Evaluation of Immunobiological Cold Chain Costs.

Background and Purpose: Studies assessing the costs of the immunobiological cold chain (CC) are scarce. Therefore, the factors that influence the allocation of resources in this process are not known. The objective of this study is to determine the cost of the immunobiological CC. Methods: The Health Economic Assessment study was carried out in Minas Gerais, Brazil, between 2021 and 2022. The unit of analysis was the municipal level of the CC. The perspective of the Public Health System (Sistema Único de Saúde) was considered as a funder, the year 2021 was considered as the time frame, and the period of 1 year was considered as the time horizon of the analysis. Direct medical, nonmedical, and indirect costs were included. A mixed technique was used involving micro- and macrocosting and sensitivity analysis to identify the influence of the main categories on the final cost. Results: The total cost was USD 20,014,545, with nonmedical direct costs being the most representative (61.24%). Human resources were the most influential items, representing 76.43% of the total cost. Conclusions: The most influential items should be those of greatest concern and planned by managers to make the CC more efficient.

Patients in insulin analogues use via judicial litigation: do they use the Brazilian Public Health System (SUS)? / Pacientes em uso de análogos de insulina via ação judicial: eles utilizam o Sistema Único de Saúde (SUS)?

Abstract Background Studies show that among the drugs most commonly used in judicial litigation in Brazil, are those used to treat diabetes mellitus, especially insulin analogues. Objective Evaluate the use of the Unified Health System (SUS) by patients with type 1 diabetes mellitus (T1DM), who receive insulin analogues through judicial action, before and after this process. Method In a retrospective longitudinal observational study, secondary data was used from these patients in Minas Gerais, Brazil, in 2018. Socio-demographic information was collected and related to the follow-up of these patients in the SUS. The McNemar χ2 test was used to compare the proportions of the variables. Results Of the 89 patients analyzed, women (53.9%) were predominant. Most patients were aged between 20 and 39 years (52.8%), and more than half, 55.1%, use only a private health system. After the judicial action, there was a significant increase (p <0.05) in the number of patients who had consultations in primary health care (from 19.1% to 30.3%) and emergency medical appointments (from 1.1% to 9.0%). Conclusion It is observed that the majority of patients with T1DM via judicial action in the SUS are not monitored by this health system through examinations, consultations, and hospitalizations.

Resumo Introdução Estudos mostram que, dentre os medicamentos mais adquiridos via ação judicial, estão os utilizados para o tratamento do Diabetes Mellitus, especialmente os análogos de insulina. Objetivo Avaliar a utilização do Sistema Único de Saúde (SUS) pelos pacientes com Diabetes Mellitus tipo 1 (DM1), que recebem insulina por meio de judicialização, antes e após este processo. Método Em um estudo observacional longitudinal retrospectivo, foram utilizados dados secundários de pacientes com DM1, que adquiriram insulinas por processos judiciais em Divinópolis-MG, Brasil, em 2018. Foram coletadas informações sociodemográficas e referentes ao acompanhamento destes pacientes no SUS Realizou-se o teste χ2 de McNemar para a comparação das proporções das variáveis utilizadas para a avaliação do acompanhamento antes e após a judicialização. Resultados Dos 89 pacientes analisados, predominou-se o sexo feminino (53,9%), com idade entre 20 e 39 anos (52,8%). 55,1% destes utilizam apenas o sistema privado de saúde. Após a judicialização, houve um aumento significativo (p< 0,05) no número de pacientes que realizaram consultas na atenção primária à saúde (de 19,1% para 30,3%) e consultas médicas de emergência (de 1,1% para 9,0%). Conclusão A maioria dos pacientes com DM1 que judicializam medicamentos no SUS não são acompanhados por este sistema de saúde através de realização de exames, consultas e hospitalizações.

Pharmacotherapeutic follow-up in patients with type 1 diabetes in context of judicialization: possibility optimize costs

Abstract In Brazil, insulin analogs stand out as one of the most demanded medications by judicial means. However, the guarantee of judicial access does not guarantee rational use. In context, pharmacotherapeutic follow-up (PF) is shown to be clinical effective strategy for patients with diabetes. To evaluate direct medical costs one year after performing PF in patients with type 1 diabetes mellitus using insulin analogs ordered by court in Public Health System (Sistema Único de Saúde - SUS). This is a partial economic analysis, nested within a quasi-experimental study. Patients with T1DM who receive insulin analogs by judicialization in a medium-sized Brazilian city participated. The PF was conducted following the method adapted from the Pharmacotherapy workup (PW). Data were collected considering the period of one year before the start of the intervention and one year after the start of the intervention. Direct medical costs were evaluated and the difference in costs was calculated. 28 patients participated in the intervention. After PF, direct costs were -$3,696.78. Sensitivity analysis showed that there is a 33.4 % chance for PF to present cost savings when compared to baseline. The PF has the potential to reduce direct medical costs from the perspective of the SUS.

