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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 Biovigilance
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Alan E. Williams, Ph.D.
Office of Blood Research and Review
January 27-29, 2010
(Japan, Singapore, South Africa)
or Public Health Authorities (Canada)
Complexity of the effort
Uncertainty of future funding
Wide variety of Data Systems
Potential for inter-organizational competition
FDA AE reporting regulations not finalized
NHLBI REDS and REDS-II
RADAR, FACTS other repositories
National Blood Collection and Utilization Survey (NBCUS)
Marker positive donor interview studies
FDA Blood Safety Mandatory Reporting
Fatalities (donors & recipients)
Biological product deviation (BPD) reports
Medical device reports
(Note: mandatory FDA drug AE reporting is far more comprehensive)
Voluntary “passive” reporting to FDA via AERS/MedWatch
Query for blood and components as primary or secondary suspect products.
Total = 44; some patients received blood components and derivatives.
Funded by DHHS
Focus on Donor Adverse Reactions
Key Participants – DHHS, AABB, ARC, DoD, BSI, Coffee Memorial, Mayo, PPTA, Canadian Blood System, KBS
Acute hemolytic transfusion reaction
Delayed hemolytic transfusion reaction
Delayed serologic transfusion reaction
Hypotensive transfusion reaction
Febrile non-hemolytic transfusion reaction
Post transfusion purpura
Transfusion associated circulatory overload (TACO)
Transfusion associated dyspnea
TA- Graft versus host disease
Transfusion associated infection (bacterial, viral, parasitic, other)
8101 Glenbrook Road
Bethesda, MD 20814-2749
Need to improve ability to detect low frequency adverse events in populations receiving approved biologics.
Development of a nationwide electronic safety monitoring system
Under FDAAA, section 905, FDA is required to link to disparate sources of safety data in order to access 25 million patient records by 2010 and 100 million by 2012
Use of CMSDatabase:
RAPID ANALYSIS OF GBS RATE vs. USE OF SEASONAL FLU VACCINE - 2006
• Data sources remain with original owners behind existing firewalls
Owners would run queries—FDA-requested or other—(or could opt out) and convey the results of their queries to the network for analysis according to strict privacy and security safeguards
System will enable FDA to partner with existing data owners (e.g., insurance companies with large claims databases, owners of electronic health records)
• New system
Will strengthen FDA's ability to monitor postmarket performance of a product
– Will augment, not replace, existing functionality
Overall goal : Establish a comprehensive System for Simultaneous End-User Reporting in Support of Multiple Applications