Concordance analysis of two databases to search for potential drug interactions in onco-hematologic patients.

INTRODUCTION: Potential drug interactions exert a significant impact on patient safety, especially within intricate onco-hematological treatments, potentially resulting in toxicity or treatment failures. Despite the availability of databases for potential drug interaction investigation, persistent heterogeneity in concordance rates and classifications exists. The additional variability in database agreement poses further complexity, notably in critical contexts like onco-hematology. AIM: To analyze the concordance of two databases for researching potential drug interaction in prescriptions for hematological patients at a University Hospital in the Midwest region of Brazil. METHOD: Cross-sectional study developed in a Brazilian hospital. The search for potential drug interaction was conducted in Micromedex® and UpToDate®. The variables were: the presence of potential drug interaction, severity, mechanism, management, and documentation. Data was analyzed in terms of frequency (absolute and relative), Cohen's kappa, and Fleiss kappa. RESULTS: The presence of potential drug interaction, showed a lack of concordance between the databases (k = -0.115 [95% CI: 0.361-0.532], p = 0.003). Regarding the mechanism, a strong agreement was observed (k = 0.805, p < 0.001 [95% CI: 0.550-0.941]). The management concordance showed a fair agreement, 46.8% (k = 0.22, p < 0.001 [95% CI: 0.099-0.341]). Stratifying the categories, significant concordance was observed in "Adjustment of dose + Monitoring" (k = 0.302, p = 0.018) and "Monitoring" (k = 0.417, p = 0.001), while other categories did not reach statistical significance. CONCLUSION: Our study emphasizes the variability in potential drug interaction research, revealing disparities in severity classification, management recommendations, and documentation practices across databases.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data.

OBJECTIVE: To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS: Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS: Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS: The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

"A lack of information keeps us from medicine, well-being, harmony ": a mixed method study with plaintiffs requesting medicines in administrative cases. / "A falta de informação nos afasta do remédio, do bem-estar, da harmonia...": estudo de método misto com demandantes de medicamentos pela via administrativa.

The need to request public health managers to ensure the right of access to medicines characterizes an administrative case and the method to do so is called the administrative route. This mixed method study aimed to analyze the perceptions of plaintiffs requesting medications by the administrative route about barriers to access medicines in the Brazilian public health sector. Data were gathered through focus groups and questionnaires. The results point to the interdependence of pharmaceutical services with the interfacing areas to ensure access. The barriers related to individuals reflect the commitment to develop citizenship, justifying the cost of the medicine to motivate the demand. Barriers to service provision include irregular availability of medicines, insufficient resources, and unsatisfactory quality of services. The difficulty in obtaining medical consultations and prescriptions originating in the public sector are barriers to the health sector. The barriers above the health sector are compliance with administrative procedures, corruption, and clientelism. The administrative route intensifies inequities in access to healthcare in Brazil.

A necessidade de recorrer ao gestor público de saúde para efetivar o direito ao acesso a medicamentos caracteriza a via administrativa. O estudo analisou as percepções dos usuários que acionaram a via administrativa sobre as barreiras para o acesso a medicamentos no setor público de saúde de uma capital brasileira. Foi realizado estudo de método misto com grupo focal, questionário com demandantes e descrição dos medicamentos demandados pela via administrativa. Os resultados apontam a interdependência da assistência farmacêutica com as áreas de interfaceamento para a garantia do acesso. As barreiras relativas aos indivíduos refletem o comprometimento do desenvolvimento da cidadania, justificando o custo do medicamento motivar a demanda. As barreiras à prestação dos serviços contemplam disponibilidade irregular dos medicamentos, insuficiência de recursos e qualidade insatisfatória dos serviços. A dificuldade para conseguir consultas médicas e a exigência da prescrição originada no setor público são barreiras ao setor saúde. As barreiras acima do setor saúde são cumprimento dos procedimentos administrativos, corrupção e clientelismo. A via administrativa intensifica as iniquidades no acesso à saúde no Brasil.

