WHO guidelines on safety monitoring of herbal medicines MCQs With Answer

Introduction: The WHO guidelines on safety monitoring of herbal medicines provide a global framework for pharmacovigilance of herbal products, emphasizing standardized reporting, product identification, quality control, and signal detection. B.Pharm students should understand adverse event documentation, causality assessment (WHO‑UMC), risk minimization, herb‑drug interactions, contamination/adulteration risks, and the role of national pharmacovigilance centres. Key concepts include batch identification, botanical names, preparation method, dose, duration, vulnerable populations, and active surveillance methods. Mastery of these topics helps ensure patient safety and effective regulatory oversight of herbal medicines. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which item is considered essential in a case report for herbal medicine adverse event monitoring according to WHO guidance?

• Patient’s favorite food
• Scientific (botanical) name and part of plant used
• Prescriber’s educational degree
• Time of day when the adverse event was reported to family

Correct Answer: Scientific (botanical) name and part of plant used

Q2. What is the primary reason WHO emphasizes recording the botanical (Latin) name in herbal pharmacovigilance?

• To increase product sales
• To ensure precise identification across languages and regions
• To comply with advertising regulations
• To track the price of raw materials

Correct Answer: To ensure precise identification across languages and regions

Q3. Which causality assessment method is recommended by WHO for evaluating adverse reactions to herbal medicines?

• WHO‑UMC causality categories
• Beers Criteria
• CONSORT checklist
• Glasgow Coma Scale

Correct Answer: WHO‑UMC causality categories

Q4. In herbal safety monitoring, why is recording the batch or lot number important?

• To identify the manufacturer’s logo
• To link specific adverse events to a production batch and detect manufacturing problems
• To determine retail pricing
• To verify the patient’s identity

Correct Answer: To link specific adverse events to a production batch and detect manufacturing problems

Q5. Which of the following is a common cause of adverse reactions associated with herbal products?

• Standardized manufacturing processes only
• Adulteration with undeclared pharmaceuticals
• Perfect botanical authentication
• Universal dosing guidelines

Correct Answer: Adulteration with undeclared pharmaceuticals

Q6. What role do national pharmacovigilance centres play in herbal medicine safety?

• They manufacture herbal products
• They collect, assess, and communicate adverse event reports and signals
• They set retail prices
• They certify herbal therapists

Correct Answer: They collect, assess, and communicate adverse event reports and signals

Q7. Which data element helps assess potential herb‑drug interactions in a safety report?

• Patient’s favorite sport
• List of concomitant conventional medicines and timing of use
• Color of the herbal product packaging
• Manufacturer’s advertising tagline

Correct Answer: List of concomitant conventional medicines and timing of use

Q8. WHO recommends coding herbal adverse event reports using which practice to improve signal detection?

• Using local nicknames for plants exclusively
• Standardized terminologies and botanical nomenclature
• Only free‑text narrative without structured fields
• Counting words in the narrative

Correct Answer: Standardized terminologies and botanical nomenclature

Q9. Which surveillance method is proactive and useful for herbal safety studies when spontaneous reporting is insufficient?

• Spontaneous reporting only
• Cohort event monitoring or active surveillance
• Advertising campaigns
• Retail inventory tracking

Correct Answer: Cohort event monitoring or active surveillance

Q10. For herbal products, why is documenting preparation method (e.g., extract, decoction) important?

• It determines the color of the label
• Preparation affects constituent concentration and toxicity profile
• It dictates the retail shelf placement
• It reveals the therapist’s training level

Correct Answer: Preparation affects constituent concentration and toxicity profile

Q11. Which contamination is a frequent safety concern for herbal medicines reported to pharmacovigilance systems?

• Excessive oxygen content
• Heavy metals such as lead, arsenic, cadmium
• High vitamin C levels
• Excessive humidity only during summer

Correct Answer: Heavy metals such as lead, arsenic, cadmium

Q12. How should suspected adverse reactions from multi‑ingredient herbal formulas be reported for assessment?

• Mention only the brand name without ingredients
• List all ingredients, proportions if known, and the specific product information
• Report only the prominent herb and ignore others
• Report only patient demographics

Correct Answer: List all ingredients, proportions if known, and the specific product information

Q13. Which of the following is a key challenge in assessing causality for herbal adverse reactions?

• Herbal medicines always have single active ingredient
• Complex mixtures, variable composition and poor standardization
• Herbal products never interact with drugs
• All herbal effects are placebo

Correct Answer: Complex mixtures, variable composition and poor standardization

Q14. WHO guidance suggests targeting which groups for active monitoring of herbal safety?

• Only healthy young adults
• Vulnerable populations such as pregnant women, elderly, children, and those with comorbidities
• Only manufacturers’ employees
• Only athletes

Correct Answer: Vulnerable populations such as pregnant women, elderly, children, and those with comorbidities

Q15. Which is a recommended action when a signal of serious harm associated with an herbal product is validated?

• Immediately ban all herbal products globally
• Perform risk assessment, notify stakeholders, and consider regulatory or communication measures
• Ignore the signal until a lawsuit occurs
• Only change the product labeling without investigation

Correct Answer: Perform risk assessment, notify stakeholders, and consider regulatory or communication measures

Q16. Which enzyme family is often involved in clinically significant herb‑drug interactions?

