Antimicrobial resistance of microorganisms present in periodontal diseases: A systematic review and meta-analysis.

Objective: The aim of this study was to estimate the antimicrobial resistance in microorganisms present in periodontal diseases. Methods: A 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. Results: Twenty-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. Conclusion: No 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 relevance: The 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].

Local anaesthetics combined with vasoconstrictors in patients with cardiovascular disease undergoing dental procedures: systematic review and meta-analysis.

OBJECTIVES: There is a lack of evidence about the use of local anaesthetics (LAs) in patients with cardiovascular diseases (CVD) in dental procedures. Thus, this study evaluated the safety of using LA with vasoconstrictor to determine the risk of cardiovascular events in patients with CVD. DESIGN: Systematic review and meta-analysis. METHODS: We have searched in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), Healthstar (via Ovid), CINAHL, Web of Science and ClinicalTrials.gov for randomised controlled trials (RCTs) up to January 2020. We have included RCTs involving adults with CVD within two groups: intervention group with LA with vasoconstrictor and control group with LA without vasoconstrictor. The primary outcomes assessed were death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding and arrhythmias. The secondary outcomes were ST segment depression, anxiety, adverse effects and changes in haemodynamic parameters. The data were pooled using random effects meta-analyses and the confidence in the estimates was verified using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Ten RCTs (n=478 participants) were included. Most of them had a high risk of bias. There were more cases of pain and bleeding in groups without vasoconstrictor. Meta-analysis demonstrated a decrease in the systolic blood pressure with the use of LA with vasoconstrictor (standard mean difference -0.95, 95% CI -1.35 to -0.55) after procedure. Overall, for the other outcomes assessed there was no statistical difference. The quality of evidence was considered low according to the GRADE profile. CONCLUSIONS: The results suggest that the use of LA with vasoconstrictors (epinephrine in low doses) is safe in patients with some types of CVD. However, the low quality of evidence demonstrated that literature needs further studies in order to confirm these results. PROTOCOL REGISTRATION: PROSPERO (CRD42016045421).

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: A methodological survey.

Acupuncture is one of the therapeutic resources used for the management of chronic pain. Variability in outcome measurements in randomized clinical trials of non-oncologic chronic pain (RCT-NOCP) generates inconsistencies in determining effects of treatments. The objective of this survey was to assess the adherence to the recommendations made by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in the measurement of RCT-NOCP of acupuncture. This methodological research made a systematic search for eligible studies from different sources of information. Eligible studies included those with number of patients ≥100, who randomized and allocated patients with chronic non-oncologic pain to be treated with acupuncture or with "sham" acupuncture, or non-acupuncture. This research included the recommendations for IMMPACT in the measurement of RCT-NOCP: presence of outcomes pain, physical function, emotional state and improvement perception of patient, the source of the outcome information pain and the tools used to measure such domains. From a total of 1,386 studies, 24 were included in this survey. Eleven studies presented low risk of bias. Pain outcome was measured in 23 studies, physical function in 22 studies, emotional state in 14 studies and improvement perception of patient in one study. As for the pain outcome, the patient was the information source in 50% of the studies. The measurement tools recommended for IMMPACT were included in eight studies (35%) that evaluated pain, one study that evaluated the emotional state (7%), and one study that evaluated the improvement perception and satisfaction of patient. It was observed that studies which did not adhere to the recommendations had more favorable results for acupuncture in the outcome pain. This study concludes that randomized clinical trials that used acupuncture to manage chronic pain failed to adhere to IMMPACT recommendations. Clinical societies and IMMPACT do not share the same recommendations. This fact reflects in the diversity of outcomes and instruments adopted in the studies, making it difficult to compare the results.

