Introduction

Pharmacovigilance plays a vital role in ensuring drug safety and

protecting patients from unexpected adverse effects. With the
increasing complexity of medications, the need to monitor their effects
post-marketing is more important than ever. This project explores the
fundamentals of pharmacovigilance and Adverse Drug Reactions
(ADRs).

Pharmacovigilance is the science of detecting, assessing, understanding,

and preventing adverse drug reactions (ADRs). It is crucial for patient
safety, ensuring that drugs remain safe even after they are approved
and available to the public. This project aims to explore the
fundamentals of pharmacovigilance and ADRs, highlighting the
importance of post-marketing surveillance in identifying and managing
potential risks.
Elaboration:
Pharmacovigilance is a vital discipline that focuses on the safety of
medications throughout their lifecycle, from clinical trials to post-
marketing surveillance. Its primary goal is to identify, assess, and
prevent adverse drug reactions (ADRs), which are unwanted or harmful
effects experienced after taking a drug.
Key aspects of pharmacovigilance:
• Post-marketing surveillance:
It's crucial to monitor drugs in real-world settings, where populations
and usage patterns may be different from clinical trials.
• Signal detection:
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Identifying new or unexpected adverse effects that may not have been
evident during clinical trials.
• Risk-benefit assessment:
Evaluating the potential harm of a drug compared to its benefits for
patients.
• Reporting and communication:
Healthcare professionals, patients, and pharmaceutical companies all
play a role in reporting ADRs to regulatory authorities.
• Preventive measures:
Taking actions to reduce or mitigate the risks associated with drug use.
Why is pharmacovigilance important?
• Patient safety: Protecting patients from potentially harmful side
effects.
• Public health: Ensuring that drugs on the market are safe for
widespread use.
• Regulatory compliance: Supporting drug regulatory authorities in
making informed decisions about drug safety and use.
• Continuous improvement: Helping to identify and address safety
issues that may emerge after a drug is approved.
In essence, pharmacovigilance is a critical component of the
pharmaceutical landscape, ensuring that drugs are safe, effective, and
beneficial for patients. This project will delve into the intricacies of this
science, exploring its importance and the various aspects involved in
ensuring drug safety.

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 Definition of Pharmacovigilance
Pharmacovigilance is defined by the World Health Organization (WHO) as "the
science and activities relating to the detection, assessment, understanding, and
prevention of adverse effects or any other drug-related problem". It focuses on
monitoring the safety of medications, including identifying new or unexpected
adverse effects, assessing the risks associated with drug use, and developing
strategies to prevent harm.
Here's a more detailed breakdown:
• Detection:
Identifying potential adverse effects from drug use, including those that may not be
evident during pre-clinical or clinical trials.
• Assessment:
Evaluating the severity, frequency, and characteristics of reported adverse effects
to understand the potential risks.
• Understanding:
Investigating the mechanisms of adverse effects and the factors that may contribute
to their occurrence.
• Prevention:
Developing strategies to mitigate the risk of adverse effects, such as adjusting
dosages, providing patient education, or withdrawing drugs from the market when
necessary.
Pharmacovigilance is a crucial process in ensuring the safe and effective use of
medicines throughout their lifecycle, from development to post-marketing
surveillance. It involves a wide range of stakeholders, including healthcare
professionals, pharmaceutical companies, and regulatory agencies, all working
together to monitor and manage the safety of medicinal products.

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 History and Evolution
Pharmacovigilance, the science of detecting and understanding adverse drug
effects, emerged after the thalidomide tragedy in 1961, leading to the
establishment of the World Health Organization's Programme for International
Drug Monitoring (PIDM) in 1968. WHO defines pharmacovigilance as the science
and activities related to detecting, assessing, understanding, and preventing
adverse effects or drug-related problems.
Elaboration:
• Thalidomide Tragedy:
The use of thalidomide during pregnancy resulted in birth defects, highlighting the
need for a formal system to monitor drug safety after they are marketed.
• WHO's Response:
The thalidomide tragedy prompted the WHO to establish the PIDM in 1968. This
program aimed to collect and analyze reports of adverse drug reactions from
different countries to identify potential safety issues.
• WHO Definition:
The WHO's definition of pharmacovigilance emphasizes the ongoing need to
monitor drug safety, assess risks and benefits, and ultimately, improve patient
safety.

