Pharmacovigilance for natural products: WHO and AYUSH guidelines MCQs With Answer

Pharmacovigilance for natural products: WHO and AYUSH guidelines MCQs With Answer

This quiz collection focuses on pharmacovigilance for natural products, tailored for M.Pharm students studying Advanced Pharmacognosy I. It integrates core concepts from WHO guidance and AYUSH initiatives, covering adverse event reporting, causality assessment, signal detection, databases like VigiBase, coding standards, and special considerations for herbal/AYUSH medicines such as botanical identification, adulteration, herb–drug interactions, and proprietary formulations. Questions are designed to deepen understanding of regulatory expectations, reporting content, and practical steps to strengthen safety monitoring of herbal products in national pharmacovigilance systems. Use these MCQs to test knowledge and prepare for clinical and regulatory responsibilities in herbal safety surveillance.

Q1. Which WHO document specifically provides guidance for safety monitoring of herbal medicines within pharmacovigilance systems?

• WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems
• ICH Guideline E2B on Clinical Safety Data Management
• Good Manufacturing Practice for Herbal Products
• WHO Essential Medicines List for Herbal Remedies

Correct Answer: WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems

Q2. How does WHO define pharmacovigilance in relation to medicines?

• A set of manufacturing quality control tests for herbal products
• Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
• Clinical trial design for safety endpoints only
• Marketing strategies to minimize reports of adverse events

Correct Answer: Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem

Q3. What is the primary aim of national pharmacovigilance programs for AYUSH medicines?

• To ban all proprietary herbal products
• To monitor adverse events and strengthen safety surveillance of ASU & H (Ayurveda, Siddha, Unani and Homoeopathy) medicines
• To replace conventional pharmacovigilance systems with traditional healers
• To standardize taste and appearance of herbal preparations

Correct Answer: To monitor adverse events and strengthen safety surveillance of ASU & H (Ayurveda, Siddha, Unani and Homoeopathy) medicines

Q4. Which of the following items is essential to include when reporting an adverse reaction suspected to be caused by a herbal product?

• Patient details, product (botanical) identification, batch/lot number, dose, treatment duration and concomitant medicines
• Only the brand name of the product and patient age
• Marketing budget for the product
• Laboratory manufacturing SOPs

Correct Answer: Patient details, product (botanical) identification, batch/lot number, dose, treatment duration and concomitant medicines

Q5. Which causality assessment method is recommended by WHO for standardized assessment of individual adverse reaction reports?

• WHO–UMC causality assessment system
• Naranjo algorithm only
• RUCAM exclusively for all herbal reports
• Cochrane risk-of-bias tool

Correct Answer: WHO–UMC causality assessment system

Q6. What is VigiBase in the context of pharmacovigilance?

• The WHO global database of individual case safety reports (ICSRs)
• An international manufacturing guideline for herbal extracts
• A repository of traditional medicine recipes
• A clinical trial registry for phytopharmaceuticals

Correct Answer: The WHO global database of individual case safety reports (ICSRs)

Q7. The ICH E2B format is used for which pharmacovigilance activity?

• Electronic transmission of individual case safety reports between stakeholders
• Botanical authentication of raw materials
• Laboratory quality control of finished herbal products
• Clinical efficacy endpoint specification

Correct Answer: Electronic transmission of individual case safety reports between stakeholders

Q8. Which standardized terminology is commonly used to code adverse events in global pharmacovigilance databases?

• MedDRA (Medical Dictionary for Regulatory Activities)
• ICD-10 only
• USP monograph codes
• FAO plant taxonomy codes

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q9. Which statistical method is frequently applied for signal detection in spontaneous reporting systems including herbal PV?

• Disproportionality analysis (e.g., reporting odds ratio, proportional reporting ratio)
• Kaplan–Meier survival analysis
• ANOVA for manufacturing batches
• Principal component analysis for plant phytochemistry

Correct Answer: Disproportionality analysis (e.g., reporting odds ratio, proportional reporting ratio)

Q10. Detection of undeclared pharmaceutical adulterants in herbal products is most effectively performed by which approach?