"A falta de informação nos afasta do remédio, do bem-estar, da harmonia... ": estudo de método misto com demandantes de medicamentos pela via administrativa / "A lack of information keeps us from medicine, well-being, harmony... ": a mixed method study with plaintiffs requesting medicines in administrative cases

Resumo A necessidade de recorrer ao gestor público de saúde para efetivar o direito ao acesso a medicamentos caracteriza a via administrativa. O estudo analisou as percepções dos usuários que acionaram a via administrativa sobre as barreiras para o acesso a medicamentos no setor público de saúde de uma capital brasileira. Foi realizado estudo de método misto com grupo focal, questionário com demandantes e descrição dos medicamentos demandados pela via administrativa. Os resultados apontam a interdependência da assistência farmacêutica com as áreas de interfaceamento para a garantia do acesso. As barreiras relativas aos indivíduos refletem o comprometimento do desenvolvimento da cidadania, justificando o custo do medicamento motivar a demanda. As barreiras à prestação dos serviços contemplam disponibilidade irregular dos medicamentos, insuficiência de recursos e qualidade insatisfatória dos serviços. A dificuldade para conseguir consultas médicas e a exigência da prescrição originada no setor público são barreiras ao setor saúde. As barreiras acima do setor saúde são cumprimento dos procedimentos administrativos, corrupção e clientelismo. A via administrativa intensifica as iniquidades no acesso à saúde no Brasil.

Abstract The need to request public health managers to ensure the right of access to medicines characterizes an administrative case and the method to do so is called the administrative route. This mixed method study aimed to analyze the perceptions of plaintiffs requesting medications by the administrative route about barriers to access medicines in the Brazilian public health sector. Data were gathered through focus groups and questionnaires. The results point to the interdependence of pharmaceutical services with the interfacing areas to ensure access. The barriers related to individuals reflect the commitment to develop citizenship, justifying the cost of the medicine to motivate the demand. Barriers to service provision include irregular availability of medicines, insufficient resources, and unsatisfactory quality of services. The difficulty in obtaining medical consultations and prescriptions originating in the public sector are barriers to the health sector. The barriers above the health sector are compliance with administrative procedures, corruption, and clientelism. The administrative route intensifies inequities in access to healthcare in Brazil.

Hospitalizations and deaths related to adverse drug events worldwide: Systematic review of studies with national coverage.

PURPOSE: Adverse drug events are related to negative outcomes in healthcare, including hospitalization, increased duration of hospital stay and death. The aim of this study was to conduct a systematic review to evaluate hospitalizations and deaths related to adverse drug events worldwide, reported in studies with national coverage. METHODS: The protocol was registered in PROSPERO (CRD42020157008). We performed a systematic search on Medline, Embase, CINAHL, LILACS, and the Cochrane Library (until March 2020) using pre-specified terms. We included published studies that reported data on hospitalizations and/or deaths related to adverse drug events from a national perspective and the use of secondary data as a source of information. Two reviewers independently extracted and synthesized data. The quality of the studies was assessed using an adapted version of the Joanna Briggs Institute critical appraisal checklist for prevalence studies. Narrative summaries of findings were undertaken. RESULTS: Among 59,336 citations, 62 studies were included for data extraction and synthesis. Among these studies, 41 studies included the outcome of hospitalization, 16 included the death outcome, and five included both outcomes. Administrative databases regarding discharges and registries of vital statistics were the most common sources of information. The relative frequency of hospitalizations ranged from 0.03% to 7.3%, and from 9.7 to 383.0/100,000 population, whereas mortality rate ranged from 0.1 to 7.88/100,000 population. CONCLUSION: Our study highlights information about adverse drug events using large administrative databases in a national scenario and provides an overview of databases and methods implemented to detect adverse drug events.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data

ABSTRACT OBJECTIVE To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Institutional strategies as a mechanism to rationalize the negative effects of the judicialization of access to medicine in Brazil.

