Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications

5588995 COMPARATIVE EFFICACY AND SAFETY OF PHARMACOLOGICAL INTERVENTIONS FOR SICKLE CELL DISEASE IN CHILDREN AND ADOLESCENTS: A NETWORK META-ANALYSIS

Background: Sickle cell disease (SCD), an inherited hemoglobinopathy characterized by anemia, severe pain, acute chest syndrome (ACS), and vaso-occlusive crisis (VOC), has an important impact on morbidity and mortality worldwide, especially in the pediatric population (over 50% die before age of 5). Although few treatment options are available, new disease-modifying therapies, intended to prevent or reduce SCD-related complications are under development. Previous systematic reviews are limited to adult patients or focused only on gathering data on a few therapies. Aims: Our aim was to synthetize the evidence on the efficacy and safety profiles of pharmacological interventions for managing SCD in children and adolescents. Methods: A systematic review with searches in PubMed, Scopus, and Web of Science was performed (May-2022). The protocol is registered at PROSPERO CRD42022328471. We included randomized controlled trials comparing any disease-modifying agent used to treat SCD complications in patients under 18 years old. The outcomes of interest included: VOC, ACS, transfusions, hospital admission, discontinuation, and serious adverse events. Data were pooled by means of Bayesian network meta-analyses with the surface under the cumulative ranking curve analyses (SUCRA). Results were reported as odds ratio (OR) with 95% credibility intervals (CrI). Additionally, stochastic multicriteria acceptability analyses (SMAA) were performed. The methodological quality of the trials and certainty of evidence were evaluated through RoB 2.0 tool and the GRADE approach, respectively. Results: Overall, 17 randomized controlled trials (n=1,972 patients) published between 1982-2022, conducted mostly in Africa (41%) and North America (35%) were included for analyses. Around one-third of the trials were restricted to homozygous patients for the SCD allele (SS HMZ); yet when reported, patients with heterozygous S-C combination represented less than 30% of the population. Males accounted for 49.0% of the cases, with ages varying from 1 to 19 years old. Almost all trials (n=15, 88.2%) directly compared active drugs with placebo. The evaluated interventions were: hydroxyurea [n=6 trials], L-arginine [n=3], antiplatelets [n=2], immunotherapy/monoclonal antibodies [n=2], sulfates [n=2], docosahexaenoic acid [n=1], niprisan [n=1] (Figure 1). SUCRA and SMAA revealed that immunotherapy/monoclonal antibodies and hydroxyurea 20 mg/kg are potentially more effective against ACS (17% and 24% probabilities, respectively), VOC (around 29% and 20%, respectively) and needing of transfusions (around 25%), while L-arginine (100-200 mg/kg) and placebo were more associated with these events. Although therapies were overall considered safe, antiplatelet and sulfates may lead to more discontinuations and severe adverse events (uncertainty evidence). Results were similar between age subgroups (<10 years vs. 10-19 years). Summary - Conclusion: The available evidence on the effect of drugs on managing SCD in children and adolescents is still insufficient and weak. No clear definition and reporting criteria for some outcomes exist. Hydroxyurea 20 mg/kg/day may remain the standard of care for these patients, however, long-term, well-designed trials comparing new immunotherapy/monoclonal antibodies should be performed. The use of monotherapies with L-arginine, antiplatelets, or sulfates should be avoided given the poor benefit-risk ratio for this population.info:eu-repo/semantics/publishedVersio

Óxidos de ferro em latossolos tropicais e subtropicais brasileiros em plantio direto Iron oxides in tropical and subtropical Brazilian oxisols under long-term no-tillage

O sistema plantio direto (SPD) altera a taxa dos processos que ocorrem no solo, porém pouco se conhece sobre sua influência na mineralogia de solos tropicais e subtropicais. Este estudo teve por objetivo avaliar o efeito do SPD na mineralogia dos óxidos de Fe pedogênicos e sua relação com a matéria orgânica do solo (MOS). Amostras de solos foram coletadas em 14 profundidades da camada superficial (0 a 0,20 m) de dois Latossolos sob SPD e sistema de preparo convencional (SPC), em áreas experimentais de longa duração, no sul do Brasil (Santo Ângelo, RS) e na região do Cerrado (Dourados, MS). A identificação mineralógica foi realizada por difração de raios X (DRX), sendo determinados os teores de Fe extraídos por DCB (Fed) e por oxalato de amônio (Feo) e os teores de carbono orgânico total (COT). Nos dois solos predominaram os minerais caulinita e hematita, e o SPD não afetou os teores médios de Fed, Feo, COT e a razão Feo/Fed na camada de 0-0,20 m, em comparação ao solo em SPC. Entretanto, no Latossolo subtropical (LVdf-1), com boa distribuição de chuvas durante o ano e temperaturas mais amenas, houve aumento dos teores de COT e da fração humina na camada superficial do solo (0-0,03 m) sob SPD. Ademais, essas variáveis apresentaram relação positiva com os teores de Feo e razão Feo/Fed. Contrariamente, no Latossolo tropical (LVdf-2), com concentração das chuvas no verão (outubro a março), não houve efeito do SPD na distribuição do COT e das frações húmicas no solo. Neste solo, os teores de Feo e da razão Feo/Fed apresentaram relação positiva com a profundidade do solo e negativa com os teores de COT e da fração humina. Provavelmente esses resultados são conseqüência do reordenamento dos óxidos de Fe, possivelmente a partir da dissolução redutiva da hematita e da maghemita nas camadas mais superficiais e da neoformação de óxidos de Fe de baixa cristalinidade nas camadas mais profundas.<br>The no-tillage system (NT) affects the rate of soil processes, but little is known about its effect on the mineralogy of tropical and subtropical soils. This study aimed to evaluate the long-term effect of NT system on pedogenetic iron oxides and their relationship with soil organic matter (SOM) fractions. Soil samples were taken at 14 depths within the top 0,20 m soil layer from two clayey Oxisols under NT and conventional tillage (CT) systems of the experimental areas located near the counties of Santo Ângelo (RS State, Southern Brazil) and Dourados (MS State, Center-Western Brazil). The soil mineralogy was analyzed by X ray diffraction, and the contents of sodium dithionite-citrate-bicarbonate (Fed), ammonium oxalate (Feo) iron oxides, total organic carbon (TOC), and humic fractions were evaluated. Kaolinite and hematite were the predominant minerals in both soils, and the NT system had not effect on the mean concentration of Fed, Feo, TOC and the Feo/Fed ratio in the 0-0.20 m soil layer, in comparison with CT soil. However, in the soil in southern Brazil, under well-distributed annual rainfall and cooler temperatures in the winter, the TOC content and humine fraction in the surface layer (0-0.03 m) of NT soil were higher. These variables were also closely related with the Feo contents and Feo/Fed ratio. On the contrary, in the Oxisol under tropical conditions, with rainfall concentrated from October to March, no effect of the tillage system was observed on TOC and humic fractions of SOM contents. In this soil, the Feo content and Feo/Fed ratio were positively related to soil depth and negatively to TOC and humine contents. These results probably are a consequence of iron oxide rearrangements, possibly through the reductive dissolution of hematite and maghmite from soil surface layer, and neo-genesis of low crystalline iron oxides in the deeper soil layers