Adverse Drug Reactions

2005-04-09T06:51:00.000-07:00

This article has been published by the International Biopharmaceutical Association http://www.ibpassociation.org/

The project is sponsored by KRC CRO and training services ( http://www.kriger.com/ ) and ClinQua CRO (http://www.clinqua.com/ )

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ADVERSE DRUG REACTIONS (ADRs)
ADRs are usually classified as mild (no antidote, therapy, or prolongation of hospitalization necessary); moderate (requires a change in drug therapy, although not necessarily cessation of the drug, and may prolong hospitalization or require special treatment); severe (potentially life-threatening, requires discontinuation of the drug and specific treatment of the adverse reaction); and lethal (directly or indirectly contributes to the death of the patient).
Dose-Related, Predictable Drug Reactions
Side effects are predictable pharmacologic effects that occur within therapeutic dose ranges and are undesired in the given therapeutic situation. Side effects may be useful under certain circumstances.
Overdosage toxicity is the predictable toxic effect that occurs with dosages in excess of the therapeutic range for a particular patient. It overlaps with side-effect toxicity to some extent, especially in drugs with a small therapeutic index. The severity of the reaction is usually dose-related.
Non-Dose-Related, Unpredictable Effects
Drug allergy: Allergic reactions depend on altered reactivity of the patient as a result of prior contact with a drug that functions as an antigen or allergen. They are not dose-related; the symptoms and signs that develop are determined by antigen-antibody interactions and are largely independent of the pharmacologic properties of the drug. Allergic reactions are not completely unpredictable; a careful clinical history may suggest at risk.
Idiosyncrasy is an imprecise term that has been used as a classification for unexpected and peculiar adverse reactions occurring in a small percentage of individuals exposed to a drug. Idiosyncratic reactions are not related to a drug's known pharmacologic effects and are not obviously allergic in nature. Idiosyncrasy has been defined by some as a genetically determined abnormal reactivity to a drug.

For more information on Clinical Research Career Training and Clinical Trials Services please contact Kriger Research Group at info@kriger.com or call (866) 757-9791 (USA and Canada) or + 1(416) 630-0038 (Internationally)

ADVERSE DRUG REACTIONS (ADRs)

2005-04-09T06:50:00.000-07:00

This article has been published by the International Biopharmaceutical Association www.ibpassociation.org

The project is sponsored by KRC CRO and training services ( www.kriger.com ) and ClinQua CRO (www.clinqua.com )

Start your Clinical Research Career Now

ADRs are usually classified as mild (no antidote, therapy, or prolongation of hospitalization necessary); moderate (requires a change in drug therapy, although not necessarily cessation of the drug, and may prolong hospitalization or require special treatment); severe (potentially life-threatening, requires discontinuation of the drug and specific treatment of the adverse reaction); and lethal (directly or indirectly contributes to the death of the patient).
Dose-Related, Predictable Drug Reactions
Side effects are predictable pharmacologic effects that occur within therapeutic dose ranges and are undesired in the given therapeutic situation. Side effects may be useful under certain circumstances.
Overdosage toxicity is the predictable toxic effect that occurs with dosages in excess of the therapeutic range for a particular patient. It overlaps with side-effect toxicity to some extent, especially in drugs with a small therapeutic index. The severity of the reaction is usually dose-related.
Non-Dose-Related, Unpredictable Effects
Drug allergy: Allergic reactions depend on altered reactivity of the patient as a result of prior contact with a drug that functions as an antigen or allergen. They are not dose-related; the symptoms and signs that develop are determined by antigen-antibody interactions and are largely independent of the pharmacologic properties of the drug. Allergic reactions are not completely unpredictable; a careful clinical history may suggest at risk.
Idiosyncrasy is an imprecise term that has been used as a classification for unexpected and peculiar adverse reactions occurring in a small percentage of individuals exposed to a drug. Idiosyncratic reactions are not related to a drug's known pharmacologic effects and are not obviously allergic in nature. Idiosyncrasy has been defined by some as a genetically determined abnormal reactivity to a drug.

For more information on Clinical Research Career Training and Clinical Trials Services please contact Kriger Research Group at info@kriger.com or call (866) 757-9791 (USA and Canada) or + 1(416) 630-0038 (Internationally)