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El presente artículo discute los avances y desafíos de las tecnologías de monitorización en salud de personas mayores y sus implicaciones en la privacidad y confidencialidad de los datos recolectados. Se trata de un estudio exploratorio, fundamentado en la literatura, con síntesis narrativa. El texto contextualiza las demandas derivadas del envejecimiento poblacional y el uso de sensores y otros dispositivos electrónicos en la monitorización de actividades diarias de personas mayores en ambientes internos y externos. Es importante resaltar que los beneficios ofrecidos por las tecnologías no deben comprometer la privacidad y confidencialidad de los datos. Para garantizar esto, es necesario mejorar los mecanismos reguladores, estableciendo estándares de seguridad y principios éticos para la protección de datos personales, respetando la privacidad y confidencialidad de los datos.

Objectives: This review of systematic reviews evaluated the effectiveness and safety of the preemptive use of anti-inflammatory and analgesic drugs in the management of postoperative pain, edema, and trismus in oral surgery.Materials and methods: The databases searched included the Cochrane Library, MEDLINE, EMBASE, Epistemonikos, Scopus, Web of Science, and Virtual Health Library, up to March 2023. Pairs of reviewers independently selected the studies, extracted the data, and rated their methodological quality using the AMSTAR-2 tool.Results: All of the 19 studies reviewed had at least two critical methodological flaws. Third molar surgery was the most common procedure (n = 15) and the oral route the most frequent approach (n = 14). The use of betamethasone (10, 20, and 60 mg), dexamethasone (4 and 8 mg), methylprednisolone (16, 20, 40, 60, 80, and 125 mg), and prednisolone (10 and 20 mg) by different routes and likewise of celecoxib (200 mg), diclofenac (25, 30, 50, 75, and 100 mg), etoricoxib (120 mg), ibuprofen (400 and 600 mg), ketorolac (30 mg), meloxicam (7.5, 10, and 15 mg), nimesulide (100 mg), and rofecoxib (50 mg) administered by oral, intramuscular, and intravenous routes were found to reduce pain, edema, and trismus in patients undergoing third molar surgery. Data on adverse effects were poorly reported.Conclusion: Further randomized clinical trials should be conducted to confirm these findings, given the wide variety of drugs, doses, and routes of administration used.

Abstract Background The judicialization of health care can be understood as a societal response to pressing healthcare needs, which probably are not being adequately addressed by the current healthcare system. This phenomenon increases the strain on service resources, both in the health sector and in the judiciary system as well, demanding an institutional reorganization to manage judicial actions. It is believed that each institution has developed strategies for coping with the problem in isolation and with little public disclosure. The purpose of this review will be to identify institutional strategies implemented and to investigate their effects in approaching the judicialization of health care. Methods Electronic searches will be conducted up to December 2021 on 11 databases, supplemented with gray literature and references lists of secondary studies. The descriptor “judicialization of health” will be the basis for conducting the main research. Studies describing any strategy implemented by public institutions to approach the judicialization of health care will be included. Results related to the quality of services provided by the implemented strategy reported in the studies and those that report accessibility, usability, and potential adverse effects or harms caused by the implemented strategy will be investigated. In addition, it will be explored if there have been changes related to the value or characteristics of health litigation. Two reviewers will independently screen all citations, abstract data, and full-text papers. The risk of bias in each study will be appraised using a tool suggested by Cochrane Effective Practice and Care Organization Group (EPOC). Subsequently, the reviewers will also extract the data of interest and classify the findings of these studies according to their performance at the institutional level. The results obtained will be described as a narrative synthesis. Discussion This review may provide evidence on the effects of the strategies implemented to approach the judicialization of health care. It will potentially benefit health care and legal professionals, decision-makers, and researchers by identifying the types and characteristics of strategies that have the potential to improve service delivery in the future. Systematic review registration PROSPERO CRD42020160608

Background: The social restrictions among coronavirus disease 2019 (COVID-19) pandemic have posed a thoughtful risk to mental health and have implications in the use of drugs, including antidepressants, anxiolytics and other psychotropics.Objective: This study analyzed the sales data of the psychotropics prescribed in Brazil, in order to verify the change in consumption trends of these drugs during the COVID-19 pandemic.Methods: This interrupted time-series analyzed psychotropic sales data, between January 2014 and July 2021, using the National System of Controlled Products Management from The Brazilian Health Regulatory Agency. The monthly mean DDDs per 1,000 inhabitants per day of psychotropic drugs was evaluated by analysis of variance (ANOVA) followed by Dunnett Multiple Comparisons Test. The changes in monthly trends in the use of the psychotropic studied were evaluated by Joinpoint regression.Results: During the period studied, clonazepam, alprazolam, zolpidem and escitalopram were the most sold psychotropic drugs in Brazil. According to Joinpoint regression, an upward trend was observed in sales during the pandemic of pregabalin, escitalopram, lithium, desvenlafaxine, citalopram, buproprion and amitriptyline. An increase in psychotropic consumption was noted throughout the pandemic period, with the maximum consumption (2.61 DDDs) occurring in April 2021, with a downward trend in consumption that accompanied the drop in the number of deaths.Conclusions: The increase in sales, mainly of antidepressants during the COVID-19 pandemic, draws attention to issues related to the mental health of the Brazilian population and on the need for greater monitoring in the dispensing of these drugs.

