WHO International Drug Monitoring Program

Information on WHO International Drug Monitoring Program

1. By Sneha Khandale Assistant Professor S hreeyash Institute of P haemaceutical Education and Research, A urangabad WHO International drug monitoring program

2. Contents 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, 143 countries are  members  of the WHO PIDM. Another 28 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 .

4. 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 ).

5. 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

6. 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. 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

7. 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 activitie s 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

8. WHO Collaborating Centre the Uppsala Monitoring Centre (UMC) E stablished 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.

9. 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 .

10. 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: Signal detection Signal review Education and advisory Research & Development

11. 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 .

12. 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 .

13. 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

14. Thank you