Treatment of high-risk bleeding with susoctocog alfa in a patient with acquired haemophilia A and a nosocomial severe acute respiratory syndrome coronavirus 2 infection.

We report the case of a man in his early 70s with idiopathic acquired haemophilia A and persistent high-titre type II inhibitors on immunosuppressive treatment to eradicate the inhibitor. As complications, he had a nosocomial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which caused severe pneumonia and an explosive inflammatory reaction that required tocilizumab and remdesivir treatment, and a high-risk retroperitoneal haematoma. Recombinant porcine factor VIII, susoctocog alfa, was requested from the Pharmacy Service in view of the extreme risk of thromboembolism resulting from the concomitant inflammatory storm caused by SARS-CoV-2. Improvement in the SARS-CoV-2 infection made it possible to complete the immunosuppressive treatment with rituximab. The patient was discharged with mycophenolate mofetil as immunosuppressive treatment after 89 days in hospital and 22 days of treatment with susoctocog alfa. His SARS-CoV-2 infection resolved and the haematoma evolved favourably.

Emergency use authorization medication distribution, utilization, and monitoring in a national integrated healthcare system.

PURPOSE: The purpose of this project was to develop and optimize a dashboard and registry to manage the distribution, utilization, and monitoring of coronavirus disease 2019 (COVID-19) emergency use-authorized medications (CEUAMs). SUMMARY: CEUAMs have specific requirements that must be met for prescribing, monitoring, and compliance. When remdesivir, the first COVID-19 medication with emergency use authorization (EUA), was approved, it immediately became necessary for the Veterans Health Administration, a national integrated health system, to describe the requirements for EUA, to distribute the medication in a fair and equitable manner, and to ensure compliance with all EUA requirements. A dashboard was developed and iteratively updated as additional CEUAMs were approved. The dashboard tracked CEUAM distribution and monitoring at the national, regional, facility, and patient level. Par stock levels were initially determined at the national level. Facilities were also able to request an additional allotment of medication based on demand and allocated supplies from the Department of Health and Human Services. Providers completed a questionnaire for the CEUAM for each patient to ensure all requirements for the medication were met. If there were data integrity concerns, the entry was flagged for review at the facility level and, upon evaluation, corrections were made. CONCLUSION: Development of the dashboard was resource intensive but provided an excellent mechanism to share information among facilities and national offices. Other healthcare systems can develop similar dashboards to ensure appropriate use of CEUAMs for their patients while meeting all CEUAM requirements.

Fast one-pot microwave-assisted green synthesis of highly fluorescent plant-inspired S,N-self-doped carbon quantum dots as a sensitive probe for the antiviral drug nitazoxanide and hemoglobin

In this study, we report a one-pot, green, cost-efficient, and fast synthesis of plant-based sulfur and nitrogen self-co-doped carbon quantum dots (S,N-CQDs). By 4-min microwave treatment of onion and cabbage juices as renewable, cheap, and green carbon sources and self-passivation agents, blue emissive S,N-CQDs have been synthesized (λex/λem of 340/418 nm) with a fluorescence quantum yield of 15.2%. A full characterization of the natural biomass-derived quantum dots proved the self-doping with nitrogen and sulfur. The S,N-CQDs showed high efficiency as a fluorescence probe for sensitive determination of nitazoxanide (NTZ), that recently found wide applicability as a repurposed drug for COVID-19, over the concentration range of 0.25–50.0 μM with LOD of 0.07 μM. The nanoprobe has been successfully applied for NTZ determination in pharmaceutical samples with excellent % recovery of 98.14 ± 0.42. Furthermore, the S,N-CQDs proved excellent performance as a sensitive fluorescence nanoprobe for determination of hemoglobin (Hb) over the concentration range of 36.3–907.5 nM with a minimum detectability of 10.30 nM. The probe has been applied for the determination of Hb in blood samples showing excellent agreement with the results documented by a medical laboratory. The greenness of the developed probe has been positively investigated by different greenness metrics and software. The green character of the proposed analytical methods originates from the synthesis of S,N-CQDs from sustainable, widely available, and cheap plants via low energy/low cost microwave-assisted technique. Omission of organic solvents and harsh chemicals beside dependence on mix-and-read analytical approach corroborate the method greenness. The obtained results demonstrated the substantial potential of the synthesized green, safe, cheap, and sustainable S,N-CQDs for pharmaceutical and biological applications. © 2022 Elsevier B.V.