O avanço das tecnologias móveis, associado à mobilidade crescente dos dispositivos, permitiu a incorporação do ambiente virtual a diversas atividades cotidianas, inclusive no âmbito da saúde, introduzindo conceitos como telemedicina, telessaúde, eHealth e mHealth. Além de apresentar esses novos conceitos, o presente artigo teve como objetivo discutir os avanços e os desafios das tecnologias móveis em saúde a partir de reflexões sobre desenvolvimento, aplicações, legislação e ética. Por seu caráter inovador, as tecnologias móveis em saúde envolvem muitos atores na jornada até o usuário final, focados na concepção, desenvolvimento técnico, regulação sanitária e elaboração de diretrizes clínicas, e têm despertado grande interesse para fins de monitoramento e cuidados em diferentes condições clínicas. Entretanto, na avaliação da efetividade e da segurança das tecnologias móveis em saúde, não se observa o mesmo rigor metodológico exigido para ensaios clínicos de medicamentos e outros produtos de saúde; ainda, o entusiasmo pela inovação se contrapõe às preocupações regulatórias e éticas relacionadas à proteção de dados, à privacidade, ao acesso aos dispositivos móveis e às disparidades tecnológicas e sociais. Apesar das possíveis limitações, as tecnologias móveis, assim como outros recursos da telessaúde, têm alcançado resultados promissores. A atenção digital em saúde tem grande potencial de expansão e representa uma oportunidade para que as práticas tradicionais de saúde sejam revisadas a partir da seleção e da incorporação das tecnologias móveis aos sistemas de saúde, sempre que sejam observados benefícios embasados nas melhores evidências.

Introduction The production of clinical practice guidelines (CPGs) has grown in the past years. Notwithstanding, the quality of these documents and their recommendations for the treatment of schizophrenia in children and adolescents is still unknown.Objective To assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population.Methods CPGs from 2004 to December 2020 were identified through a systematic search on EMBASE, MEDLINE, PsycINFO, PubMed, Epistemonikos, VHL, Global Index Medicus and specific CPG databases. The CPGs’ quality was independently assessed by three reviewers using AGREE II and they were considered of high quality if they scored ≥60% in domains 3 and 6. The evidence classification systems were described, the quality of recommendations was assessed in pairs using AGREE-REX and the recommendations were compared.Results The database search retrieved 3182 results; 2030 were screened and 29 were selected for full-text reading. Four guidelines were selected for extraction. Two CPGs were considered of high quality in the AGREE II assessment. We described the commonly agreed recommendations for each treatment phase. The pharmacological recommendations were described in all treatment phases. Scores of AGREE-REX were lower for psychosocial recommendations.Conclusion There are still few clinical studies and CPGs regarding schizophrenia in children and adolescents. The quality of the documents was overall low, and the quality of the recommendations report has much to improve. There is also a lack of transparency about the quality of the evidence and the strength of the recommendations.Protocol registration number CRD42020164899.

ObjectiveThe aim of this study was to estimate the antimicrobial resistance in microorganisms present in periodontal diseases.MethodsA systematic review was conducted according to the PRISMA statement. The MEDLINE (PubMed/Ovid), EMBASE, BVS, CINAHL, and Web of Science databases were searched from January 2011 to December 2021 for observational studies which evaluated the antimicrobial resistance in periodontal diseases in permanent dentition. Studies that allowed the antimicrobial consumption until the time of sample collection, studies that used laboratory acquired strains, studies that only characterized the microbial strain present, assessment of cellular morphological changes, sequencing system validation, and time series were excluded. Six reviewers, working in pairs and independently, selected titles, abstracts, and full texts extracting data from all studies that met the eligibility criteria: characteristics of patients, diagnosis of infection, microbial species assessed, antimicrobial assessed, identification of resistance genes, and virulence factors. “The Joanna Briggs Institute” critical appraisal for case series was adapted to assess the risk of bias in the included studies.ResultsTwenty-four studies (N = 2.039 patients) were included. Prevotella and Porphyromonas species were the most cited microorganisms in the included studies, and the virulence factors were related to Staphylococcus aureus. The antimicrobial reported with the highest frequency of resistance in the included studies was ampicillin (39.5%) and ciprofloxacin showed the lowest frequency of resistance (3.4%). The most cited genes were related to macrolides. The quality of the included studies was considered critically low.ConclusionNo evidence was found regarding the profile of antimicrobial resistance in periodontal diseases, requiring further research that should focus on regional population studies to address this issue in the era of increasing antimicrobial resistance.Clinical relevanceThe knowledge about the present microorganism in periodontal diseases and their respective antimicrobial resistance profiles should guide dentists in prescribing complementary therapy for these infections.Systematic review registration[http://dx.doi.org/10.1097/MD.0000000000013158], identifier [CRD42018077810].

