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ADVERSE DRUG REACTIONS
CONTENTS
•Definition of ADR
•Classification of ADR
•Detection of ADR
•Reporting of ADR
•Causality Assesment
•Prevention of ADRs
•Terminology of ADRs
Definition Of Adverse Drug Reactions
•According to WHO (1972)
“A response to a drug which is noxious and
unintended and which occurs at doses
normally used in man for prophylaxis,
diagnosis, or therapy of disease or for
the modification of physiologic
function”.
Classification of ADRs
Depending upon……
1)Type of reaction
•Type A
•Type B
•Type C
•Type D
•Type E
•Type F
Classification of ADRs
2)Onset of event:Acute(<60min)
Sub-acute (1-24 hrs)
Latent (>2 days)
Depending upon……
3Severity: Minor, Moderate, Severe,
Lethal ADRs.
TYPESOFREACTIONS
Augmented (Dose Related)
Bizzare (Non-Dose Related)
Chronic (Dose Related and
Time Related)
Delayed (Time Related)
End of Use (Withdrawal)
Failure (Unexpected Failure of
Therapy)
Augmented(doserelated)
Features
•Common Related to the pharmacologic action of
The drug – exaggerated pharmacologic response
•Predictable
•Low mortality
Example
•Dry mouth withTricyclic Antidepressants
•Respiratory Depression with Opioids
•Bleeding with Warfarin
Management
•Reduce Dose or Withhold Drug
•Consider effects of concomitant therapy
Bzzare(non-doserelated)
Features
•Uncommon
•Not related to the pharmacologic action of the
drug
•Unpredictable
•High mortality
Example
•Immunologic reactions: anaphylaxis to
penicillin
•Idiosyncratic reactions: malignant
hyperthermia with general anesthetics
Management
•Withhold and avoid in future
Chronic(dose&timerelated
Features
•Uncommon
•Related to the cumulative dose
Example
•Hypothalamic-pituitary-adrenal axis
suppression by corticosteroids.
•Osteonecrosis of the jaw with
bisphosphonates
Management
•Reduce dose or use an alternate day therapy
•withdrawal may have to be prolonged
Delayed(timerelated)
Features
•Uncommon
•Usually dose related
•Occurs or becomes apparent sometime after use
of the drug
Example
•Carcinogenesis
•Teratogenesis
•Tardive dyskinesia
•Leucopenia with lomustine
Management
•Often intractable
Endofuse(withdrawal)
Features
•Uncommon
•Usually dose related
•Occurs or becomes apparent sometime after use
of The drug
Example
•Carcinogenesis
•Teratogenesis
•Tardive dyskinesia
•Leucopenia with lomustine
Management
•Often intractable
Failure(unexpectedfailureoftheoropy)
Features
•Common
•Dose related
•Often caused by drug interactions
Example
•Inadequate dosage of an oral contraceptive
when used with an enzyme inducer.
•Resistance to antimicrobial agents
Management
•Increase dosage
•Consider effects of concomitant therapy
Accordingtoseverity
•Minor ADRs:
No therapy, antidote or prolongation of
hospitalization is required.
•Moderate ADRs:
Requires change in drug therapy, specific
treatment or prolongs hospital stay by
Atleast 1 day.
• Severe ADRs: Potentially life threatening,
causes permanent damage or requires
intensive medical treatment.
• Lethal: Directly or indirectly contributes to
death of the patient.
Monitoringadr
Detecting adverse drug
reaction(ADR).
Documentation of ADR
Reporting serious ADRs to pharmacovigilance centers
Assessing causality between drug and suspected
reaction
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adverse drug reaction.pptx