This blog features:
- What are indications?
- Reviewing and capturing indications from the source
- Key conventions and best practices for documenting indications
Table of Contents
Introduction
Among the various pieces of information reported in a source document, one of the most crucial is the indication.
Although it may seem like a small detail, drug indication carries significant importance in case processing and can often be surrounded by subtle nuances. This blog will guide you through everything you need to know to capture and interpret indications accurately.
Indications from the source
ource documents often contain multiple clinical details—adverse events, medical history, treatment rationales, and drug indications. Distinguishing between these elements is essential for accurate case assessment. If you want to clearly understand these critical differences, you’re in the right place.
What types of indications can appear?
In many cases, you may encounter more than one indication, such as:
- Indications for the primary (suspect) drug
- Indications for concomitant medications
- Indications inferred from clinical notes
- Or sometimes, no indication reported at all
These variations can influence how you interpret the case and map information accurately.
Up next, we’ll explore the best practices and conventions for handling indications during case analysis.
“When indications are unclear, clarity comes from discipline, not assumption.”
Best practices in choosing & Capturing indications
There are several scenarios you may encounter while capturing drug indications from source documents. Below is a concise breakdown of how to handle each one.
1. Indication reported directly
In some cases, the source clearly states the purpose for which the drug was used.
When the indication is explicitly reported, you should capture it exactly as documented, without modification.
2. Reports without an indication
This scenario falls into two categories:
a. Program or study cases where the patient is enrolled
If the indication is not reported but the patient is part of a study or program, refer to the product-specific documentation—such as the study protocol. Record the indication as per the intended use described in the documentation.
b. Spontaneous reports with no indication mentioned
When a spontaneous report does not provide any indication, assign:
- “Product used for unknown indication” or
- “Drug use for unknown indication”
This ensures consistency and avoids assumptions.
3. Indication Reported but Clinically Irrelevant
Sometimes a report may include an indication that is clearly unrelated to the drug’s actual use in the case.
In such situations:
- Capture the reported indication as-is, even if irrelevant (to preserve data integrity).
- Additionally, if the drug was prescribed by a physician for an unapproved purpose, document:
- “Product use in unapproved indication”, or
- “Drug use for unapproved indication”, or
- “Unintentional use for unapproved indication” (depending on context).
This highlights potential off-label or inappropriate use.
4. Indications reported for concomitant drugs
When concomitant products are involved, any indications reported for them should be captured as their respective drug indications.
Additionally, these indications may also reflect the patient’s current medical conditions, so they should be considered in the clinical context of the case.
5. Treatment drug with or without indication
A treatment drug may appear in the source with or without a stated indication.
a. Single event with no indication provided
If only one event is reported and the indication is missing, assign:
- “Product used for unknown indication”
Document any contextual details in the narrative to support your rationale.
b. Multiple events without indication
If several events are reported and no indication is mentioned, it is best practice to send a follow-up inquiry to request clarification.
Key takeaways
Indication is a critical data element in PV case processing and must be captured accurately as reported.
When indications are missing, use product documentation always.
Clinically irrelevant or unrelated indications must still be captured as reported.
All indications reported for concomitant drugs should also be considered as the patient’s current medical conditions.
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Conclusion
Accurately capturing drug indications is a fundamental part of high-quality pharmacovigilance case processing. Although indications may seem straightforward, the scenarios surrounding them can be nuanced—from missing information to irrelevant details, multiple drugs, concomitant therapies, and treatment-specific complexities. By following structured best practices, processors can ensure consistency, avoid assumptions, and maintain compliance with regulatory expectations.
Understanding where indications come from, how to interpret them, and when to apply default terms or seek clarification ultimately strengthens the clinical accuracy of a case.
With careful attention to these principles, every processor can contribute to more reliable safety data and better-informed decision-making within the PV system.
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