Pharmacovigilance and Method of ADR reporting

Pharmacovigilance and methods of
Adverse Drug Reactions
reporting
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Dr. Lokendra Sharma
Professor,
Department of Pharmacology &
Coordinator, ADR Monitoring Centre,
SMS, Medical College,
Jaipur.

Pharmacovigilance in India
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India

National Pharmacovigilance
Programme
02-Jan-2018

Adverse Drug Reaction (ADR)
A response to a drug which is
Noxious and Unintended
occurs at doses normally used in man for the prophylaxis, diagnosis, or
therapy of disease, or for the modifications of physiological function.
(WHO, 1972)

WHY ADR Reporting ?
 ADRs are among the leading causes of death in many countries (World Health
Organization, 2008)
 Account for 5% of all hospital admissions in India.
Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795320/
 Constitutes a significant economic burden on the patient and government

Benefits of ADR Reporting
 Assess the safety of drug therapies, especially recently approved
drugs.
 Provides updated drug safety information to health care professionals
and other stakeholders
 Measuring the economic impact of ADR prevention as manifested
through reduced hospitalization, optimal and economical drug use,
and minimized organizational liability

Benefits of ADR Reporting Cont.....
 Regulatory action on the basis of ADR reports to ensure
patient’s safety
 Upgrading package insert
 Marketing Authorization Recall (withdrawal)
 Batch recall based on clustering of ADR
 Changes in classification, e.g.
o From over the counter to prescription only medicines.
o Special prescription
o Restricted prescription

ADR Reporting Procedure
 Who can report
 What to report
 How to report
 Whom to report
 Where to report

Who can report?
• All healthcare professionals
(Clinicians, Dentist, Pharmacist, Nurses, Physician, Physiotherapist etc)
• All non- healthcare professionals including consumers/ patients etc can report ADRs.

What to Report ?
 All types of suspected adverse reactions
 Known or unknown,
 Serious or non-serious and
 Frequent or rare
 Reactions from all types of pharmaceutical products
 Allopathy,
 Ayurvedic,
 Vaccines,
 Medical devices etc.

Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India
How & Whom to Report ?
• Use the ‘Suspected Adverse Drug Reaction Reporting Form/ Medicine side effect
Reporting form which are available on the official website of IPC (www.ipc.gov.in)
to report any ADR
Link for ADR form http://ipc.nic.in/showfmkl;ile.asp?lid=416&EncHid=
 Filled ADR form submitted to nearest ADR Monitoring Centres (AMCs ) or directly
to the NCC-PvPI.
 A reporter can also email the Suspected ADR form at
pvpi@ipcindia.net or pvpi.ipcindia@gmail.com.

Health Care
Professionals
Consumer
NCC-PvPI
Ghaziabad
AMCs
Industry
Who can report? How to report ?and whom to report?

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)
Toll free-Helpline Number

Android Application
ADR Reporting App. can be downloaded from Google play store (free to download)
ADR-PvPI is the
indigenously developed
Mobile App for all
healthcare professionals
and consumers to report
adverse drug reactions

Worldwide Reporting Forms
CIOMS for US MED-WATCH FOR UK

ADR Reporting form for Healthacare
Professionals

Suspected Adverse Drug Reaction Reporting Form For
Health Care Professionals
This form is divided into four sections:
A. Patient Information
B. Suspected Adverse Reaction
C. Suspected Medication(s)
D. Reporter Details

Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India
1. Patient
Initials
_____________
2. Age at time of event
or date of birth
__________________
3. M □ F □ Other □
_________________________________
4. Weight __________ Kgs

5. Date of reaction started (dd/mm/yyyy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem

C. Suspected Medications
C. Suspected medication(s)
S.N
o
8. Name
(Brand
/Generic)
Manufact
urer
(If
known)
Batc
h
No./
Lot
no.
Exp. Date
(if known)
Dose
used
Route
used
Frequency
(OD,BD,
etc.)
Therapy dates Indica
tion
Causalit
y
assessm
ent
Date
starte
d
Date
stopped
i
ii.

