Reporting of ICSR (individual case safety report)

An Individual Case Safety Report (ICSR) is a report of an adverse event or suspected adverse reaction to a medicinal product that has occurred in a patient or study subject. Reporting of ICSRs is a critical component of pharmacovigilance, as it helps to identify and assess potential risks associated with the use of a medicinal product.

The process for reporting an ICSR typically involves the following steps:

Identification of an adverse event or suspected adverse reaction: This may occur through a variety of channels, including spontaneous reports from healthcare professionals or patients, reports from clinical trials or other studies, or signals detected through pharmacovigilance activities.

Collection of information: Once an adverse event or suspected adverse reaction has been identified, information about the event must be collected, including the patient's demographic information, medical history, and details about the adverse event or reaction.

Assessment of causality: The information collected about the adverse event or reaction must be assessed to determine whether there is a causal relationship between the medicinal product and the event.

Completion of the ICSR: Once causality has been established, an ICSR must be completed, typically using a standardized form or electronic system. The ICSR should include all relevant information about the patient, the medicinal product, and the adverse event or reaction.

Submission of the ICSR: The completed ICSR must be submitted to the appropriate regulatory authority, typically through a designated reporting system.

It is important to report ICSRs in a timely and accurate manner, as this helps to ensure that potential risks associated with the use of medicinal products are identified and addressed promptly. Failure to report ICSRs can result in serious consequences, including harm to patients, regulatory action against pharmaceutical companies, and damage to public confidence in the healthcare system.

1. Welcome INDIVIDUAL CASE SAFETY REPORT (ICSRs) Kusum Bang M.Pharmacy 025/022023 03/03/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 2 Introduction Importance of ICSR What is included in an ICSR? Work flow of ICSR How are ICSRs collected? Conclusion Type of ICSR reports

3. Introduction 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 3 An ICSR is a document that contains information about a single patient who has experienced an adverse event or suspected adverse reaction (ADR) after exposure to a drug or other medicinal product. ICSRs are typically submitted to regulatory authorities, such as the FDA in the United States, or the EMA in Europe. These reports are used to monitor the safety of medicinal products and to identify potential safety concerns. Pharmacovigilance professionals review the reports and assess the causality of the adverse event, determine the severity of the event, and decide on any necessary regulatory action. The four elements for valid assessment of an ICSR are: 1. An identifiable patient, 2. An identifiable reporter, 3. A suspect drug and 4. An adverse event.

4. Importance of ICSR: To provide critical information on the safety profile of drugs and medical products. In post-marketing surveillance, it helps to ensure that any safety concerns that may arise after approval are identified and addressed in a timely manner. To improve patient safety by providing valuable information on the risks associated with particular drugs or medical products. Uses of ICSR: Signal detection: Signals can indicate the need for further investigation or regulatory action. Risk assessment: It involves evaluating the severity, frequency, and potential outcomes of a particular adverse event or suspected adverse reaction based on the available evidence. Causality assessment: It involves evaluating the temporal relationship between the exposure to the drug and the onset of the adverse event. Benefit-risk assessment: It involves evaluating the potential benefits of the drug in terms of efficacy and patient outcomes, compared to the potential risks associated with the drug based on the available evidence. 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 4

5. What is included in an ICSR? 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 5 Patient information: Name, age, gender, weight, height, medical history, and other relevant demographic information. Medication information: Name of the drug, dosage, route of administration, frequency of use, indication, and duration of treatment. Adverse event information: Description of the adverse event, including the date of onset, severity, duration, and outcome. Causality assessment: A judgment on whether the suspected drug caused the adverse event, based on the available evidence. Other relevant information: This may include laboratory test results, imaging studies, or information about concomitant medication use.

6. How are ICSRs Collected? Spontaneous Reporting : Healthcare professionals, patients, and consumers can voluntarily report adverse events or suspected adverse reactions to regulatory authorities or pharmaceutical companies. The reports are then reviewed and evaluated by pharmacovigilance professionals. Active Surveillance: Active surveillance involves proactively monitoring patients who are using a specific medicinal product to identify any adverse events or suspected adverse reactions. This information is used in clinical trials or post-marketing surveillance studies. Electronic Health Records (EHRs): Electronic health records can be used to identify potential adverse events or suspected adverse reactions. EHRs can also be used to facilitate the reporting of ICSRs. Literature Monitoring: Medical literature, including scientific publications and case reports, can be reviewed to identify potential adverse events or suspected adverse reactions. Social Media Monitoring: Used to identify potential adverse events or suspected adverse reactions particularly useful for identifying adverse events that may not have been previously reported. 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 6

7. Work flow of ICSR 03/03/2023 www.clinosol.com | follow us on social media @ clinosolresearch 7

8. Types of ICSR Reports Based on the sources and type of data collection, ICSRs are classified into two categories: 8 Types of ICSR Reports Solicited ICSRs Non Solicited ICSRs Interventional Clinical trials/ studies Non interventional clinical trials/ studies Non-interventional Programmes Patient Registries Patient support and market research programmes Investigator initiated clinical trials, Compassionate use programmes Literature, abstracts/ articles Legal cases reported by lawyers on behalf of customers (client) Health authority case reports Spontaneous reports from health care professional and directly from consumers. Social media reports - Any ICSR information posted on social media websites like Facebook, Twitter etc www.clinosol.com | follow us on social media @ clinosolresearch 03/03/2023

9. Conclusion: ICSRs are important tools in pharmacovigilance practice, they provide valuable information on the safety of medicinal products, and help to identify potential safety concerns. Effective pharmacovigilance relies on the timely reporting and analysis of ICSRs, and continuous monitoring of the safety profile of medicinal products. By collecting and analyzing ICSRs, regulatory authorities, healthcare providers, and manufacturers can identify potential safety concerns and take appropriate actions to mitigate risks. ICSR information can be used to develop better treatment protocols, provide more accurate patient counseling, and improve patient outcomes. 9 www.clinosol.com | follow us on social media @ clinosolresearch 03/03/2023

10. References: World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/importance/en European Medicines Agency. What is a Suspected Adverse Reaction?. https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/what-suspected-adverse-reaction U.S. Food and Drug Administration. Individual Case Safety Reports (ICSRs). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/individual-case-safety-reports-icsr World Health Organization. Pharmacovigilance. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmacovigilance/en/ European Medicines Agency. Importance of Pharmacovigilance. https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance/importance-pharmacovigilance 10 www.clinosol.com | follow us on social media @ clinosolresearch 03/03/2023

11. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 03/03/2023 www.clinosol.com | follow us on social media @clinosolresearch 11