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Classification of ADR

This document discusses various methods of classifying adverse drug reactions (ADRs). It describes the Type A and Type B classification proposed by Rawlins in 1981, which categorizes ADRs as either dose-dependent and predictable (Type A) or unpredictable and not dose-related (Type B). It then outlines several other classification systems, including those based on pharmacological mechanisms, predictability, and dose dependence. The document provides details on characteristics of different ADR types according to these various classification methods.

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0% found this document useful (0 votes)
217 views

Classification of ADR

This document discusses various methods of classifying adverse drug reactions (ADRs). It describes the Type A and Type B classification proposed by Rawlins in 1981, which categorizes ADRs as either dose-dependent and predictable (Type A) or unpredictable and not dose-related (Type B). It then outlines several other classification systems, including those based on pharmacological mechanisms, predictability, and dose dependence. The document provides details on characteristics of different ADR types according to these various classification methods.

Uploaded by

sai prasad
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Classification of ADR

Drug induced ADRS are classified on the basis of


1. Pharmacological mechanism, and
2. Their preventability.
This is relatively simple method of classification. It was proposed by Rawlins in the
year1981 and was widely accepted. According to this method, adverse drug reactions
(ADRs) are of
two types –
Type A and

Type B.
Characteristics of Type A effect are dose related and predictable. Most of the
predictable characteristics would be either understood before registration or before
marketing.
While Type B ADRS are not dose related, unpredictable and can be known after
marketing .
Predictable ADRs can be classified on the basis of:
Over doses ,
Adverse effects ,
Drug-drug interaction,
and Drug-disease interaction.
A B

DOSE RELATED NOT DOSE RELATED ,UNPREDICTABLE


,PREDICTABLE
Unpredictable ADRs may happen due to:
Intolerance
Allergy
Pseudo-allergy, and.
Idiosyncrasy.

However, there are other methods of classification of ADRs. These including


Type AType B classification are tabulated below.
Classification according to Rawlins is shown below

FEATURES TYPE A TYPE B


PHARMACOLOGY AUGMENTED STRANGE
PREDICTABLE YES NO
DOSE DEPENDENT YES NO
MORBIDITY HIGH LOW
MORTALITY LOW HIGH
Pharmacological classification according to Hess and
Rieder
Predictable dose dependent
OVER DOSE Toxic reaction to specific organ system due to excessive dose or
impaired excretion

ADVERSE EFFECTS Undesirable effects pharmacologic effects by mechanisms related


to the desired EFFECTS

DRUG DRUG Action of the drug on the effectiveness or toxicity of another drug
INTERACTIONS

DRUG DISEASE Some disease processes interfere with metabolism or action of a


INTERACTION drug
UnPredictable dose independent
INTOLERANCE OVERSTATED ,SOMETIMES DISABLING EFFECTS EVEN WHEN DRUG IS
GIVEN IN USUAL DOSES

IDIOSYNCRASY ABNORMAL REACTIONS TO A DRUG RELATED TO METABOLIC OR


ENZYME DEFICIENCY WHICH CAN BE GENETICALLY DETERMINED

ALLERGY REACTION IS SPECIFIC TO A GIVEN DRUG ,SEVERE , RECURRENT


AND IMMUNOLOGICALLY MEDIATED

PSEUDO ALLERGY CLINICALLY IT IS SIMILAR TO ALLERGIC REACTIONS, BUT INVOLVES


AN UNKNOWN IMMUNE MECHANISM
PHARMACOLOGICAL CLASSIFICATION ACCORDING
TO GRUCHALLA
TYPE OF ADRS
TYPE A REACTIONS:
PREDICTABLE (EXAMPLES)
OVER DOSE HEPATIC FAILURE WITH HIGH DOSE PARACETAMOL

SIDE EFFECTS SEDATION WITH ANTIHISTAMINES

SECONDARY DIARROEA WITH ANTIBIOTIC SUCH AS AMPICILLIN DUE TO


EFFECT ALTERATION OF GASTROINTESTINAL BACTERIAL FLORA

DRUG DISEASE TOXICITY OF THEOPHYLLINE IN PRESENCE OF ERYTHROMYCIN


INTERACTION THERAPY.
TYPE B REACTIONS
UNPREDICTABLE
INTOLERANCE TINNITUS WITH USE OF ASPIRIN

IDIOSYNCRATIC OCCURANCE OF ANEMIA WITH USE OF AN ANTIOXIDANT DRUG IN


REACTION PRESENCE OF GLUCOSE-6-PHOSPHATE DIHYDROGENASE DEFICIENCY

IMMUNOLOGICAL ANPHYLAXIS WITH PENCILLIN ADMINISTRATION.


