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M. Pharm, 2nd Sem
(DEPARTMENT OF PHARMACOLOGY)
INDO-SOVIET FRIENDSHIP COLLEGE OF
• Adverse drug reaction
• ADR reporting tools
• Role of Pharmacovigilance in ADR monitoring
• Methods of ADR reporting and Process
• Software used in ADR reporting
Clinical trial study of the drug detects ADR but, the
reactions occurs after long duration in a specific population
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
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.
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
(when drug metabolism is temporarily inhibited by a
disorder or another drug).
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
2001- Start of Vigibase Online project (now VigiFlow).
2010- 100th country joins the WHO Programme for
International Drug Monitoring.
Type Type of
A Augmented Dose dependent, Predicted from the
known pharmacology of the drug
B Bizarre Unpredictable, Dose independent,
C Chronic Prolong treatment. Analgesic -
D Delayed After years of treatment. Antipsycotic-
Types of ADR
Adverse drug reaction reporting tools
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.
Objectives of ADR monitoring
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
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.
Benefits of ADR monitoring
and safety of1. It caters information about quality
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
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
ADR monitoring studies for the
identification of adverse events.
monitor• Case reports: This is done to
• 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.
• Intensive monitoring
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
• 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.
Methods of ADR monitoring
•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
•Stimulated reporting: It encourages and
facilitates health professionals report ADRs under
Active surveillance: It
is conducted in addition to
surveillance to find out more serious adverse drug
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.
Role of pharmacovigilance in ADR monitoring
Different study designs are included for proper
a. Descriptive studies: It is conducted to obtain the
rate of outcome of drug use in specific
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.
What to report
1.All ADRs as a result of Prescription and Non-Prescription
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.
Who should report
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
How to report
1.Report should be on a standardized ADR reporting
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.
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
Why post-marketing surveillance and reporting ADR
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
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
What happens to submitted information
1.The causality assessment is carried out at Adverse Drug
Reaction Monitoring Centers (AMCs) by using WHO-UMC
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
Argus oracle method of ADR reporting
• 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
Capabilities of the software
• Single global database
• Case processing updates
• E2B compliance( ICH)
• Periodic submission
• Advance querying and reporting
• Data model for single detection
• Automated unblinding, etc.
Data entry of adverse
Coding of event
and drug info
Fig.3: Argus work flow
Aris g Pharmacovigilance
•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.
• 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.
Fig.4: Reporting system in Vigiflow
ICSRs uploaded in Vigiflow at AMC
NCC for quality
Revert to AMC
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.
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
4.World Health Organization (2002) World Health Organization
Collaborating centre for International Drug Monitoring. The
Importance of Pharmacovigilance Safety Monitoring of Medicinal