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.

Mapping community pharmacy services in Brazil: a scoping review

Abstract The delivery of clinical pharmacy services has been growing in Brazilian community pharmacies, and it is necessary to have a comprehensive understanding of the topic. This scoping review aimed to provide an overview of Brazilian studies about clinical pharmacy services in community pharmacies. Original research articles, with no restriction of time, study design, or patient's health condition, were included. Searches were conducted in PubMed, Scopus, Web of Science, Scielo, and Lilacs. Two reviewers conducted the screening, full-text reading, and data extraction independently. ROB and ROBINS-I were used for the assessment of quality. Charts and tables were built to summarise the data. Seventy-two articles were included. A diversity of study designs, number of participants, terms used, and outcomes was found. São Paulo and Sergipe States had the highest number of studies (n=10). Pharmacists' interventions were not fully reported in 65% of studies, and most studies presented an unclear risk of bias. Studies were very diverse, impairing the comparisons between the results and hindering their reproducibility. This review suggests using guidelines and checklists for better structuration of pharmacists' interventions as well as reporting results and measuring fidelity in future research.

Evaluation of the epidemiological aspects and the impact of COVID-19 on tuberculosis notifications in São Paulo

Objective: This study aimed to analyze the incidence and epidemiological profile of tuberculosis (TB) cases registered in a region of the State of São Paulo (SP) and to assess the impact of COVID19 on TB incidence and completeness of notifications. Methods: This is a retrospective crosssectional study analyzing reports of adult patients with TB, who were notified in the TB-Web from January 2010 to December 2020. Sociodemographic (e.g. sex, race and scholarity) and clinical variables (e.g., clinical form, types of cases and comorbidities) were collected and analyzed. The completeness of TB notifications and the impact of COVID-19 on TB notifications were evaluated, considering the year of 2020. The study was reported following Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for cross-sectional studies [CAAE 33166620.0.0000.0102]. Results: A total of 1,509 notifications were included, with a mean incidence of 48.5/100,000 inhabitants. The median age was 42 years, most notification included males (71%), were of white race (42%) and had the pulmonary form of TB (85%). In assessing the impact of the pandemic on notifications in 2020, there was a decrease of 36% in the number of TB notifications, with an emphasis between July and August, which was the peak period of COVID-19 cases in the region. No change in the completeness of TB notifications was observed in this period. Conclusions: Results indicate the clinical and epidemiological profile in a region of SP between 2010 and 2020. The pandemic led to a decrease in the number of TB notifications but did not change the completeness of notifications.

Reports of substandard medicines: a lexicographic analysis of the Brazilian Health Surveillance Report System

Regulatory agencies are responsible for collecting and evaluating spontaneous reports of suspected problems related to medications, including those from substandard medicines (SM). Objectives: The aim was to evaluate the profile of SM reports submitted to the Brazilian Health Surveillance Notification System (Notivisa) and classify these reports objectively by means of lexicographic analysis. Methods: Was extracted all SM reports available in Notivisa during the period 1 January 2007 to 31 December 2017. Descriptive statistics were performed and the reasons for SM reporting were standardized (using OpenRefine and Microsoft Excel). The following analyses were performed using IRAMuTeQ 0.7 alpha2: lexicographic analysis to obtain the frequency of active words; descending hierarchical classification (DHC) to categorize the active words into lexical classes; factorial correspondence analysis (FCA) to obtain graphs of the classes. Approved by the Ethics Committee of the Hospital do Trabalhador/SES/PR CAAE 81873417.3.0000.5225 (protocol number: 2.506.594). Results: A total of 61,775 reports were analyzed, most of them reported by hospitals (46%). The DHC of the reasons for SM produced four classes visualized in the FCA: (i) packaging problems (16%) mainly leakages/opening issues; (ii) inadequate drug identification (22%), such as illegible label information; (iii) stability and contamination issues (11%) such as presence of particles; (iv) damaged tablets/blisters (23%) mainly broken tablets. Most SM (52%) were solutions for parenteral use; sodium chloride (9%), glucose and dipyrone (3%) were the products with most complaints. Conclusions: The reasons for SM reporting can be objectively classified into classes that represent the main problems submitted to Notivisa. This classification could guide the standardization of SM reporting and contribute to improving surveillance reporting systems worldwide.

