Explore this unique blog that dives deep first time into:
- Uncovering the “Invalid Composite Case” Terminology
- Understanding Valid ICSRs versus invalid ICSRs
- Discovering Which Protocols Advocate Processing of Such Cases.
Table of Contents:
- Introduction
- Valid ICSR vs Invalid ICSR
- Common Reasons for Considering Cases Invalid
- Importance of Processing Such Cases
- Closing Thoughts
Introduction
We’ve discussed several things about ICSR cases before, and they need to meet certain criteria to be considered valid for processing. Do you think these criteria are the minimum standards for processing ICSR cases?
Well, yes, but there are some exceptions. Some companies might still monitor cases differently, even if they don’t meet the minimum criteria. This blog will dive into that.
Valid ICSR vs Invalid ICSR
Valid ICSR
Valid Individual Case Safety Reports (ICSRs) are complete reports containing all the important parts needed to continue monitoring the safety of pharmaceutical products. Here are the basic things needed to consider an adverse event report valid:
- An identifiable patient
- An identifiable reporter
- A suspect product
- An adverse event or outcome
Invalid and composite cases
In pharmacovigilance, an invalid composite case is a report of an adverse event that doesn’t meet all the requirements to considered valid.
It’s basically a reported adverse event or individual case safety report (ICSR) that doesn’t meet the standards to be included in a composite case.
“Invalid items are not mere errors to correct, but opportunities to refine, enlighten, and innovate.”
What is composite case?
Composite cases are created by combining multiple ICSRs related to the same patient and event to provide a comprehensive overview of the safety profile.
Invalid composite case
An invalid composite case might happen when the reported individual case safety reports (ICSRs) aren’t about the same patient or event, are missing important details, have conflicting information, or have other problems that make the composite case unreliable or not suitable for safety assessment purposes.
Common Reasons for Considering Cases Invalid
- Incomplete Information: The report lacks essential details about the adverse event, such as the patient’s medical history, medication history, description of the event, and outcome.
- Inaccurate Data: Information provided in the report contains errors or inconsistencies, making it challenging to assess the safety concern.
- Lack of Causality Assessment: The report does not include an assessment of the likelihood that the adverse event is related to the use of the pharmaceutical product (To learn more about causality).
- Duplicate Reporting: The same adverse event reported multiple times by different sources, creating redundancy. (Learn more…)
- Missing or Inadequate Follow-up Information: In cases where further investigation or follow-up required, the report may considered invalid if essential follow-up information is missing or insufficient.
Importance of Processing Such Cases
Several companies are now beginning to pay attention to all types of reports, even those that considered invalid. There are several reasons behind this change in collecting and considering invalid cases:
- Gathering extra details: Looking into invalid cases helps gather additional information that might be useful.
- Enhancing safety profiles: By examining invalid cases, companies can find areas where safety profiles could require improvement.
- Discovering new signals: Invalid cases may reveal new signals or patterns that previously overlooked.
- Understanding cause and effect: Analyzing invalid cases helps in understanding the relationships between events and potential causes.
- Weighing risks and benefits: Evaluating invalid cases aids in assessing the balance between the risks and benefits of a product. (Learn more…)
- Meeting regulatory requirements: Considering all types of cases, including invalid ones, ensures compliance with regulations set by authorities.
Possible sources:
- Most of these type of cases usually come from sources like literature.
- When documented alongside a cohort of patients engaged in a study.
Closing thoughts
We’ve delved into details about ICSR case processing several times, but this blog sheds light on a lesser-known aspect: Invalid composite cases. Some may unaware that such cases considered for processing, but indeed they are.
I may have overlooked some crucial points in this important topic. If you have any additional details to add or if you notice any misleading information.
“Feel free to comment below.”
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