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NMU Sem. Examination Practice session for LY B.Pharm-09 [BP805T] organized by RCPIPER & RCPIOP Flashcards | StudBud
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NMU Sem. Examination Practice session for LY B.Pharm-09 [BP805T] organized by RCPIPER & RCPIOP
NMU Sem. Examination Practice session for LY B.Pharm-09 [BP805T] organized by RCPIPER & RCPIOP
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1
Question given in the below image
5
4
2
7
2
Medical Dictionary Regulatory Activities term abbreviation
MedD
MedDRA
MDRA
Mdra
3
Following is the method of Pharmacovigilance
Sentinel site
Active surveillance
Induced reporting
Online reporting
4
all are BASIC DRUG INFORMATION RESOURCES except
Primary resources
Secondary resources
Tertiary resources
Fourthary resources
5
Type of causality shows time relationship, rule out other treatment/disease, & respond to de-challenge & re-challenge?
Possible
Probable
Certain
Unlikely
6
This is Passive Surveillance method -
Drug event monitoring
Sentinel site
Registries
Spontaneous reports
7
It is a list of patients with the same characteristics useful in the active surveillance ofPharmacovigilance
Drug event monitoring
Sentinel sites
Case series
Registries
8
Which of following is 1st reported incidence of safety concern which prompted the inception of p'covigilance concept?
Thalidomide Tragedy
Death of the young girl Hannah Greener during chloroform anaesthesia
Aminoglycoside induced kidney toxicity incidence
Sulfanilamide in diethyl glycol Tragedy in US
9
_________________ is a serious ADR whose nature or severity is unexpected based on the applicable product information.
PSUR
Unexpected Adverse reaction
SUSAR
ADR
10
Question given in the image below
CDSCO
Drug Inspector
FDA
Department of Science and Technology
11
MED-DRA CODE
Unique number assigned to each term in the dictionary
All of the above
8 digit number
Starts with 10000001, initially started alphabeticall
12
Which of the following is not the class according to ATC 2nd level i.e.Therapeutic subgroup level of ATC classification?
Cardiovascular system
Antibacterial
Anti- Diabetic
Anti-thrombotic
13
Which of the following is not the Passive surveillance methods ofpharmacovigilance ?
Intensified reporting
Spontaneous reporting, Stimulated reporting & Intensified reporting all 3
Stimulated reporting
Spontaneous reporting
14
What is Pharmacovigilance
nalyze the risk, safety of medicin
Effects of drugs and mechanism of action
Role of the drug of Genome Response
Biochemical and physiological effect of drug
15
Sentinel system was launched by FDA in -
May 2010
April 2010
April 2008
May 2008
16
The most commonly adopted method for reporting of ADR is -
Spontaneous reporting
Expedited reporting
Suspected reporting
Longitudinal electronic patient records
17
Which of the following describes the extent to which the ADRs influence theeveryday life of the patients?
Severity
Medicine effect
Adverse drug reaction
Falsified drug effect
18
A nonproprietary name is also called
Official name
Approved name
Brand name
Generic name
19
What is the first step in management of ADR -
Dose reduction of drug causing ADR
Treatment of ADR
Withdrawal of suspected drug
Detection of ADR
20
Each MedDRA term is assigned a unique
5 digit
6 digi
8 digit
7 digit
21
For the chemical substance names are usually chosen except
BAN (British Approved Name)
USAN (United States Adopted Name)
IAN( Indian Approved Name )
The International Nonproprietary Name (INN)
22
Which of the following is considered in Causality assessment by the Naranjo scale?
A list of que. & scoring based on answers such as yes, no and do not know
Physician decision
Relationship with disease
Spontaneous reporting
23
Website of WHO for Pharmacovigilance is
Vigimel
Vigibase
Viginex
Vigimed
24
This is the type of registry -
Case registry
Disease registry
ADR registry
Case series
25
Who is responsible for WHO international drug monitoring Programme?
WHO drug dictionary
Uppsala monitoring centre
PVPI
Contract research Organization
26
To begin clinical research study it is mandatory to get approval from?
