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BIOVIGILANCE IN THE UNITED STATES: EFFORTS TO BRIDGE A CRITICAL GAP IN PATIENT SAFETY AND DONOR...
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Transcript of BIOVIGILANCE IN THE UNITED STATES: EFFORTS TO BRIDGE A CRITICAL GAP IN PATIENT SAFETY AND DONOR...
![Page 1: 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.](https://reader036.fdocuments.us/reader036/viewer/2022062304/56649daa5503460f94a98343/html5/thumbnails/1.jpg)
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
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Biovigilance
Biovigilance ….a comprehensive and integrated national patient safety program to collect, analyze and report on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, tissues, organs, and cellular therapies. (ACBSA 2006)
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Public Health Goals for a Comprehensive Biovigilance System
Benchmarking and Quality Assurance Adverse outcome measurement
Sentinel signal detection Surveillance
Incident tracking (“e.g. near misses”) Enhanced power to detect problems
Intervention evaluation (experimental studies) Regulatory oversight
Rapid action to remove unsafe products/practices
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Biovigilance Gap Report Drafted in response to 2006 ACBSA recommendations (and
concurrence by Assistant Secretary of Health): that DHHS coordinate Federal actions and programs to
support and facilitate biovigilance in partnership with private sector initiatives
that DHHS form a task group to perform a gap analysis of current systems and make recommendations for public-private partnerships in biovigilance (blood, cell, tissue, and organ therapies).
Hemovigilance is the blood-specific aspect of biovigilance
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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
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Biovigilance Design Options(All have advantages and disadvantages depending on perspective)
Single Institution vs. Aggregated Data Voluntary vs. Required Reporting Functionally Anonymous vs. Identity-Linked
Reporting Sentinel vs. Surveillance Severe Adverse Events vs All Incidents Government vs. Private vs. Partnership Commonality of data systems (HL7)
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International Hemovigilance Global Models
1993 Hemovigilance (France) Mandatory Reporting
1996 SHOT (UK) First voluntary system Made key observation: TRALI relationship to female plasma
European Blood Directive 2002/98/EC(2)
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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)
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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.
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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
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US National Hemovigilance: The Hurdles
Complexity of the effort Uncertainty of future funding
Differing definitions
Wide variety of Data Systems
Potential for inter-organizational competition
FDA AE reporting regulations not finalized
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Examples of Hemovigilance-Related Elements Currently Operational in the United States:
Investigator-initiated research Major blood organizations (donors) Individual hospitals (recipients) MERS-TM
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Examples of Hemovigilance-Related Elements Currently Operational in the United States:
Federally sponsored multi-center epidemiological studies
NHLBI REDS and REDS-II
RADAR, FACTS other repositories
National Blood Collection and Utilization Survey (NBCUS)
Marker positive donor interview studies
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Examples of Hemovigilance Elements Currently Operational in the United States:
FDA Blood Safety Mandatory Reporting Fatalities (donors & recipients)
Product deficiencies
Biological product deviation (BPD) reports
Medical device reports
(Note: mandatory FDA drug AE reporting is far more
comprehensive)
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Transfusion-Related Fatality Reports by Complication, FY2005 through FY2007
0
10
20
30
40
Complication
Num
ber
of F
atal
ities
FY05 29 16 8 1 6 0 2
FY06 35 9 7 8 3 1 0
FY07 34 2 6 5 3 2 0
TRALI HTR (non-ABO)Microbial Infection
TACO HTR (ABO) Anaphylaxis Other
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Reports of TRALI by Implicated Blood Product, FY2005 through FY2007
0
5
10
15
20
25
Blood Product
Nu
mb
er
FY05 13 5 3 4 4
FY06 22 5 1 2 5
FY07 12 12 0 1 9
FFP RBC Plasma* Platelets Pheresis
Multiple Products
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Examples of Hemovigilance Elements Currently Operational in the United States:
Voluntary “passive” reporting to FDA via
AERS/MedWatch
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AERS Reports for BloodCalendar Year 2007
Query for blood and components as primary or secondary suspect products.
Total = 44; some patients received blood components and derivatives.
Products US Foreign Total
Fresh frozen plasma 4 1 5
Platelets 4 3 7
Red blood cells 14 1 15
Blood derivative 9 7 16
Whole blood + other components 3 3 6
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The Deficiencies in US Biovigilance have Explanations
Absence of national blood system Strong programs of investigator-initiated and
federally-funded research programs Barriers to data-sharing Lack of targeted investment - especially
“real-time” data analysis/interpretation Legal liability Regulatory liability
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New Initiatives in US Biovigilance
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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
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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, Organization, Region and Nation
Levels Comparison With Peers, Region and Nation
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HHS/AABB Donor Hemovigilance
Predictive and Causality Analysis Analyze Variables (Age, Sex, Weight, BP) Affecting
Donor Reaction Rates Device and Kit Analysis Analyze Associations between Policies, Procedures of
Organizations and Donor Reaction Rates
Intervention Analysis and Management
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CDC NHSN/AABB Recipient Hemovigilance
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http://www.cdc.gov/ncidod/dhqp/nhsn_biovig.html
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Adverse Reactions
Allergic reaction 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
TRALI Transfusion associated
infection (bacterial, viral, parasitic, other)
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Case Definition Criteria
http://www.cdc.gov/ncidod/dhqp/nhsn_biovig.html
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For More Information
http://www.aabb.org/biovigilance
8101 Glenbrook Road
Bethesda, MD 20814-2749
Phone: +1.301.215.6574
Fax: +1.301.907.6895
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FDA’s Sentinel InitiativeFDA’s Sentinel Initiative
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
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Use of CMS Database:
RAPID ANALYSIS OF GBS RATE vs. USE OF SEASONAL FLU VACCINE - 2006
DOSES
GBS rates
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Initial FDA Vision of Sentinel• 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
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Harmonization on Hemovigilance: The Remaining Challenges
CDCand HHS Hemovigilance 1. Voluntary
Unlinked Surveillance design Pilot → → National roll-out
FDA Adverse Event Data Needs (Drugs and Biologics) Identity Linked (for follow-up) Sentinel (and surveillance) design Real time (to extent possible) Voluntary and Mandatory Early Middle stages of development (Patient Safety Rules, SENTINEL)
Overall goal : Establish a comprehensive System for Simultaneous End-User Reporting in Support of Multiple Applications
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PHS Biovigilance Task Group*
The PHS Biovigilance Working Group was formed to respond to the ACBSA’s recommendations to the Assistant Secretary for Health (ASH). The working group included: Matthew Kuehnert (chair), CDC; Jonathan Goldsmith (co-chair), formerly of FDA currently with NHLBI; Alan Williams (co-chair), FDA; James Bowman, formerly of CMS currently with HRSA; Simone Glynn, NIH, NHLBI; Harvey Klein, NIH; Laura St. Martin, FDA; Robert Wise, FDA; Jerry Holmberg, HHS/OPHS; James Burdick, formerly of HRSA; Elizabeth Ortiz-Rios, HRSA; Jay Epstein, FDA; Robyn Ashton, HRSA; and Karen Deasy, CDC.
Our thanks to others who contributed to this white paper, including D. Michael Strong, Barbee Whitaker and Kathy Loper, AABB; Tom Lane, University of California at San Diego; Anne Eder, American Red Cross; Peter Tomasulo, Blood Systems, Inc; Jim AuBuchon, Puget Sound Blood Center; and Susan Leitman, NIH.