Pharmacovigilance Notes
A Comprehensive Guide for Healthcare Professionals
1. Introduction to Pharmacovigilance
Pharmacovigilance (PV) is the science and practice of:
Detecting, assessing, understanding, and preventing adverse drug reactions
(ADRs) and drug-related problems.
Ensuring medicines remain safe and effective throughout their lifecycle.
Origin of the Term:
🔹 Pharmaco = Medicine
🔹 Vigilance = Watchfulness
Key Objectives of Pharmacovigilance:
Minimize harm while ensuring benefits outweigh risks.
Identify risks early, enabling regulatory actions such as dose adjustments, safety
warnings, or drug withdrawals.
2. Rationale for Pharmacovigilance
The Thalidomide Tragedy (1957-1961)
Thalidomide, a sedative used for morning sickness, caused severe birth defects in over
10,000 children. It also led to strict drug safety regulations, including pre-market testing
and post-market surveillance.
Why ADR Monitoring is Crucial
Over 70% of ADRs are preventable.
ADRs contribute significantly to hospital admissions and treatment failures.
, Regulatory agencies such as WHO, FDA, and NAFDAC enforce pharmacovigilance
measures to ensure public safety.
3. Importance of Pharmacovigilance
Pharmacovigilance Ensures:
Early detection of ADRs to prevent serious complications.
Monitoring drug interactions to avoid harmful combinations.
Safe drug use in special populations (pregnant women, children, elderly)
Improved patient adherence by managing side effects.
Regulatory decision-making, supporting authorities like NAFDAC.
Relevance in Antiretroviral (ARV) Therapy
ARVs are essential in HIV management but carry significant safety concerns.
ADRs and drug-drug interactions can impact treatment adherence and
effectiveness.
Regular monitoring helps detect toxicities, improve outcomes, and ensure safer
therapy choices.
4. Pharmacovigilance in a Clinical Setting
What Should Be Reported?
Serious ADRs (life-threatening, hospitalization, disability, congenital anomalies
Unexpected reactions, even if minor.
Increased frequency of known reactions.
Drug interactions (drug-drug, drug-food, drug-herbal).
Lack of efficacy, which may indicate counterfeit or substandard medicines.
Medication errors, including overdoses.
Who Should Report ADRs?
A Comprehensive Guide for Healthcare Professionals
1. Introduction to Pharmacovigilance
Pharmacovigilance (PV) is the science and practice of:
Detecting, assessing, understanding, and preventing adverse drug reactions
(ADRs) and drug-related problems.
Ensuring medicines remain safe and effective throughout their lifecycle.
Origin of the Term:
🔹 Pharmaco = Medicine
🔹 Vigilance = Watchfulness
Key Objectives of Pharmacovigilance:
Minimize harm while ensuring benefits outweigh risks.
Identify risks early, enabling regulatory actions such as dose adjustments, safety
warnings, or drug withdrawals.
2. Rationale for Pharmacovigilance
The Thalidomide Tragedy (1957-1961)
Thalidomide, a sedative used for morning sickness, caused severe birth defects in over
10,000 children. It also led to strict drug safety regulations, including pre-market testing
and post-market surveillance.
Why ADR Monitoring is Crucial
Over 70% of ADRs are preventable.
ADRs contribute significantly to hospital admissions and treatment failures.
, Regulatory agencies such as WHO, FDA, and NAFDAC enforce pharmacovigilance
measures to ensure public safety.
3. Importance of Pharmacovigilance
Pharmacovigilance Ensures:
Early detection of ADRs to prevent serious complications.
Monitoring drug interactions to avoid harmful combinations.
Safe drug use in special populations (pregnant women, children, elderly)
Improved patient adherence by managing side effects.
Regulatory decision-making, supporting authorities like NAFDAC.
Relevance in Antiretroviral (ARV) Therapy
ARVs are essential in HIV management but carry significant safety concerns.
ADRs and drug-drug interactions can impact treatment adherence and
effectiveness.
Regular monitoring helps detect toxicities, improve outcomes, and ensure safer
therapy choices.
4. Pharmacovigilance in a Clinical Setting
What Should Be Reported?
Serious ADRs (life-threatening, hospitalization, disability, congenital anomalies
Unexpected reactions, even if minor.
Increased frequency of known reactions.
Drug interactions (drug-drug, drug-food, drug-herbal).
Lack of efficacy, which may indicate counterfeit or substandard medicines.
Medication errors, including overdoses.
Who Should Report ADRs?
