Aspectos do contexto social atual e sua influência nas ações da vigilância de medicamentos

The text examines drugs surveillance actions departing from social movements in the last few decades, and changes in the field of human communications and economy. The background includes the uneven distribution of the information, particularly related to the results of clinical trials with drugs; and the reduction of the critical thought, by some important national and international organizations, regarding the market. Examples, in terms of diagnosis, therapy and prevention of diseases putting on opposite sides the benefits embedded in technologies and the damage arising from its abusive and extended use without a scientific basis, are presented. The text highlights positive counterpoints, such as some national and international initiatives in public policies and the social activism of health professionals and of sectors linked to the scientific press. It also enhances the prominence assumed by systematic reviews supporting evidence-based medicine as well as the development of the patient safety area.A partir dos movimentos sociais das últimas décadas e das mudanças no campo das comunicações humanas e na economia, analisam-se aspectos da vigilância sanitária de medicamentos. No cenário, está a distribuição desigual das informações, particularmente dos resultados dos ensaios clínicos com medicamentos, e o rebaixamento crítico de organizações internacionais e de setores do Estado no enfrentamento das regras impostas pelo mercado. Ilustrações em termos de diagnóstico, terapêutica e prevenção de doenças põem em lados opostos os benefícios embutidos nas tecnologias e os danos decorrentes do seu uso dilatado, abusivo e sem base científica. Destacam-se contrapontos positivos, entre os quais algumas iniciativas nacionais e internacionais nas políticas públicas, e o ativismo social de profissionais de saúde e de setores ligados à imprensa científica. Realça-se a proeminência que vêm assumindo as revisões sistemáticas que sustentam a medicina baseada em evidências e o desenvolvimento da área de segurança do paciente

Inappropriate medication use among the elderly: a systematic review of administrative databases

<p>Abstract</p> <p>Background</p> <p>Inappropriate medication use (IMU) by elderly people is a public health problem associated with adverse effects on health. There are a number of methods for identifying IMU, some involving clinical judgment and others, consensually generated lists of drugs to be avoided. This review aims to describe studies that used information from insurance company and social security administrative databases to assess IMU among community-dwelling elderly and to present the risk factors most often associated with IMU.</p> <p>Methods</p> <p>The paper search was conducted in Medline and Embase, using descriptors combined with free terms in the title or abstract. The limits applied were: publication date from January 1990 to June 2010, species (human) and publication type (excluding editorials, letters and reviews). Excluded were: case studies; studies in hospitals, nursing homes, or hospital emergency departments; studies of specific drugs or groups of drugs; studies exclusively of subgroups of ill, frail elderly or rural populations. Additional studies were identified from reference lists. Data were selected and extracted after independent reading by two of the authors, with disagreements resolved by a third author. The primary outcome assessed was prevalence of IMU, defined as the proportion of elderly who received at least one inappropriate medication.</p> <p>Results</p> <p>Of the 628 studies, 19 met the inclusion criteria, 78.9% of them conducted in the USA. All papers included used explicit criteria of inappropriateness, most commonly Beers criteria (73.7%) in their three versions (1991, 1997 and 2002). Other methods used included Zhan, which is derived from on Beers criteria and was applied in 21% of the papers selected. The study found that prevalence of IMU ranged from 11.5% to 62.5%. Only 68.4% of the studies included examined inappropriate use-related factors, the most important being female sex, advanced age and larger number of drugs.</p> <p>Conclusions</p> <p>The results show that the prevalence of IMU among community-dwelling elderly is high and depends partly on the method used to evaluate improper use. Besides the diversity of methods, other factors, such as patient sex, age and number of drugs used concurrently, appear to have influenced the estimates of IMU.</p

Preventable adverse drug events in critically ill HIV patients: Is the detection of potential drug-drug interactions a useful tool?

