1. WHO international drug monitoring programme
Anas Saifi
M.Pharm (Pharmacology) 2nd Sem.
School of Pharmaceutical Education And Research
Jamia Hamdard
2. Presentation Outline
• Introduction
• History
• Functions of International Drug Monitoring
• UMC’s role as WHO Collaborating centre
• Role of WHO in pharmacovigilance
• Reporting procedure
• Pharmacovigilance methods
• VigiBase
3. INTRODUCTION
• In 1963, 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 Program for International Drug Monitoring (PIDM).
• Initially the WHO PIDM members consisted of 10 countries.
• Currently, 155 countries are members of the WHO PIDM. Another 21 associate member
countries are in the early stages of establishing their pharmacovigilance systems in
preparation for full membership.
• The ten founder members of the WHO Program in 1968 were Australia, Canada,
Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand,
Sweden, United Kingdom, USA.
• WHO PIDM members submit reports of adverse reactions associated with medicinal
products, known as Individual Case Safety Reports (ICSRs) to the global database
VigiBase.
5. HISTORY
• The establishment of the WHO Program followed the thalidomide disaster of
1961.
• In 1963, during the 16th World Health Assembly, formation of the WHO Program
for International Drug Monitoring.
• In 1971, an international database was established at WHO headquarter in
Geneva.
• In 1978, this database, now known as VigiBase, moved to Uppsala (Pilot project in
USA. Move to Switzerland and then to Sweden).
6. WHO HQ IN GENEVA
• To become an associate member country, the government of a country needs to
send an official application to the WHO HQ in Geneva.
• To become a full member the country also needs to send at least 20 ADR reports
in a correct format.
• WHO Collaborating Centers (+6)
• UMC Sweden
• Morocco
• The Netherlands
• Norway
• India
7. FUNCTIONS OF WHO PIDM
• Functions Of Who PIDM Include-
• Identification and analysis of new adverse reaction.
• Information exchange between WHO and National centers.
• 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
eg. WHO Drug Dictionary, WHO Adverse Reaction Terminology.
8. FUNCTIONS OF WHO PIDM
• Provision of training and consultancy support to National centers and countries
establishing Pharmacovigilance system.
• Computer software for case report management designed to suit the needs of
National centers.
• Annual meetings for representative of national centers at which scientific and
organizational matters are discussed.
• Methodological research for the development of pharmacovigilance as a science.
10. FUNCTIONS OF WHO HQ
• Exchange of Information- National Information Officers Publications (WHO
Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information).
• Policies, guidelines, normative activities- The Importance of PV (2002) Safety
Reporting - A guide to detecting and reporting adverse drug reactions (2002)
Policy perspectives on medicines (PV) 2004 Safety monitoring of herbal medicines
(2004) PV in Public Health.
• Country support Training courses on PV- Training courses on pharmacovigilance
Address specific / stated needs: antimlalarials…. Annual Meeting of PV Centre.
• Collaborations or partnership
• Resource mobilization- Gates foundation European commission Global Fund
11. WHO COLLABORATING CENTRE THE UPPSALA
MONITORING CENTRE (UMC)
• Established as a foundation 1978.
• Based on agreement Sweden – WHO
• International administrative board
• WHO Headquarters responsible for policy
• Self financing
• Six board members – three appointed by the government and three appointed by
WHO.
• UMC runs the program but WHO is responsible for policy issues.
12. 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:-
1) Analyzing VigiBase data and identifying signals of potential safety problems.
2)Pursue research.
3) Broadening the scope of pharmacovigilance through debate, research and
consultation.
4) To collect, assess and communicate information from member countries
about benefits, harms and risks of drugs to improve patient therapy and public
health worldwide.
5) To collaborate with member countries.
6) Developing and providing data-entry, management, retrieval and analysis
tools such as VigiFlow and VigiLyze.
13. ROLE OF WHO IN PHARMACOVIGILANCE
• To identify ADR that could not be found through clinical trial program.
• Collecting case reports.
• Uppsala Monitoring Centre, Sweden.
• Jobs performed:
1) Signal detection
2) Signal review
3) Education and advisory
4) Research & Development
14. SIGNAL DETECTION PRIMARY UMC TASK
• Identification of previously unknown drug reactions; Our primary goal is to find
signals as early as possible
• (WHO definition)
• Reported information on a possible causal association between an adverse
event and a drug, the relationship being unclear or incompletely documented
previously.
• Information that arises from one or multiple sources (including observations and
experiments), which suggests a new potentially causal association, or a new
aspect of a known association, between an intervention and an event or set of
related events, either adverse or beneficial, that is judged to be of sufficient
likelihood to justify verificatory action.
• The process of signal management in PV is a set of activities, which aim to
determine whether there are new risks associated with a particular drug, or
whether known risks associated with a particular drug have changed.
15. Signal Detection Process
Data mining of ICSRs
Unlisted Drug ADR
combination are Checked
Generation of Hypothesis
Clinical Evaluation
SRP Discussion Information
Regulatory recommendation
16. ADVISORY COMMITTEE ON SAFETY OF
MEDICINAL PRODUCTS (ACSOMP)
• ACSoMP was established in 2003 to provide advice to WHO, including its
Collaborating Centre for International Drug Monitoring (the UMC), and through it
to the Member States of WHO, on safety issues relating to medicinal products.
• It guides WHO on general and specific issues related to Pharmacovigilance (PV).
• The Committee is composed of 12 members drawn from the WHO Expert
Advisory Panels for Drug Evaluation and for Drug Policies and Management and,
where appropriate, in consultation with other relevant WHO clusters and expert
advisory panels.
• ACSoMP meets once a year to discuss ongoing and new PV topics, with particular
focus on issues related to public health programes.
17. 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 Programe.
• 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
18. VigiMobile
• VigiMobile, a new app for field reporting of adverse events following
immunization (AEFI), is now available as part of its synchronized IT
solutions for managing AEFIs.
• This has been developed in collaboration with WHO-HQ (PVG, DDI) and the
WHO Collaborating Centre for International Drug Monitoring (UMC).
• VigiMobile follows form for AEFI reporting recommended for collecting
AEFI data and can be used on- or offline in remote areas.
• Using the system, immunization programmes can also share reports with
VigiFlow and VigiBase (the WHO global database of Individual Case Safety
Reports).
• This system will enable decision-makers at district, province, national and
international levels to obtain high-quality AEFI reports, review the vaccine
safety data and respond promptly.
19. REFERENCES
• The WHO Programme for International Drug Monitoring, WHO,
https://www.who.int/teams/regulation-prequalification/regulation-and-
safety/pharmacovigilance/health-professionals-info/pidm visited (28 March 2023)
• WHO, https://www.who.int/teams/regulation-prequalification/regulation-and-
safety/pharmacovigilance visited (28 March 2023)
• Olsson S. (1998). The role of the WHO programme on International Drug Monitoring in
coordinating worldwide drug safety efforts. Drug safety, 19(1), 1–10.
https://doi.org/10.2165/00002018-199819010-00001
• WHO international drug monitoring programme & the Uppsala Monitoring centre ppt,
Shanti Pal and mary Couper, Quality Assurance and Safety Of Medicine, WHO
https://slideplayer.com/slide/5967845/
• WHO international drug monitoring programme ppt.x, Sneha Khandale
https://www.slideshare.net/SnehaKhandale1/who-international-drug-monitoring-
program