Herbal medications for anxiety, depression, pain, nausea and vomiting related to preoperative surgical patients: a systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To summarise the effects of herbal medications for the prevention of anxiety, depression, pain, and postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic, obstetrical/gynaecological or cardiovascular surgical procedures. METHODS: Searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and LILACS up until January 2018 were performed to identify randomised controlled trials (RCTs). We included RCTs or quasi-RCTs evaluating any herbal medication among adults undergoing laparoscopic, obstetrical/gynaecological or cardiovascular surgeries. The primary outcomes were anxiety, depression, pain and PONV. We used the Grading of Recommendations Assessment, Development and Evaluation approach to rate overall certainty of the evidence for each outcome. RESULTS: Eleven trials including 693 patients were eligible. Results from three RCTs suggested a statistically significant reduction in vomiting (relative risk/risk ratio (RR) 0.57; 95% CI 0.38 to 0.86) and nausea (RR 0.69; 95% CI 0.50 to 0.96) with the use of Zingiber officinale (ginger) compared with placebo in both laparoscopic and obstetrical/gynaecological surgeries. Results suggested a non-statistically significantly reduction in the need for rescue medication for pain (RR 0.52; 95% CI 0.13 to 2.13) with Rosa damascena (damask rose) and ginger compared with placebo in laparoscopic and obstetrical/gynaecological surgery. None of the included studies reported on adverse events (AEs). CONCLUSIONS: There is very low-certainty evidence regarding the efficacy of both Zingiber officinale and Rosa damascena in reducing vomiting (200 fewer cases per 1000; 288 fewer to 205 fewer), nausea (207 fewer cases per 1000; 333 fewer to 27 fewer) and the need for rescue medication for pain (666 fewer cases per 1000; 580 fewer to 752 more) in patients undergoing either laparoscopic or obstetrical/gynaecological surgeries. Among our eligible studies, there was no reported evidence on AEs. PROSPERO REGISTRATION NUMBER: CRD42016042838.

Local anaesthetics combined with vasoconstrictors in patients with cardiovascular disease undergoing dental procedures: systematic review and meta-analysis protocol.

INTRODUCTION: The use of vasoconstrictors combined with local anaesthetics (LAs) in dentistry for patients with cardiovascular disease (CVD) is still controversial in the scientific literature. It raises concerns regarding the possibility of transient episodes, triggering negative cardiovascular outcomes. METHOD/DESIGN: Trials eligible for our systematic review will enrol patients with CVD who have undergone dental treatments carried out with the use of LAs by comparing two arms: LAs with vasoconstrictors and LAs without vasoconstrictors. The research will be conducted in the electronic databases, namely Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Healthstar (via Ovid), Cumulative Index to Nursing and Allied Health Literature and Web of Science, from their inception to December 2017, without any restrictions in terms of language and status of publication. A team of reviewers will independently assess titles, abstracts and complete text to determine eligibility. For eligible studies, the same reviewers will perform data extraction and evaluate the risk of bias in the selected articles. The selected outcomes comprise death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding, arrhythmias, ischaemic episodes, anxiety, adverse effects, changes in blood pressure, changes in heart rate, anxiety and results obtained via oximetry. Whenever possible, we will conduct a meta-analysis to establish the effects of LAs with and without vasoconstrictors in the patients with CVD, and the overall quality of evidence for each outcome will be determined using the Grading of Recommendations Assessment, Development and Evaluation classification system. ETHICS AND DISSEMINATION: Ethics committee approval was not necessary because this is a protocol of systematic review. This systematic review will be submitted for presentation at conferences and for publication in a peer-reviewed journal. Our review will assess the risks of cardiovascular events when using LAs with and without vasoconstrictors in patients with CVD, focusing on important clinical outcomes. PROSPERO REGISTRATION NUMBER: CRD42016045421.

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

INTRODUCTION: Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain. OBJECTIVE: To check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment. METHOD: This is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of 'acupuncture', 'chronic pain' and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations. ETHICS AND DISSEMINATION: This survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain.

Oral herbal medicines marketed in Brazil for the treatment of osteoarthritis: A systematic review and meta-analysis.