Rastreamento da doença renal do diabetes na atenção primária à saúde / Screening for diabetes kidney disease in primary health care

A Doença Renal do Diabetes (DRD) é assintomática nos estágios iniciais da doença, e por esse motivo, a maioria dos pacientes é diagnosticada somente quando já apresenta várias complicações. O objetivo deste estudo foi avaliar se o rastreio da DRD está sendo realizado de maneira adequada em pacientes com diabetes mellitus tipo 2 (DM2) atendidos na atenção primária à saúde (APS) do Sistema Único de Saúde. Foi realizado um estudo transversal, com duração de cinco meses, na APS dos municípios de Bernardino de Campos e Salto Grande, SP. Os critérios de inclusão foram: diagnóstico de DM2, idade > 18 anos, e ser acompanhado nas unidades participantes do estudo. Um total de 1093 atenderam aos critérios de inclusão e aceitaram participar do estudo. Foi verificado que 398 (36,4%) dos pacientes nunca realizaram os exames de albumina urinária e creatinina, e não tiveram calculados a relação albumina/creatinina em amostra de urina com o cálculo da taxa de filtração glomerular (TFG) estimada pela CKD-EPI a partir da creatinina sérica; 401 (36,7%) dos pacientes realizaram estes exames e tiveram estes índices calculados nos últimos 12 meses. Estes 401 pacientes realizaram estes exames e cálculos de rastreio da DRD uma vez a cada 12 meses nos últimos 5 anos. Os demais pacientes (294; 26,9%) realizaram somente exame de creatinina sérica nos últimos 12 meses. Os resultados demonstraram que o rastreamento da DRD não está sendo realizado de maneira adequada na maioria dos pacientes (AU).

Diabetes Kidney Disease (DRD) is asymptomatic in the early stages of the disease, and for this reason, most patients are diagnosed only when they already have several complications. The aim of this study was to assess whether DRD screening is being carried out properly in patients with type 2 diabetes mellitus (DM2) treated in primary health care (PHC) of the Unified Health System. A cross-sectional study was carried out, lasting five months, in the PHC of the municipalities of Bernardino de Campos and Salto Grande, SP. Inclusion criteria were: diagnosis of DM2, age > 18 years, and being monitored in the units participating in the study. A total of 1093 met the inclusion criteria and agreed to participate in the study. It was found that 398 (36.4%) of the patients had never performed urine albumin and creatinine tests, and they did not calculate the albumin/creatinine ratio in a urine sample, together with the calculation of the glomerular filtration rate (GFR) estimated by CKD-EPI from serum creatinine; in contrast, 401 (36.7%) of the patients underwent these exams and had these indexes calculated in the last 12 months. These 401 patients had these DRD screening tests and calculations performed once every 12 months for the last 5 years. Os demais pacientes (294; 26,9%) realizaram somente exame de creatinina sérica nos últimos 12 meses. Os resultados demonstraram que o rastreamento da DRD não está sendo realizado de maneira adequada na maioria dos pacientes (AU).

Avaliação econômica de uma estratégia individual de empoderamento farmacoterapêutico: um modelo em longo prazo aplicado do diabetes mellitus tipo II / Economic evaluation of an individual pharmacotherapeutic empowerment strategy: an applied long-term model for type II diabetes mellitus

Objetivos: contribuir para a geração de dados de avaliação econômica de estratégias de empoderamento farmacoterapêutico para pacientes com Diabetes Mellitus tipo 2 (DM tipo 2). Métodos: este estudo farmacoeconômico é aninhado a um ensaio clínico com controle não randomizado que incluiu pacientes ≥18 anos de idade, cadastrados no HIPERDIA. Os pacientes foram alocados em um modelo de Markov conforme valores de hemoglobina glicada do acompanhamento. As probabilidades do surgimento de complicações relativas ao DM, incluindo-se óbito, foram estimadas por dez anos. Cada complicação do DM tipo 2 teve seu custo estabelecido para determinação do custo anual. Resultados: entre os participantes da intervenção, não ocorrem óbitos ocasionados por DM tipo 2, e a progressão de complicações mantém-se estável durante os anos simulados, enquanto, no grupo controle, 60% dos pacientes podem evoluir para óbito nos dez anos, e a probabilidade de serem acometidos por complicações relacionadas ao DM tipo 2 é crescente. Com relação aos custos, ao final de dez anos, os pacientes que participaram da Estratégia Individual de Empoderamento Farmacoterapêutico (EIEF) tiveram um custo médio de UU$134,45 poupando a vida de 100% dos pacientes, e os pacientes do atendimento convencional um custo médio de UU$237,12 e 40% dos pacientes acompanhados chegariam ao final do ciclo com vida. Conclusão: a EIEF parece ser uma alternativa economicamente viável em longo prazo, bem como para a promoção do controle glicêmico.