BACKGROUND: Recently, the Executive Branch and Judiciary in Brazil increased spending due to larger numbers of lawsuits that forced the State to provide health goods and services. This phenomenon, known as health judicialization, has created challenges and required the Executive Branch and Judiciary to create institutional strategies such as technical chambers and departments to reduce the social, economic and political distortions caused by this phenomenon. This study aims to evaluate the effects of two institutional strategies deployed by a Brazilian municipality in order to cope with the economic, social and political distortions caused by the phenomenon of health judicialization regarding access to medicines. METHODS: A longitudinal study was carried out in a capital in the Central-West Region of Brazil. A sample of 511 lawsuits was analyzed. The variables were placed into three groups: the sociodemographic characteristics and the plaintiffs' disease, the characteristics of the claimed medical products and the institutional strategies. To analyze the effect of the interventions on the total cost of the medicines in the lawsuits, bivariate and multivariate linear regressions with variance were performed. For the categorical outcomes, Poisson regressions were performed with robust variance, using a significance level of 5%. RESULTS: A reduction in the costs of medicines in the lawsuits and of the requests for medicines within the SUS formulary was verified after the deployment of the Department of Assessment of Nonstandardized Medicines (DAMNP) and the Technical Chamber of Health Assessment (CATS); an increase in processed prescriptions from the Brazilian Universal Health System was observed after the deployment of the CATS; and an increase in medicines outside the SUS formulary without a therapeutic alternative was verified after the CATS. CONCLUSION: The institutional strategies deployed were important tools to reduce the high costs of the medicines in the lawsuits. In addition, they represented a step forward for the State, provided a benefit to society and indicated a potential path for the health and justice systems of other countries that also face problems caused by the judicialization of health.

Pharmaceutical intervention in the rational use of intravenous omeprazole.

OBJECTIVE: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. METHODS: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. RESULTS: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). CONCLUSION: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

Performance of Laboratories after 10 Years of Participating in External Quality Monitoring in Cervical Cytology.

OBJECTIVE: To evaluate the performance of laboratories accredited by the National Health System that perform cytopathology examination of the uterine cervix after 10 years of participation in external quality monitoring (eQM). STUDY DESIGN: Seven laboratories were assessed in this study. To assess the concordance of the representation of epithelia and results, 6,536 examinations (3,433 in 2007 and 3,103 in 2017) were reviewed. Statistical analysis was performed using the κ coefficient as well as the χ2 and the Fisher exact test (p < 0.05). RESULTS: All laboratories showed adequate infrastructure and internal quality monitoring. Regarding the representation of the epithelia, the concordance remained excellent (κ between 0.84 and 0.94). In 2007, 26 false-negative results (FN), 157 false-positive results (FP), and 79 delays in clinical conduct (DCC) were identified (κ = 0.80). In 2017, 24 FN, 42 FP, and 38 DCC were identified (κ = 0.90). Five laboratories showed improvement in concordance from 2007 to 2017. We observed significant improvement in cytomorphological criteria of the results: atypical squamous cells of undetermined significance (p < 0.001), atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (p < 0.016), and low-grade squamous intraepithelial lesion (p < 0.001). We also observed a considerable improvement in the results of cellular abnormalities in glandular epithelium (p < 0.0504). CONCLUSIONS: Ten years after the implementation of eQM, improvements in the concordance of results were observed as well as reductions in FN, FP, and DCC in all laboratories monitored.

Evaluation of a method for drug-related problems identification and classification in hospital setting: applicability and reliability.

Background Prescription evaluation by pharmacists has potential to improve pharmacotherapy management. It requires the use of robust methods to identify drug-related problems (DRP), which are important issues in pharmacotherapy. Objective To evaluate the applicability and reliability of Grupo de Investigação em Cuidados Farmacêuticos (GIGUF) method for prescription analysis, identification and classification of drug-related problems in inpatients prescriptions. Setting Department of Medical Clinic of a tertiary and teaching Brazilian hospital. Method An observational and retrospective study of identification and classification of drug-related problems. GIGUF method was used to evaluate prescriptions of hematological patients hospitalized between August and October 2015. The problems were categorized using GICUF-method classification. Three pharmacists performed inter-rater agreement analysis of the method using Kappa. Differences in prevalence of DRP was calculated by age, sex, pharmacotherapy complexity, length of stay and number of drugs. Main outcome measure (a) frequency and characteristics and (b) inter-rater agreement in identification and classification of the drug-related problems. Results A total of 211 problems were identified and 'inadequate dosing' was the most common problem. There was an association between the occurence of a drug-reklated problem and complexity of pharmacotherapy (p = 0.001) and number of drugs used (p = 0.010). The overall inter-rater agreement was moderate (k = 0.44 IC 95% 0.34-0.55) and the problem 'not suitable drug' (k = 0.55 IC 95% 0.44-0.66) had greater inter-rater agreement. Conclusion The method "Evaluation Drug Use Process" was useful for prescription analysis since it made the identification and classification of DRPs possible. The method demonstrated a moderate inter-rater agreement, and can contribute to pharmacotherapy management by hospital pharmacists.

