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 [email protected] 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 [email protected] 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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Adverse Event Analysis

Healthcare

Transcript of Adverse Event Analysis