Background and Objective: In order to meet the safety challenges arising from the contamination events of the 1970s and 1980s, a multi-layer safety approach was established to reduce and prevent the risk of pathogen transmission via plasma-derived medicinal products (PDMPs). This safety framework, often referred to as the safety tripod, integrates three complementary pillars: donor screening, testing, and pathogen reduction during manufacturing. Over the years, each pillar has evolved in light of changing scientific knowledge. Donor selection and increasingly sensitive testing methods have reduced the risk of potentially contaminated plasma entering the manufacture pools, while the use of validated pathogen reduction steps during manufacturing provide protection against both the known and emerging pathogens. Considering the challenges posed by the recent outbreaks, a review of safety strategies used for various PDMPs and the latest evidence on the effectiveness of safety strategies is needed for future considerations. The objective of this review was to provide an overview of the historical development and current state of the safety measures used in PDMP manufacturing. Methods: A literature search was conducted using PubMed and Google Scholar for English-language publications from 1990 to September 2025. For the construction of the historical timeline of events, publications were initially identified by author T.S. through his professional expertise in the PDMP industry and were further supplemented with a separate search of literature from 1940 to 1995. Key Content and Findings: In light of the continued evolution of each pillar, pharmacovigilance data and published literature point towards continued safety of PDMPs against known and emerging pathogens. Conclusions: While the theoretical risk of infection remains, continuous surveillance of emerging pathogens, innovation, and periodic evaluation of each element of the safety tripod based on new scientific evidence remain essential in maintaining and advancing PDMP safety.

Background: Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by isolated thrombocytopenia, most commonly mediated by pathogenic immunoglobulin G (IgG) autoantibodies. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with incompletely understood etiology, in which immune dysregulation has been implicated. Efgartigimod, the neonatal Fc receptor (FcRn) inhibitor approved for chronic/persistent ITP, accelerates IgG degradation by blocking IgG recycling via FcRn. We describe a patient with ITP and comorbid ALS in whom FcRn inhibition was temporally associated with transient improvement in both conditions. Case Description: A 66-year-old Japanese man with ALS diagnosed in March 2023 developed severe thrombocytopenia in September 2024, with a platelet count of 1.0×109/L and an elevated immature platelet fraction (18.1%). After differential diagnosis, ITP was diagnosed. Prednisolone and eltrombopag were ineffective. Intravenous efgartigimod (10 mg/kg) was initiated in October 2024 (day 0), resulting in a prompt platelet increase. Total IgG decreased from 1,643 to 858 mg/dL, and platelet-associated IgG normalized. During efgartigimod therapy, the revised ALS Functional Rating Scale (ALSFRS-R) score showed a subtle increase from 40 to 41 in January 2025 (day 83). After nine doses, efgartigimod was discontinued in January 2025 (day 91) and romiplostim was titrated with the goal of treatment cessation, but platelet counts remained unstable without remission. Unexpectedly, vital capacity increased from 81% to 93.9% in February 2025 (day 109). Thereafter ALS progressed and frequent clinic visits became difficult, romiplostim was replaced with eltrombopag and fostamatinib was added in June 2025 (day 238), resulting in stable platelet counts. In December 2025 (day 422, eleven months after efgartigimod discontinuation) total IgG increased to 1,499 mg/dL; platelet-associated IgG remained normal, however, ALSFRS-R declined to 31 and gastrostomy was required. Conclusions: This case documents concurrent ITP and ALS with transient improvement in platelet counts and ALS functional measures during FcRn inhibition with efgartigimod, followed by deterioration after discontinuation. Although causality cannot be inferred from a single case and neurologic changes may be coincidental, the temporal association raises the possibility that IgG-mediated immune mechanisms contribute to disease activity in a subset of ALS patients with autoimmune comorbidities. Further clinical and translational studies are warranted.