Evaluation of the application of the Diabetes Quality of Life Questionnaire in patients with diabetes mellitus

ABSTRACT Objective Diabetes mellitus (DM) is a chronic disease with great impact on patients' quality of life (QoL). This variable can be measured using reliable, standardized, and validated instruments. The purpose of this study was to evaluate the application and reporting of the Diabetes Quality of Life Measure (DQOL) or the Diabetes Quality of Life for Youths Measure (DQOLY), an adapted version for young patients with DM. Materials and methods A systematic review of interventional and observational studies using the DQOL or DQOLY was performed. Searches were conducted in the electronic databases Medline, Scopus, Web of Science, Lilacs, and SciELO. Results After conducting the searches, 111 studies met the inclusion criteria and were included in the qualitative analysis. Of these, 32 studies were classified as interventional and 79 as observational, with 27,481 patients. The DQOL was applied in 82 studies, the DQOLY in another 27, and two studies used both instruments. DM was classified as type 1 DM in 69 studies and type 2 DM in 35 studies. Six studies included both patients. Improvement in patients' QoL after an intervention was observed in 13 interventional studies. Most of the studies (90%) provide a detailed description of the instrument and 52% the previous validation. The interpretation of the scores obtained varies among the studies, probably due to the differences inherent in cultural validations, translations, and adaptations. Conclusion The application of the instruments in clinical practice must be rigorously standardized and requires an accurate understanding of psychometric and statistical concepts. Arch Endocrinol Metab. 2020;64(1):59-65

Risk factors associated with delay in diagnosis and mortality in patients with COVID-19 in the city of Rio de Janeiro, Brazil / Fatores de risco associados ao atraso no diagnóstico e mortalidade em pacientes com COVID-19 na cidade do Rio de Janeiro, Brasil

Abstract We investigated the predictors of delay in the diagnosis and mortality of patients with COVID-19 in Rio de Janeiro, Brazil. A cohort of 3,656 patients were evaluated (Feb-Apr 2020) and patients' sociodemographic characteristics, and social development index (SDI) were used as determinant factors of diagnosis delays and mortality. Kaplan-Meier survival analyses, time-dependent Cox regression models, and multivariate logistic regression analyses were conducted. The median time from symptoms onset to diagnosis was eight days (interquartile range [IQR] 7.23-8.99 days). Half of the patients recovered during the evaluated period, and 8.3% died. Mortality rates were higher in men. Delays in diagnosis were associated with male gender (p = 0.015) and patients living in low SDI areas (p < 0.001). The age groups statistically associated with death were: 70-79 years, 80-89 years, and 90-99 years. Delays to diagnosis greater than eight days were also risk factors for death. Delays in diagnosis and risk factors for death from COVID-19 were associated with male gender, age under 60 years, and patients living in regions with lower SDI. Delays superior to eight days to diagnosis increased mortality rates.

Resumo Investigamos os preditores de atraso no diagnóstico e mortalidade de pacientes com COVID-19 no Rio de Janeiro, Brasil. Uma coorte de 3.656 pacientes foi avaliada (fevereiro-abril de 2020) e as características sociodemográficas dos pacientes, o bairro e o índice de desenvolvimento social (IDS) foram usados como fatores determinantes dos atrasos no diagnóstico e da mortalidade. Foram realizadas análises de sobrevivência de Kaplan-Meier, modelos de regressão Cox dependentes do tempo e análises de regressão logística multivariada. O tempo mediano desde o início dos sintomas até o diagnóstico foi de oito dias (intervalo interquartil [IQR] 7,23-8,99 dias). Metade dos pacientes se recuperou no período avaliado e 8,3% faleceram. As taxas de mortalidade foram maiores nos homens. Atrasos no diagnóstico foram associados ao sexo masculino (p = 0,015) e pacientes que moravam em áreas com baixo IDS (p < 0,001). As faixas etárias estatisticamente associadas à morte foram: 70-79 anos, 80-89 anos e 90-99 anos. Atrasos no diagnóstico superiores a oito dias também foram fatores de risco para óbito. Atrasos no diagnóstico e fatores de risco para morte por COVID-19 foram associados ao sexo masculino, idade abaixo de 60 anos e pacientes que vivem em regiões com menor IDS. Atrasos superiores a oito dias no diagnóstico aumentam as taxas de mortalidade.