Objectives: contribute to the data generation for the economic evaluation of pharmacotherapeutic empowerment strategies for type 2 diabetes mellitus patients (type 2 DM). Method: This pharmacoeconomic study is nested in a clinical trial with non-randomized control that included patients ≥18 years old, registered in HIPERDIA. The patients were allocated to a Markov model according to the follow-up glycated hemoglobin values. The probabilities of the appearance of complications related to DM, including death, have been estimated for ten years. Each complication of type 2 DM had its cost established to determine the annual cost. Results: Among the participants in the intervention, there are no deaths caused by type 2 DM, and the progression of complications remains stable during the simulated years, whereas in the control group, 60% of the patients can progress to death in ten years and the probability of being affected by complications related to type 2 DM is increasing. Regarding costs, at the end of ten years, patients who participated in Individual Pharmacotherapeutic Empowerment Strategy (IPES) had an average cost of US$ 134.45, saving 100% of patient's lives, and conventional care patients cost an average of US$ 237.12 and 40% of the patients followed would reach the end of the life cycle. Conclusion: The IPES seems like an economically viable and long-term economic alternative and promotes glycemic control.

Is screening for chronic kidney disease in patients with diabetes mellitus being properly conducted in primary care? / O rastreio da doença renal crônica nos pacientes com diabetes mellitus está sendo realizado adequadamente na atenção primária?

Abstract Introduction: Screening patients with diabetes mellitus (DM) for chronic kidney disease (CKD) enables early diagnosis and helps to establish adequate treatment and avoid possible damages to health associated with disease progression. This study aimed to verify whether screening for CKD has been properly conducted in populations with diabetes mellitus seen at primary care clinics. Methods: This descriptive study included 265 individuals with DM seen at Basic Healthcare Clinics in Divinópolis, MG, Brazil. Clinical and laboratory data were collected from the Integrated Health System. Frequency of testing and kidney function evaluations performed within the last 12 months were calculated along with the proportion of patients with increased urinary albumin excretion (UAE) and decreased glomerular filtration rate (GFR) to determine the proportion of patient with kidney involvement. Results: We found that 41.2% of the patients had kidney involvement and that 61.2% of the individuals with kidney involvement were on nephroprotective medication. Of the 21.9% tested for isolated albuminuria, 46.5% had increased UAE. The albumin-to-creatinine ratio (ACR) was measured in 12.1% of the patients, with 43.8% having an increased ACR. We found that 89.0% of the patients had their serum creatinine levels measured, and that 33.1% had a decreased GFR. Conclusion: CKD screening was more frequently performed via the GFR than UAE, a parameter analyzed only in a small proportion of patients. Therefore, CKD screening for patients with diabetes is not being performed properly in primary care.

Resumo Introdução: O rastreio da doença renal crônica (DRC) em pacientes com diabetes (DM) possibilita o diagnóstico precoce e ajuda a estabelecer um tratamento adequado, evitando possíveis danos à saúde pela progressão da doença. O objetivo deste trabalho foi verificar se o rastreio da DRC está sendo feito de maneira adequada entre diabéticos acompanhados na atenção primária à saúde. Métodos: Estudo descritivo com 265 pacientes com DM atendidos nas Unidades Básicas de Saúde de Divinópolis, MG. A coleta de dados clínicos e laboratoriais foi realizada por meio de consulta ao Sistema Integrado de Saúde. Foram calculadas a frequência de realização dos exames de avaliação da função renal nos últimos 12 meses e a frequência de pacientes com excreção urinária de albumina (EUA) aumentada e a taxa de filtração glomerular (TFG) reduzida, e assim determinada a frequência de pacientes com comprometimento renal. Resultados: Foi observado que 41,2% dos pacientes têm comprometimento renal; dentre esses, 61,2% utilizam algum medicamento nefroprotetor. Apenas 21,9% realizaram o exame de albuminúria isolada, dos quais 46,5% apresentaram albuminúria aumentada. O exame de relação albumina/creatinina (RAC) foi realizado por 12,1% dos pacientes, dos quais 43,8% apresentaram RAC aumentada. Foi observado que 89,0% dos pacientes realizaram o exame de creatinina sérica, dos quais 33,1% apresentaram TFG reduzida. Conclusão: Foi observado maior índice de rastreio da DRC por meio da TFG em relação ao rastreio por meio da EUA, o qual foi realizado por pequeno número de pacientes. Portanto, o rastreio da DRC não está sendo realizado adequadamente na atenção básica ao diabético.

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia.

OBJECTIVE: To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. METHODS: Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. RESULTS: Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. CONCLUSION: The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.

Medications used in paediatric intensive care by continuous infusion: Do the technical aspects of the package inserts corroborate scientific evidence?

