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

Abstract 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.

Cost-utility analysis of interferon-free treatments for patients with early-stage genotype 1 hepatitis C virus in Brazil

Abstract INTRODUCTION We conducted a cost-utility analysis of available interferon-free treatments for patients with early-stage genotype 1 chronic hepatitis C based on a Brazilian public health system perspective. METHODS A Markov model was derived using a cohort of stage F0-F2 patients treated as recommended by the Brazilian national guidelines. RESULTS: Glecaprevir plus pibrentasvir was superior to all other treatments, followed by sofosbuvir plus velpatasvir. Sofosbuvir plus daclatasvir was identified as the least cost-effective option. CONCLUSIONS: The above findings were confirmed via probabilistic sensitivity analysis and the tested scenarios.

Effect of different interval training protocols on adiposity indicators in overweight-obese children and adolescents: a systematic review and meta-analysis / Efeito de diferentes protocolos de treinamento intervalado sobre indicadores de adiposidade em crianças e adolescentes com sobrepeso e obesidade: uma revisão sistemática e metanálise

ABSTRACT The present meta-analysis verified the impact of different protocols of high-intensity interval training (HIIT) on indicators of adiposity in overweight and obese children and adolescents. Searches were performed in the databases: PubMed, ScienceDirect, SPORTDiscus, LILACS and SciELO. Were included studies without caloric restriction that aimed to verify the effect of HIIT interventions on the adiposity indicators in overweight children and adolescents published until December 2018. The PEDro scale was used to assess the risk of bias. The meta-analysis was conducted in the Revman software using standardized mean difference (SMD) data and 95% confidence intervals (CI). Seventeen studies were selected, which involved 289 children and adolescents with overweight and obesity. HIIT interventions (mean=11.7±5.9 weeks) produced significant decreases in body fat percentage (SMD=-0.65; CI=-1.07, -0.23) and waist circumference (SMD=-0.34; CI=-0.49, -0.18). Also, major relative risk of decrease in body fat percentage were observed in favour to protocols with work/recovery interval ratios of 1:1 and 2:1. HIIT protocols with ratios (work/recovery intervals) 1:1 and 2:1 promote significant reductions in fat percentage and waist circumference in overweight and obese children, independently of the total work time.

RESUMO A presente meta-análise verificou o impacto de diferentes protocolos de treinamento intervalado de alta intensidade (HIIT) sobre indicadores de adiposidade em crianças e adolescentes com sobrepeso e obesidade. As buscas foram realizadas nas bases de dados: PubMed, ScienceDirect, SPORTDiscus, LILACS e SciELO. Foram incluídos estudos sem restrição calórica, que objetivaram verificar o efeito das intervenções do HIIT nos indicadores de adiposidade em crianças e adolescentes acima do peso publicados até dezembro de 2018. A escala PEDro foi utilizada para avaliar o risco de viés. A meta-análise foi conduzida no software Revman a partir dos dados de diferença média padronizada (SMD) e intervalos de confiança de 95% (IC). Foram selecionados 17 estudos, envolvendo 289 crianças e adolescentes com sobrepeso e obesidade. As intervenções de HIIT (duração=11,7±5,9 semanas) produziram reduções significativas no percentual de gordura corporal (SMD=-0,65; IC=-1,07,-0,23) e circunferência da cintura (SMD=-0,34; IC=-0,49-0.18). Também foi observado um risco relativo maior de diminuição do percentual de gordura corporal a favor de protocolos com proporção de intervalos de trabalho/recuperação de 1:1 e 2:1. Protocolos HIIT com proporções 1:1 e 2:1 promovem reduções significativas no percentual de gordura e circunferência da cintura em crianças com sobrepeso e obesidade, independentemente do tempo total de trabalho.

Effectiveness and tolerability of direct-acting antivirals for chronic hepatitis C patients in a Southern state of Brazil

ABSTRACT Background This study aimed to evaluate the clinical effectiveness in terms of sustained virological response and tolerability of available second generation direct-acting antivirals in Brazilian patients. Methods This was a retrospective observational study conducted in six centers in Southern Brazil. The sample comprised adult patients who were chronically infected with hepatitis C virus, regardless of virus genotype, fibrosis stage, or prior treatment. Statistical analysis was performed to compare the effectiveness among the treatments, and also to uncover the factors influencing the achievement of sustained virological response. Results A total of 296 patients were included in the study, with the majority receiving sofosbuvir with daclatasvir (59%) or sofosbuvir with simeprevir (26%). Overall sustained virological response rates were approximately 91.6%. For genotype 1, sofosbuvir with daclatasvir had an sustained virological response rate of approximately 95%, while the sustained virological response rate of sofosbuvir with simeprevir was 92%; this difference was statistically significant only for subtype 1b. The only treatment used for genotype 3 patients was sofosbuvir with daclatasvir, and lower rates of sustained virological response were observed for this group, compared to genotype 1 (84% versus 95%, p < 0.05). Apart from this difference between genotypes, and a difference between patients who achieved rapid virologic response compared with those who did not, there were no other statistically significant factors associated with sustained virological response. Conclusions The results point to the effectiveness of second-generation direct-acting antivirals in hepatitis C virus Brazilian patients, especially those with genotype 1. Furthermore, that patients with genotype 3 need more attention and adjustments in available treatment options.