Pharmaceutical intervention in the rational use of intravenous omeprazole / Intervenção farmacêutica no uso racional de omeprazol intravenoso

ABSTRACT Objective: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. Methods: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. Results: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). Conclusion: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

RESUMO Objetivo: Descrever as intervenções farmacêuticas de um serviço farmacêutico clínico vertical, para a promoção do uso racional do omeprazol intravenoso. Métodos: Estudo prospectivo e descritivo realizado em um hospital universitário da região Centro-Oeste do Brasil, no período de novembro de 2014 a maio de 2015. O serviço consistia na análise da adequabilidade da via de administração do omeprazol em relação às condições clínicas do paciente, bem como a utilização do diluente adequado. As intervenções eram registradas em prontuário e, posteriormente, avaliadas quanto à aceitação. Resultados: Foram avaliadas 770 prescrições. As intervenções relacionadas à substituição do diluente foram mais aceitas (p<0,001), e os cirurgiões foram a especialidade que utilizou a via intravenosa de maneira inadequada (p<0,001). Conclusão: Embora parcialmente aceitas, as intervenções farmacêuticas puderam contribuir com a melhoria da segurança dos pacientes, uma vez que permitiram a utilização de uma via de administração mais segura.

Administrative cases: an effective alternative to lawsuits in assuring access to medicines?

BACKGROUND: Although public policy in Brazil supports access to essential medicines, the health system cannot meet all demand. Increasingly, the population has used legal demands to seek access to medicines, an approach that can undermine equitable access by creating policy inconsistencies (e.g., granting access to medicines outside the SUS formulary). In response, the Executive Branch has signed institutional agreements to create an administrative case for submitting requests for medicines directly to the Executive Branch. The objective of this study was to assess the degree to which the administrative cases for requests are in accordance with public policies and guidelines, e.g., if administrative cases results in fewer decisions to purchase outside the SUS formulary. METHODS: This descriptive study used secondary data from lawsuits filed against the Executive Branch from 2003 to 2015 and from administrative cases granted by the Executive Branch from 2010 to 2015 in the capital of a state located in the central-western region of Brazil. The variables included plaintiffs' sociodemographic characteristics and diseases as well as the characteristics of the medical products sought via the processes. RESULTS: Comparing the requests submitted through lawsuits and the administrative cases revealed differences in the incomes of plaintiffs and the costs of medicines. Both methods for submission recorded requests for medicines for diseases of endocrine and circulatory systems; the only difference was the prevalence of diseases of the genitourinary system in the lawsuits. A higher proportion of lawsuits sought medicines outside the SUS formulary with therapeutic alternatives, while medicines outside the SUS formulary without an alternative were more commonly requested in administrative cases. CONCLUSION: Administrative cases adhere to the public policies and guidelines of the SUS. The administrative cases results in fewer decisions to purchase outside the SUS formulary with alternative, and more decisions to purchase drugs for which there is a formulary alternative. In addition, administrative cases provide greater equity by favoring lower income applicants. However, administrative cases also reveal deficiencies in the State's implementation of existing pharmaceutical policies. The public pressure for effective implementation of existing policies may help expand access to medicines.

Impact of Implementing 100% Rapid Review as a Quality Control Tool in Cervical Cytology.

OBJECTIVE: We aimed to evaluate the impact of implementing 100% rapid review (100% RR) as a quality control tool in cervical smear cytology. DESIGN: A cross-sectional study was conducted in which cytology findings, false-negative results, and quality indicators were evaluated. The variables were analyzed in 2004, the year in which 100% RR was implemented, and again in 2013, i.e., 10 years on. RESULTS: Detection of atypical squamous cells of undetermined significance (ASC-US) increased from 0.90% in 2004 to 2.47% in 2013 by routine screening. Detection of atypical squamous cells, cannot exclude a high-grade squamous intraepithelial lesion (ASC-H) increased from 13.33% in 2004 to 36.27% in 2013 by 100% RR. Detection of high-grade squamous intraepithelial lesion (HSIL) increased from 0.64% in 2004 to 4.29% in 2013 by routine screening, and increased from 0% in 2004 to 19.61% in 2013 by 100% RR. There was a significant increase (p = 0.00001) in the identification of false-negative results of ASC-US, low-grade squamous intraepithelial lesion, ASC-H, HSIL, and atypical glandular cells. All quality indicators had increased in 2013 when compared to 2004 results. CONCLUSIONS: Ten years after the implementation of the 100% RR method, improvements were found in the detection of atypia and precursor lesions and in quality indicators.

