History and Development of Pharmacovigilence.pdf

Pharmacovigilance, derived from the Greek words "pharmakon" (drug) and "vigilare" (to keep watch), is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It has a rich history that spans centuries, evolving in response to medical advancements, regulatory changes, and societal needs.

The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development.

In the early 20th century, the introduction of potent drugs like digitalis and barbiturates highlighted the need for monitoring their safety. However, it wasn't until the thalidomide tragedy of the 1950s and 1960s, where thousands of babies were born with severe birth defects due to prenatal exposure to the drug, that pharmacovigilance gained widespread recognition. This catastrophic event underscored the importance of systematic surveillance and led to the establishment of regulatory frameworks to ensure drug safety.

The 1960s witnessed the creation of formal pharmacovigilance systems by regulatory agencies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). These systems aimed to collect, analyze, and disseminate information on adverse drug reactions (ADRs) through spontaneous reporting systems.

The thalidomide tragedy also spurred the development of pharmacovigilance legislation worldwide. In 1961, the Kefauver-Harris Amendments in the United States mandated pre-market approval of drugs, rigorous testing, and post-marketing surveillance. Similar regulatory measures were adopted globally, emphasizing the importance of continuous monitoring of drugs throughout their lifecycle.

The 1970s and 1980s saw further advancements in pharmacovigilance methodologies and infrastructure. The WHO established the International Drug Monitoring Program (IDMP) in 1968, facilitating international collaboration in ADR reporting and analysis. Additionally, technological innovations, such as computerized databases and signal detection algorithms, enhanced the efficiency and accuracy of pharmacovigilance activities.

The 1990s marked a period of globalization and harmonization in pharmacovigilance. The International Conference on Harmonization (ICH) developed guidelines to standardize pharmacovigilance practices across regions, promoting consistency in data collection, analysis, and reporting. Furthermore, the emergence of the internet facilitated direct patient reporting of ADRs, empowering individuals to contribute to drug safety surveillance.

In the 21st century, pharmacovigilance has continued to evolve in response to emerging challenges and opportunities. The proliferation of biological therapies, personalized medicine, and pharmacogenomics has ne

1. History and Development of
Pharmacovigilance
Pharmacovigilance is a vital field that safeguards public health by monitoring the safety of
pharmaceutical drugs throughout their lifecycle. This presentation explores the pivotal moments, key
milestones, and ongoing advancements that have shaped the evolution of this critical discipline.
by Sasikiran Marri

2. Introduction to Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and
prevention of adverse effects or any other medicine-related problem. It is essential for ensuring the safe and
effective use of drugs by continuously evaluating their benefits and risks. This overview will highlight the
importance of drug safety monitoring and provide a roadmap for the journey ahead.
1Definition of
Pharmacovigilance
The systematic
collection, detection,
assessment, monitoring,
and prevention of
adverse effects with
pharmaceutical
products.
2Importance of
Monitoring Drug
Safety
Identifying and
mitigating potential risks
associated with
medicines to protect
public health and
promote safe, effective
drug use.
3Overview of
Presentation
Structure
Tracing the history,
development, and
advancements of
pharmacovigilance
systems and practices
over time.

3. The Thalidomide Tragedy
The Thalidomide disaster of the 1950s and 1960s was a watershed moment that catalyzed the establishment of modern
pharmacovigilance systems. This tragic event, where the drug Thalidomide caused severe birth defects in thousands of
children, exposed the urgent need for robust drug safety monitoring and regulation.
1 Thalidomide Disaster
The drug Thalidomide, promoted as a sedative and treatment for morning sickness in
pregnant women, was found to cause devastating birth defects in newborns.
2 Impact on Regulation
The Thalidomide tragedy led to major reforms in drug safety regulation, including the
introduction of rigorous pre-market testing and post-marketing surveillance requirements.
3 Catalyst for Pharmacovigilance
This pivotal event was the driving force behind the establishment of national and
international pharmacovigilance programs to systematically monitor and address drug
safety concerns.

4. Establishing Pharmacovigilance Systems
In the aftermath of the Thalidomide disaster, concerted efforts were made to develop comprehensive
pharmacovigilance systems at both the national and international levels. This section explores the key
milestones in the formation of these crucial drug safety monitoring frameworks.
National
Pharmacovigilance
Programs
Many countries established
dedicated national
pharmacovigilance centers to
collect, analyze, and respond
to adverse drug reaction
reports from healthcare
providers and the public.
Role of the World
Health Organization
(WHO)
The WHO played a pivotal role
in coordinating global
pharmacovigilance efforts,
including the creation of the
Uppsala Monitoring Centre
(UMC) to manage the WHO
Programme for International
Drug Monitoring.
Early Pharmacovigilance
Initiatives
In the 1960s and 1970s,
pharmaceutical companies,
regulatory authorities, and
healthcare professionals
began implementing
systematic processes for the
surveillance and reporting of
adverse drug reactions.