ObjectivesTo identify evidence-based strategies to improve adherence to the preventive measures against the coronavirus disease (COVID-19) at the community level.MethodThis is an evidence brief for policy, combining research evidence specific to contextual knowledge from stakeholders. A systematic search was performed in 18 electronic databases, gray literature, and a handle search, including only secondary and tertiary studies that focused on the adherence of the general population to COVID-19 preventive measures in the community. Two reviewers, independently, performed the study selection, data extraction, and assessment of the quality of the studies. Relevant evidence has been synthesized to draft evidence-based strategies to improve adherence. These strategies were circulated for external endorsement by stakeholders and final refinement. Endorsement rates >80%, 60–80% and

Abstract. Background:. The ABCDE (Awakening and Breathing Coordination of daily sedation and ventilator removal trials, Delirium monitoring and management, and Early mobility and exercise) and ABCDEF (Assessment, prevent and manage pain, Both spontaneous awakening and spontaneous breathing trials, Choice of analgesia and sedation, assess, prevent and manage Delirium, Early mobility and exercise, Family engagement) care bundles consist of small sets of evidence-based interventions and are part of the science behind Intensive Care Unit (ICU) liberation. This review sought to analyse the process of implementation of ABCDE and ABCDEF care bundles in ICUs, identifying barriers, facilitators and changes in perception and attitudes of healthcare professionals; and to estimate care bundle effectiveness and safety. Methods:. We selected qualitative and quantitative studies addressing the implementation of ABCDE and ABCDEF bundles in the ICU, identified on MEDLINE, Embase, CINAHL, The Cochrane Library, Web of Science, Epistemonikos, PsycINFO, Virtual Health Library and Open Grey, without restriction on language or date of publication, up to June 2018. The outcomes measured were ICU and hospital length of stay; mechanical ventilation time; incidence and prevalence of delirium or coma; level of agitation and sedation; early mobilization; mortality in ICU and hospital; change in perception, attitude or behaviour of the stakeholders; and change in knowledge of health professionals. Two reviewers independently selected the studies, performed data extraction, and assessed risk of bias and methodological quality. A meta-analysis of random effects was performed. Results:. Twenty studies were included, 13 of which had a predominantly qualitative and 7 a quantitative design (31,604 participants). The implementation strategies were categorized according to the taxonomy developed by the Cochrane Effective Practice and Organization of Care Group and eighty strategies were identified. The meta-analysis results showed that implementation of the bundles may reduce length of ICU stay, mechanical ventilation time, delirium, ICU and hospital mortality, and promoted early mobilization in critically-ill patients. Conclusions. : This study can contribute to the planning and execution of the implementation process of ABCDE and ABCDEF care bundles in ICUs. However, the effectiveness and safety of these bundles need to be corroborated by further studies with greater methodological rigor. Protocol registration:. PROSPERO CRD42019121307.

Wearable devices designed to improve medication adherence can emit audible and vibrating alerts or send text messages to users. However, there is little information on the validation of these technologies. The aim of this scoping review was to investigate the involvement of human volunteers in the development and evaluation of wearable devices. A literature search was conducted using six databases (MEDLINE, Embase, Scopus, CINAHL, PsycInfo, and Web of Science) up to March 2020. A total of 7087 records were identified, and nine studies were included. The wearable technologies most investigated were smartwatches (n = 3), patches (n = 3), wristbands (n = 2), and neckwear (n = 1). The studies involving human volunteers were categorized into idea validation (n = 4); prototype validation (n = 5); and product validation (n = 1). One of them involved human volunteers in idea and prototype validation. A total of 782 participants, ranging from 6 to 252, were included. Only five articles reported prior approval by a research ethics committee. Most studies revealed fragile methodological designs, a lack of a control group, a small number of volunteers, and a short follow-up time. Product validation is essential for regulatory approval and encompasses the assessment of the effectiveness, safety, and performance of a wearable device. Studies with greater methodological rigor and the involvement of human volunteers can contribute to the improvement of the process before making them available on the market.

Background: In 2019, a new type of coronavirus emerged and spread to the rest of the world. Numerous drugs were identified as possible treatments. Among the candidates for possible treatment was azithromycin alone or in combination with other drugs. As a result, many clinicians in Brazil have prescribed azithromycin in an attempt to combat or minimize the effects of COVID19.Aim: This study analyzed the sales data of the main antibiotics prescribed in Brazil to verify the change in consumption trends of these drugs during the COVID-19 pandemic.Methods: This is an interrupted time series that analyzed antimicrobial sales data between January 2014 and July 2021, publicly accessible information obtained from the Brazilian government’s website. Monthly means of “defined daily doses of DDDs” (DDDs per 1,000 inhabitants per day) of antibiotics were compared by analysis of variance, followed by the Dunnett Multiple Comparisons Test. Monthly trend changes in antibiotic use were verified using Joinpoint regression.Results: Amoxicillin (31.97%), azithromycin (18.33%), and cefalexin (16.61%) were the most sold antibiotics in Brazil during the evaluation period. Azithromycin consumption rose from 1.40 DDDs in February 2020 to 3.53 DDDs in July 2020. Azithromycin sales showed a significant increase in the pandemic period [Monthly Percent Change (MPC) 5.83%, 95% 1.80; 10.00], whereas there was a fall in amoxicillin sales (MPC −9.00%, 95% CI −14.70; −2.90) and cefalexin [MPC-2.70%, 95% (CI −6.30; −1.10)] in this same period.Conclusion: The COVID-19 pandemic changed the pattern of antibiotic consumption in Brazil, with a decrease in the use of amoxicillin and cefalexin and an increase in the consumption of azithromycin.

