Importance of Aggregate reporting in Pharmacovigilance
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved. We now recognize the significance of a systematic approach to monitoring and improving the safe use of medicines. Aggregate reporting is the process that examines the collective safety information from a broad range of sources systematically and gives the conclusions to regulators worldwide.
The aggregate safety records are presented to regulators as soon as the medicine is marketed all-around and facilitates understanding of the product’s risk and benefit profile over time. These reports focus not on individual cases, but preferably on overview, assessment of the safety profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports.
Why is aggregate reporting critical in Pharmacovigilance?
Though the Original case safety reports were tendered on an expedited basis to regulatory authorities, detailed analysis and evaluation of a drug’s benefit/risk ratio are not possible at this level. Therefore, periodically reviewing safety reports received cumulatively worldwide becomes highly significant to analyze the product’s benefit/risk balance. These reports need exceptional diligence and attention to detail, including an overview and a sense of what is essential, on the other hand.
At the individual case safety reports level, marketing authorization holders (MAH) can’t evaluate the benefit/risk ratio profile and understand a medicinal product’s detailed safety feature. In addition to presenting individual case safety reports, MAH also evaluates regular reviews of collective safety information obtained from various sources and presents the conclusions of aggregate reports to drug regulators.
Types of aggregate reports:
Pre-marketing report:
- Clinical study reports (CSR)
- Development Safety Update Report (DSUR)
Post-marketing report:
- Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER).
- NDA and ANDA annual reports
Aggregate reporting is an indispensable tool to analyze a medicinal product’s benefit/risk balance throughout its life cycle.
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