as the study of the use of and the effects of drugs in large numbers of people. Dimensions of interest include safety, effectiveness, utilization, and cost. Going back to randomized clinical trials... 

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