Herbal medications are commonly used to manage symptoms associated with osteoarthritis (OA). This systematic review evaluated the effectiveness and safety of oral medications used in Brazil for the treatment of OA. Randomized clinical trials involving adults with OA treated by a herbal medicine or a control group were eligible. The primary outcomes measured were pain, physical function, swelling, stiffness and quality of life; and the secondary outcomes were adverse events, activity limitations and treatment satisfaction. Sixteen studies were included (n = 1,741 patients) in the systematic review and nine studies in the meta-analysis, representing 6 of the 13 herbal medicines studied: Boswellia serrata (n = 2), Curcuma longa (n = 3), Harpagophytum procumbens (n = 1), Salix daphnoides (n = 3), Uncaria guianensis (n = 2) and Zingiber officinale (n = 5). B. serrata was more effective than both placebo and valdecoxib for improvement of pain and physical function. No difference was observed for H. procumbens, C. longa and U. guianensis compared with control. Z. officinale showed improvement of pain over placebo. The evidence was insufficient to support the effective and safe use of these herbal medicines, because the quality of evidence of studies was low. This study guides managers of the Brazilian public health system and prescribers in decision-making regarding the use of these herbal medicines for OA. Copyright © 2017 John Wiley & Sons, Ltd.

Brazilian oral herbal medication for osteoarthritis: a systematic review protocol.

BACKGROUND: Osteoarthritis affects 1 % of the world's population and is the most common cause of musculoskeletal impairment in the elderly. Herbal medications are commonly used in Brazil to manage symptoms associated with osteoarthritis, and some of them are financed by the Brazilian government; however, the effectiveness of most of these agents is uncertain. The aim was to systematically review the efficacy and safety of 13 oral herbal medications used in Brazil for the treatment of osteoarthritis. METHODS: Randomized clinical trials eligible for our systematic review will enroll adults with osteoarthritis treated by a Brazilian herbal medication or a control group (placebo or active control). Using terms to include all forms of osteoarthritis combined with herbal medications, we will search the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; Web of Science; Health Star; AMED, the database of the Cochrane Complementary Medicine Field, LILACS; CAB abstracts, Clinical trial.gov, WHO trials registry, and Bank of Brazil Thesis (CAPES), to 31 January 2016, without restrictions concerning language or status of publication. Outcomes of interest include the following: symptom relief (e.g., pain), adverse events (gastrointestinal bleeding, epigastric pain, nausea, and allergic reactions), discontinuation due to adverse events, quality of life, and the satisfaction with the treatment. Dichotomous data will be summarized as risk ratios; continuous data will be given as standard average differences with 95 % confidence intervals. A team of reviewers will assess each citation independently for eligibility and in duplicate it. For eligible studies, the same reviewers will perform data extraction, bias risk assessment, and determination of the overall quality of evidence for each of the outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification system. DISCUSSION: This is the first study that will evaluate the use of herbal medications used in Brazil for the treatment of pain caused by osteoarthritis. The results could guide prescribers in decision-making in clinical practice, to inform the patients with pain caused by osteoarthritis in relation to effective and safe treatment options and to inform the managers of the public health system which of the plants could actually be financed by the Brazilian government. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 42015019793.

[The list of drugs in the Popular Pharmacy Program and the Brazilian National Pharmaceutical Care Policy]. / Elenco de medicamentos do Programa Farmácia Popular do Brasil e a Política de Nacional Assistência Farmacêutica.

This study aimed to analyze the list of drugs in the Popular Pharmacy Program in Brazil (PFPB) in relation to the country's pharmaceutical care policy. The list of drugs in the PFPB was compared to the Brazilian and international reference lists of essential medicines, the components of pharmaceutical care in Brazilian Unified National Health System (SUS), and drug production by the country's government pharmaceutical laboratories. The PFPB list includes 119 drugs, of which 19.3% and 47.1% were not selected on the Brazilian and international reference lists, respectively; 16.8% are not used in primary care, and 40.3% are not produced by the country's government laboratories. A revision of the PFPB list based on the essential medicines concept (World Health Organization), alignment of pharmaceutical care policies, and production by government laboratories are essential to improve quality of health care, management, training of prescribers, and information for the population.

