Spontaneous reporting schemes for herbal ADRs MCQs With Answer

Introduction: Spontaneous reporting schemes are a cornerstone of post-marketing safety monitoring, especially for herbal medicines where pre-market evidence is often limited. This blog presents focused MCQs tailored for M.Pharm students to deepen understanding of herbal adverse drug reaction (ADR) surveillance — covering global databases, regulatory requirements, signal detection methods, causality assessment, common herbal risks and practical challenges like multi-ingredient formulations, adulteration and herb–drug interactions. By practicing these questions, students will enhance their ability to evaluate individual case safety reports (ICSRs), appreciate reporting quality elements, and apply pharmacovigilance principles to traditional and herbal products. These items emphasize critical thinking needed for real-world herbal pharmacovigilance.

Q1. What best describes a spontaneous reporting scheme in pharmacovigilance for herbal ADRs?

• A proactive, population-based active surveillance requiring regular follow-up
• A mandatory registry-based system for all prescribed herbal medicines
• A passive surveillance system relying on voluntary individual reports of suspected ADRs
• An automated clinical trial-based safety monitoring network

Correct Answer: A passive surveillance system relying on voluntary individual reports of suspected ADRs

Q2. Which global repository maintained by the Uppsala Monitoring Centre stores individual case safety reports (ICSRs) from spontaneous reporting systems worldwide?

• FAERS
• VigiBase
• EudraVigilance
• MedWatch Database

Correct Answer: VigiBase

Q3. What is the most common limitation of spontaneous reporting schemes for herbal adverse reactions?

• Excessive false-positive signal detection
• High cost of routine active surveillance
• Under-reporting and incomplete case information
• Requirement for clinical trial level evidence

Correct Answer: Under-reporting and incomplete case information

Q4. Which challenge is especially prominent when assessing ADRs from polyherbal formulations in spontaneous reports?

• Uniform pharmacokinetics across batches
• Clear single-molecule causality
• Difficulty attributing causality due to multiple ingredients and variable composition
• Reliable lot/expiry documentation

Correct Answer: Difficulty attributing causality due to multiple ingredients and variable composition

Q5. Which causality assessment method is recommended by WHO for structured evaluation of suspected ADRs in spontaneous reports?

• Naranjo algorithm exclusively for herbal products
• WHO–UMC causality assessment system
• RUCAM only for all ADR types
• Bayesian causality index for individual case reports

Correct Answer: WHO–UMC causality assessment system

Q6. Which disproportionality measure is commonly used to detect signals in spontaneous reporting databases?

• Number Needed to Harm (NNH)
• Proportional Reporting Ratio (PRR)
• Absolute Risk Reduction (ARR)
• Therapeutic Index Ratio (TIR)

Correct Answer: Proportional Reporting Ratio (PRR)

Q7. According to pharmacovigilance definitions, which outcome classifies an ADR as ‘serious’?

• Any transient nausea resolving in 24 hours
• Hospitalization, life‑threatening event, disability, congenital anomaly, or death
• Minor rash without systemic involvement
• Mild headache manageable without treatment

Correct Answer: Hospitalization, life‑threatening event, disability, congenital anomaly, or death

Q8. Which herbal product is well documented to cause clinically significant CYP3A4 induction leading to multiple drug interactions?

• Ginkgo biloba
• St. John’s wort (Hypericum perforatum)
• Kava (Piper methysticum)
• Black cohosh

Correct Answer: St. John’s wort (Hypericum perforatum)

Q9. Which of the following is NOT considered a core mandatory element of an individual case safety report (ICSR)?

• Identifiable patient
• Identified reporter
• Description of the suspected adverse reaction
• Patient’s social security number

Correct Answer: Patient’s social security number

Q10. Which national programme in India is primarily responsible for collecting and analysing ADR reports, including those for herbal/AYUSH products?

• Food Safety and Standards Authority of India (FSSAI)
• Pharmacovigilance Programme of India (PvPI)
• Central Pollution Control Board (CPCB)
• National Institute of Nutrition

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q11. Which strategy has proven most effective to increase spontaneous reporting rates of herbal ADRs among healthcare professionals?

• Reducing pharmacovigilance training and reliance on patients
• Regular awareness campaigns and targeted training for healthcare providers
• Eliminating reporter anonymity
• Restricting reports to clinical trial settings only

Correct Answer: Regular awareness campaigns and targeted training for healthcare providers

Q12. Which product quality problem commonly contributes to herbal ADRs reported spontaneously?

• Consistent phytochemical profiles across batches
• Adulteration with undeclared synthetic pharmaceuticals
• Strict adherence to Good Agricultural Practices
• Comprehensive batch traceability

Correct Answer: Adulteration with undeclared synthetic pharmaceuticals

Q13. Which software/platform is provided by the Uppsala Monitoring Centre for managing national ICSR submissions?

• MedDRA Manager
• VigiFlow
• FAERS Portal
• SignalFinder Pro

Correct Answer: VigiFlow

Q14. In signal management for herbal ADRs, which activity is essential after initial statistical signal detection?

• Immediate market withdrawal without assessment
• Clinical assessment of case series and thorough literature review
• Ignoring confounders such as concomitant drugs
• Assuming causality based solely on statistical disproportionality

Correct Answer: Clinical assessment of case series and thorough literature review

Q15. Which herbal product has been notably associated with cases of hepatotoxicity leading to regulatory restrictions in some countries?

• Chamomile
• Kava (Piper methysticum)
• Aloe vera (topical use)
• Moringa oleifera

Correct Answer: Kava (Piper methysticum)

Q16. In many regulatory frameworks, within how many days should serious and unexpected ADRs typically be reported by marketing authorisation holders?

• 7 days
• 15 days
• 30 days
• 90 days

Correct Answer: 15 days

Q17. Which causality category commonly requires evidence such as a positive and clinically plausible rechallenge to be assigned?

• Unlikely
• Possible
• Certain
• Unassessable

Correct Answer: Certain

Q18. Which data-mining method used with spontaneous reporting databases is based on a Bayesian approach and implemented by the UMC?

• Reporting Odds Ratio (ROR)
• Bayesian Confidence Propagation Neural Network (BCPNN)
• Absolute Risk Difference (ARD)
• Kaplan–Meier Signal Test

Correct Answer: Bayesian Confidence Propagation Neural Network (BCPNN)

Q19. Which factor most complicates causality assessment specifically for herbal ADR spontaneous reports?

• Standardized monograph-based composition of all products
• Clear single-active-ingredient dosing information
• Variable botanical identification, adulteration and batch-to-batch phytochemical variability
• High frequency of controlled clinical trial data accompanying each report

Correct Answer: Variable botanical identification, adulteration and batch-to-batch phytochemical variability

Q20. What is a key advantage of encouraging patient (consumer) spontaneous reporting of herbal ADRs?

• Patients provide only laboratory-confirmed ADRs
• It captures patient-experienced symptoms and milder or quality-of-life issues that professionals may not report
• Patient reports eliminate the need for causality assessment
• Patients always provide complete product batch and botanical authentication

Correct Answer: It captures patient-experienced symptoms and milder or quality-of-life issues that professionals may not report

Download