21. Drug epidemiology and drug safety. Adverse drug reactions (ADRs). Classification, registration, clinical detection of ADRs. Flashcards
what is Pharmacoepidemiology
clinical pharmacology and epidemiology, which studies the use of and the effects of drugs in large numbers of people.
what is Pharmacoepidemiology used for
Studies of drug safety
Studies of drug utilization
Studies of drug induced birth defects
study medication errors
improving physician prescribing
Methods in pharmacoepidemiology
A DOSE
Spontaneous reporting- (yellow card scheme), most common
Observational studies
Experimental (interventional) studies
Descriptive studies-
Analytical study-
what is Spontaneous reporting- (yellow card scheme),
used to collect information on ADRs from healthcare professionals and patients.
3 stages;
collection of data,
analysis
feedback
advantages of spontaneous reporting
cheap
collects data from large populations
how do observational studies differ from exp
difference in study groups is created experimentally and outcomes are observed.
Observational studies- the differences in the study groups are only observed and analysed NOT created experimentally.
examples of observ studies
case-control studies
cohort studies.
what is analysed in Analytical study
relationships between health status and other variables
Descriptive studies- describe what?
occurrence of a disease (ADR) in a population.
what is an adverse drug event
unwanted medical event during rx w. a ddrug but isnt directly caused by the rx
adr
oxious and unintended response to a drug which occurs at normal doses
causal relationship expected
Unexpected ADR
an ADR whose a nature or severity is not compatible with the drug information or cannot be predicted from the characteristics of the drug
Side-effects
unwanted but unavoidable pharmacodynamic effects, occurring at therapeutic doses.
Secondary effects
indirect consequences of a primary action of the drug
Eg disbacteriosis due to broad spectrum antibiotics
types of ADR
Minor ADRs: no therapy, antidote or prolongation of hospitalization is required.
Moderate ADRs: Require change in drug therapy, specific treatment or prolong hospital stay by at least 1 day.
Severe ADRs: Potentially life threatening, cause permanent damage or require intensive medical treatment.
Lethal: Directly or indirectly contributes to death of the patient.
