Biovigilance: A global perspective

Abstract

A biological is a substance which either comprises, contains, or is derived from human cells or human tissues. The use of biological products is associated with the risk of infection transmission, allergic reactions, and other adverse events (AEs). The science and activities relating to the detection, assessment, understanding, and prevention of AEs or any other problems related to biological products (blood, cells, tissues, organs, and vaccine in international perspective) are termed as biovigilance. With more and more biologicals being marketed and the rapid revolutionary changes in transplant-related services, the importance of biovigilance is increasing day by day. Although specific types of vigilance systems (pharmacovigilance and materiovigilance) exist, activities related to “biovigilance” are still in an infancy stage. Many developed countries such as the USA, Europe, and Australia have implemented nationwide biovigilance programs. In India, the National Institute of Biologicals, in collaboration with the Indian Pharmacopoeia Commission, has launched the Biovigilance Programme of India. In this article, the biovigilance systems of different countries across the globe have been reviewed along with highlights of the current biovigilance needs.

The value of organ and tissue biovigilance: a cross-sectional analysis

“…These tools are those proposed by the Vigilance and Surveillance of Substances of Human Origin (SoHO V&S) (29) project and the Eustite project (24). The impact matrix classification table applied in this study has four levels: minor (0-3); moderate (4-6); moderate/high (8-9); or catastrophic/extreme (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20). Finally, the preventability capacity (considered when changing or implementing a test or procedure could have avoided the notification) was considered.…”

“…Biovigilance (BV) systems analyze any unexpected occurrence related to the obtaining or the quality and safety of tissues and organs from living or deceased donors, communicating and managing them to minimize damage (10). BV programs have been implemented in a diverse, uneven manner worldwide (10)(11)(12)(13)(14) (20).…”

“…Biovigilance (BV) systems analyze any unexpected occurrence related to the obtaining or the quality and safety of tissues and organs from living or deceased donors, communicating and managing them to minimize damage (10). BV programs have been implemented in a diverse, uneven manner worldwide (10)(11)(12)(13)(14) (20). Both systems were set up in alignment with the structure of the tissue and organ Spanish Network, based on three levels of organization (Figure 1): the Spanish National Transplant Organization [Organización Nacional de Trasplantes (ONT)] responsible for the overall management and coordination; 17 regional coordination units; and, at the center level, transplant coordinators, transplant teams, and tissue establishments (TEs).…”

Educational and Electronic-Based Tools to Mitigate the Risk of Transfusion Adverse Events

“…2 Similarly, from 2010 to 2012, a total of 77 facilities in the United States reported more than 5,000 adverse transfusion reactions of two million blood products transfused with a mortality rate of 0.26 deaths per 100,000. 3,4 Additional data taken from 125 international databases determined that the average rate of adverse reactions to transfusion of blood products was 660 per 100,000 individuals with nearly 3% categorized as severe. 5 The national hemovigilance systems such as the U.S. Biovigilance Network or the AABB Donor Hemovigilance Program 4 are in place to gauge the safety of transfusions with the goal of improving patient safety.…”

“…3,4 Additional data taken from 125 international databases determined that the average rate of adverse reactions to transfusion of blood products was 660 per 100,000 individuals with nearly 3% categorized as severe. 5 The national hemovigilance systems such as the U.S. Biovigilance Network or the AABB Donor Hemovigilance Program 4 are in place to gauge the safety of transfusions with the goal of improving patient safety. 6 Various strategies to reduce the incidence of transfusion reactions include appropriate matching of the donor product to the recipient, proper storage of the blood, leukoreduction and irradiation as indicated, premedication, restrictive transfusion practices, and reduction of iatrogenic cytopenias.…”