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The document is a quiz on pharmacovigilance consisting of 12 multiple choice questions. The questions cover topics such as regulatory authorities oversight of drug administration, post-marketing safety activities including risk management plans, using pharmacoepidemiology to study adverse drug reactions, costs of adverse effects, misconduct in scientific publications, assessing causality of drug reactions using Bradford Hill criteria, important issues to report to adverse event databases, and the definition of a medication error.

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105 views3 pages

VNBNB

The document is a quiz on pharmacovigilance consisting of 12 multiple choice questions. The questions cover topics such as regulatory authorities oversight of drug administration, post-marketing safety activities including risk management plans, using pharmacoepidemiology to study adverse drug reactions, costs of adverse effects, misconduct in scientific publications, assessing causality of drug reactions using Bradford Hill criteria, important issues to report to adverse event databases, and the definition of a medication error.

Uploaded by

didibutterfly
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Quiz: Quiz 1: Pharmacovigilance https://uppsala.instructure.

com/courses/24515/quizzes/20251/take

1 din 3 30.01.2021, 20:51


Quiz: Quiz 1: Pharmacovigilance https://uppsala.instructure.com/courses/24515/quizzes/20251/take

Fråga 5 2 poäng

Medicine regulatory authorities ususally regulate all aspects of drug administration including the prescribing of drugs by health professionals.

True

False

Fråga 6 2 poäng

Post marketing safety activities nowadays do not only consist of ADR reports and periodic safety update report (PSUR) for a new drug on the market.
It also includes a risk management plan for the drug.

True

False

Fråga 7 2 poäng

Pharmacoepidemiology is needed to study adverse drug reactions in large populations after marketing.

1. Cohort studies can give both absolute and relative risk.

2. Case-control studies only gives relative risks (odds ratio).

True

False

Fråga 8 2 poäng

The only cost for adverse effects is the increased hospitalisations

True

False

Fråga 9 2 poäng

Misconduct in scientific publications may involve plagiarism, fraud or fabrication.

True

False

Fråga 10 2 poäng

2 din 3 30.01.2021, 20:51


Quiz: Quiz 1: Pharmacovigilance https://uppsala.instructure.com/courses/24515/quizzes/20251/take

The case–causality assessment of drugs and adverse reactions is important issue in pharmacovigilance.

Which issues are of importance to consider according to the Bradford Hill criteria?

Dose-response relationship

Evidence in experimental animals

The route of administration of the drug

Specificity of the reaction – no other medicines or alternative conditions

Fråga 11 2 poäng

Mark the two most important issues to report to databases with spontaneous reports of adverse events in humans?

Reactions induced by new pharmaceutical drugs.

Unusually severe reactions.

Unexpected lack of effects.

Medications errors.

Abuse of medicines

Fråga 12 2 poäng

The term “Medication error” is when a treatment has failed, which leads to or has the potential to harm the user.

True

False

Inte sparad Lämna in quiz

3 din 3 30.01.2021, 20:51

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