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INTRODUCTION: Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized reports of adverse reactions for all blood products. STUDY DESIGN AND METHODS: ICSRs involving blood products as the suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms and the International Society of Blood Transfusion haemovigilance definitions were used to stratify adverse reactions. Descriptive statistics were used to characterize ICSR demographics. RESULTS: A total of 111,033 ICSRs containing 577,577 suspected adverse reactions with 6152 MedDRA preferred terms were reported for 34 blood products. There were 12,153 (10.9%) reports for blood components, 98,135 (88.4%) reports for plasma-derived medicines, and 745 (0.7%) reports for recombinant products. The majority of reports (21.0% and 19.7%, respectively) were from patients aged 45-64 and over 65 years. The Americas contributed the most ICSRs (49.7%). Top reported suspected adverse reactions were for the following MedDRA preferred terms: headache (3.5%), pyrexia (2.8%), chills (2.8%), dyspnoea (1.8%), and nausea (1.8%). CONCLUSION: VigiBase already has a large number of reports on blood products. When compared to other existing haemovigilance databases, our study found reports from a broader range of countries and reporters. This may provide us with new perspectives, but for VigiBase to reach its full potential in haemovigilance some alterations in what is captured in reports are required.

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications. Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products. Key Messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

Background:Haemovigilance is an important element of blood regulation. It includes collecting and evaluating information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We assessed how haemovigilance is currently being implemented and performed in 10 sub-Saharan African countries. Methods:We piloted the use of the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed.Results:The countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44% (range: 7.5% - 70%). The lowest average performance scores were for the arrangement for effective organisation and coordination (35%) and human resources (35%) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50% and 60%, respectively). We identified clusters of best implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources. Conclusions:Implementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs.

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Blood products of human origin are essential treatment options for several diseases, for example, hemophilia. We studied the alignment of national essential medicines lists (NEMLs) of low- and middle-income countries (LMICs) with the World Health Organization (WHO) Model List for the selection of blood products of human origin. The most recent versions of NEMLs from all LMICs were studied for the inclusion of blood products of human origin (blood and blood components, plasma products, and immunoglobulins). Data obtained from 105 NEMLs were compared to the 2017 WHO Model List. The median number of blood products of human origin on the NEMLs was 4 (range: 0-10). Immunoglobulins were most frequently included (73%). Blood and blood components were the least selected products (15%). The uptake of plasma products was around 50%. Nine countries did not have any blood products of human origin on their NEMLs. Some NEMLs included blood products not listed on the WHO Model List (albumin, hepatitis A immunoglobulin, and cryoprecipitate). We observed variation in selection according to WHO region, income level, and year of NEML update. Alignment of NEMLs with the WHO Model List varied greatly for different groups of blood products, ranging from good uptake for immunoglobulins, reasonable uptake for plasma products, to poor uptake for blood and blood components. This heterogeneity in selection and inclusion of blood products of human origin on NEMLs may be partly explained as being due to specific country characteristics, but some of it may not be explained. Policy makers need to rely on evidence in making decisions about which blood products to select, include, and remove on their NEMLs.

Delivering genes selectively to the therapeutically relevant cell type is among the prime goals of vector development. Here, we present a high-throughput selection and screening process that identifies designed ankyrin repeat proteins (DARPins) optimally suited for receptor-targeted gene delivery using adeno-associated viral (AAV) and lentiviral (LV) vectors. In particular, the process includes expression, purification, and in situ biotinylation of the extracellular domains of target receptors as Fc fusion proteins in mammalian cells and the selection of high-affinity binders by ribosome display from DARPin libraries each covering more than 1012 variants. This way, DARPins specific for the glutamate receptor subunit GluA4, the endothelial surface marker CD105, and the natural killer cell marker NKp46 were generated. The identification of DARPins best suited for gene delivery was achieved by screening small-scale vector productions. Both LV and AAV particles displaying the selected DARPins transduced only cells expressing the corresponding target receptor. The data confirm that a straightforward process for the generation of receptor-targeted viral vectors has been established. Moreover, biochemical analysis of a panel of DARPins revealed that their functional cell-surface expression as fusion proteins is more relevant for efficient gene delivery by LV particles than functional binding affinity. Keywords: DARPin, receptor-targeted viral vectors, LV, AAV, ribosome display, GluA4, CD105, NKp46

