by Prof. Bejon Kumar Misra,
Founder, Patient Safety and Access Initiative of India
As India marches towards achieving Universal Health Coverage (UHC) by 2030 through initiatives like Ayushman Bharat, National Health Policy and the National Digital Health Mission. It is time to pause and take a closer look at providing the essentials in health care like adequate and safe blood. Notably, India still has a blood shortage of about 1.95 million units as per the World Health Organisation (WHO). The National AIDS Control Organisation (NACO), in an RTI, shared that around 1,342 people across India have contracted the HIV infection due to blood transfusion in 2018-19, giving rise to serious safety and quality concerns. The pandemic has further deepened the gaps and reminded us that we still have a long way to go to ensure the availability of adequate and safe blood for patients.
The shortage of blood supply and Transfusion-Transmitted Infections (TTIs) are two major challenges that the country is facing today. At the operational level, we find that the blood transfusion service is unorganized and fragmented resulting in a lack of communication between blood banks and the end users. This leads to incoherent demand and supply gap thus consequently affecting the availability and quality of blood. On the other side, there is a lack of awareness among people about the importance of voluntary blood donations. As per WHO, regular blood donations by 1% of the healthy population are enough to ensure safe blood availability as these people are considered the safest group of donors given the lowest prevalence of blood borne diseases among them. It is disheartening to see that even as the second most populous nation, we are still not able to achieve this minuscule target.
While it may require a detailed study by institutions like National Institute of Biologicals (NIB) Noida, who are mandated by the Government of India, Ministry of Health and Family Welfare to implement the centralized Hemovigilance Program of India to assure patient safety and to promote public health. The Hemovigilance Program was launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. NIB was identified as the National Coordinating Centre for Hemovigilance.
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This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC) Ghaziabad. It was proposed that all medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform to develop a robust plan and strategy to address the inadequacies of such a standard setting exercise on all the aspects of blood.
It is well understood that there is an urgent need to fast track the various proposed activities under the PvPi and initiate a stringent screening process across our blood blanks in partnership with Quality Council of India (QCI) to certify all the blood banks in the country as per the provisions of the law. NABH already has a well laid out standard for accreditation of the Blood Banks in our country.
It may well turn out that blood banks that get the highest load of repeat recipients are using the least sophisticated test for screening of blood for transfusion transmissible infections (TTIs) contrary to our expectations that these banks must be using sophisticated screening methodologies considering the high susceptibility of such patients to TTIs. Multiple surveys at state and country level hospitals, conducted between 2011 and 2019 have shown that 7 to 72 % of adult thalassemia patients are positive for TTI (HCV, HBV, HIV etc.) due to inadequate blood safety measures.
To control the incidences of TTIs, it is imperative to adopt efficient screening methodologies available today such as Nucleic acid testing (NAT). Such scientifically proven testing processes would significantly reduce the window phase (time between donor exposure to the virus and the appearance of antibodies) of transfusion transmissible infections (TTI) and help in improving blood safety.
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While developed countries have not reported much value in implementing this test in improving blood safety due to low prevalence of TTIs, it is definitely a viable option for countries like India, with a high prevalence of TTIs with a significant number of window period donations (time between donor exposure to the virus and the appearance of antibodies) that can be identified by such an advanced testing process to ensure safe blood transfusions.
A study showed that NAT screening in India could annually interdict 336/million (2019 infectious donations of 6 million donations) as compared to 7.5/million (3000 infectious donations of over 400 million donations) in an international survey that included 37 countries that reported results over a 10 year long period extending from 1998 to 2008 that would have been missed by serological screening methods. In fact, it would be more cost-effective for a largely populated country like ours to deploy a world-class screening methodology like what I explained to prevent transfusion-transmitted infection than allowing the spread of TTIs which puts additional, avoidable pressures on our health care system.
There must be massive communication campaign launched in India to build awareness among the masses and various patient groups including blood cancer patients, thalassemia patients, pregnant women, road accident victims, and people needing elective surgeries regarding, ‘what is safe blood’? While a donor has a “choice” to donate or not, there is no choice for recipients for whom blood-transfusion is a life-saving procedure. Based on the studies conducted during 2010-2017, the estimated prevalence of HIV, HBV, and HCV transmission among thalassemia patients alone is an alarming rate of 1 in 5 patients. These numbers highlight the need to give patients the freedom to choose a blood bank that would provide the safest blood?
To be able to make an informed choice based on credible and trustworthy information, it will be important for a patient to know what qualifies for safe blood? As per the code of ethics for blood donation and transfusion, patients should have access to risk-free safe blood free of charge or need of replacement, informed consent for transfusion, the right to refuse the transfusion, and the right to be informed if harmed. But as patients may not be able to determine the quality of blood, it is important to have a golden standard for blood quality and safety to avoid discrepancies.
Even though blood banks adopting the best global practices by using the most sophisticated screening methodologies, might become unknowingly victims of poor quality of blood due to the gaps existing in the implementation of other dimensions of good practices like voluntary blood donation. Thus it is critical that we publish a comprehensive standard for safe blood transfusion by focusing on all the aspects of blood qualify in order to assure “safe blood” to the citizens of our country. We must announce immediately the proposed strategy to go ahead with our vision to enable citizens to access safe and quality health care for all under PMJAY “Ayushman Bharat” without any compromise or shortcomings.
Organisations like Thalassemia Patients Advocacy Group (TPAG) have been working aggressively for the cause of safe blood. Such organisations – being led by patients (in case of TPAG, by thalassemics who are regular recipients of blood)- need to be heard and partnered by policy makers in efforts to implement and formulate best practices and technologies for safe blood transfusion in India.
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