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Transfusion in the WHO African Region
Transfusion Clinique et Biologique 26 (2019) 155–159
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Transfusion in the WHO African Region Transfusion dans la région Africaine de l’OMS A. Loua ∗ , J.B. Nikiema , A. Sougou , O.J.M. Kasilo World Health Organization (WHO) Regional Office for Africa, Cité du Djoue, P.O. Box 06 Brazzaville, Democratic Republic of the Congo
a r t i c l e
i n f o
Article history: Available online 18 June 2019 Keywords: Availability Access Safe blood Blood products Africa Survey
a b s t r a c t Introduction. – Different evaluations conducted on blood safety between 2004 and 2013 in Africa showed some progress in most countries. This paper describes the current status of the availability and access to safe blood in the Region. Methods. – A cross-sectional survey was conducted from January to December 2018. Data were collected through a questionnaire prepared using key indicators of blood safety and analysis was done using Excel 2010 and results were compared to those of the 2013. Results. – A total of 2,678 blood centres were reported including 244 (9%) stand-alone and 2,434 (91%) hospital based. Amongst these countries, 90.2% had a blood policy, 60.1% participated in an External Quality Assessment Scheme for Transfusion Transmissible Infections screening, 12% had accredited blood services, 73.2% had national guidelines on clinical use of blood and 78% had a government budget. The total number of blood units collected was 4,899,913 and the average proportion of voluntary blood donations was 71%. Plasma-derived medicinal products were included in the national essential medicines list in 52.6% of countries. The average proportion of units of blood tested for infections was 99.5% for HIV, 92.3% for HBV, 98.9% for HCV, 98.8% for syphilis. The percentage of whole blood separated into blood components was 63.4%. Conclusion. – Countries in the region continue to improve availability and access to safe blood, but challenges still remain and call for concrete actions required to reach universal access to quality and safe blood for transfusion throughout the region. ´ e´ franc¸aise de transfusion sanguine © 2019 Published by Elsevier Masson SAS on behalf of Societ (SFTS).
r é s u m é Mots clés : Disponibilité Accès Sang sûr Produits sanguins Afrique Enquête
Introduction. – Différentes évaluations réalisées entre 2004 et 2013 sur la transfusion sanguine en Afrique ont montré des progrès dans la plupart des pays. Cet article décrit l’état actuel de la disponibilité et de l’accès à du sang dans la Région, Méthodes. – Une enquête transversale a été réalisée de janvier à décembre 2018. Les données ont été collectées utilisant un questionnaire préparé à l’aide d’indicateurs de sécurité transfusionnelle, puis analysées et les résultats ont été comparés à ceux de 2013. Résultats. – Au total, 2,678 centres de transfusion ont été rapportés dans les 41 pays ayant fourni une réponse. Parmi eux 90,2 % avaient une politique de transfusion, 60,1 % participaient à une évaluation externe de la qualité des infections transmissibles par transfusion, 12 % avaient des services de transfusion accrédités, 73,2 % avaient des directives nationales sur l’utilisation du sang et 78 % avaient un budget gouvernemental. Le total d’unités de sang collectées était de 4,899,913 et la proportion moyenne de dons de sang volontaires était de 71 %. Les médicaments dérivés du plasma étaient inscrits sur la liste nationale des médicaments essentiels dans 52,6 %. La proportion d’unités de sang testées pour les ITT était de 99,5 % pour le VIH, 92,3 % pour le VHB, 98,9 % pour le VHC et 98,8 % pour la syphilis. Le pourcentage de sang total séparé en composants sanguins était de 63,4 %.
∗ Corresponding author. E-mail address: [email protected] (A. Loua). https://doi.org/10.1016/j.tracli.2019.06.191 ´ e´ franc¸aise de transfusion sanguine (SFTS). 1246-7820/© 2019 Published by Elsevier Masson SAS on behalf of Societ
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A. Loua et al. / Transfusion Clinique et Biologique 26 (2019) 155–159
Conclusion. – L’amélioration de la disponibilité et de l’accès au sang continue dans la région; les défis à lever exigent des actions concrètes pour la transfusion dans la région. ´ e´ franc¸aise de transfusion sanguine (SFTS). © 2019 Publie´ par Elsevier Masson SAS au nom de Societ
1. Introduction The WHO African Region is one of the six regions of WHO and covers currently 47 countries with over one billion inhabitants as of 2016, which is about 14% of the world’s population. The region includes three sub regions: Central Africa (CA), East & Southern Africa (ESA), and West Africa (WA). The African countries are facing a high rate of burden of disease of HIV, malaria, tuberculosis, non-communicable diseases and high ratio of maternal and infant mortality. The percentage population with anaemia is 42% in the region, especially in the children aged 6–59 months where it is 62% (59.6 to 64.8) and in women of reproductive age (15–49 years) with 38.6% (32.9 to 44.2). The prevalence of anaemia in the preschool children group where it ranks from 42% in Eswatini to 91% in Burkina Faso [1–3]. Blood transfusion plays an essential role in the provision of health care for these diseases, particularly among the vulnerable people such as women suffering from partum haemorrhage, undernourished and malaria-affected children, victims of trauma and accidents and patients suffering from sickle cell disease. However, most of patients requiring transfusion do not have timely access to safe blood and blood components in the region. To improve the availability of safe blood and blood products, the World Health Assembly (WHA) and the WHO Executive Board as well as Regional Committee and experts committee have adopted numerous resolutions and developed various documents since 1975. In addition, WHO provides technical and financial support Member States to implement these resolutions and guidelines. Also, the Heads of State and Government and High Representatives of countries endorsed in 2015 a new Sustainable Development Goals (SDGs) along with the 2030 agenda for which access to safe blood and blood products is a key strategy for achieving healthrelated SDGs [4–12]. Different