WHAT IS KNOWN AND OBJECTIVE: Hospitalized paediatric patients are three times more likely to experience medication errors with the potential to cause harm, when they are compared to adults. The lack of research in paediatrics, difficulties that are derived as indications and the parameters of safety and effectiveness of pharmacological therapy in children. To analyse whether the technical and legal aspects of the package insert for medicines used in paediatric intensive care units (ICU) using a continuous infusion (CI) pump corroborate the recommendations of clinical protocols and legal provisions. METHODS: A documentary study, in which technical and legal information contained in the package inserts of medications commonly used via CI in neopediatric ICUs was analysed. The consultation of the medication package insert was carried out through the electronic portal of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA). Information on the use of medications in the neonatal and paediatric populations via CI was sought in the medication package insert. To analyse the legal aspects, ANVISA's RDC no. 47/2009 was used. In order to compare the technical information, the Micromedex NeoFax®, Micromedex Paediatrics®, and Lexicomp® databases were consulted. RESULTS AND DISCUSSION: Of the 13 medications analysed, 46% (n = 6) had some non-compliance with RDC 47/2009. Only 46% (n = 6) of the medications are indicated for paediatric use and only the medication package insert for midazolam (7.7%) contained the information considered essential for use via CI in paediatrics. WHAT IS NEW AND CONCLUSION: This is an innovative study that identifies the weaknesses of the medication package inserts for medications used by CI in paediatric ICUs. Failure to comply with legal recommendations can make medication administration difficult and increase the probability that errors will occur; and the absence of specific technical information can make care difficult and compromise patient safety. It is important that there is supervision by regulatory agencies and the contribution of health professionals so that non-conformities are reported and corrected, to guarantee safe care for paediatric patients in intensive care.

Notas técnicas para judicialização de anticoagulantes orais diretos: uma avaliação do perfil / Technical notes for judicialization of direct oral anticoagulants: a profile assessment

Fundamentos: A judicialização da saúde no Brasil gera aumento anual significativo das demandas por recursos financei-ros. Em 2016, com intuito de promover uma comunicação entre o sistema jurídico e o sistema de saúde, implementaram o sistema e-NatJus (Núcleos de Apoio Técnico do Poder Judiciário). A função do e-NatJus é fornecer apoio técnico aos juízes nas questões relativas à saúde por meio da elaboração de Notas Técnicas (NT). Objetivo: Analisar o perfil e a qualidade das NT de solicitação de anticoagulantes orais diretos (DOACs) disponíveis no portal eletrônico do e-NatJus para consultas por juízes. Métodos: Trata-se de um estudo documental descritivo, em que foram avaliadas as características sociodemo-gráficas, do diagnóstico e tratamento dos pacientes, bem como informações sobre as evidências da eficácia e segurança da tecnologia e conclusão de todas as NT referentes à solicitação de DOACs obtidas na plataforma e-NatJus desde sua im-plantação em 2018 até junho de 2020. Resultados: Foram incluídas no estudo 181 NT: rivaroxabana (67,0%), apixabana (16,0%), dabigatrana (12,0%) e edoxabana (5,0%). A média de idade dos indivíduos foi de 65,7 (±15,1) anos, sendo, (50,3%) do sexo feminino. São Sebastião do Paraíso foi o município que mais solicitou apoio nas NT (5,0%), e o estado com mais solicitações foi Santa Catarina (34,8%). Em relação ao diagnóstico dos pacientes, os mais prevalentes foram fibrilação atrial (FA)(31,5%) e troembolismo venoso (TEV)(16,4%). Aproximadamente 86 NT estavam com conteúdo semelhante no item evidência científica. Observou-se que (57,5%) tiveram a conclusão não favorável para disponibilizar o medicamento solicitado. Dentre as 77 NT que tiveram a conclusão favorável, (57,1%) não avaliaram as recomendações da Comissão Na-cional de Incorporação de Tecnologias (CONITEC). Conclusão: De forma geral, nosso estudo permitiu conhecer o perfil das NT e os principais motivos de solicitações dos DOACs, com intuito de compreender melhor se são realizadas realmente de forma consciente e responsável. A população que solicitou os DOACs via judicial é uma população idosa e não houve grande diferença entre os sexos. Os diagnósticos mais prevalentes nas NT foram FA e TEV corroborando com a indicação desses medicamentos. Pode-se observar que a maioria das NT que concedeu parecer favorável não evidenciou consulta à CONITEC e não apresentou evidência científica que contemplava de forma concreta sua decisão (AU)

