Antibiotic consumption in secondary and tertiary hospitals in Colombia: national surveillance from 2018-2020 / Consumo de antibióticos en hospitales de segundo y tercer nivel en Colombia: vigilancia nacional entre 2018 y 2020 / Consumo de antibióticos em hospitais secundários e terciários da Colômbia: vigilância nacional de 2018 a 2020

ABSTRACT Objective. To assess the compliance in secondary and tertiary level hospitals with monthly reporting of antibiotic consumption to the Colombian National Public Health Surveillance System (SIVIGILA-INS), and to describe reported antibiotic consumption during 2018-2020. Methods. This study involved a secondary analysis of antibiotic consumption data reported to SIVIGILA-INS. Frequency of hospital reporting was assessed and compared against expected reports, disaggregated by intensive care units (ICU)/non-ICU wards and geographical regions. Consumption was expressed as defined daily dose (DDD) per 100 occupied beds for seven antibiotics. Results. More than 70% of hospitals reported antibiotic consumption at least once in each of the three years (79% in ICU and 71% in non-ICU wards). Of these, ICU monthly reporting was complete (12 monthly reports per year) for 59% in the period 2018-2019 but only 4% in 2020. Non-ICU reporting was complete for 52% in 2019 and for 2% in 2020. Most regions had an overall decrease in reporting in 2020. Analysis of antibiotic consumption showed an increase for piperacillin/tazobactam, ertapenem, and cefepime from 2019 to 2020. Conclusions. There were gaps in the consistency and frequency of reporting. Efforts are needed to improve compliance with monthly reporting, which declined in 2020, possibly due to the COVID-19 pandemic. Non-compliance on reporting and data quality issues should be addressed with the hospitals to enable valid interpretation of antibiotic consumption trends.

RESUMEN Objetivo. Evaluar el cumplimiento de los hospitales de segundo y tercer nivel en la presentación mensual de información sobre el consumo de antibióticos en el Sistema Nacional de Vigilancia en Salud Pública de Colombia (SIVIGILA-INS) y describir el consumo de antibióticos reportado en el período 2018-2020. Métodos. Este estudio incluyó un análisis secundario de los datos del consumo de antibióticos reportado en SIVIGILA-INS. Se evaluó la frecuencia de los informes hospitalarios y se comparó con los informes esperados, desglosados por unidad de cuidados intensivos (UCI) y otros servicios distintos a la UCI, y por región geográfica. El consumo se expresó en dosis diaria definida (DDD) por 100 camas ocupadas para siete antibióticos. Resultados. Más del 70% de los hospitales notificaron el consumo de antibióticos al menos una vez en cada uno de los tres años (79% en la UCI y 71% en los servicios distintos a la UCI). De estos, el 59% de las UCI completaron los informes mensuales (12 informes en un año) entre el 2018 y el 2019, pero solo el 4% en el 2020. El 52% de los servicios distintos a la UCI completó los informes en el 2019 y el 2% en el 2020. En la mayoría de las regiones hubo una disminución general de la notificación en el 2020. El análisis del consumo de antibióticos mostró un aumento de piperacilina/tazobactam, ertapenem y cefepima del 2019 al 2020. Conclusiones. Se encontraron disparidades en la coherencia y en la frecuencia de la presentación de informes. Es necesario destinar esfuerzos para mejorar el cumplimiento de la notificación mensual, que disminuyó en el 2020 posiblemente debido a la pandemia de COVID-19. La falta de cumplimiento en la presentación de los reportes y los problemas de calidad de los datos deben abordarse con los hospitales para facilitar la interpretación válida de las tendencias de consumo de antibióticos.

RESUMO Objetivo. Avaliar o cumprimento da exigência de notificar mensalmente o consumo de antibióticos em hospitais secundários e terciários ao Sistema Nacional de Vigilância em Saúde Pública da Colômbia (SIVIGILA-INS) e descrever o consumo informado de antibióticos de 2018 a 2020. Métodos. Este estudo envolveu uma análise secundária dos dados de consumo de antibióticos enviados para o SIVIGILA-INS. A frequência de notificação pelos hospitais foi avaliada e comparada com a frequência esperada. Os dados foram desagregados entre unidades de terapia intensiva (UTIs) e enfermarias gerais e por regiões geográficas. O consumo foi expresso como dose diária definida (DDD) por 100 leitos ocupados para sete antibióticos. Resultados. Mais de 70% dos hospitais notificaram consumo de antibióticos pelo menos uma vez em cada um dos três anos (79% na UTI e 71% nas enfermarias gerais). Entre eles, 59% dos hospitais enviaram todas as notificações relativas a UTIs (12 notificações mensais) no período de 2018 a 2019, mas apenas 4% o fizeram em 2020. No caso das enfermarias gerais, 52% dos hospitais enviaram todas as notificações em 2019 e 2% o fizeram em 2020. A maioria das regiões teve uma diminuição geral no número de notificações enviadas em 2020. A análise do consumo de antibióticos revelou um aumento no uso de piperacilina/tazobactam, ertapeném e cefepima de 2019 para 2020. Conclusões. Houve lacunas na uniformidade e frequência das notificações. São necessários esforços para melhorar o cumprimento da exigência de notificações mensais, que, possivelmente devido à pandemia de COVID‑19, diminuiu em 2020. Problemas relacionados ao não cumprimento da exigência de notificação e à qualidade dos dados devem ser resolvidos junto aos hospitais para permitir uma interpretação válida das tendências de consumo de antibióticos.

Provenance des prescriptions de médicaments reçues dans les officines de pharmacie du Département de Dakar / Origin of drug prescriptions received in pharmacies in the Department of Dakar

Introduction. L'accessibilité à des médicaments de qualité constitue un véritable problème de santé publique en Afrique. Cela est dû à des besoins énormes en soins de santé associés à des ressources limitées. La prescription de médicaments qui est un acte médical pour traiter les malades après avoir posé le diagnostic, est réservée aux professionnels de santé. L'objectif de ce travail est d'étudier la provenance des prescriptions de médicaments reçues dans les officines de Dakar. Matériels et méthodes. Il s'agit d'une étude descriptive et transversale. Elle porte sur l'exploitation de prescriptions médicales reçues dans des officines du département de Dakar. Résultats. Les résultats révèlent que plus de la moitié des prescriptions soit 61%, provient du secteur privé et 30.52% sont faites par des médecins généralistes. De plus, la classe de la parasitologie et infectiologie est la plus prescrite (18.26%). Conclusion. L'analyse de ces paramètres nous aide à mieux évaluer la situation sanitaire pour estimer les besoins en médicaments et ainsi faire des recommandations pour une meilleure accessibilité.