Elenco de medicamentos do Programa Farmácia Popular do Brasil e a Política de Nacional Assistência Farmacêutica / The list of drugs in the Popular Pharmacy Program and the Brazilian National Pharmaceutical Care Policy / Lista de medicamentos del Programa Farmacia Popular de Brasil y la Política Brasileña de Asistencia Farmacéutica

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.

This study aimed to analyze the list of drugs in the Popular Pharmacy Program in Brazil (PFPB) in relation to the country's pharmaceutical care policy. The list of drugs in the PFPB was compared to the Brazilian and international reference lists of essential medicines, the components of pharmaceutical care in Brazilian Unified National Health System (SUS), and drug production by the country's government pharmaceutical laboratories. The PFPB list includes 119 drugs, of which 19.3% and 47.1% were not selected on the Brazilian and international reference lists, respectively; 16.8% are not used in primary care, and 40.3% are not produced by the country's government laboratories. A revision of the PFPB list based on the essential medicines concept (World Health Organization), alignment of pharmaceutical care policies, and production by government laboratories are essential to improve quality of health care, management, training of prescribers, and information for the population.

El objetivo de este estudio fue analizar la lista de medicamentos del Programa Farmacia Popular de Brasil (PFPB), en contraste con la política de la asistencia farmacéutica, en vigor en el país. El catálogo de medicamentos del PFPB se comparó con las listas de referencias de medicamentos esenciales (nacionales e internacionales), así como con la lista de financiación de los componentes de la asistencia farmacéutica del sistema de salud pública, y la producción pública de medicamentos por Laboratorios Oficiales de Farmacéuticos de Brasil (LOFB). El PFPB contiene 119 medicamentos de los que un 19,3% y un 47,1% no fueron seleccionados en las listas de referencias nacionales e internacionales, respectivamente; un 16,8% no se utilizan en la atención primaria y un 40,3% no son producidos por los LOFB. La revisión del catálogo de PFPB, basado en la concepción de medicamentos esenciales de la Organización Mundial de la Salud, el alineamiento político de la asistencia farmacéutica, y la producción por los LOFB es fundamental para mejorar la calidad de la asistencia de salud, la gestión, la formación de los prescriptores y la información a los ciudadanos.

Women's values and preferences for thromboprophylaxis during pregnancy: a comparison of direct-choice and decision analysis using patient specific utilities.

BACKGROUND: Women with a history of venous thromboembolism (VTE) have an increased recurrence risk during pregnancy. Low molecular weight heparin (LMWH) reduces this risk, but is costly, burdensome, and may increase risk of bleeding. The decision to start thromboprophylaxis during pregnancy is sensitive to women's values and preferences. Our objective was to compare women's choices using a holistic approach in which they were presented all of the relevant information (direct-choice) versus a personalized decision analysis in which a mathematical model incorporated their preferences and VTE risk to make a treatment recommendation. METHODS: Multicenter, international study. Structured interviews were on women with a history of VTE who were pregnant, planning, or considering pregnancy. Women indicated their willingness to receive thromboprophylaxis based on scenarios using personalized estimates of VTE recurrence and bleeding risks. We also obtained women's values for health outcomes using a visual analog scale. We performed individualized decision analyses for each participant and compared model recommendations to decisions made when presented with the direct-choice exercise. RESULTS: Of the 123 women in the study, the decision model recommended LMWH for 51 women and recommended against LMWH for 72 women. 12% (6/51) of women for whom the decision model recommended thromboprophylaxis chose not to take LMWH; 72% (52/72) of women for whom the decision model recommended against thromboprophylaxis chose LMWH. CONCLUSIONS: We observed a high degree of discordance between decisions in the direct-choice exercise and decision model recommendations. Although which approach best captures individuals' true values remains uncertain, personalized decision support tools presenting results based on personalized risks and values may improve decision making.

