Plasma is a raw material for the production of drugs. Production of medicines from human blood or plasma
The Russian Blood Service is a strategic service that is primarily involved in emergency situations. The need to use large quantities of blood transfusions arises as a result of various man-made, environmental and other disasters, the increase in the number of which has been observed in recent years. In general, the activities of the blood service are aimed at meeting the needs of medical institutions for canned blood, its components and preparations. Achievements in industrial transfusiology are one of the conditions for further progress in clinical medicine. The importance of materials characterizing the performance indicators of the domestic blood service is emphasized in a number of works. This report presents data on the state of the blood service in the Russian Federation over time since 2002. The materials for monitoring were information from official statistical reports (form No. 39) of blood service institutions subordinate to the Ministry of Health and Social Development. At the same time, the information presented in the explanatory notes to the relevant annual reports was analyzed and summarized.
In 2009, there were 146 blood transfusion stations (BTS) and blood centers (BCs), 482 blood transfusion departments (BTDs) and 100 blood procurement hospitals (BZK) in the Russian Federation. (Table 1).
Information on the material and technical base of the blood service is presented in table 2. In 2009, compared to 2008, the number of reactors (by 4), supercentrifuges (by 10), and refrigerated centrifuges (by 62) continued to decline. At the same time, the number of refrigerated centrifuges for six glasses (by 7), the number of low-temperature counters and cabinets (by 174) and especially devices for plasmapheresis increased.
Information on the number and structure of positions in institutions and divisions by states amounted to 94.5%. The provision of states in 2002 was higher compared to 2009. The total number of full-time positions in 2009 decreased by 1,445 positions (3.9%), and those employed in the procurement of blood, components and standard serums by 1,596 positions (6.4%). The personnel structure changed due to the reform of the blood service in 2005-2009. (Table 3).
General data on blood donation and procurement in 2009 are presented in table 4. The total number of donors in 2009 compared to 2008 increased by 4.2% (77,126 people), but did not reach the levels of 2002. The most intensive increase in the number of immune donors and blood cell donors occurred in 2005-2009. The total number of blood donations increased slightly (by 1.9%), including gratuitous ones (by 1.8% since 2008), but did not reach the level of 2002.
In 2009, 81.65% of all blood was collected at blood transfusion stations (68.8% in 2002), 18.3% in military-industrial complexes (2002: 30.8%), and 0.05 in hospitals. % (2002 - 0.4%). In 2009, almost all blood service institutions stored blood and components only in polymer containers. Polymer containers produced by NPO SINTEZ (Kurgan) and foreign companies TERUMO, GREEN CROSS, BAXTER were used. The volume of collected whole blood in 2009 increased by 7.5% compared to 2008 and amounted to 1,957,401.8 liters; compared to 2002, this figure increased by 21.8%.
Institutions and divisions of the transfusion service are distributed into 9 territorial zones: starting from the Far East to the North-Western region. The division into zones and the allocation of basic SPCs can significantly improve the organizational and methodological management of the transfusion service of the zone, increase the efficiency of control over their activities, and also obtain information on the production of blood transfusion media in various constituent entities of the Russian Federation, taking into account their geographical features.
Blood procurement in 2009 increased in all zones of the Russian Federation. On average in Russia there are 25.7 subsidies per 1000 population, fluctuations ranged from 6.1 donations (Republic of Ingushetia) to 63.8 and 58.1, respectively, in the Lipetsk and Ivanovo regions. The volume of one gratuitous blood donation in Russia reached an average of 437 ml, varying in different zones and constituent entities of the Russian Federation from 319 ml (Republic of Tuva) to 466 ml (Krasnoyarsk Territory).
The proportion of plasma obtained by intermittent plasmapheresis is trending upward. The share of plasma obtained by hardware plasmapheresis also increased more than 3 times compared to 2002. (Table 5).
Estimated performance indicators of the blood service for 2005-2009. given in table 6 , and the production of canned blood, components and preparations by Russian blood service institutions is in table 7.
Russian blood service institutions have developed a system for ensuring the infectious safety of donor blood, based on strict adherence to the rules of regulatory and technical documentation (Order M3 of the Russian Federation No. 364 of September 14, 2001 “On approval of the procedure for medical examination of a blood donor and its components”). In the donor department, the donor's hemoglobin level is determined, the transfusiologist collects anamnesis and examines the donor (paying special attention to the color of the mucous membranes and sclera), and palpates the lymph nodes and abdominal organs. Based on medical history, persons who have contraindications to donation are excluded from donation. A check is carried out against the card index, i.e. screening out persons who have contact with patients with syphilis, hepatitis, and HIV-infected persons. At this stage, about 14% of people who come to the donor point are rejected.
In total, 3.4% of preserved blood was rejected in 2009. The structure of the rejected blood was as follows: hepatitis B antigen - 7.9%, antibodies to hepatitis C - 13.9%, positive tests for syphilis - 9%, antibodies to HIV - 1%, increased ALT - 44.1%. Other reasons include hemolysis, chylosis, deficiencies, contact with patients with blood-borne infections, increased bilirubin, and a false-positive reaction to HIV. Noteworthy is the increase in rejects in the “Other reasons” section; in 2009 it exceeded the same figure in 2008 and amounted to 24.1% of the total volume of rejected blood. The increase in the volume of rejected blood under the “Other reasons” section may be partly due to questionable results of reactions to blood-borne infections, which is apparently associated with the use of insufficiently high-quality test reagents.
The number of rejected donors in various territorial zones of the Russian Federation in 2008 and 2009 is presented in tables 8 and 9. In addition, due to increased activity of alanine aminotransferase, the blood of another 65,625 donors was rejected. This may be due to overdiagnosis due to low-quality reagents. It is also likely that donors have chronic liver diseases associated with poor nutrition and bad habits. According to the column “Other reasons”, the blood of 35,162 people was rejected. These individuals were temporarily withdrawn from donation. As can be seen from the presented data, the percentage of rejected donors varies significantly in different zones, which reflects the level of population health and can be used in donation planning.
IN table 10 average data on the provision of 1 bed in health care facilities with blood transfusion media are presented, which indicate that the provision of 1 bed with blood transfusion media in recent years has significantly improved according to most indicators.
In 2009, the processing of plasma into drugs was carried out by 14 blood transfusion stations in departments, laboratories and fractionation buildings with special equipment (in 2002 - 19). The largest production of blood products has been launched at the Ivanovo, Nizhny Novgorod, Samara, Sverdlovsk, Chelyabinsk, Lipetsk, Vologda regional blood transfusion stations, and the Moscow GSPC. In 2009, a 10% albumin solution was produced in 14 regions of the Russian Federation, normal human immunoglobulin - in 7 regions, anti-staphylococcal - in 9, anti-Rhesus - in 2.
In 2009, cryoprecipitate was produced in 36 regions (out of 80). The production of cryoprecipitate containing active factor VIII by domestic manufacturers is economically justified, because mass use of imported factor VIII for the treatment of patients with hemophilia is unrealistic due to its shortage and, in addition, requires significant financial costs.
According to the decree of the Government of the Russian Federation dated June 21, 2008 “On financial support in 2008 through federal budget allocations for activities for the development of blood services,” in 2008, 15 blood transfusion stations were allocated funds from the federal budget for the development of blood services in the main areas: technical re-equipment of blood service institutions, informatization, development of free mass voluntary donation. The effect of the introduction of these measures was obvious already in 2009 and was expressed in an increase in the number of donors by 9% and the volume of plasma procurement by plasmapheresis by 69% from the 2008 indicators.