Introduction. Accessibility to quality drugs is a real public health problem in Africa. This is due to huge health care needs associated with limited resources. The prescription of drugs, which is a medical procedure for treating patients after having made the diagnosis is reserved for health professionals. The objective of this work is to study the origin of prescription of drugs received in the pharmacies of Dakar. Materials and methods. This is a descriptive and cross-sectional study. It is based on the use of medical prescriptions received in pharmacies in the department of Dakar. Results. The result reveal that more than half of the prescriptions are 61%, come from the private sector and 30,52% are made by general practitioners. In addition, the class of parasitology and infectiology is the most prescribed (18,26%). Conclusion. The analysis of these parameters helps us to better assess the health situation in order to estimate the drug needs and thus make recommendations for a better accessibility.

Empirical Study on Promotion of Appropriate Pharmacotherapy in Patients with Seasonal Allergic Rhinitis / 社会薬学

The prevalence of seasonal allergic rhinitis (hereinafter “hay fever”) is increasing annually. While self-medication with over-the-counter (OTC) drugs is growing, some hay fever patients also use OTC drugs alongside medical visits. Issues arising from co-administration, such as excessive dosing and reduced quality of life (QOL) due to drowsiness, have been highlighted. However, no research has investigated the factors contributing to the concomitant use of prescribed and OTC drugs. Therefore, this study examined the following three patient groups: those using only prescribed drugs, those using only OTC drugs, and those using a combination of both. Initial analyses compared adherence, overuse extent, QOL (as measured by the Japanese Rhino-conjunctivitis Quality of Life Questionnaire [JRQLQ]), treatment satisfaction, lifestyle habits, and health literacy (as measured by the Communicative and Critical Health Literacy Scale [CCHL]) among the groups. Subsequently, a multinomial logistic regression analysis focusing on combination users identified factors associated with co-administration. The results revealed that combination users exhibited lifestyle issues and lower QOL compared to those using prescribed or OTC drugs only, although differences in CCHL were not significant. Furthermore, co-administration was linked to social life-related JRQLQ and excessive usage during symptom onset. In conclusion, patients with hay fever should avoid the concurrent use of prescribed and OTC drugs. Co-administration may not necessarily improve symptoms and might even lead to overuse risks. Thus, patients should be guided to consult medical professionals before purchasing OTC drugs, and lifestyle improvements should be emphasized as well.

Research and reference on the classification management system of prescription drugs and non-prescription drugs in Canada / 中国药房

OBJECTIVE To provide reference for improving the classification management of prescription drugs and non- prescription drugs in China by learning from the classification management system of prescription drugs and non-prescription drugs in Canada. METHODS The content and experience of classification management system of prescription drugs and non-prescription drugs in Canada were analyzed， and the thinking of the classification management of prescription drugs and non-prescription drugs in China was proposed. RESULTS ＆＆CONCLUSIONS According to the classification of prescription drugs and non-prescription drugs， drugs can be divided into class Ⅰ drugs， class Ⅱ drugs， class Ⅲ drugs， unclassified drugs in Canada. Specific evaluation factors and management requirements have been established for drug classification. Canada has established a set of systematic management systems and technical standards， which has reference value for improving the classification management system in China. It is suggested to further improve the drug classification management system and supporting policies， strengthen fine classification management of prescription drugs and non-prescription drugs and improve classification registration and transformation review standards in China， by learning from Canadian prescription drug and non-prescription drug system and management model.

Assessment of gastric-acid suppressants prescribing at an internal medicine service of a tertiary hospital in Latin America: A retrospective record review study

Gastric-acid suppressants are one of the most frequently used classes of drugs worldwide. Several studies about their overprescribing have been carried out in recent years. The aim of the study was to assess the appropriateness of these drugs at an internal medicine service of a tertiary hospital in Venezuela. A retrospective record review of patients admitted to the internal medicine service from January 2020 to February 2021 was performed. Data about indications for gastric-acid suppressants, the type used, and their continuation at discharge were collected. The prescribing was grouped into two categories, appropriate or inappropriate, according to current clinical guidelines. Of the 1203 patients who were newly prescribed gastric-acid suppressants in hospital during the study period, 993 (82.5%) had an inappropriate prescription. Prophylaxis of peptic ulcers in low-risk patients was the most frequent no evidence-based indication (20.24%). Seven hundred sixty-two patients were discharged on gastric-acid suppressants. Of these, 74.7% did not have an acceptable indication to continue this treatment on an outpatient basis. Many hospitalized patients in a Venezuelan academic tertiary healthcare center were given gastric acid suppressants not in accordance with the current clinical practice guidelines.

Los supresores del ácido gástrico son uno de los grupos farmacológicos más frecuentemente prescritos en todo el mundo. En los últimos años se han realizado varios estudios sobre su prescripción inadecuada. El objetivo del estudio fue evaluar la idoneidad de estos medicamentos en un servicio de medicina interna de un hospital de tercer nivel en Venezuela. Se realizó una revisión retrospectiva de historias medicas de pacientes ingresados en el servicio de medicina interna desde enero de 2020 hasta febrero de 2021. Se recogieron datos sobre indicaciones de supresores de ácido gástrico, tipo utilizado y su continuación al alta. La prescripción se agrupó en dos categorías, adecuada o inadecuada, según las guías clínicas vigentes. Entre los 1203 pacientes a los que se les prescribió recientemente supresores de ácido gástrico en el hospital durante el período de estudio, 993 (82,5%) tenían una prescripción inapropiada. La profilaxis de úlceras pépticas en pacientes de bajo riesgo fue la indicación no basada en evidencia más frecuente (20,24%). Setecientos sesenta y dos pacientes fueron dados de alta con supresores de ácido gástrico. De estos, el 74,7% no tenía una indicación apropiada para continuar este tratamiento de forma ambulatoria. Un alto número de pacientes hospitalizados en un centro asistencial de nivel terciario en Venezuela fueron prescritos con supresores de ácido gástrico que no se ajustaban a las guías de práctica clínica vigentes.

Factors associated with the use of a public information system of dentist-prescribed antibiotics in Minas Gerais, Brazil / Fatores associados ao uso de um sistema de informação público de antibióticos prescritos por cirurgiões-dentistas em Minas Gerais, Brasil

Abstract This article aims to investigate the association between socioeconomic factors, health care organizations, and the use of a management and monitoring system for the dispensing of antibiotics prescribed by dentists in public health services in Minas Gerais, Brazil. This is an ecological-epidemiological study that analyzed secondary data from the Integrated Pharmaceutical Care Management System (SIGAF) of the Department of Health of the state of MG, Brazil, in 2017. Thirteen independent variables were analyzed to assess their influence on municipal adherence to SIGAF system considering dental prescriptions of antibiotics. Descriptive statistical analyses were performed, and the Classification and Regression Tree technique was used to identify the municipal variables associated with the outcome. A total of 57,279 antibiotic courses prescribed by dentists and recorded in SIGAF were examined. Socioeconomic factors were not associated with the use of SIGAF to record these prescriptions. Oral healthcare coverage was positively associated with the use of SIGAF for the dispensing of antibiotics prescribed by dentists. Dental Specialties Center were negatively associated with the outcome. Municipalities with high oral healthcare coverage and those without a Dental Specialties Center were more likely to use SIGAF.

