Introduction

1. Pharmacovigilance (PV), derived from the Greek word pharmakon (drug) and the Latin vigilare (to keep
watch), is defined as “the science and activities relating to the detection, assessment, understanding, and
prevention of adverse effects or any other drug-related problems” (WHO, 2002). It is a critical component of
drug development and public health, aiming to ensure the safe and rational use of medicines.

With the rapid development and approval of new drugs and biologics, monitoring their safety profiles post-
approval has become more important than ever. Clinical trials, despite their rigor, are limited by sample size,
controlled conditions, and time constraints. Hence, rare or long-term adverse effects may only become evident
once a drug reaches the wider population (Edwards & Aronson, 2000).

2. The concept of pharmacovigilance gained momentum after the thalidomide tragedy in the late 1950s and
early 1960s. Thalidomide, prescribed as a sedative and for morning sickness in pregnant women, led to severe
birth defects in thousands of newborns. This catastrophe triggered global efforts to improve drug regulation and
led to the establishment of pharmacovigilance systems (Wiktorowicz et al., 2010).

In 1968, the World Health Organization (WHO) initiated the Programme for International Drug Monitoring
(PIDM) to support national drug regulatory authorities in monitoring the safety of medicines. Today, more than
140 countries participate in the WHO Programme, contributing data to the global database, VigiBase, managed
by the Uppsala Monitoring Centre (UMC) in Sweden.

3. The primary objective of pharmacovigilance is to improve patient care and safety regarding the use of
medicines, especially by preventing harm from adverse drug reactions (ADRs). Other objectives include:

Enhancing public health and safety in relation to drug use.

Detecting previously unknown adverse reactions.

Monitoring the incidence and prevalence of known adverse effects.

Communicating findings effectively to health professionals and the public.

Supporting informed decision-making in the regulation and use of medicines (Aagaard et al., 2007).

Pharmacovigilance also encompasses the assessment of medication errors, drug interactions, lack of efficacy,
counterfeit medicines, and issues related to drug dependence and misuse.

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4. An adverse drug reaction is defined as a harmful or unpleasant reaction resulting from an intervention related
to the use of a medicinal product. ADRs can range from mild to life-threatening, and recognizing them is vital
for patient safety. Pharmacovigilance systems use various methodologies—spontaneous reporting, cohort event
monitoring, and electronic health record analyses—to detect and assess signals of potential drug risks.

Signal detection refers to the identification of new or known associations between a drug and an adverse event
that may warrant further investigation. It is an ongoing process involving statistical algorithms, clinical
judgment, and epidemiological data (Hauben & Zhou, 2003).

5. National regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European
Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO) in India, play a key
role in pharmacovigilance. They establish reporting requirements, maintain safety databases, and evaluate risk-
benefit profiles of drugs throughout their lifecycle.

These agencies collaborate with international bodies and pharmaceutical companies to implement Risk
Management Plans (RMPs), conduct Post-Marketing Surveillance (PMS), and issue safety warnings or product
recalls when necessary.

6. Pharmacovigilance is evolving rapidly due to advances in data science, artificial intelligence, and real-world
evidence collection. New tools enable the analysis of large datasets from electronic health records, social media,
and mobile health applications, offering more proactive safety monitoring.

Moreover, pharmacogenomics and personalized medicine are shaping a future where adverse drug reactions can
be predicted and prevented based on individual genetic profiles (Talbot & Aronson, 2011). Global collaboration
and public involvement will continue to be central to pharmacovigilance success.

7. Pharmacovigilance relies on coordinated international regulatory oversight. Organizations like the ICH,
WHO, EMA, and FDA set harmonized standards such as the ICH E2E and EU’s GVP modules to standardize
safety practices. Despite global alignment efforts, regional differences in legislation, infrastructure, and data
handling persist.

8.Developing countries face unique obstacles including limited awareness, poor ADR reporting systems, and
lack of training. The WHO’s Global Benchmarking Tool assists these nations in evaluating and improving their
pharmacovigilance capacity. Countries like India have successfully integrated ADR monitoring with public
health programs, utilizing mobile technologies to close reporting gaps.

