Multiple Choice Questions

Q1. What is the primary goal of Pharmacovigilance?

a) To promote drug sales
b) To ensure drug affordability
c) To detect, assess, understand, and prevent adverse effects of drugs
d) To manufacture new drugs

Answer: c) To detect, assess, understand, and prevent adverse effects of drugs

Q2. The Thalidomide disaster in the 1960s led to the establishment of which regulatory
framework?
a) Good Manufacturing Practices
b) Drug Price Control Order
c) WHO International Drug Monitoring Programme
d) Good Pharmacovigilance Practices

Answer: c) WHO International Drug Monitoring Programme

Q3. Why is safety monitoring of medicines important?

a) To maximize drug effectiveness
b) To reduce the risk of adverse drug reactions (ADRs)
c) To prevent counterfeit drugs
d) To reduce drug production costs

Answer: b) To reduce the risk of adverse drug reactions (ADRs)

Q4. The WHO International Drug Monitoring Programme is coordinated by which

organization?
a) US FDA
b) EMA
c) Uppsala Monitoring Centre (UMC), Sweden
d) Central Drugs Standard Control Organization (CDSCO)

Answer: c) Uppsala Monitoring Centre (UMC), Sweden

Q5. Which organization is responsible for coordinating the Pharmacovigilance Programme of

India (PvPI)?
a) ICMR
b) Central Drugs Standard Control Organization (CDSCO)
c) Indian Pharmacopoeia Commission (IPC)
d) Ministry of AYUSH

Answer: c) Indian Pharmacopoeia Commission (IPC)

Q6. Adverse Drug Reactions (ADRs) are:

a) Intentional effects of drugs
b) Undesirable, unintended, and harmful effects of a drug
c) Therapeutic effects of drugs
d) All of the above
Answer: b) Undesirable, unintended, and harmful effects of a drug

Q7. Which of the following is NOT a type of ADR classification?

a) Type A (Augmented)
b) Type B (Bizarre)
c) Type X (Extended)
d) Type C (Chronic)

Answer: c) Type X (Extended)

Q8. Which of the following professionals can report ADRs?

a) Doctors
b) Nurses
c) Pharmacists
d) All of the above

Answer: d) All of the above

Q9. Which of the following is a widely used method for causality assessment in
Pharmacovigilance?
a) Naranjo Algorithm
b) Bradford-Hill Criteria
c) Wilson-Jungner Criteria
d) None of the above

Answer: a) Naranjo Algorithm

Q10. Which of the following is a criterion for defining a serious ADR?

a) Causes hospitalization
b) Causes permanent disability
c) Results in death
d) All of the above

Answer: d) All of the above

Q11. Predictability in ADR assessment refers to:

a) The likelihood of an ADR occurring based on known pharmacology
b) The severity of an ADR
c) The frequency of drug usage
d) None of the above

Answer: a) The likelihood of an ADR occurring based on known pharmacology

Q12. Which of the following is NOT a strategy for managing ADRs?

a) Dose adjustment
b) Stopping or switching medication
c) Ignoring minor ADRs
d) Symptomatic treatment

Answer: c) Ignoring minor ADRs

Q13. What does the term "Signal Detection" refer to in Pharmacovigilance?
a) A method for drug discovery
b) The identification of new potential safety issues with medicines
c) A process for approving new drugs
d) None of the above

Answer: b) The identification of new potential safety issues with medicines

Q14. Which of the following is an example of an adverse medication-related event?

a) Medication error
b) Adverse drug reaction
c) Drug overdose
d) All of the above

Answer: d) All of the above

Q15. Which of the following regulatory agencies is responsible for drug safety in India?
a) US FDA
b) EMA
c) CDSCO
d) MHRA

Answer: c) CDSCO

Q16. The primary objective of PvPI is to:

a) Regulate medicine prices in India
b) Monitor and analyze adverse drug reactions (ADRs) in India
c) Promote the export of Indian medicines
d) Manufacture vaccines

Answer: b) Monitor and analyze adverse drug reactions (ADRs) in India

Q17. The PvPI functions under the guidance of which regulatory authority?
a) Drug Controller General of India (DCGI)
b) World Health Organization (WHO)
c) US Food and Drug Administration (FDA)
d) National Institute of Health

Answer: a) Drug Controller General of India (DCGI)

Q18. Which organization is the National Coordinating Centre (NCC) for the
Pharmacovigilance Programme of India (PvPI)?
a) Central Drugs Standard Control Organization (CDSCO)
b) Indian Pharmacopoeia Commission (IPC)
c) Ministry of Health and Family Welfare
d) Medical Council of India

Answer: b) Indian Pharmacopoeia Commission (IPC)

Q19. In which year was the Pharmacovigilance Programme of India (PvPI) launched?
a) 2005
b) 2010
c) 2015
d) 2020

Answer: b) 2010

Q20. What is the primary objective of the WHO International Drug Monitoring Programme?
a) To promote the sales of pharmaceutical products
b) To identify, evaluate, and minimize adverse drug reactions globally
c) To regulate drug prices worldwide
d) To manufacture generic drugs

