Вы находитесь на странице: 1из 23

WHO International drug monitoring programme

Meena Yadav
M.Pharm (2nd semester Department of pharmacology)
• 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
• 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

• 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.

• 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

• In 1971, an international database was established at WHO headquarter in Geneva.

• In 1978, this database, now known as VigiBase, moved to Uppsala.

WHO Collaborating Centres:

• UMC Sweden

• Morocco

• The Netherlands

• Norway

• India 4
• Identification and analysis of new adverse reaction.

• Information exchange between WHO and National centres.

• 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:-

 WHO Drug Dictionary.

 WHO Adverse Reaction Terminology.

• Provision of training and consultancy support to National centres and countries establishing Pharmacovigilance

• 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.

• Methodological research for the development of pharmacovigilance as a science.

UMC’s role as a WHO Collaborating Centre:
UMC is one of five officially designated collaborating centers. UMC is responsible for managing the technical and
scientific aspects of the WHO’s worldwide pharmacovigilance network. It includes:-

• Analyzing VigiBase data and identifying signals of potential safety problems.

• Pursue research.

• Broadening the scope of pharmacovigilance through debate, research and consultation.

• To collect, assess and communicate information from member countries about benefits, harms and risks of drugs
to improve patient therapy and public health worldwide.

• To collaborate with member countries.

• Developing and providing data-entry, management, retrieval and analysis tools such as VigiFlow and VigiLyze.


Pharmacovigilance is the science and activities dealing with

• Detection

• Assessment

• Understanding

• Prevention

of adverse drug reactions or any other possible drug related problems (WHO 2002).

Evolution of Pharmacovigilance:
• 1969- reporting of mortalities with digitalis but absence of system of communication between physicians.

• Di-ethylstilbestrol (DES) for prevention of miscarriage & incidence of vaginal adenocarcinoma.

• 1971- establishment of International Drug Monitoring Program.

• In 1972 National Pharmacovigilance Centres were established to work in collaboration with WHO.

• ICH and CIOMS were established later.

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.

Current Status of PvPI:

• 14th July 2010 Pharmacovigilance Program of India was rolled out.

• AIIMS, New Delhi was National Coordination Centre.

• 15th April 2011 NCC moved to Indian Pharmacopeia Commission.

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
Aims of pharmacovigilance:

• Early detection of unknown safety problems.

• Identification of risk factors.

• Quantifying risks.

• Preventing patients from being affected unnecessarily.

• Rational and Safe use of Medicines.

• To reduce risks associated with drug prescribing and administration.

• Improve patient care and patient safety.

Role of WHO in Pharmacovigilance:

• To identify ADR that could not be found through clinical trial programme.

• Collecting case reports.

• Uppsala Monitoring Centre, Sweden.

• Jobs performed-
-Signal detection

-Signal review

-Education and advisory

-Research & Development

Reporting procedure:
Manufacturer Distributors Health Professionals

Local centres

Provincial centres

National centres WHO


Role of Pharmacovigilance in Post-marketing:

• To identify unexpected adverse reaction.

• To check interactions.

• Risk factors.

• Quality of life.

• Long term efficacy.

• Cost assessment.

Pharmacovigilance methods:

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

about the functioning of the Pv system.


Terminology is the standardized means of communication ; it allows

health care professionals to communicate in one standardized language

& enables to perform the task more efficiently for the patient’s benefit.

Adverse Drug Reaction (ADR):

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)

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

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction:

Any untoward medical occurrence at any dose that: -

 Results in death,
 Is life-threatening,

 Requires inpatient hospitalization or prolongation of existing hospitalization,

 Results in persistent or significant disability/incapacity,

 Is a congenital anomaly/birth defect .

Forms & Databases/Tools by various NRA/NPv Centres/WHO-UMC:

• 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.

Flow of Information:
National PV centres
Health care
Consumer/patients Newsletter
Pharmaceutical industry
National ICSR databases Search and analysis tool
e.g.VigiFlow VigiLyze

UMC Signal detection

Signal Detection Process:
Data mining of ICSRs

Unlisted Drug-ADR
combinations are checked

Generation of Hypothesis

Clinical Evaluation

SRP Discussion Information

Regulatory recommendation
• 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-
• https://www.who-umc.org/vigibase/vigibase/

Thank You