This blog features:
- Assessing ADR-AE from the source file
- Conducting thorough patient history and clinical assessment
Table of Contents
Introduction
During ICSR case processing, identifying and assessing Adverse Drug Reactions (ADR) and Adverse Events (AE) from the source documents can be complex. This is one of the most critical components of case processing.
At the initial stage, determining whether a case meets the four minimum criteria is essential. The presence of an adverse event is one of the key criteria required to proceed with case processing.
Below are some important points to consider:
Recognising AEs/ADRs
Identifying Adverse Drug Reactions (ADRs) in patients can be challenging. ADRs may be difficult — and sometimes impossible — to distinguish from the underlying disease being treated, as they can involve similar physiological and pathological pathways.
“Every ADR tells a story — and only through careful assessment can we transform scattered events into clear, evidence-based conclusions that protect patient lives.”
However, the following systematic approach can help in assessing potential drug-related ADRs:
1. Consider ADR as a Differential Diagnosis
An ADR should always be included in the differential diagnosis when evaluating a patient’s symptoms.
2. Verify Medication Details
- Confirm that the prescribed medicine is the one actually received and taken by the patient.
- Verify the dose, frequency, route of administration, and duration of therapy.
3. Establish Temporal Relationship
Assess the timing between drug administration and onset of the event:
- Did the adverse event occur immediately after administration?
- Did it develop after a delay?
Some reactions occur rapidly, while others may take days or weeks to manifest.
4. Review Concomitant Medications
- Evaluate all concurrent medications. To learn more in detail…
- Assess the possibility of drug–drug interactions.
- Consider additive or synergistic effects.
5. Evaluate Medical History
- Differentiate between pre-existing medical conditions and newly reported adverse events.
- Carefully assess whether the event may be related to the patient’s underlying disease. To learn more in detail…
6. Check Prior History of Similar Events
- Determine whether the patient has previously experienced the same or similar reaction.
- Review documented history and reported sections for recurrence patterns.
7. Assess Relationship Between Medical History and Current Event
- Thoroughly evaluate whether there is any plausible connection between the patient’s past medical history and the currently reported adverse event.
8. Review Pharmacological Profile of the Suspected Drug
- Check whether the reported reaction is a known adverse effect of the suspected medicine (as stated in the package insert or other reliable references).
- Remember: absence of documentation in the package insert does not exclude the possibility of a drug-related reaction.
9. Consider Patient’s Own Statement
- Pay attention to any patient-reported observations or descriptions of their reaction.
- Patient narratives can provide valuable insight into symptom onset and progression.
10. Conduct Comprehensive Clinical Evaluation
- Obtain a complete medical and medication history.
- Perform a thorough clinical examination where applicable.
- Evaluate the effects of:
- Dechallenge (improvement after stopping the drug) To learn more…
- Rechallenge (recurrence after re-administration, if applicable)
Think you can confidently distinguish an AE from a true ADR?
Every case you assess shapes a safety decision. Every conclusion you document impacts patient care.
Don’t just process reports — master the science behind them.
Dive deeper into the full ADR–AE assessment pathway and sharpen your clinical judgment from source to final conclusion.
Conclusion
Identifying and assessing Adverse Drug Reactions (ADRs) is a critical step in pharmacovigilance and patient safety. Due to the complexity of distinguishing ADRs from underlying disease or concomitant medications, a systematic approach is essential.
By carefully verifying medication details, evaluating temporal relationships, reviewing medical history, assessing pharmacological profiles, and incorporating patient input, healthcare professionals can make informed assessments of potential drug-related adverse events. Thorough documentation and clinical evaluation not only support accurate case processing but also contribute to improved patient care and safer therapeutic outcomes.
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