Pharmacovigilance Quiz: MCQs on ADR, Reporting, Yellow Card B.Pharmacy 8th Semester 2023 (2022-2023) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Multiple Choice Questions
Adverse Drug Reaction (ADR) and its reporting
By HK Technical PGIMS
1. What is an Adverse Drug Reaction (ADR)?
a) A beneficial response to a drug
b) An unexpected and harmful reaction to a drug
c) A common side effect of most drugs
d) An allergic reaction to a drug
2. Which organization is responsible for overseeing pharmacovigilance in the United
States?
a) WHO
b) FDA
c) EMA
d) MHRA
3. In the context of pharmacovigilance, what does "AE" stand for?
a) Adverse Effect
b) Adverse Event
c) Adverse Encounter
d) Adverse Experience
4. The Yellow Card System is used for reporting ADRs in which country?
a) United States
b) United Kingdom
c) Canada
d) Australia
5. Which of the following is NOT a common category of adverse drug reactions?
a) Type A (Augmented)
b) Type B (Bizarre)
c) Type C (Chronic)
d) Type D (Delayed)
6. Who can report an adverse drug reaction using the Yellow Card System in the UK?
a) Only healthcare professionals
b) Only patients
c) Both healthcare professionals and patients
d) Only pharmaceutical companies
7. Which organization is responsible for pharmacovigilance in the European
Union?
a) WHO
b) FDA
c) EMA
d) CDC
8. What is the primary purpose of pharmacovigilance?
a) To promote the sale of pharmaceuticals
b) To assess the cost-effectiveness of drugs
c) To monitor and improve the safety of medicines
d) To increase the speed of drug approvals
9. Which of the following is a common method for reporting adverse drug reactions
electronically?
a) Fax
b) Telegram
c) Yellow Card
d) Online forms
10. What is the role of the WHO in pharmacovigilance?
a) Conducting clinical trials for new drugs
b) Developing treatment guidelines
c) Coordinating global pharmacovigilance efforts
d) Regulating drug prices
11. Which phase of clinical trials is most likely to identify rare adverse drug
reactions?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
12. Which type of ADR occurs shortly after starting a drug and is dose-dependent?
a) Type A (Augmented)
b) Type B (Bizarre)
c) Type C (Chronic)
d) Type D (Delayed)
13. What is the primary purpose of the Yellow Card System?
a) To recommend the use of specific drugs
b) To collect information on adverse drug reactions
c) To provide medical advice to patients
d) To promote over-the-counter drug sales
14. What information should be included in an ADR report to the Yellow Card System?
a) Only the patient's name
b) Only the name of the drug
c) Detailed information about the ADR, the drug, and the patient
d) Only the healthcare professional's contact information
15. In pharmacovigilance, what does the term "signal" refer to?
a) A traffic signal near a pharmaceutical facility
b) A potential safety concern arising from data on a drug's side effects
c) A secret code used by pharmaceutical companies
d) A medical emergency
16. Which of the following is an example of a Type B (Bizarre) adverse drug reaction?
a) Nausea and vomiting from chemotherapy
b) Anaphylactic shock after taking a medication
c) Dry mouth as a side effect of antihistamines
d) Weight gain from a corticosteroid
17. What is the purpose of post-marketing surveillance in pharmacovigilance?
a) To approve new drugs for the market
b) To monitor the safety of drugs after they are approved
c) To promote the use of generic medications
d) To conduct clinical trials
18. Which of the following is NOT a responsibility of healthcare professionals in
pharmacovigilance? a) Reporting ADRs to regulatory authorities
b) Monitoring patients for potential ADRs
c) Promoting the sale of specific drugs
d) Educating patients about medication safety
19. Who typically initiates the recall of a drug from the market due to safety
concerns?
a) Patients
b) Healthcare professionals
c) Regulatory authorities
d) Pharmaceutical companies
20. Which regulatory authority is responsible for pharmacovigilance in
Canada?
a) WHO
b) FDA
c) EMA
d) Health Canada
21. What term is used to describe an adverse drug reaction that is caused by a medication's
known pharmacological properties and can be predicted based on its mechanism of
action?
a) Type A (Augmented)
b) Type B (Bizarre)
c) Type C (Chronic)
d) Type D (Delayed)
22. Which of the following is a characteristic of Type D (Delayed) adverse drug reactions?
a) They occur shortly after drug administration.
b) They are typically dose-dependent.
c) They may take months or years to manifest.
d) They are predictable and well-documented.
23. Which organization in the United States manages the Vaccine Adverse Event Reporting
System (VAERS)?
a) CDC (Centers for Disease Control and Prevention)
b) WHO (World Health Organization)
c) FDA (U.S. Food and Drug Administration)
d) NIH (National Institutes of Health)
24. What is the primary objective of the Vaccine Adverse Event Reporting System
(VAERS)?
a) To promote the sale of vaccines
b) To assess vaccine efficacy
c) To monitor and collect data on vaccine-related adverse events
d) To distribute vaccines to healthcare providers
25. Which of the following is an example of a serious adverse drug reaction?
a) Mild headache
b) Temporary skin rash
c) Nausea and vomiting
d) Severe allergic reaction (anaphylaxis)
26. What term is used to describe an adverse drug reaction that occurs at doses normally
used in humans for therapeutic purposes?
