The document discusses adverse drug reaction (ADR) reporting tools. It provides a brief history of pharmacovigilance and describes the ADR reporting process from healthcare professionals to regional and zonal centers, and finally to national and global databases. It emphasizes the importance of post-marketing ADR monitoring to identify uncommon or rare reactions not detected during clinical trials. Key aspects like what information to report, who can report, and how to submit reports using standardized forms are summarized. Common ADR reporting software tools like Argus are also highlighted.

1. ADVERSE DRUG
REACTION
REPORTING TOOLS
RIMA SINGH
M. Pharm, 2nd Sem
(DEPARTMENT OF PHARMACOLOGY)
INDO-SOVIET FRIENDSHIP COLLEGE OF
PHARMACY, MOGA
1

2. Contents
2
• Introduction
• History
• Adverse drug reaction
• ADR reporting tools
• Role of Pharmacovigilance in ADR monitoring
• Methods of ADR reporting and Process
• Software used in ADR reporting
• Conclusion
• References

3. Introduction
3
Clinical trial study of the drug detects ADR but, the
reactions occurs after long duration in a specific population
remains undetected.
So, (PV) Pharmacovigilance is a activity which keeps
constant watch on the drug throughout its life cycle.
In India, IPC and NCC through the CDSCO regulate the PV
activity.
Then Pharmacovigilance programme in India have been
proposed in 2010. Anyone can report ADR by filling the
suspected ADR reporting form available online or offline to
the nearest centers in suitable languages.
Then, the reported ADRs are collected and processed at
the centers in vigiflow software. The centers detects signals
which are reported to CDSCO and WHO.

4. Adverse drug reaction
According to WHO, an adverse drug reaction defined as,
“Any response to a drug which is noxious unwanted effect
of drug doses used in human for prophylaxis, diagnosis
and therapy”.
For example,
(when drug metabolism is temporarily inhibited by a
disorder or another drug).
4

5. 1957- Thalidomide tragedy.
1968- WHO Programme established with 10 member states
for International ADR terminology and drug dictionary.
1969- Definition of Adverse drug reaction.
1978- Operations transferred to the UMC (Uppsala) from
WHO(Geneva); setting-up of relational database
management system. grading field was added to Vigibase.
1991- On-line WHO database search programme available to
national centre.
2001- Start of Vigibase Online project (now VigiFlow).
2010- 100th country joins the WHO Programme for
International Drug Monitoring.
5
History

6. Type Type of
Effect
Characteristics Example
A Augmented Dose dependent, Predicted from the
known pharmacology of the drug
Hypoglycemia-
insulin
B Bizarre Unpredictable, Dose independent,
Rare.
Anaphylaxis to
penicillin
C Chronic Prolong treatment. Analgesic -
neuropathy
D Delayed After years of treatment. Antipsycotic-
turdive dyskinesia,
6
Types of ADR

7. Adverse drug reaction reporting tools
7
Adverse drug reactions reporting tools or monitoring
is a process of continuously monitoring of
undesirable effect suspected to be associated with
use of medical products. ADR reporting covers all
pharmaceutical products, biological, herbal drugs,
cosmetics and medical devices.

8. Healthcare professionals
Peripheral centers
Regional centers
Zonal centers
NPC/CDSCO
WHO/UMC
Fig.1: ADR reporting process 8

9. Objectives of ADR monitoring
9
1. Todetect the nature and frequency of ADRs
2.To assist the Drug Regulatory Authority, Public Health
Programs, Scientists and Consumer Society to minimize ADRs.
3.Providing updated Drug Safety Information to Health Care
Professionals.
5.Dissemination of information by designing proper education
program to consumers
6.To identify risk factors that may predispose, induce or
influence the development, severity and incidence of ADRs.

10. Benefits of ADR monitoring
10
and safety of1. It caters information about quality
pharmaceuticals products.
2. It initiates risk management plans.
helps in3. It prevent the predictable adverse effects and
measuring ADR incidence.
4. It instructs health care team, patients, pharmacists and
nurses about adverse drug effects and creates awareness
regarding ADRs.