Answer: b) To identify, evaluate, and minimize adverse drug reactions globally

Q21. Which of the following is a key component of Pharmacovigilance?

a) Clinical trials
b) Adverse drug reaction (ADR) monitoring
c) Drug marketing strategies
d) Pricing control of medicines

Answer: b) Adverse drug reaction (ADR) monitoring

Q22. Why is the safety monitoring of medicines essential?

a) To ensure the effectiveness of drugs
b) To detect and minimize the risks of adverse drug reactions (ADRs)
c) To promote generic medicines
d) To increase medicine production

Answer: b) To detect and minimize the risks of adverse drug reactions (ADRs)

Q23. In which year did the WHO establish the International Drug Monitoring Programme?
a) 1948
b) 1968
c) 1985
d) 2002

Answer: b) 1968

Q24. Which major disaster in the 1960s led to the development of Pharmacovigilance
programs worldwide?
a) Penicillin discovery
b) Thalidomide tragedy
c) Aspirin overuse
d) Insulin development

Answer: b) Thalidomide tragedy

Q25. The Anatomical, Therapeutic, and Chemical (ATC) classification system is used for:
a) Identifying drug prices
b) Classifying drugs based on their site of action and therapeutic properties
c) Determining pharmaceutical sales
d) Analyzing drug side effects only

Answer: b) Classifying drugs based on their site of action and therapeutic properties

Q26. How many levels does the ATC classification system have?
a) 2
b) 3
c) 4
d) 5

Answer: d) 5

Q27. In the ATC classification system, the first level represents:

a) Chemical properties of the drug
b) Anatomical main group
c) Pharmacological subgroup
d) Brand name of the drug

Answer: b) Anatomical main group

Q28. The ATC code for a drug consists of:

a) Only numbers
b) Only letters
c) A combination of letters and numbers
d) Symbols and special characters

Answer: c) A combination of letters and numbers

Q29. The International Classification of Diseases (ICD) is maintained by:

a) US FDA
b) World Health Organization (WHO)
c) European Medicines Agency (EMA)
d) Indian Pharmacopoeia Commission (IPC)

Answer: b) World Health Organization (WHO)

Q30. What is the primary purpose of the ICD system?

a) To classify pharmaceutical drugs
b) To diagnose and classify diseases and health conditions
c) To regulate the marketing of medicines
d) To determine drug dosages

Answer: b) To diagnose and classify diseases and health conditions

Q31. Which version of the ICD is currently in use worldwide?

a) ICD-8
b) ICD-9
c) ICD-10
d) ICD-11

Answer: d) ICD-11

Q32. ICD codes are primarily used for:

a) Insurance claims and reimbursement
b) Clinical diagnosis and epidemiological research
c) Health data management
d) All of the above

Answer: d) All of the above

Q33. Defined Daily Dose (DDD) is a standard measure used to:

a) Define the average maintenance dose per day of a drug
b) Identify the chemical composition of a drug
c) Classify drugs based on their mechanism of action
d) Determine the number of tablets in a drug package

Answer: a) Define the average maintenance dose per day of a drug

Q34. Which organization is responsible for assigning DDDs?

a) US FDA
b) WHO Collaborating Centre for Drug Statistics Methodology
c) European Medicines Agency (EMA)
d) Indian Pharmacopoeia Commission

Answer: b) WHO Collaborating Centre for Drug Statistics Methodology

Q35. What is the primary purpose of DDD in drug utilization studies?

a) To recommend individual patient dosages
b) To compare drug usage at an international level
c) To replace clinical judgment
d) To promote specific pharmaceutical brands

Answer: b) To compare drug usage at an international level

Q36. International Nonproprietary Names (INN) are assigned to drugs by:

a) US FDA
b) World Health Organization (WHO)
c) Indian Pharmacopoeia Commission (IPC)
d) European Medicines Agency (EMA)

Answer: b) World Health Organization (WHO)

Q37. What is the main purpose of assigning an INN to a drug?

a) To create a unique brand name for marketing
b) To provide a standard, globally recognized generic name for drugs
c) To increase drug prices
d) To classify drugs based on their adverse effects

Answer: b) To provide a standard, globally recognized generic name for drugs

Q38. Which of the following is an example of an INN?

a) Paracetamol
b) Crocin
c) Tylenol
d) Calpol

Answer: a) Paracetamol

Q39. Why is the INN system important?

a) It prevents confusion caused by multiple brand names
b) It standardizes drug names across countries
c) It ensures safe prescribing practices
d) All of the above

Answer: d) All of the above

Q40. What is the primary purpose of WHO Adverse Reaction Terminology (WHO-ART)?
a) To standardize reporting of adverse drug reactions (ADRs)
b) To classify diseases for insurance purposes
c) To define drug prices globally
d) To promote pharmaceutical sales

Answer: a) To standardize reporting of adverse drug reactions (ADRs)

Q41. WHO-ART has been replaced by which adverse reaction terminology system?
a) ICD
b) SNOMED
c) MedDRA
d) ATC classification

