Quantifying Adverse Drug Events

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Quantifying Adverse Drug Events Are Systematic Reviews the Answer? Mahyar Etminan,1,2 Bruce Carleton3,4 and Paula A. Rochon5,6,7 1 2 3 4 5 6 7

Division of Clinical Epidemiology, Royal Victoria Hospital, Montreal, Canada Division of Clinical Epidemiology and Outcomes Research, Vancouver Hospital, Vancouver, British Columbia, Canada Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada Pharmaceutical Outcomes Programme, Children’s and Women’s Health Centre of British Columbia, British Columbia, Vancouver, Canada Kunin-Lunenfeld Applied Research Unit, Baycrest Centre for Geriatric Care, Toronto, Canada Departments of Medicine and Public Health Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada Institute for Clinical Evaluative Sciences, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Canada

Abstract

Quantifying adverse drug events (ADEs) is critical to clinicians, consumers and policy makers. Most ADE information comes from large clinical trials. Systematic reviews have become a popular tool in quantifying the efficacy of different therapeutic interventions and ADE data collected in randomised trials may be helpful in quantifying the risk associated with a specific pharmacological agent. However, clinicians who are interested in conducting systematic reviews of ADEs may face many challenges. These challenges are geared towards two main areas: poor quality of ADE reporting in randomised trials and poor indexing of ADEs in medical databases. In this review, we will discuss these challenges in detail using some examples from the literature. Where possible, we also discuss strategies that may overcome these problems. More rigourous standards of reporting ADEs in randomised trials, as well as better indexing of ADE terminology in medical databases, could one day make systematic reviews of ADEs a powerful tool for practising clinicians.

Information on adverse drug events (ADEs) is an invaluable tool in the clinical decision-making process. When two drugs of the same class are believed to be equally efficacious, clinicians usually choose to prescribe the drug with the safer adverse event profile for their patients. Quantifying adverse drug data may be a challenging task to practising clinicians. Systematic reviews are a popular method of summarising clinical

evidence.[1,2] Although most systematic reviews address the efficacy of different medical interventions, such reviews may also be helpful in quantifying ADEs.[3] This paper will discuss the potential role of systematic reviews as a tool in quantifying ADEs, as well as examining the obstacles that clinician scientists may face when conducting such reviews.

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Etminan et al.

1. Why is Information on Adverse Drug Events (ADEs) Important? The direct medical costs associated with ADEs have been estimated to be in the range of $US30 billion to $US130 billion annually in the US alone.[4] These estimates are even m