evaluations of the implementation of the abovementioned resolutions and documents in the WHO African region were conducted between 2004 and 2013. Data showed that there had been significant progress in most of the countries through the increasing of the proportion of the following indicators in 2004 and 2013 respectively: countries having a national coordinated blood transfusion services (NBTS) from 80.5% to 89.1%; fully development of national transfusion policy from 65.8% to 82.6%; number of units collected annually from 2,218,576 to 4 402 680; countries where at least 80% of collected blood were came from voluntary non-remunerated blood donors (VNRBD) from 36.6% to 45.6%; participated in a national external quality assessment scheme (EQAS) for transfusion transmissible infection (TTIs) from 44% to 60.8%. However, significant challenges remained [13–17]. The objective of this article is to evaluate the implementation of the global and regional resolutions and guidelines on blood availability and safety in the WHO African Region in 2018 to measure progress made by countries using specific indicators; identify successes, constraints, and challenges; and define the priority actions to be undertaken in the coming years. 2. Methods We conducted a cross-sectional survey on the key blood safety indicators. All 47 countries in the Region were invited to complete a questionnaire on availability and access to safe blood and
blood products from January to December 2018. The questionnaire was prepared using key indicators of the WHO global database on blood safety (GDBS) including regional targets for blood safety. The questionnaire covered the following sections: administrative information, organization and management, blood donors and blood collection, blood components preparation, screening for TTIs and blood grouping, clinical use of blood and blood components, and plasma-derived medicinal products (PDMP). All submitted questionnaires were checked at country level and at WHO Regional Office for completeness and accuracy prior to analysis. Checked data were endorsed by the countries. Each participating NBTS reviewed the questionnaire itself, and subsequently provided consent for sharing anonymized data. Variables reported were expressed in number, rate, or percentage. The total population of the WHO African Region used for estimates was that provided by each country. Means and ranges of key indicators were calculated for each set of data where applicable. Data entry and analysis were performed using the Microsoft Excel and Microsoft Word 2010 applications from the Microsoft Office. 3. Results Concerning the administrative information, out of the 47 countries of the WHO African Region, 41 (87.2%) provided data in the questionnaire. Six countries did not provide any data and were excluded from the analysis. Regarding organization and management of blood services, a total of 2678 blood centres were reported including 244 (9%) standalone blood centres and 2,434 (91%) hospital based blood centres. Amongst the 41 countries that sent back the data, 37 (90.2%) countries had formulated and adopted a national blood policy, 33 countries (80.5%) had developed a strategic plan for implementing their blood policy, and the transfusion legislation was drawn up in 20 countries (50.8%). Thirty countries (73.2%) had national guidelines on the appropriate clinical use of blood and blood products while 16 countries (39%) had established a national haemovigilance system. The quality management in NBTS revealed that 25 countries (60.1%) participated in a national external quality assessment scheme (EQAS) for TTIs laboratory screening, and 18 countries (43.9%) for blood group serology and compatibility testing, while only 5 countries had accredited blood transfusion services. For the human resources, a total of 11,438 staff worked in the blood transfusion centres of which predominated nurses (19.8%), laboratory technicians (26.4%), administrative and support staff (31.4%) and many varied other staff (14.8%) while medical officers and pharmacists accounted for 7.5%. Concerning financial resources for NBTS, 32 countries (78.04%) had a national government budget and 23 (51.1%) had received funding and technical support from international agencies and/or institutions, while 20 countries (48.8%) had a system of cost recovery. With regard to the availability of blood and blood products, a total of 4,899,913 units of blood were collected ranging from 1,194 to 982,010. Only one country provided data on aphaeresis collection. The average blood donation rate was 4.9 per 1000 population (ranging from 0.5 to 36.6), and only 8 countries were collecting 10 units or more per 1,000 population. Nineteen countries (46.1%) had reached the target of 80–100% voluntary non-remunerated blood donations (VNRBD). The average proportion of VNRBD was 71%
A. Loua et al. / Transfusion Clinique et Biologique 26 (2019) 155–159 Table 1 Proportion blood units issued in clinical services in 19 countries. Clinical services
n
%
Internal medicine Paediatrics Others Gynaecology and obstetrics Surgery Emergency and resuscitation Total
489,576 466,625 461,729 427,289 275,383 128,119 2,938,317
22 21 21 19 12 6 100
(ranging from 4.2% to 100%) and the overall donor deferral rate was 9.0% of 4,646,657 donations in 36 countries. For the availability of plasma derived medicinal products (PDMP), out of 41 countries, 22 (52.6%) had included them in their national essential medicines list. Only 1 country produced all or part of PDMP through the fractionation of plasma collected in the country. In the remaining countries, all products were imported from abroad to meet the health care needs. Concerning quality and safety of blood, out of 41 countries, 35 (85.4%) prepared blood components and 3,033,525 (63.4%) of whole blood donations were separated into blood components (ranging from 0.12% to 102.8%). With 72.3%, red cell concentrate was the most component prepared, followed by fresh frozen plasma 17.4% and platelet concentrates 9.4%. The overall proportion of blood and blood components discarded was 7.5% and the main reasons being TTIs (5.0%) and incomplete blood donation (1.3%). As part of screening of blood units, the average proportion of using rapid tests as screening compared to ELISA tests in blood centres was 28.9%. Thirty-nine