Outline the organization of pharmacovigilance in Europe, and discuss the difficulties around identifying and collecting data about adverse drug reactions. Also, describe the different methods of pharmacovigilance used to address these difficulties.
The U.S. Food and Drug Administration (FDA) defines an adverse drug experience as any AE associated with the use of a drug in humans, whether or not considered drug related,4 while the International Conference on Harmonisation (ICH) guideline ICH E2A similarly defines an AE as an untoward medical occurrence in a patient administered a pharmaceutical product, whether or not the occurrence is related to or considered to have a causal relationship with the treatment.5
For marketed products regulated by FDA, AEs are categorized for reporting purposes according to the seriousness and expectedness of the event (i.e., whether the event was previously observed and included in local product labeling), as it is presumed that all spontaneously reported events are potentially related to the product for the purposes of FDA reporting. Prior to marketing approval, relatedness is an additional determinant for reporting events occurring during clinical trials or preclinical studies associated with investigational new drugs and biologics. For AEs occurring in postapproval studies and reported during planned contacts and active solicitation of information from patients, as when registries collect data regarding one or more FDA-approved products,6, 7 the requirements for mandatory reporting also include whether there is a reasonable possibility that the drug caused the adverse experience.4 For registries that do not actively solicit AEs, incidentally reported events (e.g., those reported during clinician or consumer contact for another purpose) should typically be handled and evaluated as spontaneously reported events.