This blog features:
- Guidance on selecting cases for causality assessment
- Key points to identify which cases require causality assessment
- Essential takeaways and practical insights
Table of Contents
Introduction
As a case processor, you know that causality assessment is a critical and indispensable part of case processing.
Determining causality plays a vital role in evaluating the relationship between a drug and an adverse event, and its accuracy significantly impacts the quality and outcome of regulatory submissions.
Case Selection for Causality Assessment
Case selection for causality assessment is essentially about prioritization, as the cases you choose to evaluate first can have a significant impact on regulatory submissions. In this context, serious cases must always be given priority and handled with greater attention compared to non-serious events. The same principle applies to AEFI (Adverse Events Following Immunization) cases.
“Causality assessment is not just about linking events — it’s about uncovering truth in every case, ensuring patient safety, and upholding the science behind every regulatory decision.”
The selection of cases for causality assessment should focus on the following:
- Serious cases that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or involve congenital anomalies/birth defects.
- Events occurring above the expected rate or of unusual severity.
- Signals generated from individual or clustered cases, as these may indicate a potential public health concern.
- Fulfilment of the four minimum criteria for a valid case.
- Confirmation that the suspect substance was administered before the reaction or event occurred.
- Presence of a valid diagnosis, including a clearly defined unfavourable or unintended sign, abnormal laboratory finding, symptom, or disease.
- Identification of special event categories, as these may require unique considerations in causality assessment.
Note: From a company perspective, a case should only undergo causality assessment if it involves the company’s product as the suspect drug.
Specific Conventions for AEFI Reports
According to WHO recommendations, certain Adverse Events Following Immunization (AEFI) should also undergo causality assessment if the reviewing team or committee determines that evaluation is necessary — either as a special case or to support specific studies.
Such AEFI cases may include:
- Events potentially caused by immunization errors, such as bacterial abscesses, severe local reactions, high fever or sepsis, BCG lymphadenitis, or toxic shock syndrome.
- Significant events of unexplained origin occurring within 30 days post-vaccination, particularly those not listed in the product label.
- Events generating substantial parental or community concern, such as hypotonic hyporesponsive episodes (HHE) or febrile seizures.
Key Takeaways
Causality assessment is a core component of pharmacovigilance, essential for evaluating the relationship between a drug or vaccine and an adverse event.
All suspected adverse events can influence the overall safety profile and regulatory standing of a product, making accurate assessment crucial.
Labeling updates or safety actions are not required for events that are not suspected to be related to the product.
Serious adverse events (SAEs) must always be prioritized and assessed with utmost attention and accuracy, as they carry significant regulatory and public health implications.
AEFI cases may require special causality considerations, especially when related to immunization errors, unexplained events, or community concern.
Ensuring the four minimum criteria for a valid case and verifying temporal association (i.e., exposure before the event) are key to a sound causality determination.
Causality assessment should be viewed not as a routine task but as a critical scientific evaluation that directly impacts signal detection, risk management, and regulatory decision-making.
Stay informed, stay vigilant
Want to deepen your pharmacovigilance knowledge? Explore more articles like this and enhance your expertise in drug safety practices.
Conclusion
Causality assessment is more than just a procedural step—it is the heart of pharmacovigilance, connecting clinical evidence with regulatory integrity.
Each case evaluated with precision strengthens the reliability of safety data, supports informed decision-making, and ultimately safeguards patient health.
By prioritizing serious events, adhering to defined conventions, and applying sound scientific judgment, we ensure that every causality assessment adds real value to drug safety monitoring and public trust.
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