a) Toxic reaction
b) Allergic reaction
c) Idiosyncratic reaction
d) Hypersensitivity reaction
27. In the context of the Yellow Card System, what information should be included in the
"Description of Reaction" section when reporting an ADR?
a) Only the patient's age and gender
b) Only the name of the drug
c) Detailed information about the ADR and its effects on the patient
d) The patient's contact information
28. Which healthcare professional is primarily responsible for reporting ADRs to
pharmacovigilance authorities?
a) Physicians
b) Nurses
c) Pharmacists
d) All of the above
29. In the Yellow Card System, what is the significance of providing the batch number and
expiration date of the drug when reporting an ADR?
a) It helps identify the patient.
b) It ensures reimbursement for the patient.
c) It helps track potentially faulty batches of drugs.
d) It is not necessary for ADR reporting.
30. What is the primary purpose of signal detection in pharmacovigilance?
a) To signal healthcare providers about new drug approvals
b) To identify previously unrecognized adverse drug reactions
c) To promote the sale of specific drugs
d) To determine drug prices
31. Which of the following is an example of a medication error that could result in an adverse
drug reaction?
a) Administering the correct medication at the prescribed dose
b) Administering the medication via the correct route
c) Administering the wrong medication to the patient
d) Informing the patient about potential side effects
32. What is the purpose of the MedWatch program in the United States?
a) To regulate the sale of over-the-counter drugs
b) To monitor and report adverse events related to drugs and medical devices
c) To promote the sale of dietary supplements
d) To conduct clinical trials for new drugs
33. Which of the following is NOT typically included in an ADR report submitted through the
MedWatch program?
a) Patient's medical history
b) Contact information for the healthcare provider
c) Description of the adverse event
d) Patient's social security number
34. In the Yellow Card System, what is the role of pharmaceutical companies in ADR
reporting?
a) They report ADRs on behalf of healthcare providers.
b) They are solely responsible for ADR reporting.
c) They do not have a role in ADR reporting.
d) They provide treatment recommendations to patients.
35. Which of the following statements about pharmacovigilance in clinical trials is true?
a) Adverse drug reactions in clinical trials are not reported.
b) Clinical trials are not subject to pharmacovigilance regulations.
c) Pharmacovigilance in clinical trials is essential to assess drug safety.
d) Only serious adverse drug reactions are reported in clinical trials.
36. Which phase of the Yellow Card System involves the evaluation and assessment of ADR
reports to determine potential safety concerns?
a) Data Entry
b) Data Analysis
c) Data Collection
d) Data Dissemination
37. What is the primary goal of the WHO's international pharmacovigilance program?
a) To regulate the sale of drugs worldwide
b) To promote the use of traditional medicine
c) To enhance global drug access
d) To ensure the safe and effective use of medicines worldwide
38. What term is used to describe an adverse drug reaction that occurs as a result of
individual patient characteristics and cannot be predicted based on the drug's properties?
a) Type A (Augmented)
b) Type B (Bizarre)
c) Type C (Chronic)
d) Type D (Delayed)
39. Which of the following is a responsibility of healthcare professionals in
pharmacovigilance? a) Manufacturing drugs
b) Promoting specific drug brands
c) Educating patients about ADR reporting
d) Setting drug prices
40. What is the primary purpose of the "Yellow Card" itself in the Yellow Card System?
a) To provide medication instructions to patients
b) To serve as a prescription for controlled substances
c) To serve as a reporting tool for ADRs
d) To indicate drug expiration dates
Answers:
1. b) An unexpected and harmful reaction to a drug
2. b) FDA
3. b) Adverse Event
4. B) United Kingdom
5. C) Type C (Chronic)
6. C) Both healthcare professionals and patients
7. C) EMA
8. C) To monitor and improve the safety of medicines
9. D) Online forms
10. C) Coordinating global pharmacovigilance efforts
11. C) Phase III
12. A) Type A (Augmented)
13. B) To collect information on adverse drug reactions
14. C) Detailed information about the ADR, the drug, and the patient
15. B) A potential safety concern arising from data on a drug’s side effects
16. B) Anaphylactic shock after taking a medication
17. B) To monitor the safety of drugs after they are approved
18. C) Promoting the sale of specific drugs
19. C) Regulatory authorities
20. D) Health Canada
21. A) Type A (Augmented)
22. C) They may take months or years to manifest.
23. A) CDC (Centers for Disease Control and Prevention)
24. C) To monitor and collect data on vaccine-related adverse events
25. D) Severe allergic reaction (anaphylaxis)
26. A) Toxic reaction
27. C) Detailed information about the ADR and its effects on the patient
28. D) All of the above
29. C) It helps track potentially faulty batches of drugs.
30. B) To identify previously unrecognized adverse drug reactions
31. C) Administering the wrong medication to the patient
32. B) To monitor and report adverse events related to drugs and medical devices
33. D) Patient’s social security number
34. A) They report ADRs on behalf of healthcare providers.
35. C) Pharmacovigilance in clinical trials is essential to assess drug safety.
36. B) Data Analysis
37. D) To ensure the safe and effective use of medicines worldwide
38. C) Type C (Chronic)
39. C) Educating patients about ADR reporting
40. C) To serve as a reporting tool for ADRs