BP705T · Semester 7 · B.Pharm
Unit III — Adverse Drug Reactions
Pharmacovigilance
This study page introduces Adverse Drug Reactions in Pharmacovigilance (BP705T), B.Pharm Semester 7. Read the selected definitions and short notes below, then download the full unit PDF.
Topics in this unit
- Adverse Drug Reactions — Classification, Types, Mechanisms and Risk Factors
- ADR Monitoring, Assessment and Management
- Online Reporting Mechanisms, Databases and MedDRA
Definitions and short notes
Selected extracts from this unit’s notes. Download the full PDF below for the remaining topics and examples.
Adverse Drug Reaction (ADR)
An adverse drug reaction is any harmful and unwanted effect of a medicine that happens when the medicine is used at a normal, approved dose for prevention, diagnosis or treatment of a disease. Key points in this definition: (a) the effect is harmful, (b) it is unwanted — the patient did not take the drug for this effect, and (c) it happens at a normal dose, not because of an overdose or a mistake. This is the classic WHO definition of ADR.
Unit PDF · page 2
Adverse Drug Event (ADE)
An adverse drug event is any bad health event that happens while a patient is taking a medicine, but we are not sure whether the medicine caused it. So every ADR is an ADE, but not every ADE is an ADR. Example: a patient taking a blood pressure tablet has a headache. The headache is an ADE. If we later confirm the tablet caused the headache, it becomes an ADR.
Unit PDF · page 2
Download notes
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For education and exam preparation only, not medical advice or current regulatory guidance.