Big data has brought about a transformative shift in various industries, including healthcare and pharmacovigilance. In the context of drug safety, big data has the potential to change pharmacovigilance practices from being reactive to becoming proactive. Here's how big data is facilitating this transformation

1. Welcome
HOW BIG DATA TRANSFORM REACTIVE DRUG
SAFETY TO PROACTIVE PHARMACOVIGILANCE
P. Lakshmi Bhavani
B. Pharmacy
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26/06/2023
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2. CONTENTS
• Introduction
• Traditional pharmacovigilance
• The emergence of big data
• The proactive approach
• Early signal detection
• Real Time Monitoring
• Predictive modeling
• Benefits and impacts
• conclusions
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3. INTRODUCTION
CONCEPT OF PHARMACOVIGILANCE
• Pharmacovigilance is the science and activities related to the detection, assessment, understanding,
and prevention of adverse effects or any other drug-related problems.
ROLE
1. Adverse event reporting: It involves reporting any adverse events that occur after the usage of
particular medications.
2. Signal detection: PV experts analyze collected data to identify potential signals, which are
unexpected patterns or trends that could indicate a safety concern associated with a drug.
3. Risk assessment and benefit-risk analysis: This analysis is done to evaluate whether the
benefits of the drug outweigh its risks.
4. Post-marketing surveillance: PV involves ongoing monitoring of drugs throughout their
lifecycle, from pre-market clinical trials to post-market use.
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4. SHIFT FROM REACTIVE TO PROACTIVE APPROACHES
IN ENSURING PATIENT SAFETY
• The shift from reactive to proactive in ensuring patient safety significantly advances
healthcare practices.
• This transition focuses on enhancing patient care, minimizing harm, and improving
overall healthcare outcomes by addressing potential risks and adverse events before
they occur.
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Aspects of shift
Continues monitoring : It
involves continuous
monitoring of patients
especially those at high risk
or undergoing complex
treatments.
Early warning system:
It allows healthcare
providers to detect signs
of deterioration in a
patient’s condition at an
early stage.
Predictive analytics:
Proactive patient safety
involves the use of predictive
analytics and data driven
insights to identify patterns ,
trends , and potential risk
factors.
Safety protocols and
checklist :
It’s done to ensure
consistent and safe care
delivery. These
Protocols are designed
to prevent errors,
infections, and other
Avoidable adverse
events.

5. TRADITIONAL METHODS OF
PHARMACOVIGILANCE
It involves an established approach for monitoring and assessing the safety of pharmaceutical
products after they are approved and marketed. These methods have been used for decades.
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TRADITIONAL METHODS
Case series
and case
reports
Spontaneous
reporting
system
Medical
device
reporting
Literature
Review
Adverse event
profiling

6. LIMITATION OF REACTIVE APPROACHES IN IDENTIFYING
ADVERSE EVENTS
Reactive approaches in identifying adverse events, while valuable, have several limitations that can impact
their effectiveness in ensuring patient safety. Some of the key limitations of reactive approaches.
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LIMITATIONS
Underreporting
bias
Delayed
detection
Lack of
complete
information
Variability in
reporting
standards
Lack of Control
groups
Lack of
Timelines

7. THE EMERGENCE OF BIG DATA
BIG DATA
Definition:
Big Data refers to extremely large and complex sets of data that cannot be
effectively managed, processed, or analyzed, using traditional data processing
tools and methods. It comprises structured, semi-structured, and unstructured
data from various sources.
Characteristics:
VOLUME(Large amounts of data)
VELOCITY(Rapid data generation and processing)
VARIETY(Different types of data)
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8. RELEVANCE OF BIG DATA IN TRANSFORMING
HEALTHCARE PRACTICES
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PERSONALISED
MEDICINE
PREDICTIVE
ANALYTICS
CLINICAL
DECISION
SUPPORT
DRUG
DISCOVERY AND
DEVELOPMENT
RESEARCH AND
CLINICAL TRIALS
GENOMIC
MEDICINE
BIG DATA IN
TRANSFORMING
HEALTHCARE
PRACTICES

9. POTENTIAL OF BIG DATA TO REVOLUTIONIZE
PHARMACOVIGILANCE
Big data has the potential to revolutionize PV by significantly enhancing the
efficacy, accuracy, and scope of monitoring and assessing the safety of
pharmaceutical products.
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HOW BIG DATA
REVOLUTIONIZE
PHARMACOVIGILANCE
EARLY SIGNAL
DETECTION
REAL TIME
SURVEILLANCE
ENHANCED SIGNAL
VALIDATION
POST MARKET
SURVEILLANCE
PREDICTIVE ANALYTICS

10. PROACTIVE APPROACH
ENABLED BY BIG DATA
It refers to a strategy in which organizations leverage the capabilities of advanced data analytics
and technology to anticipate and address potential issues, opportunities, and trends before they
fully manifest. This is how big data enables a proactive approach:
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EARLY DETECTION OF PATTERNS AND ANOMALIES
REAL-TIME MONITORING
PREDICTIVE MODELLING

11. EARLY SIGNAL DETECTION
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Big data analytics can identify patterns and anomalies in vast datasets
that might indicate emerging trends or potential issues.
This enables organisations to detect deviations from the norm early
and take appropriate actions

12. REAL-TIME MONITORING
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With big data analytics, organizations can monitor data streams in
real-time, identifying changes or irregularities as they happen.
This capability is essential for proactive responses in dynamic
environments.

13. PREDICTIVE MODELING
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Big data allows organizations to develop predictive models that
forecast future outcomes based on historical data and current trends.
This is valuable for anticipating customer behavior, disease
outbreaks, equipment failures, and other events.

14. BENEFITS AND IMPACTS
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EARLY DETECTION OF SAFETY SIGNALS
TIMELY INTERVENTIONS
PREVENTION OF ADVERSE EVENTS
ENHANCED PATIENT SAFETY

15. CONCLUSION
By leveraging big data analytics, pharmacovigilance can
evolve from a reactive process to a proactive one,
enhancing patient safety, improving healthcare outcomes,
and contributing to a more efficient and effective drug
regulatory environment.
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16. Thank You!
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