9.Drug withdrawals like that of Rofecoxib (Vioxx), linked to cardiovascular risks, and Cisapride, due to
arrhythmias, show how vital post-marketing surveillance is. These events underscore the importance of timely
signal detection and transparent risk communication. The hydroxychloroquine case during COVID-19 further
demonstrated the need for rapid pharmacovigilance in public health emergencies.

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10. Advances in AI and machine learning have revolutionized pharmacovigilance by allowing for quicker signal
detection through large-scale data mining. NLP is used to analyze unstructured clinical and social media data.
Additionally, blockchain offers secure data sharing, and mobile apps enable patients to report ADRs directly,
enhancing public participation and timeliness.

11.Pharmacovigilance must balance safety surveillance with ethical principles such as informed consent and
data privacy. Ensuring all populations are represented in safety monitoring helps reduce disparities.
Transparency in risk communication and independent oversight of pharmaceutical companies are crucial for
maintaining public trust and scientific integrity.

What is Pharmacovigilance?

There is a need to monitor the effects of drugs before and after it‟s successfully tested and
launched in the market. Pharmacovigilance involves monitoring and assessing the quality of
drugs, detection and preventing of any adverse effects of drugs. Pharmacovigilance involves
evaluating information provided by health care providers, pharmaceutical companies and
patients in order to understand the risks and benefits involved with a particular drug.
Pharmaceutical companies spend millions of dollars and a considerably long time in
developing new drugs.

They again spend a lot of money in conducting clinical trials before the drugs are approved
and launched in the market. It is recognized that information technology (IT) has entered and
transformed the world of health care and clinical medicine in which the work of doctors and
the care of patients proceed with higher quality, efficiency and lower costs. It is also no secret
that IT has merged in to clinical safety practice and sparks the creation of worldwide
pharmacovigilance systems for safety signal detection.

The IT transformative force and health it adoption have fundamentally changed the conduct
of clinical research, practice of medicines, and medicinal safety monitoring. In today‟s world,
pharmacovigilance pushes new boundaries and it is no longer sufficient to simply report
adverse events along with efficacy and quality requirements.

Regulators are demanding proactive surveillance programs that include comprehensive risk
management plans and signal detection /analysis throughout a clinical products‟ life cycle.

Management plans and signal detection /analysis throughout a clinical products‟ life
cycle.

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∙ This addresses what exactly is pharmacovigilance?
∙ What do we know of its benefits and risks?
∙ What challenges are out there preventing its wide spread usage?
∙ And what does the future hold for pharmacovigilance in worldwide medicine?
management plans and signal detection /analysis throughout a clinical products‟ life cycle.
∙ This addresses what exactly is pharmacovigilance?
∙ What do we know of its benefits and risks?
∙ What challenges are out there preventing its wide spread usage?
∙ And what does the future hold for pharmacovigilance in worldwide medicine?
It is now generally accepted that part of the process of evaluating drug safety needs to happen
in the post marketing phases through judgment as to whether and how this might happen lies
with the regulators. The stronger the national systems of pharmacovigilance and adverse drug
reaction (ADR) reporting, the more likely reasonable regulatory decisions will be made.

ROLE OF PHARMACIST IN PHARMACOVIGILANCE

∙ The commitment of the pharmacist to pharmacovigilance should, be that as it may, not be restricted to ADR
announcing.
∙ Assisting patients previous allergic status, patient’s drug therapy, possible drug interaction.
∙ Pharmacists are associated with conveying social insurance offices and in addition proposing therapeutic staff
on legitimate collection of medications. [11]
∙ Along these lines, support of pharmacists in wellbeing the executive’s framework is ending up extremely
crucial step by step.
∙ Documentation of all suspected reported reactions.
∙ Educating the health care professionals about the importance of reporting an ADR.
∙ Pharmacovigilance information systems managed by pharmacist can recognised ADR in emerging countries
where quality control of medicines is questionable.
∙ 73% of pharmacist work in hospital or pharmacy settings, where they can face events based on ADR or other
drug related problems. Their involvement in pharmacovigilance system is crucial [12]

INTRODUCTION TOOLS FOR ADR MONITORING IN INDIA

REPORTING TOOLS

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 Adverse Drug Reaction Mobile App- ADR PvPI
Monitoring Centre (AMC)
ADR Reporting Forms
Helpline No. 1800 180 3024 1. Healthcare Professionals
2. Consumers

\\\\\\\\\\\\\\\\\\\

Mobile Application

“ADR PvPI” mobile app: NCC-PvPI has developed an indigenous advanced version of the Android mobile app
“ADR PvPI” enabling all health-care professionals and consumers to instantly report ADRs.