Background: The judicialization of health in Brazil generates an annual increase in demands for financial resources. In 2016, to promote communication between the legal system and the health system, the implementation of e-NatJus system (Technical Support Centers of the Judiciary). The role of e-NatJus is to provide technical support to judges on health-related issues through the preparation of Technical Notes (NT). Objective: Analyze the profile and quality of TNs requesting Direct Oral Anticoagulants (DOACs) available on the e-NatJus electronic portal for consultation by judges. Methods: This is a descriptive documentary study, which evaluated the sociodemographic characteristics, diagnosis, and treatment of patients, as well as information on the evidence of the efficacy and safety of technology and the conclusion of all NT related to the request for DOACs obtained in the e-NatJus platform since its implementation in 2018 to June 24, 2020. Results: The study included 181 NT: rivaroxaban (67,0%), apixaban (16,0%), dabigatran (12,0%), and edoxaban (5,0%). The mean age of the individuals was 65.7 (±15.1) years, being (50,3%) female. São Sebastião do Paraíso was the municipality that most requested support in the NT (5,0%), and the state with the most requests was Santa Catarina (34,8%). Regarding the diagnosis, the most prevalent patients were AF (31,5%) and VTE (16,4%). Approximately 86 NT had similar content in the scientific evidence item. It was observed that (57,5%) had an unfavorable conclusion about making the requested drug available. Among the 77 NT that had a favorable conclusion, (57,1%) did not evaluate the rec-ommendations of the National Commission for the Incorporation of Technologies (CONITEC). Conclusion: In general, our study is effective to know the profile of the NT and the main reasons for consulting DOACs, to better understand the form of knowledge and the DOACs. It can be observed that most NTs granted a favorable opinion, did not evidence CONITEC and did not present scientific evidence that contemplated the concrete form of their decision (AU)

Racial Differences in Blood Pressure Control from Users of Antihypertensive Monotherapy: Results from the ELSA-Brasil Study. / Diferenças Raciais no Controle da Pressão Arterial em Usuários de Anti-Hipertensivos em Monoterapia: Resultados do Estudo ELSA-Brasil.

BACKGROUND: It seems that the worst response to some classes of antihypertensive drugs, especially angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, on the part of the Black population, would at least partially explain the worse control of hypertension among these individuals. However, most of the evidence comes from American studies. OBJECTIVES: This study aims to investigate the association between self-reported race/skin color and BP control in participants of the Longitudinal Study of Adult Health (ELSA-Brasil), using different classes of antihypertensive drugs in monotherapy. METHODS: The study involved a cross-sectional analysis, carried out with participants from the baseline of ELSA-Brasil. Blood pressure control was the response variable, participants with BP values ≥140/90 mmHg were considered out of control in relation to blood pressure levels. Race/skin color was self-reported (White, Brown, Black). All participants were asked about the continuous use of medication. Association between BP control and race/skin color was estimated through logistic regression. The level of significance adopted in this study was of 5%. RESULTS: Of the total of 1,795 users of antihypertensive drugs in monotherapy at baseline, 55.5% declared themselves White, 27.9% Brown, and 16.7% Black. Even after adjusting for confounding variables, Blacks using angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blocker (ARB), thiazide diuretics (thiazide DIU), and beta-blockers (BB) in monotherapy had worse blood pressure control compared to Whites. CONCLUSIONS: Our results suggest that in this sample of Brazilian adults using antihypertensive drugs in monotherapy, the differences in blood pressure control between different racial groups are not explained by the possible lower effectiveness of ACEIs and ARBs in Black individuals.

FUNDAMENTO: Aparentemente, a pior resposta a algumas classes de anti-hipertensivos, especialmente inibidores da enzima conversora da angiotensina e bloqueadores de receptor de angiotensina, pela população negra, explicaria, pelo menos parcialmente, o pior controle da hipertensão entre esses indivíduos. Entretanto, a maioria das evidências vêm de estudos norte-americanos. OBJETIVOS: Este estudo tem o objetivo de investigar a associação entre raça/cor da pele autorrelatadas e controle de PA em participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) utilizando várias classes de anti-hipertensivos em monoterapia. MÉTODOS: O estudo envolveu uma análise transversal, realizada com participantes da linha de base do ELSA-Brasil. O controle de pressão arterial foi a variável de resposta, participantes com valores de PA ≥140/90 mmHg foram considerados descontrolados em relação aos níveis de pressão arterial. A raça/cor da pele foi autorrelatada (branco, pardo, negro). Todos os participantes tiveram que responder perguntas sobre uso contínuo de medicamentos. A associação entre o controle de PA e raça/cor da pele foi estimada por regressão logística. O nível de significância adotado nesse estudo foi de 5%. RESULTADOS: Do total de 1.795 usuários de anti-hipertensivos em monoterapia na linha de base, 55,5% se declararam brancos, 27,9%, pardos e 16,7%, negros. Mesmo depois de padronizar em relação a variáveis de confusão, negros em uso de inibidores da enzima conversora de angiotensina (IECA), bloqueadores de receptor de angiotensina (BRA), diuréticos tiazídicos (DIU tiazídicos) e betabloqueadores (BB) in monoterapia tinham controle de pressão arterial pior em comparação a brancos. CONCLUSÕES: Os resultados deste estudo sugerem que, nesta amostra de brasileiros adultos utilizando anti-hipertensivos em monoterapia, as diferenças de controle de pressão arterial entre os vários grupos raciais não são explicadas pela possível eficácia mais baixa dos IECA e BRA em indivíduos negros.

Implementation of a text messaging intervention to patients on warfarin therapy in Brazilian primary care units: a quasi-experimental study.

