WHO guidelines for safety monitoring of natural medicines MCQs With Answer

Introduction

This quiz set focuses on the WHO guidelines for safety monitoring of natural (herbal) medicines, tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). It clarifies how global pharmacovigilance principles apply to herbal products, including adverse event reporting, causality assessment, signal detection, quality issues such as contamination and adulteration, and the roles of WHO/UMC and VigiBase. Questions cover practical aspects—case report elements, coding, analytical methods, and regulatory risk-minimization measures—helping students deepen their understanding of monitoring systems, common challenges in herbal safety evaluation, and best-practice approaches for integrating traditional medicine data into national pharmacovigilance frameworks.

Q1. What is the primary purpose of the WHO guidelines for safety monitoring of natural (herbal) medicines?

• To provide a framework for integrating herbal safety monitoring into national pharmacovigilance systems
• To mandate pricing policies for herbal products
• To replace national regulations on herbal manufacturing
• To promote marketing strategies for traditional medicines

Correct Answer: To provide a framework for integrating herbal safety monitoring into national pharmacovigilance systems

Q2. Which causality assessment system is promoted by WHO and used widely for assessing suspected adverse reactions?

• WHO-UMC causality assessment system
• Naranjo algorithm only
• Bayesian causality model specific to herbs
• Ad hoc clinical judgment without categories

Correct Answer: WHO-UMC causality assessment system

Q3. Where is the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring, located?

• Uppsala, Sweden
• Geneva, Switzerland
• London, United Kingdom
• New Delhi, India

Correct Answer: Uppsala, Sweden

Q4. What is VigiBase in the context of WHO pharmacovigilance?

• The global database of individual case safety reports (ICSRs) maintained by UMC
• A manufacturing guideline for herbal medicines
• A clinical trial registry for traditional medicine studies
• A marketing database for herbal product sales

Correct Answer: The global database of individual case safety reports (ICSRs) maintained by UMC

Q5. How does WHO define an adverse reaction in the context of pharmacovigilance?

• A harmful and unintended response to a medicinal product occurring at normal doses used in humans
• Any expected therapeutic effect of a medicinal product
• An effect only caused by overdosing or misuse
• A quality defect unrelated to clinical symptoms

Correct Answer: A harmful and unintended response to a medicinal product occurring at normal doses used in humans

Q6. Which of the following is a common quality-related safety concern for herbal medicines highlighted by WHO?

• Misidentification of plant species, contamination, adulteration and variable potency
• Exclusively chemical manufacturing impurities (no plant-related issues)
• Only packaging errors without impact on product content
• Guaranteed uniformity across all batches due to natural origin

Correct Answer: Misidentification of plant species, contamination, adulteration and variable potency

Q7. Which analytical approach is commonly used for signal detection in large adverse event databases like VigiBase?

• Disproportionality analysis (e.g., PRR, ROR, Information Component)
• Only descriptive case listing without statistics
• Random sampling of marketed batches
• Visual inspection of product labels

Correct Answer: Disproportionality analysis (e.g., PRR, ROR, Information Component)

Q8. What strategy does WHO recommend to improve reporting of adverse events from traditional medicine practitioners?

• Training, awareness raising and establishing simple reporting mechanisms tailored to traditional practitioners
• Prohibiting traditional practitioners from reporting to national systems
• Only accepting reports from biomedical doctors
• Requiring full clinical trial data before any report is submitted

Correct Answer: Training, awareness raising and establishing simple reporting mechanisms tailored to traditional practitioners

Q9. Which medical coding dictionary is recommended for coding adverse events in modern pharmacovigilance systems and is applicable to herbal product reports?

• MedDRA (Medical Dictionary for Regulatory Activities)
• ICD-10 only
• Plant Taxonomy Index (PTI)
• Proprietary sales codes

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q10. Which set of causality categories is included in the WHO-UMC system?

• Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable
• Definite, Questionable, Irrelevant, Hypothetical
• Proven, Disproven, Suspected, Unrelated
• Severe, Moderate, Mild, Asymptomatic

Correct Answer: Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable

Q11. What is a primary objective of safety monitoring activities for herbal medicines according to WHO guidance?