• Digestive enzymes only
• CYP450 enzymes (e.g., CYP3A4, CYP2D6)
• RNA polymerases
• Keratinases

Correct Answer: CYP450 enzymes (e.g., CYP3A4, CYP2D6)

Q17. What is the importance of recording onset time and outcome in herbal adverse event reports?

• They are irrelevant for causality
• Onset and outcome help assess temporal relationship and seriousness
• Only outcome matters; onset is unnecessary
• They are used only for billing

Correct Answer: Onset and outcome help assess temporal relationship and seriousness

Q18. Which type of study can help quantify risk related to a specific herbal product after initial signals?

• Case report only
• Cohort or case‑control pharmacoepidemiological studies
• Manufacturer’s marketing survey
• Animal taste preference tests

Correct Answer: Cohort or case‑control pharmacoepidemiological studies

Q19. WHO guidance recommends training which stakeholders to improve herbal adverse event reporting?

• Only marketing staff
• Healthcare professionals, traditional practitioners, pharmacists, and consumers
• Only attorneys
• Only undergraduate students with no clinical roles

Correct Answer: Healthcare professionals, traditional practitioners, pharmacists, and consumers

Q20. Adulteration of herbal slimming products with undeclared sibutramine is an example of what risk type?

• Labeling enhancement
• Safety risk due to adulteration with conventional drugs
• Increased herbal authenticity
• Reduced efficacy risk only

Correct Answer: Safety risk due to adulteration with conventional drugs

Q21. Which reporting route does WHO encourage for suspected adverse events from herbal medicines?

• Only internal manufacturer memos
• Spontaneous reports to national pharmacovigilance centres, supplemented by active surveillance
• Only social media posts
• Reporting only after legal action

Correct Answer: Spontaneous reports to national pharmacovigilance centres, supplemented by active surveillance

Q22. In the WHO framework, what is a “signal” in pharmacovigilance of herbal medicines?

• A guaranteed adverse reaction for every product
• Information that suggests a new or changed causal association between a product and an adverse event worthy of further investigation
• A promotional claim by a manufacturer
• A routine quality control pass

Correct Answer: Information that suggests a new or changed causal association between a product and an adverse event worthy of further investigation

Q23. What quality issue can arise from incorrect plant part usage (e.g., using root instead of leaf)?

• Improved therapeutic consistency
• Altered chemical profile leading to unexpected toxicity or reduced efficacy
• Reduced need for labeling
• Automatic improvement in shelf‑life

Correct Answer: Altered chemical profile leading to unexpected toxicity or reduced efficacy

Q24. Why is patient demographic information (age, sex, medical history) vital in herbal ADR reports?

• It helps target advertising
• Demographics and history influence susceptibility and help interpret causality and risk groups
• It is used only for tax purposes
• It replaces the need to document the product

Correct Answer: Demographics and history influence susceptibility and help interpret causality and risk groups

Q25. Which element distinguishes herbal pharmacovigilance from conventional drug pharmacovigilance?

• Herbal products always have well‑defined single active ingredients
• Greater variability in composition, multi‑ingredient formulas, and higher likelihood of contamination or misidentification
• Herbal products are exempt from adverse event reporting
• Herbal reactions are always mild and self‑limiting

Correct Answer: Greater variability in composition, multi‑ingredient formulas, and higher likelihood of contamination or misidentification

Q26. Which preventive measure helps reduce safety risks from herbal medicines at the manufacturing stage?

• Skipping quality testing to save costs
• Good agricultural and collection practices (GACP) and Good Manufacturing Practices (GMP)
• Only relying on traditional knowledge without testing
• Reducing label information

Correct Answer: Good agricultural and collection practices (GACP) and Good Manufacturing Practices (GMP)

Q27. When assessing a suspected adverse reaction to a herb, which temporal pattern increases the likelihood of causality?

• Reaction occurred years before herb use
• Onset shortly after starting the herb and improvement after stopping (dechallenge)
• Reaction unrelated to timing and persistent despite stopping
• Reaction only observed in laboratory animals

Correct Answer: Onset shortly after starting the herb and improvement after stopping (dechallenge)

Q28. Which documentation is especially useful to trace the source of contamination in an herbal product?

• Retail poster images
• Supply chain records, raw material certificates, and batch manufacturing records
• Consumer social media likes
• Advertising budgets

Correct Answer: Supply chain records, raw material certificates, and batch manufacturing records

Q29. Which laboratory analysis is commonly used to detect undeclared pharmaceutical adulterants in herbal products?

• Sensory tasting only
• Chromatographic techniques like HPLC coupled with mass spectrometry
• Measuring package weight alone
• Counting leaflet pages

Correct Answer: Chromatographic techniques like HPLC coupled with mass spectrometry

Q30. What is an appropriate immediate communication to healthcare providers when a serious herbal safety signal is suspected?

• Confidential memo kept within one pharmacy
• Timely safety alert with product details, suspected adverse reactions, and recommended precautions or actions
• Wait for one year before any communication
• Only communicate through product advertising

Correct Answer: Timely safety alert with product details, suspected adverse reactions, and recommended precautions or actions

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