Abstract This study examined the effects of pharmacist interventions for patients with advanced prostate cancer. A pre-post study was conducted between October 2014 and August 2017 in a community pharmacy in Brazil for outpatients with advanced prostate cancer, aged ≥ 18 years, using cyproterone acetate and/or goserelin. The patients had face-to-face meetings with a pharmacist who dispensed antiandrogenic drugs and performed interventions aimed at solving and/or preventing drug-therapy problems. Primary outcomes regarding prostate-specific antigen (PSA) and testosterone levels were compared at 0, 6, and 12 months, whereas secondary outcomes-medication adherence and quality of life-were compared at baseline and at the 12-month follow-up. Medication adherence was assessed using the Morisky-Green test, and quality of life was measured by the Medical Outcomes Study 36-item Short Form (SF-36) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The analysis included 20 patients; 311 drug-therapy problems were identified and most of them were related to adverse reactions (78.5%). The most common adverse reactions were reduced libido, erectile dysfunction, hyperglycemia, fatigue, and gynecomastia. Testosterone levels significantly decreased at 6 months, and PSA levels at 6 and 12 months. No significant changes in adherence were noted at the end of the study. A significant increase in the “pain” domain and an improvement trend in the “physical aspects” and “vitality” domains were observed based on the SF-36 instrument. The findings show that pharmacist interventions were able to improve PSA and testosterone levels, and some domains of quality of life of patients.

Resumo Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

Abstract This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF’s objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

Resumo O objetivo deste estudo foi avaliar a capacidade de gestão do Componente Especializado da Assistência Farmacêutica (CEAF) no estado de São Paulo (ESP), sob os aspectos organizacional, operacional e sustentabilidade. O desenho do estudo foi uma investigação avaliativa, com adaptação de um modelo teórico e protocolo de indicadores desenvolvido para aplicação em âmbito nacional, e validado (Grupo Nominal e Comitê Tradicional) para a aplicação na realidade do ESP. A coleta de dados, em 35 unidades, foi realizada em 2017 e 2018 e contemplou todas as áreas que participam da gestão/execução do CEAF do estado, em seu âmbito central e regional. A avaliação da capacidade de gestão foi fundamentada na análise crítica dos resultados obtidos, analisando suas fragilidades e as potencialidades. Verificou-se que a capacidade de gestão foi positiva na dimensão operacional, com desafios concentrados nas demais dimensões. Os resultados demonstraram maiores investimentos e desenvolvimento em aspectos técnicos da assistência farmacêutica, mas deficitárias em relação a aspectos como: monitoramento de resultados clínicos, regulamentação, infraestrutura e comunicação com os atores envolvidos.

Abstract The aim of this study is to evaluate the management capacity of the Specialized Component of Pharmaceutical Services (CEAF, in Portuguese) in the state of São Paulo (SP), according to the organizational, operational and sustainability aspects. The study was designed as an evaluative investigation, with the adoption of a theoretical model and protocol of indicators developed for application at the national level and validated (Nominal Group and Traditional Committee) for application in the reality of the SP. The data collection in the 35 CEAF units was carried out in 2017 and 2018, and covered all technical areas that participate in the management/execution of CEAF, in both its central and regional scopes. The assessment of management capacity was based on a critical analysis of the obtained results, analyzing their strengths and weaknesses. After collecting data from 35 CEAF units, it was found that the management capacity was positive in the operational dimension with challenges concentrated in the other dimensions. The results showed greater investments and development in the technical aspects of pharmaceutical services, but deficiencies in such areas as the monitoring of clinical results, infrastructure, regulation, and communication with the actors involved.

Resumo O objetivo deste estudo foi avaliar a capacidade de gestão do Componente Especializado da Assistência Farmacêutica (CEAF) no estado de São Paulo (ESP), sob os aspectos organizacional, operacional e sustentabilidade. O desenho do estudo foi uma investigação avaliativa, com adaptação de um modelo teórico e protocolo de indicadores desenvolvido para aplicação em âmbito nacional, e validado (Grupo Nominal e Comitê Tradicional) para a aplicação na realidade do ESP. A coleta de dados, em 35 unidades, foi realizada em 2017 e 2018 e contemplou todas as áreas que participam da gestão/execução do CEAF do estado, em seu âmbito central e regional. A avaliação da capacidade de gestão foi fundamentada na análise crítica dos resultados obtidos, analisando suas fragilidades e as potencialidades. Verificou-se que a capacidade de gestão foi positiva na dimensão operacional, com desafios concentrados nas demais dimensões. Os resultados demonstraram maiores investimentos e desenvolvimento em aspectos técnicos da assistência farmacêutica, mas deficitárias em relação a aspectos como: monitoramento de resultados clínicos, regulamentação, infraestrutura e comunicação com os atores envolvidos.