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 Objectives of Pharmacovigilance
Pharmacovigilance aims to ensure safe drug use by identifying and preventing
drug-related problems, including adverse reactions. It involves identifying
previously unrecognized adverse effects, assessing the risks and benefits of
drugs, promoting safe and rational drug use, and educating healthcare
professionals and patients. The practice originated following the thalidomide
tragedy in 1961, leading to the World Health Organization (WHO) initiating
the Programme for International Drug Monitoring in 1968.
Objectives:
• Identify previously unrecognized adverse reactions:
This involves detecting new or rare side effects that might not be known
during clinical trials or early post-marketing surveillance.
• Assess risks and benefits of drugs:
Pharmacovigilance helps to determine the overall risk-benefit profile of drugs,
ensuring that the potential benefits outweigh the risks for patients.
• Promote safe and rational drug use:
By providing information about drug safety, pharmacovigilance encourages
the appropriate and effective use of medicines, minimizing the potential for
harm.
• Educate healthcare professionals and patients:
• Pharmacovigilance plays a role in informing healthcare providers and
patients about drug safety, enabling them to make informed decisions
about drug use.

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 Importance in Healthcare
Pharmacovigilance plays a crucial role in healthcare by ensuring safer drug use
through the ongoing monitoring and assessment of drug safety. It identifies
potential risks, assesses the benefits and risks of medications, and promotes
safe and rational drug use. This process is essential for preventing drug-
related injuries, enhancing patient trust, supporting regulatory decisions, and
guiding clinical guidelines.
Key Functions of Pharmacovigilance:
• Detection of adverse drug reactions:
Identifying previously unrecognized adverse reactions, including those that
may be rare or specific to certain populations.
• Risk and benefit assessment:
Evaluating the overall balance between the benefits and risks of medications,
informing decisions about their continued use or potential modifications.
• Promotion of safe and rational drug use:
Encouraging the appropriate and responsible use of medications, including
adherence to prescribed regimens and avoiding unnecessary drug use.
• Education and training:
Providing education and training to healthcare professionals and patients on
drug safety, adverse reactions, and reporting procedures.

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 Introduction to ADRs
An Adverse Drug Reaction (ADR) is a harmful or unwanted effect
resulting from using a medicinal product, ranging from mild to
life-threatening. Pharmacovigilance is the science and activities
related to detecting, assessing, understanding, and preventing
ADRs and other drug-related problems. It aims to ensure safer
drug use by preventing injuries, building patient trust, supporting
regulatory decisions, and guiding clinical guidelines. The field of
pharmacovigilance originated after the thalidomide tragedy in
1961, and the WHO initiated the Programme for International
Drug Monitoring in 1968.
Here's a more detailed explanation:
• Definition of ADR:
An ADR is any noxious or unintended response to a medication
used for prophylaxis, diagnosis, or therapy of a disease.
• Importance of Pharmacovigilance:
It is crucial for monitoring drug safety, identifying previously
unrecognized reactions, assessing risk-benefit profiles,
promoting safe drug use, and educating healthcare professionals
and patients.

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 Types of ADRs
Adverse Drug Reactions (ADRs) are unwanted effects of medications that
can vary in severity. They are classified into different types based on their
characteristics:
1. Type A (Augmented) Reactions – These are dose-dependent and
predictable, often related to the drug’s intended effects. Examples
include excessive bleeding with anticoagulants or sedation with
antihistamines.
2. Type B (Bizarre) Reactions – These are unpredictable and not dose-
dependent, often caused by immune system responses or genetic
factors. Examples include anaphylaxis with penicillin or Stevens-
Johnson Syndrome due to certain drugs.
3. Type C (Chronic) Reactions – These occur due to prolonged drug
use and are dose-dependent. Examples include adrenal
suppression with long-term corticosteroid use.
4. Type D (Delayed) Reactions – These appear after a long time,
sometimes even after stopping the drug. Examples include cancer
caused by certain chemotherapy drugs.
5. Type E (End-of-Treatment) Reactions – These occur when a drug is
suddenly stopped. Examples include withdrawal symptoms from
opioids or benzodiazepines.
6. Type F (Failure) Reactions – These happen when a drug does not
work as expected, often due to interactions or resistance. Examples
include antibiotic resistance.