Vitamin D and respiratory infections.

Vitamin D or 1,25-hydroxyvitamin D (1,25(OH)2 D) has a well-established role in calcium homeostasis. In recent years, the discovery of vitamin D-metabolizing enzymes and vitamin D receptor (VDR) in the lungs and various cells of the immune system has led to numerous studies conducted to evaluate its role in respiratory functions and, in particular, upper respiratory tract infections (URTIs). A PubMed literature search was done using vitamin D and respiratory infections as key words. Only clinical studies were considered. This study aimed to review recent clinical and epidemiological studies conducted in adults and children, and to evaluate the functional role of vitamin D in respiratory infections. The evaluated studies show an important immunomodulatory role of vitamin D, which reduces the incidence and risk of URTIs, both in children and in adults. Combating URTIs can be done prophylactically, associating the use of vaccines against Streptococcus pneumoniae with strengthening the immune system through supplementation with vitamin D. These actions can significantly contribute to reducing the number of URTIs, the use of antibiotics, and consequently, the rates of antimicrobial resistance.

Biological drugs for the treatment of psoriasis in a public health system.

UNLABELLED: 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.

Biological drugs for the treatment of psoriasis in a public health system / Medicamentos biológicos para o tratamento de psoríase em sistema público de saúde

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 ...

OBJETIVO Analisar o acesso e o perfil de utilização, por via judicial, de medicamentos biológicos para o tratamento de psoríase. MÉTODOS Estudo transversal descritivo. Foram entrevistados 203 pacientes com psoríase que demandaram medicamentos biológicos, por via judicial, ao Estado de São Paulo, entre 2004 e 2010. Informações sobre características sociodemográficas, médico-sanitárias e político-administrativas foram complementadas com dados obtidos das respectivas ordens de dispensação quanto a medicamento biológico para tratamento de psoríase e autos correspondentes. Os dados foram analisados em banco eletrônico e as variáveis sumarizadas por frequência simples. As prescrições contidas nos processos foram analisadas quanto aos preceitos legais contidos na lei. RESULTADOS Foram analisados 190 autos referentes aos medicamentos biológicos: adalimumabe, efalizumabe, etanercepte e infliximabe. Os proponentes obtiveram o medicamento por mandado de segurança (59,5%), sem nunca ter solicitado o medicamento biológico para outra instituição (86,2%), por sistema de saúde público ou privado. Utilizaram-se da prerrogativa de gratuidade de justiça (72,6%), embora fossem representados por advogado particular (91,1%) e atendidos em consultórios médicos privados (69,5%). Utilizaram o medicamento biológico por período > 13 meses (66,0%) e 44,9% faziam uso do medicamento no momento da entrevista. Quase um terço daqueles que deixaram de usar os medicamentos abandonou o tratamento por piora do quadro (26,6%), efeitos adversos (20,5%), falta de eficácia ou suspensão pelo médico (13,8%). Nenhuma prescrição médica atendeu aos preceitos legais; 70,3% dos pacientes não haviam realizado exames laboratoriais (hemograma, função ...

Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial / A technical analysis of medicines request-related decision making in Brazilian courts / Análisis técnico para la toma de decisiones de abastecimiento de medicamentos por la vía judicial

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 por cento deveriam estar disponíveis na atenção básica do Sistema Único de Saúde, 19,5 por cento no componente de medicamentos de dispensação excepcional e 66,2 por cento 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.

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 percent should have been available through SUS primary care, 19.5 percent were classified under the exceptionally dispensed medications component of the SUS, and 66.2 percent 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.

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 por ciento deberían estar disponibles en la atención básica del Sistema Único de Salud, 19,5 por ciento en el componente de medicamentos de dispensación excepcional y 66,2 por ciento 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.

A technical analysis of medicines request-related decision making in Brazilian courts.

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.