Adverse Event Analysis

© Copyright Maitems Analytics India Pvt. Ltd. 2014
Adverse Event Analysis
Presented at
2nd International Conference on Business Analytic
and Intelligence (ICBAI)
Senthil Kumar
Director, Maitems Analytics
Date: 20th Dec 2014

© Copyright Maitems Analytics India Pvt. Ltd. 2014| 2
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Data – Adverse event
Analysis and Significance
Indian Scenario
•  Software/platform
•  Techniques and method
•  Why caveats and Drivers
( - )

Test-Tube to Market
Preclinical Phase I Phase II Phase III In Market
20 to 80
Healthy
volunteers
Several
hundred
patients with
disease or
condition
Several hundred
to thousand
patients with
disease or
condition
Development Post Approval
Controlled environment ??
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Clinical vs. In-Marketed drugs
•  AEs are monitored well in a clinical setup (carefully
controlled conditions)
–  case reports, spontaneous reporting systems, intensive event
recording, case-control studies, case-cohort studies, prospective
cohort studies, incident reports, retrospective or concurrent chart
reviews and observational studies
•  Do not have the statistical power to detect rare Adverse
Drug Reactions (ADRs) nor the effects of long-term
exposure
•  Hence monitoring of adverse event cannot be limited to
clinical trials
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How the cycle works
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Adverse Drug Event
•  An undesired effect of a medication
that either increases toxicity,
decreases desired therapeutic
effect, or both
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A significant number of AEs are preventable
in nature, and therefore this represents an
avoidable burden on health care
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Indian Scenario

Why Significant?
•  ~5.2 million injuries in India each year due to medical
errors and adverse events
•  ~43 million people are injured worldwide each year due
to unsafe medical care
•  4th leading cause of death in the United States
•  Disability are more common than death itself
•  In US alone, the costs to society are more than $136
billion annually -- greater than the total cost of
cardiovascular or diabetic care
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Source: Times of India | Sep 21, 2013
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Analysis ??
•  Structure data
•  Provides insights on the
drugs as well as the
ecosystem on which the
medical error could have
occurred
•  Valuable inputs as an early
warning to act for drug
manufacturers/marketers
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A valid report consist of
•  Identifiable patients
•  Identifiable drug
•  Identifiable reaction
•  Identifiable reporter
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Case Study
- A simple model which will track ADRs competitive
different brand as a KPI

Case Study
•  Business requirement: As part of the CI (competitive
intelligence) activity, our client company was interested
to develop a model which will track different brand
performance indicators and generate analyzed report to
track competitive performance. Input data to bring
insights on both commercial and clinical parameters is a
requirement. Adverse events reported by brand in FDA
adverse event database is an input as the geographic
scope was North America.
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Case study was removed from this version.
Contact skumar@maitemsanalytics.com for more info.

Case Study
Objective of the study:
•  To download AE (Adverse Event) data, study and
perform data cleaning to achieve consistency and
meaningful information across selected therapeutic area
•  Analyze to generate key insights pertaining to specific
marketed brands
•  Develop a process and framework for continuous data
update, analysis and report generation
•  Develop a simple tool that generates report by brand.
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Case study was removed from this version.
Contact skumar@maitemsanalytics.com for more info.

Data à Insights à Action
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Indian Scenario

Indian Scenario
•  Started in India about two decades ago (1982)
•  Joined the WHO program in 1997
–  (managed by the Uppsala Monitoring Centre, Sweden)
•  PVPI – Pharmocovigilance program of India
–  rolled out in three phases:
–  The first one being monitoring of reactions in the institutes
–  Second one in governmental bodies like CGHS
–  Third phase proposed to include general practitioners
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Yet spontaneous reporting of ADRs
was poor
•  In most instances, such reports are sent by the non-
faculty postgraduate students. Other issues include
under-reporting or biased reporting
–  A study from a large tertiary care hospital from north India
•  Data received by PvPI is shared with the WHO but not
with concerned pharmaceutical companies
–  which misses the opportunity to understand and manage the risk
benefit
•  Complete the cycle
–  Though the awareness exists among the data creation centers
(THCs), demonstration of its application/benefits and key
insights from analysis should be looped back to make this
system complete
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Path forward
•  Need
–  The gaps in the process of monitoring and reporting to
application of insights clarifies the need for an interconnected
reporting module like an online submission as well as retrieval of
drug reports
•  New Opportunities
–  This will bring up the need and challenge of developing an
integrated system for reporting, collection, collation of reports,
management and retrieval of data. Such system will open up
new opportunities for analytics industry and help develop
modules for analysis.
•  Our current knowledge on AE analysis and application
could also be an input to develop such system
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Thank You
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