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 Classification Systems
Adverse Drug Reactions (ADRs) can be classified using different systems based on
their mechanisms, predictability, and severity. Here are some commonly used
classification systems:
1. Rawlins and Thompson Classification – This system categorizes ADRs into:
o Type A (Augmented): Predictable and dose-dependent (e.g., bleeding
with anticoagulants).
o Type B (Bizarre): Unpredictable and not dose-dependent (e.g.,
anaphylaxis with penicillin).
2. DoTS Classification – This system considers:
o Dose: ADRs can be toxic, collateral, or hypersensitivity-related.
o Time: Immediate, delayed, or chronic reactions.
o Susceptibility: Genetic, age-related, or disease-related factors.
3. WHO Classification – The World Health Organization classifies ADRs based
on causality:
o Certain: Clear evidence linking the drug to the reaction.
o Probable: Strong association but other causes are possible.
o Possible: Some evidence but alternative explanations exist.
o Unlikely: Weak or no evidence linking the drug to the reaction.
4. Mechanistic Classification – ADRs are grouped based on their biological
mechanisms:
• Immune-mediated: Allergic reactions.
• Non-immune-mediated: Pharmacological effects, drug interactions, or
genetic toxicity.

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 Mechanisms of ADR
Adverse Drug Reactions (ADRs) occur due to various mechanisms, which
can be broadly categorized into the following:
1. Pharmacological Mechanisms – These result from the drug’s
intended action but at an excessive level. Example: Beta-blockers
causing bradycardia.
2. Idiosyncratic Reactions – Unpredictable and not related to the
drug’s known pharmacological effects. Example: Clozapine-induced
agranulocytosis.
3. Immune-Mediated Reactions – These involve hypersensitivity
responses:
o Type I (Immediate): Anaphylaxis due to penicillin.
o Type II (Cytotoxic): Hemolytic anemia from methyldopa.
o Type III (Immune Complex): Serum sickness from certain
antibiotics.
o Type IV (Delayed T-cell Mediated): Contact dermatitis from
topical drugs.
4. Genetic Mechanisms – Some ADRs occur due to genetic variations
affecting drug metabolism. Example: G6PD deficiency leading to
hemolysis with certain drugs.
5. Drug-Drug Interactions – When two or more drugs interact, leading
to altered effects. Example: Warfarin and NSAIDs increasing
bleeding risk.

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 Factors Influencing ADRs
Several factors influence the likelihood and severity of Adverse Drug
Reactions (ADRs). These can be broadly categorized into:
1. Patient-Related Factors
• Age: Elderly and pediatric patients are more susceptible due to
differences in drug metabolism.
• Genetics: Genetic variations affect drug metabolism (e.g., G6PD
deficiency leading to hemolysis).
• Gender: Hormonal differences can influence drug response.
• Comorbidities: Conditions like liver or kidney disease alter drug
clearance.
• Pregnancy & Lactation: Physiological changes affect drug
pharmacokinetics.
2. Drug-Related Factors
• Dose & Duration: Higher doses or prolonged use increase ADR
risk.
• Route of Administration: Intravenous drugs may cause more
severe reactions than oral ones.
• Drug Interactions: Combining drugs can lead to unexpected
effects.
• Formulation & Excipients: Some inactive ingredients may trigger
allergic reactions.
3. Environmental & Lifestyle Factors
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 • Diet & Nutrition: Certain foods interact with drugs (e.g., grapefruit
juice affecting metabolism).
• Alcohol & Smoking: Can alter drug metabolism and efficacy.
• Exposure to Pollutants: Environmental toxins may exacerbate
ADRs.
4. Healthcare System Factors
• Prescribing Practices: Inappropriate prescribing increases ADR
risk.
• Monitoring & Reporting: Lack of pharmacovigilance leads to
undetected ADRs.
• Patient Education: Poor understanding of drug use can result in
misuse.