countries were screening hundred percent for HIV, 37 for HBV, 36 for HCV and syphilis and 4 for malaria. The average proportion of units of blood tested for TTIs was 99.5% for HIV, 92.3% for HBV, 98.9% for HCV, 98.8% for syphilis. The median percentage of reactive blood units to mandatory TTIs was 0.8% for HIV (ranging from 0% - 4.1%), 2.9% for HBV (ranging from 0.07–13.1%), 1.1% for HCV (ranging from 0.005–3.8%), 0.9% for syphilis (ranging from 0.04–3.9%), and 0.1% for malaria (ranging from 0.004-0.3). For immuno-hematological analysis, 38 countries out of 41 countries were performing blood grouping by forward and reverse test, while 35 did so for weak D testing and 23 for Rhesus/Kell Phenotyping. About the clinical use of blood and blood components, out 4,440,880 blood units issued in 35 countries, 1,213,830 (27.3%) were transfused as whole blood units, 2,986,186 (67.2%) as red cells concentrates, 318,253 (7.2%) as platelets concentrates, 524,482 (11.8%) as fresh frozen plasma and 53,615 (1.2%) as cryoprecipitate. In 10 countries that reported the number of transfused patients by age showed that out of around one million patients, 30.6% were aged under 5 years, 8.3% from 5 to 14 years, 38.7% from 15 to 44 years, 10.4% from 45 to 59 years and 11.8% from 60 years or older. The proportions of blood units issued in health facilities in 19 countries are showed in Table 1. The pre-transfusion compatibility testing was performed in 37 countries often by transfusing facilities and 11 countries performed research for irregular antibodies while 17 countries did so for Rhesus/Kell phenotyping. A total of 1,287 adverse events were reported by 15 countries, but only one country provided the classification of cases among which the main types of adverse events were febrile non haemolytic reactions, allergic reaction, unclassified reaction and transfusion associated dyspnoea. 4. Discussion As in the 2013 survey on blood safety and availability in the WHO African region, 47 countries were invited to participate in the 2018 survey. Six countries did not provided data while there was only one country that did not do it in the previous survey,
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probably because the questionnaire used for the 2018 survey was disseminated offline. There is an increase in the percentage of countries that reported having developed, adopted and implemented national blood safety policy. Indeed, 83% of countries in 2013 versus 90% in 2018 had a blood policy. Similarly, 50% of countries in 2013, reported having a strategic plan, 41% a legislation and 33% of inspection and licensing of blood transfusion services. Despite this improvement, development and adoption of legislation as well as the establishment of blood regulatory system remain a big issue in organization and management of blood transfusion services in the WHO African. For the first time in a survey in the WHO African Region, countries provided an estimation of the number of human resources involved in the blood transfusion services. It has been noted the number of paramedical and support staff were predominant, while medical staff (medical officers and pharmacists) are understaffed. Regarding the funding issue of blood safety, the analysis of financial resources received by 21 countries from the government and some external donors, revealed that out of their total funding including staffing and operations, le government budget represented 10% and 6% came from external donors. For countries that had a system of cost recovery, several mechanisms were practiced such as user fees, health insurance, subsidized cost recovery, etc. but the total amount financed by this means was not specified. The total number of blood donations increased from 4,402,680 in 2013 to 4,899,913 which corresponds to an increase of the donation rate from 4.7 to 4.9 per 1000 population. Considering the WHO standard of collecting at least 10 units of blood per 1000 population as the amount of blood required for blood transfusion needs per country per year, there was a shortfall of 5,040,434 units of blood collected compared to the target for the Region in 2018. The number of countries that collected at least 10 units per 1000 population as recommended by WHO has decreased from 9 in 2013 to 8 in 2018. It is the same for the number of countries that have achieved the regional target of 80% of voluntary non-remunerated blood donation which decreased from 21 to 19 respectively and many of these countries are in East and South and West Africa [16,17]. Even though the average proportion of VNRBD rose in the WHO Region from 67% in 2013 to 71% in 2018, blood services are needed to sensitize, educate, recruit and motivate blood donors. Governments and partners should increase their support to blood services for sustainable blood supply. The mean deferral rate (9%) decreased compared to 2013 deferral rate that was 13%. However, NBTS in the region still need to improve strategy for donor medical screening implemented in countries. There is a very slight decrease in the proportion of whole blood units separated into components, dropping from 64% in 2013 to 63.4% in 2018 despite increasing in the proportion of VNRBD and types of blood components prepared. Indeed, it has been shown, in the previous survey, that countries whose blood services are organized along voluntary blood donations perform a better component preparation. This is due to the fact that their collections are not patient based, unplanned, and more often not centered around emergencies. Increased blood components preparation in countries should ensure improved availability and appropriate clinical use of blood as well as avoid wastage of a scarce resource. In this regard, the African countries need to use adequate processing technologies which will further enhance the preparation of more blood components in the region. The 2018 survey reported that the leading cause of discard of blood is reactivity to markers of TTIs as in 2010 and 2013. According to the countries that provided information on this issue, the proportion of blood units discarded for TTIs decreased from 5.6% in 2013 to 5% in 2018 [17]. This further underscore the need to invest in collecting blood from low-risk blood donors which remains the foundation of any effective safe blood supply system.