One of the main tasks of the blood service is to ensure the safety of blood transfusions, primarily infectious ones. Despite careful selection and examination of donors, blood and blood components used for transfusions remain at risk of contracting viral infections in recipients. In 2009, 32 out of 80 territories of the Russian Federation provided data on the use of autologous blood and autologous components. The number of autodonors amounted to 8,405 people (in 2007 - 5,194 people), which amounted to 0.48% of their total number (in 2007 - 0.29%). Autodonors were pregnant women preparing for planned operations, surgical and orthopedic patients. The largest number of autodonors was recorded in Moscow (3,000), Novosibirsk region (1,067), Kemerovo region (795), and the Republic of Chuvashia (740). Despite a slight increase in the number of autodonors, the data obtained suggest that autodonation does not yet have a noticeable weight in providing therapy.
In 2009, the introduction of new technologies that reduce the risk of transmitting infectious diseases continues. The most widespread is quarantine of plasma, which in 2009 was used in all regions of the Russian Federation (Table 11).
In relation to the volume of all plasma received at the clinic, quarantined plasma in 2009 was 74.5%. Of course, the plasma quarantine method has a positive effect, but blood components from the same donors are used without quarantine: erythrocyte-containing media, platelet concentrate, cryoprecipitate. Leukofiltration of hemocomponents, viral inactivation of plasma, and PCR diagnostics are also being actively introduced into the practice of blood services. It is known that more than 90% of viruses are found in the structure of leukocytes, and therefore, leukodepletion helps reduce the risk of infection of recipients with hepatitis, HIV infection, cytomegalovirus and other blood-borne infections. Leucofiltration has been carried out using domestic and foreign leucofilters since 2003. In 2009, this procedure was carried out in 62 regions of the Russian Federation. It is important to note that the share of hemocomponents filtered through leukocyte filters and issued to medical institutions in the country is steadily growing (Table 12).
In our country, the Teraflex equipment is registered and used for plasma virus inactivation. This method is used by Krasnodar KSPC, Penza OSPC and a number of other blood transfusion stations. Viral inactivation of platelet concentrate is also carried out on the device Intercept Blood System (Cerus-Baxter) and PCR diagnostics. However, the problem of infectious safety of donated blood will remain in the field of view of blood service workers, infectious disease specialists and epidemiologists for many years to come.
Blood transfusion departments are divisions of the blood service that directly address organizational and production issues of clinical transfusiology and, undoubtedly, play a large role in providing the necessary hemotherapy. IN table 13 Data are presented characterizing the activities of blood transfusion departments in 2001-2009.
During the period of reforming the blood service by 2009, less than half of the OPK that functioned in 2002 had survived. The analysis of the activities of the defense industry indicates the great role of blood transfusion departments in providing medical institutions with blood and its components. The enormous size of our country, the remoteness and inaccessibility of some hospitals, and the difficulties in delivering blood transfusion media indicate the need to maintain and develop these blood service units.
Based on the introduction of information technology, it is possible to create a Hemovigilence system in Russia, which will allow tracking each portion of blood components from the donor to the recipient, establishing a connection between blood transfusion and the occurrence of infectious diseases in the recipient. Such a system has been operating for a number of years in a number of foreign countries. It is also relevant to identify ways to bring closer the requirements for infectious safety of blood and its components with foreign countries.
Measures taken by the Russian government and the Ministry of Health and Social Development in recent years to promote donation have led to an increase in the total number of donors and the participation of the population in donating plasma, blood cells, and immune donation. Thanks to the modernization of equipment at blood transfusion stations, hardware methods for obtaining plasma and blood cells are now being increasingly used. Progress has also been made in terms of ensuring the safety of blood transfusions.
The main requirements for the work of blood service institutions remain both to ensure the current needs of medical institutions for blood components and products, and to ensure readiness to work in any extreme situations.
Literature
- Bakhmetyev A.V., Sveklo L.S., Gurtovshchikova G.V., Efimov A.S., Kuno A.S. On the issue of reform in the blood service // Bulletin of the Russian Blood Service. - 2009. - No. 1. — P.5-7.
- N. Bolbat. Concept of blood safety haemovigillanse in Latvia // Transfusiology. - 2010. - T. 11, No. 2. — P.45-50.
- Zhiburt E.B., Maksimov V.A., Vergopulo A.A., Gubanova M.N. Use of modern technologies in the constituent entities of the Russian Federation // Healthcare Economics. - 2009. - No. 3. — P.33-40.
- Zhiburt E.B., Klyueva E.A., Karavaev A.V., Shestakov E.A., Gubanova M.N. Japanese Blood Service // Transfusiology. - 2010. - T. 11, No. 2. — P.51-59.
- Erofeev Yu.G., Ravdugina T.G., Ponomarev I.E., Khabibulina R.S. New impetus for the development of the blood service in the Omsk region // Transfusiology. - 2010. - T. 11, No. 2. — P. 4-6.
- Selivanov E.A., Danilova T.N., Bogdanova V.V., Degtereva I.N., Grigoryan M.Sh. Russian Blood Service - new frontiers // Transfusiology. - 2009. - T. 10, No. 3-4. — P. 11-35.
- Mohammad Reza Abedi, Bettina Sorensen, Susanne Ekblom-Kullberg // Haemovigilanse in Nordic countries: report of donor complications 2007 // Vox Sanguinis. - 2009. - V.96 (suppl. 1). - P. 59.
- Stramar S.L. Viral diagnostics in the arena of donor screening // Vox sanguinis. - 2004. - V.87
- (supp.) 2. - P. 180-183.
Dmitry TITOV, vice president of the pharmaceutical company Octapharma for Eastern Europe and the CIS countries
Localization of drug production is one of the prerogatives of the import substitution policy in the post-Soviet space. However, harmonized criteria for the required level of localization in various EAEU countries, as well as preferences that manufacturers can count on, have not yet been developed. The localization of plasma products is an even more complex issue and is somewhat different from the localization of other drugs for a number of reasons. Among them: the origin of raw materials, imbalance of consumption, problems of laboratory diagnostics and quality control of drugs, etc. Currently, there are several small production facilities for blood plasma fractionation in the CIS, many of which began their activities back in Soviet times. However, no foreign company has so far produced finished blood plasma medicinal products in the EAEU. The article presents various types of reasons, overcoming which can possibly change the current situation.
But first, a few words about blood plasma preparations. Let us recall that various protein preparations are obtained by plasma fractionation:
Complex action drugs (albumin);
correctors of the blood coagulation system (blood coagulation factors, prothrombin complex, fibrinogen);
preparations of immunological action (immunoglobulin for intravenous and subcutaneous administration, as well as a number of specific immunoglobulins).
Albumin is a blood plasma protein. Albumin solutions are prepared from donor plasma. Albumin preparations are used without regard to group affiliation. The technology for producing albumin solutions involves inactivating hepatitis and HIV viruses in them. Albumin is used to compensate for the deficiency of bcc during bleeding, plasmapheresis, diseases accompanied by hypoalbuminemia, burn disease, purulent-septic processes, infectious diseases and poisoning.