The purpose of this study is to interrogate a ‘working’ strategy established to improve and sustain learner performance by two Life Sciences and two Physical Sciences teachers of two best-performing high schools in the North West province of South Africa. The schools in this study have had a pass rate of over 90% for seven consecutive years in Physical and Life Sciences. Ausubel’s (1963) constructs of Meaningful Reception Learning theory provided the conceptual framework for this study. The study was purely qualitative, employing an exploratory case-study approach. Purposive sampling was adopted to identify participants and research sites for the study. Data was generated through interviews, classroom observations and document analysis. The data were thematically analysed using open coding, axial coding and selective coding. Results of the study demonstrate that the aha! moment originated from the use of role-playing as a teaching strategy. Recommendations for policy and further research are suggested.

This study aimed to develop a locking T-plate and to evaluate its mechanical properties in synthetic models. A titanium 2.7mm T-plate was designed with a shaft containing three locked screw holes and one dynamic compression hole, and a head with two locked screw holes. Forty T-shaped polyurethane blocks, and 20 T-plates were used for mechanical testing. Six bone-plate constructs were tested to failure, three in axial compression and three in cantilever bending. Fourteen bone-plate constructs were tested for failure in fatigue, seven in axial compression and seven in cantilever bending. In static testing higher values of axial compression test than cantilever bending test were observed for all variables. In axial compression fatigue testing all bone-plate constructs withstood 1,000,000 cycles. Four bone-plate constructs failure occurred before 1,000,000 cycles in cantilever bending fatigue testing. In conclusion, the locking T-plate tested has mechanical properties that offer greatest resistance to fracture under axial loading than bending forces. RESUMO: O objetivo deste estudo foi desenvolver uma placa bloqueada em formato de T e avaliar as propriedades mecânicas em um modelo sintético. Uma placa-T em liga de titânio 2,7mm foi desenhada com uma haste contendo três orifícios para parafusos bloqueados e um orifício para realização de compressão dinâmica. 40 blocos de poliuretano em formato de T e 20 placas-T foram utilizados para os ensaios mecânicos. Seis montagens osso-placa foram testados até a falha, sendo três em força de compressão axial e três em flexão engastada. 14 montagens osso-placa foram testadas até a falha em fatiga, sendo 7 em força de compressão axial e 7 em flexão engastada. No teste estático, os valores mais altos foram observados em todas as variáveis no teste de compressão axial quando comparado à flexão engastada. Já nos testes de fadiga na força de compressão axial, todas as montagens osso-placa resistiram à 1000000 de ciclos. No teste de fadiga em flexão engastada, quatro montagens osso-placa falharam antes de alcançarem 1000000 de ciclos. Em conclusão, a placa-T estudada apresenta propriedades mecânicas que oferecem uma melhor resistência em estabilizar as fraturas na atuação das forças de compressão axial que nas forças de flexão.

This paper investigated Physical Science students' experiences of the nature of classroom inquiry during investigations. The paper followed a mixed method research design. One hundred and sixty-seven Grade 11 students were surveyed. The students were sampled from five schools in one of South Africa's 9 educational provinces. Students' experiences of the nature of inquiry in Chemistry practical investigations were assessed through a 20-item Likert-type questionnaire. Semi-structured interviews were conducted with five students from each Grade 11 class at each of the 5 schools. The interviewed students (25) were selected following the stratified random sampling technique. As a group, the majority of the surveyed students (82%) were found to experience generally moderate levels of inquiry in their Grade 11 Chemistry practical investigation. The nature of student experiences of laboratory experiences was found to be associated with gender. Implications for both the theory and practice of science education are raised.

The present paper investigates expected changing teacher roles in the implementation of a refined and repackaged Natural Sciences component of the Curriculum and Assessment Policy Statement (CAPS) ...