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A good proportion of blood units collected is screened for TTIs markers. However, 2 countries did not screen 100% of blood donations for HIV, 4 for HBV and 5 for HCV and Syphilis. An evaluation of each country is needed to understand reasons for such outcome. Irregular supply and unavailability of reagents, in blood transfusion centres, are often reported as key elements that hamper systematic screening [18]. Advocacy for the supply of reagents, development of screening procedures and training of staff may increase the number of units screened for TTIs. The averages proportion of blood units reactive for some TTIs markers changed slightly between 2013 and 2018: from 1.3% to 0.8% for HIV, from 4.2% to 2.9% for HBV, from 1% to 1.1% for HCV and from 0.8% to 0.9% for syphilis. However, these proportions remained high in some countries. This depends on several factors beyond the scope of this paper such as the algorithms used, the test kits on the market, validation of the test kits, storage and lack of skilled human resource, among others, etc. The blood grouping of blood donations seems well done, since only 3 countries do not perform by both forward and reverse test. The percentage of transfused red cell concentrates has increased from 58.7% in 2013 to 67% in 2018. The global reduction in proportion of transfused whole blood is linked to improvement separation of whole blood into components. Some countries did not provide all data requested regarding the clinical use of blood. Only10 countries reported data on the number of transfused patients by age group in 2018, while they were 9 countries in 2013. For the first time, 19 countries provided data for transfused patients according to the clinical services. These data revealed that the most transfused patients in the Region were aged under 45 years and internal medicine, pediatrics and gynecology were the clinical services most users of blood and blood components even though blood were also used in other medical situations. Since children and women are also hospitalized in other clinical services, we can conclude that they are the most blood users in the African region. Data on blood usage including haemovigilance are more difficult to collect and monitor in most of counties as they are produced in clinical facilities, thus not under blood services control. A sound clinical interface needs to be well developed and an effective hemovigilance system needs to be implemented in most of countries. Like the previous assessments, the 2018 survey reveals that the following challenges persist, namely: deficiencies in policy, leadership and governance including unsustainable funding for national blood services; insufficient availability of blood and blood products that directly contributes to the gap between supply and demand; deficiencies in blood and blood products quality and safety; inappropriate clinical transfusion practices and weak clinical interface; and weakness of data collection and information management system in blood transfusion services.
5. Conclusions The 2018 survey on availability and access to safe blood and blood products shows that some progress was made in most of countries in the African. However, significant challenges remain and seriously compromise the availability and access to safe blood for the transfused patients. These challenges call for concrete and appropriate actions such as (i) the development of national blood policy and regulatory framework and their effective implementation; (ii) the strengthening capacities for the leadership and management of the national blood services; (iii) strong advocacy with national governments and partners for sustainable funding for national blood services; (iv) providing support to countries to increase access to safe blood and blood products; (v) the implementation of an effective quality system to improve quality and safety of
blood and blood products; (vi) the development and implementations of guidelines on rational use of blood including strengthening of national haemovigilance system and improving clinical interface between blood transfusion services and health facilities; and (vii) the monitoring of data collection and information management to inform national blood services development.
Disclosure of interest The authors declare that they have no competing interest.
Acknowledgment We would like to thank all Directors of NBTS in the countries of the WHO African Region for their contribution in collecting, compiling and validation data on availability and access to safe blood. We also thank the WHO Country Offices for the valuable assistance in to facilitate the return process of the completed questionnaire. References [1] World Health Organization. Atlas of African Health Statistics 2018: universal health coverage and the Sustainable Development Goals in the WHO African Region; WHO Regional Office for Africa, Brazzaville, Congo, 2018. Available at: http://www.aho.afro.who.int/sites/default/files/Atlas%202018-eng 1.pdf. [2] W.H.O. The global prevalence of anaemia in 2011. Geneva: World Health Organization; 2015 https://apps.who.int/iris/bitstream/handle/10665/177094/ 9789241564960 eng.pdf;jsessionid=80677C9484839B46752658F9D5BF7A58? sequence=1. [3] Magalhães RJS, Clements ACA. Spatial heterogeneity of haemoglobin concentration in preschool-age children in sub-Saharan Africa. Bull Word Health Organ 2011;89:459–68 https://www.who.int/bulletin/volumes/ 89/6/10-083568.pdf. [4] World Health Organization. Utilization and supply of human blood and blood products. In: 28th World Health Assembly 1975. Geneva, Switzerland: WHO; 1975 [Resolution WHA28.72] https://www.who.int/ bloodsafety/en/WHA28.72.pdf. [5] World Health Organization. Blood safety: proposal to establish World Blood Donor Day. In: 58th World Health Assembly 2005. Geneva, Switzerland: WHO; 2005 [Resolution WHA58.13] https://www.who.int/ bloodsafety/WHA58 13-en.pdf. [6] World Health Organization. Availability, safety and quality of blood products. In: 63rd World Health Assembly. Geneva, Switzerland: WHO; 2010 [Resolution WHA63.12] http://apps.who.int/medicinedocs/ documents/s19998en/s19998en.pdf. [7] World Health Organization. Regulatory system strengthening for medical products. In: 67th World Health Assembly. Geneva, Switzerland: WHO; 2014 [Resolution WHA67.20] https://apps.who.int/medicinedocs/ documents/s21456en/s21456en.pdf. [8] World Health Organization. Guidelines on management of blood and blood components as essential medicines. Geneva, Switzerland: WHO Expert Committee on Biological Standardization - Sixty-seventh report; 2017 [Technical report Annex 3] http://apps.who.int/medicinedocs/ documents/s23322en/s23322en.pdf. [9] World Health Organization. AIDS control: current status of AIDS control activities in the African Region. In: 44th Regional Committee for Africa. 