Correctors of the hemostasis system are indicated for use for the prevention and treatment of bleeding in patients with hemophilia A, hemophilia B, von Willebrand's disease and other diseases. The prothrombin complex is a protein fraction of blood plasma with a high content of blood coagulation factors II, VII, IX and X. It is used for the treatment and perioperative prevention of bleeding in obstetric, cardiological practice and others, as well as for congenital deficiency of vitamin K-dependent factors. From the globulin fraction, immunologically active drugs are obtained - gamma globulins, containing antibodies in a concentrated form. The drugs are prepared from blood with a high titer of antibodies (the blood of people who have suffered a corresponding infectious disease, the blood of immune donors and the blood of immunized animals).
Immunization carried out according to special schemes makes it possible to obtain highly effective targeted γ-globulins, which are used for the treatment of primary immunodeficiencies, multiple myeloma, ITP, allogeneic bone marrow transplantation, and neurological diseases.
In short, blood plasma products are indispensable in the treatment of patients and their production should be given paramount importance. But, unfortunately, at present, not a single domestically produced blood plasma product is registered in Kazakhstan, with the exception of albumin, which is produced by the Blood Center.
The issues of localizing the production of human blood plasma preparations are somewhat specific. Localization can be implemented by locating the full production cycle or part of the production on the territory of the localization country. It can be carried out independently by the manufacturing company, or in the form of joint production, or carried out through technology transfer to a partner company. The ultimate goal of all these actions is to obtain a certificate of “domestic manufacturer” (for example, ST-1, ST-KZ, etc.)
WHY IS BLOOD PREPARATION LOCALIZATION NEEDED?
Firstly, this is the opportunity to sell products on the market of one’s own country, as well as on the markets of neighboring countries. The availability, attractiveness and proximity of markets for the purchase of raw materials and supplies also play an important role, especially for blood plasma products, since plasma is the main raw material for their production. Its availability varies in different CIS countries (and the world too). Thus, it is currently known that up to 80% of the plasma that is used in the manufacture of blood plasma products comes from the USA. And this situation should change in the near future. Localization of any production on the territory of a certain country is also the key to diversifying the economy, developing other industries, and reducing dependence on oil, gas and other raw materials.
When talking about localization in the pharmaceutical industry, we primarily mean reducing dependence on imports. This is especially important for blood plasma products. After all, if a country does not procure a sufficient amount of raw materials for the production of blood plasma products, then there is always a risk that it simply will not receive them, since there will be no source of plasma.
Localization may also lead to a reduction in the cost of purchased products. Although this is not always the case. If the production volume is small, then achieving a significant price reduction will be quite difficult. The pharmaceutical industry has its own specific feature - the ethical use of products, including blood plasma. Currently, most of the countries that procure plasma either by automatic plasmapheresis, or most often from blood by dividing it into red blood cells and plasma, do not fully utilize their products, do not use all the possibilities and do not fully extract those proteins that can be extracted from plasma and used . The main product currently produced is
is obtained from plasma in almost all CIS countries, is albumin. Everything else is simply thrown away. We must also consider that albumin is the cheapest protein. Consequently, almost all raw materials are thrown away, i.e. used irrationally. But this is raw material that could be used to treat patients in the country where this plasma is collected.
The production of blood plasma products in the post-Soviet space has a fairly long history. But, unfortunately, even during the times of the USSR, no enterprises were founded that would specialize in the production of a wide range of blood plasma products. Yes, small enterprises have remained since the times of the USSR; blood plasma products continue to be produced by institutes (transfusiology, biotechnology), which often do not comply with GMP rules, as well as blood transfusion stations, which absolutely does not fit into the framework of European and world trends. It must be admitted that some foreign companies are currently moving towards localization of packaging and quality control of medicines. But there are very, very few of them.
WHAT FORMS OF LOCALIZATION OF PRODUCTION OF BLOOD PLASMA PREPARATIONS EXIST AT THIS MOMENT?
The most common form of localization is contract manufacturing. It implies the production of blood plasma products not in the country of localization, but using plasma from the country where it was procured. A peculiarity of the production of blood plasma products is that the cost of raw materials is up to 30% of the cost of the drug. And this means that in the case of using contract fractionation, it is possible to reduce the cost of the finished drug through the use of local raw materials, and not through its disposal, as is currently the case.
It is also possible to localize processes such as beaming and packaging, transfer of certain stages of the production process (which our company is currently working on in some CIS countries). But to transfer the full cycle to the country of localization - to build a blood fractionation plant - is almost impossible. And the primary issue in this case is profitability and the possibility of procuring raw materials. In order for the plant to reach acceptable profitability levels, about 1 million liters of plasma are required, whereas currently no more than 300 thousand liters of plasma are collected throughout the CIS for fractionation. And if we are talking about just one country, then, as we understand, there will not be enough raw materials to launch a full cycle.
Thus, the reasons for the lack of localization from the point of view of the fractional company are:
Lack of harmonization within the EAEU and the CIS regarding the level of localization, as well as taking into account the specifics of the production of various medicines. For example, the required level of localization in Belarus is 30%, in Kazakhstan – 50%, and in the Russian Federation there are no standards at all defining the required level of localization for the production of blood products. We also see that when determining the localization share, the specifics of the production of blood plasma products are completely ignored. And we, for our part, would be happy to take part in the discussion and development of standards that are most acceptable to all participants in production;
Lack or lack of production of high-quality raw materials (plasma);
Regulatory barriers to the import/export (restrictions, import duties) of blood components, as well as components (medical products). I will dwell on the last point in more detail: blood plasma products are more often than other drugs included in medical devices. And we are faced with a situation that if medical products are not registered in the country, then it is very difficult to localize even the process of labeling and packaging. And we have to carry out the registration procedure for about 10 medical devices separately. This significantly affects the final cost of the product, plus time costs;
Lack of harmonized rules of preferences for domestic producers in the EAEU and the CIS. It should be noted that from this point of view the situation in Kazakhstan is the most favorable;
Trust in long-term sustainability and transparency in the public procurement market for medicines. If a company invests in the localization of production, then it must be sure that one fine day its drug will not be excluded from the government procurement list, formulary, etc. without explanation. In addition, regulatory issues are not limited only to the import and registration of drugs. The legislative framework should also regulate such a very important issue as technology transfer, in particular for the production of biological drugs. If the country does not have clear rules for players in this market, then the country will have to come to terms with the fact that there will never be blood plasma products produced by a domestic manufacturer on its territory;
The unbalanced demand for blood plasma products also creates a certain problem for sales in the country of localization.
So how can we overcome the current situation? Of course, first of all, it is necessary to eradicate those reasons that prevent the localization of the production of blood plasma products on the territory of our country.
And also:
Simplify calculations of local product content, taking into account the specifics of the production of various medicines on an individual basis;
contribute to increasing the procurement of high-quality blood components, as well as plasma for fractionation;
lift restrictions on the import/export of plasma for production purposes, revise customs duties;
cancel or simplify the registration of consumables (including medical devices) necessary for localization;
provide transparent and clear preferences for localized products;
ensure long-term sustainability and transparency in the public procurement market for medicines;
solve the problem of demand imbalance - improve the provision of healthcare organizations with all blood products (immunoglobulin, albumin, prothrombin complex, antithrombin, etc.)
Prepared by Gulzhamal RAISOVA.
The State Committee of the Russian Federation for Standardization and Metrology decides:1. Approve the national standard of the Russian Federation GOST R 52249-2004 “Rules for the production and quality control of medicines” with an effective date of January 1, 2005.