Resumo O objetivo deste artigo é avaliar a associação entre fatores socioeconômicos, organização dos serviços de saúde e a utilização de um sistema de gestão e monitoramento da dispensação de antibióticos prescritos por cirurgiões-dentistas em Minas Gerais, Brasil. Estudo epidemiológico ecológico que analisou dados secundários do Sistema Integrado de Gestão da Assistência Farmacêutica (SIGAF) da Secretaria de Estado de Saúde de MG, Brasil, em 2017. Treze variáveis independentes foram analisadas para testar a influência destas com a adesão dos municípios ao SIGAF das prescrições odontológicas de antibióticos. Foram realizadas análises estatísticas descritivas, e a técnica de Árvore de Classificação e Regressão foi utilizada. Foram examinadas 57.279 prescrições de antibióticos prescritos por dentistas e registradas no SIGAF. Fatores socioeconômicos não foram associados ao uso do SIGAF para registro dessas prescrições. A cobertura de saúde bucal esteve positivamente associada à utilização do SIGAF para as dispensações de antibióticos prescritos por cirurgiões-dentistas. A presença de Centro De Especialidade Odontológica, esteve negativamente associado ao desfecho. Municípios com maior cobertura de saúde bucal e sem Centro de Especialidade Odontológica foram mais propensos a utilizar o SIGAF.

Anonymous authorship may reduce prescription drug deaths

Anonymous sources are used by journalists when it is important to protect whistleblowers from repercussions. Healthcare is heavily influenced by vested interests which are often financial, but academic prestige and protection of guild interests also play a major role. If anonymous authorship is not allowed, many potential whistleblowers would prefer to keep quiet, even though their stepping forward would serve the public interest and might save many lives, particularly by reducing prescription drug deaths. This is especially important since drugs are the third leading cause of death in the Western world.

Risk of opioid abuse in non-oncologic chronic pain outpatient clinic / Risco de abuso de opioides em ambulatório de dor crônica não oncológica

ABSTRACT BACKGROUND AND OBJECTIVES: Chronic pain has become an extremely prevalent disease and an ever more recurrent reason for seeking medical attention. It has been treated with opioids, opening the possibility for abuse. This study's objective was to analyze the risk profile for opioid abuse in chronic pain outpatients. METHODS: Cross-sectional study with 72 patients seen in an outpatient clinic of a public hospital in the period of July and August 2019. The variables analyzed were age, gender, comorbidities, drugs in use, and aspects related to pain such as intensity, anatomical location, etiology, and need to be absent from work. In addition, a questionnaire was applied to assess the risk of opioid abuse. RESULTS: The study analyzed 72 patients with chronic pain, most of whom were women (84.7%). The mean age was 52.8 years. Patients were classified into three groups according to the risk of opioid abuse: high (21%), moderate (29%) and low (50%). There was an association of increased risk with opioid use (p=0.004) and presence of depression (p=0.003). CONCLUSION: Half of the patients presented low risk for opioid abuse. Increased risk for opioid abuse is related to the presence of depression or depressive symptoms. No relationship was observed between benzodiazepines use and increased risk for opioid abuse. Patients considered at high risk for opioid abuse are more likely to develop aberrant behaviors. Knowing the patient's risk profile is necessary to increase the safety and effectiveness of chronic pain treatment.

RESUMO JUSTIFICATIVA E OBJETIVOS: A dor crônica tem se tornado uma doença extremamente prevalente e um motivo cada vez mais recorrente para procura de atendimento médico. Tem sido tratada com opioides possibilitando o abuso de seu uso. Este estudo teve como objetivo analisar o perfil de risco para abuso de opioides em pacientes ambulatoriais com dor crônica. MÉTODOS: Estudo transversal com 72 pacientes atendidos em ambulatório de um hospital público no período de julho e agosto de 2019. As variáveis analisadas foram idade, sexo, comorbidades, fármacos em uso e aspectos relacionados à dor como intensidade, localização anatômica, etiologia e necessidade de se afastar do trabalho. Além disso, foi aplicado um questionário para avaliar o risco de abuso de opioides. RESULTADOS: Foram analisados 72 pacientes com dor crônica, sendo a maioria mulheres (84,7%). A média de idade foi de 52,8 anos. Os pacientes foram classificados em três grupos conforme o risco de abuso de opioides: alto (21%), moderado (29%) e baixo (50%). Houve associação do aumento do risco com o uso de opioides (p=0,004) e com a presença de depressão (p=0,003). CONCLUSÃO: Metade dos pacientes apresentou baixo risco para abuso de opioides. O aumento do risco de abuso de opioides está relacionado à presença de depressão ou sintomas depressivos. Não foi observada relação entre o uso de benzodiazepínico e o aumento no risco de abuso para opioides. Pacientes considerados de alto risco para abuso de opioides têm mais chances de desenvolverem comportamentos aberrantes. É preciso conhecer o perfil de risco do paciente para aumentar a segurança e eficácia do tratamento da dor crônica.

Factores asociados con la automedicación no responsable en el Perú / Factors associated with non-responsible self-medication in Peru

RESUMEN Introducción: La automedicación no responsable conduce a una baja efectividad e inseguridad en los tratamientos, daños a la salud e insatisfacción del paciente. Objetivo: Identificar los factores asociados con la automedicación no responsable en la población peruana. Material y Métodos: Se realizó un estudio analítico transversal basado en el análisis secundario de la Encuesta Nacional de Satisfacción de Usuarios en Salud 2016 realizada en Perú. Incluyó 3849 usuarios de establecimientos farmacéuticos. Se calcularon: chi-cuadrado con valor p, odds ratio crudo (ORc) y odds ratio ajustado (ORa) con su intervalos de confianza del 95% (IC 95%). Resultados: El riesgo de automedicación no responsable fue muy alto cuando el dispensador del medicamento no solicitó la receta del usuario (ORa = 29,057). Además, acudir al establecimiento farmacéutico para pedir consejo (ORa= 1,884), el consumo eventual del medicamento comprado (ORa= 1,925), menos de cinco minutos de demora en la compra del medicamento (ORa= 1,587) y ser hombre (ORa= 1,321) también fueron factores de riesgo. La proximidad del establecimiento farmacéutico a los establecimientos de salud del primer y segundo nivel de atención también actuó como un factor de riesgo (ORa= 1,340 y 1,652, respectivamente). Conclusión: La falta de solicitud de prescripción en el establecimiento farmacéutico fue el principal factor de riesgo para la automedicación no responsable.

