Spontaneous reporting and monitoring of adverse reactions to herbal medicines MCQs With Answer

Spontaneous reporting and monitoring of adverse reactions to herbal medicines MCQs With Answer

This blog provides M.Pharm students with a focused set of multiple-choice questions on spontaneous reporting and pharmacovigilance specific to herbal medicines. It covers fundamentals—definitions, reporting systems, causality assessment, signal detection and regulatory actions—plus herbal-specific challenges such as adulteration, complex mixtures and herb–drug interactions. Questions are designed to test critical thinking and practical knowledge required in advanced pharmacognosy and regulatory practice. Answers are provided to reinforce learning and prepare students for examinations and real-world pharmacovigilance tasks involving herbal products.

Q1. What best defines a spontaneous reporting system for adverse drug reactions (ADRs)?

• Mandatory surveillance during clinical trials only
• Active prospective collection of ADRs by investigators
• Voluntary submission of suspected adverse reaction reports by healthcare professionals and consumers
• Automated extraction of ADRs from electronic health records exclusively

Correct Answer: Voluntary submission of suspected adverse reaction reports by healthcare professionals and consumers

Q2. Which is the major limitation of spontaneous reporting systems for herbal product safety?

• They provide exact incidence and prevalence rates for ADRs
• They ensure complete quality control of all herbal batches
• Under-reporting of cases and variable report quality
• They replace the need for any other pharmacovigilance methods

Correct Answer: Under-reporting of cases and variable report quality

Q3. Which organization maintains the global database VigiBase for spontaneous ADR reports?

• World Health Organization (WHO) Regional Office for Europe
• European Medicines Agency (EMA)
• Uppsala Monitoring Centre (UMC) (VigiBase)
• Food and Agriculture Organization (FAO)

Correct Answer: Uppsala Monitoring Centre (UMC) (VigiBase)

Q4. Which causality assessment method is commonly recommended for spontaneous reports including herbal ADRs?

• Cochrane risk of bias tool
• WHO-UMC causality assessment system
• CONSORT checklist
• Beers criteria

Correct Answer: WHO-UMC causality assessment system

Q5. Which terminology/dictionary is widely used to code adverse event terms in pharmacovigilance databases?

• ICD-10 (International Classification of Diseases)
• ATC classification only
• MedDRA (Medical Dictionary for Regulatory Activities)
• USP-NF monograph terms

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q6. Which herbal product has been notably associated with cases of severe hepatotoxicity?

• Ginkgo biloba (cognitive enhancer)
• Kava (Piper methysticum)
• Ashwagandha (Withania somnifera)
• Chamomile (Matricaria recutita)

Correct Answer: Kava (Piper methysticum)

Q7. What is the primary purpose of spontaneous reporting systems in pharmacovigilance?

• To provide final proof of causality for regulatory decisions
• To detect signals of new, rare, or unexpected adverse reactions
• To replace pre-marketing safety studies
• To estimate drug utilization in the population precisely

Correct Answer: To detect signals of new, rare, or unexpected adverse reactions

Q8. Which disproportionality statistic is commonly used to detect safety signals in spontaneous report databases?

• Hazard ratio from cohort studies
• Reporting Odds Ratio (ROR)
• Relative risk from randomized trials
• Number needed to treat (NNT)

Correct Answer: Reporting Odds Ratio (ROR)

Q9. When reporting an adverse reaction related to a herbal product, which information is essential to include?

• Only the patient age and sex
• Only the commercial brand name
• Provide botanical name, part used, dose, formulation, brand/batch and duration of use
• Only the suspected concomitant prescription drug

Correct Answer: Provide botanical name, part used, dose, formulation, brand/batch and duration of use

Q10. What risk arises from adulteration of herbal products with undeclared pharmaceutical agents?

• Improved therapeutic outcomes with no safety concerns
• Toxicities or adverse reactions due to undeclared pharmaceuticals or contaminants
• The herbal product will degrade immediately and no ADRs occur
• Automatic detection by spontaneous reports without investigation

Correct Answer: Toxicities or adverse reactions due to undeclared pharmaceuticals or contaminants

Q11. Which statement is NOT true about spontaneous reporting systems?

• They are valuable for early detection of rare adverse events
• The quality and completeness of reports can vary widely
• They provide accurate incidence rates of ADRs
• They depend heavily on reporter awareness and motivation

Correct Answer: They provide accurate incidence rates of ADRs

Q12. According to WHO, a pharmacovigilance “signal” is best described as:

• A confirmed causal relationship between a drug and an event
• Information that suggests a new causal association or a new aspect of a known association
• An advertising claim about a herbal product
• A statistically insignificant cluster of reports

Correct Answer: Information that suggests a new causal association or a new aspect of a known association

Q13. After a signal is validated for a herbal product, which regulatory action may be taken?

• Ignoring the signal indefinitely
• Immediate global product ban without assessment
• Risk minimization measures such as label changes, warnings or product withdrawal
• Replacing spontaneous reporting with only social media monitoring

Correct Answer: Risk minimization measures such as label changes, warnings or product withdrawal

Q14. Which herb is well known to cause clinically significant drug interactions by inducing CYP3A4?

• Black cohosh (Actaea racemosa)
• St. John’s wort (Hypericum perforatum)
• Turmeric (Curcuma longa)
• Aloe vera (Aloe barbadensis)

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

Q15. What is a key advantage of spontaneous reporting systems in monitoring herbal medicine safety?

• They directly measure the incidence and prevalence of ADRs
• They are expensive and only cover small populations
• Early detection of rare or unexpected ADRs at population level
• They eliminate the need for causality assessment

Correct Answer: Early detection of rare or unexpected ADRs at population level

Q16. Which factor most increases the likelihood that a healthcare professional will submit a spontaneous ADR report for a herbal product?

• The ADR is mild, expected, and transient
• The reaction is severe, leads to hospitalization, or results in death
• The product is well studied with known safety profile
• The herbal product is used daily with no new events

Correct Answer: The reaction is severe, leads to hospitalization, or results in death

Q17. For serious and unexpected adverse reactions, many regulatory frameworks recommend initial reporting within how many days?

• Within 90 days
• Within 30 days
• Within 7 calendar days (initial report)
• No time limit is required

Correct Answer: Within 7 calendar days (initial report)

Q18. Which pharmacovigilance tool is particularly useful for detecting patterns of ADRs across large spontaneous reporting databases?

• Case report narrative review only
• Disproportionality analysis using measures like PRR or ROR
• Single uncontrolled case study design
• Traditional pharmacopeial monograph comparison

Correct Answer: Disproportionality analysis using measures like PRR or ROR

Q19. Which causality assessment approach uses an algorithmic scoring system often applied to spontaneous reports?

• Expert global introspection only
• Naranjo algorithm (algorithmic scoring system)
• Descriptive case series without scoring
• Randomized controlled trial adjudication

Correct Answer: Naranjo algorithm (algorithmic scoring system)

Q20. Which common belief contributes to under-reporting of adverse reactions to herbal medicines?

• Belief that only synthetic drugs cause ADRs
• Belief that herbal products are always safe because they are “natural”
• Complete awareness of all potential herb–drug interactions
• Mandatory reporting enforced for all herbal ADRs

Correct Answer: Belief that herbal products are always safe because they are “natural”

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