Drug safety crisis communication and management MCQs With Answer

Drug safety crisis communication and management MCQs With Answer
Effective drug safety crisis communication and management is essential for B.Pharm students to understand pharmacovigilance, adverse drug reaction (ADR) reporting, risk management plans, signal detection, and product recalls. This concise introduction covers regulatory reporting timelines, crisis response teams, message mapping, media relations, and tools like Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). Learning practical steps—early detection, transparent stakeholder communication, containment, root‑cause analysis, and corrective actions—prepares future pharmacists to protect public health. Keywords: drug safety, crisis communication, pharmacovigilance, ADR reporting, risk management, recall procedures, signal detection, regulatory reporting. These MCQs emphasize practical scenarios, regulatory expectations, documentation, stakeholder coordination, and ethical communication during drug safety crises. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary goal of crisis communication in a drug safety event?

• To conceal product deficiencies
• To protect company profits only
• To ensure timely, accurate information to protect public health
• To delay regulatory reporting

Correct Answer: To ensure timely, accurate information to protect public health

Q2. Which system is primarily responsible for collecting spontaneous ADR reports globally?

• Uppsala Monitoring Centre (UMC)
• World Health Organization Clinical Trials Registry
• European Medicines Evaluation Network
• International Recall Authority

Correct Answer: Uppsala Monitoring Centre (UMC)

Q3. Which document outlines a company’s planned actions to minimize a medicine’s risks?

• Clinical Study Report (CSR)
• Risk Management Plan (RMP)
• Marketing Authorization Application (MAA)
• Investigator’s Brochure

Correct Answer: Risk Management Plan (RMP)

Q4. What is a key component of an effective crisis response team during a drug safety incident?

• Only marketing personnel
• Clear roles and a designated crisis leader
• Unlimited public statements without review
• External contractors only

Correct Answer: Clear roles and a designated crisis leader

Q5. Which analysis method is commonly used in signal detection from spontaneous reporting databases?

• Disproportionality analysis (e.g., PRR, ROR)
• Linear regression forecasting
• Genome-wide association study
• Cost-benefit analysis

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

Q6. Under ICH guidelines, how soon must a company report a serious unexpected suspected adverse reaction (SUSAR) to regulators?

• Within 24 hours
• Within 15 calendar days
• Within 3 months
• Only at marketing renewal

Correct Answer: Within 15 calendar days

Q7. Which causality assessment tool categorizes reactions as definite, probable, possible, or doubtful?

• Naranjo algorithm
• WHO-UMC scale
• Both Naranjo and WHO-UMC
• PRR method

Correct Answer: Both Naranjo and WHO-UMC

Q8. What is the first operational step after detecting a credible safety signal?

• Immediate mass recall
• Signal validation and case assessment
• Stop all communications
• File patent applications

Correct Answer: Signal validation and case assessment

Q9. Which regulatory report provides periodic aggregated safety information after marketing authorization?

• Investigator’s Brochure
• Periodic Benefit-Risk Evaluation Report (PBRER/PSUR)
• Clinical Study Protocol
• Manufacturing Batch Record

Correct Answer: Periodic Benefit-Risk Evaluation Report (PBRER/PSUR)

Q10. In a product recall classification, what characterizes a Class I recall?

• Unlikely to cause adverse health consequences
• May cause temporary health problems only
• Reasonable probability of serious health consequences or death
• Administrative labeling update only

Correct Answer: Reasonable probability of serious health consequences or death

Q11. Which principle is essential when communicating with the media during a drug safety crisis?

• Delay until all details are final
• Use jargon to avoid public panic
• Honesty, transparency, and timeliness
• Provide speculative causes

Correct Answer: Honesty, transparency, and timeliness

Q12. What is the role of root‑cause analysis in crisis management?

• To assign legal blame only
• To identify underlying system failures and corrective actions
• To design marketing campaigns
• To increase production speed

Correct Answer: To identify underlying system failures and corrective actions

Q13. Which document specifies how adverse events are reported during clinical trials?

• Statistical Analysis Plan
• Clinical Trial Protocol
• Labeling leaflet
• Marketing Authorization

Correct Answer: Clinical Trial Protocol

Q14. Which stakeholder should be informed first in a life‑threatening safety crisis?*

• Competitors
• Regulatory authorities and affected healthcare professionals
• Only the internal sales team
• Advertising agencies

Correct Answer: Regulatory authorities and affected healthcare professionals

Q15. What is message mapping in crisis communication?