Objetivo. Determinar a prevalência de Staphylococcus aureus resistente à meticilina (MRSA) em animais destinados à produção de alimentos na região das Américas. Métodos. Foi realizada uma revisão sistemática nas seguintes bases de dados: Scopus, Web of Science, MEDLINE, EMBASE e Biblioteca Virtual de Saúde (BVS). Foram selecionados artigos publicados nos últimos 10 anos, sem restrição quanto ao idioma. O desfecho de interesse foi a prevalência de MRSA em animais destinados à produção de alimentos. As prevalências foram agrupadas em metanálises de efeitos aleatórios pelo método de DerSimonian e Laird. A distribuição geográfica dos microrganismos resistentes e o decurso temporal das tendências de resistência também foram analisados. Resultados. Dos 19 estudos incluídos, 11 foram conduzidos nos Estados Unidos e 11 analisaram amostras em suínos. Cinco estudos foram realizados na América do Sul. As amostras analisadas foram coletadas em locais de criação, de abate e de venda. A prevalência de MRSA na região das Américas foi de 7,6% (IC95%: 5,6 a 9,5%) e apresentou-se maior em suínos [12,6% (IC95%: 7,0 a 18,2%)], seguidos por bovinos [2,4% (IC95%: 1,2 a 3,7%)] e aves [1,8% (IC95%: 0,3 a 3,4%)]. Observou-se maior prevalência de MRSA na população de suínos da América do Norte e de bovinos da América Latina. Não houve variação significativa da prevalência de resistência nos 10 anos analisados. Conclusões. A prevalência de MRSA em animais destinados à produção de alimentos na região das Américas foi maior em suínos, sem variação significativa da prevalência no decurso temporal.

During the COVID-19 pandemic, people worldwide, including the scientific community, were insecure and fearful. The lack of vaccines at the beginning of the pandemic and the high mortality rate led to a search for alternative treatments for COVID-19. Among these proposals, a postulated activity of azithromycin was frequently studied in early treatment. In view of this, many countries saw an increase in the consumption of this antibiotic. Thus, the objective of this study was to evaluate, in Brazil, whether there was an increase in azithromycin prescriptions made by dentists, as they may have been prescribing this antibiotic as a probable treatment for COVID-19. This is an interrupted time series that analyzed antimicrobial prescriptions data between January 2014 and July 2021. The data were taken from the National System of Controlled Products Management, and pre- and postpandemic periods were compared. To assess changes in azithromycin consumption, Joinpoint regression and analysis of variance, followed by Dunnett’s test, were used. More than 38 million prescriptions written during the period were analyzed. Amoxicillin (72.3%), azithromycin (18.0%), cephalexin (6.1%), and metronidazole (3.58%) were the most prescribed antibiotics. At the beginning of the pandemic, there was a drop in amoxicillin prescriptions motivated by a decrease in consultations, but conversely, in less than three months, azithromycin prescriptions grew by more than 100%. The exaggerated use of this antibiotic during the pandemic will certainly have consequences in the short and medium term on indicators of bacterial resistance. The use of guidelines and respect for the therapeutic protocols of government agencies should be fundamental for collective and strategic action in the fight against health emergencies.

Background: The deinstitutionalization process is complex, long-term and many countries fail to achieve progress and consolidation. Informing decision-makers about appropriate strategies and changes in mental health policies can be a key factor for it. This study aimed to develop an evidence brief to summarize the best available evidence to improve care for deinstitutionalized patients with severe mental disorders in the community.Methods: We used the SUPPORT (Supporting Policy Relevant Reviews and Trials) tools to elaborate the evidence brief and to organize a policy dialogue with 24 stakeholders. A systematic search was performed in 10 electronic databases and the methodological quality of systematic reviews (SRs) was assessed by AMSTAR 2.Results: Fifteen SRs were included (comprising 378 studies and 69,736 participants), of varying methodological quality (3 high-quality SRs, 2 moderate-quality SRs, 7 low-quality SRs, 3 critically low SRs). Six strategies were identified: (i). Psychoeducation; (ii). Anti-stigma programs, (iii). Intensive case management; (iv). Community mental health teams; (v). Assisted living; and (vi). Interventions for acute psychiatric episodes. They were associated with improvements on a global status, satisfaction with the service, reduction on relapse, and hospitalization. Challenges to implementation of any of them included: stigma, the shortage of specialized human resources, limited political and budgetary support.Conclusions: These strategies could guide future actions and policymaking to improve mental health outcomes.

Evidence on the use of non-steroidal anti-inflammatory drugs (NSAIDs) and corticoids for rheumatoid arthritis (RA) is inconclusive and is not up to date. This systematic review assessed the effectiveness and safety of these anti-inflammatories (AI) in the treatment of RA. COCHRANE (CENTRAL), MEDLINE, EMBASE, CINAHL, Web of Science and Virtual Health Library were searched to identify randomized controlled trials (RCT) with adults which used AI (dose represented in mg/day) compared with placebo or active controls and was carried out up to December of 2019. Reviewers, in pairs and independently, selected studies, performed the data extraction and assessed the risk of bias. The quality of the evidence was assessed by GRADE. Network meta-analyses were performed using the Stata v.14.2. Twenty-six articles were selected (NSAIDs = 21 and corticoids = 5). Naproxen 1,000 improved physical function, reduced pain and the number of painful joints compared to placebo. Etoricoxib 90 reduced the number of painful joints compared to placebo. Naproxen 750 reduced the number of swollen joints, except for etoricoxib 90. Naproxen 1,000, etoricoxib 90 and diclofenac 150 were better than placebo regarding patient assessment. Assessment physician showed that NSAIDs were better than placebo. Meta-analyses were not performed for prednisolone and prednisone. Naproxen 1,000 was the most effective drug and celecoxib 200 showed fewer adverse events. However, the low quality of the evidence observed for the outcomes with NSAIDs, the absence of meta-analyses to assess the outcomes with corticoids, as well as the risk of bias observed, indicate that future RCT can confirm such findings.