Impact of a drug dispensing model at a Community Pharmacy in Goiânia, Goiás, Brazil

Although dispensing of medication has been addressed by theoretical models, studies that confirm the impact of this service are still needed. The objective was to evaluate the impact of a new model of medicine dispensing system on patients' medication knowledge, adherence to treatment and satisfaction. One hundred and four patients attending the dispensing service of a community pharmacy between 21 January 2013 and 20 April 2013 were included in this intervention study. The impact of the service on patients' medication knowledge, adherence to treatment and satisfaction was assessed by using validated questionnaires at two time points: at the moment of medication dispensing and 30 days thereafter by telephone contact. Statistical analysis was performed by McNemar's test, and a p<0.05 was set as statistically significant. The number of patients showing insufficient knowledge about medications decreased by 50% (p < 0.05), and the number of those showing sufficient knowledge was three times greater (p < 0.05) after medicine dispensing. A high level of satisfaction was observed. Improvement of medication adherence, however, was not observed. The proposed system model for drug dispensing improved patients' knowledge about medication and satisfaction

Arranjos institucionais no contexto da judicialização da saúde: avanços e desafios

Introdução: O fenômeno da judicialização da saúde no Brasil trouxe alguns desafios à gestão do sistema de saúde, em especial a assistência farmacêutica, e passou a exigir uma atuação das instituições políticas e jurídicas para racionalizar as demandas judiciais por medicamentos e garantir o acesso integral à saúde. Este artigo propõe identificar e discutir o contexto que levaram estes agentes à criarem arranjos institucionais e os seus principais avanços, em uma capital da região centro-oeste do Brasil. Metodologia: Trata-se de um estudo de caso de abordagem qualitativa, em que os dados foram coletados por meio de pesquisa documental e entrevistas semiestruturadas. Resultados e discussão: Identificou-se sete arranjos institucionais criados como mecanismo de solucionar os problemas na gestão da assistência farmacêutica, de oferecer assessoria técnica para análise das demandas judiciais e promover o diálogo e aproximação entre as instituições. Além disso, a criação dos arranjos detectou algumas falhas na implementação das políticas públicas atuais com a possibilidade de serem corrigidas. Conclusão: Os resultados sugerem que a gestão do sistema de saúde deveria atender as necessidades dos usuários do sistema de saúde de forma integral, sem a necessidade de criar novos caminhos dentro das próprias instituições.

Potential drug-drug interactions in older adults: A population-based study.

AIM: To evaluate the potential drug-drug interactions (PDDI) between drugs used by older adults, any associated factors and recommended clinical management. METHODS: A cross-sectional, population-based study was carried out through a home survey of 934 older adults (from December 2009 to April 2010). A questionnaire was applied, and the participants were asked to show all the drugs used and their respective prescriptions, thus providing data to identify polypharmacy, self-medication and PDDI. PDDI, their consequences, severity and clinical management were identified using Micromedex. RESULTS: Overall, 2846 drugs and 665 PDDI were identified, 71.0% of which were moderate and 22.4% serious. The prevalence of PDDI was 36.9%. Drugs with a narrow therapeutic index were involved in 17.0% of the PDDI. The variables female sex (PR = 1.11, 95% CI 1.02-1.20), age ≥80 years (PR = 1.15, 95% CI 1.03-1.28), no polypharmacy (PR = 0.72, 95% CI 0.67-0.78) and no hospitalization in the past year (PR = 0.90, 95% CI 0.82-0.97) remained associated with the presence of three or more PDDI in the final multivariate analysis model. CONCLUSIONS: Most PDDI were related to routinely used drugs (enalapril, hydrochlorothiazide, calcium, captopril, levothyroxine and simvastatin), and more than one-third of the older adults were exposed to PDDI with the possible risk of serious health consequences. Drugs with a narrow therapeutic index were involved in several PDDI, with increased risk of toxicity. The clinical management procedures most recommended are dose adjustment and dosing changes, control of the drugs' serum levels, and monitoring of the clinical conditions. Geriatr Gerontol Int 2017; 17: 2336-2346.

