Acontecimientos adversos en embarazadas con la vacuna tetravalente contra la gripe obtenida de cultivos celulares / Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

La vacunación de la gripe en embarazadas muestra una clara relación beneficio/riesgo. En la actualidad se están desarrollando vacunas contra la gripe utilizando nuevas plataformas. Es imprescindible analizar la seguridad de estas nuevas vacunas en este grupo poblacional, infrarrepresentado en los ensayos clínicos. En la temporada 2019-2020 se aconsejó una vacuna obtenida en cultivo celular a las embarazadas en 2comunidades autónomas. Se recogió información de los centros de vacunación y de farmacovigilancia de ambas comunidades. La tasa de notificación de casos de acontecimientos adversos tras la vacunación en embarazadas fue de 4,02/100.000 dosis administradas y, en mujeres de 18 a 64 años no embarazadas, de 5,9/100.000 dosis administradas. La tasa de acontecimientos adversos notificados fue de 8,04 y 17,74, respectivamente. No se notificaron abortos espontáneos, prematuridad ni malformaciones fetales. Este análisis señala la seguridad en embarazadas de la vacuna de la gripe obtenida de cultivos celulares.(AU)

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyze the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in 2autonomous communities. Information is collected from the vaccination and pharmacovigilance centers of both communities. The reporting rate of adverse events after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of adverse events reported was 8.04 and 17.74, respectively. No spontaneous abortions, prematurity or fetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.(AU)

Análisis de las prescripciones y dispensaciones de psicofármacos en una oficina de farmacia de la provincia de Mendoza, Argentina / Prescriptions and dispensations analysis of psychotropic drugs in a pharmacy office of Mendoza province, Argentina

El Uso Racional de Medicamentos refiere a prácticas adecuadas en cada componente de la cadena de utilización. En este trabajo, nuestro objetivo radicó en determinar el perfil de las prescripciones de psicofármacos recibidas y dispensadas en una oficina de farmacia de la provincia de Mendoza (Argentina), evaluar posibles errores, medir la magnitud del consumo e identificar los psicofármacos de primera elección. Se efectuó un análisis observacional, transversal y retrospectivo de prescripciones dispensadas entre el 1 de enero y el 30 de junio de 2020. Los datos se obtuvieron directamente desde las prescripciones. Los fármacos se codificaron según el sistema de clasificación ATC y los diagnósticos según la Clasificación Internacional de Enfermedades, ambos propuestos por la OMS. La prueba del Chi-cuadrado se utilizó para comparar las variables. Una probabilidad de p<0,05 fue considerada estadísticamente significativa. Se registraron 7.836 prescripciones en 7.041 recetas (media por paciente = 1,11±0,32). Hubo mayor prescripción de psicofármacos a pacientes femeninos (χ2 p<0,001). Las especialidades médicas que más prescribieron los psicofármacos dispensados fueron Clínica, Medicina Familiar y Psiquiatría. Los fármacos psicolépticos fueron los mayormente prescritos, seguido de los antiepilépticos, psicoanalépticos y analgésicos. El 43,76% del total correspondió a benzodiacepinas, principalmente clonazepam, alprazolam y bromazepam. Clonazepam fue el fármaco más prescrito en el período analizado (21,75%), principalmente para diagnósticos de trastornos de ansiedad, hipertensión arterial y depresión. Los registros obtenidos muestran un elevado consumo de ciertos psicofármacos, resultando coincidente con estudios semejantes, hallándose idéntica relación con los fármacos más prescritos, sexo y especialidad del profesional prescriptor. (AU)