BackgroundThe judicialization of health care is a social claim concerning the right to the access to health care. It usually occurs due to gaps in public policy or failures in its application. In Brazil, several public institutions have implemented strategies to approach this phenomenon. However, these strategies have not yet been systematized into functional categories.ObjectiveTo categorize and analyze the strategies implemented by public institutions in Brazil to approach the judicialization of health care.MethodA systematic scoping review was developed following the method proposed by the Joanna Briggs Institute. The descriptor ‘judicialization of health’ was used to conduct the searches for studies in 18 electronic databases and other types of documents in the gray literature until March 2019. Documents containing the reports of strategies implemented in public institutions to approach the judicialization of health care in Brazil were included. Two independent reviewers assessed the eligibility of the documents and extracted the data. The strategies identified were categorized using definitions from the World Health Organization and existing Brazilian legislation.ResultsSeventy eight implemented strategies were identified and organized into nine categories: i. Technical support to the judiciary; ii. State health committees; iii. Organization of assistance; iv. Compliance with court orders, v. Computerized information systems; vi. Administrative proceeding; vii. Defense of the public authority; viii. Pharmacy and therapeutics committee; ix. Alternative dispute resolution. These categories are not mutually exclusive and often act in concert or complement each other’s activities. They represent services either existing or provided for in legal provisions by the public administration to meet various types of demands.ConclusionsThe categories proposed to approach the judicialization of health care represent some of the recommendations for qualifying public administration or are provided for in Brazilian legislation, or both. The existence of recommendations and legislation facilitate, but do not guarantee, the implementation of strategies by public institutions.

BackgroundKnowledge translation (KT) is an effective strategy that uses the best available research evidence to bring stakeholders together to develop solutions and improve public health policy-making. Despite progress, the process of deinstitutionalization in Brazil is still undergoing consolidation, and the changes and challenges that are involved in this process are complex and necessitate evidence-informed decision-making. Accordingly, this study used KT tools to support efforts that aim to improve the care that is available to deinstitutionalized people with severe mental disorders in Brazil.MethodsWe used the Supporting Policy Relevant Reviews and Trials tools for evidence-informed health policymaking and followed eight steps: 1) capacity building; 2) identification of a priority policy issue within a Brazilian public health system; 3) meetings with policy-makers, researchers and stakeholders; 4) development of an evidence brief (EB) that addresses the problem of deinstitutionalization; 5) facilitating policy dialogue (PD); 6) the evaluation of the EB and PD; 7) post-dialogue mini-interviews; and 8) dissemination of the findings.ResultsCapacity building and meetings with key informants promoted awareness about the gap between research and practice. Local findings were used to define the problem and develop the EB. Twenty-four individuals (policy-makers, stakeholders, researchers, representatives of the civil society, and public defense) participated in the PD. They received the EB to subsidise their deliberations during the PD, which in turn were used to validate and improve the EB. The PD achieved the objective of promoting an exhaustive discussion about the problem and proposed options and improved communication and interaction among those who are involved in mental health care. The features of both the EB and PD were considered to be favorable and helpful.ConclusionsThe KT strategy helped participants understand different perspectives and values, the interpersonal tensions that exist among those who are involved in the field of mental health, and the strategies that can bridge the gap between research and policy-making. The present findings suggest that PDs can influence practice by promoting greater engagement among stakeholders who formulate or revise mental health policies.

Background: Biological agents used for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) are associated with serious adverse effects (SAEs). Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to a relative lack of long-term safety data.Objective: To determine the frequency and severity of adverse effects associated with the long-term use of biologics in the treatment of PsA and RA, and possible risk factors for such events in a real-life setting.Methods: We conducted a longitudinal study in PsA and RA patients only taking long-term biological agents from 2003 to 2011. Sources of information included dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients inquiring about any apparent medication-related adverse drug reactions (ADRs) or SAEs. ADR/SAE’s data was based on pharmacy reports. We conducted a multivariate analysis to identify the factors associated with the risk of ADRs.Results: Of the 305 patients identified, we interviewed 268 patients. Most of these were taking adalimumab 127 (47.4%), 52 (19.4%) etanercept, 42 (15.7%) infliximab, 25 (9.3%) rituximab, 10 (3.7%) abatacept, 9 (3.4%) efalizumab, and 3 (1.1%) tocilizumab. Of the 268 patients, 116 (43.3%) experienced one or more adverse events related to biological agents with 1.6 events per patient, and of these 29 (25%) experienced one or more SAEs, with majority subjected to hospitalizations. The most frequently reported ADRs were administration site reactions as observed in 73 patients (27.2%), infections in 30 patients (11.2%), effects on nervous system in 22 patients (8.2%), and 15 (5.6%) patients withdrew due to ADRs. The use of rituximab was related with less risk of ADR [PR 0.42, 95% CI 0.18–0.96; p = 0.04] than other agents. No other predisposing factors were associated with risk of ADR. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%).Conclusion: These data showed the early biological experience in Brazil that were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients’ perceptions are increasingly important for future decision-making.