2. Assign the approved standard to the Scientific and Technical Department.
Chairman of the State Standard of Russia V.V. Usov
Letter of the Department of State Control of Medicines, Medical Products and Medical Equipment of the Ministry of Health of the Russian Federation dated May 5, 2004 N 295-22/78
The Department of State Control of Medicines, Medical Products and Medical Equipment of the Russian Ministry of Health notifies that the national standard “Rules for the production and quality control of medicines” will come into force on January 1, 2005, the provisions of which fully comply with the requirements of GMP EC. This document is put into effect by Decree of the State Standard of Russia dated March 10, 2004 N 160-st, as the federal executive body in the field of technical regulation.This document was developed on behalf of the Russian Ministry of Health in pursuance of the order of the President of the Russian Federation dated September 12, 2003 N Pr-1682 (clause 5) by public organizations ASINCOM and ARFP.
The Department notifies that until the relevant technical regulation comes into force, the requirements above the specified national standard will be mandatory when organizing and carrying out the production of medicines in the Russian Federation, since these products have a direct impact on the life and health of citizens (Resolution of the State Standard of Russia dated January 30, 2004 N 4 "On national standards of the Russian Federation").
Application: for 3 l. in 1 copy.
Acting Head of the Department A.A. Toporkov
STATE COMMITTEE OF THE RUSSIAN FEDERATION FOR STANDARDS AND METROLOGY.
NATIONAL STANDARD OF THE RUSSIAN FEDERATION. GOST R 52249-2004
RULES FOR PRODUCTION AND QUALITY CONTROL OF MEDICINES
Moscow, 2004
Preface
The tasks, basic principles and rules for carrying out work on state standardization in the Russian Federation are established by GOST R 1.2.-92 "State standardization system of the Russian Federation. Basic provisions" and GOST R 1.2-92 "State standardization system of the Russian Federation. Procedure for the development of state standardsStandard information
1.
PREPARED BY the Association of Micropollutant Control Engineers (ASINCOM) from its own authentic translation specified in paragraph 4.
2.
INTRODUCED by the Technical Committee for Standardization TC 458 “Production and quality control of medicines.
3.
APPROVED AND ENTERED INTO EFFECT by Resolution of the State Standard of Russia dated March 10, 2004 No. 160-st
4.
This standard is identical to the European Union Guide to Good Manufacturing Practice for Medicinal Products.
When applying this standard, it is recommended to use the corresponding national standards of the Russian Federation instead of reference international standards.
5.
INTRODUCED FOR THE FIRST TIME
Information about changes to this standard is published in the “National Standards” index, and the text of these changes is published in the “National Standards” information indexes. In case of revision or cancellation of this standard, the relevant information will be published in the information index "National Standards"
Appendix 14
Production of medicines from human blood or plasma
Basic provisionsFor biological medicinal products obtained from human blood or plasma, the starting material is cells and the liquid part of the blood - plasma. Medicines obtained from human blood or plasma have a number of features related to the nature of the starting material. For example, the starting material may contain biological agents, most notably viruses that spread disease. The safety of medicines depends both on the verification of the starting material and its source, and on subsequent manufacturing operations, including the removal and inactivation of viruses.
The essential requirements of this standard apply to the manufacture of products based on human blood or plasma unless otherwise specified. Such production may also be subject to the requirements of a number of applications (for example, the production of sterile drugs, the use of ionizing radiation, the production of biological medicinal products, the use of computer-controlled systems, etc.). Since the quality of the finished product is determined by all stages of production, including the collection of blood or plasma, all operations must be performed in accordance with the accepted quality assurance system and the requirements of this standard.
Measures should be taken to prevent the transmission of infectious diseases and to comply with relevant regulations relating to fractionated plasma and medicinal products derived from blood or plasma. You should also be guided by the requirements governing the selection of blood and plasma donors and the examination of donor blood, as well as recommendations for the production, use and quality assurance of blood components.
This annex does not cover blood components used in transfusion medicine. However, many of the provisions set out may be applicable to the manufacture of blood components and competent authorities may make recommendations taking into account this annex.
Terms and definitions
blood: Whole blood obtained from a single donor and prepared for transfusion or further processing.
blood components: Therapeutic blood components (red blood cells, white blood cells, plasma, platelets) obtained by centrifugation, filtration and freezing using the methodology established in the blood bank.
medicinal products derived from blood or plasma: This term is defined in a separate document.
Quality management
1
Quality assurance extends to all stages of production of the finished product from the collection of starting materials (including the selection of donors, blood/plasma containers, anticoagulants and test reagent kits) to storage, transportation, processing, quality control and delivery of the finished product. All procedures must comply with the requirements of this annex.
2
Blood or plasma used as a starting material for the production of medicinal products must be collected in special institutions and tested in approved laboratories.
3
The procurement organization must have instructions determining the suitability of each donor to donate blood and plasma (the starting material for the production of medical products). The test results of the resulting starting material must be documented and available to the drug manufacturer.
4
A continuous quality control system should monitor the manufacturing of a medicinal product derived from human blood or plasma in such a way as to detect any deviations from quality requirements.
5
Medicines obtained from human blood and plasma that are returned as unused are, as a rule, not reissued to the consumer (clause 5.65 of this standard).
Premises and equipment
6
Facilities used for blood or plasma collection must be of sufficient size, layout and location for basic operations, sanitation and equipment maintenance. Operations for the procurement, processing and testing of blood and plasma should be carried out in different rooms. When interviewing a donor, the conditions for confidentiality of information must be met.
7
The design of equipment for production processes, collection of starting material and testing must be suitable for its intended purpose and ensure compliance with safety requirements. The equipment is subject to certification before commissioning. Regular technical inspection and calibration (verification) of equipment should be carried out with the preparation of the necessary documentation.
8
When manufacturing medical products from blood plasma, operations of inactivation or removal of viruses are provided. To avoid cross-contamination, there should be clear separation between areas and equipment for material that has undergone virus inactivation or removal treatments and material that has not.
Collection of blood and plasma
9
The relationship between the manufacturer of medical products from human blood or plasma and the institution that collects blood (plasma) or the organization responsible for collecting blood (plasma) is determined by an agreement, the content of which must meet established requirements.
10
The identity of each donor should be established upon admission and verified before blood is drawn.
11
The method for disinfecting the donor's skin must be clearly defined and justified. The accepted method must be strictly followed.
12
The blood sample number on the label must be independently verified by different individuals to ensure its identity as shown on the blood package, test specimen, and donation record.
13
Plastic blood bags and apheresis systems should be inspected prior to use when collecting blood or plasma for damage or microbial contamination. To track the movement of each unit of blood (plasma), the serial number of the plastic bag and apheresis system must be recorded.
Traceability of blood (plasma) and actions performed after blood (plasma) collection
14 A system must be organized that allows tracking the movement of each unit of blood (plasma) at all stages of its passage, from the donor to the use of the product, including to the consumer (hospital or medical practitioner). The consumer is responsible for identifying the recipient.15 The institution procuring blood or plasma and the drug manufacturer must inform each other in the following cases:
- detection of non-compliance of the donor’s health with the established criteria;
- detection of a positive test result for viral markers in a donor when donating blood, with negative results obtained during previous blood donations;
- identifying inconsistencies between virus testing and current instructions;
- donor disease caused by infectious agents carried by blood products (HBV, HCV, HAV and other non-A, non-B, non-C hepatitis viruses, HIV 1 and 2 and other currently known viruses);
- detection of Creutzfeidt-Jakob disease (CJ or vCJD) in the donor;
- detection of an infectious disease in the recipient, the source of which was (or could be) the donor.
