This blog features:
- What exactly is Condition Aggravated in pharmacovigilance?
- How such cases are handled and reported into the safety database
- Best practices in assessing Condition Aggravated cases
Table of Contents
Introduction
Even with years of experience as a case processor, it’s natural to encounter uncertainties—because in pharmacovigilance, every day brings new learning opportunities.
The field is full of learning daily and often confusing scenarios, and Condition Aggravated is one such example.
Condition Aggravated?
As a case processor, you may often come across reports that simply state “condition aggravated”, while others provide more detailed descriptions. For example:
“A 30-year-old male with known bronchial asthma developed worsening wheeze and dyspnea.”
Another scenario that can appear similar is disease progression, which is considered a special category of adverse events.
While they may seem alike, there are important distinctions between these situations.
Terms that are frequently used in a similar context include:
- Exacerbation
- Aggravation
- Deterioration
- Worsening
“Not every worsening is progression, and not every progression is an adverse event—clarity in case processing begins with this distinction.”
Recording in to Safety Database
When a report includes terms such as disease aggravation or exacerbation, it usually indicates that an existing adverse event has worsened. In most cases, this is captured as the outcome of the event at the time the report was generated.
If the outcome is clearly described as disease aggravation, the appropriate option as outcome to choose would be “condition deteriorated.”
On the other hand, when the report refers to disease progression, it specifically relates to the underlying indication for which the suspected drug was prescribed, rather than an adverse event itself.
Note: Therefore, carefully analyzing and judging whether the report is describing an adverse event or the underlying indication is crucial.
MedDRA Coding Conventions
In some companies, they do follow “condition deteriorated” may not be directly available as an outcome option. In such cases, the aggravation should be reflected through MedDRA coding of the event itself:
- Select the MedDRA term that corresponds to the existing adverse event.
- If the report specifies that the event has worsened, choose the appropriate “aggravated” or “worsened” version of that term.
- If, during follow-up, a report indicates that an existing adverse event has simply “aggravated,” the best practice is to keep the original event as it is and add an additional MedDRA code for condition aggravated.
Example:
If the existing adverse event is abdominal pain (during follow-up) and the report states it was aggravated, the appropriate MedDRA term to add is condition aggravated as standalone is a best practice. In this case, it is not necessary to amend the original event.
If the report is received initially with the description of aggravation, you can directly code it as Abdominal pain aggravated.
Key Takeaways
Disease progression and exacerbation do not always mean the same thing in reports.
In case processing, when an existing event is reported as aggravated, the outcome should be updated accordingly.
Not all terms related to deterioration require separate MedDRA coding.
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Conclusion
From this article, you should now have a clearer understanding of how condition deteriorated or aggravated is reported and handled as an adverse event. This is often a confusing scenario for many case processors, but with the right approach, it becomes much easier to manage.
If you found this article helpful and gained valuable takeaways, feel free to share it with your friends, colleagues, or anyone passionate about learning pharmacovigilance.
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