WHO International Drug Monitoring
WHO International Drug Monitoring
WHO International Drug Monitoring
Meena Yadav
M.Pharm (2nd semester Department of pharmacology)
INDO-SOVIET FRIENDSHIP COLLEGE OF PHARMACY MOGA,
(PUNJAB)
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Contents:
• Introduction
• History
• Functions of International Drug Monitoring
• UMC’s role as WHO Collaborating centre
• Pharmacovigilance
• Evolution of pharmacovigilance
• Role of WHO in pharmacovigilance
• Reporting procedure
• Role of pharmacovigilance in post-marketing
• Pharmacovigilance methods
• PV Terminologies
• VigiBase
• References 2
INTRODUCTION:
• In 1968 during the 16th world assembly a resolution called for a systemic collection of information on serious
adverse drug reactions during the development and particularly after medicines have been made available for
public use. This led to the formation of WHO Programme for International Drug Monitoring (PIDM).
• Initially the WHO PIDM members consisted of 10 countries. In 2018, 134 countries have joined the WHO
PIDM.
• WHO PIDM members submit reports of adverse reactions associated with medicinal products, known as
Individual Case Safety Reports (ICSRs) to the global database VigiBase.
• The ten founder members of the WHO Programme in 1968 were Australia, Canada, Czechoslovakia, Federal
Republic of Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA.
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HISTORY:
• The establishment of the WHO Programme followed the thalidomide disaster of 1961.
• In 1963, during the 16th World Health Assembly, formation of the WHO Programme for International Drug
Monitoring.
• Morocco
• The Netherlands
• Norway
• India 4
FUNCTIONS OF WHO PIDM INCLUDE:
• Identification and analysis of new adverse reaction.
• Publication of periodical news letters, guidelines and books in the Pharmacovigilance and risk management area.
• Supply of tools for management of clinical information including ADR case reports:-
• Provision of training and consultancy support to National centres and countries establishing Pharmacovigilance
system.
• Computer software for case report management designed to suit the needs of National centres.
• Annual meetings for representative of national centres at which scientific and organisational matters are discussed.
• Pursue research.
• To collect, assess and communicate information from member countries about benefits, harms and risks of drugs
to improve patient therapy and public health worldwide.
• Developing and providing data-entry, management, retrieval and analysis tools such as VigiFlow and VigiLyze.
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PHARMACOVIGILANCE:
• Detection
• Assessment
• Understanding
• Prevention
of adverse drug reactions or any other possible drug related problems (WHO 2002).
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Evolution of Pharmacovigilance:
• 1969- reporting of mortalities with digitalis but absence of system of communication between physicians.
• In 1972 National Pharmacovigilance Centres were established to work in collaboration with WHO.
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Pharmacovigilance in India:
• Formal drug safety monitoring system was proposed in 1986.
• 12 regional centres.
• In 1997, WHO Uppsala Monitoring Centre established National Pharmacovigilance Centre at AIIMS, New Delhi and two other centres at
Aligarh & Mumbai.
• In 2005, National Pharmacovigilance Program sponsored by WHO was launched with Pharmacovigilance Advisory Committee located at
CDSCO, New Delhi and other regional, zonal and peripheral centres.
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Need of Pharmacovigilance:
• Insufficient evidence of safety.
• Ensuring public confidence.
• Promoting rational use of medicines.
• Ethics.
Scope of Pharmacovigilance:
• Continuous monitoring of ADR’S.
• Re-assessing and updating risk/benefit profile through periodic safety update reviews (PSUR).
• Develop risk evaluation & medication strategies by adding product Information-
-Black box warning
-Withdrawal of drugs
• Continuous-
-drug monitoring
-drug surveillance
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Aims of pharmacovigilance:
• Quantifying risks.
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Role of WHO in Pharmacovigilance:
• To identify ADR that could not be found through clinical trial programme.
• Jobs performed-
-Signal detection
-Signal review
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Reporting procedure:
Manufacturer Distributors Health Professionals
Local centres
Provincial centres
SFDA/MOH
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Role of Pharmacovigilance in Post-marketing:
• To check interactions.
• Risk factors.
• Quality of life.
• Cost assessment.
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Pharmacovigilance methods:
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Objective & Importance of the Pv Terminologies:
Objective: To make all health care professional aware with the terminologies related to pharmacovigilance (Pv)
system that will give important insights
Importance:
& enables to perform the task more efficiently for the patient’s benefit.
A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the modifications of physiological function. (WHO, 1972)
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Unexpected Adverse Drug Reaction:
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (P.I.)
Adverse Event(AE):
An adverse event (AE) can be any unfavourable and unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal
product.
Results in death,
Is life-threatening,
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VigiBase:
• VigiBase is UMC’s starting-point for the journey from data to wisdom about safer use of medicines and wise
therapeutic decisions in clinical practice.
• It is the driving-force at the heart of the work of UMC and the WHO Programme.
Since 1978 UMC has been responsible for the development and maintenance of VigiBase.
• The purpose is to ensure that early signs of previously unknown medicines-related safety problems are identified
as rapidly as possible.
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Flow of Information:
National PV centres
Health care
or
Consumer/patients Newsletter
or
Pharmaceutical industry
National ICSR databases Search and analysis tool
e.g.VigiFlow VigiLyze
VigiBase
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Signal Detection Process:
Data mining of ICSRs
Unlisted Drug-ADR
combinations are checked
Generation of Hypothesis
Clinical Evaluation
Regulatory recommendation
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References:
• https://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map/en/
• Sten Olsson. The role of WHO program on international drug monitoring in co-ordinating world-wide drug
safety efforts. Drug Safety 1998;19:1-10
• Sanvidhan G Suke, Prabhat Kosta, Harsh Negi. Role of Pharmacovigilance in India: An overview. http://ojphi.org
* 7(2):e223, 2015
• Jacques Caron, Michaël Rochoy, Louise Gaboriau, Sophie Gautier. The history of pharmacovigilance. Therapie
(2016) 71, 129—134
• https://www.who-umc.org/global-pharmacovigilance/members/who-programme-members/
• https://www.who-umc.org/global-pharmacovigilance/who-programme/the-story-of-umc-and-the-who-
programme/
• https://www.who-umc.org/vigibase/vigibase/
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Thank You
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