O objetivo deste trabalho foi analisar o elenco de medicamentos do Programa Farmácia Popular do Brasil (PFPB) frente à política de assistência farmacêutica vigente no país. O elenco de medicamentos do PFPB foi comparado com listas de referência de medicamentos essenciais (nacional e internacional), com os componentes da assistência farmacêutica no Sistema Único de Saúde (SUS) e com a produção pública de medicamentos nos Laboratórios Farmacêuticos Oficiais do Brasil (LFOB). O PFPB contém 119 medicamentos, dos quais 19,3% e 47,1% não foram selecionados nas listas de referência nacional e internacional, respectivamente; 16,8% não são utilizados na atenção primária e 40,3% não são produzidos por LFO. A revisão do elenco do PFPB com base na concepção de medicamentos essenciais da Organização Mundial da Saúde, o alinhamento às políticas de assistência farmacêutica e à produção pelos LFO são fundamentais para melhorar a qualidade da atenção à saúde, a gestão, a capacitação dos prescritores e a informação aos cidadãos.

OBJECTIVE To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil. METHODS This is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions. RESULTS A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes. CONCLUSIONS The plaintiffs resorted to legal action to get access to biological medications because they were either unaware or had difficulty in accessing them through institutional public health system procedures. Access by means of legal action facilitated long-term use of this type of medication through irregular prescriptions and led to a high rate of adverse drug reactions as well as inappropriate clinical monitoring.

INTRODUCTION: Inappropriate use of antibiotics leads to increased levels of bacterial resistance making it difficult to treat upper respiratory tract infections. The appropriate use of these drugs has a fundamental role in controlling resistance and in success of treatment of childhood infections. Therefore, the aim of this study was to assess the prescription and use of antibiotics for Brazilian children. METHODS: The use of antibiotics in 160 children was monitored in two Primary Health Centers by questionnaires administered to parents and caregivers that assessed the social, demographic and clinical conditions of the children. Furthermore, the antibiotic use pattern was ascertained in these children and compared to the recommendations of the Brazilian and international guidelines. RESULTS: The use of these drugs had an inverse relationship with children breast-fed to six months of age, showing that breast-fed children had a tendency to use less of these drugs. There was great variability in the amoxicillin doses used for upper respiratory infections ranging from 8.2 to 91.9 mg/kg/day. The doses used in most treatments were far below the doses recommended in the Brazilian and international guidelines (50% and 97%, respectively). CONCLUSION: Although there are guidelines for the use of these medications, compliance is still very low, leading to under dosage and therapeutic failures. It is essential for pediatricians to be aware of and comply with the guidelines, avoid personal decisions and take measures based on strong clinical evidence. The proper use of these medications, in addition to greater therapeutic success, decreases the possibility of the appearance of resistant microorganisms.

OBJETIVO: Analisar a solicitação judicial de medicamentos previstos nos componentes da assistência farmacêutica no Sistema Único de Saúde. MÉTODOS: Foram analisados 81 processos judiciais para fornecimento de medicamentos no Estado de São Paulo, entre 2005 e 2009. As informações dos processos foram obtidas do Tribunal de Justiça do Estado de São Paulo. Portarias que regulamentam a assistência farmacêutica foram consultadas para identificar a solicitação judicial de medicamentos incorporados pelo Sistema Único de Saúde. Para análise do nível de evidência dos medicamentos nas indicações clínicas referidas, foi consultada a base de dados Thomson Micromedex®. RESULTADOS: O número de medicamentos solicitados em cada processo variou entre um e sete itens, nos quais foram identificados 77 fármacos diferentes. Dos medicamentos solicitados, 14,3% deveriam estar disponíveis na atenção básica do Sistema Único de Saúde, 19,5% no componente de medicamentos de dispensação excepcional e 66,2% não pertenciam a nenhuma lista oficial. Medicamentos do componente de dispensação excepcional apresentaram melhor evidência clínica quando indicados no tratamento de doenças cobertas pelos Protocolos Clínicos e Diretrizes Terapêuticas do Ministério da Saúde. CONCLUSÕES: A via judicial tem sido utilizada para garantir o acesso a medicamentos cujo fornecimento está previsto no Sistema Único de Saúde e para solicitar aqueles não incorporados por ele. A avaliação do nível de evidência reforça a necessidade de análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial.OBJETIVO: Analizar la solicitud judicial de medicamentos previstos en los componentes de la asistencia farmacéutica en el Sistema Único de Salud. MÉTODOS: Se analizaron 81 procesos judiciales para abastecimiento de medicamentos en el Estado de Sao Paulo, Sureste de Brasil, entre 2005 y 2009. Las informaciones de los procesos fueron obtenidas en el Tribunal de Justicia del Estado de Sao Paulo. Los documentos administrativos legales que regulan la asistencia farmacéutica fueron consultados para identificar la solicitud judicial de medicamentos incorporados por el Sistema Único de Salud. Para análisis del nivel de evidencia de los medicamentos en las indicaciones clínicas referidas, fue consultada la base de datos Thomson Micromedex®. RESULTADOS: El número de medicamentos solicitados en cada proceso varió entre uno y siete ítems, en los cuales fueron identificados 77 fármacos diferentes. De los medicamentos solicitados, 14,3% deberían estar disponibles en la atención básica del Sistema Único de Salud, 19,5% en el componente de medicamentos de dispensación excepcional y 66,2% no pertenecían a ninguna lista oficial. Medicamentos del componente de dispensación excepcional presentaron mejor evidencia clínica al ser indicados en el tratamiento de enfermedades cubiertas por los Protocolos Clínicos y Directrices Terapéuticas del Ministerio de la Salud. CONCLUSIONES: La vía judicial ha sido utilizada para garantizar el acceso a medicamentos cuyo abastecimiento está previsto en el Sistema Único de Salud y para solicitar aquellos no incorporados por él. La evaluación del nivel de evidencia refuerza la necesidad de análisis técnica para la toma de decisión del abastecimiento de medicamentos por la vía judicial.OBJECTIVE: To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS - Brazilian Unified Health System). METHODS: We analyzed 81 judicial requests for medications in the State of São Paulo between 2005 and 2009. The details of these cases were obtained electronically from the Court of Justice of the State of São Paulo. Directives that regulate pharmaceutical assistance were consulted to identify judicially requested medications that are covered by the SUS. To assess the level of evidence supporting the use of these medications to treat the clinical indications described, we consulted the Thomson Micromedex® database. RESULTS: The number of individual medications requested in each case ranged from 1 to 7; in total, 77 different pharmaceuticals agents were identified. Of the medications requested, 14.3% should have been available through SUS primary care, 19.5% were classified under the exceptionally dispensed medications component of the SUS, and 66.2% were not on any official list. Medications of the exceptionally dispensed medications component showed better clinical evidence when indicated for the treatment of medical conditions covered by the Clinical Protocols and Therapeutic Guidelines of Brazil's Ministry of Health. CONCLUSIONS: The judicial process has been used to ensure access to medications that are covered by the SUS and to request access to those that are not covered. Our assessment of the level of available evidence reinforces the need for technical analysis in the decision-making process in cases of judicially requested medications.