Reações Adversas a Medicamentos e Farmacovigilância: Conhecimentos e Condutas de Profissionais de Saúde de um Hospital da Rede Sentinela / Pharmacovigilance: Professional Knowledge and Conduct at a Teaching Hospital

RESUMO Introdução As reações adversas a medicamentos são objeto de estudo da farmacovigilância, ciência que utiliza, sobretudo, as notificações espontâneas feitas por profissionais de saúde. Há dificuldade de reconhecimento dos profissionais quanto a sua importância na segurança do paciente. As causas da subnotificação são atribuídas a falta de conhecimentos, percepção e compreensão dos incidentes. Objetivo Identificar o conhecimento e as condutas dos profissionais de saúde de um hospital de ensino em relação às reações adversas a medicamentos e à farmacovigilância e se há associação com o seu perfil profissiográfico. Métodos Estudo transversal, utilizando-se um instrumento validado que aborda questões sobre caracterização da população estudada, conhecimentos e condutas. Resultados Os médicos demonstraram maior conhecimento sobre reações adversas a medicamentos, e os técnicos em enfermagem, menor. No entanto, o entendimento sobre farmacovigilância foi maior entre os farmacêuticos. O tempo de formação e atuação na instituição está associado ao conhecimento sobre as reações adversas a medicamentos Conclusão: Os resultados deste estudo evidenciaram que a formação do profissional influencia seu conhecimento e condutas frente às reações adversas a medicamentos.

ABSTRACT Introduction Adverse Drug Reactions are studied by the science of pharmacovigilance, which makes particular use of spontaneous reports made by health professionals, although such professionals experience difficulties in recognizing adverse reactions and their importance in patient safety. The causes of underreporting are attributed to a lack of knowledge, awareness and understanding of incidents. Objective Methods: A cross-sectional study was conducted using a validated instrument in order to characterize the population under study, determining its knowledge and behaviors Results: Doctors demonstrated a greater knowledge of adverse drug reactions than nursing technicians; however an understanding of pharmacovigilance was higher among pharmacists. The length of time spent in training and working in an institution were also associated with a knowledge of adverse drug reactions Conclusion The results of this study show that professional training influences knowledge and behaviors on adverse drug reactions.

Acesso ao medicamento: perspectivas de pessoas que recorreram à via judicial / Acceso al medicamento: perspectivas de personas que recurrieron a la vía judicial / Access to medication: the perspectives of people who resort to judicial proceedings

RESUMO Trata-se de um estudo de caso interpretativo desenvolvido com o objetivo de descrever as experiências de pessoas que recorreram à via judicial para ter acesso a medicamentos no Sistema Único de Saúde. Os dados foram coletados por meio de entrevista semiestruturada nos domicílios de oito pessoas que recorreram a essa via, residentes em um município localizado no sudoeste do Estado de Goiás. A experiência de acesso ao medicamento foi marcada por barreiras que estão interligadas aos diversos níveis do sistema de saúde; envolvem aspectos organizacionais e assistenciais relacionados à informação, ao acolhimento e à resolutividade. A necessidade do tratamento contínuo da condição crônica e a dificuldade financeira foram os fatores determinantes para que os participantes recorressem à justiça. Observou-se a necessidade de aprimorar o acolhimento e a comunicação entre a equipe de saúde envolvida no acesso ao medicamento e de qualificar os profissionais da saúde para uma compreensão ampliada da assistência farmacêutica no Sistema Único de Saúde.

RESUMEN Se trata de un estudio de caso interpretativo desarrollado con el objetivo de describirlas experiencias de personas que recurrieron a la vía judicial para tener acceso a medicamentos en el Sistema Único de Salud de Brasil. Los datos fueron recolectados por medio de entrevista semiestructurada en los domicilios de ocho personas que recurrieron a esta vía, residentes en un municipio ubicado en el sudoeste del Estado de Goiás. La experiencia de acceso al medicamento fue marcada por obstáculos que están interconectados a los diversos niveles del sistema de salud; involucran aspectos organizacionales y asistenciales relacionados a la información, acogiday resolutividad. La necesidad del tratamiento continuo de la condición crónica yla dificultad financiera fueron los factores determinantes para que los participantes recurrieran a la justicia. Se observól a necesidad de perfeccionar la acogiday comunicación entre el equipo de salud involucrado en el acceso al medicamento y de calificar a los profesionales de la salud para una comprensión ampliada de la asistencia farmacéutica en el Sistema Único de Salud.