The Rational Use of Medicines it refers to adequate practices in each component of the utilization chain. In this work, our objective was to determinate profile of psychotropic drugs prescriptions received and dispensed in a pharmacy office of Mendoza province (Argentina), with evaluation of possible errors, determination of the magnitude consumption and identification of first-choice psychotropic drugs. It was performed an observational, cross-sectional, and retrospective analysis of the prescriptions dispensed between January 1 and June 30, 2020. Data were obtained directly from prescriptions. Drugs were coded according to the ATC classification system and diagnoses according to the International Classification of Diseases, both proposed by the WHO. The Chi-square test was used to compare the variables. A probability of p<0.05 was considered significant statistically. It was registered 7,836 prescriptions in 7,041 prescriptions (mean per patient = 1.11±0.32). There was a greater prescription of psychotropic drugs to female patients (χ2 p<0.001). The clinical medical did result the professional that more prescribed the psychotropic drugs dispensed followed by Family Medicine and Psychiatry specialties. Psycholeptic drugs were the most prescribed, followed by antiepileptic, psychoanaleptic and analgesic drugs. 43.76% of the total corresponded to benzodiazepines, mainly clonazepam, alprazolam and bromazepam. Clonazepam was the most prescribed drug in the analyzed period (21.75%), mainly for diagnosing anxiety disorders, arterial hypertension, and depression. The records obtained show a high consumption of certain psychotropic drugs groups, which coincides with similar studies, finding an identical relationship with the most prescribed drugs, sex, and specialty of the prescribing professional. (AU)

Patrones de uso de anticonceptivos hormonales en una población de Colombia

Objetivo: El uso de anticonceptivos hormonales ha crecido progresivamente en muchos países del mundo. Determinar los patrones de utilización de anticonceptivos hormonales, frecuencia de comorbilidades y medicaciones concomitantes en mujeres mayores de 15 años afiliadas al Sistema de Salud de Colombia. Materiales y métodos: Estudio de corte, que incluyó datos de mujeres mayores de 15 años con prescripciones y dispensaciones de algún anticonceptivo hormonal durante al menos tres meses continuos (abril a junio-2016). Se creó una base de datos con información sociodemográfica, farmacológica (tipo de anticonceptivos, dosis, comedicaciones y comorbilidades. Se realizaron análisis descriptivos y multivariados buscando identificar factores asociados con comedicaciones de riesgo. Resultados: Se identificaron 34309 mujeres que recibieron anticonceptivos hormonales, con edad media de 27,2±7,0 años (rango:13-60,8 años). Los anticonceptivos más utilizados fueron inyectables de aplicación mensual (63,0 %), inyectables de aplicación trimestral (19,1 %), de administración oral (12,1 %), los implantes subdérmicos (7,4 %) y finalmente los dispositivos intrauterinos hormonales con 0,4 %. El 5,7 % de las pacientes (n=1957), estaban recibiendo alguna comedicación, especialmente con antihipertensivos (2,9 %) y antimigrañosos (1,9 %). Ser mayor de 45 años (OR:2,3; IC95 %:1,7-3,0), utilizar dispositivo intrauterino hormonal (OR:2,4; IC95 %:1,4-4,1) y anticonceptivo inyectable trimestral (OR: 1,7; IC95 %:1,3-2,3) se asociaron con mayor probabilidad de recibir comedicaciones. Conclusiones. Las mujeres colombianas que acceden a anticonceptivos hormonales a través del Sistema de Salud están empleando principalmente presentaciones inyectables, con muy baja frecuencia de las orales, y en general tienen pocas comorbilidades que requieran tratamiento farmacológico, pese a que algunas tienen condiciones cardiovasculares que pueden implicar un potencial riesgo de eventos trombóticos.

Objective: The use of hormonal contraceptives has grown progressively in many countries of the world. The aim was to determine the patterns of use of hormonal contraceptives, frequency of comorbidities and concomitant medications in women over 15 years of age affiliated with the Colombian Health System. Methods: Cross-sectional study, which included data on women over 15 years of age with prescriptions and dispensations of a hormonal contraceptive for at least three continuous months (April-June-2016). A database with sociodemographic, pharmacological information (type of contraceptives, doses, comedications and comorbidities) was created. Descriptive and multivariate analyzes were conducted seeking to identify factors associated with risk comedications. Results: 34309 women who received hormonal contraceptives were identified, with a mean age of 27.2 ± 7.0 years (range: 13-60.8 years). The most commonly used contraceptives were injectable of monthly application (63.0 %), injectable of quarterly application (19.1 %), oral administration (12.1 %), subdermal implants (7.4 %) and finally the hormonal intrauterine devices with 0.4 %. 5.7 % of the patients (n = 1957) were receiving some medication, especially with antihypertensives (2.9 %) and anti-migraines (1.9 %). Be over 45 years old (OR:2.3; 95 %CI: 1.7-3.0), use hormonal intrauterine device (OR: 2.4; 95 % CI:1.4-4.1) and quarterly injectable contraceptive (OR:1.7; 95 %CI:1.3-2.3) were associated with a higher probability of receiving comedications. Conclusions: Colombian women who access hormonal contraceptives through the Health System are mainly using injectable presentations, with very low frequency of oral ones, and in general they have few comorbidities that require pharmacological treatment, although some have cardiovascular conditions that may involve potential risk of thrombotic events.