5. International Collaboration in
Pharmacovigilance
Recognizing the global nature of drug safety, the pharmacovigilance community has focused on fostering
international cooperation and coordination. This section highlights key initiatives and the importance of
cross-border collaboration in strengthening worldwide drug safety monitoring.
International Corporation
initiatives

The establishment of
organizations like the
International Conference on
Harmonisation (ICH) and the
International Society of
Pharmacovigilance (ISoP) have
facilitated the harmonization of
global standards and best
practices.
Strengthening Global
Networks
The development of robust
international
pharmacovigilance networks
has enabled the sharing of data,
expertise, and resources,
leading to more efficient and
effective drug safety monitoring
worldwide.
Importance of Cross-
Border Cooperation
The globalization of the
pharmaceutical industry and the
need to address safety issues
that transcend national
boundaries have underscored
the critical role of international
collaboration in
pharmacovigilance.

6. Advancements in Pharmacovigilance
Systems
Over the decades, pharmacovigilance has undergone significant technological and operational
advancements that have transformed the way drug safety information is collected, analyzed, and
disseminated. This section explores some of the key developments that have shaped the modern era of
pharmacovigilance.
1Electronic Reporting Systems
The introduction of electronic
databases, such as VigiBase, the WHO
global database of individual case
safety reports, has revolutionized the
way adverse drug reactions are
reported and analyzed.
2 Advantages of Electronic
Reporting
Electronic reporting systems have
improved data collection, enabled real-
time monitoring, and facilitated more
efficient analysis of safety signals,
leading to quicker detection and
response to potential drug safety
issues.
3Expanding Data Sources
Pharmacovigilance has evolved to
incorporate a broader range of data
sources, including electronic health
records, patient registries, and social
media, providing a more
comprehensive understanding of drug
safety profiles.

7. Regulatory Frameworks for
Pharmacovigilance
As pharmacovigilance has become more essential to public health, regulatory authorities have implemented
increasingly comprehensive frameworks to govern drug safety monitoring and risk management. This section
highlights some of the key regulatory developments that have shaped the modern pharmacovigilance
landscape.
EU Pharmacovigilance
Legislation
The European Union has
established robust
pharmacovigilance
regulations, including the EU
Pharmacovigilance Directive
and Regulation, which
mandate comprehensive post-
marketing surveillance and
risk management planning for
marketed products.
FDA Amendments Act
In the United States, the Food
and Drug Administration
Amendments Act (FDAAA) has
significantly expanded the
pharmacovigilance
requirements for drug
manufacturers, including
mandatory postmarketing
studies and the implementation
of Risk Evaluation and Mitigation
Strategies (REMS).
Integrating
Pharmacovigilance
Regulatory frameworks
have increasingly
emphasized the
importance of integrating
pharmacovigilance
throughout the entire drug
development lifecycle, from
pre-clinical trials to post-
marketing surveillance.

8. Pharmacovigilance in Drug Development
Pharmacovigilance has become an integral component of the drug development process, ensuring that safety
considerations are addressed at every stage. This section explores how pharmacovigilance has been
increasingly incorporated into the lifecycle of pharmaceutical products, from clinical trials to post-marketing
surveillance.
Pharmacovigilance in
Drug Lifecycle
Pharmacovigilance activities,
such as adverse event
reporting, safety signal
detection, and risk
management planning, are
now woven into the drug
development process, from
pre-clinical studies to post-
marketing surveillance.
Importance of Post-
Marketing Surveillance
Post-marketing surveillance
studies have become crucial
for identifying and addressing
potential safety issues that
may not have been detected
during clinical trials, which
often have limited sample sizes
and durations.
Risk Management
Planning
Comprehensive risk
management planning,
including the development of
Risk Evaluation and Mitigation
Strategies (REMS), has become
a standard requirement for
marketed products to
proactively address and
mitigate identified safety risks.

9. Advancements in Pharmacovigilance
Analytics
The field of pharmacovigilance has also seen significant advancements in data mining and signal detection
techniques, leveraging emerging technologies to enhance the identification and assessment of potential drug
safety issues.
Data Mining Techniques
Sophisticated data mining algorithms and statistical methods are being employed to analyze
large, diverse datasets and detect potential safety signals more efficiently.
Artificial Intelligence and Machine Learning
The integration of artificial intelligence and machine learning capabilities has enabled the
automation and optimization of signal detection, risk assessment, and decision-making
processes in pharmacovigilance.
Enhanced Signal Detection and Risk Assessment
These technological advancements have significantly improved the ability to identify,
evaluate, and respond to potential drug safety issues in a more timely and effective manner,
ultimately enhancing patient safety.

10. The Future of Pharmacovigilance
As the field of pharmacovigilance continues to evolve, there are exciting opportunities and challenges on the
horizon. This final section highlights the key trends and future directions that will shape the future of drug
safety monitoring and promotion of public health.
Continued Innovation
Ongoing advancements in
data collection, analytics,
and technology will drive
further enhancements in
pharmacovigilance,
allowing for more
comprehensive, real-time
monitoring and rapid
response to emerging safety
concerns.
Enhancing Global
Collaboration
The importance of
international cooperation
and the sharing of data,
expertise, and best
practices will only grow, as
the pharmaceutical industry
and drug safety challenges
become increasingly global
in nature.
Addressing Future
Challenges
Emerging issues such as the rise
of biologics, personalized
medicine, and the increasing
prevalence of digital health
technologies will require the
pharmacovigilance community
to adapt and develop innovative
approaches to ensure the
continued safety of
pharmaceutical products.