Patient reporting of adverse drug events - a narrative review

Abstract

PURPOSE : The aim of this review is to examine the role and experience with direct patient adverse drug reactions reports in the spontaneous reporting systems. MATERIAL AND METHODS : A computerized literature search or relevant English publications regarding the role and characteristics of direct patient reporting from 1996 to 2012 was completed in January 2013. The latest update in the search was performed from September to October 2013. RESULTS : The results show that direct patient reports could contribute to the pharmacovigilance system qualitatively as well as quantitatively. There are a lot of factors that influence patient participation such as personal characteristics, disease perception, and previous experience. Critical issue in the process is considered to be the noise effect on the signal generation. CONCLUSION : Inclusion of patients as a source of information will help to change the perspective of pharmacovigilance. The factors that affect the decision of the patient`s report of an adverse drug reaction and possible external influences that would shape their opinion and could affect the quality of reports are not well studied.