ABSTRACT Introduction: Non-responsible self-medication leads to low effectiveness and insecurity in treatments, damage of health and patient dissatisfaction. Objective: To identify factors associated with non-responsible self-medication in the Peruvian population. Material and Methods: An analytical cross-sectional study was conducted based on the secondary analysis of the National Survey of Users Satisfaction in Health performed in Peru in 2016. It included 3849 users of pharmaceutical establishments. Chi-square statistic with p-value, crude odds ratio (cOR) and adjusted odds ratio (aOR) with its 95% confidence interval (95% CI) were calculated. Results: When the dispenser of the medicine did not request the prescription from the user, the risk of non-responsible self-medication was very high (aOR=29.057). Additionally, going to the pharmaceutical establishment to ask for advice (aOR=1.884), eventual consumption of the purchased medicine (aOR=1.925), less than five minutes delay in purchasing medicine (aOR=1.587) and being male (aOR=1.321) were also risk factors. The proximity of the pharmaceutical store to health services from the first and second level of health care also acted as a risk factor (cOR=1.340 and 1.652, respectively). Conclusion: The lack of request for prescription in the pharmaceutical establishment was the main risk factor for non-responsible self-medication.

Prevalência de intoxicação por medicamentos no estado da Bahia entre 2007 e 2017 / Prevalence of drug poisoning in the state of Bahia between 2007 and 2017 / Prevalencia de intoxicación por medicamentos en el estado de Bahía entre 2007 y 2017

Justificativa e Objetivos: As intoxicações por medicamentos estão se tornando um problema de saúde pública. Nesse contexto, a atenção farmacêutica, bem como os cuidados dos profissionais de saúde que trabalham diretamente com medicamentos, tornam-se fundamentais na reparação da saúde do paciente e na prevenção de problemas relacionados ao uso desses produtos. Objetivou-se determinar a prevalência de intoxicação por medicamentos no estado da Bahia, Brasil, entre 2007 e 2017. Métodos: Foi realizado um estudo quantitativo, do tipo descritivo e exploratório, que avaliou as notificações relacionadas à intoxicação por medicamentos no estado da Bahia registradas no DATASUS entre 2007 e 2017, tendo como variáveis de interesse: faixa etária, raça/cor e sexo, circunstância, classificação final, critério de confirmação e evolução, ano e município de notificação. Resultados: Foram registrados 28.412 casos de intoxicação exógena no período, sendo 29,7% causados por medicamentos. A faixa etária de maior prevalência foi de 20 a 39 anos (38,5%), com maior número de casos entre pessoas do sexo feminino (66,7%), tendo a tentativa de suicídio como a principal causa, correspondendo a 38,5% das notificações. A maior concentração de casos notificados ocorreu na capital do estado. Conclusão: No período estudado, os medicamentos foram os maiores responsáveis pelos casos de intoxicação exógena, sendo a tentativa de suicídio o maior motivo. Sem dúvidas, a facilidade de acesso a esses produtos predispõe à automedicação, sendo um fator de risco para esses casos de intoxicação. Nesse cenário, é necessária a implementação de campanhas de uso racional de medicamentos no estado da Bahia, bem como de prevenção ao suicídio, direcionadas, principalmente, aos adultos jovens, faixa etária com maior prevalência de casos.(AU)

Background and Objectives: Drug poisoning is becoming a public health problem. In this context, pharmaceutical care and the care of health professionals who work directly with medications are fundamental in the repair of patients' health and in the prevention of problems related to the use of these products. This study aimed to determine the prevalence of drug poisoning in the state of Bahia, Brazil, between 2007 and 2017. Methods: This is a quantitative, descriptive and exploratory study, which evaluated the drug poisoning notifications in the state of Bahia, recorded in DATASUS between 2007 and 2017, considering as variables of interest: age group, race, sex, circumstance, final classification, confirmation criterion and evolution, year and city of notification. Results: In the period, 28,412 cases of exogenous intoxication were recorded, 29.7% of which were caused by medications. The age group with the highest prevalence was 20 to 39 years old (38.5%), females presented the highest number of cases (66.7%); suicide attempt was the main cause, corresponding to 38.5% of the notifications. The highest concentration of reported cases occurred in the state capital. Conclusion: In the studied period, the drugs were the most responsible for cases of exogenous intoxication, and suicide attempt was the main reason. Undoubtedly, the easy access to these products predisposes self-medication­a risk factor for these cases of intoxication. In this scenario, it is necessary to implement campaigns for the rational use of medicines in the state of Bahia, as well as suicide prevention, directed mainly to young adults­the age group with the highest prevalence of cases.(AU)

Justificación y Objetivos: La intoxicación por medicamentos se está convirtiendo en un problema de salud pública. En este contexto, la atención farmacéutica, así como los cuidados de los profesionales de la salud que trabajan directamente con medicamentos, se vuelven fundamentales en la reparación de la salud del paciente y la prevención de problemas relacionados con este uso. El objetivo de este estudio fue determinar la prevalencia de intoxicación por medicamentos en el estado de Bahía entre 2007 y 2017. Métodos: Se realizó un estudio exploratorio cuantitativo, descriptivo, que evaluó las notificaciones relacionadas con la intoxicación por medicamentos en el estado de Bahía registradas en DATASUS entre 2007 y 2017, teniendo como variables de interés: grupo de edad, raza/color y sexo, circunstancia, clasificación final, criterios de confirmación y evolución, año y ciudades de notificación. Resultados: Hubo 28.412 casos de intoxicación exógena en el período; de los cuales el 29,7% fueron causados por medicamentos. El grupo de edad más prevalente fue el de 20-39 años (38,5%), con un mayor número de casos entre mujeres (66,7%), con intento de suicidio como la causa principal que corresponde al 38,5% de las notificaciones. La mayor concentración de casos reportados ocurrió en la capital del estado. Conclusión: Se observó que en el período estudiado la mayoría de los casos de intoxicaciones exógenas se dieron por el uso de medicamentos, con el intento de suicidio como la principal razón. El fácil acceso a los medicamentos predispone a la automedicación, un factor de riesgo para casos de intoxicación. En este sentido, se hace necesario implementar campañas para el uso racional de medicamentos en el estado de Bahía, así como para la prevención del suicidio, sobre todo en los adultos jóvenes, grupo de edad con una mayor prevalencia de casos.(AU)

Vitamin, micronutrients and supplement prescribing patterns in a group of ambulatory colombian patients, 2016 / Patrones de prescripción de vitaminas y suplementos nutricionales en un grupo de pacientes de Colombia