Answer: c) MedDRA

Q42. WHO Adverse Reaction Terminology (WHO-ART) was primarily used for:
a) Pharmacovigilance reporting
b) Drug formulation
c) Clinical trials recruitment
d) Determining the price of medications

Answer: a) Pharmacovigilance reporting

Q43. What does MedDRA stand for?

a) Medical Dictionary for Drug Regulatory Affairs
b) Medical Dictionary for Regulatory Activities
c) Medicine Database for Regulatory Applications
d) Medical Documentation for Risk Assessment
Answer: b) Medical Dictionary for Regulatory Activities

Q45. MedDRA is used for:

a) Coding and classifying adverse events
b) Manufacturing pharmaceuticals
c) Conducting clinical trials
d) Drug pricing analysis

Answer: a) Coding and classifying adverse events

Q46. What are Standardized MedDRA Queries (SMQs) used for?

a) Standardizing drug pricing across different countries
b) Detecting and analyzing groups of related adverse events
c) Identifying new drug formulations
d) Regulating pharmaceutical advertising

Answer: b) Detecting and analyzing groups of related adverse events

Q47. Which organization maintains MedDRA?

a) US FDA
b) WHO
c) International Council for Harmonisation (ICH)
d) European Medicines Agency (EMA)

Answer: c) International Council for Harmonisation (ICH)

Q48. MedDRA classifications are structured into how many hierarchical levels?
a) 3
b) 4
c) 5
d) 6

Answer: c) 5

Q49. The WHO Drug Dictionary (WHO-DD) is primarily used for:

a) Pharmacovigilance and clinical trials
b) Drug pricing and marketing
c) Disease classification
d) Medical insurance coding

Answer: a) Pharmacovigilance and clinical trials

Q50. Which organization maintains the WHO Drug Dictionary?

a) European Medicines Agency (EMA)
b) WHO Uppsala Monitoring Centre (UMC)
c) US FDA
d) Indian Pharmacopoeia Commission

Answer: b) WHO Uppsala Monitoring Centre (UMC)

Q51. WHO-DD provides information on:
a) Drug trade names and active ingredients
b) Disease epidemiology
c) Health insurance policies
d) Hospital management systems

Answer: a) Drug trade names and active ingredients

Q52. Which regulatory body maintains the EudraVigilance Medicinal Product Dictionary?
a) US FDA
b) World Health Organization (WHO)
c) European Medicines Agency (EMA)
d) Indian Pharmacopoeia Commission

Answer: c) European Medicines Agency (EMA)

Q53. What type of information is included in the EVMPD?

a) Drug names, active substances, and manufacturers
b) Disease classifications
c) Patient medical histories
d) Hospital financial records

Answer: a) Drug names, active substances, and manufacturers

Q54. Which of the following is a primary drug information resource?

a) Textbooks
b) Clinical trial reports
c) Pharmacopoeias
d) All of the above

Answer: d) All of the above

Q55. Which of the following is an example of an internationally recognized drug

compendium?
a) Martindale: The Complete Drug Reference
b) Indian Pharmacopoeia
c) United States Pharmacopeia (USP)
d) All of the above

Answer: d) All of the above

Q56. The British National Formulary (BNF) is mainly used for:

a) Drug advertising
b) Drug prescribing and safety information
c) Pharmaceutical manufacturing guidelines
d) Clinical trial design

Answer: b) Drug prescribing and safety information

Q57. Which resource is commonly used for reporting and assessing adverse drug reactions
(ADRs)?
a) MedDRA
b) WHO Uppsala Monitoring Centre (UMC)
c) EudraVigilance
d) All of the above

Answer: d) All of the above

Q58. The Yellow Card Scheme is a pharmacovigilance program used in:

a) India
b) United Kingdom
c) United States
d) Japan

Answer: b) United Kingdom

Q59. The FDA Adverse Event Reporting System (FAERS) is used in which country?
a) United States
b) Canada
c) Germany
d) Australia

Answer: a) United States

Q60. What is the primary objective of a pharmacovigilance program?

a) To monitor and analyze adverse drug reactions (ADRs)
b) To regulate drug prices
c) To market new pharmaceutical products
d) To manufacture new drugs

Answer: a) To monitor and analyze adverse drug reactions (ADRs)

Q61. Which of the following is a key component of a pharmacovigilance program?

a) ADR reporting systems
b) Signal detection
c) Risk management plans
d) All of the above

Answer: d) All of the above

Q62. Who is primarily responsible for reporting ADRs in a hospital-based pharmacovigilance

program?
a) Only physicians
b) Only pharmacists
c) All healthcare professionals and patients
d) Only regulatory authorities

Answer: c) All healthcare professionals and patients

Q63. What is the main role of a drug safety department in the pharmaceutical industry?
a) Conducting preclinical animal studies
b) Monitoring and reporting adverse drug reactions (ADRs)
c) Approving new drug marketing campaigns
d) Increasing drug sales

Answer: b) Monitoring and reporting adverse drug reactions (ADRs)

Q64. The Qualified Person Responsible for Pharmacovigilance (QPPV) is mandatory in:
a) India
b) European Union (EU)
c) Canada
d) Australia

Answer: b) European Union (EU)

