This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.

1. • Presented by :-
• Name :- Neha Manojkumar Bachate.
• Class :- M .pharm 1st year .
• Department :- Pharmacology
• Roll no . :- 47
• Subject In charge:- Dr. Khan Dureshahwar
WORLDHEALTHORGANIZATION {WHO } ANDPHARMACOVIGILANCE
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MAULANA AZAD EDUCATIONAL TRUST’S, Y. B. CHAVAN COLLEGE OF
PHARMACY, AURANGABAD.

2. Contents :-
 Introduction .
 WHO International Drug Monitoring Program.
 Function of International Drug Monitoring Program .
 UMC’s role as WHO Monitoring collaborating centre .
 Role of WHO in Pharmacovigilance .
 VigiBase .
 Regulatory terminology of ADR .
 Evaluation of medication safety.
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3. Introduction :-
 In 1963, during the 16th world assembly a resolution called for a systemic collection of
information on serious adverse drug reactions during the development and particularly
after medicines have been made available for public use. This led to the formation of
WHO Program for International Drug Monitoring (PIDM).
 Currently, 143 countries are members of the WHO PIDM. Another 28 associate member
countries are in the early stages of establishing their pharmacovigilance systems in
preparation for full membership.
 Initially the WHO PIDM members consisted of 10 countries .
 The ten founder members of the WHO Program in 1968 were Australia, Canada,
Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand,
Sweden, United Kingdom, USA.
 WHO PIDM members submit reports of adverse reactions associated with medicinal
products, known as Individual Case Safety Reports (ICSRs) to the global database
VigiBase.
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4. •WHO international Drug Monitoring Programme .
Pharmacovigilance (PV) is defined as the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other drug-related problem.
 The WHO International Drug Monitoring Programme, also known as the WHO Programme for
International Drug Monitoring, is a global initiative established by the World Health
Organization (WHO) to monitor and evaluate the safety of medicines.
 It collects reports of adverse drug reactions (ADRs) from participating countries and
organizations around the world, analyzes the data, and disseminates information to improve
the safe use of medications. This program plays a crucial role in pharmacovigilance, helping to
identify and address potential risks associated with pharmaceutical products.
 The WHO Programme for International Drug Monitoring (WHO PIDM) is an international
collaboration with the goal to ensure timely identification of medicines-related safety problems.
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5. •Function of WHOpIDMinclude :-
• Identification and analysis of new adverse reaction.
• Information exchange between WHO and National centers.
Publication of periodical news letters, guidelines and books in the Pharmacovigilance and risk management
area.
• Supply of tools for management of clinical information including ADR case reports
example :- WHO Drug Dictionary
WHO Adverse Reaction Terminology.
• Provision of training and consultancy support to National centers and countries establishing
Pharmacovigilance system.
• Computer software for case report management designed to suit the needs of National centers.
• Annual meetings for representative of national centers at which scientific and organizational matters are
discussed.
• Methodological research for the development of pharmacovigilance as a science
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6.  The main function of the WHO International Drug Monitoring Programme is to monitor and
evaluate the safety of medicines worldwide. This includes:
1. COLLECTING DATA: Gathering reports of adverse drug reactions (ADRs) from healthcare
professionals, regulatory authorities, and pharmaceutical companies globally .
2. ANALYZING DATA: Analyzing the collected data to identify patterns, trends, and potential
safety concerns associated with specific medications.
3. ASSESSING RISKS: Assessing the risks and benefits of medicines based on reported
adverse events to ensure their safe and effective use
4. COMMUNICATION AND DISSEMINATION: Disseminating information and findings to
healthcare professionals, regulatory agencies, and the public to promote awareness and
facilitate informed decision-making regarding medication use.
5. SUPPORTING REGULATORY DECISION-MAKING: Providing evidence-based
recommendations to regulatory authorities to support regulatory decision-making
processes, such as product approvals, label updates, or safety advisories
 Overall, the program aims to enhance pharmacovigilance efforts globally and improve
patient safety by identifying, assessing, and mitigating the risks associated with
pharmaceutical products.
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7. Who collaborating Center the Uppsala monitoring centre
{UMC}
Established as a foundation 1978
• Based on agreement Sweden – WHO
• International administrative board
• WHO Headquarters responsible for policy, self financing.
• Six board members – Three appointed by the government and Three appointed by WHO.
• UMC runs the program but WHO is responsible for policy issues.