The procedure for informing and the necessary actions when the above situations occur are regulated by the instructions. An analysis of previous cases of blood (plasma) donation should be carried out for a period of at least 6 months preceding the last blood donation with negative test results. If one of these cases is identified, the product batch documentation should be re-examined and evaluated. The need to recall the entire batch must be carefully assessed, taking into account the type of disease, the volume of the blood pool (plasma), the time interval between blood donation and serum processing, product characteristics and production technology. If it is determined that the pool contains plasma contaminated with HIV or hepatitis A, B or C viruses, this information, along with the facility's decision as to whether the production process from this pool of blood (plasma) can continue or whether a recall of this product(s) is necessary, is communicated to information from regulatory authorities.
Production and quality control
16
Blood and plasma, their processed products must be tested using certified (validated) methods with the required sensitivity and specificity for the following markers of pathogens of vector-borne diseases:
- HBsAg;
- antibodies to HIV 1 and HIV 2
- antibodies to HCV
If one of these tests gives a repeated positive result, the blood (plasma) portion is rejected. Regulatory documents may require additional tests.
17
The storage temperature of blood, plasma and intermediate products during storage and transportation from procurement institutions to processing plants should be regulated. These conditions must be observed when delivering products to the consumer.
18
The first homogeneous pool of blood plasma (including after separation of cryoprecipitate) must be tested using certified (validated) methods with the required sensitivity and specificity. When performing these tests, a positive reaction to the following markers of specific transmissible infectious agents should not be detected in the blood plasma pool: - HBsAg; - antibodies to HIV 1 and HIV 2 - antibodies to HCV If the results are positive, this pool should not be allowed into production.
19
A pool of plasma that has been tested for HCV RNA using the NAT method (nucleic acid amplification technology) may be allowed into the production process. Certified (validated) methods of sufficient sensitivity and specificity must be used for testing.
20
Requirements for testing for viruses or other infectious agents should be formulated taking into account knowledge of the hazards of infectious agents and the suitability of the test procedures used.
21
Labels on containers of individual plasma units stored prior to pooling and fractionation must comply with current requirements. Labels must contain at least the following information: identification number of the blood unit collected, name and address of the donor center or transfusion service responsible for the drugs, serial number of the container, storage temperature, total weight or volume of plasma, type of anticoagulant and date of collection and/ or blood separation.
22
To reduce the risk of microbial contamination of plasma or introduction of foreign material, plasma pooling and thawing operations should be performed in a clean area of at least Type D; personnel must have appropriate clothing, masks and gloves. Methods for opening containers, pooling and thawing plasma should be regularly monitored, for example by testing for microbial contamination.
23
Intermediate or final products that have undergone virus inactivation or removal operations should be clearly distinguished from materials that have not been subjected to such processing.
24
It is not allowed to carry out certification (validation) of methods for removing or inactivating viruses on equipment used for production in order to avoid contamination of products with viruses used for certification (validation).
Sample storage
25 Where possible, individual blood samples should be retained to facilitate retrospective analysis if necessary. This is usually the responsibility of the procuring institution. Samples of each plasma pool must be stored under appropriate conditions for at least one year after the expiration date of the product with the longest shelf life.Disposal of discarded blood/plasma and intermediate products
26 Instructions must be in place for the safe and efficient disposal of discarded blood/plasma or intermediate products.UDC 615.2/3.03:616- 085:618.2/3(081)
OBVIOUS PROSPECTS FOR ORGANIZING THE PRODUCTION OF BLOOD PREPARATIONS IN THE RUSSIAN FEDERATION
The article provides an analysis of the state of the level of provision of the population of the Russian Federation (RF) with donor blood products, which is insufficient and dependent on import supplies. The main problems of organizing the production of blood products in Russia are considered. The concept of organizing the collection, transportation and storage of plasma for subsequent processing in specially created new structures of the blood service - plasma centers, capable of improving the quality of harvested plasma, ensuring its safety and creating the necessary reserves for organizing the uninterrupted production of valuable medicinal products (MD) from donor blood is presented.
Key words: drugs
blood, production modules, plasma, plasma centers.
e-taI:ipp1tr@ipp1tr,gi
All over the world and in our country, there is an increase in the need of medical organizations (MO) for plasma products, which are in demand in almost all areas of medicine and play an important role in providing medical care in emergency situations and mass casualties of the population. In this regard, the state of their production is of great national importance and is directly related to national security.
Currently, the industrial production of therapeutic drugs from donor blood plasma in the Russian Federation (RF) is carried out in extremely small volumes. The drugs are mainly manufactured on small-scale or laboratory lines at some regional blood transfusion stations. The equipment and technology used does not meet the requirements of virus safety, economic and technical efficiency criteria, or the requirements of good manufacturing practice ^MP).
Blood products are purchased in significant quantities abroad. In 2011, the volume of imported drug purchases amounted to $272 million. In 2012, the volume of purchases amounted to $303 million, in 2013 $369 million is expected. To achieve the global level of drug consumption by 2030, the purchase of imported products in the amount of $983 will be required million
Albumin is a drug of strategic importance, since it is used for emergency medical care in emergency situations. Albumin consumption in Russia is only 6.5 tons per year; according to the World Health Organization (WHO), it should be at least 30 tons.
Immunoglobulin is a means of therapy and prevention for various infectious and immunodeficiency diseases, including AIDS. Consumption of this drug in Russia per capita is about 5% of the need - 30 times lower than in the USA and 18 times less than in EU countries.
The creation of a modern production of plasma preparations in the Russian Federation is possible with the simultaneous development of two directions - the construction of technological capacities for plasma fractionation and the creation of a system of plasma centers to provide enterprises with initial donor plasma.
The leadership of the country and Moscow made decisions on the construction in the cities of Moscow and Kirov of modern complexes for the production of blood products that meet international requirements for quality, safety of technology and products (Order of the Government of the Russian Federation dated April 23, 2004 - No. 516-r “On the creation of modern production blood products in Kirov"; Decree of the Moscow Government of April 24, 2007 "On the implementation of the investment project for the reconstruction of the Moscow public health institution "Blood Transfusion Station of the Moscow Health Department" and the construction of a technological block-module for the production of blood plasma products ").
The total design capacity of fractionation enterprises provides for fractionation of 800 thousand liters. plasma per year from the release of basic drugs: albumin, im-
S. V. THAI1, V.M. RUSANOV2 A.YU. PETROV3
1) Federal State Budgetary Institution “Russian Medical Research and Production Center “Rosplasma” of the Federal Medical Biological Agency”, Kirov
State budgetary healthcare institution of the city of Moscow "Blood transfusion station of the Department of Health, Moscow
h) Ural State Medical Academy, Yekaterinburg
munoglobulin for intravenous administration, concentrates of purified blood coagulation factors VIII and IX. It is obvious that in the future production capacity will be increased to produce medicinal products in a volume that meets healthcare needs.
The purpose of this study was to develop a concept for the production of blood products in the Russian Federation from its own raw materials - donor blood.
To implement the project in the city of Kirov, the Volga Regional Medical Center for Expertise of the Quality of Blood Products and Research on the Fractionation of Donor Plasma was created, later the Federal State Budgetary Institution Russian Medical Research and Practical Center "Rosplasma".