Q65. What is the primary function of a Contract Research Organization (CRO)?

a) Conducting drug safety surveillance
b) Managing and monitoring clinical trials
c) Manufacturing pharmaceutical products
d) Approving new drugs

Answer: b) Managing and monitoring clinical trials

Q66. CROs assist pharmaceutical companies in:

a) Conducting clinical trials
b) Regulatory submissions
c) Pharmacovigilance activities
d) All of the above

Answer: d) All of the above

Q67. Which of the following is an example of a well-known CRO?

a) IQVIA
b) Covance
c) Parexel
d) All of the above

Answer: d) All of the above

Q68. Which country was the first to establish a national pharmacovigilance program?
a) United States
b) Sweden
c) United Kingdom
d) France

Answer: b) Sweden

Q69. The Pharmacovigilance Programme of India (PvPI) is coordinated by:

a) Indian Pharmacopoeia Commission (IPC)
b) Drug Controller General of India (DCGI)
c) World Health Organization (WHO)
d) National Institute of Health

Answer: a) Indian Pharmacopoeia Commission (IPC)

Q70. A national pharmacovigilance program typically includes:

a) ADR monitoring centers
b) Regulatory compliance guidelines
c) Public awareness campaigns
d) All of the above

Answer: d) All of the above

Q71. What is the primary aim of vaccine pharmacovigilance?

a) To monitor and ensure vaccine safety
b) To regulate vaccine prices
c) To increase vaccine sales
d) To compare vaccine brands

Answer: a) To monitor and ensure vaccine safety

Q72. Which of the following organizations plays a key role in global vaccine
pharmacovigilance?
a) World Health Organization (WHO)
b) United Nations (UN)
c) International Monetary Fund (IMF)
d) World Trade Organization (WTO)

Answer: a) World Health Organization (WHO)

Q73. What is the primary method for collecting vaccine safety data in pharmacovigilance?
a) Passive surveillance (spontaneous reporting)
b) Active surveillance (monitoring and follow-up studies)
c) Clinical trials
d) All of the above

Answer: d) All of the above

Q74. Which of the following systems is used to monitor vaccine safety in the United States?
a) Vaccine Adverse Event Reporting System (VAERS)
b) EudraVigilance
c) Yellow Card Scheme
d) VigiBase

Answer: a) Vaccine Adverse Event Reporting System (VAERS)

Q75. The Global Advisory Committee on Vaccine Safety (GACVS) was established by:
a) US FDA
b) WHO
c) European Medicines Agency (EMA)
d) Centers for Disease Control and Prevention (CDC)

Answer: b) WHO

Q76. What is vaccination failure?

a) A vaccine not providing the expected protection
b) A vaccine causing mild side effects
c) A vaccine being recalled due to manufacturing defects
d) A vaccine being administered to the wrong age group

Answer: a) A vaccine not providing the expected protection

Q77. Primary vaccination failure occurs when:

a) The vaccine fails to generate an adequate immune response
b) The vaccine wears off over time
c) The vaccine is not stored properly
d) The patient refuses vaccination

Answer: a) The vaccine fails to generate an adequate immune response

Q78. Secondary vaccination failure is due to:

a) The immune response waning over time
b) Incorrect administration technique
c) Contaminated vaccine doses
d) Errors in patient identification

Answer: a) The immune response waning over time

Q79. Which factor can contribute to vaccination failure?

a) Improper storage conditions
b) Poor immune response in the individual
c) Incorrect vaccine administration
d) All of the above

Answer: d) All of the above

Q80. What does AEFI stand for?

a) Adverse Events Following Immunization
b) Adverse Effects of Food Intake
c) Acute Events of Fatal Infections
d) Autoimmune Events Following Infection

Answer: a) Adverse Events Following Immunization

Q81. The classification of AEFI includes:

a) Vaccine product-related reactions
b) Vaccine quality defect-related reactions
c) Coincidental events
d) All of the above
Answer: d) All of the above

Q82. Which of the following is an example of a minor AEFI?

a) Fever and pain at the injection site
b) Anaphylactic shock
c) Guillain-Barré syndrome
d) Seizures

Answer: a) Fever and pain at the injection site

Q83. A severe AEFI may include:

a) Persistent high fever
b) Seizures
c) Anaphylaxis
d) All of the above

Answer: d) All of the above

Q84. What is the most serious type of allergic reaction to a vaccine?

a) Rash
b) Mild fever
c) Anaphylaxis
d) Redness at the injection site

Answer: c) Anaphylaxis

Q85. Which global database is used to collect AEFI reports?

a) VigiBase
b) MedDRA
c) WHO-DD
d) FAERS

Answer: a) VigiBase

Q86. What is the role of the AEFI surveillance system?

a) Detect and assess vaccine safety issues
b) Stop vaccine distribution immediately
c) Promote a particular brand of vaccine
d) Replace all vaccines with alternative medicine

Answer: a) Detect and assess vaccine safety issues

Q87. Which of the following is an example of a passive surveillance system?

a) Spontaneous adverse drug reaction (ADR) reporting
b) Cohort studies
c) Randomized controlled trials (RCTs)
d) Sentinel surveillance

