The Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring)

1. The Uppsala Monitoring Centre(WHO Collaborating Centre for International Drug Monitoring) Dr Richard Hill Minsk May 2011

2. Spontaneous reporting • History of international program: • established 1968, after thalidomide • 10 countries • already an “international” program from the beginning

3. Founding Members (1968) • Australia • Canada • Czechoslovakia • Ireland • Netherlands • Germany • New Zealand • Sweden • United Kingdom • United States

4. Spontaneous reporting • History of international program: • now 104 countries (+32 associate members) • based in Uppsala, Sweden • Uppsala Monitoring Centre (UMC) • a WHO Collaborating Centre • 6,403,161 reports in international database (“VigiBase”) • data managed by UMC on behalf of National Centres

5. WHO Program, 2011

6. CIS & region • Members: • Armenia • Belarus • Kazakhstan • Kyrgyzstan • Moldova • Russia • Ukraine • Uzbekistan • Associate members: • Azerbaijan • Georgia • Non-members: • Tajikistan • Turkmenistan

7. UMC activities • Scientific activities: • report collection • signal detection • methodological development • pharmacovigilance tools • training • international communication • standardisation and guidelines

8. Reports in VigiBase

9. Data analysis • Routine signal detection performed by UMC staff and expert advisory panel • All reports in VigiBase searchable by all program members using online search tool: • line listings • individual cases • statistical information

10. Methodological development • Research using spontaneous reports: • statistical data-mining • automated duplicate detection • drug interactions • stratification (gender, age) • time-to-onset • Research using other datasets: • Cohort Event Monitoring • Electronic Health Records

11. Methodological development • Cohort Event Monitoring • information for Public Health Programmes • recording patients exposed (cohort, target 10 000) • active and systematic follow-up for adverse events • incidence rates and risk profiles • identification of sub-groups at risk • piloted in Tanzania and Nigeria for malaria treatment • supported by CemFlow management tool

12. Methodological development • Electronic Health Records • A complementary source of information on the real world use of medicinal products • Data collected directly from the computer systems in which the doctors manage their patient records • Listings over time for each patient of • medical diagnoses • drug prescriptions • administrative information (test results, life style, ...)‏

13. Pharmacovigilance tools • Tools available to all program members: • VigiSearch: online searching of VigiBase • VigiFlow: ICSR management system • WHO-ART: adverse reaction terminology • WHO-DD: drug dictionary • CEMFlow: cohort event monitoring • PaniFlow: H1N1 influenza vaccine monitoring

14. Other UMC activities • International communication • annual meeting of participants • online discussion forum • Pharmacovigilance training • regular training courses in Uppsala and elsewhere • UMC-Africa • example: collaboration with Global Fund

15. Global Fund HIV/AIDS Coverage BG/281108/8

16. Pharmacovigilance in Global Fund grants • A 2010 analysis of grant applications in the Global Fund database • 431 individual Global Fund proposals • 31% had “acceptable reference to PV'' • interviews: even if mentioned, PV not implemented in practice

17. Joint WHO/Global Fund pharmacovigilance strategy • Establish basic functions and minimum requirements of national pharmacovigilance system • Pharmacovigilance toolkit to support training and development • Funding for pilot countries to reach minimum level • Intention: only countries with pharmacovigilance systems should get Global Fund funding

18. Thankyou!