C. Suspected Medications Cont...
Action taken- Mark the appropriate option for the action taken with respect to
Suspected drug.
S.No.
as per
C
9. Action Taken ( Please Tick)
Drug
withdrawn
Dose
increased
Dose
reduced
Dose not
changed
Not
applicable
Unknown
i
ii

C. Suspected Medications Cont..
• Rechallenge/ Reintroduction - The point at which a drug is again given to a
patient after its previous withdrawal.
• Mark the appropriate option whether the suspected drug reintroduced & reaction
occurred or not or effect unknown.
10. Reaction reappeared after reintroduction ( Please Tick)
S.No. Yes No Effect Unknown Dose
(If reintroduced)
i
ii

Concomitant medications Cont..
Concomitant medical product (s) information given in the following tabs.
11. Concomitant medical product including self medication
and herbal remedies with therapy dates (exclude those
used to treat reaction)
S.No. Name
(Brand
/Generic)
Dose
used
Route
used
Frequency
(OD, BD, etc.)
Therapy dates Indication
Date
started
Date
stopped
i
ii

D. Reporter Details
D. Reporter Details
16. Name and professional address ____________________________
Pin ___________________ E - mail___________________________
Tel. No. (With STD code)____________________________________
Occupation__________________________ Signature ___________
17. Date of this Report (dd/mm/yyyy) ___________________________

Other important sections of ADR Reporting form
12. Relevant test and laboratory data with dates
13. Relevant medical / medication history ( Allergies, race, pregnancy,
smoking , alcohol use, renal and hepatic dysfunction etc.)
14. Seriousness of the reaction: No □ If Yes □ (please tick anyone)
□ Death (dd/mm/yyyy) □ Congenital anomaly
□ Life threatening □ Required intervention to prevent
permanent impairment/ damage
□ Hospitalization/ prolonged □ Disability
□ Other (specify)

15. Outcome (please tick anyone)
□ Recovered □ Recovering
□ Not Recovered □ Fatal
□ Recovered with Sequelae □ Unknown

Additional Information:
More information on the ADR report that are not fit in the respective column given
in ADR form can be entered in the filed of additional information (i.e. More
information about suspected drug, indication etc.)

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
Consumers can provide detailed first-
hand information about their experiences
with medicines and how these medicines
have affected their life.
NCC-PvPI launched its first ADR
reporting form for consumers in August
2014.
Medicine Side Effect Reporting Form for
Consumers and Journal Release

ADR reporting form for consumers
(in Hindi)

Consumer Reporting Form launched in different
languages by NCC-PvPI.
Available in English, Hindi & Nine other regional languages
Gujarati, Kannada, Bengali
Malayalam, Oriya, Tamil
Marathi, Telugu, Assamese
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India

Materiovigilance Programme of India (MvPI)
• To monitor and report the adverse events due to the medical
devices,
• The MvPI was launched by the DCGI, Dr. G.N. Singh at Indian
Pharmacopoeia Commission, Ghaziabad, on July 6, 2015.
• The MoHFW, Government of India, nominated Sree Chitra
Tirunal Institute of Medical Science & Technology,
Thiruvanthapuram,
• As a National Collaboration Centre and National Health
System Resource Centre for providing technical support.

Medical Devices Adverse Event Reporting Form

Adverse event following Immunization (AEFI)
• AEFI is defined as a medical event that takes place after
immunization , cause concern and is believed to be caused by
immunization programme .
• AEFI surveillance system in India has come a long way since its
inception in 1986.
• In India, the safety of vaccines is monitored by the division of
AEFI , Ministry of Health and Family Welfare, Government of
India and PvPI.

AEFI reporting form (in case of serious event)

Haemovigilance Programme of India
• Heamovigilance Programme of India was launched on
10/12/2012 as an integral part of PvPI.
• National Institute of Biological, Noida is functioning as a
National Coordination Centre for this Programme.
It is responsible for
1. Collate & analyze adverse drug reaction data for blood and
blood products
2. Help in identifying trends, recommend best practices and
interventions required to improve patient care and safety, while
reducing overall cost of the healthcare system.