• Targeted and untargeted laboratory chemical analysis (e.g., HPLC, LC–MS/MS)
• Visual inspection of packaging only
• Asking the patient to taste the product
• Reviewing marketing claims on websites

Correct Answer: Targeted and untargeted laboratory chemical analysis (e.g., HPLC, LC–MS/MS)

Q11. Compared to classical/formulation-heritage ASU products, proprietary herbal formulations typically require what special PV attention?

• Closer safety monitoring because new combinations, excipients and processes can change risk profiles
• No monitoring since they are always safe
• Only quality testing but no pharmacovigilance
• Immediate withdrawal from market without investigation

Correct Answer: Closer safety monitoring because new combinations, excipients and processes can change risk profiles

Q12. Which term best describes an adverse event that results in death, is life-threatening, requires hospitalization, results in persistent disability, or is a congenital anomaly?

• Serious adverse event (SAE)
• Adverse fashionable effect
• Expected side effect
• Non-serious adverse reaction

Correct Answer: Serious adverse event (SAE)

Q13. Which entity is primarily responsible for coordinating pharmacovigilance activities and integrating them into national health systems?

• National regulatory authority or designated national pharmacovigilance centre
• Local herbal shop owners’ association
• Individual clinical trial sponsors only
• International marketing teams without national oversight

Correct Answer: National regulatory authority or designated national pharmacovigilance centre

Q14. For a robust herbal adverse event report, which additional documentation can significantly improve causality assessment?

• Photographs of the product and plant material, and laboratory test results when available
• Only a verbal description of taste
• Manufacturer’s unpublished marketing slides
• Patient’s income statement

Correct Answer: Photographs of the product and plant material, and laboratory test results when available

Q15. What is a primary objective of the WHO guidance specific to herbal medicine pharmacovigilance?

• To integrate herbal safety monitoring into existing national pharmacovigilance systems and promote consistent reporting
• To mandate the immediate ban of all herbal medicines
• To prevent patients from using conventional medicines concurrently
• To standardize taste profiles of traditional remedies

Correct Answer: To integrate herbal safety monitoring into existing national pharmacovigilance systems and promote consistent reporting

Q16. Which unique risk factor is especially important when assessing safety of herbal products?

• Complex mixtures causing potential herb–drug interactions and variable phytochemical content
• Guaranteed uniform active principle across all batches
• Absence of any pharmacodynamic activity
• Identical toxicology to synthetic drugs

Correct Answer: Complex mixtures causing potential herb–drug interactions and variable phytochemical content

Q17. What does the acronym ICSR stand for in pharmacovigilance?

• Individual Case Safety Report
• International Committee for Safety Reporting
• Integrated Chemical Safety Registry
• Inventory of Certified Safety Reports

Correct Answer: Individual Case Safety Report

Q18. Which of the following is NOT a core element of a high-quality herbal adverse event report according to PV guidance?

• Manufacturer’s internal marketing strategy documents
• Patient demographics and clinical history
• Precise product identification including botanical name and batch number
• Details on onset, dechallenge/rechallenge and concomitant medications

Correct Answer: Manufacturer’s internal marketing strategy documents

Q19. Which data source most commonly contributes to early signal generation for herbal medicine safety concerns?

• Spontaneous (passive) adverse event reports from healthcare professionals and consumers
• Only randomized controlled trials
• Annual sales volume reports
• Herbal taste-testing surveys

Correct Answer: Spontaneous (passive) adverse event reports from healthcare professionals and consumers

Q20. In pharmacovigilance planning for a new herbal product, what does an RMP refer to?

• Risk Management Plan for identifying, characterizing and minimizing risks
• Raw Material Procurement list
• Recommended Manufacturing Procedure
• Regulatory Marketing Permit

Correct Answer: Risk Management Plan for identifying, characterizing and minimizing risks

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