Answer: a) Spontaneous adverse drug reaction (ADR) reporting

Q88. What is the main limitation of spontaneous reporting in passive surveillance?
a) High cost
b) Underreporting of adverse drug reactions (ADRs)
c) Ethical concerns
d) Excessive regulation

Answer: b) Underreporting of adverse drug reactions (ADRs)

Q89. Case series in pharmacovigilance refer to:

a) A single patient's case report
b) A collection of similar case reports to identify patterns
c) A randomized control trial
d) A drug manufacturing process

Answer: b) A collection of similar case reports to identify patterns

Q90. Which of the following is an example of stimulated reporting?

a) Direct patient reporting
b) Prescription event monitoring (PEM)
c) Drug safety communication initiatives
d) Both b) and c)

Answer: d) Both b) and c)

Q91. Drug event monitoring (DEM) in active surveillance is primarily used to:
a) Track adverse events related to newly marketed drugs
b) Regulate drug pricing
c) Increase sales of pharmaceutical products
d) Conduct animal testing

Answer: a) Track adverse events related to newly marketed drugs

Q92. A cross-sectional study is best used for:

a) Studying the prevalence of a disease or ADR at a single point in time
b) Tracking long-term effects of drug use
c) Investigating rare ADRs
d) Conducting controlled drug trials

Answer: a) Studying the prevalence of a disease or ADR at a single point in time

Q93. A case-control study is used to:

a) Compare patients with and without an ADR to identify risk factors
b) Observe a single case over time
c) Monitor drug prescriptions in real time
d) Study only healthy volunteers

Answer: a) Compare patients with and without an ADR to identify risk factors

Q94. What is a cohort study?

a) A study that follows a group of individuals over time to assess outcomes
b) A randomized controlled trial
c) A case report about a single patient
d) A survey conducted on hospital staff

Answer: a) A study that follows a group of individuals over time to assess outcomes

Q95. Targeted clinical investigations are used in pharmacovigilance to:

a) Study specific safety concerns related to a drug
b) Develop new drugs
c) Conduct marketing research
d) Reduce drug prices

Answer: a) Study specific safety concerns related to a drug

Q96. Targeted clinical investigations focus on:

a) Identifying and confirming ADRs in specific populations
b) Randomly selecting drugs for safety testing
c) Replacing traditional clinical trials
d) Avoiding regulatory approvals

Answer: a) Identifying and confirming ADRs in specific populations

Q97. Effective communication in pharmacovigilance should be:

a) Clear, transparent, and evidence-based
b) Complex and technical to ensure confidentiality
c) Delayed to avoid panic
d) Limited to internal stakeholders only

Answer: a) Clear, transparent, and evidence-based

Q98. Which of the following is NOT a key stakeholder in pharmacovigilance

communication?
a) Regulatory agencies
b) Healthcare professionals
c) The general public
d) Illegal drug manufacturers

Answer: d) Illegal drug manufacturers

Q99. What is the best way to communicate pharmacovigilance findings to the general public?
a) Using scientific jargon
b) Publishing research papers only
c) Providing easy-to-understand safety alerts and guidelines
d) Keeping safety data confidential

Answer: c) Providing easy-to-understand safety alerts and guidelines

Q100. What is the first step in managing a drug safety crisis?

a) Ignoring public concerns
b) Identifying and assessing the severity of the issue
c) Withdrawing all drugs from the market immediately
d) Blaming healthcare professionals

Answer: b) Identifying and assessing the severity of the issue

Q101. In a drug safety crisis, communication should be:

a) Delayed until full investigation
b) Proactive, transparent, and fact-based
c) Kept confidential to avoid legal consequences
d) Managed only by pharmaceutical companies

Answer: b) Proactive, transparent, and fact-based

Q102. What is the primary role of regulatory agencies in pharmacovigilance?

a) Marketing pharmaceutical products
b) Ensuring drug safety and efficacy
c) Controlling drug pricing
d) Promoting brand-specific medications

Answer: b) Ensuring drug safety and efficacy

Q103. Which regulatory agency oversees drug safety in the United States?
a) WHO
b) US FDA (Food and Drug Administration)
c) EMA (European Medicines Agency)
d) CDSCO (Central Drugs Standard Control Organization)

Answer: b) US FDA (Food and Drug Administration)

Q104. When communicating with regulatory agencies, companies must:

a) Provide timely and accurate drug safety reports
b) Only share positive data
c) Delay reporting to avoid penalties
d) Communicate only through legal representatives

Answer: a) Provide timely and accurate drug safety reports

Q105. What is the most important factor in communicating safety concerns to business
partners?
a) Financial profitability
b) Accuracy, clarity, and regulatory alignment
c) Delayed communication to avoid legal issues
d) Avoiding disclosure of adverse effects

Answer: b) Accuracy, clarity, and regulatory alignment

Q106. Which of the following is an effective tool for communicating safety concerns with
healthcare facilities?
a) Drug safety newsletters
b) Scientific journals only
c) Social media influencers
d) Television advertisements

