[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

Psychoactive substance consumption after the Fundão dam mine tailing disaster in Minas Gerais State, Brazil / Consumo de psicoativos após o desastre da Barragem de Fundão, em Minas Gerais, Brasil / Consumo de psicoactivos tras el desastre de la presa Fundão, en Minas Gerais, Brasil

Abstract: Disasters cause changes in morbidity, mortality, and medicine use. Brazil is one of the main producers of mineral ores at great environmental cost. Mine tailings are stored in dams and ruptures have led to major disasters. We investigated the consumption of psychoactive medicines in the municipalities affected by the Fundão dam disaster in Minas Gerais State. An ecological study was carried out on drug consumption, estimated using public purchases in Minas Gerais and dispensing data from private retail pharmacies. Consumption (in number of defined daily doses/100,000 inhabitants per day) was analyzed descriptively in eight municipalities, stratified according to consumption level during a 25-month period. Six comparisons of mean consumption values for both data sets were done for pre- and post-disaster periods. The means of medicine consumption before and after the event were plotted and linear trends were added. Public purchase data evinced high consumption levels. Only pharmaceutical retail showed significant differences between the strata in the pre-disaster versus two post-disaster periods. Smaller municipalities showed an increase in consumption 15 months after the disaster. Clonazepam led the way in pharmaceutical retail consumption, followed by fluoxetine. Medicines showed an upward trend after the disaster. The high public provision may have stifled significant consumption patterns of psychoactive drugs; however, peak consumption were observed in private retail, suggesting a modification in use patterns after the disaster. The decrease in consumption immediately after the event was probably related to lower care-seeking behavior on the part of the population, and significant peaks after the disaster may reflect economic consequences of it.

Resumo: Os desastres provocam alterações na morbidade, mortalidade e no uso de medicamentos. O Brasil é líder na produção de minérios com grande custo ambiental. Os rejeitos de mineração são armazenados em barragens e as rupturas dessas barragens têm causados grandes desastres. Investigamos o consumo de medicamentos psicoativos em municípios atingidos pelo desastre da Barragem de Fundão, em Minas Gerais. Foi realizado um estudo ecológico sobre o consumo de medicamentos, com base em dados de compras públicas e distribuição de farmácias privadas do varejo de Minas Gerais. O consumo (em número de doses diárias definidas/100 mil habitantes por dia) foi analisado descritivamente em oito municípios, estratificados segundo o nível de consumo durante um período de 25 meses. Foram feitas seis comparações de valores médios de consumo para os dois conjuntos de dados dos períodos pré- e pós-desastre. Foram calculadas as médias de consumo de medicamentos antes e depois do evento e adicionadas tendências lineares. Os dados de compras públicas mostraram elevados níveis de consumo. Apenas o varejo farmacêutico apresentou diferenças significativas entre os estratos no período pré-desastre versus dois períodos pós-desastre. Municípios menores apresentaram aumento no consumo a partir do 15º mês após o desastre. Clonazepam liderou o consumo no varejo farmacêutico, seguido pela fluoxetina. Os medicamentos apresentaram tendência de alta após o desastre. A elevada oferta pública pode ter afetado os padrões de consumo significativo de medicamentos psicoativos; no entanto, foram observados aumentos no comércio privado, sugerindo alterações nos padrões de uso após o desastre. A diminuição do consumo imediatamente após o evento estava provavelmente relacionada a um menor comportamento de procura de cuidados por parte da população e os aumentos significativos posteriores podem refletir as consequências econômicas do desastre.

Resumen: Los desastres provocan cambios en la morbilidad, mortalidad y en el uso de medicamentos. Brasil es líder en la producción de minerales con grandes costos ambientales. Los desechos mineros se almacenan en represas y las roturas de dichas represas han causado grandes desastres. Investigamos el consumo de medicamentos psicoactivos en municipios afectados por el desastre de la presa de Fundão, en Minas Gerais. Se realizó un estudio ecológico sobre el consumo de medicamentos, con base en datos de compras públicas y distribución en farmacias privadas minoristas de Minas Gerais. El consumo (en número de dosis diarias definidas/100.000 habitantes por día) se analizó descriptivamente en ocho municipios, estratificados según el nivel de consumo durante un período de 25 meses. Se realizaron seis comparaciones de los valores medios de consumo para los dos conjuntos de datos de los períodos anterior y posterior al desastre. Se calculó el consumo medio de medicamentos antes y después del evento y se añadieron las tendencias lineales. Los datos de compras públicas mostraron altos niveles de consumo. Solo el comercio minorista farmacéutico presentó diferencias significativas entre los estratos en el período anterior al desastre frente a dos períodos posteriores al desastre. Los municipios más pequeños presentaron un aumento en el consumo a partir del 15º mes después del desastre. El clonazepam lideró el consumo en el comercio minorista farmacéutico, seguido de la fluoxetina. Los medicamentos presentaron una tendencia al alza después del desastre. La elevada oferta pública puede haber afectado los patrones de consumo significativo de medicamentos psicoactivos; sin embargo, se observaron aumentos en el comercio privado, lo que sugiere cambios en los patrones de uso después del desastre. La disminución del consumo inmediatamente después del evento probablemente relacionada con un menor comportamiento de búsqueda de cuidados por parte de la población, y los aumentos significativos posteriores pueden reflejar las consecuencias económicas del desastre.

Perfil clínico, farmacoterapêutico e laboratorial de pacientes internados com insuficiência cardíaca aguda / Clinical, pharmacotherapeutic and laboratory profile of hospitalized patients with acute heart failure / Perfil clínico, farmacoterapéutico y de laboratorio de los pacientes hospitalizados com insuficiência cardíaca aguda

A insuficiência cardíaca aguda (ICA) é uma das causas mais comuns de internação hospitalar, associada a um alto risco de mortalidade. O tratamento atual é principalmente sintomático, sendo os exames laboratoriais realizados, a fim de complementar a avaliação clínica no diagnóstico e auxiliar no estabelecimento do perfil de risco admissional e prognóstico. Este estudo teve como objetivo caracterizar o perfil clínico, farmacoterapêutico e laboratorial de pacientes internados com insuficiência cardíaca aguda em hospital referência regional. Trata-se de um estudo transversal retrospectivo, descritivo, de abordagem quantitativa. Os participantes do estudo foram aqueles com alta médica por ICA pela classificação Internacional de Doenças (CID-10), admitidos na sala de emergência. Excluindo-se a participação de pacientes com tempo de internação inferior a 24 horas, menores de 18 anos. Para análise estatística foi usado o programa SPSS versão 21.0. Quanto ao perfil farmacoterapêutico, os medicamentos mais frequentes foram os que atuam no aparelho cardiovascular e aparelho digestivo e metabolismo, sendo a furosemida o fármaco mais frequente. A análise entre as alterações laboratoriais e a escala de ADHERE, revelou diferença estatística significativa entre os pacientes com risco baixo e risco intermediário/alto nos valores de hemoglobina (p=0,005), TGO (p=0,001), creatinina (p=0,000), ureia (p=0,000), potássio (p=0,004), TTPA (p=0,004) e RNI (p=0,021). Concluiu-se que os medicamentos frequentemente corresponderam ao tratamento recomendado no manejo inicial de pacientes com ICA. O risco de mortalidade intra-hospitalar intermediário/alto de acordo com a escala de ADHERE estavam associados com alterações laboratoriais dos pacientes com ICA.

Acute heart failure (AHF) is one of the most common causes of hospitalization, associated with a high risk of mortality. The current treatment is mainly symptomatic, and laboratory tests are carried out in order to complement the clinical evaluation in the diagnosis and help in establishing the admission and prognostic risk profile. This study aimed to characterize the clinical, pharmacotherapeutic and laboratory profile of patients hospitalized with acute heart failure in a regional reference hospital. This is a retrospective, descriptive, cross-sectional study with a quantitative approach. Study participants were those discharged due to AHF according to the International Classification of Diseases (ICD-10), admitted to the emergency room. Excluding the participation of patients with hospitalization time of less than 24 hours, under 18 years old. For statistical analysis, SPSS version 21.0 was used. As for the pharmacotherapeutic profile, the most frequent drugs were those that act on the cardiovascular and digestive systems and metabolism, with furosemide being the most frequent drug. The analysis between laboratory changes and the ADHERE scale revealed a statistically significant difference between patients at low risk and intermediate/high risk in hemoglobin (p=0.005), TGO (p=0.001), creatinine (p=0.000) values, urea (p=0.000), potassium (p=0.004), APTT (p=0.004) and INR (p=0.021). It was concluded that the medications often corresponded to the recommended treatment in the initial management of patients with AHF. Intermediate/high risk of in-hospital mortality according to the ADHERE scale were associated with laboratory alterations in patients with AHF.