Adverse Blood Donor Reaction Reporting Form

Transfusion Reaction Reporting Form (TRRF) For Blood & Blood
Components & Plasma Products

VIGI Flow

VIGI FLOW

Journey of S.M.S. Medical College as ADR Monitoring Centre in Jaipur
• Establishment: In year 2011 by IPC Ghaziabad
• CME & Presentations:
-3 CME
- More than 40 presentation on PVI & ADR Reporting for the health care professional
& consumer

Academics working in India with UK academics in
Bangor, Manchester and Oxford Universities. The
purpose of the GMHAT and GCRF-SASHI project is to
help to find effective responses to deliberate PvPI,self-
harm and suicide in South Asia by building research
infrastructure and expertise in India
.

Sensitization of PVI
Training:
• 20 training for Doctors
• 4 training for Nurses
• 3 training for BDS student
• 4 training for Pharmacists & pharmacy students

Training of Digital technique of Students in
Safe Medication

Details of Poster Presentations
• 1st July, 2017 : Poster on “Awareness on
Pharmacovigilance and ADR reporting” in Hindi
was launched by the Principal, SMS Medical
College, Jaipur.
• 16th December, 2017 :Poster on“ Materiovigilance-
an Approach for monitoring and evaluation of
medical device associated adverse events"
presented at ICMR Institute , Jodhpur.

Details of Poster Presentations
• Poster presentation on "Pharmacists as
Pharmacovigilance Practitioner" in the 12th
Indo-African International Conference on on
“Trends,
• Challenges and Future Scenario of
Pharmaceutical Science” held on 6th March,
2018 at Arya College of Pharmacy, Jaipur.

ADR Reporting From SMS Medical
College
• Targeted Reporting:
• In Year 2017:Total 327 ADR reports have been sent
to PVI Ghaziabad
• Monthly Average ADR reporting in 2017: 27 /
month
• From Jan to March 2018: 91 ADR reports have
been collected.

ADR Monitoring in SMS Medical
College
ADR
monitoring
& reporting
for the drugs
used in
national
health
programmer
s as
NACO ,T.B.,
Deworming

Preface
• Medical students play an important
role for screening the health status of
public.
• So this study was undertaken to screen
the hidden cases of ADR present among
MBBS students Clinical Training .

Research Projects of Digital
Training
1. Mental health assessment by medical students of Batch 2016
using GMHAT.
2. Mental health assessment by medical undergraduate of Batch 2017
students using GMHAT.
3.Assessment of Mental health of participants by MBBS Batch 2018 by
using
GMHAT.
4. To assess and compare the effect of traditional teaching with Integrated
teaching in MBBS students with the help of GMHAT this also
included in teaching timetable.
5. Use GMHAT By Postgraduate students in there training & thesis work
on Cancer,
HIV, TB, Diabetes and Osteoarthritis patients.

Projects with National and
international university

Approach
• Integrated teaching on PvPI was
implemented by the active
involvement of the departments of
Physiology, Medicine and Psychiatry
etc.
• At the end of their training, both
groups were again assessed with a
post-test questionnaire.

Present Pharmacovigilance Committee
• Dr. Lokendra Sharma : Co-ordinator
• Dr. Rupa Kapadia : Member Secretary
• Dr. Monica Jain : Assistant Co-ordinator
• Dr. Monika Mishra : Member
• Chaitanya Prakash : Pharmacovigilance Associate
• There are also co-opting Pharmacovigilance members from the various
Departments of SMS Medical College, Jaipur.

ADR Monitoring Centers
• Total number of Adverse Drug Reaction Monitoring Centres in India : 250
(till Dec-2018)
• Total number of Adverse Drug Reaction Monitoring Centres in Rajasthan : 11
(till Jan-2019)
• S.M.S. Medical College, Jaipur
• S. P. Medical College, Bikaner
• R.N.T. Medical College, Udaipur
• Dr. S. N. Medical College, Jodhpur
• Government Medical College, Kota
• J.L.N. Medical College, Ajmer
• Institute of Respiratory Diseases, Sashtri Nagar, Jaipur
• AIIMS, Jodhpur
• Geetanjali Medical College, Udaipur
• NIMS Medical College, Jaipur
• JNU Medical College, Jaipur

ADR reporting status
• In the Year-2017 : 327 ADR reports were sent
• From January to December-2018 : 463 ADR reports have been
sent to NCC-PVPI.
• From January-2011 to June-2018 : More than 2000 ADR
reports have been sent to the National coordination Centre-
Pharmacovigilance Programme of India.

