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Adverse drug reaction (ADR), Type I hypersensitivity, Type III…
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Type I hypersensitivity
immediate type, anaphylaxis
exposure to certain drugs e.g. aspirin, penicillin
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on re-exposure to the same drug, Ag-Ab reaction occurs on mast cell surface
release of mediators like histamine, prostaglandins, leukotrienes etc
hypotension, angioedema, anaphylactic shock, urticaria, asthmatic attack etc
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Type II hypersensitivity
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hemolytic anemia due to methyldopa, penicillin
Type A (Augmented)
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Side effects: These are unwanted pharmacological effects of drug
e.g. Atropine used to treat heart block also produces dryness of mouth and urinary retention etc
Secondary effects: The primary action of a drug may result in other effects
e.g. immunosuppression by corticosteroids lead to development of opportunistic infection
Toxic effects: The drug in overdoses or in toxic doses cause toxicity
Toxicity may also occur in usual doses, if used in hepatic or renal dysfunction
e.g. Nephrotoxicity due to aminoglycosides
Type IV hypersensitivity
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e.g. captopril, allopurinol
Signal
Signal generation implies detection of early warning signs of adverse effects and can be generated by all
the health professionals i.e. doctors, dentists, nursing staff and pharmacists
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As per WHO-UMC definition, a signal is reported information on a possible causal relationship between an adverse event and a drug,
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usually more than a single report is required to generate a signal
depending upon the seriousness of the event and the quality of the information
Adverse drug reaction
Drugs are used for the favorable response i.e. for benefit of patients
However, drugs also produce unfavorable (adverse) response called adverse drug reaction (ADR) or adverse effect
Definition: It can be defined as noxious, undesired, or unintended effect of a drug,
which may occur at doses normally in man for various purposes
prophylactic, therapeutic, and diagnostic
or for the modification of a physiological state
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Type C (Chronic use)
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e.g. Chloroquine retinopathy, Cushing's syndrome due to corticosteroids, analgesic nephropathy
Type D (delayed)
Occur long after stopping treatment, sometimes after years
e.g. Leukaemia following treatment of hodgkin's lymphoma with alkylating agents, teratogenic effects
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Adverse drug event
Any untoward medical occurence (symptom/disease/abnormal laboratory finding) that may present during treatment
in a patient or healthy volunteer with a pharmaceutical product (medicine)
but which doesn't necessarily have a causal relationship with the treatment
Type B (Bizarre)
These are non dose related unpredictable reactions to a drug
They are not related to pharmacological action of drug
Qualitative adverse effect
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Type E (end of use)
These effects are due to sudden discontinuation of a drug after prolonged use
e.g. angina with sudden withdrawal of atenolol
adrenal insufficiency after sudden cessation of glucocorticoids
Clonidine may lead to rebound hypertertension
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Pharmacovigilance
As per WHO definition (2002), Pharmacovigilance is the science and activities relating to
the detection, assessment, understanding and prevention of adverse effects or any other drug related problems
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