Abstract Introduction: Vitamins and micronutrients are essential organic substances in the metabolic processes of living things, and supplementation is only recommended in conditions of nutritional deficits. Objective: To determine the prescription patterns of vitamins and supplements in a group of patients enrolled in the Colombian Health System in 2016. Methodology: This was a cross-sectional study based on a population database. Vitamin-prescribed patients of both sexes and all ages were selected for 3 consecutive months. A database was designed using the dispensing records. SPSS 23.0 was used for the univariate, bivariate and multivariate analyses. A p-value <0.05 was considered statistically significant. Results: In total, 9998 patients receiving vitamin supplementation were identified. A female predominance was observed (n=8341, 83.4%). The mean age was 57.7±18.7 years. The most commonly formulated vitamins and micronutrients were vitamin D (58.0%), calcium (55.0%) and folic acid (25.0%). Overall, 60.8% of patients were prescribed more than one vitamin. The most frequent multiple-nutrient association was between calcium and vitamin D (n=5505); 77.3% received concurrent treatment with other medications to manage comorbidities. The probability of comedication in the multivariate analysis was higher for folic acid (OR:3.10, 95%CI 2.69-3.59), thiamine (OR:2.75, 95%CI:2.15-3.5) and calcium + vitamin D (OR:1.61, 95%CI: 1.42-1.82) and for those individuals older than 65 years (OR:1.24, 95%CI:1.02-1.51). Conclusions: Vitamins are widely used in the Colombian population. The results of this study elucidate the patterns of use of these supplements and offer proposed strategies to the future and to evaluate and minimize prescriptions that are potentially inappropriate or of little therapeutic value. MÉD.UIS. 2020;33(2):41-8.

Resumen Introducción: Las vitaminas y micronutrientes son sustancias orgánicas esenciales en los procesos metabólicos de los seres vivos y solo se recomienda suplementación en condiciones con déficits nutricionales. Objetivo: Determinar los patrones de prescripción de vitaminas y suplementos en un grupo de pacientes afiliados al Sistema de Salud en Colombia, en el año 2016. Métodos: Estudio de corte transversal a partir de una base de datos poblacional. Se seleccionaron pacientes con prescripción de vitaminas por 3 meses consecutivos de ambos sexos y todas las edades. Se diseñó una base de datos con los registros de dispensación. Se usó SPSS 23.0 para análisis univariados, bivariados y multivariados. Se consideró estadísticamente significativo un valor de p<0,05. Resultados: Se hallaron 9998 pacientes con prescripción de suplementos vitamínicos. Se halló un predominio femenino (n=8341; 83,4%). La edad media fue de 57,7±18,7 años, las vitaminas y micronutrientes más formulados fueron: vitamina D (58,0%), calcio (55,0%) y ácido fólico (25,0%). El 60,8% de pacientes tenía más de un suplemento prescrito. La asociación más frecuente fue calcio y vitamina D (n=5505), y el 77,3% recibía tratamiento simultáneo con otros medicamentos para el control de comorbilidades. La probabilidad de comedicacion en el análisis multivariado fue mayor en formulados con ácido fólico (OR:3,10; IC95%:2,69-3,59), tiamina (OR:2,75; IC95%:2,15-3,50), calcio+vitamina D (OR:1,61; IC95%:1,42-1,82) y los mayores de 65 años (OR:1,24; IC95%:1,02-1,51). Conclusiones: Las vitaminas son ampliamente usadas en la población colombiana, los hallazgos de este estudio permiten conocer un estado de los patrones de uso de estos suplementos, así como plantear estrategias para racionalizar las prescripciones potencialmente inapropiadas o de poco valor terapéutico. MÉD.UIS. 2020;33(2):41-8.

Medicalización psiquiátrica en tres prisiones femeninas brasileras: un abordaje etnográfico sobre los itinerarios de criminalización, patologización y farmacologización / Psychiatric medicalization in three Brazilian womens prisons: an ethnographic approach to the itineraries of criminalization, pathologization and pharmaceuticalization

RESUMEN Este artículo analiza los procesos de medicalización psiquiátrica de las mujeres dentro de tres prisiones femeninas brasileñas, desde los campos de la salud mental, la antropología del confinamiento y los estudios de género. Se llevó a cabo un estudio cualitativo de carácter etnográfico (de octubre de 2006 a febrero de 2007) con observación participante, conversaciones informales, entrevistas semiestructuradas y relatos de vida. Entendidos como dispositivos estatales de poder, los procesos de medicalización psiquiátrica están marcados por tres itinerarios: criminalización masiva de mujeres, patologización (de la criminalidad femenina) y farmacologización psiquiátrica (en especial, a través de la administración de fármacos psicoactivos). Estos procesos instauran un círculo vicioso que perpetúa o produce los trastornos psiquiátricos que pretende curar, alimentando el uso y consumo de drogas (ilícitas-lícitas-ilícitas) y su vinculación con la ilegalidad, y permiten ver cómo el género, intersectado con otras categorías de diferenciación, influye en la producción de enfermedades mentales, las cuales deben ser tratadas como un problema de salud pública que se extiende más allá de los muros de las prisiones femeninas.

ABSTRACT This article analyzes the psychiatric medicalization of women in three Brazilian women's prisons, from the fields of mental health, the anthropology of confinement, and gender studies. A qualitative study employing ethnographic methods was carried out from October 2006 to February 2007, which included participant observation, informal conversations, semi-structured interviews, and life histories. Understood as a state device of power, psychiatric medicalization processes are marked by three itineraries: the mass criminalization of women, pathologization of women's crimes, and psychiatric pharmaceuticalization (especially through the administration of psychoactive drugs). These processes thus establish a vicious cycle that perpetuates or produces the disorders that psychiatry seeks to heal and enables the continuity of drug use (illicit-licit-illicit) and its ties to the illegal drug market, while highlighting how gender - in its intersections with other categories of differentiation - influences the production of mental illnesses, which must be treated as a public health problem that extends beyond the walls of women's prisons.

Promoção do uso racional de medicamentos no contexto dos 3º e 4º ciclos da educação de jovens e adultos / Promotion of the rational use of medicines in the context of the 3th and 4th cycles of youth and adult education / Promoción del uso racional de medicamentos en el context de los 3º y 4º ciclos de educación juvenil y adulta

Introdução: O alto consumo de medicamentos no Brasil impulsiona o desenvolvimento de estratégias para promoção do uso racional dos mesmos, especialmente em população mais vulneráveis. Objetivo: Traçar o perfil socioeconômico, demográfico e farmacoterapêutico dos alunos incluídos na presente pesquisa; bem como, promover atividades de educação em saúde.Metodologia: Trata-se de uma pesquisa epidemiológica transversal, quantitativa e descritiva realizada com 33 alunos do terceiro e quarto ciclos do programa de Educação de Jovens e Adultos de uma escola pública de João Pessoa-PB. Os dados foram coletados através de formulário, ficha de medicamentos e atividades de educação em saúde. Resultados:A maioria dos estudantes jovens e adultos com idade abaixo de 60 anos(75,7%), predominando o sexo feminino(69,6%)e parda(63,3%). Quase metade dos participantes é constituída de desempregados(45,5%). Parte dos alunos(39,9%) afirmaram ter renda mensal de até um salário mínimo. Para realização desse projeto foram efetuadas atividades que proporcionavam, através de metodologias ativas, a educação e promoção do uso racional de medicamentos e o autocuidado. Quanto ao perfil farmacoterapêutico observa-se interações medicamentosas entre anti-hipertensivos, hipoglicemiantes, anti-tireoidiano e medicamentos isentos de prescrição, apresentando presença de automedicação. As classes medicamentosas predominantes foram os analgésicos, anti-hipertensivos, anti-inflamatórios,antiácidos e hipoglicemiantes. Conclusões:O desenvolvimento de práticas educativas no âmbito da Educação de Jovens e Adultos incentivam o diálogo e a participação dos envolvidos, com grande potencial para ampliação do acesso às informações associadas ao autocuidado em saúde em suas famílias, escola e comunidade (AU).