La insuficiencia cardiaca aguda (ICA) es una de las causas más frecuentes de hospitalización, asociada a un alto riesgo de mortalidad. El tratamiento actual es principalmente sintomático y se realizan pruebas de laboratorio para complementar la evaluación clínica en el diagnóstico y ayudar a establecer el perfil de riesgo de ingreso y pronóstico. Este estudio tuvo como objetivo caracterizar el perfil clínico, farmacoterapéutico y de laboratorio de pacientes hospitalizados con insuficiencia cardíaca aguda en un hospital regional de referencia. Se trata de un estudio retrospectivo, descriptivo, transversal con enfoque cuantitativo. Los participantes del estudio fueron los dados de alta por ICA según la Clasificación Internacional de Enfermedades (CIE-10), ingresados en urgencias. Se excluye la participación de pacientes con tiempo de hospitalización menor a 24 horas, menores de 18 años. Para el análisis estadístico se utilizó SPSS versión 21.0. En cuanto al perfil farmacoterapéutico, los fármacos más frecuentes fueron los que actúan sobre los sistemas cardiovascular, digestivo y el metabolismo, siendo la furosemida el fármaco más frecuente. El análisis entre los cambios de laboratorio y la escala ADHERE reveló una diferencia estadísticamente significativa entre los pacientes de riesgo bajo e intermedio/alto en los valores de hemoglobina (p=0,005), TGO (p=0,001), creatinina (p=0,000), urea (p =0,000), potasio (p=0,004), APTT (p=0,004) e INR (p=0,021). Se concluyó que los medicamentos correspondían muchas veces al tratamiento recomendado en el manejo inicial de pacientes con ICA. El riesgo intermedio/alto de mortalidad hospitalaria según la escala ADHERE se asoció con alteraciones de laboratorio en pacientes con ICA.

Retrospective review of medicine utilization for noncommunicable diseases in three public sector pharmacies in Jamaica / Revisión retrospectiva del uso de medicamentos para enfermedades no transmisibles en tres farmacias del sector público de Jamaica / Revisão retrospectiva do uso de medicamentos para doenças não transmissíveis em três farmácias da rede pública na Jamaica

ABSTRACT Objective. The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization's (WHO's) prescribing indicators. Methods. In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO's prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results. A total of 1 500 prescriptions covering 5 979 medicines were reviewed; prescriptions were mostly written for female patients aged 42-60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5 722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions. The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

RESUMEN Objetivo. El uso racional de los medicamentos proporciona una estrategia de ahorro de costos para maximizar los resultados terapéuticos tanto en los países en desarrollo como en los países desarrollados. El objetivo de este estudio fue evaluar el uso racional de medicamentos para algunas enfermedades no transmisibles (ENT) seleccionadas en tres farmacias de hospitales públicos de Jamaica, usando los indicadores de prescripción de la Organización Mundial de la Salud (OMS). Métodos. En este estudio transversal retrospectivo se examinaron las prescripciones realizadas a pacientes ambulatorios adultos que incluían al menos un medicamento para enfermedades cardiovasculares, diabetes, cáncer, enfermedad pulmonar obstructiva crónica o asma, dispensadas entre enero y julio del 2019, utilizando los indicadores de prescripción para el uso racional de medicamentos de la OMS. Los datos se analizaron y expresaron mediante estadística descriptiva e inferencial. Para todos los análisis realizados se estableció un nivel de significación de p <0,05. Resultados. Se examinó un total de 1 500 prescripciones que incluían 5 979 medicamentos; la mayor parte de ellas correspondían a pacientes de sexo femenino de 42 a 60 años. Se observó que había polimedicación en el 35,6% (534) de las prescripciones, con un promedio de 4 y un máximo de 17 medicamentos por receta. En todos los centros se dispensó la mayor parte de los medicamentos prescritos, y el motivo principal para no hacerlo fue la falta de existencias del medicamento en cuestión. La prescripción de genéricos fue elevada en todos los centros y supuso más del 95% (5 722) de los medicamentos prescritos. En dos centros la prescripción se realizó en su totalidad de acuerdo con la Lista Modelo de Medicamentos Esenciales de la OMS, pero en el centro 1 no se alcanzó el objetivo por un 1,4%. Conclusiones. Se siguieron las directrices de la OMS para el uso racional de medicamentos en cuanto a la proporción de medicamentos prescritos de la Lista Modelo de la OMS y la proporción de antibióticos prescritos. El número de medicamentos por receta y la proporción de medicamentos prescritos mediante su nombre genérico no cumplieron con los criterios de la OMS. Sin embargo, las prescripciones estaban en consonancia con las directrices de tratamiento de las enfermedades no transmisibles seleccionadas.

RESUMO Objetivo. O uso racional de medicamentos é uma estratégia de contenção de custos para maximizar os resultados terapêuticos em países desenvolvidos e em desenvolvimento. O objetivo deste estudo foi avaliar o uso racional de medicamentos para algumas doenças não transmissíveis selecionadas em três farmácias de hospitais públicos na Jamaica a partir dos indicadores de prescrição preconizados pela Organização Mundial da Saúde (OMS). Métodos. Estudo transversal retrospectivo que avaliou receitas médicas de pacientes ambulatoriais adultos contendo pelo menos um medicamento prescrito para doença cardiovascular, diabetes, câncer, doença pulmonar obstrutiva crônica ou asma e dispensadas entre janeiro e julho de 2019. A avaliação foi realizada a partir dos indicadores de prescrição preconizados pela OMS para o uso racional de medicamentos. Os dados obtidos foram analisados por meio de estatísticas descritivas e inferenciais. O nível de significância de p <0,05 foi adotado em todas as análises. Resultados. Ao todo, foram analisadas 1 500 receitas médicas compreendendo 5 979 medicamentos. Em sua maioria, as receitas foram prescritas para pacientes do sexo feminino com idades entre 42 e 60 anos. A polifarmácia foi observada em 35,6% (534) das receitas; em média, foram prescritos 4 medicamentos, até um máximo de 17. As farmácias estudadas dispensaram a maior parte dos medicamentos receitados. O principal motivo para não fornecer algum medicamento foi o desabastecimento. O percentual de medicamentos genéricos foi alto em todos os locais, representando mais de 95% (5 722) do volume receitado. Houve plena observância da Lista Modelo de Medicamentos Essenciais da OMS nas receitas analisadas em dois dos locais estudos, e observância quase completa (diferença de 1,4%) no local 1. Conclusões. As diretrizes da OMS de uso racional de medicamentos foram cumpridas no que se refere ao percentual de medicamentos receitados de acordo com a Lista Modelo da OMS e o percentual de antibióticos receitados. Os critérios da OMS não foram cumpridos quanto ao número de medicamentos por receita e ao percentual receitado usando o nome genérico. Porém, os medicamentos foram receitados de acordo com as diretrizes terapêuticas para as doenças não transmissíveis selecionadas.