• A method to hide negative facts
• A structured way to craft clear, audience‑focused messages
• A map of manufacturing sites
• A legal document for recalls

Correct Answer: A structured way to craft clear, audience‑focused messages

Q16. Which quality system helps ensure consistent pharmacovigilance processes during a crisis?

• Good Clinical Practice (GCP)
• Good Pharmacovigilance Practices (GVP)
• Good Laboratory Practices (GLP)
• Good Distribution Practices (GDP)

Correct Answer: Good Pharmacovigilance Practices (GVP)

Q17. Which metric indicates the proportion of reports containing a specific ADR for a drug versus all other drugs?

• Case fatality rate
• Proportional Reporting Ratio (PRR)
• Hazard ratio
• Number needed to treat

Correct Answer: Proportional Reporting Ratio (PRR)

Q18. When planning recall communications, which element is least important?

• Clear instructions for patients and providers
• Timely notification channels
• Complex technical language without guidance
• Contact information for inquiries

Correct Answer: Complex technical language without guidance

Q19. What is the main ethical responsibility of a pharmacist during a drug safety crisis?

• Protect company secrecy
• Ensure patient safety and provide accurate information
• Maximize product returns
• Delay reporting to avoid market impact

Correct Answer: Ensure patient safety and provide accurate information

Q20. Which activity helps prevent recurrence after a safety crisis?

• Ignoring root causes
• Implementing corrective and preventive actions (CAPA)
• Replacing all staff immediately
• Removing safety warnings permanently

Correct Answer: Implementing corrective and preventive actions (CAPA)

Q21. In pharmacovigilance, what is a ‘signal’?

• A confirmed causal relationship proven in RCTs only
• Information suggesting a new or changing causal association between a drug and an event
• A marketing signal to promote sales
• A label change request

Correct Answer: Information suggesting a new or changing causal association between a drug and an event

Q22. Which internal record is crucial for documenting decisions during a safety crisis?

• Marketing strategy memo
• Safety or crisis management log
• Employee attendance sheet
• Product brochure

Correct Answer: Safety or crisis management log

Q23. What is the function of a Safety Data Exchange Agreement (SDEA)?

• To outline data sharing between regulators only
• To define pharmacovigilance obligations between partners or licensors
• To list manufacturing procedures
• To regulate advertising claims

Correct Answer: To define pharmacovigilance obligations between partners or licensors

Q24. Which reporting source is most important for early detection of rare serious ADRs?

• Spontaneous individual case reports
• Annual sales reports
• Marketing surveys
• Packaging quality checks

Correct Answer: Spontaneous individual case reports

Q25. Which action best demonstrates transparency during a recall?

• Withholding information until legal clearance
• Issuing clear public notices and guidance promptly
• Providing vague statements to avoid attention
• Communicating only to shareholders

Correct Answer: Issuing clear public notices and guidance promptly

Q26. Which element is part of a Risk Minimization Plan?

• Enhanced safety monitoring and targeted education for prescribers
• Only increased advertising
• Removal of all warnings
• Reduction of pharmacovigilance staff

Correct Answer: Enhanced safety monitoring and targeted education for prescribers

Q27. What is the primary purpose of expedited reporting of serious ADRs?

• To delay label updates
• To allow regulatory bodies to take timely actions to protect patients
• To increase sales
• To inform competitors

Correct Answer: To allow regulatory bodies to take timely actions to protect patients

Q28. Which source of information is essential when assessing a suspected ADR case?

• Complete clinical and medication history
• Company profit reports
• Advertisement content
• Unrelated literature only

Correct Answer: Complete clinical and medication history

Q29. During a crisis, what is the advantage of having pre‑approved message templates?

• They guarantee legal immunity
• They speed up accurate communication while still allowing updates
• They replace the need for a crisis team
• They avoid all regulatory reporting

Correct Answer: They speed up accurate communication while still allowing updates

Q30. Which regulatory agency guidance commonly influences global pharmacovigilance practices?

• International Conference on Harmonisation (ICH) guidelines
• Local advertising guidelines only
• Trade union policies
• Non‑scientific marketing blogs

Correct Answer: International Conference on Harmonisation (ICH) guidelines

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com