Chapter 9: Aggregate Reporting in Pharmacovigilance

Author

Miss Pallavi Vangapandu,

PharmD Scholar, Department of Pharmacy Practice, Sir C.R.Reddy College of Pharmaceutical Sciences, Eluru, Andhra Pradesh, India

Abstract

While individual case reports provide immediate signals of potential harm, the true benefit-risk profile of a medicinal product is only visible through the lens of Aggregate Reporting. This discipline shifts the focus from the micro-level of the single patient to the macro-level of population health. Different stages of a drug's lifecycle dictate specific periodic reporting requirements. During clinical development, the Development Safety Update Report (DSUR) serves as an annual, cumulative review of safety data for investigational drugs, synchronizing reporting across global regions via the Development International Birth Date. Once a drug is approved, the reporting requirements transition to the Periodic Benefit-Risk Evaluation Report (PBRER) or the US-specific PADER. These post-marketing reports require a sophisticated synthesis of data from spontaneous reports, clinical trials, and scientific literature to re-evaluate the benefit-risk balance continuously. A specialized skill in this domain is the writing of aggregate safety narratives, which differs fundamentally from ICSR narratives by focusing on pattern recognition, exposure estimates, and the analysis of safety signals rather than the chronological details of individual events. This comprehensive review ensures that the medicinal product remains safe for the general population and that the product labeling accurately reflects the current safety profile.

Keywords: Aggregate Reporting, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Benefit-Risk Assessment, Safety Signals

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