ADVERSE DRUG REACTION

(ADR)

DIMAS ADHI PRADANA

DEFINITIONS
 ADVERSE DRUG REACTION

Any noxious change which is

Suspected to be due to a drug
At doses normally used in man
May requires treatment or decrease in dose
Caution in the future use of the same drug
 ADVERSE DRUG EVENT (ADE)
 ‘any untoward medical occurrence that may present
during treatment with a medicine but which does not
necessarily have a causal relationship with this treatment’.
The basic point here is the coincidence in time without any
suspicion of a causal relationship (WHO, 2005)

Injuries caused by medical interventions related to

a drug. Adverse drug events may result from
medication errors or from ADRs in which there was
no error (Bates)
 GRADING OF SEVERITY OF ADVERSE DRUG REACTIONS :

Minor : No therapy, antidote or prolongation of

hospitalization is required.

Moderate: Requires change in drug therapy, specific

treatment or prolongs hospital stay.

Severe. : Potentially life-threatening, causes permanent

damage or requires intensive medical treatment.

Lethal : Directly or indirectly contributes to death of the

patient.
PREVENTION OF ADVERSE EFFECTS TO DRUGS
◦ Avoid inappropriate use of drugs .
◦ Appropriate drug administration (Rational Therapeutics)
◦ Dose
◦ Dosage form
◦ Duration
◦ Route
◦ Frequency
◦ Technique
◦ Ask for previous history of drug reactions and allergies
◦ Always suspect ADR when new symptom arises after initiation of
treatment. ( No new drug for new symptom).
◦ Ask for laboratory findings like serum creatinine etc.
Determining Medicine Safety: Identifying and
Managing ADRs

Premarketing clinical trials

 Animal studies, human studies—Phases I, II, III
 Cannot identify ADRs with incidence < 1%
 Unproven ADRs listing for legal protection of manufacturer

Postmarketing surveillance
 Spontaneous reporting
 Postmarketing clinical trials—Phase IV
 Other methods—observational studies, meta-analysis, case reports
 Determining causality
 Actions taken to manage new ADRs
 Determining Causality of an ADR
Factors in determining causality
 STRENGTH of the ASSOCIATION
 CONSISTENCY of the OBSERVED EVIDENCE
 TEMPORALITY of the relationship
 ADR that occurs in association with a medicine does not mean the medicine is
responsible
 Delayed reactions do not rule out the medicine as causing the ADR
 DOSE-RESPONSE RELATIONSHIP
 CONFOUNDING FACTORS
Classifying Causality of an ADR: Naranjo Algorithm

Total the score to determine the category of the reaction. The categories
are defined as follows: Definite>9; Probable 5–8; Possible 1–4; Doubtful 0.
Reporting
Reporting