Seasonal variation and ecological risk assessment of Pharmaceuticals and Personal Care Products (PPCPs) in a typical semi-enclosed bay — The Bohai Bay in northern China

The Bohai Bay as a typical semi-enclosed bay in northern China with poor water exchange capacity and significant coastal urbanization, is greatly influenced by land-based inputs and human activities. As a class of pseudo-persistent organic pollutants, the spatial and temporal distribution of Pharmaceuticals and Personal Care Products (PPCPs) is particularly important to the ecological environment, and it will be imperfect to assess the ecological risk of PPCPs for the lack of systematic investigation of their distribution in different season. 14 typical PPCPs were selected to analyze the spatial and temporal distribution in the Bohai Bay by combining online solid-phase extraction (SPE) and HPLC-MS/MS techniques in this study, and their ecological risks to aquatic organisms were assessed by risk quotients (RQs) and concentration addition (CA) model. It was found that PPCPs widely presented in the Bohai Bay with significant differences of spatial and seasonal distribution. The concentrations of ∑PPCPs were higher in autumn than in summer. The distribution of individual pollutants also showed significant seasonal differences. The high values were mainly distributed in estuaries and near-shore outfalls. Mariculture activities in the northern part of the Bohai Bay made a greater contribution to the input of PPCPs. Caffeine, florfenicol, enrofloxacin and norfloxacin were the main pollutants in the Bohai Bay, with detection frequencies exceeding 80 %. The ecological risk of PPCPs to algae was significantly higher than that to invertebrates and fish. CA model indicated that the potential mixture risk of total PPCPs was not negligible, with 34 % and 88 % of stations having mixture risk in summer and autumn, respectively. The temporary stagnation of productive life caused by Covid-19 weakened the input of PPCPs to the Bohai Bay, reducing the cumulative effects of the pollutants. This study was the first full-coverage investigation of PPCPs in the Bohai Bay for different seasons, providing an important basis for the ecological risk assessment and pollution prevention of PPCPs in the bay. © 2022 Elsevier B.V.

Telefarmacia y atención farmacéutica: Una revisión narrativa de la Federación Internacional Farmacéutica

