Presentation BIOVIGILANCE IN THE UNITED STATES BIOVIGILANCE介绍在美国Biovigilance Biovigilance.pptVIP

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Presentation BIOVIGILANCE IN THE UNITED STATES BIOVIGILANCE介绍在美国Biovigilance Biovigilance.ppt

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Presentation BIOVIGILANCE IN THE UNITED STATES BIOVIGILANCE介绍在美国Biovigilance Biovigilance

BIOVIGILANCE IN THE UNITED STATES: EFFORTS TO BRIDGE A CRITICAL GAP IN PATIENT SAFETY AND DONOR HEALTH Alan E. Williams, Ph.D. Office of Blood Research and Review CBER, FDA Pharma Conference January 27-29, 2010 HHS Biovigilance Gap report:Key Deficiencies of Hemovigilance in the United States Absence of………. Long-term stability National scope Multicenter design Common definitions Broad data access and sharing Real Time Data Availability Active use to document practice improvement International Hemovigilance Global Models (cont.) Some hemovigilance systems are governed by regulations (France, Germany Switzerland) Some are managed by blood manufacturers (Japan, Singapore, South Africa) Others are managed by Medical Societies (Netherlands, UK) or Public Health Authorities (Canada) International Hemovigilance Global Models (cont.) Hema-Quebec (non-profit blood establishment serving Quebec) Established transfusion safety officers (TSOs) in each medical facility High rate of transfusion AE reporting. International Hemovigilance Global Models (cont.) Recognized need for uniformity in definitions of adverse events and incidents International Hemovigilance Network (EHN/IHN) 50 members, 34 countries. includes most EU Nations Defined grading for severity, imputability, and clinical signs (subsequently modified and expanded by the ISBT hemovigilance working party) US may soon join the IHN Examples of Hemovigilance Elements Currently Operational in the United States: Voluntary “passive” reporting to FDA via AERS/MedWatch HHS/AABB Donor Hemovigilance Funded by DHHS Focus on Donor Adverse Reactions Key Participants – DHHS, AABB, ARC, DoD, BSI, Coffee Memorial, Mayo, PPTA, Canadian Blood System, KBS HHS/AABB Donor Hemovigilance National Standards for Donor Reaction Data Collection Data Elements and Definitions Reactions and Reaction Categorization Systemic, Standard Mechanism to Calculate Donor Reaction Rates Trends at Facility, Organizati