Uso de inhaladores para la enfermedad pulmonar obstructiva crónica en un grupo de pacientes colombianos

Introducción: En Colombia son escasos los datos sobre el uso de los inhaladores en pacientes con EPOC. Objetivo: Describir la técnica de uso de inhaladores de dosis medida y polvo seco en pacientes de un hospital colombiano. Materiales y métodos: Estudio descriptivo en pacientes mayores de 40 años con EPOC atendidos en un hospital en La Virginia, Risaralda, Colombia, entre el 1 de septiembre de 2019 al 31 de enero de 2020. La unidad de análisis fueron los pacientes. Se incluyeron variables sociodemográficas, clínicas y lista de chequeo para uso de inhaladores. Se aplicaron frecuencias y proporciones para variables discretas, estadísticas de tendencia central y dispersión para variables continuas. Resultados: Se incluyeron 104 pacientes con edad media de 73,6 ± 10,1 años; 57 eran mujeres (54,8 %). Además, 48 pacientes estaban clasificados como GOLD-D (46,2 %). Igualmente, 89 pacientes manifestaron haber recibido educación sobre el uso de broncodilatadores (85,6 %). Los más frecuentes fueron los inhaladores de dosis medida (DM) en 95 casos (91,3 %), seguido de los de polvo seco unidosis (7,7 %). Así mismo, 37 pacientes que usaron DM sin inhalocámara (35,6 %) no cumplieron los pasos de la lista de chequeo. En el sistema multidosis, el más realizado fue cerrar de manera adecuada el inhalador y el menos ejecutado, expulsar el aire lentamente evitando hacerlo cerca del inhalador (n = 6; 5,7 %). Discusión: Se lograron describir las características de la técnica de uso de los inhaladores en pacientes con EPOC. A pesar de que ningún paciente logró utilizar el inhalador de forma "perfecta", la mayoría han recibido educación por parte de los profesionales de la salud. Conclusión: Un alto porcentaje de pacientes usa inadecuadamente los dispositivos para suministrar los broncodilatadores. Esto puede impactar negativamente en el control de la enfermedad.

Introduction: In Colombia, there is limited data on the use of inhalers in patients with COPD. Objective: The objective was to describe the technique of using metered-dose inhalers and dry powder in patients in a Colombian hospital. Methods: Observational, descriptive study of patients over 40 years of age with COPD, treated in a hospital in La Virginia, Risaralda, Colombia, between September 1st, 2019 and January 31st, 2020. The unit of analysis were patients in consultation. Sociodemographic and clinical variables, and a checklist for use of inhalers were included. Frequencies and proportions were applied for discrete variables, statistics of central tendency and dispersion for continuous variables. Results: A total of 104 patients with an average age of 73.6 ± 10.1 years were included; 57 were women (54.8%). In addition, 48 patients were classified as GOLD-D (46.2%). Similarly, 89 patients reported having received education on the use of bronchodilators (85.6%). The most common were metered-dose (MD) inhalers in 95 cases (91.3%), followed by single-dose dry powder inhalers in eight patients (7.7%). Likewise, 37 patients who used DM without inhalochamber (35.6%) did not comply with the steps of the checklist. In the multidose system, the most performed was to properly close the inhaler and the least performed was to expel the air slowly, avoiding doing so near the inhaler (n=6; 5.7%). Discussion: The characteristics of the technique of using inhalers in patients with COPD were described. Although no patient was able to use the inhaler "perfectly", most have received education from health professionals. Conclusion: A high percentage of patients misuse the devices to deliver bronchodilators. This can negatively impact the control of the disease.

Self-medication associated with toothache: a systematic literature review / Automedicação associada à dor de dente: uma revisão sistemática da literatura / Automedicación asociada al dolor de dientes: una revisión sistemática de la literatura

Introduction: Self-medication consists of selecting and using medication without a poprescription or guidance from a healthcare professional. This practice has been widely reported worldwide, which has contributed to a series of adverse health outcomes, such as delayed diagnosis, worsening of clinical conditions, drug interactions, intoxication, and adverse reactions, which tend to compromise patient safety. Objective:To analyze the prevalence of self-medication associated with toothache, the main factors associated with self-medication in dental patients, as well as outline the profile of medications used by these individuals, the preferred route of administration, and the main sources of medication.Methodology:Asystematic review was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Relevant articles published in the last ten years, without limitations of language were searched using the following descriptors/MeSHterms and keywords: "self-medication" and (toothache or "dental pain") not Child. Results:The initial search returned 61 manuscripts. Fourteen papers, all cross-sectional studies, were eligible for inclusion in the systematic review.Conclusions:The prevalence of self-medication for toothache ranged from 6.5% to 100.0%. Cultural and economic factors, barriers to access, the high cost of dental treatments, lack of time and money, and the perception that dental problems are not a serious problem are among the main factors associated with the practice. Regarding the drugs used, the most used classes were paracetamol, especially anti-inflammatory drugs, particularly ibuprofen, and analgesics administered orally (AU).

Introdução:A automedicação consiste na escolha e uso de medicamentos sem prescrição ou orientação de um profissional de saúde. Essa prática tem sido amplamente divulgada em todo o mundo, o que tem contribuído para uma série de desfechos adversos à saúde, como atraso no diagnóstico, piora do quadro clínico, interações medicamentosas, intoxicações e reações adversas, que tendem a comprometer a segurança do paciente. Objetivo:Analisar a prevalência da automedicação associada à dor de dente, os principais fatores associados à automedicação em pacientes odontológicos, bem como traçar o perfil dos medicamentos utilizados por esses indivíduos, a via preferencial de administração e as principais fontes de medicação. Metodologia:Uma revisão sistemática foi desenvolvida de acordo com os itens de relatório preferidos para revisões sistemáticas e meta-análises (PRISMA). Foram pesquisados artigos relevantes publicados nos últimos dez anos, sem limitação de linguagem, utilizando os seguintes descritores/MeSHterms e palavras-chave: "self-medication" e (toothache or "dental pain") não Child. Resultados:A busca inicial encontrou61manuscritos. Quatorze artigos, de delineamento transversal,foram considerados elegíveis e incluídos para a revisão.Conclusões:A prevalência de automedicação para dor de dente variou de 6,5% a 100,0%. Fatores culturais e econômicos, barreiras de acesso, alto custo dos tratamentos odontológicos, falta de tempo e dinheiro e a percepção de que os problemas odontológicos não são um problema grave estão entre os principais fatores associados à prática. Em relação aos medicamentos utilizados, as classes mais utilizadas foram o paracetamol, principalmente os anti-inflamatórios, principalmente o ibuprofeno, e os analgésicos por via oral (AU).

Introducción: La automedicación consiste en seleccionar y utilizar medicamentos sin receta ni orientación de un profesional sanitario. Esta práctica ha sido ampliamente reportada a nivel mundial, lo que ha contribuido a una serie de resultados adversos para la salud, como retraso en el diagnóstico, empeoramiento de las condiciones clínicas, interacciones medicamentosas, intoxicaciones y reacciones adversas, que tienden a comprometer la seguridad del paciente.Objetivo: Analizar la prevalencia de automedicación asociada al dolor de muelas, los principales factores asociados a la automedicación en pacientes odontológicos, así como delinear el perfil de medicamentos utilizados por estos individuos, la vía de administración preferida y las principales fuentes de medicación. Metodología: Se desarrolló una revisión sistemática de acuerdo con los Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Se buscaron artículos relevantes publicados en los últimos diez años, sin limitaciones de idioma, utilizando los siguientes descriptores/MeSHterms y palabras clave: "self-medication" y (toothache or "dental pain") not Child. Resultados: La búsqueda inicial arrojó 61 manuscritos. Catorce artículos, todos estudios transversales, fueron elegibles para su inclusión en la revisión sistemática.Conclusiones: La prevalencia de automedicación para el dolor de muelas osciló entre 6,5% y 100,0%. Los factoresculturales y económicos, las barreras de acceso, el alto costo de los tratamientos dentales, la falta de tiempo y dinero, y la percepción de que los problemas dentales no son un problema grave se encuentran entre los principales factores asociados con la práctica. En cuanto a los fármacos utilizados, las clases más utilizadas fueron el paracetamol, especialmente los antiinflamatorios, especialmente el ibuprofeno, y los analgésicos por vía oral (AU).

Actividades de superación profesional de médicos generales integrales sobre el uso racional de medicamentos / Professional training activities of comprehensive general doctors on the rational use of medications i: en

Introducción: El uso irracional de medicamentos se debe, entre otros elementos, a la falta de superación profesional; situación con mayor repercusión en la atención primaria de salud, donde generalmente laboran los médicos generales integrales. Objetivo: Caracterizar las actividades de superación profesional de médicos generales integrales sobre el uso racional de medicamentos. Métodos: Se realizó un estudio descriptivo y transversal de 269 médicos generales integrales que laboraban en los consultorios del médico de la familia o en los servicios de urgencia de las 17 áreas de salud del municipio de Santiago de Cuba en el período comprendido desde enero hasta julio de 2022, quienes fueron seleccionados mediante muestreo probabilístico por conglomerado bietápico. Se consideró como variable las actividades de superación profesional relacionadas con el uso racional de medicamentos, las cuales fueron valoradas a través de 5 indicadores. Resultados: La triangulación metodológica de los resultados evidenció que el nivel alcanzado en cuanto a la frecuencia de realización de dichas actividades fue bajo (índice de 1,18), al igual que lo obtenido en los indicadores analizados, excepto en el referido a la autopreparación que mostró un nivel medio. Conclusiones: Las actividades de superación profesional de los médicos generales integrales relacionadas con el uso racional de medicamentos en el municipio de Santiago de Cuba se caracterizaron por un nivel bajo de frecuencia de realización.