1994 [Resolution AFR/RC44/R12] https://apps.who.int/iris/bitstream/handle/ 10665/99667/AFR RC44 R12 eng.pdf?sequence=1. [10] World Health Organization. Blood safety: a strategy for the African Region. In: 51st Regional Committee for Africa. Brazzaville, Congo; 2001 [Resolution AFR/RC51/R2] https://www.afro.who.int/sites/default/ files/sessions/resolutions/AFR-RC51-R2%20Blood%20safety.pdf. [11] World Health Organization. Regional strategy on regulation of medical products in the African region, 2016-2025. In: 66th Regional Committee for Africa. Addis Ababa, Ethiopia; 2016 [Resolution AFR/RC66/R2] https://www.afro.who.int/sites/default/files/sessions/resolutions/afr-rc66-r2en-2109.pdf. Nations. Transforming our World: The 2030 Agenda [12] United for Sustainable Development (A/RES/70/1), 2015. Available at: https://sustainabledevelopment.un.org/content/documents/21252030%20 Agenda%20for%20Sustainable%20Development%20web.pdf [consulted on 31 May 2019]. [13] World Health Organization. Status of Blood Safety in the WHO African Region; Report of the 2004 Survey. Brazzaville, Republic of Congo: World Health Organization; 2007.
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[17] Loua A, Nikiema JB, Kasilo OMJ, T.C. Tayou. Blood safety and availability in the WHO African Region. Blood safety and availability in the WHO African Region. Glob Surg 2018;4:1–7 https://www.oatext.com/ blood-safety-and-availability-in-the-who-african-region.php. [18] Bloch EM, Vermeulen M, Murphy E. Blood transfusion safety in Africa: A literature review of infectious disease and organizational challenges. Transfus Med Rev 2012;26:164–80, http://dx.doi.org/10.1016/j.tmrv.2011.07.006 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668661/pdf/nihms467533. pdf.
Disponible en ligne sur
ScienceDirect www.sciencedirect.com
Update article
Transfusion in the WHO African Region Transfusion dans la région Africaine de l’OMS A. Loua ∗ , J.B. Nikiema , A. Sougou , O.J.M. Kasilo World Health Organization (WHO) Regional Office for Africa, Cité du Djoue, P.O. Box 06 Brazzaville, Democratic Republic of the Congo
a r t i c l e
i n f o
Article history: Available online 18 June 2019 Keywords: Availability Access Safe blood Blood products Africa Survey
a b s t r a c t Introduction. – Different evaluations conducted on blood safety between 2004 and 2013 in Africa showed some progress in most countries. This paper describes the current status of the availability and access to safe blood in the Region. Methods. – A cross-sectional survey was conducted from January to December 2018. Data were collected through a questionnaire prepared using key indicators of blood safety and analysis was done using Excel 2010 and results were compared to those of the 2013. Results. – A total of 2,678 blood centres were reported including 244 (9%) stand-alone and 2,434 (91%) hospital based. Amongst these countries, 90.2% had a blood policy, 60.1% participated in an External Quality Assessment Scheme for Transfusion Transmissible Infections screening, 12% had accredited blood services, 73.2% had national guidelines on clinical use of blood and 78% had a government budget. The total number of blood units collected was 4,899,913 and the average proportion of voluntary blood donations was 71%. Plasma-derived medicinal products were included in the national essential medicines list in 52.6% of countries. The average proportion of units of blood tested for infections was 99.5% for HIV, 92.3% for HBV, 98.9% for HCV, 98.8% for syphilis. The percentage of whole blood separated into blood components was 63.4%. Conclusion. – Countries in the region continue to improve availability and access to safe blood, but challenges still remain and call for concrete actions required to reach universal access to quality and safe blood for transfusion throughout the region. ´ e´ franc¸aise de transfusion sanguine © 2019 Published by Elsevier Masson SAS on behalf of Societ (SFTS).
r é s u m é Mots clés : Disponibilité Accès Sang sûr Produits sanguins Afrique Enquête
Introduction. – Différentes évaluations réalisées entre 2004 et 2013 sur la transfusion sanguine en Afrique ont montré des progrès dans la plupart des pays. Cet article décrit l’état actuel de la disponibilité et de l’accès à du sang dans la Région, Méthodes. – Une enquête transversale a été réalisée de janvier à décembre 2018. Les données ont été collectées utilisant un questionnaire préparé à l’aide d’indicateurs de sécurité transfusionnelle, puis analysées et les résultats ont été comparés à ceux de 2013. Résultats. – Au total, 2,678 centres de transfusion ont été rapportés dans les 41 pays ayant fourni une réponse. Parmi eux 90,2 % avaient une politique de transfusion, 60,1 % participaient à une évaluation externe de la qualité des infections transmissibles par transfusion, 12 % avaient des services de transfusion accrédités, 73,2 % avaient des directives nationales sur l’utilisation du sang et 78 % avaient un budget gouvernemental. Le total d’unités de sang collectées était de 4,899,913 et la proportion moyenne de dons de sang volontaires était de 71 %. Les médicaments dérivés du plasma étaient inscrits sur la liste nationale des médicaments essentiels dans 52,6 %. La proportion d’unités de sang testées pour les ITT était de 99,5 % pour le VIH, 92,3 % pour le VHB, 98,9 % pour le VHC et 98,8 % pour la syphilis. Le pourcentage de sang total séparé en composants sanguins était de 63,4 %.