The most important condition for the effective functioning of the plant is the uninterrupted supply of its raw materials - donor plasma. To achieve this goal, the feasibility of deploying a network of plasma centers in the territory of a constituent entity of the Russian Federation - the Volga, partly Central, Northwestern and Ural federal districts - was studied.
To meet the plant's design requirement of 600 liters. plasma, it was necessary to organize at least 50 plasma collection points in stationary, modular and mobile versions, equipped with a modern set of equipment for plasma fractionation and freezing.
It is advisable to organize and commission plasmapheresis points in stages, depending on the progress of the construction project. By the start-up technological stage, the level of plasma procurement should reach at least 50-70 thousand liters per year. The basic algorithm for collecting and moving plasma is shown in the figure.
Rice. The concept of a plasma collection and supply system for the purpose of its procurement and subsequent processing
The plant under construction in Kirov for the production of blood products is designed for 2.28 thousand immunoglobulins; 16.2 thousand albumin; 99 million IU of blood clotting factor VIII; 168 million IU of blood clotting factor IX.
In accordance with WHO recommendations, the Russian Federation's need for blood products was calculated: it will be provided 100% for immunoglobulin and coagulation factor IX, more than 58% for albumin, and 40% for coagulation factor IIIV.
The possibilities for creating mobilization reserves of the listed drugs in the Russian Federation will increase.
Volumes of consumption of blood products in the Russian Federation and prospects for their production at the Kirov plant
Drug Requirement (according to WHO data) Actual volume of consumption (in volume terms) Annual production volume at the plant (in volume terms)
Albumin 5%,20% 29.7t. 1.48t. 1b,2t.
Immunoglobulin intravenous 1.3 t. 0.37t. 2.28t.
Factor VIII 568 million IU 475 million IU 99 million IU
Factor IX 113.6 million IU 60 million IU 174 million IU
As follows from the data presented in the table, the blood products required for release have a high demand, which is not covered by small-scale domestic products and purchased products abroad. Establishing our own production will partially solve the problem of shortage of blood products in Russia.
Thus, a concept has been developed for the collection, storage and supply of donor blood plasma with subsequent processing into vitally needed blood products, the need for which is currently not satisfied, which allows us to solve the most important tasks of Russian healthcare: implement an import substitution program for blood products and satisfy the population’s need for domestic medicinal assistance.
Literature
1. Zakharov, V.V. Self-sufficiency of Russia with plasma and blood products is an entirely achievable goal / V.V. Zakharov, S.A. Oprischenko, V.M. Rusanov // Healthcare and medical technology.” - 2005. - No. 7.
2. Oprishchenko, S.A. Medicinal blood products in modern medicine / S.A. Oprischenko, V.V. Zakharov, V.M. Rusanov // M: Medpraktika 2011. - 252.
3. Gabrielyan, N.V. Comprehensive assessment of the development of pharmaceutical markets in the countries of the Commonwealth of Independent States / N.V. Gabrielyan [and others] // Vest. Russian military medical academy. - 2012. - 1 (37).
4. Zakaryaeva, Z.T. Dynamics of the capacity of the pharmaceutical market of the Russian Federation / Z.T. Za-karyaeva [and others]// Natural and technical sciences. - 2011. - No. 6. - With. 256- 259
5. Rusanov, V.M. The concept of organizing a system for the procurement and supply of donor plasma for a new production of blood products / V.M. Rusanov / Bulletin of the Russian Blood Service, 2001. - No. 3. - p.13 - 18.
OBVIOUS PROSPECTS OF THE ORGANIZATION OF MANUFACTURE OF PREPARATIONS OF BLOOD IN THE RUSSIAN FEDERATION
S.V. THAI1, V.M. RUSANOV2 A.Yu. PETROV3
1) Federal State Institution "Russian Medical Research and Production Center "Rosplazma "Federal Medical-Biological Agency"
2) State Institution of Moscow Health "Station of Blood Transfusion Department of Health Moscow"
3)Ural State Medical Academy, Ekaterinburg
e-mail: [email protected]
The article provides an analysis of the state of security of the population of the Russian Federation (RF) drugs donated blood, which is insufficient and dependent on imports. The main problems of the organization of manufacture of preparations of blood in Russia. Given the concept of the organization of the collection, transportation and storage of plasma for further processing in a specially created new structures of the blood service is plasma center that can improve the quality of the harvested plasma, ensure its security and to create the necessary reserves for the organization of uninterrupted production of valuable medicinal products of donor blood
Key words: medicinal preparations of blood, industrial modules, plasma.
BLOOD SERVICE DEVELOPMENT CONCEPT
IN THE RUSSIAN FEDERATION
in 2004 - 2010
The Concept for the Development of Blood Services in the Russian Federation (hereinafter referred to as the Concept) was developed as a development of the Concept of protecting the health of the population of the Russian Federation for the period until 2005, approved by Order of the Government of the Russian Federation of August 31, 2000 No. 1202-r and the Concept of the development of healthcare and medical science in of the Russian Federation, approved by Decree of the Government of the Russian Federation of November 5, 1997 No. 1387.
STATE OF THE PROBLEM AND JUSTIFICATION OF THE NEED FOR DEVELOPING THE CONCEPT
The Blood Service of the Russian Federation is one of the most important components of national healthcare and provides transfusion care in peacetime and in emergency situations.
The problem of developing the blood service is of a national strategic nature, as it affects the country’s security issues.
Over the past decades, there has been a revolution in the understanding of the tasks of transfusiology related to the awareness of the risk of transfusion of blood and its components, on the one hand, and the need for their transfusion to provide care to patients, on the other. In accordance with the decision of the Board of the USSR Ministry of Health dated May 18, 1988, the country switched to component therapy, and whole blood practically ceased to be used in clinical practice. The need for blood components is disproportionate to their content in the blood and changes with changes in patient management protocols. In modern surgery, the need for red blood cells is decreasing, but the need for fresh frozen plasma is increasing. In oncohematology and acute radiation sickness, therapy is impossible without the use of large quantities of platelet mass. Further development of transfusiology is associated with a gradual transition from blood-based therapy to the predominant use of blood products, including genetically engineered ones, in clinical practice.
The Russian Blood Service is represented by a network of institutions (institutes, centers, blood transfusion stations) and departments (departments, blood transfusion rooms of medical institutions) that ensure the quality of transfusion therapy. Most blood service institutions are under the jurisdiction of health authorities of the constituent entities of the Russian Federation and municipalities and are financed from the corresponding budgets.
In recent years, the blood service has maintained a clear structure and organization and has not allowed a sharp drop in production. In 2002, there were 192 blood transfusion stations and 1,077 blood transfusion departments in Russia; 293 hospitals stocked blood and its components. Highly qualified teams have been preserved in blood service institutions. The blood service employs a total of 21,481 people, of which 3,863 are doctors, 9,804 paramedical workers, 3,795 junior medical workers, 744 engineering and technical workers. Staffing levels in 2002 were 94.4%.