• UMC is one of five officially designated collaborating centers.
• UMC is responsible for managing the technical and scientific aspects of the WHO’s worldwide pharmacovigilance network.
It includes:- 1) Analyzing VigiBase data and identifying signals of potential safety problems.
2) Pursue research.
3) Broadening the scope of pharmacovigilance through debate, research and consultation.
4) To collect, assess and communicate information from member countries about benefits, harms and risks of drugs to improve patient therapy and public
health worldwide.
5) To collaborate with member countries.
6) Developing and providing data-entry, management, retrieval and analysis tools such as VigiFlow and VigiLyze.
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8. Advisory committee on safety of medicinal products..
(ACSoMp )
• ACSoMP was established in 2003 to provide advice to WHO, including its Collaborating Centre for
International Drug Monitoring (the UMC), and through it to the Member States of WHO, on safety
issues relating to medicinal products.
• It guides WHO on general and specific issues related to Pharmacovigilance (PV).
• The Committee is composed of 12 members drawn from the WHO Expert Advisory Panels for Drug
Evaluation and for Drug Policies and Management and, where appropriate, in consultation with other
relevant WHO clusters and expert advisory panels.
• ACSoMP meets once a year to discuss ongoing and new PV topics, with particular focus on issues
related to public health programes.
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9. •Role of Who in pharmacovigilance …
• To identify ADR that could not be found through clinical trial program.
• Collecting case reports.
• Uppsala Monitoring Centre, Sweden.
⚫ Jobs performed:
1) Signal detection
2) Signal review
3) Education and advisory
4) Research & Development
5) Setting standard and guidelines.
6) Capacity Building.
7) Risk communication.
Overall, WHO plays a crucial role in promoting pharmacovigilance as an essential component of public health by
ensuring the safe and effective use of medicines worldwide.
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10. VigiBase
VigiBase is the World Health Organization’s (WHO) global database of individual case safety reports (ICSRs) of
adverse drug reactions (ADRs). It is maintained by the WHO Programme for International Drug Monitoring.
VigiBase collects and stores reports of suspected adverse reactions to medicines submitted by national
pharmacovigilance centers, regulatory authorities, pharmaceutical companies, healthcare professionals, and
patients from around the world .
The database contains millions of anonymized case reports dating back several decades, making it one of the
largest and most comprehensive repositories of pharmacovigilance data globally. VigiBase serves as a valuable
resource for signal detection, risk assessment, and pharmacovigilance research. It allows pharmacovigilance
experts to analyze patterns and trends in adverse drug reactions, identify potential safety signals associated with
specific medications, and contribute to the evaluation of drug safety profiles.
• VigiBase is UMC’s starting-point for the journey from data to wisdom about safer use of medicines and wise
therapeutic decisions in clinical practice.
• It is the driving-force at the heart of the work of UMC and the WHO Programe.
• Since 1978 UMC has been responsible for the development and maintenance of VigiBase.
• The purpose is to ensure that early signs of previously unknown medicines-related safety problems are
identified as rapidly as possible
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11. •Regulatory terminology of adr
In pharmacovigilance, ADR stands for Adverse Drug Reaction, which refers to any harmful or
unintended response to a medication at normal doses during clinical use. Regulatory agencies and
organizations have developed specific terminologies and classifications related to ADRs. Here are
some of them:
1) WHOART (WHO Adverse Reaction Terminology): Developed by the World Health Organization
(WHO), WHOART is a standardized dictionary of terms used to code adverse reactions. It provides a
common language for reporting and analyzing adverse drug reactions.
2) MedDRA (Medical Dictionary for Regulatory Activities): MedDRA is a standardized medical
terminology developed by the International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH). It is widely used by regulatory authorities and the
pharmaceutical industry for the classification and analysis of adverse events and drug safety data.
3) CIOMS (Council for International Organizations of Medical Sciences) Reporting Form: The CIOMS
form is a standardized format for reporting adverse drug reactions, developed by CIOMS in
collaboration with the WHO. It includes key information such as patient demographics, medication
details, and characteristics of the adverse reaction.
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12. 4) ICH E2D Guidelines: The International Council for Harmonisation (ICH) E2D
guidelines provide guidance on the safety data management for drug development
and post-marketing surveillance. It includes recommendations for the collection,
coding, and reporting of adverse drug reactions.