∗ Corresponding author. E-mail address: [email protected] (A. Loua). https://doi.org/10.1016/j.tracli.2019.06.191 ´ e´ franc¸aise de transfusion sanguine (SFTS). 1246-7820/© 2019 Published by Elsevier Masson SAS on behalf of Societ
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A. Loua et al. / Transfusion Clinique et Biologique 26 (2019) 155–159
Conclusion. – L’amélioration de la disponibilité et de l’accès au sang continue dans la région; les défis à lever exigent des actions concrètes pour la transfusion dans la région. ´ e´ franc¸aise de transfusion sanguine (SFTS). © 2019 Publie´ par Elsevier Masson SAS au nom de Societ
1. Introduction The WHO African Region is one of the six regions of WHO and covers currently 47 countries with over one billion inhabitants as of 2016, which is about 14% of the world’s population. The region includes three sub regions: Central Africa (CA), East & Southern Africa (ESA), and West Africa (WA). The African countries are facing a high rate of burden of disease of HIV, malaria, tuberculosis, non-communicable diseases and high ratio of maternal and infant mortality. The percentage population with anaemia is 42% in the region, especially in the children aged 6–59 months where it is 62% (59.6 to 64.8) and in women of reproductive age (15–49 years) with 38.6% (32.9 to 44.2). The prevalence of anaemia in the preschool children group where it ranks from 42% in Eswatini to 91% in Burkina Faso [1–3]. Blood transfusion plays an essential role in the provision of health care for these diseases, particularly among the vulnerable people such as women suffering from partum haemorrhage, undernourished and malaria-affected children, victims of trauma and accidents and patients suffering from sickle cell disease. However, most of patients requiring transfusion do not have timely access to safe blood and blood components in the region. To improve the availability of safe blood and blood products, the World Health Assembly (WHA) and the WHO Executive Board as well as Regional Committee and experts committee have adopted numerous resolutions and developed various documents since 1975. In addition, WHO provides technical and financial support Member States to implement these resolutions and guidelines. Also, the Heads of State and Government and High Representatives of countries endorsed in 2015 a new Sustainable Development Goals (SDGs) along with the 2030 agenda for which access to safe blood and blood products is a key strategy for achieving healthrelated SDGs [4–12]. Different evaluations of the implementation of the abovementioned resolutions and documents in the WHO African region were conducted between 2004 and 2013. Data showed that there had been significant progress in most of the countries through the increasing of the proportion of the following indicators in 2004 and 2013 respectively: countries having a national coordinated blood transfusion services (NBTS) from 80.5% to 89.1%; fully development of national transfusion policy from 65.8% to 82.6%; number of units collected annually from 2,218,576 to 4 402 680; countries where at least 80% of collected blood were came from voluntary non-remunerated blood donors (VNRBD) from 36.6% to 45.6%; participated in a national external quality assessment scheme (EQAS) for transfusion transmissible infection (TTIs) from 44% to 60.8%. However, significant challenges remained [13–17]. The objective of this article is to evaluate the implementation of the global and regional resolutions and guidelines on blood availability and safety in the WHO African Region in 2018 to measure progress made by countries using specific indicators; identify successes, constraints, and challenges; and define the priority actions to be undertaken in the coming years. 2. Methods We conducted a cross-sectional survey on the key blood safety indicators. All 47 countries in the Region were invited to complete a questionnaire on availability and access to safe blood and
blood products from January to December 2018. The questionnaire was prepared using key indicators of the WHO global database on blood safety (GDBS) including regional targets for blood safety. The questionnaire covered the following sections: administrative information, organization and management, blood donors and blood collection, blood components preparation, screening for TTIs and blood grouping, clinical use of blood and blood components, and plasma-derived medicinal products (PDMP). All submitted questionnaires were checked at country level and at WHO Regional Office for completeness and accuracy prior to analysis. Checked data were endorsed by the countries. Each participating NBTS reviewed the questionnaire itself, and subsequently provided consent for sharing anonymized data. Variables reported were expressed in number, rate, or percentage. The total population of the WHO African Region used for estimates was that provided by each country. Means and ranges of key indicators were calculated for each set of data where applicable. Data entry and analysis were performed using the Microsoft Excel and Microsoft Word 2010 applications from the Microsoft Office. 3. Results Concerning the administrative information, out of the 47 countries of the WHO African Region, 41 (87.2%) provided data in the questionnaire. Six countries did not provide any data and were excluded from the analysis. Regarding organization and management of blood services, a total of 2678 blood centres were reported including 244 (9%) standalone blood centres and 2,434 (91%) hospital based blood centres. Amongst the 41 countries that sent back the data, 37 (90.2%) countries had formulated and adopted a national blood policy, 33 countries (80.5%) had developed a strategic plan for implementing their blood policy, and the transfusion legislation was drawn up in 20 countries (50.8%). Thirty countries (73.2%) had national guidelines on the appropriate clinical use of blood and blood products while 16 countries (39%) had established a national haemovigilance system. The quality management in NBTS revealed that 25 countries (60.1%) participated in a national external quality assessment scheme (EQAS) for TTIs laboratory screening, and 18 countries (43.9%) for blood group serology and compatibility testing, while only 5 countries had accredited blood transfusion services. For the human resources, a total of 11,438 staff worked in the blood transfusion centres of which predominated nurses (19.8%), laboratory technicians (26.4%), administrative and support staff (31.4%) and many varied other staff (14.8%) while medical officers and pharmacists accounted for 7.5%. Concerning financial resources for NBTS, 32 countries (78.04%) had a national government budget and 23 (51.1%) had received funding and technical support from international agencies and/or institutions, while 20 countries (48.8%) had a system of cost recovery. With regard to the availability of blood and blood products, a total of 4,899,913 units of blood were collected ranging from 1,194 to 982,010. Only one country provided data on aphaeresis collection. The average blood donation rate was 4.9 per 1000 population (ranging from 0.5 to 36.6), and only 8 countries were collecting 10 units or more per 1,000 population. Nineteen countries (46.1%) had reached the target of 80–100% voluntary non-remunerated blood donations (VNRBD). The average proportion of VNRBD was 71%