Digital transformation impacts health care through technology. Telepharmacy is set to become one of the most important aspects of Telemedicine in the years to come with its ability to provide patients with increased and more timely access to pharmaceutical care, reduced costs for individuals and health systems, improved patient satisfaction, experience and convenience, and better health outcomes. Telepharmacy has gained increasing importance in the delivery of pharmaceutical care, largely due to the COVID-19 pandemic which has placed enormous pressures on healthcare systems globally. There is a significant amount of published literature from different countries around the world that provide examples of Telepharmacy. There are some innovative models of Telepharmacy services aimed at optimizing and improving access to pharmaceutical care, resulting in improved patient safety and outcomes. The benefits of Telepharmacy include increased value for pharmacies and pharmacists and adapting to patients´ needs, enhanced interprofessional care and increased efficiency of health systems and increased provision of patient- centred services, among others. However, despite these benefits, major barriers for implementation of Telepharmacy remain such as patient confidentiality and privacy of health information. These barriers to the implementation of Telepharmacy have been identified and can be divided into four different environments: technological, organizational, human and economic. Delivering pharmaceutical care and services through digital media is identified as a key priority for the International Pharmaceutical Federation. Digital health is one of the 21 Development Goals launched by International Pharmaceutical Federation in 2020. The International Pharmaceutical Federation Digital Health in Pharmacy Education report in 2021, describes the readiness, adaptability and responsiveness of pharmacy education and knowledge and skill needs of pharmaceutical workforce on digital health. Amongst other digital health tools, telehealth/Telepharmacy has been reported as one of the most preferred tools to teach and learn about by respondents. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved. La tecnología surgida de la transformación digital ha traído consigo cambios en la asistencia sanitaria. En los próximos años, la Telefarmacia previsiblemente se convertirá en uno de los aspectos más importantes de la Telemedicina, ya que ofrece a los pacientes un acceso más inmediato a la atención farmacéutica, supone una reducción de costes tanto para los pacientes como para los sistemas sanitarios, y deriva en una mayor satisfacción, experiencia y comodidad de los pacientes, mejorando así los resultados clínicos. Debido en gran medida a la pandemia de COVID‑19, la Telefarmacia ha adquirido gran importancia en el ámbito de la atención farmacéutica, ya que esta crisis ha provocado una enorme presión sobre los sistemas sanitarios de todo el mundo. Se pueden encontrar multitud de experiencias publicadas en la literatura científica sobre modelos de Telefarmacia en diferentes países del mundo. Existen algunos modelos innovadores de servicios de Telefarmacia orientados a optimizar y mejorar el acceso a la atención farmacéutica, lo que se traduce en una mejora de la seguridad y los resultados de los pacientes. Entre las ventajas de la Telefarmacia se incluye el aumento del valor para las farmacias y los farmacéuticos y la adaptación a las necesidades de los pacientes, la mejora de la atención interprofesional, el aumento de la eficiencia de los sistemas sanitarios y la mayor prestación de servicios centrados en el paciente, entre otras. Sin embargo, a pesar de presentar múltiples ventajas, siguen existiendo importantes barreras para la implantación de la Telefarmacia, como la confidencialidad del paciente y la privacidad de la información clínica. Estas barreras para la implantación de la Telefarmacia pueden dividirse en cuatro ámbitos: tecnoló ico, organizativo, humano y económico. La prestación de atención y servicios farmacéuticos a través de medios digitales es una prioridad clave de la Federación Internacional Farmacéutica. La salud digital es uno de los 21 Objetivos de Desarrollo lanzados por la Federación Internacional Farmacéutica en 2020. El informe de la Federación Internacional Farmacéutica sobre salud digital en la formación farmacéutica en 2021 describe la preparación, adaptabilidad y capacidad de respuesta de la formación farmacéutica y las necesidades de conocimientos y habilidades de los farmacéuticos sobre la salud digital. Entre otras herramientas de salud digital, la Telemedicina/Telefarmacia ha sido señalada como una de las herramientas preferidas por los encuestados para formar y aprender.

An internet-based cross-sectional study on infection control practices and drug use for COVID-19 prevention in Nigerian adults.

Introduction: COVID-19 has affected several millions of people globally and various means have been employed to curb the spread. This nationwide survey investigated adherence to infection control protocols and drug uptake among Nigerian adults. Methods: this was a descriptive cross-sectional survey using an internet-based questionnaire to investigate adherence to infection control practices and drug use among adults, who have been resident in Nigeria for at least 6 months. The data was analyzed using Stata software version 16 with levels of significance at p<0.05. Results: a total of 1235 adults participated in the study. The respondents were aged 18-78 years with a mean age of 36.3 ±11.1 years. Over half (53.0%) of the participants were between 31-50 years. The male to female ratio was 1: 1.45. Majority (92.6%) had a minimum of tertiary educational qualification. One hundred (27.1%) reported a positive test result for COVID-19. A total of 1,204 (97.5%) admitted to wearing of face masks, 1,125 (91.1%) washed hands regularly, 1,142 (92.5%) used hand sanitizers while physical distancing was maintained in 985 (79.8%). A total of 854 (69.2%) were on at least a drug or herbal based therapy. Herbal based remedies were used in 112 (9.1%), supplements in 763 (61.8%), antibiotics in 210 (17%), ivermectin in 205 (16.6%), and antimalarials in 128 (10.4%) participants. Conclusion: adherence to behavioural measures was high among the population, with widespread uptake of supplements, antibiotics, and antimalarial drugs. The high uptake of antibiotics emphasizes the need to step up regulatory policies for antibiotic use.

