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Background Analysis: US HHS Advisory Committee to Discuss Blood Safety from a Patient Perspective – SEP 13, 2018 (ACBTSA)

Announcement

The US Department of Health & Human Services (HHS) has scheduled a meeting of the Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) for Thursday, September 13, 2018 to discuss tolerable infectious disease risk in blood safety from a patient perspective.

Background – Blood Safety

Blood centers and hospitals collect and transfuse millions of units of blood each year. The HHS Agencies that are responsible for helping to assure the safety of blood supplies include:

·       The National Institutes of Health (NIH), which conducts research on blood transfusion basic science, epidemiology, and clinical practices;

·       The Food and Drug Administration (FDA), which regulates how blood donations are collected and blood is transfused; and

·       The Centers for Disease Control and Prevention (CDC), which leads investigations and surveillance.

Donor screening is a key component of blood safety. Blood donors are asked a set of standard questions to assist in determining if they are in good health and free of any transmittable diseases. Blood donors whose answers indicate illness or risk of transmittable diseases are not permitted to donate. For those eligible to donate, their blood is tested for several variables, including: blood type (ABO group); Rh type; bacterial contamination; Hepatitis B and C viruses, HIV viruses, Human T-Lymphotropic viruses, syphilis; West Nile virus; and certain proteins (antibodies). Tests for Chagas disease and Cytomegalovirus are not required, but they are often performed by blood centers or for special needs patients.

According to the CDC, adverse reactions (ARs) are not common following blood transfusions, but the following ARs are being tracked through the National Healthcare Safety Network (NHSN) Hemovigilance Module so that the CDC can better understand them and develop interventions to prevent them: allergic reaction; acute hemolytic transfusion reaction (AHTR); delayed hemolytic transfusion reaction (DHTR); delayed serologic transfusion reaction (DSTR); febrile non-hemolytic transfusion reaction (FNHTR); hypotensive transfusion reaction; transfusion-associated circulatory overload (TACO); transfusion-related acute lung injury (TRALI); transfusion-associated dyspnea (TAD); transfusion-associated graft vs. host disease (TAGVHD); and transfusion-transmitted infection (TTI).

According to the FDA, the blood safety system is dependent on five key variables, as follows:

1) accurate and complete educational material for donors so that they can assess their risk;

2) sensitive communication of the donor screening questions;

3) donor understanding and honesty;

4) quality controlled infectious marker testing procedures; and

5) appropriate handling and distribution of blood and blood products for patient use.

Agenda

At this meeting, the Committee will discuss tolerable infectious disease risk in blood safety from a patient perspective. The meeting will focus on laying the groundwork for a subsequent substantive discussion at a future ACBTSA meeting. It is interesting to note that the FDA also has recently increased its efforts to ensure that patient perspectives are incorporated in decision-making. This move by the FDA has been prescribed under recent iterations of the Prescription Drug User Fee Act, a main source of FDA funding. Tarius has not found a specific impetus for HHS to review patient perspectives of blood safety at this time, but it may indicate a more over-arching approach within HHS to increase consideration of patient perspectives across a wider array of public health decisions.

Regulatory Background – Establishment of the ACBTSA

The ACBTSA provides advice to the HHS Secretary through the Assistant Secretary for Health (ASH) on a range of policy issues related to blood, blood products, and tissues. In 1995, the National Academies Institute of Medicine (IOM), now known as the National Academy of Medicine, issued three significant reports on blood safety and availability. These reports were based on an industry-wide roundtable exploration of the topic. In response to the IOM reports, the Advisory Committee on Blood Safety & Availability (ACBSA), and the executive-level Blood Safety Council (BSC) were established under the Office of the ASH (OASH). In 2012, HHS re-chartered the BSC into the HHS Blood, Organ, and Tissue Senior Executive Council (BOTSEC) and re-chartered the ABCSA into the federal Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA). Both expansions added the purview to explore and coordinate public health issues related to tissue products and donor-derived infectious disease complications of transplantation in organs and blood stem cells. OASH placed the council, committee, and staff into the Office of HIV/AIDS and Infectious Disease Policy (OASH/OHAIDP).  In OHAIDP, staff members identify nationally significant topics for committee and council deliberations and explore policy and programmatic solutions to the recommendations provided to the HHS Secretary and the Assistant Secretary.

The Committee consists of voting members who represent a diverse group of health professionals, patient advocates, and scientists; representatives from blood, tissue, and organ professional organizations; and relevant manufacturing and healthcare organizations. In addition, there are non-voting ex-officio members from HHS Agencies and the Department of Defense.

Except for 2017, the Committee has met at least once a year, in accordance with the estimated meeting frequency described in the Committee’s charter. Recommendations from the Committee are posted at the following website: https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/recommendations/index.html.

What’s Next?

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none Other: blood safety


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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.