ABSTRACT The present study is an interpretative case study developed to describe the experiences of people who have resorted to judicial proceedings to gain access to medications in the Unified Health System. Data were collected through semi-structured interviews in the homes of eight individuals who have used this approach, who lived in a city in the southwest of the State of Goiás. The experience of access to medications was marked by barriers that are interconnected to the different levels of the health system; they involve organizational and assistance aspects related to information, embracement and resolution. The need for continued treatment of chronic conditions and financial difficulties were the determining factors for participants to resort to judicial proceedings. The need to improve embracement and communication among the health teams involved in access to medications, and to qualify health professionals for a broader understanding of pharmaceutical care in the Unified Health System, was observed.

Medication adherence in patients in treatment for rheumatoid arthritis and systemic lupus erythematosus in a university hospital in Brazil.

Medication adherence is essential for the control of symptoms and progression of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The aim of the study was to investigate medication adherence in outpatients in treatment for RA and SLE in a university hospital in Brazil. This was a quantitative, cross-sectional analytical study. A total of 92 patients (55 RA patients and 37 SLE patients) were included in the study. A structured questionnaire for patients' interview and a form for collecting data from medical records were used for data collection. Adherence to drug treatment was assessed by the Morisky scale questionnaire. Data storage and analysis were performed using Epi Info 3.5.4 and statistical analysis by Stata/SE 12.0. The Pearson's chi-squared test and Fisher's exact test were applied for statistical and bivariate analyses. For multivariate data analysis the Poisson regression and the Wald test were used. The prevalence of adherence to drug treatment was 16.4% in RA patients and 45.9% in SLE patients. The final model of the multivariate analysis demonstrated associations between medication adherence and the following covariates for both RA and SLE groups: duration of therapy for rheumatic disease at the institution greater than 15 years and presence of more than six chronic comorbidities. The parameter "acquisition of medication at the high-cost pharmacy" was differently associated with medication adherence by group, and for the SLE group, living outside the city of Goiânia was a protective factor associated with adherence. This study demonstrated a low prevalence of medication adherence in patients in treatment for RA and SLE treated at this institution. These findings will serve as a base for future studies to elucidate what factors may positively or negatively affect medication adherence in this population. In addition, multidisciplinary approaches are needed to enhance adherence to drug treatment in patients in treatment for rheumatic disease.

Reproducibility of cervical cytopathology following an intervention by an external quality control laboratory.

BACKGROUND: This study assessed the effects of a continued education program on the agreement between cervical cytopathology exams interpreted by local laboratories and interpretation made by an external quality control laboratory (LabMEQ). METHODS: Overall, 9,798 exams were analyzed between 2007 and 2008, prior to implementation of a continued education program, and 10,028 between 2010 and 2011, following implementation. Continued education consisted of theoretical and practical classes held every two months. The chi-square test and the kappa coefficient were used in the statistical analysis. RESULTS: Following implementation of continued education, the rate of false-negative results, and those leading to delays in clinical management fell in eight laboratories and the rate of false-positive results in five. Agreement between the results reported by the laboratories and the findings of LabMEQ, evaluated according to clinical management, remained excellent in three laboratories (kappa >0.80 and <1.0), went from good (kappa >0.60 and <0.80) to excellent in seven and from excellent to good in two. Agreement regarding the identification of metaplastic epithelium was poor (kappa = 0.25) but progressed to excellent following the implementation of continued education (kappa = 0.950). Agreement between cytopathology results improved significantly following implementation of continued education in cases reported as unsatisfactory (P < 0.001), atypical squamous cells of undetermined significance, cannot exclude high-grade squamous intraepithelial lesion (P < 0.001), low-grade squamous intraepithelial lesion (P < 0.001), and glandular atypia (P < 0.001). CONCLUSION: Continued education contributed towards improving the reproducibility of cervical cytopathology, decreased the rates of false-negative and false-positive results, and reduced delays in clinical management.