Clinical research
Who are the primary reporters in Pharmacovigilance?
Healthcare professionals
Pharmaceutical sales representatives.
Patients without medical background.
Insurance companies.
What is the purpose of the Yellow Card in Pharmacovigilance?
To report suspected adverse drug reactions
To approve new drugs for the market
To certify pharmacists.
To track patient demographics.
What constitutes a serious adverse drug reaction?
An event that results in death or is life-threatening
A mild headache following medication intake
Temporary discomfort.
Common side effects of medications
How soon should serious reports be submitted in Pharmacovigilance?
As soon as possible, no later than 15 calendar days.
Once a year during annual review.
Only at the time of drug re-approval.
Within 5 years of the event.
What kind of drugs should have all suspected reactions reported, regardless of
severity?
severity?
New medicines.
Well-established medicines.
Over-the-counter medicines only
Herbal remedies only.
What additional roles do pharmacists have in Pharmacovigilance?
Stimulating reporting and providing additional information.
Prescribing medications.
Performing surgeries.
Designing drug formulas.
What should be included in a good case report according to Pharmacovigilance
guidelines?
guidelines?
Description of the adverse reaction, patient characteristics, and clinical course.
Marketing strategies for the drug.
Financial reports of the drug's sales.
Personal opinions about the drug's effectiveness.
Which of the following is an example of a Type E adverse drug reaction?
End-of-treatment effects.
Immediate allergic reactions.
Chronic toxicity.
Predictable pharmacologic effects
What is the minimum requirement for a case report to be valid in Pharmacovigilance
Completion of at least four sections of the reporting form.
Approval by a regulatory authority.
A minimum of ten reports on similar cases.
Confirmation of the reaction by laboratory tests.
Adverse drug reactions in which population should always be reported, regardless of the drug's licensing status?
Children under the age of 18.
Elderly over the age of 65.
Adults between 18 and 65.
Patients with chronic diseases only.
Which type of adverse drug reactions is known for being unpredictable and bizarre?
Type B effects.
Type A effects
Type C effects.
Type D effects.
What characterizes a Type C adverse drug reaction?
Chronic effects that increase the frequency of a spontaneous disease.
Immediate hypersensitivity reactions.
Effects only during drug withdrawal.
Predictable and dose-dependent reactions.
Which professionals are considered the preferred source for reporting in
Pharmacovigilance?
Pharmacovigilance?
Physicians and medical specialists.
Pharmaceutical marketing teams.
. Health insurance representatives.
. Drug manufacturing personnel.
Which report form is adapted from the international Yellow Card for reporting
suspected adverse drug reactions?
suspected adverse drug reactions?
Unified reporting form developed by EPVC.
Generic medical report forms.
. Internal hospital incident reports.
Consumer feedback forms
What is a serious reaction that should be reported if suspected in a patient?
Any reaction leading to death or life-threatening conditions
Common side effects like nausea or dizziness.
Expected reactions listed on the drug label.
Mild allergic reactions not requiring medical intervention.
For which of the following is an increased frequency of a given reaction suspected?
Established medicines.
Only new medicines.
Only over-the-counter medicines.
Only non-prescription drugs
What should be reported concerning medicine use in special conditions?
All suspected ADRs during pregnancy and lactation.
Only reactions resulting in hospitalization.
Reactions only from prescribed medicines.
Only non-serious ADRs
What is Pharmacovigilance according to WHO?
The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.
The study of drugs under experimental conditions.
A method for promoting pharmaceutical products.
The process of drug approval by regulatory authorities.
Why is post-marketing surveillance important in Pharmacovigilance?
It helps in detecting less common but serious ADRs
It is used only for gathering data on common drug effects.
It replaces the need for clinical trials.
It is only for tracking the sales of drugs.
What distinguishes an adverse drug reaction (ADR) from an adverse event?
An ADR has a suspected causal relationship with the medicinal product.
An adverse event always leads to hospitalization.
An ADR does not relate to the dosage used.
An adverse event is always preventable
What characterizes Type A adverse drug reactions?
They are dose-dependent and predictable.
They are rare and unpredictable.
They only occur in specific populations.
They are always serious.
Type B adverse drug reactions are best described as:
Bizarre effects, dose-independent and unpredictable.
Common and predictable reactions.
Always associated with long-term drug use
Effects that occur in every patient.
Which type of adverse drug reaction is known for chronic effects?
Type C effects.
Type A effects.
Type B effects.
Type D effects
What does Type D adverse drug reaction signify?
Delayed effects such as carcinogenicity.
Immediate hypersensitivity reactions.
Effects seen only during the drug's active use.
Adverse effects immediately after drug withdrawal.
What is the role of Individual Case Safety Report (ICSR)?
It provides the most complete information related to an individual case at a certain point of time.
It is used for initial drug approval processes.
It serves as a generic report for all similar cases.
It is only filed when a drug is discontinued
Pharmacovigilance is exclusively concerned with the efficacy of medications.
True
False
Post-marketing surveillance is crucial because the pre-marketing phase often has incomplete information about adverse drug reaction.
True
False
An adverse drug reaction (ADR) does not necessarily have a causal relationship with the medicinal product
True
False
Type A adverse drug reactions are unpredictable and not dose-dependent.
True
False
Type B reactions are also known as bizarre effects and can occur without any dose relationship.
True
False
Chronic effects from medication usage, referred to as Type C effects, are often
predictable and dose-dependent
predictable and dose-dependent
True
False
Type D adverse drug reactions include delayed effects such as carcinogenicity.
True
False
Individual Case Safety Reports (ICSR) are used to gather statistical data for marketing purposes.
True
False
Pharmacists play an essential role in stimulating the reporting of adverse drug
reactions
reactions
True
False
The Yellow Card is a reporting form used internationally by all healthcare providers and patients.
True
False
A serious adverse drug reaction always results in hospitalization
True
False
Serious adverse drug reaction reports must be submitted within 15 calendar days.
True
False
Only adverse drug reactions from new medicines need to be reported.
True
False
Healthcare professionals are the preferred source of information in
pharmacovigilance.
pharmacovigilance.
True
False
All elements of a case report, including patient initials, are mandatory for the report to be considered valid.
True
False
End-of-treatment effects are classified under Type E adverse drug reactions.
True
False
Reporting adverse drug reactions is mandatory only for prescription medications.
True
False
Adverse drug reactions occurring in children under the age of 18 should always be reported, regardless of the licensing status of the medicine.
True
False
Type B effects are common and dose-related.
True
False
Seriousness of an adverse drug reaction is determined only by its frequency of
occurrence.
occurrence.
True
False
Physicians and medical specialists are not considered primary reporters in
pharmacovigilance
pharmacovigilance
True
False
The unified reporting form used for pharmacovigilance was adapted from the
international Yellow Card.
international Yellow Card.
True
False
Only life-threatening or fatal reactions should be reported as serious adverse drug reactions.
True
False
Increased frequency of a given reaction should be reported for established medicines.
True
False
Suspected adverse drug reactions associated with drug-food interactions need not be reported
True
False
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