Answer: a) Drug safety newsletters

Q107. What is the biggest risk of ineffective communication with the media in a drug safety
crisis?
a) Public misinformation and panic
b) Increased drug sales
c) Regulatory approval delays
d) Reduced competition in the market

Answer: a) Public misinformation and panic

Q108. Which of the following is a best practice when engaging with the media regarding
drug safety issues?
a) Presenting clear, evidence-based facts
b) Avoiding all communication with journalists
c) Using only technical terminology
d) Waiting for legal action before making a statement

Answer: a) Presenting clear, evidence-based facts

Q109. What is the primary purpose of the preclinical phase in drug development?
a) To test the drug in human volunteers
b) To assess safety and efficacy in animals and laboratory models
c) To manufacture the drug for commercial use
d) To market the drug globally

Answer: b) To assess safety and efficacy in animals and laboratory models

Q110. Which of the following studies is NOT part of the preclinical phase?
a) Toxicology studies
b) Pharmacokinetic studies
c) Clinical trials on humans
d) Pharmacodynamic studies

Answer: c) Clinical trials on humans

Q111. What is the primary goal of toxicology studies in the preclinical phase?
a) To test drug pricing strategies
b) To determine the drug’s effectiveness in humans
c) To assess potential harm and safe dosage levels
d) To market the drug

Answer: c) To assess potential harm and safe dosage levels

Q112. What is the purpose of the clinical trial phase?

a) To evaluate the safety and efficacy of a drug in humans
b) To determine the cheapest way to manufacture the drug
c) To increase public awareness of the drug
d) To study the effects of the drug only in laboratory settings

Answer: a) To evaluate the safety and efficacy of a drug in humans

Q113. Phase 2 clinical trials primarily focus on:

a) Testing the drug’s effectiveness and short-term side effects in patients
b) Testing the drug only on animals
c) Large-scale marketing campaigns
d) Determining the drug’s shelf life

Answer: a) Testing the drug’s effectiveness and short-term side effects in patients

Q114. Which phase of a clinical trial involves a large population (typically thousands of
patients) to confirm the drug's safety and effectiveness before approval?
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4

Answer: c) Phase 3

Q115. A drug can only proceed to the post-approval phase (PMS) after successfully
completing which phase of clinical trials?
a) Phase 1
b) Phase 2
c) Phase 3
d) Preclinical phase

Answer: c) Phase 3

Q116. What is the primary goal of post-marketing surveillance (PMS)?

a) To track adverse drug reactions (ADRs) and long-term safety
b) To conduct new clinical trials on animals
c) To test the drug’s chemical composition
d) To increase the drug’s market price

Answer: a) To track adverse drug reactions (ADRs) and long-term safety

Q117. Which phase is also known as Phase 4 in drug development?

a) Preclinical testing
b) Post-marketing surveillance (PMS)
c) Phase 1 trials
d) Phase 3 trials

Answer: b) Post-marketing surveillance (PMS)

Q118. Why is post-marketing surveillance (PMS) necessary?

a) To identify rare or long-term adverse drug reactions
b) To speed up the drug approval process
c) To conduct marketing campaigns
d) To stop the production of new drugs

Answer: a) To identify rare or long-term adverse drug reactions

Q119. Which organization is responsible for monitoring post-marketing drug safety globally?
a) WHO (World Health Organization)
b) FDA (Food and Drug Administration)
c) EMA (European Medicines Agency)
d) All of the above

Answer: d) All of the above

Q120. The Pharmacovigilance Program of India (PvPI) primarily monitors:

a) The economic impact of drug sales
b) Adverse drug reactions (ADRs) in Indian patients
c) Drug patents and intellectual property rights
d) Manufacturing costs

Answer: b) Adverse drug reactions (ADRs) in Indian patients

Q121. Which of the following is a key tool used in post-marketing surveillance?

a) Spontaneous adverse drug reaction (ADR) reporting systems
b) Preclinical animal studies
c) Drug pricing regulations
d) Laboratory research on cells

Answer: a) Spontaneous adverse drug reaction (ADR) reporting systems

Q122. In pharmacovigilance studies, adherence to Good Clinical Practice (GCP) guidelines

ensures:
a) Ethical treatment of study participants
b) Manipulation of clinical data
c) Faster approval of unsafe drugs
d) Drug testing only in animals

Answer: a) Ethical treatment of study participants

Q123. Good Clinical Practice (GCP) guidelines ensure that:

a) Clinical trials are conducted ethically and scientifically sound
b) Drug companies can avoid reporting adverse events
c) Trials focus only on drug effectiveness, not safety
d) Studies are conducted only in high-income countries

Answer: a) Clinical trials are conducted ethically and scientifically sound

Q124. Which ICH guideline provides recommendations for pharmacovigilance planning?

a) ICH Q7
b) ICH E2E
c) ICH M1
d) ICH GCP

Answer: b) ICH E2E

Q125. What is the primary goal of pharmacovigilance planning?

a) To identify potential risks and implement risk minimization strategies for a drug
b) To develop pricing strategies for new drugs
c) To market new drugs without regulatory approval
d) To monitor drug sales

Answer: a) To identify potential risks and implement risk minimization strategies for a drug

