Pharmacovigilance
Introduction
Pharmacovigilance: Greek
➢ Pharmakon = drug
➢ Vigilare = to be observed
Definition: (WHO)
➢ It is the science & activities related to Detection,
Assessment, Understanding & Prevention of
adverse effect or any other drug-related problem
1. Detection : Identify & reporting of ADR
2. Assessment : For responsible drugs, severity &
preventability of ADR
3. Understanding : Mechanisms responsible for the
development of ADR
4. Prevention : Steps to be taken to prevent the ADR
based on above knowledge
Specific Aim
➢ To improve patient care & safety in relation to
use of medicines
➢Formal training of doctors in ADR reporting →
necessary to sensitize → ADR reporting forms
a life-long habit → second only to writing
prescription
Adverse Drug Reaction (ADR)
• A response to a drug which is noxious & unintended,
and which occurs at doses normally used in man for
the prophylaxis, diagnosis or therapy of disease or
for the modification of physiological function
Adverse Drug Events (ADE)
• Any untoward medical occurrence that may present
during treatment with a medicine but which does
not necessarily have a causal relationship with this
treatment
➢Why is there a need to report adverse drug
reaction ?
• It is necessary to report and monitor ADRs for
the following reasons:
1. Tests in animals do not always predict human
safety
2. The information collected during the pre-
marketing phase of a drug is incomplete with
regard to possible ADRs
3. In Clinical trails, patients are limited in number,
the conditions of use differ from those in clinical
practice & the duration of trails is limited
4. A good number of ADRs surface up when the
drug is used on a large scale
5. Information about rare but serious adverse
reactions, chronic toxicity and use in special
groups (such as children, elderly or pregnant
women) or drug interactions is incomplete or
not available and this can be obtained only
through sustained vigilance
• The activities involved in pharmacovigilance are:
a) Postmarketing surveillance and other methods of ADR monitoring
such as voluntary reporting by doctors (e.g. yellow card system of
UK), prescription event monitoring, computerized medical record
linkage and other cohort/case control studies as well as anecdotal case
reports by doctors.
• Voluntary reporting depends on the initiative and willingness of the
health professionals.
• It is minimal in India, while even in the developed countries only
~10% ADRs are reported voluntarily.
• Immediately occurring reactions and those that are dramatic are
mostly reported.
• Though even rare reactions can be detected by this method, it does
not provide incidence of the reaction.
b) Dissemination of ADR data through ‘drug alerts’, ‘medical letters’,
advisories sent to doctors by pharmaceuticals and regulatory
agencies (such as FDA in USA, committee on safety of medicines
in UK).
c) Changes in the labelling of medicines indicating restrictions in use
or statuary warnings, precautions, or even withdrawal of the drug,
by the regulatory decision making authority.
TYPESOF ADRs
Type Mnemonic Features Examples Management
-Common related to -Reduce dose or
-Anticholinergic effect of
1. Dose pharmacological withhold drug
Antidepressants
Related AUGMENTED action of the drug -Modify
-Predictable concomitant
-Digoxin toxicity therapy
-Low mortality
-Immunological
-Uncommon reactions:Penicillin
2. Non- -Unpredictable Hypersensitivity
Dose -Not related to -Idiosyncratic reaction: Withhold and
BIZARRE Pharmacological Acute porphyria,
Related avoid in future
action of the drug Malignant Hyperthermia
-High Mortality Pseudoallergy,
(eg.ampicillin rash)
Reduce dose or
3. Dose -Hypothalamic Pituitary
-Uncommon withhold ;
related and - adrenal axis
CHRONIC -Related to the withdrawal may
time suppression by
cumulative dose have to be
related corticosteroids
prolonged
Type Mnemonic Features Examples Management
-Teratogenesis
-Uncommon (eg. vaginal
-Occurs or become adenocarcinoma with
4. Time Often
DELAYED apparent sometimes diethylstilbestrol )
Related untreatable
after the use of the -Carcinogenesis
drug -Tardive dyskinesia
-Opiate withdrawal
-Uncommon
Syndrome
5. -Occur soon after Reintroduce and
END OF USE -Beta blocker withdrawal
Withdrawal withdrawal of the withdraw slowly
may lead to Myocardial
drug
ischaemia.
-Inadequate dosage of
6. -Common -Increase Dose
an oral contraceptive,
Unexpecte -Dose related -Consider effects
FAILURE particularly when used
d Failure of -Often caused by of concomitant
with specific enzyme
therapy drug interactions therapy.
inducers
Pharmacovigilance Programme, India
(PvPI)
• India is the 4th largest producer of
pharmaceuticals in the world
• There is need for a vibrant pharmacovigilance
system in the country to protect the
population from the potential harm that may
be caused by some of these new drugs
➢ The Central Drugs Standard Control Organisation
(CDSCO), New Delhi has initiated a nation-wide
pharmacovigilance programme under the aegis of
Ministry of Health & Family Welfare,
Government of India
➢ The programme is coordinated by
The Indian Pharmacopoeia Commission (IPC)
located at Ghaziabad
➢ WHO Uppsala Monitoring Center, Sweden
➢ Who should report ADRs?
• Professionals working in healthcare, e.g.