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 Detection and Assessment
Detecting and assessing Adverse Drug Reactions (ADRs) is crucial for patient safety and
effective pharmacovigilance. Here are the key methods used:

1. Detection Methods

• Spontaneous Reporting: Healthcare professionals and patients report suspected

ADRs to regulatory agencies.

• Electronic Health Records (EHR) Monitoring: AI-driven systems analyze patient

records for potential ADRs.

• Prescription Event Monitoring (PEM): Tracks ADRs by analyzing prescribing

patterns.

• Cohort & Case-Control Studies: Epidemiological studies identify ADR risks in

specific populations.

• Clinical Trials & Post-Marketing Surveillance: ADRs are monitored during drug
development and after-market release.

2. Assessment Methods

• Causality Assessment:

o Naranjo Algorithm: Uses a scoring system to determine the likelihood of an

ADR.

o WHO-UMC Scale: Categorizes ADRs as certain, probable, possible, or

unlikely.

• Severity Assessment:

o Hartwig and Siegel Scale: Classifies ADRs as mild, moderate, or severe.

• Preventability Assessment:

• Schumock and Thornton Scale: Determines if an ADR could have been avoided.

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 Signal Detection
Signal detection in pharmacovigilance is crucial for identifying potential adverse
drug reactions (ADRs) early. It involves analyzing data from various sources to
determine whether a drug may be linked to an unexpected safety concern.
Key Methods of Signal Detection
1. Statistical Algorithms – These methods analyze large datasets to identify
disproportionate reporting of ADRs:
o Proportional Reporting Ratio (PRR) – Compares the frequency of ADRs
for a specific drug against others.
o Bayesian Data Mining – Uses probabilistic models to detect unusual
patterns.
o Multi-item Gamma Poisson Shrinker (MGPS) – A statistical approach
used by regulatory agencies.
2. Case Reports & Spontaneous Reporting – Individual reports from healthcare
professionals and patients provide early warnings of ADRs.
3. Pattern Recognition & Machine Learning – AI-driven models analyze
electronic health records (EHRs) and social media data to detect emerging
ADR trends.
4. Clinical Trials & Post-Marketing Surveillance – Continuous monitoring of
drug safety beyond initial trials.

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 Reporting Systems
Adverse Drug Reaction (ADR) reporting systems help track and manage drug
safety concerns. Here are the key types:
1. Spontaneous Reporting Systems
• Yellow Card Scheme (UK) – Allows healthcare professionals and patients to
report suspected ADRs.
• MedWatch (USA) – FDA’s system for voluntary reporting of ADRs and
medical device issues.
• VigiBase (WHO) – Global database for ADR reports.
2. Active Surveillance
• Prescription Event Monitoring (PEM) – Tracks ADRs by analyzing
prescribing patterns.
• Cohort Studies – Monitors specific patient groups for ADRs.
• Targeted Safety Monitoring – Focuses on high-risk drugs or populations.
3. EHR-Based Systems
• AI-Driven Pharmacovigilance – Uses machine learning to detect ADR
patterns in electronic health records.
• Automated Signal Detection – Identifies potential ADRs based on patient
data trends.
4. Mobile Reporting Apps
• ADRMS (India) – Indigenous ADR monitoring system by the Indian
Pharmacopoeia Commission.
• WHO Mobile Reporting – Allows real-time ADR submissions via
smartphones.