Introduction: Irrational use of medications is, among other elements, due to the lack of professional training; situation with more repercussion in primary health care, where comprehensive general doctors generally work. Objective: To characterize the professional training activities of comprehensive general doctors on the rational use of medications. Methods: A descriptive and cross-sectional study of 269 comprehensive general doctors who worked in the family doctor offices or in the emergency services of the 17 health areas of Santiago de Cuba municipality was carried out from January to July, 2022, who were selected by means of a probabilistic sampling by biphase conglomerate. The activities of professional training related to the rational use of medications were considered as variable, which were valued through 5 indicators. Results: The methodological triangulation of the results evidenced that the level reached as for the frequency of realization of this activities was low (index of 1.18), as well as what was obtained in the analyzed indicators, except the one referred to the self-preparation which showed a mean level. Conclusions: Professional training activities of comprehensive general doctors related to the rational use of medications in Santiago de Cuba municipality were characterized by a low level of realization frequency.

Estudio de utilización de nirmatrelvir/ritonavir en tres centros de atención primaria durante 2022 / Drug use evaluation of nirmatrelvir/ritonavir in three primary care centres during 2022

Introducción: Nirmatrelvir/ritonavir (Paxlovid®) es el único tratamiento oral autorizado en Europa para tratar la enfermedad por COVID-19 en adultos que no requieren aporte de oxígeno suplementario y que tienen un riesgo alto de progresar a COVID-19 grave. Está disponible en España previa validación debido al perfil de interacciones y advertencias de uso. El objetivo es determinar efectividad, seguridad y manejo de interacciones. Método: Estudio retrospectivo de todos los pacientes con tratamiento validado de nirmatrelvir/ritonavir en tres centros de salud urbanos durante 2022. La efectividad fue la proporción de participantes sin hospitalización relacionada con COVID-19 o muerte por cualquier causa hasta el día 28. Resultados: Se analizaron 24 pacientes. Se consideró efectivo en 23 (95,8 %). Más del 80 % de pacientes presentaban interacción potencial con la medicación concomitante, recomendándose la suspensión temporal de medicamentos destacando simvastatina y metamizol. Conclusiones: Nirmatrelvir/ritonavir se ha considerado efectivo pero con difícil manejo en pacientes pluripatológicos polimedicados. (AU)

Introduction: Nirmatrelvir/ritonavir (Paxlovid®) is the only oral treatment authorized in Europe to treat COVID-19 disease in adults who do not require supplemental oxygen and who are at high risk for progression to severe COVID-19. It is available in Spain after validation due to the profile of interactions and warnings for use. The objective is to determine effectiveness, safety and management of interactions. Method: Retrospective study of all patients on validated nirmatrelvir/ritonavir treatment at three urban health cen-tres during 2022. Effectiveness was the proportion of participants without COVID-19-related hospitalization or death from any cause through day 28. Results: 24 patients were analyzed. It was considered effective in 23 (95.8 %). More than 80 % of patients presented potential interaction with the concomitant medication, recommending the temporary suspension of medications, highlighting simvastatin and metamizole. Conclusions: Nirmatrelvir/ritonavir has been considered effective but difficult to manage in polymedicated poly-pathological patients. (AU)

Reducción del tiempo de tratamiento antimicrobiano en unidades de cuidados intensivos en Fortaleza, Brasil / Reduction of antimicrobial treatment time in intensive care units in Fortaleza, Brazil

Objetivo: Evaluar la aplicación de la estrategia reducción del tiempo de tratamiento Antimicrobiano (ATM) en Unidades de Cuidados Intensivos (UCI) en un Programa Stewardship de Antimicrobiano (ASP). Método: Este es un estudio descriptivo y transversal, realizado en dos UCI de un hospital universitario de Fortaleza, Brasil, de enero/2017 a enero/2019. Se incluyeron pacientes adultos, acompañados por un farmacéutico y utilizando ATM, en los que se aplicó la estrategia de reducción del tiempo de tratamiento. La evaluación de la estrategia se realizó a través de la diferencia entre el tiempo previsto establecido al inicio del tratamiento y los días efectivos de uso de cada ATM. Resultados: De los 100 pacientes incluidos, 51,0 % eran del sexo masculino y 64,0 % ancianos. El sistema respiratorio fue el más frecuentemente afectado (37,4 %) y las clases de ATM más prevalentes fueron los carbapenémicos (23,0 %) y los glicopéptidos (20,1 %). Hubo una disminución de 831 días innecesarios de terapia antimicrobiana y de un promedio de 13,7 a 8,9 días de tratamiento. Las mayores reducciones en días se observaron para meropenem, con 202 días reducidos. El estudio también permitió identificar asociaciones entre la reducción > 8 días de tratamiento y las variables estancia > 22 días y pacientes en cuidados paliativos exclusivos; y asociaciones entre alta hospitalaria y reducciones de hasta 7 días de terapia. Conclusiones: Los datos obtenidos sugieren que la presencia de un ASP influye en las prácticas de uso de ATM y su tiempo de tratamiento y enfatizan el papel de los profesionales farmacéuticos en estos programas. (AU)

Objective: To evaluate the application of the Antimicrobial (ATM) treatment time reduction strategy in Intensive Care Units (ICU) in an Antimicrobial Stewardship Program (ASP).Method: This is a descriptive and cross-sectional study, carried out in two ICU of a university hospital in Fortaleza, Brazil, from January/2017 to January/2019. Adult patients were included, accompanied by a pharmacist, and using ATM, in which the treatment time reduction strategy was applied. The evaluation of the strategy was made through the difference between the predicted time established at the beginning of the treatment and the effective days of use of each ATM.Results: Of the 100 patients included, 51.0 % were male and 64.0 % were elderly. The respiratory system was the most frequently affected by the infections (37.4 %) and the most prevalent classes of ATM were carbapenems (23.0 %) and glycopeptides (20.1 %). There was a decrease from 831 unnecessary days of antimicrobial therapy and from an average of 13.7 to 8.9 days of treatment. The greatest reductions in days were observed for meropenem, with 202 days reduced. The study also allowed the identification of associations between the reduction > 8 days of treatment and the variables length of stay > 22 days and patients in exclusive palliative care, and associations between hospi-tal discharge and reductions of up to 7 days of therapy.Conclusions: The data obtained suggest that the presence of an ASP influences the practices of ATM use and its treatment time and emphasize the role of pharmaceutical professionals in these programs. (AU)

Current situation and evolution of the availability of drugs in the paediatric population in Spain. / Situación actual y evolución de la disponibilidad de medicamentos en la población pediátrica en España.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last three years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorised or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13,9% of them are not marketed, 46,5% are in a situation of non-financing, under study, or without a request for financing, and 4,6% are financed for a specific pediatric subpopulation. 52,7% are original drugs, 4,7% are generic, 38,8% are biological, 3,8% are biosimilar and 17,8% are orphan drugs. 57,36% of these medicines obtain the pediatric indication due to extension of the indication and 42,64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorised indications are increasingly available in the paediatric population and the trend is to extend the indication of authorised drugs to the adult population. However, barriers in terms of financing and marketing need to be expedited and overcome to facilitate access to them.

