Document Type
Editorial
Publication Date
2008
Abstract
"Regulatory agencies approve drugs for marketing when the ratio of risk to benefit of the drugs is positive, i.e. the potential benefit of using the drug justifies the risk of drug related adverse reactions (ADR). At the point of approval of a drug there is not adequate information about all possible negative outcomes arising from its use in clinical practice. The information is even more limited for patient subgroups, diseases and treatment combinations that were not evaluated in the clinical trials required for approval. Therefore, performing post-marketing pharmacoepidemiological studies is necessary for a better understanding of drug use in usual clinical practice conditions and the effect of the drugs on the general patient population."
Recommended Citation
Seoane-Vazquez E. Drug selection and adverse drug reactions: Balancing outcomes and costs. Electronic Journal of Biomedicine. 2008;2:3-5.
Copyright
The author
Included in
Health and Medical Administration Commons, Pharmacy Administration, Policy and Regulation Commons
Comments
This editorial was originally published in Electronic Journal of Biomedicine, volume 2, in 2008.