A. Loua et al. / Transfusion Clinique et Biologique 26 (2019) 155–159 Table 1 Proportion blood units issued in clinical services in 19 countries. Clinical services
n
%
Internal medicine Paediatrics Others Gynaecology and obstetrics Surgery Emergency and resuscitation Total
489,576 466,625 461,729 427,289 275,383 128,119 2,938,317
22 21 21 19 12 6 100
(ranging from 4.2% to 100%) and the overall donor deferral rate was 9.0% of 4,646,657 donations in 36 countries. For the availability of plasma derived medicinal products (PDMP), out of 41 countries, 22 (52.6%) had included them in their national essential medicines list. Only 1 country produced all or part of PDMP through the fractionation of plasma collected in the country. In the remaining countries, all products were imported from abroad to meet the health care needs. Concerning quality and safety of blood, out of 41 countries, 35 (85.4%) prepared blood components and 3,033,525 (63.4%) of whole blood donations were separated into blood components (ranging from 0.12% to 102.8%). With 72.3%, red cell concentrate was the most component prepared, followed by fresh frozen plasma 17.4% and platelet concentrates 9.4%. The overall proportion of blood and blood components discarded was 7.5% and the main reasons being TTIs (5.0%) and incomplete blood donation (1.3%). As part of screening of blood units, the average proportion of using rapid tests as screening compared to ELISA tests in blood centres was 28.9%. Thirty-nine countries were screening hundred percent for HIV, 37 for HBV, 36 for HCV and syphilis and 4 for malaria. The average proportion of units of blood tested for TTIs was 99.5% for HIV, 92.3% for HBV, 98.9% for HCV, 98.8% for syphilis. The median percentage of reactive blood units to mandatory TTIs was 0.8% for HIV (ranging from 0% - 4.1%), 2.9% for HBV (ranging from 0.07–13.1%), 1.1% for HCV (ranging from 0.005–3.8%), 0.9% for syphilis (ranging from 0.04–3.9%), and 0.1% for malaria (ranging from 0.004-0.3). For immuno-hematological analysis, 38 countries out of 41 countries were performing blood grouping by forward and reverse test, while 35 did so for weak D testing and 23 for Rhesus/Kell Phenotyping. About the clinical use of blood and blood components, out 4,440,880 blood units issued in 35 countries, 1,213,830 (27.3%) were transfused as whole blood units, 2,986,186 (67.2%) as red cells concentrates, 318,253 (7.2%) as platelets concentrates, 524,482 (11.8%) as fresh frozen plasma and 53,615 (1.2%) as cryoprecipitate. In 10 countries that reported the number of transfused patients by age showed that out of around one million patients, 30.6% were aged under 5 years, 8.3% from 5 to 14 years, 38.7% from 15 to 44 years, 10.4% from 45 to 59 years and 11.8% from 60 years or older. The proportions of blood units issued in health facilities in 19 countries are showed in Table 1. The pre-transfusion compatibility testing was performed in 37 countries often by transfusing facilities and 11 countries performed research for irregular antibodies while 17 countries did so for Rhesus/Kell phenotyping. A total of 1,287 adverse events were reported by 15 countries, but only one country provided the classification of cases among which the main types of adverse events were febrile non haemolytic reactions, allergic reaction, unclassified reaction and transfusion associated dyspnoea. 4. Discussion As in the 2013 survey on blood safety and availability in the WHO African region, 47 countries were invited to participate in the 2018 survey. Six countries did not provided data while there was only one country that did not do it in the previous survey,
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probably because the questionnaire used for the 2018 survey was disseminated offline. There is an increase in the percentage of countries that reported having developed, adopted and implemented national blood safety policy. Indeed, 83% of countries in 2013 versus 90% in 2018 had a blood policy. Similarly, 50% of countries in 2013, reported having a strategic plan, 41% a legislation and 33% of inspection and licensing of blood transfusion services. Despite this improvement, development and adoption of legislation as well as the establishment of blood regulatory system remain a big issue in organization and management of blood transfusion services in the WHO African. For the first time in a survey in the WHO African Region, countries provided an estimation of the number of human resources involved in the blood transfusion services. It has been noted the number of paramedical and support staff were predominant, while medical staff (medical officers and pharmacists) are understaffed. Regarding the funding issue of blood safety, the analysis of financial resources received by 21 countries from the government and some external donors, revealed that out of their total funding including staffing and operations, le government budget represented 10% and 6% came from external donors. For countries that had a system of cost recovery, several mechanisms were practiced such as user fees, health insurance, subsidized cost recovery, etc. but the total amount financed by this means was not specified. The total number of blood donations increased from 4,402,680 in 2013 to 4,899,913 which corresponds to an increase of the donation rate from 4.7 to 4.9 per 1000 population. Considering the WHO standard of collecting at least 10 units of blood per 1000 population as the amount of blood required for blood transfusion needs per country per year, there was a shortfall of 5,040,434 units of blood collected compared to the target for the Region in 2018. The number of countries that collected at least 10 units per 1000 population