Background and Objective: The European Society for Medical Oncology has defined the term “end-of-life” in their clinical practice guideline as care for people with advanced disease once they have reached a point of rapid physical decline, typically the last few weeks or months before and inevitable death as a natural result of a disease. End-of-life care is often delivered at home, hospital, or in hospice facilities, while palliative care can be provided in various settings. Blood transfusions provide symptomatic relief and improve subjective well-being of end-of-life or hospice care patients. The objective of this study was to narrate the accessibility of transfusion facilities, different guidelines, and policy issues in ‘end-of-life’ patients. Methods: We performed literature search on “PubMed” and “Google Scholar” within 1994–2024 using search terms “blood transfusion” OR “blood product” AND “end-of-life” OR “terminal illness” OR “palliative” OR “advanced diseases” OR “hospice care” OR “terminal care”, “actively dying”. A narrative review is conducted to assess the potential benefits of transfusion in end-of-life care patients in comparison to adverse outcomes, associated guidelines for end-of-life transfusion, potential barriers to these services and to resolve myths associated in this service pathway. Key Content and Findings: Patients having hematological or non-hematological malignancies and suffering from anemia or thrombocytopenia, and other transfusion-dependent chronic conditions like hemoglobinopathies are important candidates for end-of-life transfusion support. The potential barriers for end-of-life blood transfusion have been identified as reimbursement issues, lack of knowledge of physicians, unavailable round the clock facilities, and to some extent transportation issues. Administration of treatment in home environment is evolving over the last few decades to decrease hospital-acquired infection risks and substantial reduction of medical costs and it is a potentially feasible option. Conclusions: Home transfusion, also called out-of-hospital transfusion is a great alternative for transfusion dependent chronically ill patients for whom it is difficult to receive blood transfusion in traditional hospital setting. However, further research is needed to establish the effectiveness of end-of-life transfusion, resolve certain ethical queries like appropriate usage of blood products, as well as organizational and economic issues.

Background and Objective: Patient blood management (PBM) requires translating complex medical data into understandable and actionable information for diverse audiences and stakeholders. The utilization of storytelling in PBM, permits information delivery that is effective, persuasive and motivating by presenting logical data, establishing trust and authority, and engaging the audience’s emotions. This approach may enhance the effectiveness of communication strategies in PBM, leading to better understanding and to ultimately help facilitate uncomplicated program implementation. As there is no available literature that discusses the role of storytelling in PBM, this manuscript aims to review the current strategies for effective storytelling in PBM. Methods: A thorough literature search was performed (PubMed, Google Scholar, and CINAHL) limited to English language and the last 10 years (Feb 2014 to Feb 2024) with keywords including patient blood management, PBM education, metrics, benchmarking, program development, and other related terms. The initial literature search using only the terms PBM and “storytelling” did not yield any results. Knowledge gaps were identified, and a narrative review structure was prepared. Key Content and Findings: The manuscript discusses how one can leverage academic literature, social media, educational tools, and surveys, to enhance the communication of PBM strategies. Additionally, the paper addresses the challenges of implementing storytelling in PBM, such as maintaining clarity and relevance about the meaning of PBM, across different audiences (clinicians and patients), and the need for a unified language that enhances the adoption of PBM best practices. Conclusions: Integrating storytelling with robust data presentation and analysis facilitates better understanding and drives meaningful changes in patient care and safety.

Background and Objective: Daratumumab, a novel anti-CD38 monoclonal antibody therapy approved for multiple myeloma, has seen increased use in the treatment of non-neoplastic conditions. This literature review summarizes the published experience with daratumumab in non-neoplastic immunologic disorders. Methods: A literature search was conducted in PubMed utilizing the following MESH terms: (Daratumumab) AND (immune) with added restrictions of humans, English language, and date range January 1, 2015 to November 1, 2023. Articles were first screened by title and abstract. Preclinical animal studies, in vitro experiments, reviews, or reports with non-immunologic use intention were excluded. Instances of uncertainty were resolved through full manuscript review and discussion between authors. Extracted datapoints included indication, prior lines of treatment, days to initiation of daratumumab, its dose and route, and response to daratumumab. Patient demographics and infusion reactions to daratumumab were recorded if available. Extracted data were analyzed according to diagnostic group (wherever 3 or more individuals had the same daratumumab use indication) and utilizing descriptive statistics. Nonparametric data are presented as medians with interquartile ranges. Key Content and Findings: The literature search yielded 192 articles for consideration. Following review, 50 reports, encompassing 99 patients met inclusion criteria. Daratumumab was most used in the following conditions: post-transplant autoimmune hemolytic anemia (22, 22%), post-transplant pure red cell aplasia (11, 11%), post-transplant autoimmune cytopenias (9, 9%), thrombotic thrombocytopenic purpura (9, 9%), systemic lupus erythematosus (8, 8%), immune thrombocytopenia (7, 7%), autoimmune encephalitis (6, 6%), and organ transplant rejection (5, 5%). Prior to daratumumab, patients received a median of 4 lines [interquartile range (IQR), 2 to 5 lines] of therapy. Complete and partial responses were reported in 58% and 31% of cases, respectively. Median time to response with daratumumab was 28 days (IQR, 14 to 61 days), and responses were durable (median 270 days; IQR, 123 to 365 days). Mild infusion reactions occurred in 11 cases (11%). No severe allergic reactions or deaths due to daratumumab were reported. Conclusions: Our comprehensive review highlights the efficacy, durability of response, and safety of daratumumab in several refractory non-neoplastic conditions. Future investigation may define a role for daratumumab earlier in the treatment hierarchy for select antibody-mediated disorders.