OBJECTIVES: The aim of this study was to develop a strategy to identify adverse drug events associated with drug-drug interactions by analyzing the prescriptions of critically ill patients. METHODS: This retrospective study included HIV/AIDS patients who were admitted to an intensive care unit between November 2006 and September 2008. Data were collected in two stages. In the first stage, three prescriptions administered throughout the entire duration of these patients’ hospitalization were reviewed, with the Micromedex database used to search for potential drug-drug interactions. In the second stage, a search for adverse drug events in all available medical, nursing and laboratory records was performed. The probability that a drug-drug interaction caused each adverse drug events was assessed using the Naranjo algorithm. RESULTS: A total of 186 drug prescriptions of 62 HIV/AIDS patients were analyzed. There were 331 potential drug-drug interactions, and 9% of these potential interactions resulted in adverse drug events in 16 patients; these adverse drug events included treatment failure (16.7%) and adverse reactions (83.3%). Most of the adverse drug reactions were classified as possible based on the Naranjo algorithm. CONCLUSIONS: The approach used in this study allowed for the detection of adverse drug events related to 9% of the potential drug-drug interactions that were identified; these adverse drug events affected 26% of the study population. With the monitoring of adverse drug events based on prescriptions, a combination of the evaluation of potential drug-drug interactions by clinical pharmacy services and the monitoring of critically ill patients is an effective strategy that can be used as a complementary tool for safety assessments and the prevention of adverse drug events

Study of wound healing in rats treated with topical and injected mitomycin-C

Estudo experimental em animais. A mitomicina C vem sendo usada como inibidor de fibroblastos, acarretando, com isso, diminuição do processo cicatricial em feridas cirúrgicas. OBJETIVO: Este trabalho visa avaliar o uso de Mitomicina C para diminuir o processo cicatricial, através de seu uso tópico com reforços posteriores injetáveis. MATERIAL E MÉTODOS: Foi usado um modelo de feridas em dorso de ratos, com retirada circular da pele e cicatrização por segunda intenção. Foram usados 18 ratos, divididos em três grupos: controle; com uso tópico; e com reforço de mitomicina C injetável, mensalmente e por 2 meses. Após 3 meses os animais foram sacrificados e as cicatrizes retiradas cirurgicamente e submetidas a estudo histológico. RESULTADOS: Notou-se sob vários critérios que a cicatrização com o uso tópico é menos intensa, mas ao se usar o reforço injetável os parâmetros voltam a ser comparados ao do grupo controle. DISCUSSÃO: Acreditamos que a administração injetável de mitomicina C nas cicatrizes, pela sua elevada característica tóxica, acarreta destruição tecidual e neoformação cicatricial. CONCLUSÕES: A mitomicina C diminui o processo cicatricial quando usada topicamente, mas acarreta aumento da cicatrização quando nestas feridas são feitos reforços injetáveis.Experimental study in animals. Introduction: Mitomycin C has been used as a fibroblasts inhibitor, thus reducing the scaring process in surgical wounds. AIM: This paper aims at assessing the use of Mitomycin C to reduce the scaring process through its topical use and later injected reinforcements. MATERIALS AND METHODS: We used a model of a creating a wound in the dorsum of rats, removing a circular piece of skin and letting it heal by itself. We used 18 rats, divided in three groups. The first group - Control, the second with topical use, and a third group with injected mitomycin C reinforcement, monthly for 2 months. After 3 months the animals were slaughtered and the scars were surgically removed and sent for histology study. RESULTS: We noticed, under different criteria, that healing with topical mitomycin is less intense; however, when it was injected, the parameters were again comparable to those from the control group. DISCUSSION: We believe that injected mitomycin C in the scar, since it is highly toxic, it destroys tissue and brings about scar neoformation. CONCLUSIONS: Mitomycin C reduces the scaring process when used topically; however, it increases scar tissue formation when injected in these wounds

The role of children in household transmission of SARS-CoV-2 across four waves of the pandemic.

BACKGROUND: It is important to understand the dynamics of SARS-CoV-2 transmission in close-contact settings such as households. We hypothesized that children would most often acquire SARS-CoV-2 from a symptomatic adult caregiver. METHODS: This prospective cohort study was conducted from April 2020 to July 2022 in a low-resource, urban settlement in Brazil. We recruited families who brought their children to a public clinic. We collected nasopharyngeal and oral swabs from household members and tracked symptoms and vaccination. RESULTS: In total, 1,256 participants in 298 households were tested for SARS-CoV-2. A total of 4073 RT-PCR tests were run with 893 SARS-CoV-2 positive results (21.9%). SARS-CoV-2 cases were defined as isolated cases (n=158) or well-defined transmission events (n=175). The risk of household transmission was lower if the index case was a child (OR: 0.3 [95% CI: 0.16-0.55], p<0.001) or was vaccinated (OR: 0.29 [95%CI: 0.1-0.85], p=0.024), and higher if the index was symptomatic (OR: 2.53 [95% CI: 1.51-4.26], p<0.001). The secondary attack rate for child index cases to child contacts was 0.29, whereas the secondary attack rate from adult index cases to child contacts was 0.47 (p=0.08). CONCLUSIONS: In this community, children were significantly less infectious to their household contacts than adolescents or adults. Most children were infected by a symptomatic adult, usually their mother. There was a double benefit of vaccination as it protected the vaccinee from severe illness and prevented onward transmission to household contacts. Our findings may also be valid for similar populations throughout Latin America

Long COVID-19 syndrome associated with Omicron XBB.1.5 infection: a case report.

