Blood products - becoming self-sufficient

The theme of this year's World Health Day observed on April 7- blood safety, and its slogan 'Safe blood starts with me; blood saves lives'- highlighted the fact that the country can get over the problem of a shortage of stock. In this article, Dr. K. G. BADAMI spells out the steps needed to attain self-sufficiency in safe blood products.

IN India, there is both scarcity and prodigious waste. There are examples in every area of the economy.The same exists in the medical sciences and the health care system. To be specific, blood transfusion services is one area where scarce resources are squandered when there is no need and where desperate patients go- a-begging. There is also a real or an absolute scarcity of blood. Yet, India is a country with the resources - not least human - which would easily enable us to become self-sufficient in this essential area of medical infrastructure.

Deficiencies exist in all four aspects of blood transfusion services: collection, processing, distribution and use.

The reasons: a lack of funds, lack of trained manpower and a lack of facilities, but most of all because of poor planning, vision and integrity and an abundance of politics and waste. Self- sufficiency is, therefore, not just about being able to collect enough blood. With proper planning, the plight of patients or their relatives running from pillar to post for what ought to be their right can become a thing of the past. Blood components and products can be available to all, rich or poor, urban or rural.

Apart from it being an issue of national pride and prestige, there are sound, practical reasons for attaining self-sufficiency in stocking blood. The lack of indigenous, high quality blood components and products results in (a) inadequately treated patients and (b) the loss of foreign exchange. With the increasing complexity of medical procedures being performed in our country, the demand for blood components, especially special products, will increase. If planning takes into account all those people living in towns and villages as well as the large mass of the urban poor, then it will become apparent how much blood is really needed. With planning, it may become possible to ensure the supply of safe and effective blood components and products. Having control over our own resources will make the system more responsive and flexible in the face of sudden demands such as war or after natural disasters.

This apart, tangible benefits from working towards self- sufficiency could be (a) avoidance of exposure to "exotic" infections, (b) new opportunities for training for our doctors and scientists, (c) opportunities for research and (d) the chance to create a stem cell donor registry. It is worth remembering that not all "exotic" infections are imports from the underdeveloped parts of the world. Currently, the concern in many countries about the risks posed by blood products derived from the United Kingdom, on account of CJD or Mad Cow Disease is a case in point.

An essential part of the process of planning transfusion services is to estimate blood requirements. There are many ways in which this can be done. For the developed countries, all the cellular requirements (i.e. red blood cells and platelets) can be met, if the number of blood units donated annually, is about five per cent of the population.

There are World Health Organisation (WHO) statistics of blood donation rates in different countries depending on the level of economic development. In industrialised countries, it is, on an average, 52 donations per 1,000 population. In middle income countries, it is 10 per 1,000 population, while in the less developed parts it is one to three per 1,000 population. Likewise, it is estimated that there are five donations for every hospital bed in the first two categories and 1.5 per hospital bed in the last. According to another formula, seven donations are required to cover the Red Blood Corpusule (RBC) needs of each acute hospital bed, estimated to be about 70 per cent of the hospital beds in a country. Platelet requirements are much harder to estimate but data from the United States and Europe suggest that requirements may vary from around 10 per cent of RBC requirements to around 40 per cent. One thing we can be sure of is that in keeping with the trend in other countries, platelet requirements will steadily increase over and above that necessitated by the population increase.

India has a population of nearly a billion people, between one and two million hospital beds (how many patients though?) but only two or three million donations annually. This gives us an idea of the amount of blood required to meet the demand for RBC and platelets, but not that for plasma and coagulation factors.

How much blood do we need to become totally self-sufficient? One way to estimate this is to calculate the amount of blood needed to provide adequate amounts of those blood-derived substances that are required in the greatest quantities. These are usually considered to be Factor VIII (F VIII) and albumin. The use of albumin, particularly as a plasma expander, is declining because of the increasing use of crystalloid and other colloid solutions for this purpose. Let us consider F VIII deficiency or Haemophilia A, the commonest, inherited coagulation factor deficiency. The demand for F VIII is such, that if enough plasma is collected to achieve self-sufficiency in F VIII, then that plasma will be enough to produce adequate amounts of the other coagulation factors and of substances such as immunoglobulin and albumin. Thirty million donations a year means three per cent of India's population (or 30 million donors) must donate once a year or half that number, i.e., 15 million donors must donate regularly twice a year. In India, donation rates are about three donations per 1,000 population annually. This needs to rise to around 30 per 1,000 for total self-sufficiency. In terms of donation rates per hospital bed, India, with around two million beds, needs at least 10 million donations annually. If 70 per cent of these beds are acute hospital beds and if, as stated by the WHO, each acute hospital bed needs seven donations annually to meet RBC requirements, then, the number of donations required annually in India would be 9.8 million. This grossly underestimates requirements because the number of hospital beds is very small and relative to the population. So, whichever way we look at it, not less than nine million and perhaps as many as 30 million units are needed annually. Remember though, that these figures do not take into account the 1.6 per cent annual increase (1995 estimates) in our population.