Naltrexona em baixa dose (LDN): tendência de consumo nas capitais brasileiras e Distrito Federal, 2014-2020 / Low-dose naltrexone (LDN): consumption trend in Brazilian capitals and the Federal District, 2014-2020

Resumo Estudo ecológico com objetivo de determinar o consumo de naltrexona em baixa dose (LDN) nas 26 capitais brasileiras e Distrito Federal e acompanhar a tendência entre os anos de 2014 e 2020. A coleta de dados da dispensação de naltrexona manipulada, se deu por meio do Sistema Nacional de Gerenciamento de Produtos Controlados, publicizado em 2020, considerando-se baixa dose prescrições de até 5 mg. O cálculo dos coeficientes de dispensação utilizou as estimativas populacionais do Instituto Brasileiro de Pesquisa Geografia e Estatística. Utilizou-se análise estatística descritiva e de regressão generalizada de Prais-Winsten para a série temporal. As tendências observadas foram classificadas em crescentes, estáveis ou decrescentes, com intervalo de confiança de 95% e nível de significância de 5%. Os resultados demonstraram maiores coeficientes de consumo de LDN nas regiões Centro-Oeste, Sul e Sudeste e menores nas Norte e Nordeste. Observou-se dispensação de LDN crescente em 55,6% das capitais, estacionária em 44,4% e ausência de coeficientes decrescentes. Apesar das evidências limitadas quanto à farmacoterapia de LDN e da sua prescrição off-label, os dados demonstram que a prescrição, dispensação e consumo vem crescendo no Brasil, com ênfase nas regiões centro-sul do país.

Abstract The scope of this paper is an ecological study to determine the consumption of low-dose naltrexone (LDN) in the 26 Brazilian capitals and the Federal District and monitor the trend between the years 2014 to 2020. Data collection on the dispensation of manipulated naltrexone was done through the National Management System of Controlled Products, published in 2020, considering low-dose prescriptions of up to 5 mg. The calculation of the dispensation coefficients used the population estimates of the Brazilian Institute of Geography and Statistics. Descriptive statistical analysis and generalized Prais-Winsten regression analysis were used for the time series analysis. The trends observed were classified as increasing, stable, or decreasing, with a 95% confidence interval and 5% significance level. The results showed higher LDN consumption coefficients in the Mid-West, South and Southeast regions and lower coefficients in the North and Northeast. Increasing dispensation of LDN was observed in 55.6% of the capitals, being stationary in 44.4%, with no decreasing coefficients. Despite the limited evidence regarding LDN pharmacotherapy and its off-label prescription, the data show that prescription, dispensing, and consumption have been on the increase in Brazil, with emphasis on the central-south regions of the country.