Sponsor
Regulator
ethics committee
Regulators and ethics committee
27
Which of the following database is maintained by UMC on behalf of World HealthOrganization?
Vigibase
General Practice Research Database (GPRD)
EudraVigilance
Motherisk
28
The Uppasala Monitoring Center is located in which of the following country?
Japan
China
Sweden
India
29
Anatomical Therapeutic Chemical (ATC) classification system 2nd level is
Chemical substance
Anatomical group
Clinical subgroup
Pharmacological or Therapeutic subgroup
30
MedDRA includes all of the following except
Toxicologic issues
Medical and surgical procedures
Patient demographic terms
Product quality issues
31
The Pharmacovigilance Programme of India (PvPI), coordinated by the IndianPharmacopeia Commission, is situated at
Ghaziabad
Calcutta
Jaipur
Mumbai
32
What is Pharmacovigilance
Effects of drugs and mechanism of action
Analyze the risk, safety of medicine
Role of the drug of Genome Response
Biochemical and physiological effect of drug
33
Which of the following is related with the ‘Module 3’ of the Pharmacovigilance program of India?
Submission of risk management plan
Audits and vigilance of pharmacovigilance systems at MAH’s organisation
Preparation and submission of Periodic safety report
Pharmacovigilance system master file
34
Question given in the image below
International non-proprietary Name (INN)
IUPAC
Vedic Name
Brand name
35
Which one of the following comprise primary drug information resource?
EMBASE and MEDLINE
Review and research articles
Major compendia
Clinical research study reports
36
A known limitation of spontaneous ADR reporting is:
Under reporting
Excess reporting
Spontaneous ADR reporting has no limitations
False reporting
37
Vaccine pharmacovigilance is defined as “the science and activities relating to the”
Detection
Assessment
All of the above
Understanding
38
the WHO Programme for International Drug Monitoring(IDM) is managed by
BMC
UMC
VMC
TMC
39
Which of the following is not the method of pharmacovigilance?
Active surveillance
Cohort Pharmacovigillance clinical studies
Passive surveillance
Preclinical Efficacy Evaluation
40
Targeted clinical investigations required -
IRB / ICE approval
FDA approval
IRB approval
IEC approval
41
WHO-ART has:
10 levels hierarchical structure
4 levels hierarchical structure
6 levels hierarchical structure
5 levels hierarchical structure
42
Aims of spontaneous reporting are -
To keep watch on event
Case studies
Adverse drug event
Benefit risk analysis
43
Sentinel meaning -
To keep watch for an event
Adverse drug event
Sponsor reporting
Adverse drug reaction
44
Question given in the image
Aminoglycoside induced kidney toxicity incidence
Tragedy of chloroform anaesthesia
Retrospective analysis of Incidences of Thalidomide Tragedy
Sulphanilamide in diethyl glycol Tragedy in US
45
Following is not a method of stimulated reposting
Prompt / induced reporting
Sponsor encouragement reporting
Offline reporting
Online reporting
46
Effective communication in pharmacovigilance occur between
Sponsor and FDA
Sponsor and Trainer
Sponsor and Head
Head and Trainer
47
Purpose of Eudravigilance
Medicinal product authorization information
All of the above
Pharmacovigilance information
To support the public health of EU
48
“MSSO” term full form is
Minimum and Support Service Organization
Mean and Support Service Organization
Maximum and Support Service Organization
Maintenance and Support Service Organization
49
Which of the following is not the aim of “Pharmacovigilance”?
Promote and market the medicinal product
Contribute to assess safety, harm and effectiveness of medicine
Improve patient care and safety
Promote understanding, clinical training and education of Pharmacovigilance
50
Which of the following is related with the ‘Module 1’ of the Pharmacovigilance program of India?