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WHO Programme for International Drug
Monitoring
The WHO Programme for International Drug Monitoring (PIDM) was
established in 1968 to enhance global pharmacovigilance efforts. It
operates from the Uppsala Monitoring Centre (UMC) in Sweden, which
serves as the WHO Collaborating Centre for International Drug
Monitoring.
Key Functions of WHO PIDM
• Global ADR Data Collection – Member countries submit reports
of adverse drug reactions (ADRs) to VigiBase, the world’s largest
ADR database.
• Signal Detection & Risk Assessment – Uses statistical tools and AI-
driven methods to identify potential safety concerns.
• Capacity Building & Training – Supports national
pharmacovigilance programs through training and technical
assistance.
• Public Access to ADR Data – WHO launched VigiAccess, a web
application that allows public access to ADR reports.

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 Regulatory Authorities
The provided list accurately identifies the key regulatory bodies for
pharmaceuticals in the US, EU, India, and the UK: FDA (US), EMA (EU),
CDSCO (India), and MHRA (UK). Additionally, the listing of PvPI (India)
alongside CDSCO indicates a focus on pharmacovigilance in India, where PvPI
is a program that oversees post-marketing surveillance.
Here's a breakdown of each regulatory body:
• US FDA (United States Food and Drug Administration):
The FDA is responsible for regulating food, drugs, cosmetics, and medical
devices in the US, ensuring their safety and efficacy.
• EU EMA (European Medicines Agency):
The EMA evaluates and monitors medicines for both human and veterinary
use in the European Union and European Economic Area.
• India CDSCO (Central Drugs Standard Control Organization):
The CDSCO is India's national regulatory authority, overseeing drug
manufacturing, import, and distribution to ensure safety, efficacy, and
quality.
• India PvPI (Pharmacovigilance Program of India):
PvPI is a program within the CDSCO that focuses on post-marketing
surveillance, monitoring the safety of drugs after they have been approved
and placed on the market.
• UK MHRA (Medicines and Healthcare products Regulatory Agency):
The MHRA regulates medicines and medical devices in the UK, ensuring their
safety and effectiveness.

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Pharmacovigilance in India is a drug safety monitoring program,
overseen by the Government of India, aiming to protect the
public health by ensuring the benefits of medicines outweigh
their risks. The Pharmacovigilance Programme of India (PvPI),
launched in 2010, is the central body responsible for collecting,
collating, and analyzing drug-related adverse events. It works by
receiving reports of adverse drug events and taking necessary
actions to address any safety concerns.

Key aspects of Pharmacovigilance in India:

• Goal:

To improve patient safety and welfare by monitoring the safety

of medicines and ensuring the benefits of use outweigh the
risks.

• Structure:

The Central Drugs Standard Control Organization (CDSCO)

oversees the PvPI, which operates through a network of
Adverse Drug Reaction (ADR) monitoring centers.

• Activities:

The PvPI collects, analyzes, and reports on adverse drug events,

and recommends regulatory measures to the CDSCO.

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 • Impact:

The program plays a crucial role in detecting substandard

medicines, prescribing errors, and building trust between
healthcare professionals and patients.

• Evolution:
Pharmacovigilance in India has evolved from a formal ADR
monitoring system established in 1986 to the national
Pharmacovigilance Programme of India launched in 2005 and
renamed in 2010.

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 Tools and Technologies
Pharmacovigilance relies on various tools and technologies to
enhance adverse drug reaction (ADR) detection and reporting.
Here’s a structured overview:

1. Databases for ADR Monitoring

• VigiBase – The WHO’s global ADR database, managed by

the Uppsala Monitoring Centre.

• EudraVigilance – The European Medicines Agency’s (EMA)

system for ADR reporting and analysis.

• FAERS (FDA Adverse Event Reporting System) – Used by

the U.S. FDA for pharmacovigilance.

2. AI and Machine Learning for Signal Detection

• Natural Language Processing (NLP) – Extracts ADR-related

insights from clinical notes and reports.

• Bayesian Data Mining – Identifies unexpected ADR

patterns in large datasets.

• Deep Learning Models – Predict potential ADRs based on

patient history and drug interactions.

3. Mobile Apps for ADR Reporting

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 • MedSafety App – Used in multiple countries for direct ADR
reporting by healthcare professionals and patients.