Fármacovigilancia de la carbamazepina en el Policlínico Marta Abreu. Santa Clara, 2022

Fundamento: en la práctica, el término estupefaciente se aplica a las especialidades farmacéuticas que contienen principios activos que actúan sobre el sistema nervioso central modificándolo y a las fórmulas magistrales con los mismos principios activos. Objetivo: caracterizar clínica y epidemiológicamente los pacientes que consumen carbamazepina en un área de salud del municipio de Santa Clara. Métodos: estudio descriptivo, transversal, en pacientes que consumen carbamazepina, pertenecientes al Policlínico Docente Marta Abreu, en el período del 1 de enero de 2021 al 1 de abril de 2022. Se incluyeron 209 pacientes y se midieron las siguientes variables: edad, sexo, número de pacientes según diagnósticos, número de pacientes según nuevos protocolos y tiempo de consumo del tratamiento. Resultados: predominó el grupo de edades de 51 a 60 con 43 pacientes (20,5 %), dentro de este grupo el sexo femenino (11,0 % del total); el diagnóstico predominante fue la epilepsia generalizada (93 pacientes). Predominó el sexo femenino, con 59 pacientes, y en ellas se encontró la mayor cantidad de expedientes vencidos, con un total de 16. Según nuevos protocolos, prevalecieron los pacientes con diagnóstico de neuralgia trigeminal, glosofaríngeo o facial (7 pacientes). En cuanto al tiempo de consumo predominaron los pacientes con igual diagnóstico a los anteriores y trastorno del comportamiento debido a enfermedad médica, ambos grupos con tratamientos de hasta tres años. Conclusiones: es importante el conocimiento sobre el uso y abuso de los estupefacientes así como mantener actualizado a todo el personal sanitario para lograr el óptimo control sobre estas sustancias.

Background: in practice, the term narcotic is applied to pharmaceutical specialties that contain active ingredients that act on the central nervous system, modifying it, and to master formulas with the same active ingredients. Objective: to characterize clinically and epidemiologically the patients who consume carbamazepine in a health area of the Santa Clara municipality. Methods: descriptive, cross-sectional study in patients consuming carbamazepine, belonging to the Marta Abreu Teaching Polyclinic, from January the 1st, 2021 to April the 1st, 2022. 209 patients were included and the following variables were measured: age, sex, number of patients according to diagnoses, number of patients according to new protocols and time of consumption of the treatment. Results: the age group from 51 to 60 predominated with 43 patients (20.5%), within this group the female sex (11.0% of the total); the predominant diagnosis was generalized epilepsy with a total of 93 patients. The female sex predominated with a total of 59 patients and in them the largest number of expired files was found, with a total of 16. According to new protocols, patients with a diagnosis of trigeminal, glossopharyngeal or facial neuralgia (7 patients) predominated. Regarding the time of consumption, patients with the same diagnosis as the previous ones and behavioral disorder due to a medical illness predominated, both groups with treatments of up to three years. Conclusions: knowledge about the use and abuse of narcotic drugs is important, as well as keeping all health personnel updated to achieve optimal control over these substances.

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)

Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures.

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyse the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in two autonomous communities. Information is collected from the vaccination and pharmacovigilance centres of both communities. The reporting rate of adverse events (AEs) after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of AE reported was 8.04 and 17.74 respectively. No spontaneous abortions, prematurity or foetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.

Use of Psychotropic Drugs during the COVID-19 pandemic in Minas Gerais, Brazil / Perfil de utilização de psicofármacos durante a pandemia de COVID-19 em Minas Gerais, Brasil

ABSTRACT Objective: To describe the profile of dispensation of mental health drugs by analyzing trends in use before and during the COVID-19 pandemic within the Unified Health System (Sistema Único de Saúde [SUS]). Methods: Pharmacoepidemiological study based on the retrospective analysis of records regarding the dispensation of psychotropic medicines in the SUS database in the state of Minas Gerais between 2018 and 2021, considering the periods before (2018-2019) and during the COVID-19 pandemic (2020-2021). A database with the records of dispensation of municipalities was created, and the consistency of releases was verified using the Analysis of Variance (ANOVA) test. Medicine consumption was measured in a defined daily dose (DDD) per 1,000 inhabitants/day for SUS, and the difference between periods was evaluated using Student's t-test. Results: During the COVID-19 pandemic, there was an increase in the consumption of psychotropic drugs in SUS-MG. The most consumed medicines were fluoxetine hydrochloride, diazepam and phenobarbital sodium (DDD=5.89; 3.42; 2.49) in the Basic Pharmaceutical Services Component(CBAF), and olanzapine, risperidone and quetiapine hemifumarate (DDD=0.80; 0.47; 0.38) in the Specialized Pharmaceutical Services Component (CEAF). The highest percentage increase in consumption was attributed to clonazepam (75.37%) and lithium carbonate (35.35%), in CBAF, and levetiracetam (3,000.00%) and memantine hydrochloride (340.0%) in CEAF. Conclusion: The change in the psychotropic drug dispensation profile during the COVID-19 pandemic highlights the need to produce more studies to complete, confirm or rule out this profile and monitor the use of psychotropic drugs by the population in the post-pandemic context.