Establishing an effective antimicrobial therapeutic requires choosing the appropriate antibiotic and ensuring compliance with times and doses prescribed. Problems concerning early abandonment and unfinished prescriptions due to lack of information, as well as more resistant microorganisms, have been identified as the major factors responsible for therapeutic failure in bacterial infections. This study aimed to determine the level of information among antibiotic users undergoing treatment with these drugs, and habits related to other therapies. A survey was applied to 403 users and identified great difficulties in understanding prescriptions, especially among users with no formal schooling who understood only 21 to 28% of the prescribed instructions. This same group reported having received the lowest amount of information during the consultation, with only 28.6% receiving verbal information from the prescriber on the length of course with the drug. Additionally, 21% of this group reported a tendency to use the antibiotic until symptoms resolved, without heeding the length of course prescribed. Guidance on antibiotics use should be an integral and fundamental part of effective therapy.Para se estabelecer uma terapêutica antimicrobiana eficaz, é necessário que se escolha o fármaco adequado e que este seja utilizado na dose e tempo prescritos. Abandonos precoces e o não cumprimento da prescrição, originados por falta de informação adequada, têm sido apontados, juntamente com microrganismos resistentes, como os grandes responsáveis por falhas terapêuticas no tratamento de infecções bacterianas. Este trabalho teve por objetivo conhecer o nível de informação de usuários de antibióticos sobre estes fármacos, tanto na terapêutica a que estavam sendo submetidos, quanto em seus hábitos em outras terapêuticas. Por meio de um questionário aplicado a 403 usuários, notou-se uma grande dificuldade de entendimento da prescrição, especialmente por usuários sem estudo formal, chegando a níveis de entendimento de apenas 21 a 28% das prescrições estabelecidas. Esse mesmo grupo relatou ter recebido a menor quantidade de informações durante a consulta, apenas 28,6% receberam informações verbais do prescritor sobre o tempo que deveriam utilizar o medicamento. Adicionalmente, foi percebido que 21% desse grupo informaram que têm o costume de utilizar o antibiótico até desaparecer os sintomas, sem se preocupar com o tempo prescrito. A orientação para a utilização do medicamento é parte integrante e fundamental de uma terapêutica eficaz.

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17% dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões. CONCLUSÕES: Os resultados reforçam a necessidade de qualificação técnica para tratar as demandas judiciais e exige capacitação dos profissionais no manejo da literatura científica, na seleção adequada dos fármacos e na escolha da melhor conduta terapêutica para cada condição clínica. Dessa forma será possível garantir o acesso a tecnologias eficazes e seguras, e assim aprimorar o modelo de assistência farmacêutica em oncologia.OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17% de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones. CONCLUSIONES: Los resultados refuerzan la necesidad de calificación técnica para tratar las demandas judiciales y exige capacitación de los profesionales en el manejo de la literatura científica, en la selección adecuada de los fármacos y en la escogencia de la mejor conducta terapéutica para cada condición clínica. De esta forma será posible garantizar el acceso a tecnologías eficaces y seguras, y así perfeccionar el modelo de asistencia farmacéutica en oncología.OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.

