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Blood Line Document 43 Promoting Voluntary Blood BLOOD LNE Donation THE BLOOD DONATION JOURNAL 2017 | 43 voluntary HAEMOVIGILANCE IN INDIA- A VITAL STEP TO BLOOD SAFETY Blood transfusion saves lives and plays a low up of patients also. key role in improving the health status of any community. Blood Transfusion Service There are 2757 licensed blood banks in is a vital part of the National Health Ser- India and the average annual Blood col- vice and there is no substitute for Human lection is around 7- 8 million units . Our P.K.Sreekumar, Blood and its components In order to country still faces a deficit in terms of Assistant Drugs Controller, Kerala. improve the standards of Blood and its the availability of blood or blood compo- .................................................................. components, the Central Govt. through nents as the gap of demand and supply national Network of Haemovigilance(INH) Drugs Controller General of India, has of safe blood is wide. A Hemovigilance on December 2014. formulated a comprehensive legislation, program as an integral part of pharma- through the Drugs & Cosmetics Act, covigilance program of India at a national 1940 and Rules to ensure better qual- level was launched on December 10, 2012 Characteristics of Haemovigilance ity control system on collection, storage, with a road map of 5 years, i.e., year Programme – India: testing and distribution of blood and its 2012–17, with four phases, i.e., initiation components. It is in this context that the phase, expansion and consolidation phase, The main characteristics of HvPI term Hemovigilance becomes important. expansion and maintenance phase, and are developed in accordance with WHO The term Haemovigilance has Lat- optimization phase. Hemovigilance pro- guidelines for adverse event reporting. in and Greek roots(“haema”=blood and gram in India has been launched with the The reporting and learning systems are “vigilans”=paying special attention to). following objectives. adopted. It is non-punitive, independent It is a tool to improve the quality of • Monitor transfusion reactions of Public Authority and confidentiality of the blood transfusion chain, primar- • Create awareness among health care the reporter is maintained. Reporters ily focusing on safety. Haemovigilance professionals are free from fear of retaliation against systems will be of benefit also for vigi- • Generate evidence-based themselves or punishment of others as lance and surveillance of the treatment recommendations a result of reporting. The identities of with other human products such as cells, • Advise Central drugs standard the patient , reporter and institution are tissues and organs. This strict attitude control organization (CDSCO) for never revealed to a third party and hence includes blood donor selection and bio- safety related regulatory decisions confidential. The reporting system is logical control, labile blood component • Communicate findings to all independent of any authority with power processing, qualification, transport and key stakeholders to punish the reporter or the organiza- conditioning, prescription and distribu- • Create national and international tion. Reports are subjected to evaluation tion of blood components and follow-up linkages by experts. The Privacy and security of of transfused patient. Quality controls, The activities of hemovigilance between data are well ensured "safety locks",should be implemented at the blood banks and National Coordi- Medical Colleges/ Institutes/ Hospitals/ every stage to allow early problem detec- nating Centre at National Institute of Blood Banks of India can enroll under tion, thus avoiding potentially dangerous biologicals(NIB) are co-ordinated by a HvPI. The Head / Incharge of Transfu- attitudes and guaranteeing transfusion core group. The advisory committee in- sion Medicine Department / Blood Bank quality all along the process and the fol- troduced Transfusion Reaction Reporting provides the necessary details to the Na- Form (TRRF) and gives expert opinion for tional Coordinating Centre (NCC) - Hae- collection, collation, and analysis of he- movigilance Programme of India (HvPI) by movigilance. A software ‘Haemovigil’ was sending the duly filled Enrolment Form also developed for reporting the adverse either to NCC at National Institute of reactions. They also monitor the func- Biologicals, Ministry of Health & Family tioning and quality of the data collect- Welfare, Plot No. A-32, Sector-62, In- ed by the Adverse Transfusion Reaction stitutional Area, NOIDA - 201 309 (U.P.) Reporting Centres, i.e., ADR Monitoring or via E-mail to NCC at haemovigilance@ Centers and have also developed training nib.gov.in. NCC verifies the details pro- modules and guidelines aiming blood safe- vided by the Center. After verification, ty. India has become a member of Inter- NCC issues the User Id and Password to Continued Continued the Head /Incharge of Transfusion Medi- received by the Haemo-Vigil Software safety. cine Department / Blood Bank to access by 71 centers in India Optimal blood use, which comes under the Haemo - Vigil Software for