Dr. C. S.

BHARATHAN
PROFESSOR OF PHARMACOLOGY
P.K. DAS IMS, VANIAMKULAM
 Pharmacovigilance is “the science and
activities relating to detection, assessment,
understanding and prevention of adverse
effects or any other drug related problems”
 PV is concerned with Adverse Drug Reaction
Monitoring
AMC NCC CDSCO
Collecting ADR Preparation of Regulatory
reports training decision &
manuals actions
Perform follow Conduct safety related
up Training decisions to
workshops stakeholders
Assessment of
Publication Collaboration
ADRs
of Newsletter with WHO-UMC
Provide
Data entry in to
Reporting to provisions &
Vigiflow
CDSCO support to
Training/ National PvPI
sensitization/ Analysis of
feedback PSUR
‘‘A response to a drug which is noxious and
unintended, and which occurs at dose normally
used in man for diagnosis, prophylaxis,
treatment of a disease, or for modification of
physiological function’’
 ADE is used to mean any untoward medical
occurrence that may present during the
treatment with a medicine but does not
necessarily have a causal relationship with
the treatment
 Eg : Brassy cough with ACE inhibitors
• ADRs are among the leading causes of death
in many countries (World Health Organization,
2008)
• This constitutes a significant economic
burden on the patient and government
• During the Clinical trial in the development of
new drugs, only insufficient evidence of safety
is arising . Rare adverse drug reactions and
ADE which take a long time to develop cannot
be detected
 Ministry of Health and Family Welfare Dept
(MoH & FW), Government of India launched
a nationwide programme, PvPI to monitor
safety of medicines in Indian population in
the year 2010
 CDSCO ( Central Drug Standard Control
Organisation ) is coordinating PvPI under the
aegis of MoH & FWD,Govt of India in
collaboration with Indian Pharmacopoeia
Commission, Ghaziabad
 This nationwide program was initiated for
protecting the health of patients by assuring
drug safety
NATIONAL COORDINATION CENTRE
(NCC)

ADR Monitoring Centers (AMC) all over India

(2010)
INTERNATIONAL COORDINATION CENTRE

NCC-PvPI, Ghaziabad
SIGNAL REVIEW PANEL REGULATORY
ACTION
QUALITY REVIEW PANEL

FEED BACK AS DRUG

ALERTS

ADR Monitoring Centres

Health Care Professionals

A reporter can also report ADR Via
Helpline number launched in October
2013

1800 180 3024

(Monday to Friday 9:00AM to 5:30 PM)

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India

 No drug is completely safe
 Risks due to Drugs may contribute to 5 –10%
of all hospital admissions
 10 –20% of all inpatients may suffer a serious
ADR in hospital
 ADR the 4th - 6th leading cause of deaths in
USA
 ADRs may contribute 5 –10% of hospital
costs

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 Rising cost of patient care, increasing
awareness of patients towards the untoward
effects of drugs and rise in the frequency of
cases of litigation against doctors and
hospitals have made clinicians, hospital
administrators and Health care planners
aware of the necessity of closely monitoring
adverse drug reactions
Therefore the monitoring of the adverse
reactions of drugs is an important
component of Good medical practice

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 Early Identification
Dissemination
Detection of
detection of risk
of increase information
of factors & Estimation
in needed to
unknown mechanisms of benefit/
frequency underlying risk analysis
improve
adverse prescription
of known adverse
drug pattern and
reactions reactions
reactions drug therapy
1)INTRINSIC FACTORS
a) Pharmacological (ABCDEFG..)
b)Idiosyncratic
c)carcinogenicity , mutagenicity
d)Teratogenicity
2)EXTRINSIC FACTORS
a)adulterants
b)contamination
3)Others
a)Interactions
b)Wrong usage (Irrational Use)
 Types of Adverse Drug Reactions

Type A Effects (“Augmented”)