11. Information required for ADR monitoring
1. Patient Information
2. ADRs Description
3. Information Related to Suspected Drug(s)
4. Information on Management of ADR
5. Information about the reporter
11

12. ADR monitoring studies for the
identification of adverse events.
12
monitor• Case reports: This is done to
unpredictable ADRs.
• Anecdotal reporting: This monitoring is done
for the medicinal product whose ADR are not
reported in medical bulletin.
• Impulsive reporting system: it is most efficient
and spontaneous method of ADR recording.

13. • Intensive monitoring
13
studies: In this, selected
population is screened and continuously watched
to record all the events when the drug or
different drug is administered.
• Contingent studies: These types of studies are
conducted on population on a specific conditional
bases and comparing a particular drug ADR group
or population with another population having
similar treatment.

14. • Case control studies: These are retrospective
study design. Patient have illness or disease due
to the use of drug are investigated to check if
they have taken the drug, these patients are
compared with matched control group.
• Case cohort studies: Both prospective &
retrospective in nature.
• Meta analysis: It is performed by applying
statistical analysis on two or more independent
studies to predict the long term outcomes of a
particular drug treatment or a disease situation.
14

15. Methods of ADR monitoring
15
•Spontaneous reporting: Mostly used ADR for
monitoring, it records the safety of a drug based
on post marketing surveillance to identify new,
rare, serious ADRs of a drug.
•Case series reporting: It is used to develop a
hypothesis between approved drugs and it
outcomes.
•Stimulated reporting: It encourages and
facilitates health professionals report ADRs under
special situation.

16. Active surveillance: It
which
16
is pre-designed
is conducted in addition to
process
passive
surveillance to find out more serious adverse drug
events.
Comparative observation studies: Includes study
designs such as cross- sectional, cohort and case
study to compare the possible ADR associated
with drug use with other group etc.

17. Role of pharmacovigilance in ADR monitoring
17
Different study designs are included for proper
pharmacovigilance study:
a. Descriptive studies: It is conducted to obtain the
rate of outcome of drug use in specific
population.
b. Analytical studies: Analytical studies are
performed to study related outcomes of the
exposure to the drugs.
c. Observational based study: Usually help to
evaluate the effectiveness of the drug in the
patients during treatment.

18. What to report
1.All ADRs as a result of Prescription and Non-Prescription
medicinal products.
2. All suspected ADRs regardless of product information
provided by the company.
3. Unexpected reaction with the product regardless of
their nature or severity.
4. A serious reaction, whether expected or not.
5.All suspected ADRs associated with drug-drug, drug-
food or drug-food supplements interactions.
6. ADRs occurring from overdose or medication error.
7. Unusual lack of efficacy or when
pharmaceutical defects are observed.
suspected
18

19. Who should report
19
as possible.
inaccurate
1. Health care Professionals and Providers
2. Manufacturers of Product
3. Health care centers
When to Report
1. ADR should be reported as soon
2.Delay in reporting make the report
and unreliable

20. How to report
20
1.Report should be on a standardized ADR reporting
form.
2.Dully filled the ADRs in the reporting from when an
ADR is encountered.
3.Use a separate from for each patient and filled with
the complete information.
4.The completed ADR form is then returned to the
nearest adverse drug reaction monitoring Centre
(AMC) or to National Coordinating Centre.

21. 5.Any follow-up information for an ADR case that has
already been reported can be sent on another ADR
form, or communicated by telephone, fax or e-mail.
6.Follow-up reports should be identifiable and the
following should be indicated on the report
a) Follow-up Information
b) Date of Original Report
c) Patient Identity
21

22. Why post-marketing surveillance and reporting ADR
is needed
The information collected during the pre-marketing phase of
drug development is incomplete with regard to possible ADRs.
This is mainly because, tests in animals are insufficient to
predict human safety, Patients used in clinical trials are
selected and limited in number, the conditions of use differ
from those in clinical practice and the duration of trials is
limited.
Information about rare but serious adverse reactions, chronic
toxicity, use in special groups (such as children, the elderly or
pregnant women) or drug interactions is incomplete or not
available. Thus, post-marketing surveillance is important to
permit detection of less common, but sometimes very serious
ADRs. 22