5) FDA Adverse Event Reporting System (FAERS): The FDA’s FAERS is a database
that contains information on adverse event and medication error reports submitted
to the FDA. It serves as a key resource for monitoring the safety of medications
marketed in the United States.
• These terminologies and reporting systems play a crucial role in the
standardization and harmonization of adverse drug reaction data, enabling
regulatory agencies, healthcare professionals, and pharmaceutical companies to
effectively monitor and evaluate the safety of medications.
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13. Evaluation of medication safety ..
Evaluation of medication safety in pharmacovigilance involves several key steps and considerations :-
1) Data Collection: Pharmacovigilance systems gather data from various sources including spontaneous
reporting systems, clinical trials, electronic health records, and literature reviews.
2) Signal Detection: Analyzing collected data to identify potential safety signals, which are indications of
previously unknown adverse effects associated with a particular medication.
3) Signal Validation: Validating identified signals through further investigation to determine whether there
is a causal relationship between the medication and the adverse event.
4) Risk Assessment: Assessing the magnitude and seriousness of the identified risks associated with the
medication, including factors such as frequency, severity, and potential patient outcomes.
5) Risk Management: Developing strategies to minimize or mitigate identified risks, which may include
updating product labeling, implementing risk communication strategies, or imposing additional
regulatory measures.
6) Benefit-Risk Evaluation: Balancing the potential benefits of the medication against its identified risks
to determine whether the overall benefit-risk profile remains favorable for its continued use.
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14. 7) Post-Marketing Surveillance: Continuously monitoring the safety of medications after they
have been approved and marketed to detect any new or emerging safety concerns that may
arise in real-world use.
8) Regulatory Compliance: Ensuring compliance with regulatory requirements for reporting and
managing adverse drug reactions, including timely submission of safety data to regulatory
authorities.
9) Communication: Communicating relevant safety information to healthcare professionals,
patients, and other stakeholders to facilitate informed decision-making regarding medication
use.
10) Continuous Improvement: Continuously evaluating and improving pharmacovigilance
processes and systems to enhance medication safety and minimize patient harm.
Overall, the evaluation of medication safety in pharmacovigilance requires a comprehensive and
systematic approach to identify, assess, and manage risks associated with the use of
medications, with the ultimate goal of maximizing patient safety and public health outcomes.
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15. Pharmacovigilance drug safety:
 Adverse Drug Reaction (ADR) Monitoring: Pharmacovigilance systems aim to identify and
monitor adverse drug reactions, which are harmful and unintended responses to
medications. Healthcare professionals and patients are encouraged to report suspected
ADRs to regulatory authorities or pharmacovigilance programs, enabling the ongoing
collection and analysis of safety data.
 Signal Detection: Pharmacovigilance activities involve the systematic monitoring and
analysis of safety data to identify potential signals or patterns that may indicate new or
previously unrecognized risks associated with a drug. This involves the use of various tools
and methods, such as data mining, statistical analysis, and signal management, to detect
and investigate potential safety concerns.
 Benefit-Risk Assessment: Pharmacovigilance plays a critical role in assessing the balance
between the benefits and risks of medications. By collecting and analyzing safety data from
various sources, including clinical trials and post-marketing surveillance, regulators and
healthcare professionals can evaluate the overall benefit-risk profile of drugs and make
informed decisions regarding their use.
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16.  Regulatory Reporting: Pharmaceutical companies are required to report safety data and suspected
adverse reactions to regulatory authorities as part of their regulatory obligations. These reports
provide important information for regulatory decision-making, including labeling updates,
contraindications, or restrictions on drug use.
 Post-Marketing Surveillance: Once a drug is approved and available on the market,
pharmacovigilance activities continue to monitor its safety in real-world clinical practice. Post-
marketing surveillance systems track and evaluate the safety of drugs in larger and more diverse
patient populations, detecting rare or long-term adverse events that may not have been identified
during clinical trials.
 Risk Management Strategies: Pharmacovigilance also involves the development and implementation
of risk management strategies to minimize or mitigate known risks associated with specific drugs.
This may include prescribing restrictions, monitoring requirements, educational materials for
healthcare professionals and patients, and communication of safety information.
 International Collaboration: Pharmacovigilance operates on a global scale, with international
collaboration and information sharing being essential for timely detection and response to drug
safety issues. Regulatory agencies, healthcare organizations, and pharmacovigilance network.
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17. Thankyou…
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