FINAL YEAR UNIVERSITY EXAMINATION 2019-2020
Final Year B.Pharm. Semester VIII
SUBJECT-BPH_E_808_T-Pharmacovigilance
MULTIPLE CHOICE QUESTIONS: ANSWER KEY
SET 1
Q. No. Correct Option
1 A
2 A
3 C
4 A
5 B
6 B
7 A
8 D
9 B
10 A
11 D
12 D
13 D
14 C
15 D
16 C
17 D
18 B
19 B
20 C
21 B
22 C
23 C
24 A
25 C
26 D
27 A
28 A
29 B
30 B
31 D
32 C
33 B
34 C
35 B
FINAL YEAR UNIVERSITY EXAMINATION 2019-2020 (Regular Exam)
SUBJECT-BPH_E_808_T-PHARMACOVIGILANCE
SET 2
1. What is Pharmacovigilance
Ans:- C: Analyze the risk, safety of medicine
2. Who is responsible for WHO international drug monitoring Programme?
Ans :- A: Uppsala Monitoring Center
3. The functions of UMC are:
Ans :- D: Collecting, assessing and communicating information from member countries
4. The no of volunteers involved in phase I are -
Ans :- B: 20-80
5. CROs stand for:
Ans :- A: Contract research organizations
6. Pharmacovigilance programme of India was started by Govt of India on -
Ans :- B: 14th July 2010
7. The objectives of PVPI includes
Ans :- D: Create national wide system for patient safety reporting
8. Adverse drug reactions are
Ans :- B: Noxious and unintended response of drug at normal therapeutic dose
9. Type A adverse reactions are -
Ans :- C: Dose independent
10. Type B adverse reactions are -
Ans :- A: Dose independent
11. Delayed adverse reactions –
Ans :- B: Adverse event occurs after some time
12. Continuous drug use adverse reactions may be -
Ans :- A: Irreversible, unexpected
13. The most commonly adopted method for reporting of ADR is -
Ans :- C: Spontaneous reporting
14. What is the first step in management of ADR -
Ans :- C: Withdrawal of suspected drug
15. Management of ADR involves
Ans: - A: Symptomatic and specific treatment of suspected reaction
16. Naranjio scale method of causality assessment is -
Ans: - A: Algorithmic method
17. What is the meaning of highly probable ADR?
Ans :- B: If frequencies of ADR are more
18. Which one of the following in not true in infants, that may influence safety of drugs?
Ans: D: Less volume of distribution for hydrophilic drugs
19. Infants have lower renal clearance because:
Ans: B: GFR reaches adult levels by 2 years of age
20. A known limitation of spontaneous ADR reporting is:
Ans: A: Under reporting
21. Which of the following is special aspects of drugs in the elderly?
Ans: B: Increased hepatic metabolism capacity
22. Which of the following is not a possible pregnancy outcome?
Ans: D: Leukaemia
23. What is pre-term birth?
Ans: A: less than 37 completed
24. Following is the method of Pharmacovigilance
Ans :- B: Active surveillance
25. This is Passive Surveillance method -
Ans :- A: Spontaneous reports
26. Aims of spontaneous reporting are -
Ans :- B: Benefit risk analysis
27. Following is not a method of stimulated reposting
Ans :- C: Offline reporting
28. Sentinel meaning -
Ans :- B: To keep watch for an event
29. Sentinel system was launched by FDA in -
Ans :- B: May 2008
30. Type of comparative observational studies is
Ans :- C: Cohort studies
31. Targeted clinical investigations required -
Ans :- B: FDA approval
32. This is the type of registry -
Ans :- A: Disease registry
33. Which of the following is false about prescription event monitoring (PEM) -
Ans :-B: PEM is expensive to set up
34. WHO-ART has:
Ans: A: 4 levels hierarchical structure
35. Which one is proper description of term “Benefit-risk analysis”?
Ans: B: Examination of the favourable and unfavourable results of undertaking a specific
course of action.
36. What is an Attributable risk?
Ans: D: Difference between the risk in an exposed population (absolute risk) and the risk in
an unexposed population (reference risk)
37. What is full form of MedDRA
Ans: A: Medical Dictionary for Regulatory Activities
38. PV tools not used by UMC are
Ans: D: VigiPassTM
39. Which one of the following is High level term?
Ans: A: Peptic ulcer
40. Which of the following define Cohort studies?
Ans. B: Studies that identify defined populations and follow them forward in time, examining
their rates of disease.
41. Define Solicited reports
Ans. A: Those derived from organized data collection systems, which include clinical trials,
registries, post-approval named patient use programs, other patient support and disease
management programs, surveys of patients or healthcare providers, or information gathering
on efficacy or patient compliance
42. Type C adverse drug reaction are
Ans: C: A dose- and time-related reaction
43. Type E adverse drug reaction is
Ans: A: A withdrawal reaction
44. ICH stands for –
ANS :- A: The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use
45. ICH guidelines E6 is for -
ANS :- A: Good Clinical Practice
46. CIOMS is based in –
ANS :- C:Geneva
47. To date, there are ___CIOMS working groups
ANS :- B: 8
48. CDSCO is located in __
ANS :- B: New Delhi
49. D& C act was passed in -
ANS :- D: 1940
50. Indian Pharmacovigilance system is regulated by -
ANS :- B: CDSCO
