This blog features:
- Clear overview of key definitions
- Scenarios illustrating common confusions between these concepts
- Explanations: understanding when to incorporate or omit
Table of Contents
Introduction
Confusions and uncertainty are common in every profession. Gaining clarity in subject matter is the only choice to excelling in the field.
Similarly, many healthcare professionals (HCPs) in pharmacovigilance still face challenges. Particularly in capturing different types of medical conditions.
This often stems from a insufficient updates within the them.
In this discussion, we will explore one of the key confusions in the source. That are between adverse events/reactions, indications, and current conditions.
These misleading increases complexities in monitoring the drug safety profiles and sometimes result in the generation of unrelated signals.
“Assessing and differentiating between medical conditions requires not only careful observation but also a deep understanding of their nuances, as each condition tells its own unique story in the context of patient care.”
Definitions: Perspective on Case Processing
As discussed in previous articles, these concepts have explained theoretically. Though below are the brief, logical definitions from the case source and processing perspective:
Adverse Events/Reactions:
Based on source, Adverse events and reactions refer to conditions that occur after the administration of a suspect drug to a study.
For example: The patient reported rashes after taking medication (X).
This source explains, the rashes that appear after the drug administered an adverse event based on the case source.
Indication:
Indication refers to the specific condition for which the suspected drug is being used or prescribed.
For example: The patient reported rashes after taking medication (X) for severe cold.
Here, “severe cold” is the indication, as the drug (X) is being used to treat this condition.
Current Condition:
Current conditions are pre-existing medical conditions that the patient has ongoing since before the suspected drug administered.
For example: The patient reported rashes after taking medication (X) for severe cold. Additionally, the patient mentioned having asthma and diabetes for the past 10 years.
This source stated, asthma and diabetes are the current conditions, as they existing from before the drug (X).
Current conditions refer to all pre-existing conditions that are ongoing from before the initiation of the suspected drug.
Uncertainties: simplified
This section breaks down the uncertainties around capturing reported terms into three simple differences, making it easier to understand.
Professionals often face confusion when assessing and capturing reported conditions. At times, they may even have in mind why they can’t capture a condition as reported in certain cases.
These scenarios are generally applicable, unless there are exceptions specific to company guidelines that instruct otherwise.
Current Conditions as Indication
In many source files, you may find the indication reported in the same way as the condition listed under current conditions.
This is a straightforward situation. In such cases, either one is applicable. Reported indications should not be captured under current conditions. Capturing it twice contradicts the case.
Current Condition as Event
This is a slightly more assessing scenario. The current condition should not be captured as an event unless there is a clear progression or worsening of the same condition after the suspected drug is administered.
It is not valid for an event, If the current condition remains unchanged.
Indication vs. Event
This scenario is similar to the previous one. It is a valid event, If there is progression of the condition for which the drug is being used (the indication). No change, then there is no adverse event.
For an event to be considered, there must be a noticeable change in signs or symptoms, indicating that the condition has progressed.
Key Takeaways
- Carefully assess the conditions before coding a case file.
- Not everything reported in the sections should be coded; some conditions may be negligible.
- Focus on the changes of conditions, especially when the same condition is reported in multiple sections.
- In case of uncertainty, always consult the medical team for clarity and further inquiries.
- Some cases may become null even if conditions are reported in all sections of the source.
- Certain scenarios may differ for specific products based on safety profile monitoring, especially for certain drugs.
Conclusion
This blog aims to provide clarity on often confusing or questionable aspects of pharmacovigilance.
While conditions may be reported, not all of them are always considered significant for coding.
Therefore, it’s important to remain diligent when coding and to seek clarity before starting. Incorrect coding can impact the safety profile of drugs.
We hope this guide has been brief, concise, and helpful.
If you think there’s anything we missed or could add to improve this content, feel free to share your insights.
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