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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.

In this qualitative study, the researchers explored the ways in which 21st-century skills (specifically communication and critical thinking) are enhanced by Grade 10 beginner Physical Sciences teachers while teaching Particulate Nature of Matter (PNM) through the implementation of problem-based learning (PBL). The study was conducted in one of the four educational districts of the North West province, South Africa. The district was selected due to its geographical proximity and accessibility to the researchers. Two participants were purposively selected from two rural government secondary schools. Research instruments for the study comprised an open-ended questionnaire and a reflective portfolio. The data were analyzed manually using Saldana’s model and Smith et al.’s assessment rubric. The findings show that PBL enhances communication and critical thinking skills. It is recommended that a teacher professional development (TPD) training program be presented for beginner Physical Sciences teachers which targets the formulation of PBL problems, the promotion of 21st-century skills (communication and critical thinking), and the implementation of PBL in other topics in Chemistry.

This study aimed to perform histological, immunohistochemical, biomechanical, and wettability assessments of leukocyte- and platelet-rich fibrin (L-PRF) membranes obtained from the blood of healthy dogs. Ten client-owned Labrador Retriever dogs were enrolled. Blood samples were obtained from the external jugular vein using a vacuum tube without anticoagulant, which was immediately centrifuged at 400 g for 12 min in a dedicated centrifuge. The L-PRF clot was removed from the tube, and the red clot was released from the buffy coat using a spatula. The membrane was produced using a PRF box. Histological examination identified the three portions of the L-PRF membranes. The first portion was composed mainly of red blood cells with the presence of a low number of leukocytes among them. The second portion was composed of white blood cells, mainly neutrophils. The third portion was composed of the fibrin network which was characterized by acidophilic staining. The immunohistochemical analysis showed that vascular endothelial growth factor and platelet-derived growth factor were expressed in all samples at different intensities, both in cellular components and fibrin mesh. The tensile test and wettability assessments were measured in membranes 30 min and 3 h after production. The 30 min L-PRF membranes supported twice the ultimate tensile strength compared to 3 h L-PRF membranes. The wettability of the 30 min sample membranes was statistically higher than the 3 h sample membranes. In conclusion, the centrifugation protocol allowed production of the L-PRF membrane using canine blood and this was confirmed by histological and immunohistochemical analysis. The mechanical resistance and wettability of the L-PRF membrane were significantly reduced over time.

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.

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

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The chapter addresses one of the burning issues in science teacher education. We argue that by making science more compelling and relevant for learners, we might see improved performance. In this regard, indigenous knowledge could serve as an entry point into the abstract world of science. However, indigenous knowledge is generally not considered when developing science curricula. In an era in which the decolonisation of the curriculum is widely debated, it is important to consider how indigenous knowledge could be incorporated into science teacher education programmes. The epistemological border-crossing between western science and indigenous knowledge asks for a nuanced understanding of their shared tenets and differences. We advocate for such an understanding in this chapter. To that end, we examined short learning courses that used an inquiry-learning approach to teaching, which incorporated indigenous knowledge and which scaffolded teachers’ learning across the ‘zone of proximal teacher development’. Our findings lead us to make suggestions for pre-service science teacher education.

In addressing the relevancy of education for the 21st-century context, Zimbabwe had to establish a curriculum where learners develop an understanding of a new set of competences which goes beyond basic knowledge and skills. Today’s citizens require a new set of competences and conceptual understanding of complex concepts, need to develop communication skills and collaborate creatively to produce new ideas, new products and new knowledge, while developing a critical mind in order to face the challenging world. Inquiry-based science education becomes the basis for incorporation of this new set of competencies in Zimbabwean schools. The Zimbabwe science curriculum stipulates that inquiry skills are learned through practical work where learners apply and hence understand scientific concepts. As such, learners should employ scientific skills in solving real-life problems. This chapter aims to determine the nature and level of inquiry-based science education in Zimbabwean schools. The chapter describes inquiry-based practices that are encapsulated in the Zimbabwean science curriculum; analyses the relationship between the prescribed curriculum inquiry-based practices and the examination frameworks; evaluates the extent of learner preparation and performance in practical assessments; discusses teacher professional development for implementing inquiry-based science teaching; explores the use of technology in the teaching of practical work; and identifies challenges and problems in the implementation of inquiry-based practices. Finally, implications and recommendations are made for teacher professional development in scientific inquiry-based teaching.

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.