• ADRMS (India) – India’s mobile-based ADR monitoring

system.

• FDA MedWatch App – Enables ADR submissions to the

U.S. FDA.

4. Integration with Electronic Health Records (EHRs)

• Automated ADR Detection – AI-driven systems analyze

EHRs for potential ADR signals.

• Clinical Decision Support Systems (CDSS) – Alerts

healthcare providers about possible drug interactions.

• Blockchain for Secure Data Sharing – Ensures integrity and

traceability of ADR reports.

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 Risk Management
Risk management in pharmacovigilance ensures drug safety by identifying,
assessing, and mitigating adverse drug reactions (ADRs). Here is a structured
overview:

1. Risk Minimization Plans (RMPs)

• Developed by pharmaceutical companies and regulatory agencies.

• Includes strategies like restricted prescribing, patient education, and

monitoring programs.

• Example: REMS (Risk Evaluation and Mitigation Strategies) in the U.S.

2. Risk-Benefit Analysis

• Evaluates whether a drug’s therapeutic benefits outweigh its risks.

• Conducted during drug approval and post-marketing surveillance.

• Example: Withdrawal of drugs with unacceptable risk profiles.

3. Product Labeling Updates

• Regulatory agencies update drug labels based on new safety data.

• Includes warnings, contraindications, and dosage adjustments.

• Example: Boxed warnings for severe ADRs.

4. Black Box Warnings

• The strongest warning issued by the FDA for serious ADR risks.

• Appears on drug packaging and prescribing information.

• Example: Isotretinoin carries a black box warning for teratogenic effects.

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 Case Studies
Here’s a structured overview of these significant pharmacovigilance case studies:

1. Thalidomide Tragedy

• Background: Thalidomide was introduced in the late 1950s as a sedative

and treatment for morning sickness in pregnant women.

• Issue: It caused severe birth defects, leading to phocomelia (limb

malformations) in thousands of infants.

• Impact: The tragedy led to stricter drug regulations, including the Kefauver-
Harris Amendment (1962) in the U.S., which mandated rigorous drug safety
testing.

2. Rofecoxib (Vioxx) Withdrawal

• Background: Rofecoxib (Vioxx) was a COX-2 selective NSAID approved in

1999 for pain relief.

• Issue: Studies revealed an increased risk of cardiovascular events, including

heart attacks and strokes.

• Outcome: Merck voluntarily withdrew Vioxx in 2004, affecting thousands of

patients and leading to lawsuits.

• Lessons Learned: Highlighted the importance of long-term drug safety

monitoring and transparency in reporting adverse events.

3. COVID-19 Vaccine Monitoring & Safety Assessment

• Background: COVID-19 vaccines were developed at unprecedented speed,

requiring extensive post-marketing surveillance.

• Monitoring Methods:

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 o Global ADR Databases (e.g., VigiBase, VAERS).

o Real-World Evidence Studies to track rare side effects.

o AI-Driven Signal Detection for emerging safety concerns.

• Outcome: Continuous monitoring ensured rapid identification and

management of rare adverse events, reinforcing public confidence in
vaccine safety.

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 Challenges and Limitations
Pharmacovigilance faces several challenges and limitations that impact the
effectiveness of adverse drug reaction (ADR) detection and management. Here’s a
structured overview:
1. Underreporting of ADRs
• Many healthcare professionals and patients do not report ADRs due to lack
of awareness or time constraints.
• Fear of legal consequences or professional reputation concerns may
discourage reporting.
2. Data Quality & Inconsistencies
• ADR reports often lack detailed clinical information, making causality
assessment difficult.
• Variability in reporting standards across countries affects global
pharmacovigilance efforts.
3. Signal Detection Complexity
• Differentiating true ADR signals from background noise in large datasets is
challenging.
• AI-driven methods help, but require continuous validation to avoid false
positives.
4. Regulatory & Legal Barriers
• Differences in pharmacovigilance regulations across regions create
inconsistencies in drug safety monitoring.
• Legal restrictions on data sharing limit international collaboration.
5. Limited Resources & Infrastructure

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 • Developing countries often lack robust pharmacovigilance systems and
trained personnel.
• Funding constraints hinder research and implementation of advanced
monitoring tools.
6. Challenges in Post-Marketing Surveillance
• Long-term ADRs may not be detected during clinical trials, requiring
extensive post-marketing studies.
• Patient adherence and real-world data collection remain difficult.