Introduction:The high consumption of medicines in Brazil drives the development of strategies to promote their rational use, especially in the most vulnerable populations. Objective:Draw the socioeconomic, demographic and pharmacotherapeutic profile of the students included in this research; as well as promoting health education activities. Methodology:This is a cross-sectional, quantitative and descriptive epidemiological research carried out with 33 students from the third and fourth cycles of the Youth and Adult Education program of a public school in João Pessoa-PB. The data were collected through a form, medication form and health education activities. Results:The majority of young and adult students under the age of 60 (75.7%), predominantly female (69.6%) and brown (63.3%). Almost half of the participants are unemployed (45.5%). Part of the students (39.9%) said they had a monthly income of up to one minimum wage. In order to carry out this project, activities were carried out that provided, through active methodologies, education and promotion of the rational use of medicines and self-care. Regarding the pharmacotherapeutic profile, drug interactions are observed between antihypertensive drugs, hypoglycemic agents, anti-thyroid agents and non-prescription drugs, with the presence of self-medication. The predominant drug classes were analgesics, antihypertensives, anti-inflammatories, antacids and hypoglycemic agents. Conclusions:The development of educational practices within the scope of Youth and Adult Education encourages dialogue and the participation of those involved, with great potential for expanding access to information associated with self-care in health in their families, school and community (AU).

Introducción: El alto consumo de medicamentos en Brasil impulsa el desarrollo de estrategias para promover su uso racional, especialmente en las poblaciones más vulnerables. Objetivo:Dibujar el perfil socioeconómico, demográficoy farmacoterapéutico de los estudiantes incluidos en esta investigación; así como promover actividades de educación para la salud. Metodología:Esta es una investigación epidemiológica transversal, cuantitativa y descriptiva realizada con 33 estudiantes del tercer y cuarto ciclo del programa de Educación para Jóvenes y Adultos de una escuela pública en João Pessoa-PB. Los datos fueron recolectados a través de un formulario, formulario de medicamentos y actividades de educación para la salud.Resultados:La mayoría de los estudiantes jóvenes y adultos menores de 60 años (75.7%), predominantemente mujeres (69.6%) y marrones (63.3%). Casi la mitad de los participantes están desempleados (45,5%). Parte de los estudiantes (39.9%) dijeron que tenían un ingreso mensual de hasta un salario mínimo. Para llevar a cabo este proyecto, se llevaron a cabo actividades que proporcionaron, a través de metodologías activas, educación y promoción del uso racional de medicamentos y autocuidado. En cuanto al perfil farmacoterapéutico, se observan interacciones farmacológicas entre fármacos antihipertensivos, agentes hipoglucemiantes, agentes antitiroideos y medicamentos sin receta, con presencia de automedicación. Las clases de drogas predominantes fueron analgésicos, antihipertensivos, antiinflamatorios, antiácidos y agentes hipoglucemiantes. Conclusiones:El desarrollo de prácticas educativas en el ámbito de la educación de jóvenes y adultos fomenta el diálogo y la participación de los involucrados, con un gran potencial para ampliar el acceso a la información asociada con el autocuidado en salud en sus familias, escuelas y comunidades (AU).

Intoxicaciones agudas por medicamentos consumidos con fines de abuso / Acute poisoning due to medications used for abuse purposes

Introducción: El consumo de sustancias con fines de abuso y entre ellas los medicamentos, se ha incrementado a nivel mundial. Objetivo: Caracterizar a los pacientes atendidos por intoxicaciones agudas debido a medicamentos consumidos con fines de abuso. Métodos: El universo estuvo constituido por consultas de 961 pacientes, realizadas al servicio de información toxicológica de urgencia del Centro Nacional de Toxicología, durante el período 2010 al 2014. Fueron todas las intoxicaciones agudas por consumo de sustancias con fines de abuso. La serie incluyó 578 pacientes con intoxicaciones agudas con fines de abuso, donde el agente causal fueron los medicamentos. Se recopilaron los datos sociales y biológicos, formas de consumo, grupos farmacológicos, manifestaciones clínicas, aspectos de la toxicocinética y la toxicodinamia. Resultados: Los consumidores de medicamentos con fines de abuso, representaron el 60,14 por ciento de las consultas por consumo de sustancias con fines de abuso. El grupo etario de hasta 20 años fue el de mayor consumo (360 consultas; 62,28 por ciento) y el sexo masculino el más frecuente (447 pacientes; 77,3 por ciento). La combinación de medicamentos más alcohol fue la forma de consumo más empleada (292 consultas; 50,5 por ciento). La carbamazepina fue el medicamento más consumido (305 consultas; 52,7 por ciento). Conclusiones: Predominó la intoxicación aguda en el grupo etario de 10-20 años y del sexo masculino. La ingestión de medicamentos más alcohol, fue la forma de consumo más empleada. El grupo farmacológico más utilizado con fines no médicos, fue el de los anticonvulsivantes (carbamazepina), seguido de las benzodiacepinas y los opiáceos. Las manifestaciones clínicas que predominaron fueron del sistema neurológico, seguido del cardiovascular y el digestivo(AU)

ABSTRACT Introduction: The consumption of substances for the purpose of abuse, including drugs, has increased worldwide. Objective: To characterize patients treated for acute intoxications due to drugs consumed for abuse purposes. Methods: The universe was constituted by consultations of 961 patients, made to the emergency toxicology information service of the National Center of Toxicology, during the period from 2010 to 2014. They were all acute intoxications due to the consumption of substances for the purpose of abuse. The series included 578 patients with acute intoxications for abuse, where the causative agent was medication. We collected social and biological data, forms of consumption, pharmacological groups, clinical manifestations, aspects of toxicokinetics and toxicodynamics. Results: Consumers of medications for the purpose of abuse accounted for 60.14 percent of consultations for the consumption of substances for the purpose of abuse. The age group of up to 20 years consumed the most (360 consultations, 62.28 percent) and the most frequent was the male sex (447 patients, 77.3 percent). The combination of drugs plus alcohol was the most used form of consumption (292 consultations, 50.5 percent). Carbamazepine was the most commonly used medication (305 consultations, 52.7 percent). Conclusions: Acute intoxication predominated in the age group of 10-20 years and of the male sex. The ingestion of drugs plus alcohol was the most used form of consumption. The most used pharmacological group for non-medical purposes was the anticonvulsant group (carbamazepine), followed by benzodiazepines and opiates. The clinical manifestations that predominated were of the neurological system, followed by cardiovascular and digestive(AU)