Pharmacovigilance system master file
Submission of risk management plan
Preparation and submission of Periodic safety report
Collecting, processing and reporting of individual case safety report
51
Pharmacovigilance programme of India was started by Govt of India on -
14th July 2010
10 June 2012
14th July 2012
10 June 2010
52
Drug and disease classification in pharmacovigilance contained
Daily defined doseS
All of the above
International classification of diseases
Anatomical, therapeutic and chemical classification of drugs
53
The objectives of PVPI includes
Adverse drug reaction
Monitoring the Patients
Patient counselling
Create national wide system for patient safety reporting
54
-- is an unintended failure in drug treatment process that leads to, or has the potential to lead to harm to the patient
Medicine effect
Falsified drug effect
Medication error
Adverse drug reaction
55
Question given in the below image
Japan
Londan
NewYork
Uppsala
56
A response to a medicinal product which is noxious and unintended is called as -----------------------
Falsified drug effect
Medication error
Medicine effect
Adverse drug reaction
57
Type of comparative observational studies is
Qualitative studies
Randomized controlled trials
Cohort studies
Test controlled studies
58
The first official European database for monitoring andanalysing the suspected adverse reactions to medicines?
Medvigilance
Eudravigilance
Europevigilance
Drugvigilance
59
What is considered at the ATC 3rd level of Anatomical Therapeutic ChemicalClassification?
Pharmacological subgroup
Anatomical groups
Chemical subgroup
Therapeutic subgroup
60
What is pre-term birth?
less than 32 completed weeks of gestation
less than 37 completed weeks of gestation
less than 34 completed weeks of gestation
less than 38 completed weeks of gestation
61
CROs stand for
Contract risk organizations
Controlled risk organizations
Contract research organizations
Controlled research organizations
62
ICH stands for –
International council on harmonization
The International Council for Harmonisation of Technical Requirements
Indian committee on harmonization
Internal conference on harmonization
63
Question given in below image
Observational studies
Survey based study
Phase IV clinical studies
Cohort studies
64
Which of the following is related with the Falsified medicinal product?
All three of above
False representation of source, including its mfg, its country of origin
False representation of name or its composition & strength of ingredients
False representation of identity, including its packaging and labelling
65
In which year India first time adopted the global standard level clinical trials in India?
1969
1996
2016
1989
66
The no of volunteers involved in vaccine phase I are -
<10
200 -300
20-80
1000-3000
67
What is specified by “A” in ATC code of Metformin (ATC code of Metformin:A10BA02)?
Alimentary tract and metabolism
Bigaunides
metformin
Diabetes
68
MedDRA is developed by
WHO
PCI
CDSCO
ICH
69
The functions of UMC are
Development of adverse reaction signals
Collecting, assessing and communicating information from member countries
Exchange information
Analyse data
70
Which of the following ICH guideline define the guidance on planning pharmacovigilance activities?
ICH 7A
ICH E2E
ICH 3A
ICH 7b
71
Naranjio scale method of causality assessment is -
Algebraic Method
Probabilistic method
Global introspection
Algorithmic method
72
In pharmacovigilance, a method of finding the relationship between drugsadministered & reported ADR is called as -----
causality assessment
Classification of ADR
Adverse reaction reporting
Medication error
73
Which of the following is the example of real incidents of Safety crises ofvaccination programs?
Tuberculosis following oral BCG
Impotency, deaths, due to COVID vaccine
Death after sulphanilamide elixir in diethyl glycol
Thalidomide crisis
74
EudraVigilance is which country medicinal product dictionary
Ecuadorb
Egyptc
Europed
Estonia
75
Question given in the below Image
Cohort study
Case control study
Cross sectional study
Spontaneous reporting
76
Which of the following is the eg of Rumours, poor science & overreaction related Safety crises of vaccination programs?
Vaccine-associated paralytic poliomyelitis
Impotency, deaths, due to COVID vaccine
Death after sulphanilamide elixir in diethyl glycol
Thalidomide crisis
77
---- is an adverse reaction, nature, severity or outcome of which is not consistent with the applicable product inform.
Unexpected Adverse reaction
ADR
PSUR
SUSAR
78
Perceived as adverse reactions, but may be visible signs of the non-serious immune response of the host after vaccine
Rash
Death
Fever
Anaphylactic reaction
79
MedDRA is actively developed and maintained
All of the above
Success depends on these activities
Evolves to meet needs of regulators, industry, other users
Two releases per year
80
Pharmacovigilance is related to which scientific disciplines except
Psychology
Immunology
Epidemiology
Toxicology