BACKGROUND: There is interest in lingering non-specific symptoms after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, referred to as Long coronavirus disease 2019 (Long COVID-19). It remains unknown whether the risk of Long COVID-19 is associated with pre-existing comorbidities or initial COVID-19 severity, including infections due to new Omicron lineages which predominated in 2023. OBJECTIVES: The aim of this case report was to characterize the clinical features of acute XBB.1.5 infection followed by Long COVID-19. METHODS: We followed a 73-year old female resident of Rio de Janeiro with laboratory-confirmed SARS-CoV-2 during acute infection and subsequent months. The SARS-CoV-2 lineage was determined by genome sequencing. FINDINGS: The participant denied comorbidities and had completed a two-dose vaccination schedule followed by two booster doses eight months prior to SARS-CoV-2 infection. Primary infection by viral lineage XBB.1.5. was clinically mild, but the participant subsequently reported persistent fatigue. MAIN CONCLUSIONS: This case demonstrates that Long COVID-19 may develop even after mild disease due to SARS-CoV-2 in fully vaccinated and boosted individuals without comorbidities. Continued monitoring of new SARS-CoV-2 lineages and associated clinical outcomes is warranted. Measures to prevent infection should continue to be implemented including development of new vaccines and antivirals effective against novel variants

Accuracy of saliva for SARS-CoV-2 detection in outpatients and their household contacts during the circulation of the Omicron variant of concern.

BACKGROUND: While nasopharyngeal (NP) swabs are considered the gold standard for severe acute respiratory coronavirus 2 (SARS-CoV-2) real-time reverse transcriptase-polymerase chain reaction (RT-PCR) detection, several studies have shown that saliva is an alternative specimen for COVID-19 diagnosis and screening. METHODS: To analyze the utility of saliva for the diagnosis of COVID-19 during the circulation of the Omicron variant, participants were enrolled in an ongoing cohort designed to assess the natural history of SARS-CoV-2 infection in adults and children. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa coefficient were calculated to assess diagnostic performance. RESULTS: Overall, 818 samples were collected from 365 outpatients from January 3 to February 2, 2022. The median age was 32.8 years (range: 3-94 years). RT-PCR for SARS-CoV-2 was confirmed in 97/121 symptomatic patients (80.2%) and 62/244 (25.4%) asymptomatic patients. Substantial agreement between saliva and combined nasopharyngeal/oropharyngeal samples was observed with a Cohen's kappa value of 0.74 [95% confidence interval (CI): 0.67-0.81]. Sensitivity was 77% (95% CI: 70.9-82.2), specificity 95% (95% CI: 91.9-97), PPV 89.8% (95% CI: 83.1-94.4), NPV 87.9% (95% CI: 83.6-91.5), and accuracy 88.5% (95% CI: 85.0-91.4). Sensitivity was higher among samples collected from symptomatic children aged three years and older and adolescents [84% (95% CI: 70.5-92)] with a Cohen's kappa value of 0.63 (95% CI: 0.35-0.91). CONCLUSIONS: Saliva is a reliable fluid for detecting SARS-CoV-2, especially in symptomatic children and adolescents during the circulation of the Omicron variant

Post-acute COVID-19 syndrome after reinfection and vaccine breakthrough by the SARS-CoV-2 Gamma variant in Brazil.

We describe a case of prolonged COVID-19 caused by the SARS-CoV-2 Gamma variant in a fully vaccinated healthcare worker, 387 days after an infection caused by lineage B.1.1.33. Infections were confirmed by whole-genome sequencing and corroborated by the detection of neutralizing antibodies in convalescent serum samples. Considering the permanent exposure of this healthcare worker to SARS-CoV-2, the waning immunity after the first infection, the low efficacy of the inactivated vaccine at preventing COVID-19, the immune escape of the Gamma variant (VOC), and the burden of post-COVID syndrome, this individual would have benefited from an additional dose of a heterologous vaccine