CMEs and Seminar organized at AMC
• One day CME on “Pharmacovigilance it’s relevance in current
Medical Practice” was organized on 23rd September, 2011 at
Rajasthan University of Health Sciences, Jaipur.
• A half day Seminar on “Pharmacovigilance” funded by Indian
Pharmacological Society was held on 17th September, 2012 in the
Library Seminar Hall, SMS Medical College, Jaipur.
• One day CME on “Pharmacovigilance” funded by Indian
Pharmacopoeia Commission, Ghaziabad with the technical support
of PGIMER, Chandigarh, was organized on 08th May, 2015 in the
Library Seminar Hall, SMS Medical College, Jaipur.

Awareness programmes and PV trainings
• Total 41 Awareness
programmes and PV
trainings on
Pharmacovigilance have
been conducted at ADR
Monitoring Centre, and other
hospitals as well as Medical,
Nursing and Pharmacy
Colleges.
• More than 2800 healthcare
professionals and students
have been sensitized through
these programs and
trainings.

Poster publications
• A poster regarding “Awareness on Pharmacovigilance and ADR
reporting” in hindi was launched on 1st July, 2017 by Dr. U. S.
Agrawal, Principal & Controller, SMS Medical College, Jaipur.
• The Addl. Principal, Coordinator, Members of Pharmacovigilance
Committee and the Faculty, Department of Pharmacology, SMS
Medical College, Jaipur were present in the launching ceremony.
• The poster was placed in various clinical Departments of SMS
Medical College & attached hospitals.

Launching of Pharmacovigilance Poster on 01st July, 2017

Pharmacovigilance poster in Hindi

Activities in the Science of life exhibition held from 15th Feb,
2018 to 25th Feb, 2018 at SMS Medical College, Jaipur.

Appreciation by Principal Sir for Good
Pharmacovigilance Stall

PV-Sensitization during Exhibition

Workshop-cum-Training Programme on Pharmacovigilance for
NABH-Accredited Hospitals in Rajasthan State
• Indian Pharmacopoeia Commission,
National Coordination Centre (NCC)
for Pharmacovigilance Programme of
India (PvPI), has signed a
Memorandum of Understanding with
National Accreditation Board for
Hospitals and Healthcare Providers
(NABH) for effective implementation
of ADR-reporting.
• To train NABH-Accredited Hospitals
staff on Pharmacovigilance, one day
Workshop-cum-Training programme
was organized on 20th June 2018 at
Santokba Durlabhji Memorial
Hospital, Jaipur.
• 62 healthcare professionals
participated in the Workshop.

ADR Data entry through Vigiflow
• VigiFlow is a web-based Individual Case Safety Report (ICSR)
management system that is available for use by national
pharmacovigilance centres of the WHO Programme for
International Drug Monitoring.
• VigiFlow supports the collection, processing and sharing of
data of ICSRs to facilitate effective data analysis.

ADR Data entry through Vigiflow
• ADRs reports (Individual Case Safety Report) are
processed through VigiFlow to NCC, Ghaziabad.
• At NCC, the Signal Review Panel, Quality Review Panel
evaluate the ICSR and send the regulatory
recommendations to the CDSCO, New Delhi.

Please Report
Adverse Drug Reactions
(Known, Unknown, Serious and Non-Serious)
Due to Medicines, Medical Devices, Blood products, Vaccines and Herbal products
To
Adverse Drug Reaction Monitoring Centre, SMS Medical College, Jaipur.
Dr. Lokendra Sharma
Prof. Pharmacology & Coordinator,
Phone No. 9414048334, 0141-2518682
Email ID: drlokendra29@gmail.com
Mr. Chaitanya Prakash
Patient Safety-Pharmacovigilance Associate
Mob. No. 7727017839
Email ID: pchaitanya84@gmail.com
ADR Reporting Toll free number: 1800-180-3024
ADR reporting Android App ‘ADR PvPI’ available on Google play Store
For more information please visit at www.ipc.gov.in

Pharmacovigilance sensitization with
EC of NIA

THANK YOU
.
Lets join hands to promote patient safety

Pharmacovigilance and Method of ADR reporting

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