2. What is Pharmacovigilance ?
• Pharmakon (Greek) = Medicinal Substances
• Vigilia (Latin) = To keep watch
• WHO Definition
– The science & activities relating to the detection,
assessment, understanding & prevention of
adverse effects or any other drug related
problems
6. Historical Background Thalidomide
• 1960 marketed in 46 countries (hypnotic,
prevention of nausea in pregnancy)
• Heavily promoted
• 1960 first reports of deformed infants
(phoecomelia) total more than 20,000 cases
7. Direct result of thalidomide incident:
• USA: 1962 amendment to Federal Food, drug
& Cosmetic Act - required both safety &
efficacy data
• UK: 1964 Yellow card scheme
• WHO: 1968 Programme for International Drug
Monitoring
8. Aims
• To improve patient care and safety in relation
to the use of medicines, and all medical and
paramedical interventions
• To improve public health and safety in relation
to the use of medicines
9. To contribute
• to the assessment of benefit, harm,
effectiveness and risk of medicines,
encouraging their safe, rational and more
effective use
• To promote understanding, education and
clinical training in pharmacovigilance and its
effective communication to health
professionals and the public
10. Terminology
• Adverse Drug Reaction (ADR)
• An unintended reaction to a drug taken at
doses normally used in man When an
association between an AE and a drug is
established it becomes an ADR
11. • Adverse Event (AE) – A negative experience
encountered by an individual during the
course of a clinical trail, which may or may not
be associated with a drug
• Serious Adverse Event (SAE) – Any adverse
event which is fatal, life- threatening,
permanently disabling or which results in
hospitalilsation
12. Pharmacovigilance Process
• Detecting and reporting an ADR ADR form is
filled out with the patient and reaction details,
this later forms basis for data entry
1. Spontaneous reporting
2. Mandatory reporting
13. Spontaneous reporting
• Most common form of ADR reporting
• Healthcare professionals identify and report
any suspected adverse drug reaction to their
national pharmacovigilance centers or to the
manufactuters
14. Mandatory reporting
• Manufacturers are required to submit reports to they
receive from healthcare providers to the national
authority, in the form of a PSUR (Periodic Safety
Update Report)
• A regulatory document prepared by the Marketing
Authorisation Holder & submitted to the Agency
• Worldwide post-authorisation safety experience
• Includes information on all ADRs collected irrespective
of the reporting country
• Includes scientific evaluation of the risk-benefit
balance
15. • Data Collection and Capture
• Data Storage & Maintenance
• Data selection, Retrieval & Manipulation
16. Signal Detection
• Signal: New, previously unknown safety
information
WHO Definition
• Reported information on a possible causal
association between an Adverse Event and a
drug, the relationship being unclear or
incompletely documented previously
17. Regulatory actions on
• the basis of ADR reports
• Summary of Product Characteristics (SPC) –
basis of information for Healthcare
Professionals on how to use the medicinal
product safely and effectively
• Patient Information Leaflets (PIL) – drawn up
in accordance with the SPC
18. • • Changes in classification: – From Over the
counter to Prescription only Medicine – From
renewable prescription to non-renewable –
Special medical prescription – Restricted
prescription • Marketing Authorization
withdrawal • Batch recall based on clustering
of ADRs
19. • WHO & UMC
• Uppsala Monitoring Centre (UMC) is a field
name of the WHO collaborating Centre for
International Drug Monitoring.
• It is responsible for the management of the
WHO program for International Drug
Monitoring.
20. Functions of WHO
• Program for international drug monitoring include:
• Identification and analysis of new adverse reaction
signal from the case report information submitted to
the National Centers and from them to the database
• Information exchange between WHO and National
Centers, mainly through ‘Vigimed’ an e-mail
information exchange system
• Publication of periodical newsletters, guidelines and
books in the pharmacovigilance and risk management
area
21. Supply of
• tools for management of clinical information
including adverse drug reaction case reports –
WHO Drug Dictionary – WHO Adverse Reaction
Terminology
• Provision of training and consultancy support to
National Centers and countries establishing
pharmacovigilance systems
• Computer software for case report management
designed to suit the needs of National Centers
(Vigiflow)
22. Annual meetings
• for representatives of National Centers at
which Scientific and Organizational matters
are discussed
• Methodological research for the development
of pharmacovigilance as a science
23. Functions of UMC
• To co-ordinate the WHO program for
international drug monitoring and its more than
eighty member countries
• To collect, assess and communicate information
from member countries about the benefits,
harms and risks of drugs and other substances
used in medicine to improve patient therapy and
public health worldwide
• To collaborate with member countries in the
development and practice of the science of
pharmacovigilance
24. Goal
• To ensure that the benefits of use of medicine
outweighs the risks and thus safeguard the
health of the Indian population.
25. Objectives
• To monitor Adverse Drug Reactions (ADRs) in Indian
population
• To create awareness amongst health care professionals
about the importance of ADR reporting
• To monitor benefit-risk profile of medicines
• Generate independent, evidence based recommendations
on the safety of medicines
• Support the CDSCO for formulating safety related
regulatory decisions for medicines
• Communicate findings with all key stakeholders
• Create a national centre of excellence at par with global
drug safety monitoring standards
