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At the end of the chapter, the reader will be able to:

  1. Understand the importance of critically evaluating the pharmacoepidemiology literature

  2. Understand key topics in evaluating the pharmacoepidemiology literature

  3. Apply checklist questions in evaluating the pharmacoepidemiology literature

The beginning of pharmacoepidemiology as a research area started in the late 1980s with crudely designed studies appearing in the literature. For example, Somerville et al.1 published a brief report in The Lancet, quantifying the risk of gastrointestinal bleeding following nonsteroidal antiinflammatory drug (NSAID) use in elderly people; the report then sparked a flurry of studies trying to compare and contrast results. Since then, the research area has grown with pharmacoepidemiologists developing specialized methodologies and terminologies to describe the association between a medication exposure and an outcome. In fact, over the past few decades there has been an increase in the number of published articles in the field of pharmacoepidemiology.2 Draugalis and Plaza2 examined the trends in the use of epidemiology-related terminology over the past 20 years in 3 representative journals in pharmacy, the American Journal of Health-System Pharmacy, The Annals of Pharmacotherapy, and Pharmacotherapy; in two medical journals, TheNew England Journal of Medicine and JAMA; and also the American Journal of Public Health. The authors found that there was a general increase in the proportion of epidemiologic terms used in these journals, with the most significant increase observed in Pharmacotherapy, from none in 1984 to 17.8% in 2004. This increase reflects the growing importance of population-based research of drug use and drug effects. More pharmacoepidemiology studies are being conducted and used by various stakeholders in the health care system.

Evidence-based medicine derives best practices for the management of patients from published clinical and epidemiologic research findings. For health care practitioners to practice evidence-based medicine and make informed decisions, it is critical that they understand and interpret the phar-macoepidemiology literature. By interpreting the findings, health care practitioners can better understand the risks and benefits of a medication when used in a diverse patient population. A growing number of entities are also using the pharmacoepidemiology literature for a variety of reasons, including (a) regulatory bodies to ensure that newly marketed medications are safe and effective in large, “real-world” populations where adverse events can be monitored beyond randomized control trials; (b) marketing bodies to assess the impact of pharmacoepidemiology research findings on the market and identify groups of patients who would benefit the most from a medication; and (c) legal bodies to assess causality of negative outcomes in anticipation of possible legal issues. A description of how various stakeholders are using pharmacoepidemiology studies is provided in Case Study 7-1, thereby illustrating the importance of being able to critically evaluate the pharmacoepidemiology literature.

This chapter allows the reader to connect the concepts and methods presented in previous chapters and apply them in evaluating published pharmacoepidemiology studies. When evaluating ...

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