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E-Reporting of ADRs:
 Android Mobile App – ‘ADR PvPI’

An indigenous android mobile app “ADR PvPI”, which was dedicated to the nation on 29 th September
2017, has been instrumental in equipping all stakeholders, including the consumers, for reporting ADRs.

Helpline
ADRs can be also reported via PvPI helpline number (1800 180 3024) on weekdays (Monday to Friday)
from 9:00 am to 5:30 pm. The mobile Android application for ADR reporting has also been made available to
the public.

ADVERSE DRUG REACTION / ADVERSE EVENT REPORTING FORM

Healthcare professionals (HCPs) and patients are encouraged to report adverse events due to pharmaceutical
products (if any) to their preferred ADRs monitoring centre by using Suspected ADRs reporting form:

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1. Suspected Adverse Drug Reaction Reporting Form

The Suspected ADR Reporting Form (Version 1.4) is specifically designed for healthcare professionals to
capture detailed information about an AE/ADR. This form is available on IPC website (www.ipc.gov.in) or
CDSCO website (www.cdsco.gov.in) and in National Formulary of India 2016.

2. Medicines Side Effect Reporting Form (For Consumers)

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Consumers/patients may also make use of Medicines Side-effect Reporting Form (Version 1.0) for reporting
any suspected AE/ADR to PvPI. This form is available in 10 Indian languages: Hindi, Bengali, Gujarati,
Kannada, Malayalam, Marathi, Assamese, Oriya, Tamil and Telugu. E-mail for Non-AMCs
icsr.nccpvpi@gmail.com E-mail for Consumers pvpi.compat@gmail.com .

3. Suspected Adverse Drug Reaction Reporting Form (For drugs used in Prophylaxis/
Treatment of COVID-19)

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The Suspected ADR Reporting Form is designed for healthcare professionals during pandemic to capture
detailed information about an AE/ADR related to the drugs used in Prophylaxis/ Treatment of COVID-19. This
form is available on IPC (www.ipc.gov.in).

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10
 REPORTING OF ADVERSE DRUG REACTIONS

Report non-serious, known or unknown, frequent or rare adverse drug

reactions due to Medicines, Vaccines, Medical Devices and Herbal products
etc.

What
to
report?

Report serious adverse drug reactions. Serious patient outcome is: Death, Life-
threatening, Hospitalization (initial or prolonged), Disability (significant, persistent
or permanent), and Congenital anomaly, required intervention to prevent permanent
impairment or damage.

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 PHARMACT

IS
AMC

Who
can
Report

CONSUMERS/
PATIENTS PHARMACEUT-
ICAL
INDUSTRIES

NURSES

WHOM TO
REPORT??

National Coordination Centre- PvPI,

Indian pharmacopoeia

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Guidelines For Reporting Adverse Drug Reactions

In India, adverse drug reactions (ADRs) are reported through the Pharmacovigilance Programme of India
(PvPI), coordinated by the Indian Pharmacopoeia Commission (IPC). Here are the key guidelines:

1. Who Can Report ADRs?

 Healthcare professionals (doctors, pharmacists, nurses)

 Patients and caregivers
 Pharmaceutical companies

2. Where to Report?

 Adverse Drug Reaction Monitoring Centres (AMCs) across India

 PvPI Helpline (Toll-Free: 1800-180-3024)
 Online Submission via the Central Drugs Standard Control Organization (CDSCO) portal
 Email Submission to PvPI (pvpi.ipc@gov.in)

3. What to Report?

 All suspected ADRs, including mild, moderate, and severe reactions.