Abstract The aim of this study is to evaluate the management capacity of the Specialized Component of Pharmaceutical Services (CEAF, in Portuguese) in the state of São Paulo (SP), according to the organizational, operational and sustainability aspects. The study was designed as an evaluative investigation, with the adoption of a theoretical model and protocol of indicators developed for application at the national level and validated (Nominal Group and Traditional Committee) for application in the reality of the SP. The data collection in the 35 CEAF units was carried out in 2017 and 2018, and covered all technical areas that participate in the management/execution of CEAF, in both its central and regional scopes. The assessment of management capacity was based on a critical analysis of the obtained results, analyzing their strengths and weaknesses. After collecting data from 35 CEAF units, it was found that the management capacity was positive in the operational dimension with challenges concentrated in the other dimensions. The results showed greater investments and development in the technical aspects of pharmaceutical services, but deficiencies in such areas as the monitoring of clinical results, infrastructure, regulation, and communication with the actors involved.

Resumo Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

Abstract This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF’s objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

ABSTRACT Objectives: Prostate cancer is the most common and fatal cancer amongst Brazilian males. The quality of prostate cancer care in Brazil was systematically reviewed and compared to United Kingdom (UK) National Institute for Health and Care Excellence (NICE) guidelines, which are considered an international benchmark in care, to deter- mine any treatment gaps in Brazilian practice. Materials and Methods: A systematic review of Brazilian and UK literature was under- taken. Additionally, quality of life scores was measured using a FACT-P questionnaire of 36 prostate cancer patients attending the Farmácia Universitária da Universidade de São Paulo (FARMUSP). These scores were compared against NICE care measures for patient safety, clinical efficacy and quality of life indicators determined by either quantitative or qualitative methods. Key findings: The quality of prostate cancer care in Brazil was considered good when compared to NICE guidelines. However, FACT-P data strongly indicated a poor under- standing of treatment received by Brazilian patients and that their mental health needs were not being met. Conclusions: NICE quality statements that address the holistic needs of patients should be implemented into Brazilian outpatient care plans. Addressing the non-medical concerns of patients may improve quality of life and can be easily rolled-out through existing Brazilian pharmacy services at no financial cost to the Brazilian Unified Health System (SUS).

One of the actions taken was to offer training on pharmaceuticals via the distance education model (EAD) with the course titled Pharmaceutical Services and Supply Management Course (PSSMC). PSSMC, which was based on the idea of expanded management, is guided by Strategic Situational Planning (PES) concepts, and structured around an Operational Plan (OP) that serves as a practical didactic tool. The aim of this study is to report and analyze a case study based on the implementation of the Operational Plan in a municipality in the State of São Paulo, while focusing on the judicialization of access to medicines and health products. Since judicialization is an important topic, the problem chosen for resolution with the PES was attendance at the issuance of court orders by the municipality for items of medium and high complexity. The PES allows researchers to analyze reality through different points of view, of which participation is a key aspect. With the OP, it was possible to disseminate a proposal for expanded planning, to advance resolution of the problem, achieve positive results, and reduce expenses associated with the municipality’s legal actions.

ABSTRACT The purpose of the work was to assess the incidence of potential drug interactions (pDDI), major pDDI, and the use of potentially inappropriate medication (PIM) at hospital admission, during hospitalization, and at discharge to evaluate whether hospital admission provides an opportunity for improving pharmacotherapy in elderly patients at a University hospital that has a clinical pharmacist. A prospective cohort study was carried out using data from the medical records of patients admitted to an internal medicine ward. All admissions and prescriptions were monitored between March and August 2006. Micromedex(r) DrugReax(r) and Beers Criteria 2015 were used to identify pDDI, major pDDI, and PIMs, respectively. A comparison of admission and discharge prescriptions showed the following: an increase in the proportion of patients using antithrombotic agents (76 versus 144; p<0.001), lipid modifying agents (58 versus 81; p=0.024), drugs for acid-related disorders (99 versus 152; p<0.001), and particularly omeprazole (61 versus 87; p=0.015); a decrease in the number of patients prescribed psycholeptics (73 versus 32; p<0.001) and diazepam (54 versus 13; p<0.001); and a decrease in the proportion of patients exposed to polypharmacy (16.1% versus 10.1%; p=0.025), at least one pDDI (44.5% versus 32.8%; p=0.002), major pDDI (19.9% versus 12.2%; p=0.010) or PIM (85.8% versus 51.9%; p<0.001). The conclusion is that admission to a hospital ward that has a clinical pharmacist was associated with a reduction in the number of patients exposed to polypharmacy, pDDI, major pDDI, and the use of PIMs among elderly inpatients.