Q126. Post-approval expedited reports must be submitted to regulatory agencies within:

a) 24 hours
b) 7 days
c) 15 days
d) 60 days

Answer: c) 15 days

Q127. How frequently should a PSUR be submitted during the first two years after drug
approval?
a) Every month
b) Every 6 months
c) Every 2 years
d) Every 5 years

Answer: b) Every 6 months

Q128. What is the purpose of Periodic Safety Update Reports (PSURs)?

a) To assess the benefit-risk balance of a drug at regular intervals
b) To replace clinical trials
c) To approve new drugs without regulatory review
d) To provide financial reports for pharmaceutical companies

Answer: a) To assess the benefit-risk balance of a drug at regular intervals

Q129. What is the primary purpose of an Individual Case Safety Report (ICSR)?
a) To document and report adverse drug reactions (ADRs) from individual patients
b) To provide a marketing strategy for new drugs
c) To conduct a cost analysis of a new drug
d) To summarize the manufacturing process

Answer: a) To document and report adverse drug reactions (ADRs) from individual patients

Q130. What does ICSR stand for in pharmacovigilance?

a) International Clinical Study Report
b) Individual Case Safety Report
c) Independent Clinical Safety Review
d) International Council for Safety Regulation

Answer: b) Individual Case Safety Report

Q131. In expedited reporting, how soon should a life-threatening or fatal ADR be reported to
regulatory agencies?
a) Within 24 hours
b) Within 7 days
c) Within 15 days
d) Within 30 days

Answer: c) Within 15 days

Q132. The ICH is a collaboration between regulatory agencies and the pharmaceutical
industry from which three major regions?
a) USA, Europe, and Japan
b) USA, India, and China
c) Europe, Africa, and South America
d) Australia, Canada, and UK

Answer: a) USA, Europe, and Japan

Q133. Which of the following ICH guidelines is primarily related to pharmacovigilance?

a) ICH M7
b) ICH E6
c) ICH E2E
d) ICH Q8

Answer: c) ICH E2E

Q134. What does ICH stand for in the context of pharmacovigilance?

a) International Council for Healthcare
b) International Conference on Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use
c) International Clinical Health Organization
d) Indian Council for Health

Answer: b) International Conference on Harmonisation of Technical Requirements for

Pharmaceuticals for Human Use

Q135. Genetic variations can affect pharmacokinetic parameters of a drug. Which of the
following pharmacokinetic processes can be influenced by genetic factors?
a) Absorption
b) Distribution
c) Metabolism
d) All of the above

Answer: d) All of the above

Q136. The pharmacokinetic parameter metabolism is primarily influenced by genetic
variations in:
a) Absorption receptors
b) Liver enzymes such as CYP450
c) Protein binding
d) Plasma volume

Answer: b) Liver enzymes such as CYP450

Q137. Which pharmacogenetic test is recommended before administering azathioprine to

avoid potential ADRs?
a) Testing for CYP2D6 polymorphism
b) Testing for TPMT (thiopurine methyltransferase) deficiency
c) Testing for CYP2C9 polymorphism
d) Testing for CYP3A4 polymorphism

Answer: b) Testing for TPMT (thiopurine methyltransferase) deficiency

Q138. Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a genetic disorder that

can cause severe hemolysis when a patient is exposed to:
a) Aspirin
b) Furosemide
c) Sulfonamides
d) Paracetamol

Answer: c) Sulfonamides

Q139. Which of the following drugs can cause adverse drug reactions in patients with
CYP2C19 poor metabolizers?
a) Omeprazole – Reduced metabolism and risk of toxicity
b) Aspirin – Increased risk of gastrointestinal bleeding
c) Methotrexate – Increased renal excretion
d) Ciprofloxacin – Increased absorption and therapeutic effect

Answer: a) Omeprazole – Reduced metabolism and risk of toxicity

Q140. Which of the following factors should be considered when evaluating drug safety in
pediatric populations?
a) Immature liver and renal function
b) Higher drug metabolism rates
c) Adult-like pharmacokinetics
d) Lack of need for dose adjustments

Answer: a) Immature liver and renal function

Q141. When assessing drug safety for pediatric patients, which pharmacokinetic factor is
often different from adults?
a) Higher volume of distribution due to higher body fat
b) Lower gastric pH in neonates and infants
c) Reduced renal excretion in older children
d) Increased plasma protein binding in infants

Answer: b) Lower gastric pH in neonates and infants

Q142. Which of the following categories on the FDA’s pregnancy category classification
system refers to drugs that have been shown to cause harm to the fetus but may still be used if
the benefits outweigh the risks?
a) Category A
b) Category B
c) Category C
d) Category D

Answer: d) Category D

Q143. Which of the following is the safest choice for drug use during pregnancy?
a) Drugs classified under Category C
b) Drugs that are lipophilic
c) Drugs classified under Category A
d) Drugs that are excreted in the urine

Answer: c) Drugs classified under Category A

Q144. Elderly patients are more prone to adverse drug reactions (ADRs) due to:
a) Increased cardiac output
b) Polypharmacy and altered drug metabolism
c) Higher body water content
d) Improved kidney function

