Abstract
Marketing authorization holders should report adverse drug reactions (ADRs) derived from spontaneous case reports and literature for their medicinal products to competent authorities. Yet the difference in quality of data from both sources has never been analyzed. To this end, YES Pharmaceutical Development Services in cooperation with the German Medicines Manufacturers Association has conducted an analysis examining more than 25,100 spontaneous and literature cases that occurred between 2007 and 2008. Reporting rates of ADRs for specific drug substances (DSs), expectedness, and the system organ class (SOC) referred to were examined. It was found that the distribution of ADRs to specific SOCs differs between both groups for selected DSs. For more than 37% of the DSs being evaluated, a difference of 10% or more regarding reporting rates of unexpected ADRs was observed between both groups. These findings underline the substantial importance of regular literature reviews in addition to the spontaneous reporting system for a sufficient safety assessment of medicinal products.