Automedicación en profesionales de un laboratorio farmacéutico paraguayo / Self-medication among professionals in a Paraguayan pharmaceutical company

Objetivo: determinar la prevalencia de la automedicación entre las personas trabajadoras de un laboratorio farmacéutico del área metropolitana de Asunción (Paraguay) y describir sus características.Método: estudio descriptivo transversal (nov 2016). Se incluyó a todas las personas adultas trabajadoras del laboratorio (N= 400). Se solicitó su participación por correo electrónico en dos ocasiones. Se midieron variables sociodemográficas, laborales y la automedicación mediante cuestionario heteroadministrado diseñado ad hoc y pilotado (síntomas que motivaron, frecuencia, grupo de fármaco, motivos, fuente de la recomendación, eficacia y peligro percibido, finalización, acción en caso de persistencia del síntoma, publicidad, lugar de compra, fuentes de información). Se realizó estadística descriptiva y bivariante.Resultados: participaron 166 personas (edad media 33,2 años; 60,2% hombres). El 34,3% se había automedicado en los tres meses anteriores. El 90,4% consideraba que la automedicación era peligrosa. La práctica de automedicación fue mayor en el nivel universitario que en el secundario (44,8% vs. 22,8%; p= 0,004). No se encontraron diferencias en función de la edad, el sexo, ni el tiempo trabajado en la empresa. La causa más frecuente fue el tratamiento del dolor de cabeza (64,9%) y los fármacos más consumidos, los analgésicos/antiinflamatorios (82,4%). El 66,6% no consideró necesario ir al médico para la prescripción y en el 35,1% de los casos fue el familiar o amigo quien lo recomendó.Conclusiones: la automedicación fue una práctica habitual en la población estudiada, aunque inferior a otros estudios. Es necesario el abordaje de este problema.(AU)

Objective: to determine the prevalence of self-medication among the persons working at a pharmaceutical company from the metropolitan area of Asunción (Paraguay), and to describe its characteristics.Method: a descriptive cross-sectional study (November 2016). All adult persons working at the company were included (N= 400). Their participation was requested by email in two occasions. Sociodemographic and occupational variables were measured, as well as self-medication, through a self-administered questionnaire, designed ad hoc and piloted (symptoms causing it, frequency, drug class, reasons, source of recommendation, efficacy and perceived danger, conclusion, action in case of symptom persistence, publicity, place of purchase, sources of information). Descriptive and bivariate statistics was conducted.Results: the study included 166 persons (mean age 33.2 years; 60.2% were male). Of these, 34.3% had self-medicated within the past three months; 90.4% considered that self-medication was dangerous. Self-medication was higher with university than with high school level (44.8% vs. 22.8%; p= 0.004). No differences were found based on age, gender or time worked at the company. The most frequent cause was treatment for headache (64.9%) and the drugs more widely used were analgesics / anti-inflammatories (82.4%); 66.6% of the participants did not consider it was necessary to see their doctor for prescription, and they followed recommendations by relatives or friends in 35.1% of cases.Conclusions: self-medication was a frequent practice among the population studied, although lower than in other studies. It is necessary to address this problem.(AU)

[Translated article] Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study.

OBJECTIVE: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription. METHOD: Observational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to seven different days of the week, in seven consecutive weeks. INCLUSION CRITERIA: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by two specialists in emergencies, two pharmacists and one specialist in infectious diseases, all unrelated to prescriptions. RESULTS: 168 patients with 192 prescriptions were evaluated. Seventy-six (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa = 0.71). CONCLUSIONS: A high rate of inappropriate antimicrobial prescriptions was obtained in a hospital emergency department according to local guidelines. The hospital pharmacist has an opportunity to improve the use of antimicrobials in this area.

Perfil do uso de medicamentos sintéticos e fitoterápicos por gestantes atendidas em uma Unidade Básica de Saúde localizada na região norte do Ceará / Profile of synthetic drugs and herbal medicines used by pregnant women seen in basic health unit in northern Ceará State, Brazil / Perfil de utilización de medicamentos sintéticos y fitoterápicos por mujeres embarazadas atendidas en Unidad Básica de Salud ubicada en la región norte de Ceará

Introdução: Há escassez de dados clínicos sobre os medicamentos em pacientes gestantes. Para auxiliar na conduta da farmacoterapia nessas pacientes, a Food and Drug Administration (FDA) criou, em 1979, normas de classificação de risco gestacional para os medicamentos. Além disso, no Brasil, há o uso de fitoterapia pela população, atrelada a fatores socioculturais e econômicos, por vezes sem que se saiba quais os riscos que as plantas medicinais possam trazer aos pacientes, sobretudo em gestantes. Objetivo: Descrever o uso de medicamentos sintéticos e fitoterápicos por gestantes atendidas em uma Unidade Básica de Saúde, relatando o perfil socioeconômico e histórico de paridade das entrevistadas e classificando o risco gestacional dos insumos utilizados. Métodos: Trata-se de uma pesquisa exploratória, descritiva, com abordagem qualitativa, em uma Unidade Básica de Saúde localizada no interior do Ceará. Foram incluídas no estudo as gestantes que realizavam acompanhamento pré-natal na unidade, em qualquer trimestre gestacional, sendo excluídas aquelas menores de idade. Os dados foram coletados por meio de um formulário estruturado, após as participantes assinarem o Termo de Consentimento Livre e Esclarecido. Os dados foram tabulados utilizando o Microsoft Excel 365. A classificação de risco dos medicamentos foi realizada utilizando os critérios do FDA, e as plantas medicinais foram classificadas de acordo com os resultados obtidos na literatura em "Indicadas", "Indicadas com ressalvas" ou "Contraindicadas". Estudo aprovado pelo Comitê de Ética em Pesquisa, com número do parecer 3.569.328. Resultados: Participaram um total de 43 gestantes, das quais 15 (34,88%) apresentaram algum tipo de comorbidade, sendo diabetes gestacional, rinite alérgica e hipertensão as mais prevalentes. 41 participantes (95,35%) utilizaram algum medicamento durante a gestação, com destaque de medicamentos de risco B e C (84,44% do total). Em relação ao uso de fitoterapia, 13 gestantes (30,23%) fizeram uso de alguma planta medicinal, onde somente uma das espécies utilizadas apresentou ser indicada com ressalvas durante a gestação. Conclusões: Observou-se que um dos fatores associados com o uso de medicamentos na gestação é o início do pré-natal. Apesar de as gestantes evitarem o uso de medicamentos sintéticos sem indicação, o mesmo não ocorre em relação ao uso fitoterapia, que é realizado de forma indiscriminada. Ademais, ressalta-se a falta de estudos dos riscos de medicamentos durante o período gestacional e a falta do farmacêutico no acompanhamento pré-natal, profissional capaz de promover Uso Racional de Medicamentos, podendo melhorar o perfil de uso de medicamentos por essas pacientes.

Introduction: There is a shortage of clinical data on drugs in pregnant patients. To assist in the management of pharmacotherapy in these patients, the Food and Drug Administration (FDA) created, in 1979, rules for classification of pregnancy risk for drugs. In addition, in Brazil, there is use of phytotherapics by the population, linked to socio-cultural and economical factors, at times without knowing what risks medicinal plants can bring to patients, especially in pregnant women. Objective: To describe the use of synthetic drugs and herbal medicines by pregnant women seen at a Basic Health Unit, reporting the socioeconomic profile and historical parity of the interviewees and classifying the gestational risk of the medicines used. Methods: This is an exploratory, descriptive research, with a qualitative approach, in a Basic Health Unit located in a provincial city of Ceará. Pregnant women who underwent prenatal care at the unit in any gestational trimester were included in the study, and those underage were excluded. Data was collected using a structured form, after the participants signed the Free and Informed Consent Form and charted using Microsoft Excel 365. The risk classification of drugs was carried out using the FDA criteria and medicinal plants were classified according to the results obtained in the literature under "Indicated", "Indicated with reservations" or "Admonished". Study approved by the Research Ethics Committee, under the file 3,569,328. Results: A total of 43 pregnant women participated, of which 15 (34.88%) had some type of comorbidity, with gestational diabetes, allergic rhinitis and hypertension being the most prevalent. 41 participants (95.35%) used some medication during pregnancy, with emphasis on medications with risks on B and C (84.44% of the total). Regarding the use of phytotherapy, 13 pregnant women (30.23%) used some medicinal plant, where only one of the species described was Indicated with reservations during pregnancy. Conclusions: It was observed that one of the factors associated with use of medications during pregnancy is the beginning of prenatal care. Although pregnant women avoid the use of synthetic medicines without indication, the same does not happen on the use of phytotherapy, which is carried out indiscriminately. In addition, the lack of studies on the risks of medications during pregnancy and the absence of pharmacists in prenatal care, a professional capable of promoting rational use of medications who could improve the profile of medication used by these patients.

