Pharmacovigilance Flashcards
•Untoward medical occurrence or injury•Occurs during drug treatment•Does not necessarily have a causal relationship
Adverse Drug Event/Experience (ADE)
•A response to a drug that is noxious and unintended •Occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function
Adverse Drug Reaction (ADR)
•A negative or harmful patient outcome that seems to be associated with treatment, including there being no effect at all.
Adverse effect
Unintended but expected or known effect of a drug (not the intended therapeutic outcome)
Side effect
positive therapeutic effects of treatment in an individual;
Benefit
•a description of both positive and negative effects of a medicine and the likelihood of their occurrence, as far as they are known, as perceived by an individual.
Benefit-harm
A measure of the chances or odds (probability) of a medicine working positively as expected for patients.
Effectiveness
A measure of the extent to which a chemical substance or medicine works positively under laboratory conditions and in a selected group of patients.
Efficacy
A comparison of the statistical chances (probability) of a medicine working as expected and/or causing harm.
Effectiveness-risk
damage or injury that is or might be caused by a medicine, including death.
Harm
The intrinsic chemical or biological characteristics of a medicine or its use that have the potential to cause harm.
Hazard
An adverse event or reaction that results in death; requires hospitalization or extension of hospital stay; results in persistent or significant disability or incapacity; is life-threatening.
Serious
used to indicate intensity (as in severe headache)
Severe
Possible causal relationship between an adverse event and a drug
Signal
global ADR database
VigiBase