BACKGROUND: Warfarin remains the most affordable oral anticoagulant in many countries. However, it may have serious side effects, and the success of the therapy depends on the patient's understanding of the medication and their adherence to treatment. The use of short messages services (SMS) is a strategy that can be used to educate patients, but there are no studies evaluating this intervention in patients taking warfarin. Therefore, we aimed to develop, implement, and assess the feasibility of an intervention using SMS to primary care patients taking warfarin in a medium-sized Brazilian city. METHODS: A bank of 79 SMS was drafted and validated by an expert panel. During 6 months, three times a week, patients received messages about anticoagulation with warfarin. At baseline and after 3 months, we assessed their knowledge and adherence with validated instruments. At the end of the follow-up, participants answered a satisfaction questionnaire. Subsequently, a scale-up phase was conducted, with another round of the intervention including 82 participants (29 from the first phase and 53 newly recruited). Seven months after the end of the scale-up, we asked the patients for their insights about the long-term effects of this program. All patients signed informed consent. The study was approved by the Research and Ethics committee of the Universidade Federal de Minas Gerais. RESULTS: In the pilot, 33 (89.2%) patients completed the follow-up. Among the participants who answered the satisfaction questionnaire (n = 29), 86.2% considered that the intervention motivated a healthy lifestyle and improved their understanding of warfarin therapy. All patients were willing to continue receiving the messages. Adherence measured by the Measure of Adherence to Treatment (MAT) test was high in the pre-intervention assessment and remained high (96.7% vs. 93.3%; p = 1.0000). The proportion of patients who achieved > 75% correct answers on the Oral Anticoagulation Knowledge (OAK) test increased from 6.5% to 25.6, p = 0.0703. In the scale-up, 23 patients answered the long-term assessment questionnaire. The main long-term knowledge reported was dietary information. Nine patients received the messages but did not remember their content. CONCLUSION: The intervention was well-accepted and had a positive impact on patient's knowledge about oral anticoagulation therapy. The scale-up assessment reinforced the need to constantly monitor digital interventions.

Diferenças Raciais no Controle da Pressão Arterial em Usuários de Anti-Hipertensivos em Monoterapia: Resultados do Estudo ELSA-Brasil / Racial Differences in Blood Pressure Control from Users of Antihypertensive Monotherapy: Results from the ELSA-Brasil Study

Resumo Fundamento Aparentemente, a pior resposta a algumas classes de anti-hipertensivos, especialmente inibidores da enzima conversora da angiotensina e bloqueadores de receptor de angiotensina, pela população negra, explicaria, pelo menos parcialmente, o pior controle da hipertensão entre esses indivíduos. Entretanto, a maioria das evidências vêm de estudos norte-americanos. Objetivos Este estudo tem o objetivo de investigar a associação entre raça/cor da pele autorrelatadas e controle de PA em participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) utilizando várias classes de anti-hipertensivos em monoterapia. Métodos O estudo envolveu uma análise transversal, realizada com participantes da linha de base do ELSA-Brasil. O controle de pressão arterial foi a variável de resposta, participantes com valores de PA ≥140/90 mmHg foram considerados descontrolados em relação aos níveis de pressão arterial. A raça/cor da pele foi autorrelatada (branco, pardo, negro). Todos os participantes tiveram que responder perguntas sobre uso contínuo de medicamentos. A associação entre o controle de PA e raça/cor da pele foi estimada por regressão logística. O nível de significância adotado nesse estudo foi de 5%. Resultados Do total de 1.795 usuários de anti-hipertensivos em monoterapia na linha de base, 55,5% se declararam brancos, 27,9%, pardos e 16,7%, negros. Mesmo depois de padronizar em relação a variáveis de confusão, negros em uso de inibidores da enzima conversora de angiotensina (IECA), bloqueadores de receptor de angiotensina (BRA), diuréticos tiazídicos (DIU tiazídicos) e betabloqueadores (BB) in monoterapia tinham controle de pressão arterial pior em comparação a brancos. Conclusões Os resultados deste estudo sugerem que, nesta amostra de brasileiros adultos utilizando anti-hipertensivos em monoterapia, as diferenças de controle de pressão arterial entre os vários grupos raciais não são explicadas pela possível eficácia mais baixa dos IECA e BRA em indivíduos negros.

Abstract Background It seems that the worst response to some classes of antihypertensive drugs, especially angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, on the part of the Black population, would at least partially explain the worse control of hypertension among these individuals. However, most of the evidence comes from American studies. Objectives This study aims to investigate the association between self-reported race/skin color and BP control in participants of the Longitudinal Study of Adult Health (ELSA-Brasil), using different classes of antihypertensive drugs in monotherapy. Methods The study involved a cross-sectional analysis, carried out with participants from the baseline of ELSA-Brasil. Blood pressure control was the response variable, participants with BP values ≥140/90 mmHg were considered out of control in relation to blood pressure levels. Race/skin color was self-reported (White, Brown, Black). All participants were asked about the continuous use of medication. Association between BP control and race/skin color was estimated through logistic regression. The level of significance adopted in this study was of 5%. Results Of the total of 1,795 users of antihypertensive drugs in monotherapy at baseline, 55.5% declared themselves White, 27.9% Brown, and 16.7% Black. Even after adjusting for confounding variables, Blacks using angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blocker (ARB), thiazide diuretics (thiazide DIU), and beta-blockers (BB) in monotherapy had worse blood pressure control compared to Whites. Conclusions Our results suggest that in this sample of Brazilian adults using antihypertensive drugs in monotherapy, the differences in blood pressure control between different racial groups are not explained by the possible lower effectiveness of ACEIs and ARBs in Black individuals.

Is screening for chronic kidney disease in patients with diabetes mellitus being properly conducted in primary care?

INTRODUCTION: Screening patients with diabetes mellitus (DM) for chronic kidney disease (CKD) enables early diagnosis and helps to establish adequate treatment and avoid possible damages to health associated with disease progression. This study aimed to verify whether screening for CKD has been properly conducted in populations with diabetes mellitus seen at primary care clinics. METHODS: This descriptive study included 265 individuals with DM seen at Basic Healthcare Clinics in Divinópolis, MG, Brazil. Clinical and laboratory data were collected from the Integrated Health System. Frequency of testing and kidney function evaluations performed within the last 12 months were calculated along with the proportion of patients with increased urinary albumin excretion (UAE) and decreased glomerular filtration rate (GFR) to determine the proportion of patient with kidney involvement. RESULTS: We found that 41.2% of the patients had kidney involvement and that 61.2% of the individuals with kidney involvement were on nephroprotective medication. Of the 21.9% tested for isolated albuminuria, 46.5% had increased UAE. The albumin-to-creatinine ratio (ACR) was measured in 12.1% of the patients, with 43.8% having an increased ACR. We found that 89.0% of the patients had their serum creatinine levels measured, and that 33.1% had a decreased GFR. CONCLUSION: CKD screening was more frequently performed via the GFR than UAE, a parameter analyzed only in a small proportion of patients. Therefore, CKD screening for patients with diabetes is not being performed properly in primary care.

Frequency of A1C tests undertaken by patients assisted by pharmaceutical care services in Brazil.

BACKGROUND AND AIMS: The test of glycated hemoglobin is used to assess the glycemic control of patients with diabetes mellitus, however is essential that the monitoring is carried out with adequate frequency. In this context, the objective of study is evaluate the frequency of A1C tests undertaken by patients assisted by pharmaceutical care services. METHODS: Descriptive study that included patients with DM treated at pharmaceutical care services in Brazil. This service is provided by pharmacists, for optimizing of patient's drug therapy to achieve outcomes that improve a patient's quality of life. Frequency of A1C tests was collected, with a minimum interval of three and a maximum of six months being considered adequate. Tests performed with a minimum interval of less than three or greater than six months frequency were considered inadequate. The comparison of the mean time between the A1C tests between the groups was investigated by the Student's t-test. The significance level adopted was p < 0.05. The study was conducted using data recorded from March 2018 to December 2019. RESULTS: The study included 66 patients and 67% of these underwent A1C test with inadequate frequency. The mean time between A1C tests was significantly higher (p < 0.0001) in group with inadequate frequency. CONCLUSION: Only one third of DM patients treated by pharmaceutical care services are monitored with adequate A1C frequency. It is necessary to identify the causes of this underutilization and to develop tools to optimize the monitoring.

Deprescribing clonazepam in primary care older patients: a feasibility study.

Background Inappropriate use of clonazepam by older adults is associated with cognitive impairment, delirium, and falls. Strategies to optimize its use are important to increase patient safety. Objective To evaluate the feasibility of a clonazepam deprescription protocol in the elderly. Methods This is a quasi-experimental study. Elderly people with chronic use of clonazepam and attended in primary care units in two Brazilian municipalities were selected. A deprescription protocol was used, which included five fortnightly meetings between the older adults and the research team, to reduce the dose by 25%. Patients received instructions on sleep hygiene behaviors and the advantages of clonazepam deprescription; family physicians followed a flowchart for gradual dose reduction. In the 1st and 5th meetings, there were medical appointments for anamnesis and discharge. The monitoring of patients and the application of tests were carried out by the research team. Results Of the 35 elderly people included in the study, 27 reached the end; 81.5% achieved deprescription: 22.2% stopped completely and 59.3% decreased the dose. At the last meeting, 20% of elderly patients reported an increase in blood pressure. Conclusion The high rate of deprescription and the little relevance of clonazepam withdrawal reactions, showed that the use of the protocol was effective. However, the increase in blood pressure and the worsening of sleep quality in the last meeting show the need for adjustment in the last stage of the deprescription process.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Antimicrobial stewardship for surgical antibiotic prophylaxis and surgical site infections: a systematic review.