Treatment interruption of biological drugs and tofacitinib in rheumatoid arthritis: A systematic review of case reports

The aim of this study was to evaluate interruption of treatment with biological drugs and tofacitinib due to adverse events in patients with rheumatoid arthritis. A systematic review was performed in the electronic databases MEDLINE, Cochrane, Scopus, CRD, IPA, Lilacs and Scielo. Case reports addressing interruption of treatment due to any adverse event related to abatacept (ABA), adalimumab (ADA), anakinra (ANA), certolizumab pegol (CER), etanercept (ETA), golimumab (GOL), infliximab (IFX), rituximab (RTX), secukinumab (SEC), tocilizumab (TCZ), tofacitinib (TOF) or ustekinumab (UST) in rheumatoid arthritis patients were evaluated. Baseline data, patient profile, previous and current treatments, cause of discontinuation and information on reintroduction of treatment were extracted from the case reports. One hundred and fifty-four studies (154 patients) reported 162 discontinuations of rheumatoid arthritis treatment due to adverse events (ETA = 57; IFX = 46; ADA = 32; TCZ = 13; RTX = 5; ANA = 3; GOL = 2; ABA = 2; TOF = 1; CER = 1; SEC = 0 and UST = 0). The mean age of patients was 56 (± 12.1) years and 82% were female. Seventy-four adverse events were confirmed (related to used drug), and 138 were observed in patients using anti-TNF. The most common adverse events were infections (21%), skin disease (15%), autoimmune disease (13%) and hematological disorders (9%). Case reports are important in the detection of rare adverse events and should be considered in the choice of appropriate therapy for patients.

Revisão sistemática da eficácia e da segurança das terapias livres de interferon para hepatite C crônica em pacientes coinfectados com o Vírus da Imunodeficiência Humana / Systematic review of the efficacy and safety of interferon-free therapies for chronic hepatitis C in patients coinfected with the Human Immunodeficiency Virus

RESUMO O objetivo deste estudo foi realizar uma revisão sistemática para avaliar a eficácia e a segurança de terapias livres de interferon para hepatite C em pacientes coinfectados com o Vírus da Imunodeficiência Humana. Ao todo, 10 ensaios clínicos foram incluídos em um total de 1.626 pacientes coinfectados com o Vírus da Hepatite C/Vírus da Imunodeficiência Humana, em sua maioria, portadores do genótipo 1, e tratados principalmente por 12 ou 24 semanas. Os pacientes apresentaram taxas de aproximadamente 91% para desfechos de eficácia, enquanto descontinuações por eventos adversos foram inferiores a 3%. Desta forma, as terapias livres de interferon aparecem como uma boa opção para tratamento da hepatite C crônica no grupo de pacientes coinfectados com o Vírus da Imunodeficiência Humana.

ABSTRACT The aim of this study was to conduct a systematic review to evaluate the efficacy and safety of interferon-free therapies for hepatitis C in patients coinfected with the Human Immunodeficiency Virus. In all, 10 clinical trials were included in a total of 1.626 patients coinfected with Hepatitis C Virus/Human Immunodeficiency Virus, mostly, carriers of genotype 1, and treated mainly for 12 or 24 weeks. Patients presented rates of approximately 91% for efficacy outcomes, while discontinuations due to adverse events were less than 3%. In this way, interferon-free therapies appear as a good option for the treatment of chronic hepatitis C in the group of patients coinfected with Human Immunodeficiency Virus.

Condições microbiológicas e higienicossanitárias do caldo de cana comercializado no município de Curitiba- PR / Microbiological and hygienic sanitary conditions of saccharum juice marketed in the city of Curitiba, PR

O caldo de cana é uma bebida popular e amplamente comercializada por ambulantes em diversas cidades brasileiras. Esse tipo de comércio deve cumprir as boas práticas determinadas pela legislação, uma vez que pode propiciar as Doenças Transmitidas por Alimentos (DTA) pela venda de bebidas contaminadas. O objetivo deste trabalho foi avaliar as condições higienicossanitárias e microbiológicas da produção de caldo de cana no município de Curitiba em 10 pontos de venda. O estudo foi dividido em duas etapas: avaliação de cinco parâmetros relativos às condições estruturais e dos manipuladores, por meio de um roteiro de inspeção; e avaliação da qualidade microbiológica do caldo de cana, por meio da coleta de duas amostras em cada ponto de venda. Foi observado que 60% dos comerciantes manipulavam dinheiro simultaneamente ao preparo do caldo e não utilizavam luvas. Além disso, em 40% havia a presença de insetos, 30% apresentavam estrutura precária e 10% dos manipuladores não usavam cabelos presos. Dos locais avaliados, 60% tiveram amostras classificadas como impróprias para o consumo, sendo observados valores superiores a 2 Log.NMP/mL de coliformes termotolerantes, em que todas estavam contaminadas por E. coli. Por fim, a melhoria no cumprimento das boas práticas relaciona-se com a qualidade microbiológica. De acordo com os resultados obtidos no presente estudo, foi visto que se faz necessária a implementação de medidas para a capacitação deste grupo de comerciantes sobre as boas práticas e constante atuação de vigilância de seu cumprimento, preservando a saúde da população no sentido de prevenir as DTA.(AU)