Individual Case Safety Reports (ICSRs) are detailed reports of adverse events or suspected adverse reactions associated with the use of a specific drug or medical product. These reports play a crucial role in pharmacovigilance services, which is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

ICSR Case Processing typically contains comprehensive information about an individual patient's experience with a drug, including Patient Demographics: Basic demographic information about the patient, such as age, sex, and medical history.

1. Drug/Product Information: Details about the drug or medical product involved, including the brand name, generic name, dose, frequency, route of administration, and indication for use.
2. Adverse Event Description: A description of the adverse event or reaction experienced by the patient, including the onset, duration, severity, and outcome (e.g., recovered, resolved, ongoing).
3. Concomitant Medications: Information about any other medications the patient was taking at the time of the adverse event, including prescription drugs, over-the-counter medications, and herbal supplements.
4. Clinical Course: Additional clinical details about the patient's condition, relevant laboratory findings, diagnostic test results, and medical interventions.
5. Reporter Information: Information about the person or entity reporting the adverse event, such as healthcare professionals, patients, consumers, or pharmaceutical companies.

ICSRs serve as the primary source of data for pharmacovigilance activities, allowing regulatory authorities, pharmaceutical companies, healthcare professionals, and other stakeholders to monitor the safety of drugs and medical products. These reports are typically collected from various sources, including spontaneous reporting systems, clinical trials, literature, and post-marketing surveillance programs.

Upon receipt of an ICSR, pharmacovigilance experts review and analyze the information to assess the potential causal relationship between the drug or medical product and the reported adverse event. If deemed necessary, further investigations may be conducted to better understand the nature and significance of the reported event, which may lead to regulatory affairs services, changes in product labeling, or other risk management services measures to ensure patient safety.