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WorksheetsQuiz Competition. Title: Know The Drug & Know The ADR
Total questions: 40
Worksheet time: 13mins
Uppsala Monitoring Centre (UMC) UMC was established in Uppsala, ________ in the year_______ as the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring
Swedan,1979
Switzerland, 1978
Swedan, 1978
Switzerland, 1979
Who is the Canadian-American pharmacologist and physician was a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety.
Darrell R. Abernethy
Frances Oldham Kelsey
Charles Antzelevitch
Margaret Georgia Kelly
The Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safeguard the health of _____billion people of India
2.0
2.5
1.27
1.29
In which year, PvPI- Indian Pharmacopoeia Commission (IPC), in Ghaziabad, India, became a WHO Collaborating Centre?
2017
2011
2016
1978
With which three Collaborating centers the WHO Pharmacovigilance team works?
Pharmacovigilance roche, Uppsala Monitoring centre, Pharmacovigilance Program of India
Uppsala Monitoring centre, Pharmacovigilance Program of India, Global Pharmacovigilance
Pharmacovigilance roche, Uppsala Monitoring centre, Global Pharmacovigilance
Uppsala Monitoring centre, Centre Anti poison et de Pharmacovigilance du Maroc, Pharmacovigilance Program of India
What are the various causality assessment categories?
certain, possible, probable/likely, unlikely, conditional, and unassessable
certain, possible, probable/likely, conditional, unlikely, and unassessable
certain, probable/likely, possible, unlikely, conditional, and unassessable
certain, possible, probable/likely, unlikely, unassessable, and conditional
SUSAR: What does that mean?
Suspected Unwanted Serious Adverse Reaction
Suspected Unexpected Serious Adverse Reaction
Serious Unexpected Suspected Adverse Reaction
Serious Unwanted Suspected Adverse Reaction
Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of
pharmacovigilance
Marketing Authorisation Holders
Competent Authorities of medicinal products
All the above
What is the Minimum Criterion Required For A Valid Case?
An identifiable patient
A suspect product
An identifiable reporter
An adverse drug event
Explain the Hierarchy In Meddra?
System Organ Class (SOC)
High Level Term (HLT)
High Level Group Term (HLGT)
Lower Level Term (LLT)
PV tools not used by UMC are
VigiFlowTM
VigiSearchTM
VigiMineTM
VigiPassTM
What role does Pharmacovigilance play in Medical Affairs?
The Robin Hoods of the Pharma world
Dealing with negligent behavior during clinical drug trials
Dealing with the enforcement of restrictions by the FDA during clinical trials
Dealing with reports of adverse events in patients during clinical trials
In the case of disaster, which of the following is not part of a contingency plan?
data backup
indemnification policy
emergency mode operation
disaster recovery
Within Medical Affairs, what is the role of Medical Communications?
Medical Communications is responsible for communicating unbiased non-promotional information, the company's products.
Medical Communications is responsible for disseminating information that supports the positive outcomes of the company's products.
Medical Communications acts as a relay centre between Medical Affairs and the outside world, performing triage and routing calls from healthcare professionals and patients
Medical Communications is responsible for the brand messaging and marketing materials for a new product
Council for International Organizations of Medical Sciences (CIOMS) Constituted in the year
1948
1949
1947
1950
Adverse effect(s) of laxatives
Dehydration
Spastic colitis with stimulant laxatives
Gastrointestinal obstruction with bulk forming agents
Electrolyte disturbances (hypernatremia, hypokalemia)
All of these options
Grey baby syndrome occurs with which of the following drugs?
Doxycycline
Penicillin
Clarithromycin
Chloramphenicol
Reversible Oligospermia is assoicated with which of the following drugs?
Methotrexate
Sulfasalazine
Spironolactone
Cimetidine
Hydrocortisone
Which of the following are Type IV hypersensitivity reactions?
Chrons disease
Asthma
Chrons disease and Rhematioid arthritis
Rhematioid arthritis
Asthma and Rhematioid arthritis
Which one of the following drugs is least likely to cause drug induced blood dyscrasia or agranulocytosis?
Clozapine
Methotrexate
Aminosalicylates such as sulfasalazine
Phenytoin
Carbimazole
Which of these drugs causes Reye’s syndrome?
Acetaminophen
Ibuprofen
Aspirin
Tramadol
Hypothyroidism, diabetes insipidus, and weight gain are known side effects of which of these drugs?
Pioglitazone
Lithium
Risperidone
Levothyroxine
“shake and bake reaction” is a response to the administration of which of these drugs?
Flucytosine
Ketoconazole
Amphotericin B
Caspofungin
Which of these drugs is known to cause “hand-foot syndrome”?
Busulfan
Cyclophosphamide
Irinotecan
Capecitabine
Tendon rupture / damage is a known side effect of which antimicrobial drug class?
Fluoroquinolones
Aminoglycosides
Oxazolidinediones
Macrolides
Which of these drugs can cause a black tongue?
Carbocisteine
Bismuth subgallate
Senna
Loperamide
Which of the following drugs causes xanthopsia?
Digoxin
Nilotinib
Everolimus
Warfarin
Haloperidol causes Extrapyramidal effects. What type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
Warfarin causes Bleeding, what type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
Which is NOT the cause of IgE-mediated Hypersensitivity reaction?
Increased Vascular Permeability
Bronchoconstriction
Urticaria
Angiospasm
Amiodarone prolonged exposure leads to pulmonary fibrosis what type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
Amlodipine causes Ankle swelling, what type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
Which one of the following is NOT the Type C ADR reaction?
NSAIDs – Analgesic nephropathy
Dapsone – pneumonitis
Steroids – Osteoporosis
Amiodarone – Pulmonary fibrosis
Which one of the following is Type D ADR reaction?
Prazosin – Hypotension
Antipsychotics – Tardive dyskinesia
Anticonvulsant – Hypersensitivity
Steroid withdrawal – adrenocortical insufficiency
Which one of the following is Type E ADR reaction?
Prazosin – Hypotension
Antipsychotics – Tardive dyskinesia
Anticonvulsant – Hypersensitivity
Steroid withdrawal – adrenocortical insufficiency
Which one of the following is Type A ADR reaction?
Penicillin - anaphylaxis
Anticoagulants – bleeding
Paracetamol - hepatotoxicity
Steroid withdrawal – adrenocortical insufficiency
Which one of the following is Type B ADR reaction?
Penicillin - anaphylaxis
Anticoagulants – bleeding
Paracetamol - hepatotoxicity
Steroid withdrawal – adrenocortical insufficiency
Which is not the drug and its effect that was discovered from ADR?
Minoxidil – Hair growth
Vincristine – Lymphocytic leukaemia
Sulfonylureas – Hypoglycemia
Acetazolamide – Diuresis
Furosemide, Loop diuretic casues dehydration, what type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
Temazepam induces daytime drowsiness. What type of ADR reaction is this?
Type A (Augmented)
Type B (Bizairre)
Type C (Chronic)
Type D (Delayed)