• To detect and characterize safety signals and implement risk-minimization measures
• To accelerate market entry without safety evaluation
• To limit information flow between regulators and the public
• To replace chemical analysis with anecdotal reports only

Correct Answer: To detect and characterize safety signals and implement risk-minimization measures

Q12. Which elements should be included in an ICSR for a suspected adverse reaction to an herbal product?

• Clear product identification (botanical name, part used, formulation), dose, route, duration, concomitant medicines, adverse event description, outcome and reporter details
• Only the product brand name and a vague symptom description
• Only manufacturing batch number without clinical details
• Marketing claim texts and promotional materials

Correct Answer: Clear product identification (botanical name, part used, formulation), dose, route, duration, concomitant medicines, adverse event description, outcome and reporter details

Q13. Which laboratory methods are most appropriate for detecting adulteration or contamination in herbal preparations?

• Chromatographic and spectrometric techniques (e.g., HPLC, GC-MS, LC-MS/MS)
• Only organoleptic (taste and smell) testing
• Counting tablets without chemical testing
• Marketing surveys among consumers

Correct Answer: Chromatographic and spectrometric techniques (e.g., HPLC, GC-MS, LC-MS/MS)

Q14. Which factor most complicates causality assessment for adverse reactions to herbal products?

• Multi-ingredient formulations with variable composition
• Presence of a single, well-characterized active pharmaceutical ingredient only
• Universal standardization across all herbal products
• Complete absence of concomitant medication use

Correct Answer: Multi-ingredient formulations with variable composition

Q15. Which minimum data elements does WHO recommend collecting when reporting an adverse event associated with a herbal medicine?

• Patient identifier (or demographics), suspected product identity, suspected reaction, onset date, reporter information and outcome
• Only the product price and store location
• Only the manufacturer name without clinical details
• Only traditional use claims and folklore references

Correct Answer: Patient identifier (or demographics), suspected product identity, suspected reaction, onset date, reporter information and outcome

Q16. How can traditional knowledge contribute to WHO-style safety monitoring for herbal medicines?

• By generating hypotheses and prioritizing signals based on patterns of traditional adverse reports
• By replacing systematic clinical monitoring completely
• By ensuring that no adverse events are recorded due to assumed safety
• By standardizing dosing across all herbal systems without testing

Correct Answer: By generating hypotheses and prioritizing signals based on patterns of traditional adverse reports

Q17. If a safety signal for a marketed herbal product is confirmed, which regulatory action does WHO guidance suggest may be appropriate?

• Risk-minimization measures such as label changes, contraindications, targeted communication or, if necessary, market restriction or withdrawal
• Immediate global ban without risk assessment
• No action; signals should be ignored for traditional products
• Only allow sale to trained practitioners without public information

Correct Answer: Risk-minimization measures such as label changes, contraindications, targeted communication or, if necessary, market restriction or withdrawal

Q18. Which type of testing is recommended to evaluate the stability and shelf-life of herbal formulations?

• Accelerated and long-term stability studies under defined conditions
• Only consumer feedback on freshness
• Only testing at room temperature once
• Relying solely on traditional storage advice without testing

Correct Answer: Accelerated and long-term stability studies under defined conditions

Q19. What practice is essential to ensure traceability of raw plant materials used in herbal medicinal products?

• Good documentation with batch numbers, supplier certificates of analysis and provenance records
• Allowing anonymous sourcing without records
• Only recording final product packaging date
• Trusting verbal supplier assurances without written documentation

Correct Answer: Good documentation with batch numbers, supplier certificates of analysis and provenance records

Q20. Which organization developed the “Good Agricultural and Collection Practices (GACP) for medicinal plants” that WHO endorses?

• World Health Organization (WHO) in collaboration with partner organizations
• Only national herbal industry associations without WHO input
• Commercial marketing groups for dietary supplements
• Local market vendors exclusively

Correct Answer: World Health Organization (WHO) in collaboration with partner organizations

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