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Adverse drug reactions and its type|MBBS, Slides of Pharmacology
This document defines adverse drug reactions (ADR) and its types. It explains the criteria for causality assessment of ADR and the classification of severity, frequency, and reaction time. It also presents the Rawling-Thompson classification of ADR, which includes fixed dose eruptions, bizarre non-dose related, and genetic/immunological types. The document further discusses the dose-related (type A) and non-dose related (type B) ADR, their incidence, predictability, prevention, and treatment.
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2022/2023
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ADR - Definition
An adverse drug reaction is any response to the drug which is noxious & unintended and which occurs at doses used in man for prophylaxis, diagnosis or therapy or modification of physiological functions (WHO Technical Report No 498, 1972) excludes
- Drug overdosage
- Drug abuse
- Therapeutic error
- Therapeutic failure
Side Effects “Any unintended effect of pharmaceutical product occurring at doses normally used in man , which is related to pharmacological properties of the drug” Adverse Event “An unwanted medical occurrence that may present during treatment with pharmaceutical product but which does not necessarily have a causal relationship with this treatment”
Causality assessment of ADR
- Five criterias a. Laboratory test abnormality b. Reasonable time sequence to adminisration of a drug. c. Unlikely to be attributed to concurrent drug, chemical or disease. d. Dechallenge e. Rechallenge
Types of ADR
- Severity classification (1977- Velvett) Mild, Moderate, Severe
- Frequency classification Incidence 10%,1-10%,1%
- Reaction time classification Acute, Subacute, Latent
- RAWLING-THOMPSON CLASSIFICATION (1977)
Severity of ADR
Mild: No antidote No change in treatment No prolonged stay in hospital Moderate: May require change in treatment May require specific treatment May prolong stay in hospital Severe: Life threatening/ Permanent disability Discontinuation of drug is must Require specific treatment Lethal: Death directly/indirectly contributes to death
Fixed Dose Eruptions: Type B (Type II) Bizarre Non-dose related Unpredictable Serious, Rare Need stoppage of drug. Genetic/immunological
Types of ADR
Types of ADR
Dose related (type A) ❖ 95 % incidence ❖ predictable ❖ Extension & severity are related to conc. of drug ❖ Prevention and treatment by adjustment of dose insulin- hypoglycemia Non- dose related (type B) ❖ 5 % incidence ❖ unpredictable ❖ Usually qualitative change ❖ Prevention difficult; ❖ done by avoidance ❖ discontinuation SLE with hydralazine