RESUMO Objetivo: Descrever o perfil de dispensação de medicamentos da saúde mental analisando o uso antes e durante a pandemia de COVID-19 no âmbito do Sistema Único de Saúde (SUS). Métodos: Estudo farmacoepidemiológico a partir da análise retrospectiva dos registros de dispensação de psicofármacos na base de dados do SUS no estado de Minas Gerais (MG) nos períodos antes (2018-2019) e durante a pandemia de COVID-19 (2020-2021). Um banco de dados com os registros de dispensação dos municípios foi elaborado, sendo verificada a consistência de lançamento pelo teste de Análise de Variância (ANOVA). O consumo dos medicamentos foi mensurado em dose diária definida (DDD) por 1.000 habitantes/dia para o SUS, sendo a diferença entre os períodos avaliada pelo teste estatístico t de Student. Resultados: Durante a pandemia de COVID-19 houve aumento no consumo de psicofármacos no SUS-MG. Os medicamentos mais consumidos foram cloridrato fluoxetina, diazepam e fenobarbital sódico (DDD=5,89; 3,42; 2,49) no componente básico (CBAF), e olanzapina, risperidona e hemifumarato de quetiapina (DDD=0,80; 0,47; 0,38) no componente especializado da Assistência Farmacêutica (CEAF). Os maiores aumentos percentuais no consumo foram atribuídos ao clonazepam (75,37%) e carbonato de lítio (35,35%) no CBAF e levetiracetam (3.000,00%) e cloridrato de memantina (340,00%) no CEAF. Conclusão: A alteração do perfil de dispensação de psicotrópicos durante a pandemia de COVID-19 alerta quanto à necessidade de produção de mais estudos a fim de completar, confirmar ou afastar este perfil e monitorar o uso de psicofármacos pela população no contexto pós-pandêmico.

Relationship between anticholinergic load and self-perceived health in a population aged 44 years or older / Relação entre carga anticolinérgica e autopercepção de saúde em população com mais de 44 anos

OBJECTIVE: To investigate the relationship between anticholinergic load (ACL) and self-perceived general health in adults in a medium-sized municipality in southern Brazil. METHODS: This cross-sectional study was based on 2015 data from a medium-sized municipality in southern Brazil. All respondents aged 44 years or older who reported using drugs in the 2 weeks before the interview were included (n = 662). The Anticholinergic Drug Scale was used to measure the ACL. Self-perceived health was categorized as positive self-perception (PSP) or negative self-perception (NSP). Crude and adjusted Poisson regression analyses were conducted to investigate the association between ACL and self-perceived health. RESULTS: NSP was found in 50.91% of 662 respondents. Significant ACL, older age, lower economic status, lower education, polypharmacy, and depression correlated with a higher frequency of NSP. Individuals with significant ACL had a prevalence of NSP of 1.27 (95% confidence interval: 1.02 ­ 1.58), and each additional ACL level represented a 6.10% higher chance of worse self-perceived health, regardless of confounding factors. CONCLUSIONS: An association was found between significant ACL and NSP, with an effect dependent on ACL level