 Due to extension of pharmacological effects
and often Dose related – can be avoided by
using appropriate dose
Example:
 Hypoglycemia due to Insulin use
 Hypotension following the use of
Antihypertensive agents
Type B Effects (“Bizarre”, idiosyncratic
reactions)
 Generally rare and unpredictable
 Little or no dose relationship, not related to
drug pharmacodynamics
 Occur in predisposed, intolerant patients –
can be explained by rare genetic
polymorphism, allergic reactions
 Example: Penicillin allergy
Agranulocytosis due to Chloramphenicol
Type C Effects (“Chronic”)
 Adverse reactions after long term therapy
often dose related
 Eg-HPA axis suppression due to use of
corticosteroids in RA leading to adrenal
insufficiency
Type D Effects (“Delayed”)
 Adverse effect may be presented years after
a drug was used
 Example: Vaginal adenocarcinoma can occur
in daughters whose mothers were treated
with Diethylstilbestrol as ovulation inducing
agent
 Type E (Ending) :Rebound Hypertension on
Clonidine Withdrawal
 Type F (Failure) : eg : Oral contraceptive
failure by enzyme inducers like Rifampicin
 Type G : Genotoxicity
 Drug allergy- Skin rashes, Anaphylaxis due to Penicillin
 Intolerance –Gastric intolerance with Aspirin
 Side effects –Constipation with Codeine
 Toxic effects- CNS toxicity with Theophylline
 Idiosyncrasy –Agranulocytosis due to Chloramphenicol
 Photosensitivity - Sparfloxacin
 Dependence- Morphine
 Withdrawal symptoms-Alcohol
 Teratogenicity-Thalidomide causing Phocomelia
Assessment scales for causality evaluation
 Naranjo scale
 WHO probability scale
 Jones scale
 Karch and Lasagna scale
>9-certain
5-8-probable
1-4-possible
0 - unlikely
 Yes No Don't know

us ion reports on this reaction? +1 0 0

ppear after the s us pect drug was adminis tered? +2 -1 0

n the drugDechallenge
was dis continued or a s pecific
+1 0 0
red?

n drug was readminis tered? Rechalleng +2 -1 0

e
es [other than the drug] that could s olely have
-1 +2 0

r when a placebo was given? -1 +1 0

the blood [or other fluids ] in a concentration

+1 0 0

evere when the dos e was increas ed, or les s

+1 0 0
as decreas ed?

milar reaction to the s ame or s imilar drugs in any

+1 0 0

onfirmed by objective evidence? +1 0 0

 1)CERTAIN
It is related to clinical event , with plausible time
relationship to drug intake.
- cannot be explained by concurrent disease or other
drugs
2)PROBABLE /LIKELY
-with reasonable time relationship to drug intake
-unlikely to be due to concurrent disease or drugs
3)POSSIBLE
-with reasonable time relationship to drug intake
-could also be explained by concurrent disease or drugs
4)UNLIKELY
-clinical event or lab test with improbable time
relationship with drug intake
-other drugs/disease provide plausible explanation
5)INACCESSIBLE/UNCLASSIFIABLE
-insufficient /contradictory evidence which cannot
be supplemented /verified
6)CONDITIONAL/UNCLASSIFIED
- more data is essential for proper assessment or
additional data are under examination
 WHO –ADR monitoring Centre Located in
Uppsala, Sweden and Started in 1968
ROLE
 1. Identify early warning signals of ADRs
( Signal detection)
 2. Evaluate the hazards
 3. Undertake research for development of safer
& more effective medicines
1.NEW DRUGS :all suspected reactions
2. ESTBLISHED/WELL KNOWN DRUGS
all serious , unexpected and unusual ADRs
Serious ADRs - result in death and life
threatening situation
- inpatient or prolongation of hospitalization
- congenital anomaly
- disability(significant, persistent or permanent)
- require intervention to prevent permanent
impairment or damage
 Or directly they may
report ADRs by
phone or mail

Notification Boxes- If any ADR occurs, healthcare

placed all over hospitals Professionals will write the ADR
with notification forms & put it in red box

Technical associate will

Under supervision of
Coordinator / Sub
coordinator
collect ADR & write it in
a red form
Assessment of ADRs by
Pharmacologists
 Brand name
 Batch number
 Indication for which it was prescribed
 Dosage and strength
 ROA
 Starting date & time
 Stopping date , time & duration of treatment
AMC: an over view
 Pharmacovigilance
Programme of India

National Coordinating
centre
Red form will be
checked & signed by
Coordinator / Sub
coordinator ADRs will be entered in
Vigiflow, WHO
database
ADRs reviewed &
analyzed for any
alerts/signals by
signal review
committee
& sent to CDSCO

ADRs will be
reviewed & sent to
UMC.
•Creating awareness
•Compulsory reporting system
•Online ADR reporting form

Reporting ADRs is our professional obligation..!

 An identifiable patient
 A suspected medicinal product
 An identifiable reporting source
 An event or outcome
 Thank you

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