1. General practitioners, specialists & all
prescribers
2. Pharmacist &
3. Other health workers
➢ What to report ?
▪ All the suspected adverse reactions, known or
unknown, serious or the otherwise should be
reported
▪ It is important to report even minor reactions
of new drugs
▪ For established drugs, the reporting of serious
ADRs is important
➢Whom to report ?
• ADR can be reported to the nearest ADR
Monitoring Centre (AMC) under
Pharmacovigilance Programme of India
➢How to report ?
• Reporting is the process of providing ADR
information by filling in the ADR reporting
form appropriately giving details of the clinical
case as well as the ADR
• All AMCs (at present 877 AMCs) are engaged to
monitor and report ADRs to NCC via VigiFlow, a web
based Individual case safety reports (ICSRs)
management system that is specially designed for use by
the authorized national centres in the WHO Programme
for International Drug Monitoring.
➢ Causality assessment in ADR monitoring :
• It is a process of inference of a causal drug of an
ADR through continuous assessment of
information obtained from the case report
WHO categorizes causality as follows:
1. Definite/Certain
2. Probable/Likely
3. Possible
4. Unlikely
5. Conditional/Unclassified
6. Unassessable
• Causality is assessed on the basis of:
• Temporal relationship: How the time-sequence of the event is
related to drug administration.
• Previous knowledge: Whether the drug is known to produce the
event in earlier recipients with a certain degree of consistency.
• Dechallenge: Whether the event subsided on stopping the drug.
• Rechallenge: Whether the event reappeared when the drug was
administered again after a gap during which the event had
subsided.
• Many times rechallenge is unethical/dangerous, and is not
done.
The ADR reporting forms:
• There are several types of ADR reporting forms developed
by Indian Pharmacopeia Commission, Ghaziabad
1. The Red Form is meant for ADR reporting by health
professionals. (Also called as Suspected ADR
Reporting Form)
2. The Blue form for direct ADR reporting for consumers.
3. Transfusion related ADR reporting Form and
4. Medical devices related ADR reporting Form.
• The Red ADR reporting form is used to notify a case report
relating to a medical event (or laboratory abnormality)
suspected to be induced by a drug.
• HAEMOVIGILANCE: A set of surveillance procedures
covering whole transfusion chain from the collection of
blood and its components to the follow up of its recipients,
intended to collect and access information on unexpected or
undesirable effects resulting from the therapeutic use of
labile blood products, and to prevent their occurrence and
recurrence.
• MATERIOVIGILANCE: The study of adverse events
associated with the use of medical devices after post
marketing phase.
CASE 1
Dr. Smruti Shah (MBBS, MD)
G.K. General Hospital, Bhuj
mobile: 97249xxxxx
date : 17/4/17
Name : Nita Patel
Age: 55 , Sex: F , wt. 70 kg
Address : C-25, Ankur apartment, Bhuj.
Mobile : 94563xxxxx
• Patient complains of intermittent mild grade
fever without chills & rigor for last 3 days
• She also complains of productive cough &
yellowish sputum
• There were no similar events in the past
• General physical examination, Vitals and systemic
examination are within normal limits except
temperature was 38 0 C
• Respiratory System : Throat Congestion
• Lab. Investigation: NAD
➢ Diagnosis : Upper respiratory tract infection
On 17/4/17
Drug treatment :
S no. Name of drug Dose Frequency Route
1 Tab. 400mg 2-0-2 Oral
Cotrimoxazole
2 Tab. Ibuprofen 400 mg 1-1-1 Oral
Therapy dates Manufacturer Batch no. Expiry
17-04-17 Cipla Not known July 2020
To Pharmaceuticals
18-04-17 Ltd.
17-4-17 Bombay Not known June 2020
To Pharmaceuticals
26-04-17 Ltd.
• Salt water gargles for five days
18/04/2017
• Patients complains of maculopapular rash and
itching all over the body
• She was asked to stop Tab. Cotrimoxazole and
prescribed Tab. Azithromycin 500 mg once
daily for three days
• She was also prescribed Cetirizine 10 mg once
daily for five days and advised follow-up after
one week
25/04/2017
• Patient was better
• Rashes disappeared
• No other complaints
➢ADR was reported to AMC under National
Pharmacovigilance Program
N.P. 55 yr
70
18/04/2017
25/04/2017
Patient was diagnosed URTI for which she
was prescribed drugs mentioned in col. 8 &
11. After taking the medicines, on 2nd day,
she developed itching & maculopapular
rashes. The suspected drug (Cotrimoxazole)
was stopped & replaced by Tab.
Azithromycin 500 mg OD for 3 days.
Tab. Cetirizine 10 mg OD for 5 days was
given for symptomatic treatment of the
reaction.
T.Cotrimoxazole Cipla --- Jul 400mg Oral 2 tab BD 17/04/17 18/04/17 URTI WHO-Probable
2020
NA
Tab. Ibuprofen 400mg Oral TDS 17/04/17 26/04/17 Fever
Patient was also advised
Salt water gargles for 5 days
--- NA ---
--- NA ---
Dr Smruti Shah
G. k. General Hospital, Bhuj.
370 001 drsmrutishah@----.com
97249xxxxx
Doctor MD (Medicine)
26/04/2017
