An Effective Pharmacovigilance System
National Coordination Centre
Pharmacovigilance Programme of India
Introduction
Pharmacovigilance is a system to monitor the
safety and effectiveness of medicines and other
pharmaceutical products.
A pharmacovigilance system should include all
entities and resources that protect the public
from medicine related harm, whether in personal
health care or public health services.
National Coordination Centre
Pharmacovigilance Programme of India
Pharmacovigilance as “science and activities
relating to the detection, assessment,
understanding and prevention of adverse effects
or any other possible drug-related problems”.
National Coordination Centre
Pharmacovigilance Programme of India
Good Pharmacovigilance Practice
•Higher management to lead implementation of the quality
system and motivation for all staff in relation to quality
objective.
•All person within the organization to be involved in and
support the pharmacovigilance system on the basis of task
ownership and responsibility; all person should engage in
continuous quality improvement
•Resources and tasks to be organized to support proactive,
risk-proportionate, continuous and integrated conduct of
pharmacovigilance
•All available evidence on benefit-risk of medicinal products
National Coordination Centre
Pharmacovigilance Programme of India
Ultimate Goals of pharmacovigilance
The rational and safe use of medical drugs
The risks and benefits of drugs on the market
educating and informing of patients
To ensure that the benefits of use of medicine
outweighs the risks and thus safeguard the health
of the Indian population
National Coordination Centre
Pharmacovigilance Programme of India
Functions of Pharmacovigilance Programme of
India
To create a nation-wide system for patient safety reporting
To identify and analyse the new signal from the reported
cases.
To analyse the benefit - risk ratio of marketed
medications
To generate the evidence based information on safety of
medicines
To support regulatory agencies in the decision-making
process on use of medications
National Coordination Centre
Pharmacovigilance Programme of India
Continuing…
To communicate the safety information on use of
medicines to various stakeholders to minimise the
risk
To emerge as a national centre of excellence for
Pharmacovigilance activities
To collaborate with other national centres for the
exchange of information and data management
To provide training and consultancy support to
other National Pharmacovigilance Centres located
across globe.
National Coordination Centre
Pharmacovigilance Programme of India
Documents of Pharmacovigilance Programme
Pharmacovigilance Programme of India
Guidance Document for Reporting Individual Case Safety Report
Pharmacovigilance
Toolkit
PHARMACOVIGILANCE PROGRAMME
OF INDIA (PvPI) 2013
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare Indian Pharmacopoeia Commission
(National Coordination Centre – PvPI)
Government of India
Ministry of Health & Family Welfare
Government of India
Sector-23, Raj Nagar, Ghaziabad (U.P.) 201002.
National Coordination Centre
Pharmacovigilance Programme of India
Guidance Document helps to expand the role and scope of
PvPI to identify, analyse and minimise the risk associated with
drugs. Further it promotes better and broader use of existing
pharmacovigilance data for patient safety by spontaneous
reporting system.
PvPI Toolkit provides the PV professionals with the
necessary support and tools to be able to carry out
pharmacovigilance activities effectively and in a harmonised
way to ensure that data collected across the country can be
used globally.
National Coordination Centre
Pharmacovigilance Programme of India
Performance & effectiveness of the
Pharmacovigilance System
Who can Report What to Report Whom to Report
Healthcare professionals All types of suspected ADRs- Use the ‘Suspected
(clinician, dentist irrespective of whether they Adverse Drug Reaction
pharmacist ,nurses and are known or unknown, Reporting Form’ which is
others) can report serious and non-serious, available on the official
suspected adverse drug frequent or rare. Although website of IPC (
reaction. Pharmaceutical pharmacovigilance is [Link]) as well as
companies can also send primarily concerned with CDSCO ([Link])
ICSRs specific for their pharmaceutical medicines, to report any ADR. A
product to NCC. adverse reactions associated reporter who is not a part
with drugs used in traditional of AMC can submit the
medicine (e.g. herbal ICSR to the nearest AMC or
remedies) should also be directly to the NCC.
considered.
National Coordination Centre
Pharmacovigilance Programme of India
Resources for ADRs Reporting
Clinician NCC PvPI Pharmacist
Nurses Pharmaceutical Industries
National Coordination Centre
Pharmacovigilance Programme of India
Collaboration
Drug regulatory authority
Public health/immunization programmes
Pharmaceutical companies
Academic institution/Hospitals
Professional associations
Media
WHO-UMC
National Coordination Centre
Pharmacovigilance Programme of India
Reporting Methods in PvPI
National Coordination Centre
Pharmacovigilance Programme of India
A spontaneous report, is an unsolicited communication by
healthcare professionals or consumers to a company,
regulatory authority or other organisation
Targeted spontaneous reporting, estimate the incidence of a
known ADR to a specific medicine in your population
Cohort event monitoring , a prospective, longitudinal,
observational, cohort study of adverse events associated
with one or more monitored medicines.
National Coordination Centre
Pharmacovigilance Programme of India
Organization
Committees under NCC
Steering Committee PvPI Working Group
Core Training Panel
Quality Review Panel Signal Review Panel
National Coordination Centre
Pharmacovigilance Programme of India
Steering Committee
PvPI is administered and monitored by Steering
Committee to supervise and give proper direction
to the programme.
PvPI Working Group
It is constituted to approve major technical issues
related to establishment, implementation of
programme and giving technical inputs to CDSCO
for regulatory intervention of medicine.
National Coordination Centre
Pharmacovigilance Programme of India
Quality Review Panel
It is constituted to review quality, causality
Quality Review Panel
assessment and completeness of ICSRs.
It is constituted to review quality, causality
assessment Signal Review Panel of ICSRs.
and completeness
It is constituted of experienced scientists and
clinical experts
Signal to Review
assesses the computerized
Panel
It screening of ICSRs
is constituted in NCC database
of experienced for the
scientists and
clinical expertsoccurrence of signals
to assesses the computerized
screening of ICSRs in NCC database for the
occurrence of signals
National Coordination Centre
Pharmacovigilance Programme of India
Communication of Pharmacovigilance
Press : Advertisements through news
paper/pamplets for public awareness.
Website : Updating news on official/social
networking site.
Newsletter: Release PvPI newsletter thrice in year.
Training/Workshops: NCC Provide trainings &
workshop to healthcare professional & technical
associate at ADR monitoring centres.
National Coordination Centre
Pharmacovigilance Programme of India
Achievements
Collaboration with National Health Programme
and Immunization Programme.
Integration of PvPI and Revised National
Tuberculosis Control Programme for patient
Safety.
Helpline number for reporting ADRs to NCC.
National Coordination Centre
Pharmacovigilance Programme of India
National Coordination Centre
Pharmacovigilance Programme of India