Consumo do benzodiazepínico clonazepam (Rivotril®) no estado do Rio de Janeiro, Brasil, 2009-2013: estudo ecológico / Consumption of the benzodiazepine clonazepam (Rivotril®) in Rio de Janeiro State, Brazil, 2009-2013: an ecological study

Resumo O objetivo do estudo é estimar a prevalência do uso de clonazepam no Estado do Rio de Janeiro (RJ). Estudo ecológico e descritivo do consumo de clonazepam (2009-2013), com dados do Sistema Nacional de Gerenciamento de Produtos Controlados da Anvisa. O consumo foi medido pela Dose Diária Definida, com indicadores por população total e com 18 anos e mais utilizando a DDD padronizada de 8mg (anticonvulsivante) e a de 1mg (hipnosedativo). Os Municípios da Região Metropolitana foram agrupados segundo os Índices de Desenvolvimento Humano (IDH) e de GINI, submetidos à análise de conglomerados e apresentados segundo o consumo de clonazepam. No Estado do RJ, o consumo entre 2009 e 2013 aumentou de 0,35 para 1,97 DDD/1000 habitantes. Os valores são maiores para os indivíduos acima de 18 anos. Empregando-se 1mg ao invés de 8mg, chega-se a 21 DDD/1000 habitantes acima de 18 anos, em 2013. Rio de Janeiro e Niterói, com os maiores IDH, apresentaram em 2013 os maiores consumos, 3,38 e 4,52 DDD, respectivamente. Os dados sugerem que até 2% da população adulta é usuária de clonazepam, possivelmente como hipnosedativo. Deve-se atentar para o uso ampliado e fora de indicações terapêuticas, dados o potencial de abuso e as reações adversas ao clonazepam.

Abstract This descriptive, ecological study of clonazepam consumption in Rio de Janeiro State (RJ) estimated use prevalence from 2009 to 2013 using data from the National Controlled Product Management System operated by Brazil's health surveillance agency, Anvisa. Consumption was measured by total population and by population over 18 years old, using the standardised Daily Defined Doses of 8 mg (anticonvulsant) and 1 mg (sedative-hypnotic). The municipalities of the Rio de Janeiro Metropolitan Region were grouped by Human Development Index (HDI) and GINI index, subjected to cluster analysis and ranked by clonazepam consumption. From 2009 to 2013, consumption in the state rose from 0.35 to 1.97 DDD/1000 population, but the figures are higher for individuals over 18 years of age. A DDD of 1 mg instead of 8mg returns consumption in 2013 of 21 DDD/1000 population over 18 years of age. Consumption in 2013 was highest - 3.38 and 4.52 DDD, respectively - in Rio de Janeiro and Niterói, which have the highest HDIs. This suggests that up to 2% of the adult population uses clonazepam, possibly as a sedative-hypnotic. This broad use and use outside therapeutic indications deserves attention, given clonazepam's potential for abuse and adverse reactions.

Restrictive measure for the commercialization of antimicrobials in Brazil: results achieved / Medida restritiva para comercialização de antimicrobianos no Brasil: resultados alcançados

ABSTRACT OBJECTIVE To assess whether the incidence of hospital infection by a resistant microorganism decreased after the implementation of the restrictive measure of the National Health Surveillance Agency for the commercialization of antimicrobials. METHODS A historical cohort study of medical records of adult patients admitted to a general and public hospital from May 2010 to July 2011. A cohort was formed with patients admitted in the period before the restrictive measure for the commercialization of antimicrobials (Phase I) and a second cohort was formed with patients admitted after the implementation of the restrictive measure (Phase II). RESULTS The instantaneous risk of hospital infection by a resistant microorganism was estimated at seven by 1,000 people-time (95%CI 0.006-0.008) in Phase I, and four by 1,000 people-time (95%CI 0.003-0.005) in Phase II of the study. The differences between the survival curves in the different phases of the study and stratified by age group were also significant (p < 0.05). CONCLUSIONS The results suggest that the implementation of the restrictive measure of the commercialization of antimicrobials by the National Health Surveillance Agency reduced the incidence of hospital infection by a resistant microorganism.

RESUMO OBJETIVO Avaliar se a incidência de infecção hospitalar por microrganismo resistente diminuiu após a implementação da medida restritiva da Agência Nacional de Vigilância Sanitária para comercialização de antimicrobianos. MÉTODOS Estudo de coorte histórica de registros de prontuários de pacientes adultos admitidos para internação em um hospital geral e público no período de maio de 2010 a julho de 2011. Foi formada uma coorte com pacientes internados em período anterior à medida restritiva para comercialização de antimicrobianos (Fase I) e uma segunda coorte com pacientes admitidos após a implantação da medida restritiva (Fase II). RESULTADOS O risco instantâneo de infecção hospitalar por microrganismo resistente foi estimado em sete por 1.000 pessoas-tempo (IC95% 0,006-0,008) na Fase I, e quatro por 1.000 pessoas-tempo (IC95% 0,003-0,005) na Fase II do estudo. As diferenças entre as curvas de sobrevida nas diferentes fases do estudo e estratificadas pela faixa etária também foram significativas (p < 0,05). CONCLUSÕES Os resultados sugerem que a implantação da medida restritiva de comercialização de antimicrobianos pela Agência Nacional de Vigilância Sanitária reduziu a incidência de infecção hospitalar por microrganismo resistente.

The iatrogenic triad in a group of elderly women contracted to a health plan / Tríade iatrogênica em um grupo de mulheres idosas vinculadas a um plano de saúde

Abstract Objective: to study the main elements of the iatrogenic triad in a group of elderly women with a Chronic Non-Communicable Disease (CNCD) contracted to a health plan. Method: A cross-sectional and descriptive epidemiological study was carried out by analyzing 3,501 medical prescriptions of 725 elderly women aged ≥65 years. The medications were determined to be Potentially Inappropriate Medications (PIM) based on four instruments (AGS Beers 2015, PRISCUS List, EU(7)-PIM, Brazilian Consensus of PIM - CBPIM). In addition, the most prescribed drugs were assessed for possible Drug Interactions (DI) and classified according to degree of severity. Results: the present study revealed that 89.3% of the studied group used at least one element of the iatrogenic triad, and 44.9% of the sample were associated with the use of polypharmacy and PIM. A total of 48.0% were taking at least five continuous use medications. The main DI were omeprazole, simvastatin and levothyroxine, all of which are of significant severity and have potential drug-food interactions. A total of 35.1% of PIM were identified through the four criteria used, 26.6% were identified by the CBPIM, 25.8% by the EU(7)-PIM, and 24.6% and 6.6% by AGS Beers and PRISCUS, respectively. Conclusion: a high index of continuous use medications, PIM and potential DI were identified, mainly enzymatic inhibitors in a group of elderly women at risk due to their clinical characteristics. Old age was associated with the presence of all the elements of the iatrogenic triad. It was also noted that there were no significant differences between the criteria applied, except for the PRISCUS list.