 Serious ADRs (life-threatening, hospitalization, disability, congenital anomalies).
 Unexpected ADRs (not listed in drug information).
 ADR due to vaccines, herbal medicines, or self-medication.

4. How to Report?

 Use the Suspected Adverse Drug Reaction Reporting Form.

 Provide details such as:
Patient information (age, gender, medical history).
Suspected drug details (name, dose, frequency).
Reaction description (onset, severity, outcome).
Concomitant medications (other drugs taken).
Causality assessment (whether the drug is responsible for the reaction).

5. Follow-Up & Evaluation

 Reports are analyzed by PvPI experts to assess causality.

 Regulatory actions may be taken, including drug safety updates.

 Feedback is provided to reporters when necessary.

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 Antibiotics
1. Introduction

Antibiotics are powerful medicines used to treat bacterial infections by either killing bacteria or inhibiting their
growth. They are ineffective against viruses such as those that cause the flu or common cold. The discovery of
penicillin by Alexander Fleming in 1928 revolutionized medicine, leading to the development of many life-
saving antibiotics.

2. Definition and Properties

Antibiotics are natural or synthetic compounds that destroy or inhibit bacterial growth. They exhibit selective
toxicity, targeting bacterial cells while minimizing harm to human cells. Based on their effect, antibiotics are
either bactericidal (kill bacteria) or bacteriostatic (inhibit growth).

---

3. Classification of Antibiotics

A. Based on Mechanism of Action

Cell wall synthesis inhibitors: Penicillins, Cephalosporins

Protein synthesis inhibitors: Tetracyclines, Macrolides, Aminoglycosides

DNA/RNA synthesis inhibitors: Fluoroquinolones

Metabolic inhibitors: Sulfonamides

Cell membrane disruptors: Polymyxins

B. Based on Spectrum

Narrow-spectrum: Effective against specific bacteria (e.g., Penicillin G)

Broad-spectrum: Act on a wide variety (e.g., Tetracycline)

C. Based on Chemical Structure

Beta-lactams: Penicillins, Cephalosporins

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Macrolides: Azithromycin

Tetracyclines: Doxycycline

Aminoglycosides: Gentamicin

Fluoroquinolones: Ciprofloxacin

Sulfonamides: Trimethoprim-Sulfamethoxazole

4.Common Antibiotics and Their Uses

5. Antibiotic Resistance

Antibiotic resistance occurs when bacteria evolve to survive antibiotic treatment. This is a global health threat
driven by:

Overuse and misuse of antibiotics

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Incomplete treatment courses

Agricultural use of antibiotics

Poor infection control in hospitals

Examples of Resistant Bacteria:

MRSA – resistant to methicillin

VRE – resistant to vancomycin

MDR-TB – multidrug-resistant tuberculosis

Consequences include longer hospital stays, increased medical costs, and higher mortality rates.

1. Introduction

Antibiotics are among the most commonly prescribed drugs worldwide and have played a pivotal role in
reducing mortality and morbidity from infectious diseases. However, their use is not without risks. Adverse
drug reactions (ADRs) associated with antibiotics pose a significant public health challenge, especially in a
country like India, which has one of the highest rates of antibiotic consumption globally.

ADRs can range from mild symptoms like gastrointestinal discomfort to life-threatening conditions such as
Stevens-Johnson Syndrome or anaphylaxis. According to the World Health Organization (WHO), ADRs are
among the leading causes of morbidity and mortality globally. In India, the widespread availability of over-the-
counter antibiotics, combined with a lack of awareness and robust pharmacovigilance systems in certain
regions, has exacerbated the problem.

This paper provides an in-depth analysis of antibiotic-induced ADRs in India over the last decade (2015–2025),
classifies them by severity (easy, medium, critical), and presents case data highlighting the scope of the issue. It
also discusses public health interventions and future strategies.

