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Here's a complete note with an introduction and broad classification of AEFI, suitable
for exam or assignment use:
Adverse Events Following Immunization (AEFI)
Introduction:
An Adverse Event Following Immunization (AEFI) is defined by the World Health
Organization (WHO) as “any untoward medical occurrence which follows immunization and
does not necessarily have a causal relationship with the usage of the vaccine.”
AEFIs can range from minor side effects like fever or pain at the injection site to more severe
reactions such as anaphylaxis. Monitoring AEFI is crucial for:
Ensuring vaccine safety
Identifying potential problems early
Sustaining public confidence in immunization programs
Broad Classification of AEFI
AEFIs are broadly classified into five categories:
1. Vaccine Product–Related Reaction
o Caused by the inherent properties of the vaccine itself.
o Example: Mild fever after DPT vaccine, anaphylaxis due to measles vaccine.
2. Vaccine Quality Defect–Related Reaction
o Results from a defect in the manufacturing process, storage, or transport of the
vaccine.
o Example: Contaminated vaccine causing local infection.
3. Immunization Error–Related Reaction (Programmatic Error)
o Occurs due to mistakes in vaccine preparation, handling, storage, or
administration.
o Example: Abscess at the injection site due to non-sterile technique.
4. Immunization Anxiety–Related Reaction
o Caused by fear or stress related to the act of vaccination rather than the vaccine
itself.
o Example: Fainting (vasovagal syncope), hyperventilation.
5. Coincidental Event
o An event that happens after immunization but is unrelated to the vaccine or
immunization process.
o Example: Onset of epilepsy after vaccination, but due to an underlying
neurological disorder.
Conclusion:
AEFI surveillance and reporting systems help in identifying and managing risks associated with
vaccines. A prompt investigation of serious AEFIs is vital for maintaining the safety and
effectiveness of immunization programs globally.
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Pharmacovigilance Programme of India (PvPI)
Introduction:
The Pharmacovigilance Programme of India (PvPI) was launched by the Ministry of Health
and Family Welfare, Government of India in July 2010. It aims to monitor, detect, assess, and
prevent adverse drug reactions (ADRs) in the Indian population, ensuring drug safety and
improving patient care.
Objectives of PvPI:
To monitor ADRs of medicines used in India.
To identify and minimize the risks associated with pharmaceutical products.
To support regulatory decisions and policies related to drug safety.
To promote rational and safe use of medicines in India.
To generate evidence-based data for formulating guidelines on drug use.
Organization of PvPI:
1. National Coordination Centre (NCC):
o Located at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
o Coordinates all PvPI activities across India.
o Functions under the guidance of the Central Drugs Standard Control
Organization (CDSCO).
2. Adverse Drug Reaction Monitoring Centres (AMCs):
o PvPI operates through a network of over 500 AMCs established in medical
colleges, hospitals, and research institutions across India.
oAMCs collect ADR reports from healthcare professionals and forward them to the
NCC.
3. Data Management:
o ADRs are collected using Suspected ADR Reporting Forms.
o Reports are entered into VigiFlow, a web-based tool developed by the Uppsala
Monitoring Centre (UMC), Sweden.
o India contributes data to the WHO global database (VigiBase).
Key Activities under PvPI:
Training and sensitization of healthcare professionals on ADR reporting.
Promoting patient safety and pharmacovigilance awareness.
Signal detection and risk assessment of drug-related problems.
Collaboration with regulatory authorities for necessary action (e.g., label changes, drug
recall).
Conclusion:
The Pharmacovigilance Programme of India plays a vital role in ensuring drug safety and
public health. By actively involving healthcare professionals, institutions, and patients, PvPI
strengthens the national framework for monitoring adverse drug reactions and supports safe use
of medicines.
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Sure! Here's an expanded version of the note on Individual Reporting and Spontaneous
Reporting, suitable for a long answer question:
Individual Reporting and Spontaneous Reporting in Pharmacovigilance
1. Introduction:
Pharmacovigilance is the science and activities involved in the detection, assessment,
understanding, and prevention of adverse effects or any other drug-related problems. After a
drug is approved and released into the market, its safety continues to be monitored. Two of the
most important tools for post-marketing surveillance are individual reporting and spontaneous
reporting. These methods play a crucial role in identifying unknown or rare adverse drug
reactions (ADRs), improving patient safety, and guiding regulatory decisions.
2. Individual Reporting:
Definition:
Individual reporting refers to the submission of detailed reports on adverse drug reactions or
other drug-related problems concerning a single patient. These reports are typically collected in
the form of Individual Case Safety Reports (ICSRs) and are used by pharmacovigilance
systems worldwide.
Who Can Report:
Healthcare professionals (doctors, pharmacists, nurses, etc.)
Patients or consumers
Pharmaceutical companies
Clinical researchers
Contents of an Individual Report:
Patient information (age, sex, weight, etc.)
Description of the suspected adverse event
Name and dosage of the suspected drug
Duration of drug use
Other medications being taken
Medical history of the patient
Outcome of the event
Importance:
Helps in identifying rare, serious, or previously unrecognized adverse effects.
Allows tracking of drug safety in real-world settings.
Provides data for generating drug safety signals (alerts or hypotheses regarding new
adverse effects).
Supports regulatory authorities in taking appropriate safety actions, such as label
changes, warnings, or drug withdrawals.
Example:
If a patient develops liver toxicity after taking a newly introduced antibiotic, the treating
physician may submit an individual report to the national pharmacovigilance centre. This case,
along with similar reports, can lead to further investigation and possible safety updates.
3. Spontaneous Reporting:
Definition:
Spontaneous reporting is an unsolicited, voluntary submission of information about a suspected
adverse drug reaction. It is the most widely used method of pharmacovigilance and is the
backbone of post-marketing surveillance systems worldwide.
Features:
Voluntary and does not arise from a pre-planned study or investigation.
May be submitted by health professionals, patients, or pharmaceutical companies.
Collected by national or regional pharmacovigilance centres or drug regulatory
authorities.
Often reported through online portals, paper forms, telephone calls, or dedicated mobile
applications.
Advantages:
Cost-effective method for monitoring drug safety.
Can detect new, rare, or serious ADRs not identified during clinical trials.
Covers a large and diverse population, offering insights into real-world drug usage and
safety.
Supports early signal detection and public health protection.
Limitations:
Under-reporting is a major problem; many ADRs go unreported.
Reports may lack important clinical details or documentation.
Possibility of reporting bias, especially after media coverage or legal issues.
Cannot provide accurate incidence rates due to lack of denominator data (i.e., number of
users).
4. Relationship Between Individual and Spontaneous Reporting:
Spontaneous reporting includes individual case reports that are voluntarily submitted.
Both systems contribute to databases like VigiBase, the global ICSR database maintained
by the WHO-Uppsala Monitoring Centre.
Together, they form the foundation of pharmacovigilance systems and play a major role
in drug safety monitoring.
5. Regulatory Use:
Regulatory authorities such as the U.S. FDA, EMA, and India’s CDSCO-NPvPI utilize data
from individual and spontaneous reports to:
Update product safety labels.
Issue public safety warnings.
Restrict or ban unsafe drugs.
Improve prescribing guidelines.
6. Conclusion:
Individual and spontaneous reporting are essential for ensuring the safety of medicines once they
are on the market. These systems rely on active participation from healthcare professionals and
patients. While they have some limitations, their role in identifying adverse drug reactions,
initiating regulatory actions, and ultimately safeguarding public health is undeniable.
Strengthening awareness and encouraging reporting can greatly enhance the effectiveness of
pharmacovigilance worldwide.
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