The vancomycin dose for hemodialysis (HD) patients should be adjusted by monitoring drug serum concentrations. However, this procedure is not available in most health services in Brazil, which usually adopts protocols based on published studies. The trials available are controversial, and several have not been conducted with current dialyzers. This study aimed at assessing the suitability of vancomycin serum concentrations in HD patients at a public hospital. Blood samples of HD patients were collected from November 2006 to May 2007, at time intervals of 48, 96, 120, or 168 hours after vancomycin administration. Drug measurement was performed with polarized light immunofluorescence. Approximately 86% of trough vancomycin serum concentrations were below the recommended value, indicating exposure to subtherapeutic doses and a higher risk for selecting resistant microorganisms. Keywords: vancomycin, chronic renal failure, hemodialysis

INTRODUÇÃO: O objetivo deste estudo foi conhecer os padrões de utilização de antibióticos no município de Sorocaba, avaliando o diagnóstico referido, a terapêutica empregada e sua utilização. MÉTODOS: Utilizou-se um instrumento de avaliação aplicado por 12 meses em usuários de antibióticos. Foram coletados dados de 403 usuários e referiram-se à: informações sociodemográficas e de saúde, diagnóstico e terapêutica. RESULTADOS: Encontrou-se grande utilização e a maior utilização prévia na faixa etária de 0-10 anos (pINTRODUCTION: The aim of this study was to find out about the patterns of antibiotic use in the municipality of Sorocaba, through evaluating the reported diagnosis and the therapy used. METHODS: An evaluation tool was applied among antibiotic users over a 12-month period. Sociodemographic data and information relating to health, diagnosis and therapeutics were gathered in relation to 403 users. RESULTS: Great present use and the greatest previous use was found in the 0-10 year-old age group (p < 0.05). Infections with lung involvement were the ones most mentioned (p < 0.05) and penicillins were the drugs most used, present in 45.1% of the prescriptions. The mean duration of therapy for otitis (8.9 days) was below the recommendation. For sinusitis, 22% of the prescriptions did not give guidance regarding recommended use (10 days). CONCLUSIONS: The lack and/or nonuse of therapeutic protocols resulted in great differences in prescription patterns, thereby leading to therapeutic failure and recurrence of infections, which were situations frequently found in this study.

The vancomycin dose for hemodialysis (HD) patients should be adjusted by monitoring drug serum concentrations. However, this procedure is not available in most health services in Brazil, which usually adopts protocols based on published studies. The trials available are controversial, and several have not been conducted with current dialyzers. This study aimed at assessing the suitability of vancomycin serum concentrations in HD patients at a public hospital. Blood samples of HD patients were collected from November 2006 to May 2007, at time intervals of 48, 96, 120, or 168 hours after vancomycin administration. Drug measurement was performed with polarized light immunofluorescence. Approximately 86% of trough vancomycin serum concentrations were below the recommended value, indicating exposure to subtherapeutic doses and a higher risk for selecting resistant microorganisms.

OBJETIVO: Analisar a solicitação judicial de medicamentos previstos nos componentes da assistência farmacêutica no Sistema Único de Saúde. MÉTODOS: Foram analisados 81 processos judiciais para fornecimento de medicamentos no Estado de São Paulo, entre 2005 e 2009. As informações dos processos foram obtidas do Tribunal de Justiça do Estado de São Paulo. Portarias que regulamentam a assistência farmacêutica foram consultadas para identificar a solicitação judicial de medicamentos incorporados pelo Sistema Único de Saúde. Para análise do nível de evidência dos medicamentos nas indicações clínicas referidas, foi consultada a base de dados Thomson Micromedex®. RESULTADOS: O número de medicamentos solicitados em cada processo variou entre um e sete itens, nos quais foram identificados 77 fármacos diferentes. Dos medicamentos solicitados, 14,3% deveriam estar disponíveis na atenção básica do Sistema Único de Saúde, 19,5% no componente de medicamentos de dispensação excepcional e 66,2% não pertenciam a nenhuma lista oficial. Medicamentos do componente de dispensação excepcional apresentaram melhor evidência clínica quando indicados no tratamento de doenças cobertas pelos Protocolos Clínicos e Diretrizes Terapêuticas do Ministério da Saúde. CONCLUSÕES: A via judicial tem sido utilizada para garantir o acesso a medicamentos cujo fornecimento está previsto no Sistema Único de Saúde e para solicitar aqueles não incorporados por ele. A avaliação do nível de evidência reforça a necessidade de análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial.

INTRODUCTION: Inappropriate use of antibiotics leads to increased levels of bacterial resistance making it difficult to treat upper respiratory tract infections. The appropriate use of these drugs has a fundamental role in controlling resistance and in success of treatment of childhood infections. Therefore, the aim of this study was to assess the prescription and use of antibiotics for Brazilian children. METHODS: The use of antibiotics in 160 children was monitored in two Primary Health Centers by questionnaires administered to parents and caregivers that assessed the social, demographic and clinical conditions of the children. Furthermore, the antibiotic use pattern was ascertained in these children and compared to the recommendations of the Brazilian and international guidelines. RESULTS: The use of these drugs had an inverse relationship with children breast-fed to six months of age, showing that breast-fed children had a tendency to use less of these drugs. There was great variability in the amoxicillin doses used for upper respiratory infections ranging from 8.2 to 91.9 mg/kg/day. The doses used in most treatments were far below the doses recommended in the Brazilian and international guidelines (50% and 97%, respectively). CONCLUSION: Although there are guidelines for the use of these medications, compliance is still very low, leading to under dosage and therapeutic failures. It is essential for pediatricians to be aware of and comply with the guidelines, avoid personal decisions and take measures based on strong clinical evidence. The proper use of these medications, in addition to greater therapeutic success, decreases the possibility of the appearance of resistant microorganisms.