Regulatory aspects of Implementing Haemo-Vigilance
Mr. Vignesh M, Dr. Sureshkumar Raman*
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India.
*Corresponding Author E-mail: firstname.lastname@example.org, email@example.com
Online published on 30 April, 2021.
Background: According to WHO (World Health Organization), like Pharmaco-vigilance, which is about monitoring on safety aspects of drugs, similarly, there should be a regulation for the Blood transfusion safety due to many risk factors involved during the Blood transfusion process. So Haemo-vigilance has been introduced for continuous monitoring on Blood, for possible risks during their collection, storage and transfusion of blood to the recipients. This work defines what are the current situations in the Blood transfusion safety, Regulations to be followed to avoid further occurring errors and provides recent issues and controversies involved during the Blood transfusion process and also determines what were the challenges and barriers involved for implementation of Haemovigilance in basic and effective aspects. Methods: “This article does not contain any studies with human or animal subjects performed by any of the authors.” Results: There were many Non-Compliance issues with the Guidelines which are framed by the regulatory agencies, usually deviates from the protocols during the study or process of Blood transfusion. Training staff members who are involved in the study should be given without any failure and negotiation. Summary of common Blood transfusion issues and frequent Blood transfusion issues cited by inspections of various regulatory authorities have been enlisted and discussed. Conclusion: Throughout the overall basis of this Programme around the world that there were many technical challenges were involved in this implementing criteria to bring out a successful measure and make it a common standard. Since there were benefits in the Blood transfusion, similarly there were also Risk factors were involved due to sensitive characteristics of this system. Based on the recommendations and applicable solutions, the implementation of Haemo-vigilance around the world in International, as well as a National basis, will become successful.
Why Haemovigilance, Adverse reactions, Benefits, Importance, Recommendations.