A Malawian pharmaceutical response to the COVID-19 Pandemic

AJOL : The COVID-19 pandemic has elicited swift and innovative responses due to the severity of the outbreak. Higher education institutions worldwide with pharmacy programs have identified vital gaps in COVID-19 care and has undertaken proactive steps to aid in the fight against the coronavirus. In Malawi, the Kamuzu University of Health Science's Department of Pharmacy initiated the production of a modified formulation of the World Health Organization's (WHO) recommended hand sanitizer. This manufacturing venture involved mobilizing the pharmacy faculty, identifying gaps in supplies and equipment, and utilizing evidenced-based information to create a high-quality sanitation product, which passed the requirements as tested by the Malawi Bureau of Standards. The department of pharmacy is expanding their distribution of the product to meet the needs of frontline healthcare workers and vulnerable populations. With historical issues of accessing care in Malawi and with COVID-19's spread among healthcare workers, this hand sanitizer venture is vital in the public healthcare's system response. The department of pharmacy will continue to lead the pharmacy profession in Malawi to provide targeted interventions in this unprecedented time

A Malawian pharmaceutical response to the COVID-19 Pandemic.

The COVID-19 pandemic has elicited swift and innovative responses due to the severity of the outbreak. Higher education institutions worldwide with pharmacy programs have identified vital gaps in COVID-19 care and has undertaken proactive steps to aid in the fight against the coronavirus. In Malawi, the Kamuzu University of Health Science's Department of Pharmacy initiated the production of a modified formulation of the World Health Organization's (WHO) recommended hand sanitizer. This manufacturing venture involved mobilizing the pharmacy faculty, identifying gaps in supplies and equipment, and utilizing evidenced-based information to create a high-quality sanitation product, which passed the requirements as tested by the Malawi Bureau of Standards. The department of pharmacy is expanding their distribution of the product to meet the needs of frontline healthcare workers and vulnerable populations. With historical issues of accessing care in Malawi and with COVID-19's spread among healthcare workers, this hand sanitizer venture is vital in the public healthcare's system response. The department of pharmacy will continue to lead the pharmacy profession in Malawi to provide targeted interventions in this unprecedented time.

Neuropsychiatric drugs against COVID-19: What is the clinical evidence?

Since the beginning of the coronavirus disease (COVID)-19 pandemic, the need for effective treatments for COVID-19 led to the idea of "repurposing" drugs for antiviral treatment. Several antipsychotics and antidepressants have been tested for in vitro activity against the severe acute respiratory syndrome coronavirus 2. Chlorpromazine, other phenothiazine antipsychotics, and the antidepressant fluoxetine were found to be rather potent in these studies. However, whether effective plasma concentrations can be obtained with clinically accepted doses of these drugs is not clear. Data of COVID-19 patients are not yet available but several clinical studies are currently underway. The specific serotonin reuptake inhibitor fluvoxamine is a potent Sigma-1 receptor agonist and reduces inflammation in animal models of cytokine-stress. Accordingly, fluvoxamine treatment was superior to placebo in reducing impaired respiratory function and other symptoms of inflammation in COVID-19 patients in a placebo-controlled clinical study and another open clinical trial. The beneficial effects of fluvoxamine on the course of COVID-19 were recently confirmed in a large placebo-controlled double-blind trial with several hundred patients. Inflammation represents a major risk factor for many psychiatric disorders which explains the high susceptibilitiy of COVID- 19 patients for psychiatric diseases. Many antidepressants and antipsychotics possess anti-inflammatory properties independent of sigma-1 activity which might be important to reduce psychiatric symptoms of COVID-19 patients and to improve respiratory dysfunction and other consequences of inflammation. This might explain the rather unspecific benefit which has been reported for several cohorts of COVID-19 patients treated with different psychotropic drugs. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Implementation of a novel home delivery service during pandemic.

INTRODUCTION: During the COVID-19 pandemic, measures have been put in place to adapt to patients' needs during home quarantine, such as "telehealthcare". With this service, hospital pharmacists develop a distinct role via the implementation of pharmacovigilance services and pharmaceutical care plans for patients with comorbidities, and for special populations as immunosuppressed patients.MethodsCross-sectional study involving hospital and community pharmacists actively practising during the COVID-19 pandemic. Patients who could not come to the hospital pharmacy department were provided with a delivery service to the community pharmacy of their choice. RESULTS: A total of 1186 patients requested this service. Erythropoiesis-stimulating agents were the most in-demand medication, followed by rheumatoid arthritis and antiretroviral drugs. 125 patients responded to the telephone survey, most of whom stated that they would use the delivery service again, and expressed their desire to continue doing so. DISCUSSION: Without a doubt, telepharmacy and medication delivery services have provided multiple benefits during home quarantine. The delivery service enabled us to provide drugs to patients in their immediate environment through a service that was free for both the patient and the hospital pharmacy service. However, at present, the available evidence of the impact of telepharmacy models is sparse. CONCLUSIONS: This medication delivery service has provided multiple benefits to patients during home quarantine. Although the users of this service seem to be satisfied with the current model, in the future, we should consider which patients would benefit most from this service and shape it to individual needs.