Introducción: Los datos clínicos sobre medicamentos en mujeres embarazadas son escasos. Para ayudar en la realización de la farmacoterapia en estos pacientes, la Administración de Alimentos y Medicamentos (FDA) creó, en 1979, reglas para la clasificación del riesgo gestacional de los medicamentos. Además, en Brasil, la fitoterapia es utilizada por la población, vinculada a factores socioculturales y económicos, a veces sin conocer los riesgos que las plantas medicinales pueden traer a los pacientes, especialmente a las mujeres embarazadas. Objetivo: Describir el uso de medicamentos sintéticos y herbales por gestantes atendidas en una Unidad Básica de Salud, reportando el perfil socioeconómico y paridad histórica de las entrevistadas y clasificando el riesgo gestacional de los insumos utilizados. Métodos: Se trata de una investigación exploratoria, descriptiva, con enfoque cualitativo, en una Unidad Básica de Salud ubicada en el interior de Ceará. Se incluyeron en el estudio las mujeres embarazadas que se sometieron a atención prenatal en la unidad en cualquier trimestre de gestación y se excluyeron las menores de edad. Los datos fueron recolectados a través de un formulario estructurado, luego de que los participantes firmaran el Formulario de Consentimiento Libre e Informado. Los datos se tabularon mediante Microsoft Excel 365. La clasificación de riesgo de los fármacos se realizó según los criterios de la FDA y las plantas medicinales se clasificaron según los resultados obtenidos en la literatura en "Indicados", "Indicados con reservas" o "Contraindicados". Estudio aprobado por el Comité de Ética en Investigación, con dictamen número 3.569.328. Resultados: Participaron un total de 43 gestantes, de las cuales 15 (34,88%) presentaban algún tipo de comorbilidad, siendo la diabetes gestacional, rinitis alérgica e hipertensión las más prevalentes. 41 participantes (95,35%) utilizaron algún medicamento durante el embarazo, destinado a medicamentos de riesgo B y C (84,44% del total). En cuanto al uso de fitoterapia, 13 gestantes (30,23%) utilizaron alguna planta medicinal, donde solo una de las especies utilizadas se indicó con reservas durante la gestación. Conclusiones: Se observó que uno de los factores asociados al uso de medicamentos durante el embarazo es el inicio de la atención prenatal. Si bien las mujeres embarazadas evitan el uso de medicamentos sintéticos sin indicación, no ocurre lo mismo con relación al uso de fitoterápicos, que se realiza de forma indiscriminada. Además, la falta de estudios sobre los riesgos de los medicamentos durante el embarazo y la falta de farmacéuticos en la atención prenatal, un profesional capaz de promover el Uso Racional de los Medicamentos, puede mejorar el perfil de uso de medicamentos por parte de estas pacientes.

Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study. / Evaluación de la prescripción de antibióticos en un servicio de urgencias hospitalarias: estudio piloto.

OBJECTIVE: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription. METHOD: Observational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to 7 different days of the week, in 7 consecutive weeks. INCLUSION CRITERIA: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by 2 specialists in emergencies, 2 pharmacists and one specialist in infectious diseases, all unrelated to prescriptions. RESULTS: One hundred sixty eight patients with 192 prescriptions were evaluated. 76 (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa=0.71). CONCLUSIONS: A high rate of inappropriate antimicrobial prescriptions was obtained in a hospital emergency department according to local guidelines. The hospital pharmacist has an opportunity to improve the use of antimicrobials in this area.

Evaluación de la prescripción de antibióticos en un servicio de urgencias hospitalarias: estudio piloto / Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study

Objetivo: describir la adecuación de las prescripciones de antimicrobianos a las guías de tratamiento locales de infecciones, en el área de urgencias hospitalarias, así como conocer las características clínicas y epidemiológicas de los pacientes que reciben dichos tratamientos. Llevar a cabo un estudio de viabilidad para el diseño y la ejecución de investigaciones que aborden aspectos específicos de la inadecuación de prescripción de antimicrobianos.Métodoestudio piloto observacional, descriptivo y transversal, con recogida de datos retrospectiva de prescripción de antimicrobianos en un servicio de urgencias hospitalario. Se realizaron 7 cortes transversales, correspondientes a los 7 días diferentes de la semana, en 7 semanas consecutivas. Criterios de inclusión: paciente mayor de 14 años de edad, con al menos una primera dosis de tratamiento antimicrobiano prescrita el día del estudio. La variable principal fue la prescripción de antimicrobianos inadecuada según las guías locales. Como variables secundarias se recogieron parámetros epidemiológicos y clínicos de los pacientes. La evaluación de la adecuación la realizaron 2 especialistas médicos de urgencias y 2 especialistas en farmacia hospitalaria, más un tercer evaluador, especialista en enfermedades infecciosas, todos ajenos a la prescripción.Resultadosse evaluaron 168 pacientes con 192 prescripciones. Setenta y seis (39,6%) de las prescripciones no se ajustaron a las guías de tratamiento locales, de estas el 55% fueron con cobertura antimicrobiana activa frente al microorganismo, pero no recomendada, el 23,5% con fármacos inactivos, el 13,7% presentaban una dosis inapropiada y el 7,8% eran tratamientos innecesarios. La fuerza de la concordancia en la evaluación de la adecuación del tratamiento entre médicos y farmacéuticos fue alta (kappa=0,71). (AU)

Objective: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription.MethodObservational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to 7 different days of the week, in 7 consecutive weeks. Inclusion criteria: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by 2 specialists in emergencies, 2 pharmacists and one specialist in infectious diseases, all unrelated to prescriptions.ResultsOne hundred sixty eight patients with 192 prescriptions were evaluated. 76 (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa=0.71). (AU)

Tiempo hasta la modificación de la terapia antiparkinsoniana en un grupo de pacientes de Colombia / Time until modification of antiparkinsonian therapy in a group of patients from Colombia

Introducción: Se buscó determinar el tiempo transcurrido desde el inicio del tratamiento con fármacos antiparkinsonianos hasta la modificación en la terapia y establecer sus factores relacionados en un grupo de pacientes con enfermedad de Parkinson de Colombia. Pacientes y métodos: Estudio de cohorte retrospectiva que recolectó información sobre el tratamiento de pacientes con enfermedad de Parkinson que iniciaron terapia farmacológica entre junio de 2011 y diciembre de 2013; se realizó seguimiento a cinco años. Se generaron análisis de sobrevida para el tiempo trascurrido hasta la modificación de la terapia y se determinaron los factores relacionados con estos cambios utilizando modelos de regresión de Cox. Resultados: Un total de 3.224 pacientes (51,8%, hombres), con edad media de 73,1 ± 13,5 años, iniciaron tratamiento con fármacos antiparkinsonianos. Después de cinco años, 2.046 pacientes (63,5%) tuvieron modificaciones en la terapia farmacológica, con un promedio de tiempo de 36,4 meses (intervalo de confianza al 95%: 35,7-37,1). Un total de 1.216 pacientes (37,8%) requirió adición de otro principio activo, mientras que 830 (25,7%) tuvieron un cambio por otro medicamento. En el análisis multivariado, el sexo masculino, la edad mayor de 65 años y el inicio de amantadina se identificaron como factores que aumentaron la probabilidad de modificar la terapia. El uso de bromocriptina y biperideno, y la monoterapia como tratamiento inicial redujeron dicho riesgo. Conclusión: Después de cinco años de tratamiento, el 63,5% de los pacientes con enfermedad de Parkinson requirió modificaciones de la terapia, con un tiempo promedio de tres años. El sexo masculino, la edad mayor de 65 años y recibir terapia inicial con amantadina afectaron a la probabilidad de cambio de terapia en estos pacientes en Colombia.(AU)

Introduction: The aim was to determine the time elapsed between the start of treatment with antiparkinsonian agents and the modification of the pharmacological therapy, and to establish its related factors, in a group of patients with Parkinson’s disease from Colombia. Patients and methods: Retrospective cohort study that collected information about the treatment of patients with Parkinson’s disease who started drug therapy between June, 2011 and December, 2013; a five-year follow-up was performed. Survival analyses for time to therapy modification were generated, and factors related to these changes were determined using Cox regression models. Results: A total of 3,224 patients (51.8% men) with a mean age of 73.1 ± 13.5 years started treatment with antiparkinsonian agents. After five years, 2,046 patients (63.5%) had modifications in drug therapy, in a mean time of 36.4 months (95% confidence interval: 35.7-37.1). A total of 1,216 patients (37.8%) required the addition of another active principle, while 830 (25.7%) had a switch to another drug. In the multivariate analysis, male sex, age over 65 years, and the start of amantadine were identified as factors that increased the likelihood of therapy modification. The use of bromocriptine, biperiden, and monotherapy as an initial treatment were associated with a reduction in this likelihood. Conclusions: After five years of treatment, 63.5% of the patients with Parkinson’s disease required modifications to their therapy, with a mean time of three years. Male sex, age over 65 years, and receiving initial therapy with amantadine affected the likelihood of switching therapy in these patients in Colombia.(AU)