Resumo Objetivo: Investigar os principais elementos da Tríade Iatrogênica em um grupo de mulheres idosas, com doenças crônicas não transmissíveis (DCNT) e vinculadas a um plano de saúde. Método: Estudo epidemiológico, transversal e descritivo, realizado mediante a análise de 3.501 prescrições médicas realizadas à 725 mulheres idosas com ≥65 anos. As medicações foram determinadas como medicamentos potencialmente inapropriados (MPI) segundo quatro instrumentos (AGS Beers 2015; lista PRISCUS; EU(7)-PIM; Consenso Brasileiro de MPI - CBMPI). Além disso, os medicamentos mais prescritos foram estudados segundo as possíveis interações medicamentosas (IM) e classificados quanto ao grau de severidade. Resultados: Este estudo revelou que 89,3% do grupo estudado faziam uso de, pelo menos, um elemento da Tríade Iatrogênica, sendo que 44,9% estavam associados ao uso de polifarmácia e MPI. Um total de 48,0% estavam em uso contínuo de pelo menos cinco medicamentos. As principais IM foram entre omeprazol, sinvastatina e levotiroxina, todos de gravidade significativa e com potencial de interação medicamento-alimento. Encontrou-se 35,1% de MPI através dos quatro critérios utilizados, sendo identificado 26,6% pelo CBMPI, 25,8% através do EU(7)-PIM, 24,6% e 6,6% pelo AGS Beers e o PRISCUS, respectivamente. Conclusão: Evidenciou-se um alto índice de medicamentos em uso contínuo, MPI e interações medicamentosas potenciais, principalmente de inibidores enzimáticos em um grupo de idosas de risco, devido às suas particularidades clínicas. A idade avançada esteve associada à presença de todos os elementos da tríade iatrogênica. Notou-se ainda que todos os critérios aplicados não apresentaram diferenças significativas, com exceção da lista PRISCUS.

A study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warning

Background: The package insert (PI) is important for providing accurate and reliable product information which is essential for the safe and effective use of medications.Methods: A total number of 115 PIs from pharmacological drug class such as antibiotics, drugs acting on central nervous system and drugs acting on endocrine system were collected from pharmacy store. Contents and presentation of the PIs was critically evaluated by comparing the information as listed in the Drugs and Cosmetics Rules, 1945.Results: The results were expressed under headings as listed in the Drugs and Cosmetics Rules, 1945. The information in the package inserts was inadequate in many aspects; for example, adverse drug reactions were not mentioned completely, information for special population and guidelines for use of the drugs also was lacking. Moreover, black box warning was seen only in few PI. For PI of antibiotics; legibility 80%, use in special populations 76.66%, undesirable effects 46.66%. For PI of CNS of legibility 60%, use in special populations 73.33%, undesirable effects 70%. For PI of endocrine system of legibility 70%, use in special populations 70%, undesirable effects 36.66%.Conclusions: The results reveal that, information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.

Renovação de Prescrição Médica na atenção primária: uma análise crítica / Prescription refill in primary health care: a critical analysis

A renovação de receita é uma prática comum nos serviços de atenção básica no Brasil, ainda que pouco discutida. Embora exista um número expressivo de artigos em língua inglesa sobre o assunto, pouco se encontra a respeito na literatura brasileira. A renovação de medicamentos de uso contínuo traz consigo riscos e potenciais danos à saúde do usuário quando praticada sem protocolos bem definidos e sem a correta avaliação clínica das pessoas acompanhadas. Dessa forma, a renovação de receita pode perpetuar o uso de medicações com indicação duvidosa, efeitos colaterais significativos, interações medicamentosas importantes, medicamentos contraindicados e/ou que não são mais necessários. Além disso, pode transmitir a sensação de que a população está sendo bem assistida apenas pelo fato de as pessoas conseguirem receber medicamentos, ainda que sem uma avaliação periódica. Por outro lado, caso realizada de forma ideal, poderia favorecer aumento da adesão ao tratamento, bem como a avaliação de interações medicamentosas, o cumprimento da terapêutica e a necessidade de exames complementares. O presente artigo realizará uma discussão crítica sobre os riscos e benefícios da renovação de receita da maneira como é feita no Brasil, incluindo seus aspectos legais e pontos passíveis de melhorias segundo a literatura internacional. (AU)

Repeat prescribing is a common practice at primary health care in Brazil which is poorly discussed. Despite the large number of articles in English, the Brazilian literature barely discuss this subject. The renewal of continuous-use medication may lead to risks and potential harms to patient health when used without defined protocols or adequate clinical evaluation. This practice may perpetuate the use of medication with arguable indication, significant side effects, significant drug interactions, contraindicated drugs or that are no longer needed. It also may leads to a misperception of being well attended, although it is a mere transcription of medical receipts. However, if performed in an adequate way, it might be associated with increased adherence to treatment. It also might allow assessment of drug interactions, compliance with therapy and checking out the need for complementary tests. This article will critically discuss the risks and benefits of prescription renewal in the way it is done in Brazil, including its legal aspects and possible points for improvement according to the international literature. (AU)

Real-Life Clinical Use of Symbicort® Maintenance and Reliever Therapy for Asthmatic Patients in Korea

The aim of this study was to examine the daily practice patterns of Symbicort® Maintenance and Reliever Therapy (SMART) in Korean asthmatic patients and to analyze clinical signs related to overuse. This study used an observational, multicenter, noninterventional, prospective, uncontrolled design for examining asthmatic patients prescribed SMART to assess the frequency and pattern of Symbicort® usage as a maintenance and reliever medication. The characteristics of patients showing signs of overuse (frequency of inhalation: 8 or more times per day) were also analyzed. Among the 1,518 patients analyzed, 1,292 (85.1%) completed the trial. The number of mean inhalations per day was 2.14±1.15; the number of patients who had at least 1 as needed usage (PRN) inhalation per day was 843 (55.5%); the mean frequency of PRN use was 0.25±0.67 inhalations per day. The number of patients who overused for at least 1 day was 260 (17.1%). In particular, young patients, patients with limited physical activity, and patients with nocturnal symptoms demonstrated high frequency of overuse. The frequency of overuse during SMART was not high in Korean asthmatic patients and the asthma status of follow-up outpatients improved overall. However, there is a need for careful education targeted toward younger patients, patients with limited physical activity, and patients with nocturnal symptoms owing to their tendency to frequently overuse.