<p>O objetivo do presente estudo foi avaliar a bioequivalência de duas formulações de cefalexina disponíveis no mercado brasileiro (produto A como formulação referência e produto B como formulação teste). A eficiência de dissolução (DE%) foi calculada para ambas as formulações para avaliar suas características biofarmacêuticas. O estudo de bioequivalência oral foi realizado em vinte e quatro voluntários sadios utilizando um desenho cruzado. Uma dose oral única (comprimido contendo 500 mg de cefalexina) de cada produto foi administrada com um período de <italic>washout</italic> de duas semanas. Concentrações urinárias de cefalexina foram mensuradas por método de cromatografia líquida de alta eficiência (CLAE) e os parâmetros farmacocinéticos foram estimados por dados de excreção urinária. A bioequivalência foi determinada pelos seguintes parâmetros: quantidade acumulada da cefalexina excretada na urina, quantidade total da cefalexina excretada na urina e a taxa de excreção máxima da cefalexina. Os valores de DE dos comprimidos de liberação imediata de cefalexina (500 mg) foram 68,69±4,18% para o produto A e de 71,03±6,63% para o produto B. Com relação ao teste de dissolução das duas marcas analisadas (A e B), ambas apresentaram-se de acordo com as especificações farmacopéicas, uma vez que a dissolução de ambas formulações foi superior a 80% da quantidade declarada após 45 minutos de teste (A=92,09%±1,84; B=92,84% ±1,08). Os resultados obtidos indicaram que os produtos A e B são equivalentes farmacêuticos. Os intervalos de confiança para os parâmetros farmacocinéticos estavam de acordo com os padrões internacionais, demonstrando que os produtos A e B podem ser considerados bioequivalentes e, portanto, intercambiáveis.</p>

<p>The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation). Dissolution efficiency (DE%) was calculated for both formulations to evaluate their <italic>in vitro</italic>biopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin) of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC) method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg) were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B) analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08). The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards, indicating that products A and B can be considered bioequivalents and, therefore, interchangeable.</p>

O presente estudo teve por objetivo avaliar a atuação do farmacêutico na dispensação de medicamentos, sendo realizada pesquisa transversal exploratório-descritiva em oito Centros de Atenção Psicossocial (CAPS) Adulto do Município de São Paulo. Questionário semiaberto sobre o serviço de dispensação foi aplicado aos farmacêuticos responsáveis de cada unidade estudada. Foram selecionadas duas unidades CAPS Adulto das regiões Norte, Sul, Leste e Oeste de São Paulo. A região central não dispõe de CAPS adulto, razão pela qual não fez parte do estudo. A maior parte dos entrevistados apresentou idade entre 35 e 40 anos, com predomínio do gênero feminino. Verificou-se que metade dos entrevistados realizou apenas 25% das dispensações e poucos fizeram a análise de todas as prescrições antes de dispensar o medicamento. Todos os respondentes entravam em contato com o prescritor na presença de algum problema relacionado ao medicamento. Entretanto, intervenções farmacêuticas não eram realizadas comumente. Ainda, um dos respondentes indicou que todas as suas funções na farmácia poderiam ser delegadas a outro profissional. Os dados reforçam a necessidade de ações que possibilitem o aprimoramento contínuo do farmacêutico a fim de que esteja apto à prática clínica voltada aos pacientes com transtornos mentais.

The objective of this study was to evaluate the role of the pharmacist in dispensing medication by conducting cross-sectional exploratory-descriptive research in eight Adult Psychosocial Care Centers (CAPS) in São Paulo. The pharmacists responsible for each of the dispensing units studied filled out a semi-structured questionnaire about the service provided. Two Adult CAPS units were selected from each of the North, South, Eastand West regions of São Paulo. The central region has no Adult CAPS, and was therefore not included in the study. Most of the respondents were aged between 35 and 40 years and were predominantly female. It was found that half of the respondents performed only 25% of dispensations and few conducted an analysis of all prescriptions before dispensing medication. All respondents contacted the prescriber if any medication-related problems a rose. However, few pharmaceutical interventions were commonly performed. Furthermore, one respondent indicated that all his/her functions in the pharmacy could be delegated to another professional. These findings reveal the pressing need for actions that ensure the ongoing training of pharmacists to enable them to be clinically prepared to deal with patients with mental disorders.