Pharmaceutical Approaches on Antimicrobial Resistance: Prospects and Challenges.

The rapid increase in pathogenic microorganisms with antimicrobial resistant profiles has become a significant public health problem globally. The management of this issue using conventional antimicrobial preparations frequently results in an increase in pathogen resistance and a shortage of effective antimicrobials for future use against the same pathogens. In this review, we discuss the emergence of AMR and argue for the importance of addressing this issue by discovering novel synthetic or naturally occurring antibacterial compounds and providing insights into the application of various drug delivery approaches, delivered through numerous routes, in comparison with conventional delivery systems. In addition, we discuss the effectiveness of these delivery systems in different types of infectious diseases associated with antimicrobial resistance. Finally, future considerations in the development of highly effective antimicrobial delivery systems to combat antimicrobial resistance are presented.

Medication of Hydroxychloroquine, Remdesivir and Convalescent Plasma during the COVID-19 Pandemic in Germany-An Ethical Analysis.

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions.

Observational study on off-label use of tocilizumab in patients with severe COVID-19.

BACKGROUND: In December 2019 a novel coronavirus designated SARS-CoV-2 was identified, and the disease COVID-19 has caused many deaths. SARS-CoV-2 infection has been associated with the development of cytokine storm (including interleukin 6 (IL-6)), which can cause lung damage and lack of oxygen. Tocilizumab (TCZ) inhibits ligand binding to the IL-6 receptor and may be a potential treatment for the hyperinflammation symptoms of COVID-19. However, data regarding the efficacy of TCZ in COVID-19 are lacking. The rapid spread of the pandemic in France, especially in the Paris region, constrained us to the off-label use of TCZ in patients with severe clinical conditions. METHODS: A single-centre observational cohort study of 44 patients infected with COVID-19 was carried out between 6 April and 21 April 2020 in Groupe Hospitalier Intercommunal Le Raincy-Montfermeil (GHILRM). Twenty-two patients diagnosed with COVID-19 were treated with TCZ and were compared with 22 patients not treated with TCZ matched for age, gender and length of hospital stay for COVID-19. Respiratory rate and oxygen supplementation as well as laboratory parameters (such as C-reactive protein (CRP), aspartate aminotransferase and alanine aminotransferase) were collected at baseline and during 14 days of follow-up. Our primary objective was to assess the efficacy of TCZ on respiratory clinical conditions. FINDINGS: The average respiratory rate was lower in the TCZ group than in the control group (21.5 vs 25.5 breaths/min at day 14, 95% CI -7.5 to -0.4; p=0.03). Treated patients tended to be intubated less during the course of the disease (2/22 vs 6/22, 95% CI -0.4 to 0.1; p=0.12). In each group, 10 patients no longer required oxygen therapy. We found a significant decrease in CRP in treated patients on day 7 (p=0.04). TCZ caused cytolysis in more than half (14/22) of the patients but without clinical impact. INTERPRETATION: There was a significant difference in the respiratory rate on day 14 of follow-up, with a greater decrease observed in the treated group. Fewer patients required mechanical ventilation in the TCZ group, especially among patients with more extensive CT lung damage, than in the control group. The same number of patients were weaned off oxygen on day 14 in the two groups, while the patients in the TCZ group had more severe impairment at inclusion. We consider that TCZ showed significant control of the biological inflammatory syndrome, suggesting that it may limit the effect of the cytokine storm. Our study seems to indicate the efficacy of TCZ, particularly in patients with severe initial pulmonary impairment. Selecting the best candidates and the best timing for TCZ therapy needs to be determined in randomised clinical trials.