23. ADR reporting form, IPC
23

24. ADR reporting form, CDSCO
24

25. Fig.2: Workflow of PV for reporting ADR 25

26. What happens to submitted information
26
1.The causality assessment is carried out at Adverse Drug
Reaction Monitoring Centers (AMCs) by using WHO-UMC
scale.
2.The analyzed forms are forwarded to the National
Coordinating Centre through the ADR database.
3.Finally the data is analyzed and forwarded to the Global
Pharmacovigilance Database managed by WHO Uppsala
Monitoring Center in Sweden.
4.The reports are periodically reviewed by the National
Coordinating Centre (PvPI).
5.The information generated on the basis of these reports
helps in continuous assessment of the benefit-risk ratio of
medicines.

27. Argus oracle method of ADR reporting
27
• It is a software for ADR monitoring, mainly used by
drug manufacturer in USA.
• It is a comprehensive pharmacovigilance platform
enabling manufactures to make faster and better safety
decision and risk management.
• In other words it is necessary for clinical and post
marketing surveillance.

28. Capabilities of the software
28
• Single global database
• Case processing updates
• E2B compliance( ICH)
• Periodic submission
• Advance querying and reporting
• Data model for single detection
• Automated unblinding, etc.

29. Adverse
event
Literature
review
Data entry of adverse
event information
Coding of event
and drug info
Medical
review
Writing
case
narratives
Safety data
reconciliation
Verificationof
case
information
Aggregate
report
writing
Regulatory
reporting
Periodic safety
update reports
29
Fig.3: Argus work flow

30. Aris g Pharmacovigilance
30
•It is a software for ADR monitoring, and is mainly used
by drug manufacturer in Europe.
•Arisg is a leading pharmacovigilance and clinical safety
system that helps companies efficiently process all safety
cases and generate appropriate global reports for
distribution to regulatory authorities and partners.

31. Vigiflow, Vigibase
31
• Vigiflow: It is a management system for recording,
processing and sharing reports of adverse effects. It
supports the domestic collection and processing of
individual case safety report data.
• Vigibase: It is the single largest drug safety data
repository in the world. Since 1978, the Uppsala
Monitoring Centre on behalf of WHO, have been
maintaining Vigibase, used to obtain the information
about a safety profile of a medicinal product.

32. Fig.4: Reporting system in Vigiflow
ICSRs uploaded in Vigiflow at AMC
Received at
NCC for quality
Valid or
complex
ICSR
WHO-UMC Sweden
CDSCO HQ
32
QuerySafety
updates
Invalid ICSR
Revert to AMC

33. Conclusion
33
In India, PV system has increased awareness in people
regarding ADR reporting. The issues of underreporting are
resolving due to available reporting facilities like toll free
dial number, message, mail and ADR form in vernacular
languages. Various multinational companies have started
the outsourcing of PV activity in India which is creating the
good PV culture. Various universities have incorporated PV
courses in their curriculum as compulsory or elective
subject. Still government needs to focus on the awareness
and enhancement of pharmacists knowledge and providing
them facilities and power to conduct PV activity. Every
hospitals should have special PV cell for ADR monitoring.

34. References
34
1.Safety Monitoring of Medicinal Products. Guidelines for setting
up and running a Pharmacovigilance centre. Uppsala Monitoring
Centre-WHO Collaborating Centre for International Drug
Monitoring, EQUUS, London, 2000.
2.Ghewari P, Salunke S, Bhatiya N, Killedar S (2014) Strategies and
current scenario of pharmacovigilance in India. JADD 1: 122-134.
3.Indian Pharmacopoeia Commission Pharmacovigilance Program
of India.
4.World Health Organization (2002) World Health Organization
Collaborating centre for International Drug Monitoring. The
Importance of Pharmacovigilance Safety Monitoring of Medicinal
Products, Geneva.

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