World Blood Donor Day 2021: Urgent need for comprehensive regulation for safety: Chetan Makam, Terumo Penpol

Chetan Makam, MD, Terumo Penpol and Vice President, Global Services of Terumo BCT.

World Blood Donor Day 2021: A comprehensive regulatory system for blood management has not received priority in the country, thereby failing to address many systemic issues including maternal casualties. Having worked for over 25 years in the medical device/blood and cell, healthcare industries and based in Colorado, Chetan Makam, MD, Terumo Penpol and Vice President, Global Services of Terumo BCT shares in-depth knowledge of what legislations are required to address safe, sustainable and adequate blood in the country and how to address the issue of shortage of blood donations particularly during the pandemic and systemic issues that plague the operation of blood banks in the country.

According to Chetan Makam, “Most of these challenges in the blood system in India exist because we don’t have a comprehensive regulatory system for blood management. We have traditionally accorded very low priority and funding for safe blood transfusion. There is an urgent need for a dedicated overarching regulation for blood transfusion services. The Supreme Court of India in 1996 had nudged the government to dwell on the possibility of a blood law in the country to regulate the collection, processing, storage, distribution of blood, and the operation of blood banks…Safety of blood in India will improve further if screening methods like Nucleic Acid Testing (NAT) are put into place in all of India’s blood banks. The issue of shortage of blood requires attention at two ends.”

For those donating blood, there are a few basic factors to keep in mind now during the pandemic, he points out, “Donors should be between 18-65 years of age, weigh at least 50 kgs, and have a minimum hemoglobin count of 12.5 grams per 100 ml. Pre and post blood donation, the donor should consume plenty of fluids and avoid any immediate strenuous physical activity. And now, follow all COVID-19 safety guidelines at the blood center or mobile drive for mask wearing, social distancing etc.”

He also adds, “Legislation on blood will homogenize the blood ecosystem of the country, leading to more efficiency and sustainability.”

The National Blood Policy was enacted in 2002. However, there is still no law on blood in the country despite many experts clamoring for it. Do you think it is an opportune time for the Government of India to bring legislation on safe, sustainable, and adequate blood?

India suffers from one of the highest accidents and surgical burdens in the world. That combined with the high prevalence of blood disorders here means that an effective and well-functioning blood system should be one of the government’s top priorities. Patients suffering from chronic ailments like Thalassemia also need access to safe blood at regular intervals; India particularly has a high burden of thalassemia patients with over 30 million cases. In addition, Postpartum Hemorrhage (PPH) accounts for about 30% of maternal deaths in India. Replacement of blood and blood products plays an essential role in managing PPH. So, access to timely delivery of care and safe and adequate blood for transfusion can go a long way to address maternal casualties.

One of the major bottlenecks in India’s blood ecosystem is the presence of multiple authorities. Human blood and its products are treated as ‘drugs’ in India. Therefore, the Drug Controller General of India and State Drug Control Authorities govern licensing of blood banks. In addition, the National AIDS Control Council (NACO) and National Blood Transfusion Council (NBTC) are two bodies responsible for a sustainable blood transfusion ecosystem of the country. Moreover, certification of laboratories is handled by National Accreditation Board for Testing and Calibration Laboratories (NABL)/ National Accreditation Board for Hospitals & Healthcare Providers (NABH). Legislation on blood will homogenize the blood ecosystem of the country, leading to more efficiency and sustainability.

Would you like to share some global practices which India can adapt to mitigate the challenges around shortage and safety?

The issue of shortage of blood requires attention at two ends. Innovative solutions like the Hub & Spoke model, that drive efficiency and scale, can also help the situation to a great extent. In our experience of working with most blood systems worldwide, we believe that the adoption of a hub and spoke model in both centralized blood services or those that are partially centralized, benefit from a hub-and-spoke model. We consider that a hub-and-spoke model is the most effective way to ascertain access, safety, and sustainability of blood. Ideally, a hub-and-spoke model can substantially aid in meeting the demand-supply gap while maintaining cost-efficiency.

Moreover, sustained information and awareness campaigns can bust myths and provide accurate information and encourage more people towards this philanthropic activity.

The COVID-19 pandemic has worsened the blood shortage crisis in India. How can technology be leveraged to alleviate blood shortages and ensure a sustainable blood supply in the future?

Not only India, but the pandemic has also impacted blood collection across the globe. In many parts of India, the blood collection had practically come to a stand-still. However, one should leverage the available technology to help maximize each donation. While some patients require whole blood units, many others require specific blood components like platelets and blood plasma. Historically, India has suffered from low componentization of blood. There is a need to gravitate towards the Hub & Spoke model of blood collection. The Hub & Spoke model will allow large blood banks with component separation facilities to store different blood components. These components can be then dispatched to even distant centers (spokes) when the need arises. Such an approach can certainly lead us towards a more sustainable blood supply.

