BIOVIGILANCE IN THE UNITED STATES: Endeavors TO Connect A Basic Crevice IN PATIENT Wellbeing AND Giver Wellbeing.

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BIOVIGILANCE IN THE UNITED STATES: Endeavors TO Connect A Basic Crevice IN PATIENT Wellbeing AND Contributor Wellbeing Alan E. Williams, Ph.D. Office of Blood Research and Audit CBER, FDA Pharma Gathering January 27-29, 2010 Biovigilance
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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

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Biovigilance ….a thorough and coordinated national patient security project to gather, break down and report on the results of accumulation and transfusion and/or transplantation of blood parts and subsidiaries, tissues, organs, and cell treatments. (ACBSA 2006)

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Public Health Goals for a Comprehensive Biovigilance System Benchmarking and Quality Assurance Adverse result estimation Sentinel signal location Surveillance Incident following (“e.g. close misses”) Enhanced energy to identify issues Intervention assessment (exploratory studies) Regulatory oversight Rapid activity to evacuate risky items/hones

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Biovigilance Gap Report Drafted in light of 2006 ACBSA proposals (and simultaneousness by Assistant Secretary of Health): that DHHS coordinate Federal activities and projects to bolster and encourage biovigilance in association with private area activities that DHHS structure an errand gathering to perform a hole examination of current frameworks and make suggestions for open private organizations in biovigilance (blood, cell, tissue, and organ treatments). Hemovigilance is the blood-particular part of biovigilance

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HHS Biovigilance Gap report: Key Deficiencies of Hemovigilance in the United States Absence of………. Long haul solidness National degree Multicenter configuration Common definitions Broad information get to and sharing Real Time Data Availability Active utilization to report hone change

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Biovigilance Design Options (All have focal points and drawbacks relying upon viewpoint) Single Institution versus Accumulated Data Voluntary versus Obliged Reporting Functionally Anonymous versus Character Linked Reporting Sentinel versus Reconnaissance Severe Adverse Events versus All Incidents Government versus Private versus Organization Commonality of information frameworks (HL7)

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International Hemovigilance Global Models 1993 Hemovigilance (France) Mandatory Reporting 1996 SHOT (UK) First deliberate framework Made key perception: TRALI relationship to female plasma European Blood Directive 2002/98/EC(2)

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International Hemovigilance Global Models (cont.) Some hemovigilance frameworks are administered by regulations (France, Germany Switzerland) Some are overseen by blood producers (Japan, Singapore, South Africa) Others are overseen by Medical Societies (Netherlands, UK) or Public Health Authorities (Canada)

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International Hemovigilance Global Models (cont.) Hema-Quebec (non-benefit blood foundation serving Quebec) Established transfusion security officers (TSOs) in every therapeutic office High rate of transfusion AE reporting.

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International Hemovigilance Global Models (cont.) Recognized requirement for consistency in meanings of unfavorable occasions and occurrences International Hemovigilance Network (EHN/IHN) 50 individuals, 34 nations. incorporates most EU Nations Defined reviewing for seriousness, imputability, and clinical signs (in this way altered and extended by the ISBT hemovigilance working gathering) US might soon join the IHN

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US National Hemovigilance: The Hurdles Complexity of the exertion Uncertainty of future financing Differing definitions Wide mixed bag of Data Systems Potential for between authoritative rivalry FDA AE reporting regulations not concluded

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Examples of Hemovigilance-Related Elements Currently Operational in the United States: Investigator-started examination Major blood associations (givers) Individual doctor\'s facilities (beneficiaries) MERS-TM

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Examples of Hemovigilance-Related Elements Currently Operational in the United States: Federally supported multi-focus epidemiological studies NHLBI REDS and REDS-II RADAR, FACTS different archives National Blood Collection and Utilization Survey (NBCUS) Marker positive contributor meeting studies

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Examples of Hemovigilance Elements Currently Operational in the United States: FDA Blood Safety Mandatory Reporting Fatalities (givers & beneficiaries) Product lacks Biological item deviation (BPD) reports Medical gadget reports (Note: required FDA drug AE reporting is much more exhaustive)

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Transfusion-Related Fatality Reports by Complication, FY2005 through FY2007

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Reports of TRALI by Implicated Blood Product, FY2005 through FY2007

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Examples of Hemovigilance Elements Currently Operational in the United States: Voluntary “passive” answering to FDA by means of AERS/MedWatch

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AERS Reports for Blood Calendar Year 2007 Query for blood and parts as essential or auxiliary suspect items. Complete = 44; a few patients got blood parts and subsidiaries.

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The Deficiencies in US Biovigilance have Explanations Absence of national blood framework Strong projects of agent started and governmentally financed examination programs Barriers to information sharing Lack of focused on speculation - particularly “real-time” information investigation/understanding Legal obligation Regulatory risk

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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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Adverse Reactions Allergic response Acute hemolytic transfusion response Delayed hemolytic transfusion response Delayed serologic transfusion response Hypotensive transfusion response Febrile non-hemolytic transfusion response Post transfusion purpura Transfusion related circulatory over-burden (TACO) Transfusion related dyspnea TA-Graft versus host ailment TRALI Transfusion related contamination (bacterial, viral, parasitic, other)

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Case Definition Criteria

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For More Information 8101 Glenbrook Road Bethesda, MD 20814-2749 Phone: +1.301.215.6574 Fax: +1.301.907.6895

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FDA’s Sentinel Initiative Need to enhance capacity to recognize low recurrence unfavorable occasions in populaces getting affirmed biologics. Improvement of an across the country electronic security checking framework Under FDAAA, area 905, FDA is obliged to connection to different wellsprings of wellbeing information keeping in mind the end goal to get to 25 million patient records by 2010 and 100 million by 2012

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DOSES Use of CMS Database: RAPID ANALYSIS OF GBS RATE versus Utilization OF SEASONAL FLU VACCINE - 2006 GBS rates

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Initial FDA Vision of Sentinel • Data sources stay with unique proprietors behind existing firewalls Owners would run queries—FDA-asked for or other—(or could quit) and pass on the aftereffects of their questions to the system for examination as per strict protection and security shields System will empower FDA to cooperate with existing information proprietors (e.g., insurance agencies with substantial cases databases, proprietors of electronic wellbeing records) • New framework Will reinforce FDA\'s capacity to screen postmarket execution of an item – Will increase, not supplant, existing usefulness

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Harmonization on Hemovigilance: The Remaining Challenges CDCand HHS Hemovigilance Voluntary Unlinked Surveillance configuration Pilot → National take off FDA Adverse Event Data Needs (Drugs and Biologics) Identity Linked (for postliminary) Sentinel (and observation) outline Real time (to degree conceivable) Voluntary and Mandatory Early Middle phases of improvement (Patient Safety Rules, SENTINEL) Overall objective : Establish an extensive 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 shaped to react to the ACBSA’s proposals to the Assistant Secretary for Health (ASH). The working gathering included: Matthew Kuehnert (seat), CDC; Jonathan Goldsmith (co-seat), once in the past of FDA right now with NHLBI ; Alan Williams (co-seat), FDA; James Bowman, some time ago of CMS as of now with HRSA; Simone Glynn, NIH, NHLBI; Harvey Klein, NIH; Laura St. Martin, FDA; Robert Wise, FDA; Jerry Holmberg, HHS/OPHS ; James Burdick, in the past of HRSA; Elizabeth Ortiz-Rios, HRSA; Jay Epstein, FDA; Robyn Ashton, HRSA; and Karen Deasy, CDC. Our gratitude to other people who added 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 Cen

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