This blog focuses on the following topics:
- Understanding ICSR Management
- ICSR Management and its Role in Pharmacovigilance
Table of Contents:
- Definition
- What is ICSR in pharmacovigilance?
- What is a valid ICSR?
- Recommendations
- Regulatory timelines for ICSR
- Conclusion
- References
- FAQ
Definition
ICSR – Individual Case Safety Report(s)
Individual: A single identified subject/ Human
Case: A valid case
Safety: To ensure the safety of the drug
Report: To facilitate the submission of the report to authorities
What is ICSR in pharmacovigilance?
- ICSR case processing is a primary role in whole Pharmacovigilance process.
- Each report treated as an individual case.
- The reported adverse events experienced by individuals are taken into consideration and can be processed as Individual Case Safety Reports (ICSRs).
- The reported case does not involve an individual, it does not fall within the scope of Individual Case Safety Reports (ICSRs).
- Individual Case Safety Reports (ICSR) play a key role in assessing the risk-benefit profile of a given medicinal product.
- ICSRs are time sensitive and should be filed as soon as a safety issue has been identified.
- ICSR is a fundamental and important database source for all over pharmacovigilance.
“ICSR processing is not just paperwork; it’s a commitment to patient safety. Each case handled diligently is a step toward a healthier, safer future, ensuring medications benefit without harm. The importance lies not just in processing, but in safeguarding lives and building trust in healthcare.”
A Valid ICSR
To build or consider a valid ICSR report, there are four mandatory elements is to consider:
- A reporter
- Drug administered/ diagnosed patient/ an individual
- A suspected drug(s)
- An adverse event(s)
If one or more of these four elements is missing, the case is not a valid AE report.
Regulatory timelines
Based on seriousness criteria and adherence to the country specific regulations the submission of Individual Case Safety Reports (ICSR), within a time-frame of either 7, 15, 90 days respectively.
Conclusion
This concise and highly focused blog delves into the essence of ICSR (Individual Case Safety Report) and its pivotal role within pharmacovigilance.
Readers are encouraged to explore the comprehensive understanding of ICSR management in a sophisticated category here, while also welcome to contribute any additional insights or perspectives.
References:
FAQ:
Can you please explain the term “ICSR”?
Define ICSR in pharmacovigilance?
Case – A valid case
Safety – To ensure the safety of the drug
Report – To facilitate the submission of the report to authorities
What are the four (4) minimum criteria for valid ICSR?
1. A reporter
2. Drug administered/ diagnosed patient/ an individual
3. A suspected drug(s)
4. An Adverse Event(s)
If one or more of these four elements is missing, the case is not a valid AE report.
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