O presente estudo teve por objetivo avaliar a atuação do farmacêutico na dispensação de medicamentos, sendo realizada pesquisa transversal exploratório-descritiva em oito Centros de Atenção Psicossocial (CAPS) Adulto do Município de São Paulo. Questionário semiaberto sobre o serviço de dispensação foi aplicado aos farmacêuticos responsáveis de cada unidade estudada. Foram selecionadas duas unidades CAPS Adulto das regiões Norte, Sul, Leste e Oeste de São Paulo. A região central não dispõe de CAPS adulto, razão pela qual não fez parte do estudo. A maior parte dos entrevistados apresentou idade entre 35 e 40 anos, com predomínio do gênero feminino. Verificou-se que metade dos entrevistados realizou apenas 25% das dispensações e poucos fizeram a análise de todas as prescrições antes de dispensar o medicamento. Todos os respondentes entravam em contato com o prescritor na presença de algum problema relacionado ao medicamento. Entretanto, intervenções farmacêuticas não eram realizadas comumente. Ainda, um dos respondentes indicou que todas as suas funções na farmácia poderiam ser delegadas a outro profissional. Os dados reforçam a necessidade de ações que possibilitem o aprimoramento contínuo do farmacêutico a fim de que esteja apto à prática clínica voltada aos pacientes com transtornos mentais.

The objective of this study was to evaluate the role of the pharmacist in dispensing medication by conducting cross-sectional exploratory-descriptive research in eight Adult Psychosocial Care Centers (CAPS) in São Paulo. The pharmacists responsible for each of the dispensing units studied filled out a semi-structured questionnaire about the service provided. Two Adult CAPS units were selected from each of the North, South, Eastand West regions of São Paulo. The central region has no Adult CAPS, and was therefore not included in the study. Most of the respondents were aged between 35 and 40 years and were predominantly female. It was found that half of the respondents performed only 25% of dispensations and few conducted an analysis of all prescriptions before dispensing medication. All respondents contacted the prescriber if any medication-related problems a rose. However, few pharmaceutical interventions were commonly performed. Furthermore, one respondent indicated that all his/her functions in the pharmacy could be delegated to another professional. These findings reveal the pressing need for actions that ensure the ongoing training of pharmacists to enable them to be clinically prepared to deal with patients with mental disorders.

Introduction: starting from 1990, several pharmaceutical care programs have been developed at the hospital setting, focused on the pharmacotherapeutic follow-up of the patient. However, the international scientific community of pharmacists has envisaged some problems such as the lack of systematic, continuous and permanent implementation. Objective: to design an organizational system to support the pharmaceutical care as a professional practice at the Cuban hospital settings, particularly in Santiago de Cuba province. Methods: the systemic method tools were used for the system design and the components, the principles, the structure and the graphic presentation as well as the characteristics and the approach were all defined. Results: acomplex, dynamic, probabilistic, adaptive and unstable system was put forward, which will depend on the integration of interacting factors as the following: System of essential relationships, Structure, Process and Result will be applicable to any clinic-oriented pharmaceutical activity at hospital under the concepts of the Pharmaceutical Care. Conclusions: the implementation of the suggested system could represent a significant contribution to the pharmaceutical care at hospital in Cuba as long as the Cuban health authorities adopt the recommendations made in this respect.

Introducción: a partir de 1990 se han desarrollado programas de Atención Farmacéutica en ambiente hospitalario, centrando su atención en el Seguimiento farmacoterapéutico, sin embargo, la comunidad científica internacional farmacéutica visualiza problemáticas como la ausencia de un ejercicio sistematizado, continuo y permanente. Objetivo: diseñar un sistema organizativo para implementar el ejercicio de la atención farmacéutica como práctica profesional, en el ámbito hospitalario cubano, específicamente en la provincia Santiago de Cuba. Métodos: para el diseño del sistema se aplicaron herramientas del método sistémico; se definieron: partes componentes, principios, estructura y representación gráfica, así como, características y enfoque. Resultados: se propuso un sistema organizativo complejo, dinámico, probabilístico, adaptable e inestable, dependiente de la integración de factores interactuantes que son: sistema de relaciones esenciales, estructura, proceso y resultado; aplicable a cualquier actividad farmacéutica hospitalaria orientada a la clínica, bajo los conceptos de la atención farmacéutica. Conclusiones: la implementación del sistema propuesto se podrá constituir en elevada contribución para la atención farmacéutica hospitalaria en Cuba, en la medida en que las recomendaciones puedan ser adoptadas por las autoridades sanitarias cubanas.