1.0 ADR Reporting and Management PDF
1.0 ADR Reporting and Management PDF
1.0 ADR Reporting and Management PDF
and Monitoring
K.Swapna
Introduction
Type A (Augmented)
Type B (Bizarre)
Newer Classification
Type A (Augmented)
Type B (Bizarre)
Type C (Continuous)
Type D (Delayed effects)
Predisposing Factors
Age
Gender
Polypharmacy
Multiple and intercurrent diseases
Race and genetics
Drug characteristics
Previous history of allergy / intolerance
Inappropriate dosing and prolonged therapy
Detection of ADRs
– Under reporting
– Reporting bias
• Doctors
• Dentists
• Pharmacists
• Nurses
• Consumer reporting is the need of the hour
Reporting - What should be the
minimum information ?
patient identity
description of reaction
exposure to the drug
temporal time relationship between the
exposure and the reaction
other possible causes (disease or concomitant therapy)
reporter’s identity
What to report ?
• Fatal reactions