The method developed by domestic scientists for the use of fresh frozen plasma for DIC syndrome and crash syndrome has made it possible to sharply reduce the mortality of patients, including those injured in emergency situations, and in relation to obstetric DIC, it has allowed to reduce the mortality rate of postpartum women in the Russian Federation by an average of 40%. Domestic technologies for the production of blood clotting factors VIII and IX have been developed, and unique blood substitutes and oxygen carriers have been created. The specialty "transfusiologist" is included in the list of medical and pharmacist specialties. The Russian Ministry of Health has prepared a number of important regulatory legal documents aimed at improving the work of the blood service and developing blood donation. In 2002, the state institution "Blood Center of the Ministry of Health of the Russian Federation" was created, providing organizational and methodological assistance to the country's blood service institutions. In many regions of the Russian Federation, territorial programs for the development of blood services have been developed and are being successfully implemented.
At the same time, the socio-economic difficulties observed in the country over the last decade have had negative consequences for the development of the domestic blood service. The lack of adequate funding has led to the fact that the material and technical base of most blood service institutions has become morally and physically worn out, which significantly hinders the introduction into practice of modern world and domestic technologies to ensure the safety and effectiveness of blood transfusion therapy. Numerous blood service facilities are underpowered and ineffective. There is an urgent need to carry out work to optimize the network of blood service institutions (as part of the ongoing restructuring of the overall healthcare network).
The most important issue in transfusiology is ensuring the safety of transfusion of blood components and products. Measures to improve the safety of blood transfusion therapy are regulated by a number of industry-specific regulatory legal documents - on the procedure for medical examination of donors, the introduction of quarantine of fresh frozen plasma, leukofiltration during the procurement of blood components, etc. At the same time, in the context of the growth of blood-borne infections in the country, issues regarding the virus safety of manufactured products, including quarantine and virus inactivation of components and blood products, are clearly not being addressed sufficiently. The system of external quality control of laboratory tests in the blood service needs to be improved. Modern methods of gene diagnostics of blood-borne infections are practically not used in the blood service.
Effective hardware methods for procuring plasma and cellular blood components are slowly being introduced into the practice of blood services, which leads to irrational use of already limited donor resources.
The production of blood products in the Russian Federation is in a particularly difficult situation. None of the domestic production of blood products complies with GMP rules. The existing plasma fractionation buildings, built in the 70s of the last century, operate on outdated equipment and need reconstruction and modernization. Clinical medicine's need for blood products is met by 17-25% of WHO standards. There is no industrial production of blood coagulation factors VIII and IX in the Russian Federation; very little intravenous immunoglobulin is produced. Domestic blood products lag significantly behind foreign ones in quality and cannot be considered safe in terms of transmitting blood-borne infections. The country is forced to constantly purchase expensive blood products abroad.
In order to solve the problem of self-sufficiency of the Russian Federation with high-quality and safe blood products, it is necessary to create an industry for processing blood plasma by modernizing existing plasma fractionation buildings and building modern, powerful, cost-effective plasma processing plants based on the introduction of the latest technologies for the full cycle of plasma processing (with double virus inactivation). The functioning of these industries is impossible without a major restructuring of the raw material base. It is necessary to have a wide network of donor points equipped with advanced equipment, a system for storing and transporting raw materials.
The system of state quality control of blood components and products requires improvement.
The country produces few modern blood substitutes, including domestic ones, which have no analogues in the world.
It is advisable to reorganize the activities of blood service institutions according to the principle of centralization of high-tech and material-intensive processes in the work of the blood service, such as laboratory testing, storage, processing of components, inventory management, and the functioning of a single donor center. In conditions of limited budget funding opportunities, it is relevant to attract private investment in the development of the blood service industry. Improving the work of the blood service will also be facilitated by providing blood service institutions with greater economic independence and introducing a system of state orders.
A necessary condition for the successful operation of the blood service in order to provide medical institutions with high-quality components and blood products is the further development of the raw material base for blood donation and its components.
Donor blood, its components and preparations are a national treasure. Donation is a freely expressed voluntary act of donating blood and its components for use for therapeutic purposes. Donation instills in a person high moral principles - humanism, kindness, responsiveness, patriotism.
The problem of donating blood and its components is one of the priorities for the state and key for domestic healthcare. Positive public attitude and active participation of the population in donation correspond to the goals of the state in the field of security and social policy - the formation of a healthy generation, a physically and spiritually strong society.
However, in the last decade, donation has experienced a significant decline, which is primarily due to the difficult socio-economic situation in the country, the deterioration of the demographic situation, the liquidation of the previous planned system for organizing donation, the virtual cessation of donation propaganda in the media, and the failure to fulfill obligations on benefits provided donors, extremely unsatisfactory financing of blood service institutions. The administrations of institutions and enterprises, where visits were previously made for the purpose of collecting blood, take a passive position in carrying out this action, and often oppose the participation of the workforce in donation. The total number of donors in Russia has decreased by more than 2 times over 15 years (in 1985 - 5.6 million people, in 2002 - 2.1 million people). In 2002, unpaid donors accounted for 87.5% of the donor contingent, providing 83% of all blood donations. The number of donors in Russia per 1 thousand population in 2002 was 14.6 (25 blood donations per 1 thousand population), while, according to the Council of Europe, for the country to be self-sufficient in blood and its components it is necessary to have 40-60 donors per 1 thousand people In Europe this number averages 40.2.
Taking into account the changed socio-economic conditions in the country, it is necessary to take measures to expand the social base of gratuitous donation and search for moral incentives for donation. It is required to develop national programs to promote free voluntary donation, aimed at various age groups and social strata of society; using all media for this purpose, especially television and radio. The Russian Red Cross Society and other public and medical organizations should be actively involved in working with the donor contingent. The donor movement needs the support of representatives of government bodies at all levels, famous politicians, artists, and entrepreneurs.
The regulatory legal framework regulating the work of the blood service and the development of the donor movement needs to be revised. Many provisions of the Law of the Russian Federation dated 06/09/1993 No. 5142-1 “On the donation of blood and its components” are outdated, are declarative in nature, and do not take into account the changes that have occurred in the socio-economic life of the country over the past 10 years. In this regard, it is relevant to develop a new version of the above-mentioned Law, which provides for advanced approaches to organizing and promoting the donation of blood and its components, and the activities of the blood service.
In order to improve the work of the blood service, further development of measures for standardization, licensing, certification, and accreditation is required.
The issues of computerization of blood service institutions - one of the important components of ensuring the safety of blood transfusion therapy - are not being adequately addressed. The development of an industry information standard and the organization of a unified information space for the country's blood service will make it possible to create federal and regional donor centers, a national register of donors diverted from donation, and an all-Russian automated system for accounting and managing blood and its components.
Further development of the blood and transfusiology service should be associated with improving the quality of training of transfusiologists, organizing the training of specialist technologists for the production of blood products, nursing and technical personnel for blood service institutions.
It is necessary to intensify the research work of specialized research institutes. Advanced scientific developments must be quickly introduced into the practice of blood services.
The state of the material and technical base of blood service institutions should improve significantly in the coming years through the acquisition of modern domestic and foreign equipment. In this regard, the development of the blood service is largely influenced by the state of domestic production of medical and technological equipment and consumables. Despite the fact that domestic enterprises in recent years have been offering an increasing range of products and equipment for blood service institutions, often unique and unparalleled in the world, in general, domestic production of equipment does not satisfy the needs of the blood service, which requires the adoption of appropriate interdepartmental decisions on its further development.
In order to coordinate the actions of the Russian Ministry of Health and interested ministries and departments, public and medical organizations, in 2004 it is necessary to create an interdepartmental council for the development of blood services in the Russian Federation.
