Author(s): Vignesh M, Raman Sureshkumar

Email(s): sureshcoonoor@jssuni.edu.in , vickyrover007@gmail.com

DOI: 10.5958/0974-360X.2021.00123.2   

Address: Mr. Vignesh M, Dr. Raman Sureshkumar*
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
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.


Cite this article:
Vignesh M, Raman Sureshkumar. Regulatory aspects of Implementing Haemo-Vigilance. Research J. Pharm. and Tech. 2021; 14(2):701-704. doi: 10.5958/0974-360X.2021.00123.2


REFERENCES:
1.    WB. Liang, RY. Zhang, XF. Ye, J. Sun, J. Xu, WB. Tan. The haemovigilance: the best quality management system of the transfusion chain. ISBT Science series. 02 February 2018; Available at https://doi.org/10.1111/voxs.12419.
2.    Haemovigilance Programme of India. National Institute of Biologicals and Indian Pharmacopoeia Commission Collaboration. Available at http://nib.gov.in/haemovigilance.html [Last accessed 7 December 2013]
3.    Somnath Mukherji, Rituparna Maiti. Haemovigilance: A Current Update in Indian Perspective: Systemic review. Journal of Clinical and Diagnostic Research. 2016 Nov; 10(11): EE05–EE09; doi: 10.7860/JCDR/2016/21029.8868.
4.    Blood Transfusion Errors – Malpractice. Available at https://www.boyerslaw.com/blood-transfusion-errors-malpractice.html.
5.    ISTARE, Available at https://www.ihn-org.com/istare/
6.    Elhence P1, Veena S, Sharma RK, Chaudhary RK. Root cause analysis of transfusion error: identifying causes to implement changes, NCBI Journal. 2010 Dec; 50(12 Pt 2):2772-7; doi: 10.1111/j.1537-2995.2010.02943.x.
7.    de Vries RRP1, Faber J-C, Strengers PF. Haemovigilance: an effective tool for improving transfusion practice. NCBI Journal; 2011; 100:60–67; doi: 10.1111/j.1423-0410.2010.01442.x.

Recomonded Articles:

Author(s): Ahmed Hilal Sheriff, Preetham Prasad Nittla

DOI: 10.5958/0974-360X.2019.00968.5         Access: Open Access Read More

Author(s): Niha Naveed, Karthikeyan Murthykumar, Subasree Soundarajan, Sripradha Srinivasan

DOI: Not Available         Access: Open Access Read More

Author(s): Muhammad Hamdan, Noorhamdani AS, Masruroh Rahayu, Mohammmad Hasan Machfoed

DOI: 10.5958/0974-360X.2019.01020.5         Access: Open Access Read More

Author(s): Rahar Sandeep, Nagpal Navneet, Swami Gaurav, Arora Manisha, Bansal Suraj, Goyal Sandeep, Singla Shwali, Singh Preeti, Kapoor Reni

DOI: Not Available         Access: Open Access Read More

Author(s): Sonte Sushmitha, Sedimbi Revathi Priyanka, L. Mohan Krishna, M. Srinavasa Murthy

DOI: Not Available         Access: Open Access Read More

Author(s): Sandeep D. S, Prashant Nayak, Jobin Jose, Rishal Relita M, Sumana D. R.

DOI: 10.5958/0974-360X.2017.00317.1         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Fatemeh Abbasi, Malahat Nikravan Mofrad, Fariba Borhani, Malihe Nasiri

DOI: 10.5958/0974-360X.2017.00045.2         Access: Open Access Read More

Author(s): Vaseeha Banu T.S., Sandhya K.V., K.N. Jayaveera

DOI: Not Available         Access: Open Access Read More

Author(s): Siripurapu Sriram, Venkata Ravibabu Mandla, Chaithanya Sudha M, Saladi S.V. Subba Rao, Nagaveni Ch, Vani V., Gobinath P., Raj Kumar KVG., Jaydeep Lella, Sannidhi Krishna Praveen, Debjit Datta

DOI: 10.5958/0974-360X.2017.00078.6         Access: Open Access Read More

Author(s): Justin Antony, Satadal Debroy, Chennu Manisha, Peet Thomas, Victoria Jeyarani, Tenzin Choephel

DOI: 10.5958/0974-360X.2019.00367.6         Access: Open Access Read More

Author(s): Vijayalakshmi. S , Disalva. X, Chittaranjan Srivastava, Arun A

DOI: 10.5958/0974-360X.2019.00520.1         Access: Open Access Read More

Author(s): Amutha K*, Ashok Kumar A, Godavari A

DOI: 10.5958/0974-360X.2017.00100.7         Access: Open Access Read More

Author(s): G. Nithya Karpagam, Mahesh, Shanmugavel

DOI: 10.5958/0974-360X.2016.00179.7         Access: Open Access Read More

Author(s): Yarnykh T.G., Azarenko Iu. M., Buryak M.V., Bubilieva L. A.

DOI: 10.5958/0974-360X.2016.00115.3         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags