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. Brazil means However use context followup follow up (PF Sistema SUS . SUS) quasiexperimental quasi experimental study TDM T DM mediumsized medium sized PW. PW (PW) calculated 2 $3,696.78. 369678 3 696 78 -$3,696.78 334 33 4 33. baseline (PW $3,696.78 36967 69 7 -$3,696.7 $3,696.7 3696 6 -$3,696. $3,696. 369 -$3,696 $3,696 36 -$3,69 $3,69 -$3,6 $3,6 -$3, $3, -$3 $3 -$ $

Abstract The incorrect disposal of medicines and their environmental impact has been related to the health medicalization and the improper use of medication by society. In this sense, it is very important to know the profile of drug disposal for foster health policies. The aim was to identify the profile of disposal of medicines by the population, including the cost perspective. This is an inquiry descriptive study that began in September 2019. Medicine disposal health education program was carried out over six months in two University pharmacies. A questionnaire for sociodemographic and discarded medicines data collection was applied. Logistic regression analysis for variables association of correct disposal and the chi-square and t-student analysis for comparison between disposal programs were performed for a level of 5% and test power of 80%. Medicines weighed 23.3 kg and 28.5 kg, with the cost variation from US$ 13.5 to US$ 16.1 until the final treatment. The correct disposal was strongly associated with the disposal reason (p=0.013), source of information (p=0.006), prescription (p=0.03), form of use (p=0.01), acquisition source (p=0.001), cost with medication (p=0.0001), education (p=0.028) and age (p=0.05). The correct medicine disposal was associated with important features of the community related to education health. society sense policies population perspective 2019 pharmacies applied chisquare chi square tstudent t student 5 80 80% 233 23 3 23. 285 28 28. US 135 13 13. 161 16 1 16. treatment p=0.013, p0013 p p=0.013 , 0 013 (p=0.013) p=0.006, p0006 p=0.006 006 (p=0.006) p=0.03, p003 p=0.03 03 (p=0.03) p=0.01, p001 p=0.01 01 (p=0.01) p=0.001, p0001 p=0.001 001 (p=0.001) p=0.0001, p00001 p=0.0001 0001 (p=0.0001) p=0.028 p0028 028 (p=0.028 p=0.05. p005 p=0.05 . 05 (p=0.05) 201 8 2 (p=0.013 p000 p=0.00 00 (p=0.006 p00 p=0.0 (p=0.03 (p=0.01 (p=0.001 p0000 p=0.000 000 (p=0.0001 p=0.02 p002 02 (p=0.02 (p=0.05 20 (p=0.00 p0 p=0. (p=0.0 (p=0.000 p=0 (p=0. p= (p=0 (p= (p

Abstract The insertion of Pharmaceutical Care in Primary Health Care (PHC) improves patients’ clinical outcomes and quality of life. Pharmacotherapeutic follow-up can contribute to the management of chronic diseases such as diabetes, promoting better glycemic control and adherence to therapy. This study aimed to assess the Drug-therapy Problems (DTPs) and Pharmacist Interventions (PIs) on the pharmacotherapeutic management in patients with type 2 diabetes mellitus (T2DM) in a community pharmacy. A quantitative, retrospective, and cross-sectional study was conducted in a Pharmaceutical Care Program within the PHC in Juiz de Fora (Minas Gerais, Brazil). Inclusion criteria were patients with T2DM above 18, who attended at least three pharmaceutical consultations between July 2016 and October 2018 and presented two or more glycated hemoglobin tests. The study group (n = 17) was largely composed of women (65%), elderly (76%), sedentary (72%), and obese people (52%). The resolution was achieved in 79% of the DTPs identified (n = 115). Most of DTPs were related to administration and adherence to pharmacotherapy (46%). 60% of the 437 PIs involved the provision of information and counseling. In other words, accessible interventions lead to high resolvability. Therefore, clinical actuation of pharmacists could improve the prognosis in diabetes treatment.

Resumo: A análise de custo-efetividade tem sido essencial para a tomada de decisões em saúde. Diversos países utilizam esse tipo de análise como síntese das evidências para incorporar as tecnologias em saúde. Os inibidores de protease (IPs) boceprevir (BOC) e telaprevir (TVR) são indicados para o tratamento da hepatite C crônica e foram incorporados nas diretrizes internacionais. Os ensaios clínicos pré-marketing demonstraram taxas mais altas de resposta virológica sustentada em relação às terapias anteriores, mas a incorporação dos IPs gerou um impacto financeiro significativo. O estudo teve como objetivo discutir a relevância da análise de custo-efetividade, através de um estudo que envolveu a inclusão de IPs em um protocolo clínico. A análise fez parte de um estudo de vida real que incluiu pacientes com infecção pelo vírus da hepatite C, genótipo 1, tratados em um hospital universitário terciário no Brasil. As terapias triplas (TTs) com ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) e BOC ou TVR foram comparadas às terapias duplas com RBV e Peg-INF α-2a. A análise de sensibilidade da custo-efetividade indicou odds de 88,2% de TTs apresentarem custo mais elevado por paciente curado. Em todos os cenários propostos, as razões de custo-efetividade incremental (ICERs) superaram em três vezes o produto interno bruto (PIB) per capita brasileiro. A sensibilidade da ICER mostrou probabilidade de 88,4% das TTs não serem custo-efetivas. O impacto da incorporação dos IPs foi negativo, e a conduta teria sido diferente se tivesse sido realizada uma análise prévia de custo-efetividade.

Abstract: Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

Resumen: El análisis de coste-efectividad ha sido esencial para la toma de decisiones en salud. Diversos países utilizan este tipo de análisis como síntesis de evidencias para incorporar tecnologías en salud. Los inhibidores de proteasa (IPs) boceprevir (BOC) y telaprevir (TVR) se indican para el tratamiento de la hepatitis C crónica y fueron incorporados en directrices internacionales. Los ensayos clínicos pre-marketing demostraron tasas más altas de respuesta virológica sostenida, respecto a las terapias anteriores, pero la incorporación de los IPs generó un impacto financiero significativo. El objetivo del estudio fue discutir la relevancia del análisis de coste-efectividad, a través de un estudio que implicó la inclusión de IPs en un protocolo clínico. El análisis formó parte de un estudio de vida real que incluyó a pacientes con infección por el virus de la hepatitis C, genotipo 1, tratados en un hospital universitario terciario en Brasil. Las terapias triples (TTs) con ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) y BOC o TVR se compararon con las terapias dobles con RBV y Peg-INF α-2a. El análisis de sensibilidad del coste-efectividad indicó odds de 88,2% de que las TTs presentaran un coste más elevado por paciente curado. En todos los escenarios propuestos, las razones de coste-efectividad incremental (ICERs) superaron tres veces el producto interno bruto (PIB) per cápita brasileño. La sensibilidad de la ICER mostró una probabilidad de que un 88,4% de las TTs no eran costo-efectivas. El impacto de la incorporación de los IPs fue negativo, y el resultado habría sido diferente si se hubiese realizado un análisis previo de coste-efectividad.

Resumo: A análise de custo-efetividade tem sido essencial para a tomada de decisões em saúde. Diversos países utilizam esse tipo de análise como síntese das evidências para incorporar as tecnologias em saúde. Os inibidores de protease (IPs) boceprevir (BOC) e telaprevir (TVR) são indicados para o tratamento da hepatite C crônica e foram incorporados nas diretrizes internacionais. Os ensaios clínicos pré-marketing demonstraram taxas mais altas de resposta virológica sustentada em relação às terapias anteriores, mas a incorporação dos IPs gerou um impacto financeiro significativo. O estudo teve como objetivo discutir a relevância da análise de custo-efetividade, através de um estudo que envolveu a inclusão de IPs em um protocolo clínico. A análise fez parte de um estudo de vida real que incluiu pacientes com infecção pelo vírus da hepatite C, genótipo 1, tratados em um hospital universitário terciário no Brasil. As terapias triplas (TTs) com ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) e BOC ou TVR foram comparadas às terapias duplas com RBV e Peg-INF α-2a. A análise de sensibilidade da custo-efetividade indicou odds de 88,2% de TTs apresentarem custo mais elevado por paciente curado. Em todos os cenários propostos, as razões de custo-efetividade incremental (ICERs) superaram em três vezes o produto interno bruto (PIB) per capita brasileiro. A sensibilidade da ICER mostrou probabilidade de 88,4% das TTs não serem custo-efetivas. O impacto da incorporação dos IPs foi negativo, e a conduta teria sido diferente se tivesse sido realizada uma análise prévia de custo-efetividade.

Abstract: Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

Resumen: El análisis de coste-efectividad ha sido esencial para la toma de decisiones en salud. Diversos países utilizan este tipo de análisis como síntesis de evidencias para incorporar tecnologías en salud. Los inhibidores de proteasa (IPs) boceprevir (BOC) y telaprevir (TVR) se indican para el tratamiento de la hepatitis C crónica y fueron incorporados en directrices internacionales. Los ensayos clínicos pre-marketing demostraron tasas más altas de respuesta virológica sostenida, respecto a las terapias anteriores, pero la incorporación de los IPs generó un impacto financiero significativo. El objetivo del estudio fue discutir la relevancia del análisis de coste-efectividad, a través de un estudio que implicó la inclusión de IPs en un protocolo clínico. El análisis formó parte de un estudio de vida real que incluyó a pacientes con infección por el virus de la hepatitis C, genotipo 1, tratados en un hospital universitario terciario en Brasil. Las terapias triples (TTs) con ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) y BOC o TVR se compararon con las terapias dobles con RBV y Peg-INF α-2a. El análisis de sensibilidad del coste-efectividad indicó odds de 88,2% de que las TTs presentaran un coste más elevado por paciente curado. En todos los escenarios propuestos, las razones de coste-efectividad incremental (ICERs) superaron tres veces el producto interno bruto (PIB) per cápita brasileño. La sensibilidad de la ICER mostró una probabilidad de que un 88,4% de las TTs no eran costo-efectivas. El impacto de la incorporación de los IPs fue negativo, y el resultado habría sido diferente si se hubiese realizado un análisis previo de coste-efectividad.

ABSTRACT OBJECTIVE: To perform a cost-benefits analysis of a clinical pharmacy (CP) service implemented in a Neurology ward of a tertiary teaching hospital. METHODS: This is a cost-benefit analysis of a single arm, prospective cohort study performed at the adult Neurology Unit over 36 months, which has evaluated the results of a CP service from a hospital and Public Health System (PHS) perspective. The interventions were classified into 14 categories and the costs identified as direct medical costs. The results were analyzed by the total and marginal cost, the benefit-cost ratio (BCR) and the net benefit (NB). RESULTS: The total 334 patients were followed-up and the highest occurrence in 506 interventions was drug introduction (29.0%). The marginal cost for the hospital and avoided cost for PHS was US$182±32 and US$25,536±4,923 per year; and US$0.55 and US$76.4 per patient/year. The BCR and NB were 0.0, -US$26,105 (95%CI −31,850 − –10,610), -US$27,112 (95%CI −33,160–11,720) for the hospital and; 3.0 (95%CI 1.97–4.94), US$51,048 (95%CI 27,645–75,716) and, 4.6 (95%CI 2.24–10.05), US$91,496 (95%CI 34,700–168,050; p < 0.001) for the PHS, both considering adhered and total interventions, respectively. CONCLUSIONS: The CP service was not directly cost-benefit at the hospital perspective, but it presented savings for forecast cost related to the occurrence of preventable morbidities, measuring a good cost-benefit for the PHS.

ABSTRACT OBJECTIVE: To perform a cost-benefits analysis of a clinical pharmacy (CP) service implemented in a Neurology ward of a tertiary teaching hospital. METHODS: This is a cost-benefit analysis of a single arm, prospective cohort study performed at the adult Neurology Unit over 36 months, which has evaluated the results of a CP service from a hospital and Public Health System (PHS) perspective. The interventions were classified into 14 categories and the costs identified as direct medical costs. The results were analyzed by the total and marginal cost, the benefit-cost ratio (BCR) and the net benefit (NB). RESULTS: The total 334 patients were followed-up and the highest occurrence in 506 interventions was drug introduction (29.0%). The marginal cost for the hospital and avoided cost for PHS was US$182±32 and US$25,536±4,923 per year; and US$0.55 and US$76.4 per patient/year. The BCR and NB were 0.0, -US$26,105 (95%CI −31,850 − –10,610), -US$27,112 (95%CI −33,160–11,720) for the hospital and; 3.0 (95%CI 1.97–4.94), US$51,048 (95%CI 27,645–75,716) and, 4.6 (95%CI 2.24–10.05), US$91,496 (95%CI 34,700–168,050; p < 0.001) for the PHS, both considering adhered and total interventions, respectively. CONCLUSIONS: The CP service was not directly cost-benefit at the hospital perspective, but it presented savings for forecast cost related to the occurrence of preventable morbidities, measuring a good cost-benefit for the PHS.

Pharmaceutical care (PC) is in the implementation process in Brazil and Latin America. Synthesis of evidence has been requested for monitoring and evaluating the process regarding the treatment effect. The objective is to build and disseminate a systematic review protocol to make a standard for updating results from pharmaceutical care for hypertension and for other diseases. This is a protocol for systematic review studies regarding a real example of a protocol reasoned in pharmaceutical care for hypertension in primary care. This protocol was delineated grounded in the Cochrane Handbook. Descriptors and words were defined using MeSH (Medical Subject Headings), DeCS (Descriptors in Health Sciences) and Emtree thesaurus, and the search was performed in English, Spanish and Portuguese, without filters, up to March, 27th, 2017. The results were structured in the PRISMA flowchart. Results found from all databases were: the Cochrane Library (n= 202); PubMed (n= 2608); LILACs (n= 909); Embase (n= 1653); Scopus (n=1298); IPA (n=967); and Web of Sciences (n=435). From these, 1688 were duplicate articles. The content of this paper can aid the constant monitoring of pharmaceutical care implementation and contribute to the improvement of the quality and evidence levels of published studies.

Diabetes mellitus type 2 (DM2) affects millions of people worldwide and causes several complications for the patient, consuming large sums of financial resources from the health services. This study aims to estimate the financial investment of DM2 treatment for glycemic control of the patient, from the point of view of the municipal Public Health System (SUS). The Delphi technique was used to validate the opinion of a team of judges, specialists in DM2, and health service managers, on the investment necessary for glycemic control of patients with DM2 through the application of questionnaires. In order for the patient to achieve glycated hemoglobin (A1c) < 7%, an investment of US$ 2,419.06 (value/patient/year) is necessary. As the value of A1c increases, investment is reduced. This result reveals the intention to allocate resources for the prevention of DM2 and its complications.

ABSTRACT Human insulin is provided by the Brazilian Public Health System (BPHS) for the treatment of diabetes, however, legal proceedings to acquire insulin analogs have burdened the BPHS health system. The aim of this study was to perform a cost-effectiveness analysis to compare insulin analogs and human insulins. This is a pharmacoeconomic study of cost-effectiveness. The direct medical cost related to insulin extracted from the Ministry of Health drug price list was considered. The clinical results, i.e. reduction in glycated hemoglobin (HbA1c), were extracted by meta-analysis. Different scenarios were structured to measure the uncertainties regarding the costs and reduction in HbA1c. Decision tree was developed for sensitivity of Incremental Cost Effectiveness Ratio (ICER). A total of fifteen scenarios were structured. Given the best-case scenario for the insulin analogs, the insulins aspart, lispro, glargine and detemir showed an ICER of R$ 1,768.59; R$ 3,308.54; R$ 11,718.75 and R$ 2,685.22, respectively. In all scenarios in which the minimum effectiveness was proposed, lispro, glargine and detemir were dominant strategies. Sensitivity analysis showed that the aspart had R$ 3,066.98 [95 % CI: 2339.22; 4418.53] and detemir had R$ 6,163.97 [95% CI: 3919.29; 11401.57] for incremental costs. We concluded there was evidence that the insulin aspart is the most cost-effective.

ABSTRACT In Brazil, 80% of hypertensive patients have no blood pressure controlled, this fact has caused severe financial consequences for the public health system (PHS) and the Pharmaceutical Care (PC) has emerged as an effective alternative. The aim of this study was to analyze the costs and outcomes of systemic arterial hypertension (SAH) for conventional assistance compared to assistance with PC in the PHS. This is a pharmacoeconomic study with cost-consequence analysis nested to clinical trial. Hypertensives patients were followed-up from 2006 to 2012. During 2009 they were assisted by the PC program in Ribeirão Preto-SP, Brazil. Clinical indicators, systolic and diastolic blood pressure (SBP and DBP), triglycerides, total cholesterol (TC) and its fractions and healthcare indicators, consumption of antihypertensive medication and consultations were analyzed. Costs were listed as direct medical and direct non-medical. The average cost of conventional care for 104 patients followed-up was US$ 198.97, in the PC period and after discharge was US$ 407.91 and US$ 214.96 patient/year. After discharge of patients from PC there was reduction of SBP, DBP, TC and cardiovascular risk, 9.4 mmHg, 4.6 mmHg, 12.0 mg/dL, and 23% [p<0.005], respectively. The PC program optimized clinical and healthcare indicators and impacted in the SAH costs for the PHS.

RESUMO CONTEXTO E OBJETIVO: A demência é uma síndrome caracterizada por declínio funcional e cognitivo, sendo a doença de Alzheimer (DA) uma das causas mais comuns e de alta prevalência em idosos. Sabe-se que não há medicamento capaz de interferir no curso da doença e as pesquisas para o tratamento da DA têm sido marcadas pelo surgimento e abandono de novas drogas. O objetivo deste estudo foi descrever as drogas capazes de influenciar o curso da DA que têm sido estudadas para o tratamento da doença. TIPO DE ESTUDO E LOCAL: Revisão narrativa de artigos originais publicados mundialmente. MÉTODOS: Foi realizada uma busca sistematizada nas bases de dados PubMed/MEDLINE, Cochrane Library/Cochrane e SciELO/Bireme. Cada um dos seguintes descritores "Mecanismos Moleculares de Ação Farmacológica" e "Quimioterapia" foram combinados com o descritor "Doença de Alzheimer", todos encontrados no MeSH e DeCS. Os descritores foram usados sozinhos ou em combinação, fixando como filtros as publicações de 2009 a 2015, em língua inglesa, espanhola e portuguesa. RESULTADOS: Foram encontrados 6.888 artigos, dos quais 37 foram incluídos nesta revisão; 70,3% dos artigos selecionados tiveram boa qualidade com baixo ou indefinido risco de viés. Foram elencadas 86 drogas promissoras ao tratamento da AD. Elas foram classificadas em 20 categorias farmacológicas. CONCLUSÃO: Não há fármacos capazes de interferir no curso da DA com efetividade e segurança no tratamento. Contudo, os imunomoduladores foram considerados promissores devido ao fato de apresentarem efetividade e qualidade nos artigos analisados.

ABSTRACT CONTEXT AND OBJECTIVE: Dementia is a syndrome characterized by functional and cognitive decline. Alzheimer's disease (AD) is one of the most common causes of dementia and has high prevalence among the elderly. It is known that there is no drug capable of interfering with the course of the disease. Research on treatments for AD has been marked by the appearance of new drugs and their abandonment. This study aimed to describe drugs that have been studied with regard to treating AD and which are capable of influencing the course of the disease. DESIGN AND SETTING: Narrative review on original articles published worldwide. METHODS: A systematized search was conducted in the PubMed/MEDLINE, Cochrane Library/Cochrane and SciELO/Bireme databases. The descriptors "Molecular Mechanisms of Pharmacological Action" and "Drug Therapy" were each combined with the descriptor "Alzheimer disease". All of these can be found in MeSH and DeCS. These descriptors were used alone or in combination, and a filter specifying publication between January 2009 and October 2015 in English, Spanish or Portuguese was set. RESULTS: 6,888 articles were found, of which 37 were included in this review; 70.3% of the articles selected were of good quality with low or unclear risk of bias. 86 drugs were considered promising for AD treatment and these were classified into 20 pharmacological categories. CONCLUSION: There are no drugs capable of influencing the course of AD such that treatments are safe and effective. However, immunomodulators stood out as promising, given their effectiveness and quality in the articles analyzed.