PVC Adverse Drug Reaction Reporting 3 — Questions and Answers
Question 1: A spontaneous report arrives with only the patient's initials, the suspect drug, and the adverse event description. Is this a valid ICSR?
- No, because patient age and sex are required
- Yes, if the four minimum elements are present: identifiable patient, identifiable reporter, suspect drug, and adverse event (Correct answer)
- No, because the reporter's contact information is missing
- Yes, only if a healthcare professional submitted the report
Correct answer: Yes, if the four minimum elements are present: identifiable patient, identifiable reporter, suspect drug, and adverse event
A valid ICSR requires only four minimum elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event/reaction.
Question 2: Under ICH E2B(R3), what format is used for electronic transmission of ICSRs to regulatory authorities?
- PDF with structured attachments
- XML following the HL7 ICSR schema (Correct answer)
- CSV flat file with standard headers
- CIOMS I paper form scanned to TIFF
Correct answer: XML following the HL7 ICSR schema
ICH E2B(R3) mandates XML-based electronic transmission of ICSRs using the HL7 structured product labeling ICSR schema.
Question 3: What is the key difference between a Type A and Type B adverse drug reaction?
- Type A is dose-independent; Type B is dose-dependent
- Type A is dose-related and predictable; Type B is idiosyncratic and unpredictable (Correct answer)
- Type A occurs only in elderly patients; Type B occurs in pediatric populations
- Type A requires rechallenge confirmation; Type B does not
Correct answer: Type A is dose-related and predictable; Type B is idiosyncratic and unpredictable
Type A (Augmented) reactions are pharmacologically predictable and dose-dependent, while Type B (Bizarre) reactions are idiosyncratic, not dose-related, and not predictable from the drug's known mechanism.
Question 4: Which regulatory authority requires MAHs to submit Periodic Safety Update Reports (PSURs) on a predefined International Birth Date schedule?
- US FDA
- European Medicines Agency (EMA) (Correct answer)
- Health Canada
- Japan PMDA
Correct answer: European Medicines Agency (EMA)
The EMA requires PSURs to be submitted according to the EU Single Assessment Procedure aligned with the International Birth Date under ICH E2C(R2).
Question 5: A clinical trial investigator reports a SAE that is both unexpected and possibly related to the IMP. What document determines 'expectedness' for SUSAR classification?
- The trial protocol
- The Investigator's Brochure (IB) or Reference Safety Information (Correct answer)
- The patient information leaflet
- The latest published clinical trial result
Correct answer: The Investigator's Brochure (IB) or Reference Safety Information
Expectedness for SUSAR classification is assessed against the Reference Safety Information, typically the Investigator's Brochure for investigational products.
Question 6: What is 'dechallenge' in the context of pharmacovigilance causality assessment?
- Increasing the drug dose to confirm the effect
- Stopping or reducing the suspect drug and observing whether the adverse event resolves or improves (Correct answer)
- Switching to a different drug in the same class
- Administering an antidote to reverse the adverse effect
Correct answer: Stopping or reducing the suspect drug and observing whether the adverse event resolves or improves
Dechallenge refers to stopping or reducing the suspect drug; a positive dechallenge (event improves) supports a causal relationship.
Question 7: In the Naranjo ADR probability scale, which total score range indicates a 'probable' adverse drug reaction?
- ≥ 9
- 5 to 8 (Correct answer)
- 1 to 4
- ≤ 0
Correct answer: 5 to 8
In the Naranjo scale, a total score of 5–8 indicates a probable ADR, while ≥9 is definite, 1–4 is possible, and ≤0 is doubtful.
PVC Adverse Drug Reaction Reporting 3
A spontaneous report arrives with only the patient's initials, the suspect drug, and the adverse event description.
Is this a valid ICSR?