Suporte Social e HIV: Relações Entre Características Clínicas, Sociodemográficas e Adesão ao Tratamento / Social support and HIV: Relationship between Clinical and Sociodemographic Characteristics and Treatment Adherence

RESUMO Este estudo investigou a relação entre suporte social, características sociodemográficas, clínicas e adesão ao Tratamento Antirretroviral (TARV) utilizando o questionário Social Support Inventory for People who are HIV Positive or Have AIDS. Para isso, foram avaliados 119 usuários HIV-positivos - dos quais 53,8% eram homens. Em relação à disponibilidade e satisfação, os valores médios foram de 3,37 (DP=1,00) para o suporte instrumental e 3,48 (DP=1,06) para o suporte emocional. Observaram-se diferenças significativas na disponibilidade e satisfação do suporte social com variáveis sociodemográficas e clínicas. Verificou-se que, quanto maior a disponibilidade e a satisfação com o suporte social, maior o OR para a adesão ao tratamento. O desenvolvimento de estratégias de apoio social pode contribuir positivamente para o controle da doença e melhor qualidade de vida dos usuários.

ABSTRACT This study aimed to assess the relationship between social support, sociodemographic and clinical characteristics and treatment adherence using the Social Support Inventory for People who are HIV Positive or Have AIDS. Thus, it were evaluated 119 HIV-positive patients, of which 53.8% were men. Regarding the availability and satisfaction mean values were 3.37 (DP=1.00) for the instrumental support and 3.48 (DP=1.06) for emotional support. Significant differences were found in the availability and satisfaction of social support with clinical and sociodemographic variables. It was found that the greater the availability and satisfaction with social support, the greater the OR for adherence to treatment. The development of social support strategies can positively contribute to disease control and better quality of life of HIV-positive patients.

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.

New drugs for the treatment of agitation in schizophrenia: a systematic review and meta-analysis of inhaled loxapine and infused sodium nitroprusside / Novos fármacos para o tratamento da agitação na esquizofrenia: revisão sistemática e meta-análise da loxapina inalável e nitroprussiato de sódio

The use of novel drugs such as inhaled loxapine (LOXi) for schizophrenia and the off-label use of substances such as sodium nitroprusside (NIT) for the management of mental disorders require further investigation. We aimed to evaluate the efficacy and safety of LOXi and NIT for the treatment of agitation associated with schizophrenia. A systematic review of randomized controlled trials (RCTs) comparing the use of LOXi or NIT versus placebo or other antipsychotic agents was conducted, and we evaluated the efficacy (CGI-scale) and safety (adverse events) of the therapies. Altogether, 71 studies were identified, of which 2 (LOXi) were included in the meta-analysis, and 1 (NIT) was included in the systematic review only. The efficacy data showed superiority of LOXi against placebo, regardless of the dose (5 and 10 mg). No significant differences were observed concerning the safety results. Treatment with NIT showed favorable results, with significant reduction of the symptoms. The efficacy of these medications is difficult to assess because of the lack of RCTs. However, there is some information regarding the efficacy and safety of LOXi in the treatment of agitation in schizophrenic patients.

Fármacos mais recentes como a loxapina inalável (LOXi) para o tratamento da esquizofrenia e o uso off- label de substâncias como o nitroprussiato de sódio (NIT) para o manejo de desordens mentais requerem mais investigações. O objetivo do estudo foi avaliar eficácia e segurança da LOXi e do NIT para tratamento da agitação na esquizofrenia. Foi realizada revisão sistemática de ensaios clínicos randomizados (ECR) comparando o uso de LOXi ou NIT versus placebo ou outros antipsicóticos. Foram avaliados desfechos de eficácia (escala CGI-I) e segurança (eventos adversos). Ao todo 71 estudos foram identificados, dos quais dois foram incluídos nas meta-análises (ambos da LOXi) e 1 sobre NIT foi incluído somente na revisão sistemática. Os dados de eficácia demonstraram superioridade da LOXi frente ao placebo, independente das doses avaliadas (5 ou 10 mg). Não foram observadas diferenças significativas entre os resultados de segurança com o controle. O único estudo incluído sobre o NIT mostrou resultados favoráveis, com redução significativa dos sintomas. Apesar da carência de ECR com esses fármacos dificultar a determinação e a reunião de informações, há potenciais evidências de eficácia e segurança da LOXi no tratamento da agitação em pacientes com esquizofrenia.