HYPERSENSITIVITY
REACTIONS
PSEUDO- RADIO CONTRAST DYE REACTION
ALLERGIC
REACTION
PHARMACOLOGICAL CLASSIFICATION ACCORDING TO GHARAIBEH

FEATUERES TYPE 1 TYPE 2


SYNONYMS AUGMENTED,PREDICTA STRANGE,UNPREDICTAB
BLE,DOSE RELATED LE,ALLERGIC,DOSE
INDEPENDENT
MECHANISM UNDERSTOOD,PREDICTA POORLY UNDERSTOOD
BLE
SITE SAME SITE OF PRIMARY SITE OF ACTION IS NOT
DRUG ACTION RELATED
INCIDENCE HIGH(70%) LOW(30%)
MORBIDITY MILD SEVERE
MORTALITY LOW HIGH
CAUSES
PHARMCEUTICAL INCREASE AVAILABILITY DECOMPOSITION
DOSAGE FORM AT THE SITE OF PRODUCTS,ADDITIVES ,
ABSORPTION EXCIPIENTS
PHARMACOKINETICS AMOUNT OF DRUG LIBERATION OF
INCREASED AT THE ANABNORMAL
SITE OF ACTION DUE TO METABOLISM
ADME
A.RESPONSE OF ORGAN A.GENETIC
PHARMACODYNAMICS OR TISSUE INCREASED B.IMMUNOLOGIC
DUE TO INCREASED C.NEOPLASTIC
NUMBER OR SENSITIVITY D.TERATOLOGIC
RECEPTORS
B.HOMEOSTATIC
IMBALANCE
C.DISEASE STATE
REPRODUCIBILITY REPRODUCIBLE NOT REPRODUCIBLE
TREATMENT DOSE TO BE ADJUSTED TREATMENT TO BE
DISCONTINUED
PHARMACOLOGICAL CLASSIFICATION ACCORDING TO ROYER AND
STEPHENS

TYPE
CHARACTERSTICS
TYPE A Reactions that result from exaggerated pharmacological actions of a
(EXAGGERATED) drug given as normal therapeutic doses usually dose dependent.
Some referred to as Type 1

TYPE B Represents a new or novel response different from usual


(RARE) pharmalogical action- sometimes referred to as Type 2

TYPE C Adaptive changes, rebound phenomena, other long-term


(CHRONIC) effectsType

TYPE D Carcinogenesis, effects concerned with reproduction (impaired


(DELAYED) fertility teratogenesis (adverse effects on the fetus during early
stages pregnancy), adverse effects on the fetus during later stages
of pregnancy drug in breast milk.
PHARMACOLOGICAL CLASSIFICATION ACCORDING TO Wills AND Brown:

Type characterrstics
A Dose related, pharmacologically predictable, commonly improves withdrawal of
medicine
B Involves interaction with a microorganism, pharmacologically predictable
commonly improves after withdrawal of medicine.
C An irritant reaction, related to concentration of a drug

D Depends on the route of administration or nature of formulation , improves if the


medicine is withdrawn or route of administration is changed
E Begins when medicine is stopped or the dose is reduced, pharmacologically
predictable
F Occurs only in those genetically predisposed, improves if the medicine
withdrawn.
G
G Causes irreversible genetic damage.
H Requires activation of immune system, improves if the medicine is withdrawn

U Mechanism is not understood.


ACCORDING TO Edwards and Aronson in2000 the ADRs CAN BE CLASSIFIED AS:

Type Characterstics

A Related to dose

B Not related to dose

C Related to both dose and time

D Related to time

E Withdrawal related

F Unexpected failure of therapy


TYPE characterstics actions

ARONSON:
PHARMACOLOGICAL CLASSIFICATION ACCORDING TO EDWARDS
A (augmented) Pharmacological effects Withdrawal or
Dose related Dose reduction
Frequent
Predictable
Low mortality
B( Bizzare) Rare Withdrawal or
Unpredictable Avoid in the
Idosyncratic future
High mortality
C(Chronic) Rare Withdrawal
Cumulative dose (longer period )
D(delayed) Rare mostly dose realed ,
Sometimes only after
withdrawal
E(End of use) Rare or unpredictable Restart and
,rapid after withdrwal tapering
F(Failure) Frequently dose related Dose increase
:result of interactions effects
Co medication
G(genetic) Pharmacokinetics, Doses adjustment
pharmacodynamics

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