What is the Origin of Individual Case Safety Report?

The practice of systematically reporting adverse drug reactions originated in the mid-twentieth century following major drug safety crises, leading to the establishment of national and international pharmacovigilance systems. The term ICSR is a standardized regulatory term defined by global health authorities like the FDA and EMA to ensure consistent data collection for drug safety monitoring. This systematic approach is critical for all medications, including hormonal therapies.

What is the Mechanism of Individual Case Safety Report?

The reporting mechanism is a structured process where healthcare professionals, manufacturers, or patients submit the event data to a central pharmacovigilance database. These individual reports are then aggregated, validated, and analyzed by safety experts to identify patterns, trends, or previously unknown risks associated with the medication. This continuous data collection and signal detection process allows for the timely issuance of regulatory actions, such as labeling changes or dose modifications, to protect public health.

Individual Case Safety Report

Meaning

An Individual Case Safety Report (ICSR) is a document detailing a suspected adverse drug reaction (ADR) experienced by a single patient following the administration of a pharmaceutical product. This report includes comprehensive clinical information, such as patient demographics, the drug involved, the adverse event description, and the outcome. ICSRs are the fundamental unit of data in pharmacovigilance, serving as an early signal detection tool for potential drug safety issues in the post-marketing phase.