The sooner the steps to meet the shortage of blood the better. Some of the steps include:

* Setting up a national transfusion service: we need a change from a hospital-based and a "stand-alone" blood banking system to an integrated national transfusion service. This should consist of a national centre, regional centres and sub-regional centres with responsibilities as follows:

The national centre: Formulation of a national policy with respect to transfusion medicine and accreditation.

Regional centres: General direction, training, research, statistics, quality assurance, reagent production and control, donor mobilisation, blood collection and testing, plasmapheresis, plasma fractionation, transport of fractionated and other special products to the sub-regional centres and facilities for specialised services.

Sub-regional centres: Blood collection and testing, transporting expressed plasma to the regional centre, storing blood components and products, compatibility testing and supplying hospitals in the area with blood components and products.

To start with, there should be a regional centre for every 50 million of population and a sub-regional centre for every five million thereby giving a total of 20 regional centres for India, each with 10 sub-regional centres.

Reliable statistics: Planning depends heavily on statistics, which illuminate problems, suggest solutions and measure progress. As far as transfusion services are concerned, we need to know the number of beds, the number of patients of different categories, current usage of blood components and products, donor demography, number of donations per donor, results of microbiological screening of donor blood and the incidence of transfusion related complications. These statistics are often not available. If so, they are treated as secret.

Donor recruitment and retention: It is obvious that relative to the number of potential blood donors in our country, donations are very few indeed. The shortfall is at least six to seven million units or as much as 27 million units annually. This may seem large but for a country of our size, mobilising additional donations should not be difficult. The number of potential blood donors (healthy adults between the ages of 18 and 60) is huge - perhaps 40 to 50 per cent of the total population or 400 to 500 million people. The aim should be to create a pool of at least seven to eight million regular donors donating thrice a year. Let us remember that our armed forces alone have nearly two million able-bodied adults of the desired age group.

Donor recruitment is considered to be successful if at least three per cent of the total population are donors.

Where donor recruitment is especially successful, as many as 10 per cent of the population may be donors and 60 to 70 per cent of these, repeat donors. Even if we assume that the two to three million donations that are collected in India annually come from an individual donor (they do not), this represents, at most, 0.3 per cent of the population. With regard to retaining donors, the experience at this centre shows that nearly 75 per cent of donations each year come from one-time donors (most of whom are donating for a family member or friend in hospital). Only 25 per cent are from voluntary, regular donors. For nutritional, health and other reasons, the average number of donations per donor per year in our country is lower than that in the more developed countries, where it is probably between 1.5 to 2.0 donations per donor per year.

The other problem is the waste incurred due to donations that need to be discarded on account of testing positive for infectious disease markers. More and better donor education would allow donor self-exclusion. Rigorous pre-donation screening would exclude, as far as possible, donors with potential problems. These methods, by excluding the "non-productive donor", would result in savings apart from ensuring safety.

Educating doctors and changing transfusion practice: As far as transfusion medicine is concerned, the average doctor is in need of nearly as much instruction as the educated layman.

The lack of up-to-date information, logical ways of thinking about transfusion and the stubborn resistance to change causes a great deal of wastage and more than a little harm. At medical school, training in transfusion medicine should start during the undergraduate years and continue during post-graduate courses.

New technology: There already exist several applications of bio- technology in transfusion medicine. It is now possible to manufacture many coagulation proteins and growth factors using recombinant DNA technology. These can replace blood-derived products and cells in some instances.

Government-private sector cooperation: With all the demands on its time, energy and resources, the government will not be able to single-handedly create and maintain the infrastructure required for a national transfusion service, as outlined. The private sector cannot be expected to, nor will provide this service unless there is a reasonable expectation of commercial gain. Government-private sector cooperation is the only answer. What Government can do is to provide direction and establish laws.

Self-sufficiency in blood products in not merely desirable but has practical benefits, including saving money.

Currently, there is a gap between supply and demand. However, India has the human and material resources to become self- sufficient in transfusion within a relatively short time.

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