Has someone seen this before - VigiBase - the WHO international database of suspected adverse events and how to access it. Rebecca E.

Transcription

1 Has someone seen this before - VigiBase - the WHO international database of suspected adverse events and how to access it. Rebecca E. Chandler, MD

2 Session outline WHO Programme history VigiBase UMC Patient reports within VigiBase VigiAccess Take & Tell

3 The WHO Programme for International Drug Monitoring Thalidomide 1961 In 1968 WHO creates Programme for International Drug Monitoring In 1978 Swedish Government and WHO creates the WHO Collaborating Centre for International Drug

4 Member countries today 10!> 120

5 VigiBase - the WHO international database First international ICSR database, in continuous use for nearly 50 years The data is accessible to all National Centres in the WHO PIDM Used by UMC for global signal detection

6 VigiBase cumulative increase Over 12 million Individual Case Safety Reports (ICSRs)

7 Country distribution for ICSRs received over the past year ( ) Singapore Other Countries in VigiBase Germany United Kingdom 1% 9% Japan 1% 2% Italy 2% India 2% 2% Republic of Korea 7% United States 43% France 12% China 17%

8 The vision, mission and aim of UMC Vision: A world where all patients and health professionals make wise therapeutic decisions in their use of medicines Mission: Supporting and promoting patient safety through building sustainable and effective pharmacovigilance practices globally Aim: To ensure that early signs of previously unknown medicinerelated safety problems would be identified and information about them shared and acted upon

9 The main activities of the UMC Product s & services Scientifi c develop ment Capacit y building

10 The main activities of the UMC Find and explain signals Develop the science of pharmacovigilance Visibility and status Scientific development

11 Scientific development

12 Scientific development

13 Activities Products & services Secure funding Technical solutions Global and local

14 Products and services WHODrug The Dictionary Active ingredients All countries where the products are sold Trade names Pharmaceutical forms Strengths Manufacturers

15 Products and Services WHO Programme Funding Commercial sector activities WHODrug

16 Products and Services VigiLyze to WHO Programme member countries

17 Activities Capacity building Sustainable PV systems Quality PV practices Evaluation

18 Annual Pharmacovigilance Course, Uppsala - May 2015

19 Consultancy, Training, Visits

20 Patient reports within VigiBase As of 1 January 2016: 2,983,163 reports had been received from consumers or non health care professionals Analysis performed last spring revealed: Females > Males; North America > all other Drugs: Exenatide, Etaneracept, Natalizumab, Nicotine, Interferon, Orlistat Events: Medicine ineffective, injection site pain, Insomnia, Hyperglycemia, Depersonalisation

21 VigiAccess - the WHO global database on a limited scale

22 VigiAccess visitor statistics Average: ~4000 visitors/month; 152/day Since launch in April visitors (1 Oct 2015) Device type US & China, 6 in top 20 are Latin America Visitors Mobile Tablet Desktop 6408 Most active countries Japan India United States China Brazil Apr May Jun Jul Aug Sep Others

23 New campaign for the public

24 Take & Tell App

25 Access to VigiAccess in Take & Tell App

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27 A WHO Collaborating Centre One goal In our role as a WHO Collaborating Centre, we adhere to WHO policies and work in close liaison with WHO headquarters. We provide scientific leadership and operational support to the WHO Programme for International Drug Monitoring. We share the WHO s goal of better health for all, but are organisationally and professionally distinct from the WHO itself.