as recommended by WHO has decreased from 9 in 2013 to 8 in 2018. It is the same for the number of countries that have achieved the regional target of 80% of voluntary non-remunerated blood donation which decreased from 21 to 19 respectively and many of these countries are in East and South and West Africa [16,17]. Even though the average proportion of VNRBD rose in the WHO Region from 67% in 2013 to 71% in 2018, blood services are needed to sensitize, educate, recruit and motivate blood donors. Governments and partners should increase their support to blood services for sustainable blood supply. The mean deferral rate (9%) decreased compared to 2013 deferral rate that was 13%. However, NBTS in the region still need to improve strategy for donor medical screening implemented in countries. There is a very slight decrease in the proportion of whole blood units separated into components, dropping from 64% in 2013 to 63.4% in 2018 despite increasing in the proportion of VNRBD and types of blood components prepared. Indeed, it has been shown, in the previous survey, that countries whose blood services are organized along voluntary blood donations perform a better component preparation. This is due to the fact that their collections are not patient based, unplanned, and more often not centered around emergencies. Increased blood components preparation in countries should ensure improved availability and appropriate clinical use of blood as well as avoid wastage of a scarce resource. In this regard, the African countries need to use adequate processing technologies which will further enhance the preparation of more blood components in the region. The 2018 survey reported that the leading cause of discard of blood is reactivity to markers of TTIs as in 2010 and 2013. According to the countries that provided information on this issue, the proportion of blood units discarded for TTIs decreased from 5.6% in 2013 to 5% in 2018 [17]. This further underscore the need to invest in collecting blood from low-risk blood donors which remains the foundation of any effective safe blood supply system.
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A good proportion of blood units collected is screened for TTIs markers. However, 2 countries did not screen 100% of blood donations for HIV, 4 for HBV and 5 for HCV and Syphilis. An evaluation of each country is needed to understand reasons for such outcome. Irregular supply and unavailability of reagents, in blood transfusion centres, are often reported as key elements that hamper systematic screening [18]. Advocacy for the supply of reagents, development of screening procedures and training of staff may increase the number of units screened for TTIs. The averages proportion of blood units reactive for some TTIs markers changed slightly between 2013 and 2018: from 1.3% to 0.8% for HIV, from 4.2% to 2.9% for HBV, from 1% to 1.1% for HCV and from 0.8% to 0.9% for syphilis. However, these proportions remained high in some countries. This depends on several factors beyond the scope of this paper such as the algorithms used, the test kits on the market, validation of the test kits, storage and lack of skilled human resource, among others, etc. The blood grouping of blood donations seems well done, since only 3 countries do not perform by both forward and reverse test. The percentage of transfused red cell concentrates has increased from 58.7% in 2013 to 67% in 2018. The global reduction in proportion of transfused whole blood is linked to improvement separation of whole blood into components. Some countries did not provide all data requested regarding the clinical use of blood. Only10 countries reported data on the number of transfused patients by age group in 2018, while they were 9 countries in 2013. For the first time, 19 countries provided data for transfused patients according to the clinical services. These data revealed that the most transfused patients in the Region were aged under 45 years and internal medicine, pediatrics and gynecology were the clinical services most users of blood and blood components even though blood were also used in other medical situations. Since children and women are also hospitalized in other clinical services, we can conclude that they are the most blood users in the African region. Data on blood usage including haemovigilance are more difficult to collect and monitor in most of counties as they are produced in clinical facilities, thus not under blood services control. A sound clinical interface needs to be well developed and an effective hemovigilance system needs to be implemented in most of countries. Like the previous assessments, the 2018 survey reveals that the following challenges persist, namely: deficiencies in policy, leadership and governance including unsustainable funding for national blood services; insufficient availability of blood and blood products that directly contributes to the gap between supply and demand; deficiencies in blood and blood products quality and safety; inappropriate clinical transfusion practices and weak clinical interface; and weakness of data collection and information management system in blood transfusion services.
5. Conclusions The 2018 survey on availability and access to safe blood and blood products shows that some progress was made in most of countries in the African. However, significant challenges remain and seriously compromise the availability and access to safe blood for the transfused patients. These challenges call for concrete and appropriate actions such as (i) the development of national blood policy and regulatory framework and their effective implementation; (ii) the strengthening capacities for the leadership and management of the national blood services; (iii) strong advocacy with national governments and partners for sustainable funding for national blood services; (iv) providing support to countries to increase access to safe blood and blood products; (v) the implementation of an effective quality system to improve quality and safety of
blood and blood products; (vi) the development and implementations of guidelines on rational use of blood including strengthening of national haemovigilance system and improving clinical interface between blood transfusion services and health facilities; and (vii) the monitoring of data collection and information management to inform national blood services development.
Disclosure of interest The authors declare that they have no competing interest.
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