Background Surgical site infections account for 14-17% of all healthcare-associated infections. Antimicrobial stewardship (AMS) are complementary strategies developed to optimize the use of antimicrobials. Aim to evaluate the effectiveness of AMS in promoting adherence to surgical antibiotic prophylaxis protocols in hospitalized patients, reducing surgical site infection rate and cost-benefit ratio. Method This systematic review of randomized clinical trials, non-randomized clinical trials and before and after studies was performed using Pubmed, Cochrane, Web of Science, Scopus, Embase, Google Scholar and ClinicalTrials.gov, in addition to reference lists of included studies. The risk of bias of studies was measured by the ROBINS-I checklist and the quality of the evidence synthesis by GRADE. Results Fourteen before and after design studies were included. In 85.7% of the studies, AMS was effective in increasing adherence to surgical antibiotic prophylaxis protocols and in 28.5%, there was reduction in surgical site infection rate. Three studies evaluated cost-benefit ratio and found a favorable impact. Eight (57%) studies were at risk of moderate bias and six had severe bias. The evaluation of the synthesis of evidence showed quality ranging from low to very low. Conclusion AMS, such as audit, feedback, education, implementation of a protocol, and a computer-assisted decision support methodology, appear to be effective in promoting adherence to surgical antibiotic prophylaxis protocols, reducing surgical site infection rate with a positive economic impact. However, more studies, particularly randomized clinical trials, are needed to improve the level of evidence of available information on AMS in order to favor decision-making.

Progression of chronic kidney disease in non- dialysis patients: a retrospective cohort

Abstract Evidence on factors associated with the progression of chronic kidney disease (CKD) is still under construction. The present study aimed to evaluate sociodemographic, clinical, and drug use factors associated with the progression of CKD. A retrospective cohort study was conducted with 193 patients with CKD stages 3A to 5- non-dialysis followed for three years in a Brazilian city. The outcome was the evolution to renal replacement therapy (RRT) or death. A total of 52.3 % (n = 101) were men and 83.4 % (n = 161) elderly. The median age was 72.0 years, and 22.3 % (n = 44) progressed to RRT or death, and the three-year mortality rate was 20.2 %. Participants exposed to angiotensin converting enzyme inhibitors or angiotensin II receptor blockers had a lower risk of progressing to the outcome (hazard ratio (HR) 0.25; p = 0.003) and higher survival (p = 0.022) when compared to those not exposed to these drugs. Age (HR 1.06;) and use of omeprazole (HR 6.25; CI; p <0.01) and hydrochlorothiazide (HR 2.80; p = 0.028) increased the risks of RRT or death. The results highlight the importance of rational management of pharmacotherapy for patients with CKD

Perception of pharmacists regarding human resources, training, and development of a national hospital pharmacy: a preliminary report on Basel Statements

Abstract The hospital pharmacy needs a constant process of evaluation and monitoring of its activities. In Brazil, several agencies establish tasks and duties for pharmacists, but little is known about the compliance and the perception of the professional regarding these policies. The present study aims to characterize the pharmacist's perception of Brazilian hospital pharmacy policies according to the Basel Statements. A search was performed for the contacts of all medium and high complexity hospitals in the country. Subsequently, a questionnaire elaborated following the Basel Statements was sent by e-mail to hospital pharmacists throughout the country. The domain analyzed was "Human Resources, Training, and Development". Statistical analyses were performed using SPSS 19.0. Pharmacists representing a total of 111 hospitals from all Brazilian regions answered the survey questionnaire and showed that more than half of the hospital pharmacists perceive themselves as not complying, whether in the service of local, national, or pharmaceutical education. Besides updating the professionals in relation to national policies, it is necessary that the representative bodies of the pharmaceutical class be more present in the elaboration and evaluation of the policies directed to human resources, seeking uniformity and the possibility of carrying out the activities required.

Sodium alendronate: proposal and reliability of indicators

Abstract The present study proposes and evaluates the test-retest reliability of indicators of the correct use of sodium alendronate in elderly patients. This is a test-retest reliability study for use of sodium alendronate. Six questions to evaluate the correct use of this medicine were elaborated after analysis of information in the literature. Data collection was performed through questionnaires in face-to-face in-home interviews by previously trained interviewers. The participants were initially interviewed (test) when they agreed to participate in the study, and secondly (retest), after a period of 7 to 14 days from the first interview. The reliability of the questions was evaluated by means of the agreement percentage and the Kappa coefficient. Fifty-seven pairs (test-retest) were obtained. The mean age was 69.3 (SD = 6.9) years, the majority (92.5%) completed elementary education, and declared themselves white (50.9%). All the questions presented high concordance ranging from 79.0% to 98.3%. The Kappa values ranged from 0.1 (low) to 0.83 (very good). The agreement percentage and the Kappa values suggest adequate reliability of the proposed questions. We suggest that they can be used as a simple and quick way to evaluate the quality of sodium alendronate use among the elderly.