Why are voluntary blood donation rates low in India; less than 1pc of the population, which is the minimum limit prescribed by WHO?

With a population of 1.3 billion, it is perplexing why we have not met the minimum percentage of population who should donate blood set by WHO. One of the reasons behind this can be the myths associated with blood donation. Many people believe that donating blood would weaken their immunity, and it is a painful process, or that blood transfusion will lead to HIV/AIDS. None of which is true. There is an urgent need to motivate people in the 18-65 years group to donate blood. We should also actively work to convert one-time replacement/voluntary donors to regular donors. While informative campaigns hold the key for increased sensitization, innovative incentives like honoring a donor with a certificate, letting them know that their donation saved lives could be explored. In fact, the government can particularly reach out to the youth of the country to come forward and donate blood voluntarily and spread the message of voluntary blood donation, in line with what the WHO is trying to focus on for this year’s campaign- “to encourage youth to embrace the humanitarian call to donate blood and inspire others to do the same and celebrate the potential of youth as partners in promoting health.”

What are the Safety guidelines/basic checks for those donating blood and general guidelines for NGOs/ organizations that are arranging/holding blood donation drives during this time?

The National Blood Transfusion Council (NTBC) is in place to promote voluntary donations, ensure safe blood transfusion and provide infrastructure to blood centers. The various NGOs and organizations involved in blood collection during the ongoing pandemic are following appropriate COVID-19 behavior. The Indian Red Cross Society has information on their website and shares that they are taking “all precautions to ensure safety of staff, blood donors as well as patients by using thermal scanners, regularly cleaning couches, gloves, makes etc. with disinfectants and maintaining adequate distance by practicing social distancing.”. According to the guidelines released by NBTC for blood donation during the COVID-19 pandemic regular follow-up of all the donors is suggested for at least 14 days. NBTC also mandates that the blood units of any donor who contracts COVID-19 be discarded.

When there are blood transfusion requirements in cancer patients, thalassemia, pregnancy issues etc., some basic safety-related information for the concerned families, many of whom would have been affected during COVID time.

Unfortunately, many patients requiring frequent blood transfusion due to cancer, thalassemia, and sickle cell disease have suffered due to the shortage of blood in the pandemic. These patients are immunocompromised and therefore more susceptible to contracting COVID-19 and other contagious infections. To that end, the blood bank staff should pay utmost attention to enforce social distancing and COVID-19 appropriate behavior. In addition, there should be strict adherence to hygiene standards for the equipment in use. We suggest that concerned families and friends should stay in close contact with their doctors and treating hospitals to ensure they follow all safety guidelines to help avoid bringing infection risk to their loved ones. And anything they can do to advocate for much needed blood donations is always helpful.

There is very little awareness related to blood donations in India. Are there specific organizations that can be contacted about this for authorized and authentic information? Or any studies/documented works/books on the same that can be helpful to readers.

The awareness related to blood donation would be even lower if not for the advocacy by various civil society organizations. Indian Medical Association, Indian Red Cross Society, Lion’s Club, Rotary Club etc., have been working tirelessly to raise awareness about the various aspects of blood donation in India. Recently, the Indian Medical Association released a comprehensive docket that addresses some of the myths that perpetuate blood donation in India.

Of late, many initiatives like Blood Donors India, United by Blood, and Blood Connect etc., have leveraged the strength of social media to spread awareness and mobilize blood collection. My company actively encourages blood donation. We organize donation camps throughout the year, across the country, as part of our ongoing corporate responsibility to our community.

What are some of the things to be kept in mind for a successful donation?

Let me start by saying, blood donation is completely safe. Blood banks use sterile equipment for each donor eliminating the risk of contracting infections. Moreover, donation centers employ professional healthcare staff who are trained in collecting and processing blood donations and monitoring donors for proper medical conditions before, during and after their donation. Healthy adults can usually donate a pint (about half a liter) of blood without any health repercussions.

It is also imperative that the donors answer the screening questionnaire correctly; for instance, you have to be the right age and weight, you need to fill out a medical history and list any medications you make be taking now or previously. Many people are either unaware of completing a donor form or deem it unnecessary. A donor form provides consent for voluntary donation and helps in follow-up. During the screen, your hemoglobin is tested and if low, the staff can advise you on things to do to improve it ahead of your next donation.

You should eat healthy food and drink plenty of water before and after you donate blood. This is essential else the donor can feel lightheaded and tired after the donation.

Lastly, I encourage everyone who donates blood to share their experiences with their friends and family. This would help in busting myths associated with blood donation and motivate more people towards blood donation.