2. Methodology and Data Sources

This retrospective study is based on secondary data collected from:

The Pharmacovigilance Programme of India (PvPI),
Indian Council of Medical Research (ICMR) bulletins,
Peer-reviewed journals and case reports (2015–2025),

16
Hospital-based surveillance data from tertiary care centers including AIIMS, PGI Chandigarh, and JIPMER.
A classification framework was developed to categorize ADRs as:
Easy (mild): Self-limiting, non-life-threatening,
Medium (moderate): Requiring medical intervention or hospitalization,

Critical (severe): Life-threatening or fatal.

3. Overview of Antibiotic Use and ADR Trends in India

India’s antibiotic consumption has increased by over 100% from 2000 to 2020. The misuse of antibiotics, often
driven by self-medication, irrational prescribing, and agricultural use, contributes not only to antimicrobial
resistance but also to an increase in drug-related adverse effects.

PvPI data (2015–2022) indicate that antibiotics accounted for approximately 15% of all reported ADRs. Of
these:

65% were classified as mild (easy),

25% as moderate (medium),

10% as severe (critical).

Most common antibiotic classes involved:

Penicillins (e.g., amoxicillin, cloxacillin)

Cephalosporins (e.g., ceftriaxone, cefixime)

Fluoroquinolones (e.g., ciprofloxacin, levofloxacin)

Sulfonamides (e.g., co-trimoxazole)

Aminoglycosides (e.g., gentamicin, amikacin)

4. Classification of ADRs

4.1 Easy (Mild) Reactions

These are commonly encountered and usually self-limiting.

Symptoms: Nausea, vomiting, minor skin rashes, mild diarrhea, headache.

Common Drugs: Amoxicillin, Azithromycin.
Management: Usually requires no intervention beyond symptomatic treatment.

17
Prevalence: Accounted for about 65% of antibiotic-related ADRs.

Example: A study from PGI Chandigarh reported that 80% of pediatric patients given oral amoxicillin
developed mild gastrointestinal symptoms that resolved on discontinuation.

4.2 Medium (Moderate) Reactions

Require medical intervention, sometimes hospitalization, but are rarely fatal.

Symptoms: Severe diarrhea (especially C. difficile), allergic reactions with urticaria, hepatotoxicity, interstitial
nephritis.
Common Drugs: Fluoroquinolones, Cephalosporins, Doxycycline.
Management: Discontinuation of the antibiotic, supportive therapy, monitoring of vital functions.
Prevalence: About 25% of ADRs fall under this category.

Example: AIIMS Delhi reported a 3-year cluster of 56 patients who developed severe pseudomembranous
colitis after cephalosporin use, requiring ICU monitoring.
4.3 Critical (Severe) Reactions

Life-threatening or fatal, requiring intensive care.

Symptoms: Anaphylaxis, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), acute kidney
injury, drug-induced liver failure.
Common Drugs: Vancomycin, Sulfonamides, Fluoroquinolones, Aminoglycosides.
Management: Emergency discontinuation, ICU admission, intensive supportive care (e.g., dialysis, ventilation).
Prevalence: Account for 10% of ADRs, but cause over 90% of antibiotic-related deaths.

Example: A 2020 study at JIPMER recorded 14 cases of TEN from co-trimoxazole use, with a 35% fatality rate.

5. Mortality and Morbidity: The Human Cost

Despite being a small fraction of total ADRs, critical reactions are the most devastating.
PvPI reports between 2015–2022 show over 1,500 deaths were associated with antibiotic-induced ADRs.

Fluoroquinolones have been linked with over 450 deaths in 5 years due to severe cardiac and neurological
complications.

Aminoglycosides contributed significantly to renal failure cases in ICUs, particularly in sepsis management.

A cross-sectional analysis of 10 tertiary hospitals revealed that up to 8% of ICU deaths were related to antibiotic
toxicity.
In rural areas, poor diagnostic access often results in mismanagement of allergic reactions, leading to avoidable
fatalities.

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6. Public Health Measures and Policy Response

India has made notable efforts to curb antibiotic misuse and monitor ADRs:

Pharmacovigilance Programme of India (PvPI) launched over 250 ADR Monitoring Centres (AMCs).

Red Line Campaign launched by the Ministry of Health marked prescription-only medicines with a red line to
discourage over-the-counter sales.