Risco de queda relacionado a medicamentos em hospitais: abordagem de aprendizado de máquina / Riesgo de caída relacionado con medicamentos en hospitales: enfoque de aprendizaje de máquina / Drug-related fall risk in hospitals: a machine learning approach

Resumo Objetivo Comparar o desempenho de modelos de aprendizado de máquina com o Medication Fall Risk Score (MFRS) na previsão de risco de queda relacionado a medicamentos prescritos. Métodos Trata-se de um estudo caso-controle retrospectivo de pacientes adultos e idosos de um hospital terciário de Porto Alegre, RS, Brasil. Medicamentos prescritos e classes de medicamentos foram investigados. Os dados foram exportados para o software RStudio para análise estatística. As variáveis foram analisadas por meio dos algoritmos de Regressão Logística, Naive Bayes, Random Forest e Gradient Boosting. A validação do algoritmo foi realizada usando validação cruzada de 10 vezes. O índice de Youden foi a métrica selecionada para avaliar os modelos. O projeto foi aprovado pelo Comitê de Ética em Pesquisa. Resultados O modelo de aprendizado de máquina que apresentou melhor desempenho foi o desenvolvido pelo algoritmo Naive Bayes. O modelo construído a partir de um conjunto de dados de um hospital específico apresentou melhores resultados para a população estudada do que o MFRS, uma ferramenta generalizável. Conclusão Ferramentas de previsão de risco que dependem de aplicação e registro adequados por parte dos profissionais demandam tempo e atenção que poderiam ser alocados ao cuidado do paciente. Modelos de previsão construídos por meio de algoritmos de aprendizado de máquina podem ajudar a identificar riscos para melhorar o atendimento ao paciente.

Resumen Objetivo Comparar el desempeño de modelos de aprendizaje de máquina con Medication Fall Risk Score (MFRS) para la previsión del riesgo de caída relacionado con medicamentos prescriptos. Métodos Se trata de un estudio caso-control retrospectivo de pacientes adultos y adultos mayores de un hospital terciario de Porto Alegre, estado de Rio Grande do Sul, Brasil. Se investigaron los medicamentos prescriptos y las clases de medicamentos. Los datos fueron exportados al software RStudio para el análisis estadístico. Las variables se analizaron a través de los algoritmos de regresión logística Naive Bayes, Random Forest y Gradient Boosting. La validación del algoritmo se realizó usando validación cruzada de 10 veces. El índice de Youden fue la métrica seleccionada para evaluar los modelos. El proyecto fue aprobado por el Comité de Ética en Investigación. Resultados El modelo de aprendizaje de máquina que presentó el mejor desempeño fue el desarrollado por el algoritmo Naive Bayes. El modelo construido a partir de un conjunto de datos de un hospital específico presentó mejores resultados en la población estudiada que el MFRS, una herramienta generalizada. Conclusión Herramientas de previsión de riesgo que dependen de la aplicación y el registro adecuados por parte de los profesionales demandan tiempo y atención que podría ser destinado al cuidado del paciente. Modelos de previsión construidos mediante algoritmos de aprendizaje de máquina pueden ayudar a identificar riesgos para mejorar la atención al paciente.

Abstract Objective To compare the performance of machine-learning models with the Medication Fall Risk Score (MFRS) in predicting fall risk related to prescription medications. Methods This is a retrospective case-control study of adult and older adult patients in a tertiary hospital in Porto Alegre, RS, Brazil. Prescription drugs and drug classes were investigated. Data were exported to the RStudio software for statistical analysis. The variables were analyzed using Logistic Regression, Naive Bayes, Random Forest, and Gradient Boosting algorithms. Algorithm validation was performed using 10-fold cross validation. The Youden index was the metric selected to evaluate the models. The project was approved by the Research Ethics Committee. Results The machine-learning model showing the best performance was the one developed by the Naive Bayes algorithm. The model built from a data set of a specific hospital showed better results for the studied population than did MFRS, a generalizable tool. Conclusion Risk-prediction tools that depend on proper application and registration by professionals require time and attention that could be allocated to patient care. Prediction models built through machine-learning algorithms can help identify risks to improve patient care.

Utilización de antibióticos restringidos en la práctica clínica: ceftolozano/tazobactam, ceftazidima/avibactam, ceftarolina y dalbavancina / Use of restricted antibiotics in clinical practice: ceftolozane/tazobactam, ceftazidime/avibactam, ceftaroline and dalbavancin

Objetivo: Evaluar la utilización en la práctica clínica de cuatro antibióticos de amplio espectro o innovadores: ceftolozano/tazobactam, ceftazidima/avibactam, ceftarolina y dalbavancina. Métodos: Estudio retrospectivo en que se han recogido datos de los pacientes que han recibido dichos antibióticos entre julio de 2018 y junio de 2019 en un hospital terciario. Se recogen las condiciones de uso y los resultados en efectividad a los 30 días para dalbavancina, y para el resto de antimicrobianos a los 3-5 días del inicio, a los 14 y a los 30 días para determinar mortalidad. Resultados: Se recogieron datos de 51 pacientes, con una mediana de edad de 63 años. La infección más comúnmente tratada fue neumonía (41,2%). Tres pacientes (5,9%) recibieron la terapia en estudio como primera línea y 43 (84,3%) recibieron antibióticos concomitantes. En el 66,7% de las infecciones se había aislado previamente un microorganismo sensible. En el 19,6% de los casos el cultivo fue negativo. En el grupo dalbavancina, el 75% de los pacientes se curaron a los 30 días. En el resto de antimicrobianos, el tratamiento resultó efectivo a los 3-5 días en el 65,1%. El 51,2% se curaron a los 14 días y un 30,2% fallecieron a los 30 días. Conclusiones: Los resultados de efectividad resultan comparables a estudios publicados con diseños similares. Se detecta la importancia de fomentar un uso adecuado de los antibióticos, como tratamientos dirigidos o empíricos en casos de riesgo de resistencias, priorizando su desescalada. Es esencial la implantación de equipos multidisciplinares PROA. (AU)

Objective: To evaluate the use in clinical practice of four recently marketed antibiotics: ceftolozane/tazobactam, ceftazidime/avibactam, ceftaroline, and dalbavancin. Methods: Retrospective study in which data have been collected from patients who have received these antibiotics between July 2018 and June 2019, in a third-level hospital. The conditions of use and the results in clinical efficacy measured in three periods have been studied: 3-5 days after the start of treatment, 14 days and 30 days to determine mortality. Results: Data were collected from a total of 51 patients, with a median age of 63 years. The most commonly treated infection was pneumonia (41.2%). Three patients (5.9%) received study therapy as the first line of treatment and 43 (84.3%) received concomitant antibiotics. In 66.7% of the infections, a sensitive microorganism to the antibiotic under study had been previously isolated. In 19.6% of the cases, the culture was negative. In the dalbavancin group, 75% of the pacients cured at day 30. In the other groups, the treatment was effective at 3-5 days in 65.1% of the cases. 51.2% experienced clinical cure at 14 days and 30.2% died at 30 days. Conclusions: The effectiveness results are comparable to published studies with similar designs. The importance of promoting an adequate use of antibiotics is detected, as directed or empirical treatments in cases of risk of resistance, prioritizing their de-escalation. The implementation of multidisciplinary PROA teams is essential. (AU)

Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos / Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials / Procesamiento de datos del Sistema Nacional de Gestión de Productos Controlados para estudios de utilización medicamentos con antimicrobianos

Resumo: O Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC) armazena dados de dispensação de medicamentos industrializados, manipulados e insumos farmacêuticos sob controle especial e antimicrobianos, a partir dos registros de farmácias e drogarias privadas. Este trabalho explorou a qualidade dos dados inseridos no SNGPC, a partir dos registros de dispensação de antibióticos industrializados, com o objetivo de propor seu emprego em estudos de utilização de medicamentos (DUR). A pesquisa foi desenvolvida por meio de desenho descritivo e retrospectivo, examinando o conjunto dados brutos do sistema, para o período de janeiro de 2014 a dezembro de 2020. Um total de 475.805.207 registros de dispensação de medicamentos foi coletado. Os antibióticos corresponderam em média a 54,5% do total de registros. A dimensão de qualidade "não informado" foi identificada, sistematicamente, nas variáveis "princípio ativo", "sexo", "idade" e "CID-10". As quantidades de frascos e caixas variaram de 1 a 536 unidades, e as quantidades de formas farmacêuticas dispensadas de 1 a 7.500 unidades. Os resultados mostram que 25% dos registros extrapolam uma terapia individual e que o sistema não apresenta um mecanismo de crítica para evitar dispensações não conformes ao padrão terapêutico para a classe. Apesar das vulnerabilidades decorrentes da qualidade dos dados, que podem ser superadas, o SNGPC possibilita construir diferentes planos analíticos, envolvendo tempo e outras agregações, na investigação de uso comunitário de antimicrobianos e medicamentos sob controle especial, o que faz dele uma potente fonte de dados para DUR.