Answer: b) Polypharmacy and altered drug metabolism

Q145. Which of the following drug classes is commonly associated with adverse drug
reactions in elderly patients?
a) Diuretics
b) Beta-blockers
c) Antidepressants
d) All of the above

Answer: d) All of the above

Q146. Which pharmacodynamic change is commonly observed in elderly patients?

a) Decreased sensitivity to the effects of sedatives
b) Increased sensitivity to anticoagulants
c) Increased tolerance to opioids
d) Decreased risk of gastrointestinal bleeding

Answer: b) Increased sensitivity to anticoagulants

Q147. What does CIOMS stand for in the context of pharmacovigilance?

a) Committee for the International Organization of Medical Services
b) Council for International Organization of Medical Sciences
c) Centralized International Organization for Medical Studies
d) Collaborative International Organization for Medical Safety

Answer: b) Council for International Organization of Medical Sciences

Q148. The CIOMS Working Groups primarily focus on:

a) Developing guidelines for drug formulation
b) Standardizing drug pricing across regions
c) Advancing the safety and regulatory aspects of pharmacovigilance
d) Promoting market access for new drugs

Answer: c) Advancing the safety and regulatory aspects of pharmacovigilance

Q149. CIOMS Working Group XI is focused on which aspect of pharmacovigilance?

a) Establishing guidelines for drug pricing
b) Improving pharmacovigilance systems in resource-limited settings
c) Standardizing clinical trial methodologies
d) Developing a database for preclinical research

Answer: b) Improving pharmacovigilance systems in resource-limited settings

Q150. What is the purpose of the CIOMS form in pharmacovigilance?

a) To collect information on drug pricing and distribution
b) To standardize adverse drug reaction (ADR) reporting
c) To gather data for drug marketing authorization
d) To evaluate the pharmacokinetics of a drug

Answer: b) To standardize adverse drug reaction (ADR) reporting

Q151. The CIOMS form for adverse drug reaction (ADR) reporting typically includes which
of the following fields?
a) Patient’s age, gender, and medical history
b) The price of the drug
c) The patient's previous medication regimen
d) The drug's country of origin

Answer: a) Patient’s age, gender, and medical history

Q152. Which of the following is NOT included in a standard CIOMS form for ADR
reporting?
a) Information on the suspected drug
b) A detailed analysis of the drug’s clinical efficacy
c) Description of the adverse event
d) Patient outcome

Answer: b) A detailed analysis of the drug’s clinical efficacy

Q153. The CIOMS form plays a crucial role in which of the following?
a) The development of new drug formulations
b) The monitoring of drug sales worldwide
c) The collection and reporting of adverse drug reactions
d) The regulation of drug patent laws

Answer: c) The collection and reporting of adverse drug reactions

Q154. Which of the following describes the CIOMS form's impact on pharmacovigilance?
a) It helps centralize ADR data for regulatory bodies
b) It provides guidelines on the legal distribution of drugs
c) It eliminates the need for clinical trials
d) It focuses only on clinical efficacy

Answer: a) It helps centralize ADR data for regulatory bodies

Q155. What does CDSCO stand for in the context of pharmacovigilance in India?
a) Central Drug Safety and Control Organization
b) Central Drug Standard Control Organization
c) Clinical Drug Safety and Control Organization
d) Centralized Drug Surveillance and Control Organization

Answer: b) Central Drug Standard Control Organization

Q156. What is the primary role of CDSCO in pharmacovigilance in India?

a) To regulate the pricing of pharmaceutical drugs
b) To monitor the quality and safety of drugs
c) To conduct clinical trials for new drugs
d) To promote the sale of pharmaceutical products in the market

Answer: b) To monitor the quality and safety of drugs

Q157. Which organization does the CDSCO work closely with to ensure drug safety in
India?
a) Indian Medical Association (IMA)
b) World Health Organization (WHO)
c) Ministry of Health and Family Welfare
d) Central Bureau of Investigation (CBI)

Answer: c) Ministry of Health and Family Welfare

Q158. What does Schedule Y of the Drugs and Cosmetics Act (D&C Act) primarily deal
with?
a) Drug pricing regulation
b) Clinical trials and drug approval processes
c) Post-marketing surveillance of drugs
d) The sale and distribution of medical devices

Answer: b) Clinical trials and drug approval processes

Q159. The Pharmacovigilance Program of India (PvPI) aims to:

a) Monitor and ensure the safety and efficacy of drugs only during clinical trials
b) Regulate drug manufacturing processes in India
c) Collect and analyze ADR data for the safety monitoring of marketed drugs in India
d) Monitor drug prices and control pharmaceutical marketing strategies

Answer: c) Collect and analyze ADR data for the safety monitoring of marketed drugs in
India

Q160. In global pharmacovigilance systems, what is a key regulatory body that India follows
in terms of safety monitoring?
a) European Medicines Agency (EMA)
b) Food and Drug Administration (FDA)
c) World Health Organization (WHO)
d) International Society for Pharmacoepidemiology (ISPE)

Answer: c) World Health Organization (WHO)