Current Status

1. QUALITY INDICATOR OF ADR
REPORTS AND MEASURES FOR
IMPROVMENT
Submitted by-
Anurag Chourasia
M.Pharma 2nd Year
Pharmacology

2. CONTENTS
• Definitions
• Introduction
• Types of Pharmacovigilance Indicators
• Why need to learn about ADRs
• Suspected ADR Form
• Completeness Criteria of ADR form
• Measures to improve ADR reporting
• References

3. DEFINATIONS
• Indicators: Indicators are specific objective measures
that allow the evaluation of the baseline situation and
progress in systems and the assessment of services and
interventions.
• Adverse Drug Reaction: An adverse drug reaction is a
“response to a drug which is noxious and unintended
and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease or for the
modification of physiologic function.” Note that there
is a causal link between a drug and an adverse drug
reaction.
• Pharmacovigilance: is the science and activities
relating to the Detection, assessment, understanding,
reporting and prevention of adverse effects or any
other drug related problems.

4. INTRODUCTION
Pharmacovigilance indicators are measures of inputs, processes, outputs, outcomes, and impacts
of development projects, programmes or policies related to health systems and services. They
provide information for measuring how well a pharmacovigilance programme is achieving its
objectives.
Includes-
• provide objective measures to describe the pharmacovigilance situation in a country;
• assess pharmacovigilance activities – at the global (national), regional and health-care
facility levels;
• provide tools for supervision and monitoring of pharmacovigilance activities;
• assess progress and enable the prioritization of efforts, based on this assessment;
provide information for governments and other stakeholders to enable them to take a
appropriate action in ensuring drug safety.

5. TYPES OF PHARMACOVIGILANCE INDICATORS
• Structural indicators
• Process indicators
• Outcome and impact indicators
WHO Categories the pharmacovigilance indicators
Core indicators (C) are those considered to be highly relevant, important and useful in characterizing
pharmacovigilance.
Complementary indicators (T) are those additional measurements considered to be relevant and useful.

6. .
Only reports of
good quality
can produce
reliable
signals!
Why Quality Assurance Matters?

7. WHY NEED TO LEARN ABOUT ADR
• Over 2 MILLION Serious ADRsYearly
• 100,000 DEATHSYearly
• ADRs 4th leading cause of death ahead of Pulmonary Disease, Diabetes, AIDs, Pneumonia,
Accident
• Ambulatory patients ADR rate- Unknown
• Nursing home patientsADRs rate- 350,000 yearly

11. AMC’S
Pharmaceutical
Industries
Safety Alerts
Communication
Mobile App
Case Processing/
Quality Review
ADR Monitoring
Center (s)
[AMC’s]
Invalid/
Incomplete Report
Valid/
Complete Report
Causality assessment & data mining of
reports
Case
Reverted
Case
Reverted
ADVERSE DRUG REACTION (ADR) REPORTING IN INDIA
HOW INDIAN POPULATION GETTING BENIFITED...
Global safety data
collection
Regulatory
action
Reporting
Tools
NCC -PvPI

12. ADRs Reporting Status in
India
14847
23138
28411
41926
50533
67115
71586
0
10000
20000
30000
40000
50000
60000
70000
80000
2011 2012 2013 2014 2015 2016 2017

14. ICSRs Completeness Score: India Vs Other Countries

17. REFERENCES
• https://www.slideshare.net/Anindyabanerjee1988/role-of-pharmacovigilance-against-adverse-
drug-reaction
• http://www.mjdrdypu.org/article.asp?issn=0975-
2870;year=2013;volume=6;issue=2;spage=126;epage=131;aulast=Mulkalwar
• https://www.slideserve.com/fay/proposed-set-of-indicators-for-monitoring-and-evaluation-of-
pharmacovigilance-activities
• Plessis L, Gomez A, Garcia N, Cereza G, Figueras A. Lack of essential information in spontaneous
reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal
detection. Received: 9 December 2016/Accepted: 17 February 2017 # Springer-Verlag Berlin
Heidelberg 2017.
• Manali MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of
adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India.
DOI: 10.4103/picr.PICR_105_17.
• Hoffman KB, Demakas AR, Dimbil M, Tatonetti NP, Erdman CB.Stimulated reporting:the impact
of US food and drug administration-issued alerts on the adverse event reporting
system(FAERS).Drug.Saf.2014;37:971–80.doi:10.1007/s40264-014-02250PMID:25255848.