Abstract: The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected. On average, antibiotics corresponded to 54.5% of the total records. The quality dimension "unreported" was systematically identified in the variables "active ingredient", "sex", "age" and "ICD-10". The amount of vials/bottles and packages ranged from one to 536 units and the amount of pharmaceutical inputs dispensed, from one to 7,500 units. Results show that 25% of the records exceed an individual therapy and the SNGPC has no critical mechanism to avoid dispensations outside the therapeutic standard for the class. Despite vulnerabilities due to data quality, which can be overcome, the SNGPC allows for the construction of different analytical plans, involving time and other aggregations, in the analysis of community use of antimicrobials and controlled drugs, which makes it a powerful source of data for DUR.

Resumen: El Sistema Nacional de Gestión de Productos Controlados (SNGPC) almacena datos sobre la dispensación de medicamentos industrializados, manipulados, insumos farmacéuticos bajo control especial y de antimicrobianos con base en los registros de farmacias y de boticas privadas. Este trabajo analizó la calidad de los datos ingresados en el SNGPC relacionados a los registros de la dispensación de antibióticos industrializados, para proponer su posible aplicación en estudios sobre el uso de medicamentos (DUR); para ello, realizó un análisis descriptivo y retrospectivo del conjunto de datos brutos para el periodo de enero de 2014 a diciembre de 2020. Se recogieron un total de 475.805.207 registros de dispensación de medicamentos. Los antibióticos correspondieron en promedio al 54,5% del total de los registros. La dimensión de calidad "no informado" se identificó sistemáticamente en las variables "principio activo", "sexo", "edad" y "CIE-10". Las cantidades de viales y cajas oscilaron entre 1 y 536 unidades, y las cantidades de formas farmacéuticas dispensadas entre 1 y 7.500 unidades. Los resultados muestran que el 25% de los registros exceden una terapia individual y que el sistema no tiene un mecanismo crítico para evitar la dispensación que no se ajusta al patrón terapéutico de la clase. A pesar de las vulnerabilidades derivadas de la calidad de los datos, que pueden ser superadas, el SNGPC permite la construcción de diferentes planes analíticos, involucrando tiempo y otras agregaciones, en la investigación del uso comunitario de antimicrobianos y medicamentos bajo control especial, lo que hace que el Sistema sea una potente fuente de datos para DUR.

Uso ambulatorio de medicamentos potencialmente inapropiados en adultos mayores usuarios de la RAP Metropolitana de ASSE durante 2019 / Potentially inappropriate medication use in older adults assisted as outpatients in ASSE's Metropolitan RAP (Primary Health Care) during 2019 / Uso ambulatorial de medicamentos potencialmente inapropriados em idosos usuários da RAPE Metropolitana da ASSE durante 2019

Introducción: los adultos mayores son una población de riesgo para el desarrollo de reacciones adversas a los medicamentos. Los medicamentos potencialmente inapropiados son aquellos que representan mayores riesgos que beneficios en este grupo etario. Se cuenta con herramientas de apoyo a la prescripción en geriatría que permiten identificar a estos medicamentos y mediante la aplicación de estudios de utilización de medicamentos, podemos describir o analizar el uso de los mismos en una población. Objetivos: reconocer disponibilidad de medicamentos potencialmente inapropiados para adultos mayores en la RAP metropolitana de ASSE durante 2019 y establecer un diagnóstico de situación de consumo de los mismos durante ese año. Método: se realizó un análisis del vademécum institucional mediante la aplicación de los Criterios de Beers 2019 y dos escalas de riesgo anticolinérgico para identificar medicamentos potencialmente inapropiados. Posteriormente se realizó un estudio de utilización de los medicamentos identificados, mediante datos de dispensación de farmacia entre el 1 de enero y 31 de diciembre de 2019. El consumo se expresó en Dosis Diarias Definidas por cada 1000 adultos mayores-año (DHD). Resultados: se identificaron 16 medicamentos potencialmente inapropiados, de los cuales los más usados fueron clonazepam (DHD 69), quetiapina (65,6), alprazolam (DHD 43,7), flunitrazepam (DHD 42,7) y zolpidem (DHD 36,4). Conclusiones: la aplicación de herramientas explícitas facilita la identificación de medicamentos potencialmente inapropiados para adultos mayores y se evidenció un consumo elevado de los mismos durante el año 2019 a expensas de derivados benzodiazepínicos y quetiapina.

Introduction: older adults are at higher risk for developing adverse drug reactions. Potentially inappropriate medications are drugs that have more risks than benefits in this age group. There are a number of tools to support the prescription of medication in geriatrics that allow the identification of these medications, and by applying studies developed on the use of medications we may describe or analyze their impact on a given population. Objectives: to recognize availability of potentially inappropriate medications in older adults in ASSE's Metropolitan RAP during 2019 and to draw conclusions about the current situation in terms of the consumption of this kind of medications. Method: an institutional analysis of medications available in each healthcare provided was conducted through the application of Beers Criteria 2019, and two anticholinergic risk scales were used to identify potentially inappropriate medications. Subsequently, the use of the medications identified was studied by applying pharmacy dispensing data between January 1 and December 31, 2019. Consumption was expressed in defined daily doses every 1000 adults per year (DHD). Results: 16 potentially inappropriate medications were identified, the most widely used of which were clonazepam (DHD 69), quetiapine (65.6), alprazolam (DHD 43.7), flunitrazepam (DHD 42.7) and zolpidem (DHD 36.4). Conclusions: Applying explicit tools makes it easier to identify potentially inappropriate medications for older adults. An increased consumption of these kinds of drugs was noticed during 2019, as a result of benzodiazepine derivatives and quetiapine.

Introdução: os idosos são uma população de risco para o desenvolvimento de reações adversas a medicamentos. Medicamentos potencialmente inapropriados são aqueles que apresentam maiores riscos do que benefícios nessa faixa etária. Existem ferramentas de apoio à prescrição em geriatria que permitem identificar esses medicamentos e, por meio da aplicação de estudos de utilização de medicamentos, descrever ou analisar seu uso em uma população. Objetivos: reconhecer a disponibilidade de medicamentos potencialmente inapropriados para idosos na RAP metropolitana da ASSE durante o ano de 2019 e estabelecer um diagnóstico de consumo durante esse ano. Método: o formulário institucional foi analisado utilizando os Critérios de Beers 2019 e duas escalas de risco anticolinérgico para identificar medicamentos potencialmente inapropriados. Posteriormente, foi realizado um estudo de consumo dos medicamentos identificados, através dos dados de dispensação da farmácia entre 1 de janeiro e 31 de dezembro de 2019. O consumo foi expresso em Doses Diárias Definidas por 1000 idosos-ano (DHD). Resultados: foram identificados 16 medicamentos potencialmente inapropriados, sendo clonazepam (DHD 69), quetiapina (65,6), alprazolam (DHD 43,7), flunitrazepam (DHD 42,7) e zolpidem (DHD 36,4) os mais utilizados Conclusões: a aplicação de ferramentas explícitas facilita a identificação de medicamentos potencialmente inapropriados para idosos; foi observado um alto consumo dos mesmos em detrimento dos derivados benzodiazepínicos e da quetiapina durante o período do estudo.