onward With the success of the HvPI it was de- the purview of Haemovigilance, is also transmission of Transfusion Reactions cided to undertake donor vigilance ac- very important as blood components Reports to NCC. tivity as it is highly essential to achieve prepared from each unit of blood can, in the target of getting safe blood ac- turn, be used to cater to the needs of The TRR Form submitted to National cording to demand, as the gap between individual patients. Unwanted transfusion Coordinating Center –HvPI, is assessed demand and supply is wide. Thereby a of components and the resulting compli- by HvPI Personnel for completeness and National Blood Donor Vigilance Pro- cations can also be prevented. correctness. Once the data is assessed gramme (NBDVP) was launched on June Challenges in the the Core Group forward it to the Qual- 14, 2015. The Programme is an in- implementation of HV system ity Review Panel for the quality check. tegral part of the HvPI and is a com- Then the data is further forwarded to prehensive, centralized, and well-struc- The major challenges faced in the the Signal Review Panel for the statisti- tured approach to collect, collate, and implementation of HV system include cal analysis and also for the detection of analyze data to continuously improve enrolment of reporting centres, fear of “Signal”. Quality Review Panel and Signal donor safety and satisfaction so that punitive action, sense of additional work Review Panel in turn provide their rec- the blood donors have a feeling of being and responsibility especially for clinicians, ommendations to the Core Group which well-treated and well taken care of that shortage of staff, limited availability of further forwarded to the Haemovigilance may cause blood donors to continue as computers and lack of easy access of Advisory Committee. The recommenda- repeat donors and will have an positive internet facility, lack of perception of tions from the Haemovigilance Advisory impact on the National Blood Supply.An immediate benefit of reporting. Committee is forwarded by the Core Adverse Donor Reaction Reporting Form Better haemovigilance can be achieved Group of HvPI to CDSCO, Headquar- (ADRRF) has been devised to capture by ensuring better national blood quality ter and CDSCO further takes regula- information about adverse reactions or and safety initiatives, reducing or mini- tory decisions and forward them to the complications related to blood dona- mizing human errors, imparting training, Stakeholders (Patients, Healthcare Pro- tion. The donor recruitment, retention generating data standards, improving fessionals, Blood Banks, National Aids and efforts for the sufficiency and safe reporting capacity, designing and imple- Control Organisation(NACO), State Blood blood are of prime importance. Regu- menting motivational programmes. Transfusion Council etc.)The Governa- lar voluntary blood donors is one of the Though the implementation of the sys- ment of India recently issued a memo- biggest challenges and motivation for tem currently faces a lot of challenges, randum to all the blood banks for up- voluntary blood donation plays a key overcoming these and setting up a prop- linking of Transfusion Adverse Reactions role in this regard. The Donor Haemo- er HV system in India and elsewhere can record with HvPI. vigilance Programme aims at the col- go a long way in ensuring blood safety At present the number of centres for lection of informations on reactions oc- and thereby, an increase in the general reporting are 206. 2301 reports were curring during or after donation among health standard of the population. received by these centres. 2296 donors and thereafter, to recommend Transfusion reaction reports have been the best practices for donor care and World Health Day Celebrations TERUMO PENPOL PVT Limited in associ- ation with TEJUS, KEBS and Prathidhwani - Socio Cultural Organization of Technopark Employees celebrated the World Health Day as a gala event on 7th April, at phase 111 of Technopark Mr. Vasanth Varadh, Business Develop- ment Manager of TECHNOPARK inaugurated the function and delivered the inaugural address. Dr. P V Sulochana the Chief Blood Transfusion Of- ficer of SCTIMST delivered a talk on Apheresis Donation. The theme for World Health Day 2017 is Depression-Let’s Talk. Dr. P V Sulochana de- livered the special address on Depression-Let’s Talk. A special Voluntary Blood Donation Quiz Contest was organized for General Public. A Blood donation camp was organized and SCTIMST collected the blood from 39 Donors in the mobile Blood Van. BLOOD LINE 2 BLOOD DONATION CAMPAIGNING AS PART OF INTERNATIONALThere is very low awareness about blood donation WOMEN’s in India. People still believe thatD AYwomen will become weak and anemic if they donate blood. People should know that anybody aged 18-65 years can donate blood. A healthy person can donate blood once every three months. Trivandrum city has witnessed a sharp rise in the number of female blood donors, busting the myth that doing so could lead to health complications among them. The number of female donors was very low till 2010.
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