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 Predictability and preventability
assessments
Predictability and preventability assessments help determine whether
an adverse drug reaction (ADR) could have been anticipated or avoided.
Predictability Assessment
Predictability refers to the likelihood of an ADR occurring based on
known drug properties, patient factors, or usage patterns. ADRs can be
classified as:
• Predictable ADRs – Typically dose-dependent and related to the
drug’s pharmacological action (e.g., bleeding with anticoagulants).
• Unpredictable ADRs – Idiosyncratic or allergic reactions that are
not dose-dependent (e.g., anaphylaxis with penicillin).
Factors influencing predictability:
• Pharmacology of the drug – Drugs with a narrow therapeutic
index have more predictable ADRs.
• Patient factors – Age, genetics, renal/hepatic function, and
concurrent diseases affect ADR predictability.
• Drug interactions – Known interactions can predict ADR risks (e.g.,
serotonin syndrome with SSRIs and MAO inhibitors).
Preventability Assessment
Preventability refers to whether an ADR could have been avoided
through appropriate drug selection, dose adjustment, monitoring, or
other interventions.
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Tools for assessing preventability:
• Schumock and Thornton Scale – Classifies ADRs as definitely
preventable, probably preventable, or not preventable.
• Modified Hallas Criteria – Evaluates preventability based on drug
appropriateness, monitoring, and patient adherence.
Examples of preventable ADRs:
• NSAID-induced ulcers – Can be prevented with gastroprotective
agents.
• Opioid-induced respiratory depression – Avoidable with proper
dose titration.
• ACE inhibitor-induced cough – Preventable by switching to an
ARB.

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 Conclusion
Pharmacovigilance plays a vital role in ensuring drug safety by detecting,
assessing, and preventing adverse drug reactions (ADRs). With the evolution of AI,
big data analytics, and real-world evidence, pharmacovigilance systems are
becoming more sophisticated, enabling better signal detection and risk
management. However, challenges such as underreporting, regulatory
inconsistencies, and data limitations still exist. Strengthening global collaboration,
improving reporting infrastructure, and advancing AI-driven methodologies will be
key to enhancing drug safety worldwide.
Pharmacovigilance is a crucial component of modern healthcare systems, aimed
at ensuring the safety and efficacy of pharmaceutical products throughout their
lifecycle. One of its core functions is the identification, assessment,
understanding, and prevention of adverse drug reactions (ADRs). ADRs can range
from mild side effects to severe or even life-threatening conditions, and their
detection is essential to protect patients and improve clinical outcomes.
Despite rigorous clinical trials, not all adverse effects of a drug can be discovered
before it reaches the market due to limited sample sizes and controlled
environments. Therefore, continuous post-marketing surveillance through
pharmacovigilance becomes necessary. This system enables the collection of real-
world data from diverse populations, helping identify rare, delayed, or unexpected
ADRs that may not have been evident earlier. Effective pharmacovigilance
practices rely on active participation from healthcare professionals,
pharmaceutical companies, regulatory authorities, and patients themselves.

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 Reference
Here are some resources for further reading:
1. WHO Programme for International Drug Monitoring – WHO Website
2. EudraVigilance (EU ADR Database) – EMA Website
3. FDA MedWatch (U.S. ADR Reporting System) – FDA Website
4. PvPI (India's Pharmacovigilance Programme) – IPC Website
5. VigiBase (WHO Global ADR Database) – Uppsala Monitoring Centre
6. K.D TRIPATHI – PHARMOCOLOGY

7. ANNAVARAPU TRIPATHI RAO- PHARMACOVIGILANCE

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