From this blog, we elucidate the step-by-step process:
- The procedure for conducting causality assessment
- Our effective method of performing causality assessment
- The necessity of causality assessment.
Table of Contents:
- Definition
- Need for causality assessment
- The Stages of Causality Assessment (Identification, Investigation, Assessment)
- Thoughts
- References
- FAQ
Definition:
Causality is the word mean derived from the word cause. Causality is the fundamental concept of identifying the cause behind a particular effect or event.
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To simply determine:
“Causality is essentially about identifying the cause, whether it’s who, what, which, why, or how it happened, to comprehend the connection between a drug and an adverse event.”
Need for Causality assessment
Causality assessment plays a crucial role in all branches of medical practice. It holds immense importance in identifying the responsibility to adverse events, which helps in saving lives and preventing further harm.
Often, patients are prescribe with many medications, making it challenging to determine the exact drug causing a reaction, especially when the underlying disease itself can manifest similar symptoms.
Regrettably, there are no definitive diagnostic tests available for this purpose. While histopathology can offer some insights into diagnosing drug reactions, it alone cannot pinpoint a particular drug as the culprit.
✍️ Note: Once a causal relationship is established, the adverse drug event (ADE) is referred to as an adverse drug reaction (ADR).
Causality Assessment: Who takes charge?
Determining causality assessment within pharmacovigilance at different levels begins with:
- Investigators (if any pre-determined causality available)
- Physician
- Case processor
- Quality control
- Internal Medical reviewer
- Regulatory authority (After submission)
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The Stages of Causality Assessment
Causality assessment in pharmacovigilance (PV) involves a three-stage process of identification, investigation, and final assessment of a case to determine whether an event is related to a drug.
This assessment is to conduct based on the available information extracted from existing studies.
Although there isn’t a proper standard to follow for this process, the typical procedure is outlined below.
The three stages aim to analyze the data and evidence to establish a clear link between the reported event and the use of the specific drug under investigation.
Identification:
In the context of causality assessment, the stage of identifying the relevant information mentioned in the source document.
- This initial step is pivotal for discerning the reported cause (the potential causal relationship between the event and the drug).
- By identifying the reported information about causal relationship, further investigation can carry out with a clear focus on the specific event-drug connection.
The majority of cases remain unreported or unassessed.
Investigation:
Once the information had identified from the source, the next step is to proceed with the investigation.
- This involves referring to relevant product-specific documents to examine what they say about the event in question and its potential relationship to the drug.
- During this investigation, the aim is to compare or find the details obtained from the source with the information provided in the product specific documents.
✍️ Note: The product-specific documents consist solely of the information gathered from the pre-investigation study protocol report, such as clinical trials.
By scrutinizing these documents, a comprehensive understanding of the event and its association with the drug can be established, aiding in the overall causality assessment process.
Assessment:
The final stage of the causality assessment involves evaluating the case based on the gathered information.
- If any discrepancies or clarifications arise during this process, it is important to seek guidance from internal medical experts.
- Their input and expertise can help address any uncertainties and provide further insights.
- In cases where a decision has been reached based on the considerations of the medical experts, it is essential to explicitly state that the decision was made in accordance with their recommendations.
- If the situation does not require immediate attention, it is possible to raise queries or seek additional information for further clarification.
Based on the final decision and resolution, the assessment can be appropriately listed or unlisted from the case, ensuring transparency and accuracy in the overall process.
Uniform Approach for Causality Assessment in Case Processing
- The case processor must define the causality assessment within the case, whether it’s reported or not reported.
- Many cases, especially those from patient-oriented programs and spontaneous reports, may lack reported causality. In such instances, referring to documented conventions is essential.
- For special events in spontaneous reports, the default should be to consider them suspected unless explicitly reported otherwise.
- The chronology or association in time (or place) between drug administration and the event.
- Current knowledge of the nature and frequency of adverse reactions due to the suspect molecule, or the pharmacology of the drug.
- Likelihood or exclusion of other causes for the same adverse events, often the disease condition or concomitant medication.
Final note
In conclusion, it is evident from this article how crucial establishing a causal relationship is in assessing cases and how it significantly influences the probability of the outcome.
Errors in determining causality can have substantial consequences, leading to significant impacts.
Therefore, exercising caution and diligence in conducting causality assessments is of utmost importance. It is imperative to recognize the gravity of potential mistakes and strive for accuracy and precision in order to mitigate potential adverse effects.
It aims to establish to connect the dots between who played a role in causing the reported harmful reaction.
References:
- Bibliography: Meyboom, R.H., Hekster, Y.A., Egberts, A.C., Gribnau, F.W., Edwards, I.R., 1997. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 17, 374–389. https://doi.org/10.2165/00002018-199717060-00004
- SpringerLink
- PubMed
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