ICMR’s Antibiotic Stewardship Program implemented in hospitals to rationalize antibiotic prescriptions.

Ban on certain fixed-dose combinations (FDCs) by the Drugs Controller General of India (DCGI) to reduce
irrational use.

FSSAI guidelines aim to control antibiotic use in livestock and poultry.

However, challenges such as underreporting, lack of awareness among healthcare workers, and inadequate rural
infrastructure persist.

7. Recommendations and Future Directions

To reduce antibiotic-induced ADRs and associated fatalities in India, the following are recommended:

Strengthening pharmacovigilance, particularly in rural and semi-urban areas.

Mandatory ADR reporting for hospitals and pharmacies.

Inclusion of ADR risk in medical education curriculum.

Development of rapid diagnostic kits for drug allergies.

Public awareness campaigns on antibiotic misuse.

Enhanced electronic health records for real-time ADR tracking.

8. Conclusion

Over the past decade, the increasing prevalence of adverse drug reactions (ADRs) associated with antibiotic
usage in India has emerged as a significant public health concern. This study has highlighted that antibiotics,
while essential in combating infections, are also responsible for a substantial number of ADRs, ranging in

19
severity from mild allergic responses to life-threatening complications. The classification of these reactions into
easy, medium, and critical categories has helped to better understand the risks associated with different
antibiotic classes and patient populations.

It is evident that irrational use of antibiotics, lack of proper surveillance, over-the-counter availability, and self-
medication practices have exacerbated the occurrence of ADRs. Data collected from pharmacovigilance
programs and hospital reports indicate that commonly used antibiotics such as beta-lactams, fluoroquinolones,
and aminoglycosides are frequently implicated in serious ADRs. Furthermore, certain populations—including
the elderly, pediatric patients, and those with co-morbid conditions—are particularly vulnerable.

Despite the implementation of the Pharmacovigilance Programme of India (PvPI), the underreporting of ADRs
remains a major hurdle in accurately assessing the scale of the problem. There is an urgent need to strengthen
ADR reporting systems, enhance healthcare professionals’ awareness and training, and implement stricter
regulations regarding antibiotic prescriptions and sales. Public education on the dangers of misuse and the
importance of adherence to prescribed regimens is also crucial.

In conclusion, while antibiotics are indispensable in modern medicine, their safe and rational use must be
prioritized to minimize harm. Comprehensive strategies encompassing surveillance, education, regulation, and
research are essential to curb the incidence of antibiotic-related ADRs and ensure patient safety in India. Only
through coordinated efforts can we achieve a balance between effective infection control and the mitigation of
drug-related risks.

ADRs caused by antibiotics have claimed lives and imposed a burden on India’s healthcare system. While most
ADRs are mild, the critical ones, although less frequent, are often fatal. A multi-pronged approach involving
healthcare professionals, policymakers, and the public is necessary to mitigate the risks. The path forward lies
in rational use, strong surveillance, and a culture of safety in antibiotic prescribing.

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References:

1. Aagaard, L., Strandell, J., Melskens, L., Petersen, P. S., & Hansen, E. H. (2007). Global patterns of adverse
drug reactions over a decade: Analyses of spontaneous reports to the WHO database. Basic & Clinical
Pharmacology & Toxicology, 101(5), 421-433.

2. Edwards, I. R., & Aronson, J. K. (2000). Adverse drug reactions: definitions, diagnosis, and management.
The Lancet, 356(9237), 1255-1259

3. Hauben, M., & Zhou, X. (2003). Quantitative methods in pharmacovigilance: focus on signal detection.
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4. Talbot, J. C., & Aronson, J. K. (2011). Stephens' detection of new adverse drug reactions. Wiley-Blackwell.

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8.Reference: Olsson, S. (2008). The role of the WHO Programme for International Drug Monitoring in
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harmacovigilance-and-role-of
pharmacist&psig=AOvVaw3ZIK_q_aDY8PFgrk0BIhpY&ust=1679649017459000&source=images&cd=vf
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Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products
Version 1.0
Annual Report of PvPI (2020-2021)

.15. CDC, 2023 – Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United
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