PVC Individual Case Safety Reports 3 — Questions and Answers
Question 1: A company receives a case where the only reporter is a patient who cannot name the specific drug, only describing it as 'a white pill for blood pressure.' Is this a valid ICSR?
- Yes, because a suspect drug category is identifiable
- No, because the specific drug cannot be identified (Correct answer)
- Yes, if the patient's outcome is documented
- No, because patients cannot be reporters
Correct answer: No, because the specific drug cannot be identified
A valid ICSR requires an identifiable suspect medicinal product; a vague description insufficient to identify the drug means the minimum dataset is not met.
Question 2: Under EMA regulations, what is the reporting timeframe for a non-serious spontaneous adverse drug reaction for a marketed product?
- 7 days
- 15 days
- 30 days (Correct answer)
- 90 days
Correct answer: 30 days
EMA regulations require non-serious spontaneous adverse drug reactions for marketed products to be submitted to EudraVigilance within 90 days.
Question 3: Which coding dictionary is most commonly used to code adverse events in ICSRs?
- ICD-10
- MedDRA (Correct answer)
- SNOMED CT
- WHO-ART
Correct answer: MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is the international standard used to code adverse events, medical history, and indications in ICSRs.
Question 4: An ICSR is received for a patient who died. The cause of death is listed as the suspect adverse event. What seriousness criterion applies?
- Medically significant
- Results in death (Correct answer)
- Life-threatening
- Requires hospitalization
Correct answer: Results in death
When a patient dies and the adverse event is the cause, the seriousness criterion 'results in death' is checked, which is one of the defined ICH E2A criteria.
Question 5: What does the term 'de-duplication' refer to in ICSR processing?
- Removing duplicate drugs from a suspect list
- Identifying and merging cases reported more than once about the same patient event (Correct answer)
- Deleting cases with incomplete data
- Splitting one case into multiple reports
Correct answer: Identifying and merging cases reported more than once about the same patient event
De-duplication is the process of identifying ICSRs that represent the same patient event reported through multiple sources and merging them to avoid double-counting.
Question 6: Which MedDRA level is used as the primary basis for signal detection in pharmacovigilance databases?
- System Organ Class (SOC)
- High Level Group Term (HLGT)
- Preferred Term (PT) (Correct answer)
- Lowest Level Term (LLT)
Correct answer: Preferred Term (PT)
Preferred Terms (PTs) are the primary level for signal detection because they represent distinct medical concepts at a clinically meaningful level of specificity.
Question 7: A marketed drug's ICSR contains a concomitant medication that is also suspect. How should both drugs be documented?
- Only the primary suspect drug is coded
- Each suspect drug is listed as a separate drug entry with its own causality assessment (Correct answer)
- Concomitant drugs are listed in the narrative only
- The drug with more severe interaction is coded as suspect
Correct answer: Each suspect drug is listed as a separate drug entry with its own causality assessment
E2B(R3) allows multiple drug entries, each with its own characterization (suspect, concomitant, interacting) and individual causality assessment.
PVC Individual Case Safety Reports 3
A company receives a case where the only reporter is a patient who cannot name the specific drug, only describing it as 'a white pill for blood pressure.' Is this a valid ICSR?