Declaration Letter
From
Subashree V,
Jawahar S.R,
2nd M.B.B.S.,
Government Kilpauk Medical College,
Chennai 10.
To
The dean,
Government Kilpauk Medical College,
Chennai 10.
Sub: Submission of study proposal for review by institutional ethics committee
Respected sir,
We are herewith submitting a study proposal titled KNOWLEDGE AND AWARENESS OF
PHARMACOVIGILANCE AMONG VARIOUS MEDICAL FRATERNITIES for review by the institutional ethics
committee.
Thanking you
Yours faithfully,
Subashree V.
Jawahar S R .
Letter of permission
We, Subashree V and Jawahar S R, undergraduate M.B.B.S., apply for ethical committee
clearance of the project KNOWLEDGE AND AWARNESS OF PHARMACOVIGILANCE AMONG VARIOUS
MEDICAL FRATERNITIES under the guidance of Dr. Malar Shivaraman, Associate Professor, Dept of
Pharmacology, GKMC, Chennai.
We understand the complications of doing research and willfully comply with the regulations.
Subashree V
Jawahar S R
II M.B.B.S., GKMC
I have no objections in guiding Subashree V and Jawahar S R, undergraduate M.B.B.S., in the project
mentioned above. I shall supervise that the project is carried out in accordance with ethical principles.
Dr. Malar Shivaraman
Associate Professor, Dept. of Pharmacology, GKMC
STUDY PROTOCOL
KNOWLEDGE AND AWARNESS OF PHARMACOVIGILANCE AMONG VARIOUS MEDICAL FRATERNITIES
Principal investigators:
Subashree V
Jawahar S R
Guide:
Dr. Malar Shivaraman
Co Guide:
Dr. T. Aruna
Dr. S. Jeyaponmari
Place of Study:
GKMC, Chennai.
Study design:
Questionnaire based - descriptive
Sampling:
Fifty CRRI, Fifty final MBBS, fifty staff nurses
Study duration:
2 months
AIM OF THE STUDY
To access the knowledge and awareness of pharmacovigilance among the healthcare professionals in
GKMC.
OBJECTIVE
GKMC, is world recognized ADR monitoring centre since, 2012. The various adverse effects collected
are uploaded to the upsala centre by the department of pharmacology. so to access the baseline
knowledge involved in the reporting of ADR among healthcare professionals in our centre this current
study was planned.
METHODOLOGY
After getting the consent of the medical fraternities involved the questionnaire will be given and twenty
uninterrupted minutes will be given to answer.
DATA ANALYSIS
Data from the completed questionnaires will be charted categorically in MS Excel, analyzed and results
will be expressed using suitable pictorial representations or as percentages and proportions.
JUSTIFICATION OF THE STUDY
This study will throw light on the awareness level of the pharmacovigilance.
ETHICAL ASPECTS
Privacy and confidentiality will be maintained
RELEVANCE OF THE STUDY
There is a definite need for the medical fraternities to know about pharmacovigilance and this study will
bring out findings in this currently expanding subject.
BENIFTS OF THE STUDY
Enabling knowledge and awareness about pharmacovigilance
LIMITATIONS
The study findings will depend on the extent of participation of the medical fraternities.
REFERENCES
1. The importance of pharmacovigalance WHO 2002
2. WHO Technical Report No.498 (1972)
3. Current Challenges in Pharmacovigilance Pragmatic Approaches (Report of CIOMS Working
Group V), 2001 Geneva
4. Pharmacovigilance, Mann RD, Andrews EB, eds, John Wiley & Sons Ltd. Chichester, 2002.
5. A short history of involvement in Drug Safety Monitoring by WHO.
ANNEXURE
QUESTIONNAIRE
NAME:
YEAR OF STUDY/DESTINATION:
QUESTIONS:
1. Define Pharmacovigilance (Most appropriate only)
a. The science of Monitoring ADRs happening in a hospital
b. The process of improving the safety of drugs
c. The detection, assessment, understanding and prevention of adverse effect
d. Science detecting the type and incidence of ADR after the drug is marketed.
2. The importance purpose of pharmacovigilance
a. To identify the safety of drugs
b. To calculate the incidence of ADRs
c. To identify predisposing factors to ADR
d. To identify the unrecognized ADR
3. Which of the following method(s) is commonly employed by the pharmaceutical companies to
monitor ADR of new drugs once they are launched in the marked?
a. Meta analysis
b. Post marketing Surveillance studies
c. Population studies
d. Regression anlaysis
4. Serious adverse event in India should be reported to the regulatory body within
a. 1 day
b. 7 calendar days
c. 14 calendar days
d. 15 calendar days
5. The international centre for ADR monitoring is located in
a. USA
b. Australia
c. France
d. Sweden
6. One of the following is the Agency in USA involved in drug safety issues
a. American Society of Health system Pharmacist
b. United States Food and Drug Administration
c. American Medical Association
d. American Pharmaceutical Association
7. One of the following is the major risk factor for the occurrence of maximum ADR
a. Arthritis
b. Renal failure
c. Visual impairment
d. Vacuities
8. In India which regulatory body is responsible for monitoring of ADRs
9.
10.
11.
12.
13.
14.
15.
16.
a. Central drugs Standard Control Organisation
b. Indian Institute of Science
c. Pharmacy council of India
d. Medical Council of India
Which of the following scales is most commonly used to establish the casualty of ADR
a. Hartwig Scale
b. Naranjo Algorithm
c. Schumock and Thomton scale
d. Karch & Lasanga Scale
Match the ADR reporting system to respective countries
a. Yellow card
1. India
b. Green card
2. Australia
c. ADR reporting form
3. UK
d. Blue card
4.Scotland
One among of these is a regional pharmacovigilance centre
a. Kasturba hospital, Manipal
b. JIPMER, Puducherry
c. JSSMCH, Mysore
d. CMC, Vellore
Which one of the following is the WHO online database for ADR
a. ADR Advisory committee
b. MedSafe
c. Vigibase
d. Medwatch
Rare ADRs can be identified in the following phase of clinical trial
a. 1
b. 2
c. 3
d. 4
The heath care professionals for reporting ADRs in hospital
a. Doctor
b. Pharmacist
c. Nurses
d. All of the above
Which among the following factors discourage you from reporting ADRs
a. Non remuneration for reporting
b. Lack of time
c. Single Unreported case may not affect ADR database
d. Difficult to decide whether ADR has occurred or not
Do you think reporting is a professional obligation for you
a. Yes
b. No
17.
18.
19.
20.
c. Dont know
d. Perhaps
What is your opinion about establishing ADR monitoring center in every hostpital
a. Should be
b. Not necessary
c. One in a city
d. Depends on Number of bed size
Do you think reporting of ADR is necessary
a. Yes
b. No
Do you think Pharmacovigilance should be taught to medical professionals
a. Yes
b. No
Have you anytime read any article on prevention of ADR
a. Yes
b. No