The strategic importance of the blood service in ensuring the national security of the country, in protecting the health of the population of Russia, the need to solve the problem of self-sufficiency of the country with blood, its components and preparations dictates the need to adopt the Concept for the development of the blood service in the Russian Federation for 2004-2010.
The implementation of the Concept will make it possible to solve the problems of the blood service at the state level, comprehensively, using the resources of the state and society as efficiently as possible.
The concept will be the basis for the development of regional programs for a full-scale reorganization of transfusion medicine in the country.
CONCEPT
Global Goal Concept- guaranteeing the quality of blood transfusion therapy through continuous improvement of the activities of institutions and divisions of the blood service in the Russian Federation, achieving a level of self-sufficiency in Russia with donor blood, its components and drugs.
Concept goals:
· improving state policy in the field of development of free voluntary donation of blood and its components, achieving and maintaining a level of donation sufficient for the country’s self-sufficiency in components and products of donor blood.
· further development of the legislative and regulatory framework in the blood service;
· ensuring a modern level of quality assurance (safety and effectiveness) of blood transfusion therapy products and methods;
· modernization of the production base of the country's blood service;
· improving the system of state quality control of blood components and products.
Basic principles of the concept:
· consolidation of actions of government bodies of all levels, organizations and citizens in the field of support and development of the donor movement;
· harmonization of legislative and regulatory legal acts in the blood service, taking into account the international obligations of the Russian Federation;
· the most efficient use of the country's donor resources based on the improvement of existing and the introduction of new modern integrated technologies;
· centralization of high-tech and material-intensive components of the blood service: processing and storage of blood components, laboratory tests, inventory management, a single donor center, organization of transfusion care;
· ensuring high quality (safety and effectiveness) of means and methods of blood transfusion therapy at all stages of procurement, production, storage, transportation and clinical use of blood, its components and preparations.
Objectives of the concept:
In the direction - development of blood donation and its components:
· attracting the healthy population of Russia to donate blood and its components; educating the population on the issues of donation and therapeutic use of blood components and products;
· improving the regulatory framework for blood donation;
· creation of national and regional public associations of donors;
· propaganda of the donor movement as an act of humanism using modern advertising technologies;
· formation of favorable social, legal, economic and medical conditions for the implementation of donor functions;
· improving the system of moral incentives for gratuitous donations and encouraging organizers of the donor movement, including encouraging managers of enterprises and organizations that promote the participation of their employees in donation;
· maintaining the prestige of persons awarded the “Honorary Donor of Russia” badge;
· development of medical technologies for monitoring and maintaining the health status of donors;
· improving the structure and organization of the donation management system; improving the quality of organizational and methodological management of the donor movement in the regions;
· professional training of specialists to work with donor personnel and develop blood donation;
· improving the system of medical and social insurance for blood donors and its components;
· creation of a modern information and analytical base for working with donor personnel;
· organization of federal and regional registers of persons exempt from donation.
· use of international experience in recruiting and working with donor personnel in order to develop optimal approaches to solving the problem of developing donation in Russia.
In the direction of ensuring the quality (safety and effectiveness) of blood transfusion therapy products and methods:
· improving the system of state quality control of blood components and products;
· introduction of uniform requirements and conditions for licensing institutions and divisions of the blood service;
· centralization of processing of donor blood and its components with the presence of a wide network of donor points;
· organization of reliable primary diagnosis of blood-borne infections, centralization of laboratory diagnostic services in the regions or federal districts;
· improving the quality of enzyme immunoassay kits and developing gene diagnostic technologies for blood testing;
· improving the system of external quality control of laboratory tests in the blood service;
· transfer of all blood service institutions to the use of polymer containers for blood collection and refusal to use glass containers;
· widespread introduction of quarantine and leukofiltration methods for the procurement of blood components;
· development of standard requirements for blood components and products and their quality control, introduction of quality management principles into the practice of blood service institutions;
· creation of regional or district banks for storing quarantined blood components - fresh frozen plasma and red blood cells;
· development and implementation of methods for viral inactivation of blood components and products.
· creation of registers of CMV-negative donors, donors of rare erythrocyte groups and HLA-typed donors.
In the direction - creating a blood service industry, increasing the production of safe and effective components and blood products:
· improving the material and technical base of blood service institutions, developing approximate lists of standard equipment for blood service institutions with modern equipment;
· creation of a plasma processing industry that meets international standards to obtain a full range of high-quality blood products based on the modernization of existing plasma fractionation buildings and the construction of modern powerful plasma processing plants based on the introduction of advanced technologies for the full cycle of plasma processing with double virus inactivation;
· organization of production of a blood substitute-oxygen carrier based on modified hemoglobin;
· introduction of modern methods of plasma procurement, including the method of hardware plasmapheresis;
· creation of modern centers for hardware donor plasmapheresis with the aim of forming plasma reserves as raw materials for the production of modern highly effective blood products;
· organization of an effective system for transportation and storage of blood components and products;
· organization of production of domestic erythrocyte preservatives, transition from the procurement of erythrocyte mass to the production of erythrocyte suspension;
· increasing the shelf life of hemocomponents through the use of special types of equipment for storing red blood cells, platelets, plasma, cryoprecipitate;
· improving methods of cryopreservation of blood cells, organizing the work of long-term storage banks based on the development and implementation of polymer cryocontainers for storing blood at low and ultra-low temperatures;
In the direction of organizational and methodological support of measures to improve the work of the blood service:
· improvement of the legislative and industry regulatory framework governing the donation of blood and its components, the activities of the blood service, its harmonization taking into account the international obligations of the Russian Federation;
· improvement of methods for managing the country's blood service using modern information technologies, comprehensive development of the institute of chief transfusiologists of federal districts and constituent entities of the Russian Federation;
· restructuring the network of institutions and divisions of the blood service by centralizing expensive and material-intensive processes of the blood service;
· improving the state order system in the work of blood service institutions in peacetime and in emergency situations;
· expanding the economic independence of blood service institutions in order to increase the efficiency of their work.
In the direction - development of clinical transfusiology:
· further introduction of the principles of hemocomponent therapy with a gradual transition to the predominant use of blood products;
· development of standards for the provision of transfusiological care for various pathologies;
· introduction of autodonation into widespread clinical practice;
· creation of banks of hematopoietic cells;
· improvement of work on the prevention of post-transfusion complications, centralization of data on post-transfusion complications.
In the area of professional training of blood service specialists:
· introduction of the principles of continuous full-time and part-time postgraduate education in the field of industrial and clinical transfusiology for transfusiologists and clinicians of other specialties;
· establishment of a system for training specialist technologists for the production of blood products, paramedical and technical personnel for blood service institutions.
In the direction of conducting applied scientific research to solve the problems of the blood service:
· scientific substantiation of measures to improve the organization of blood donation and its components, the activities of the blood service;
· support for research and development work on the creation and development of technologies for the production, storage and transportation of safe and effective blood components, informatization of the blood service, development of clinical technologies, including methods for saving autologous blood;
· development of economic research in the blood service in order to optimize the cost-effectiveness ratio and improve the use of available resources when introducing new technologies in the blood service;
· intensifying R&D for the development and implementation of domestic equipment and medical products for the blood service;
· development of new blood transfusion media and blood replacement solutions, including those with the function of oxygen transport.
The tasks for implementing the Concept for the Development of the Blood Service in the Russian Federation should be carried out on the basis of the Action Plan for the period until 2010.