OBJETIVO: Investigar a relação entre carga anticolinérgica (CAC) e autopercepção de saúde em adultos de um município de médio porte do sul do Brasil. METODOLOGIA: Trata-se de um estudo transversal com dados de 2015, realizado em um município de médio porte do sul do Brasil. Todos os entrevistados com 44 anos ou mais que relataram uso de drogas nas duas semanas anteriores à entrevista foram incluídos (n = 662). A Anticholinergic Drug Scale (ADS) foi utilizada para medir a CAC. A autopercepção da saúde foi categorizada em autopercepção positiva (APP) ou autopercepção negativa (APN). Análises de regressão de Poisson bruta e ajustada foram realizadas para investigar a associação entre CAC e autopercepção de saúde. RESULTADOS: Entre os 662 participantes, a CAC foi encontrada em 50,91% dos respondentes. CAC significativa, idade avançada, situação econômica mais baixa, menor escolaridade, polifarmácia e depressão foram correlacionados com maior frequência de APN. Indivíduos com CAC significativo apresentaram prevalência de APN de 1,27 (intervalo de confiança de 95%: 1,02 ­ 1,58), e cada nível adicional de CAC representou uma chance 6,10% maior de pior autopercepção de saúde, independentemente de fatores de confusão. CONCLUSÕES: Encontrou-se associação entre ACL significativo e APN, com efeito dependente do valor do CAC

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.

Perfil prescriptivo de corticoides en el servicio de urgencias del Hospital Odontológico de la ciudad de Formosa, Argentina / Prescriptive Profile of Corticoids in the Emergency Department of the Dental Hospital of the City of Formosa, Argentina

Objetivo: identificar el perfil prescriptivo de corticoides en pacientes que asistieron al Servicio de Urgencias del Hospital Odontológico de la ciudad de Formosa, Argentina. Métodos: se realizó un estudio transversal, observacional y descriptivo, se analizaron las prescripciones de corticoides realizadas por odontólogos que atendieron en el Servicio de Urgencias del Hospital Odontológico de la ciudad de Formosa desde marzo 2019 a febrero 2020. Las variables de estudio fueron: características demográficas del paciente, diagnóstico clínico odontológico, corticoide prescrito, dosis y forma farmacéutica. Resultados: de un total de 9.635 historias clínicas, se observaron 3.244 prescripciones de corticoides (33,6%). De acuerdo a los corticoides prescritos, se halló a la dexametasona para vía intramuscular y además se utilizó dexametasona en tratamientos combinados con dipirona para vía intramuscular e ibuprofeno para vía oral. Los diagnósticos relacionados con prescripción de estos medicamentos fueron: pulpitis, periodontitis apical aguda, flemón/absceso, entre otras. De acuerdo al valor intrínseco terapéutico potencial, los fármacos prescritos en el hospital odontológico son de valor elevado, esto significa que demostraron eficacia para el tratamiento, el diagnóstico o la prevención de enfermedades del ser humano. Conclusiones: el estudio de la utilización de medicamentos en el Hospital Odontológico de la ciudad de Formosa permitió observar situaciones donde los corticoides no están indicados. Además, se señala la prescripción excesiva de la vía intramuscular. A partir de los resultados obtenidos es necesario realizar una retroalimentación a los prescriptores, por lo que se sugieren intervenciones para elaborar propuestas de solución a los problemas identificados y formular políticas de medicamentos.

Objective: to identify the prescriptive profile of corticosteroids in patients who were treated at the Emergency Service of the Dental Hospital of the City of Formosa, Argentina. Methods: a cross-sectional, observational, and descriptive study was carried out, and corticosteroid prescriptions made by dentists who attended the Emergency Service of the Dental Hospital of the City of Formosa, from March 2019 to February 2020 were analyzed. The study variables were: demographic characteristics of the patient, dental clinical diagnosis, corticosteroid prescribed, dose, and pharmaceutical form. Results: Of 9,635 medical records, 3,244 corticosteroid prescriptions (33.6%) were observed. According to the prescribed corticosteroids, dexamethasone was found for the intramuscular route, and dexamethasone was also used in combined treatments with dipyrone for the intramuscular route and ibuprofen for the oral route. The diagnoses related to the prescription of these medications were: pulpitis, acute apical periodontitis, phlegmon/abscess, trauma, pericoronitis, hypersensitivity and alveolitis. According to the potential therapeutic intrinsic value, the drugs prescribed in the dental hospital are of high value, which means that they have demonstrated efficacy for the treatment, diagnosis or prevention of diseases that affect humans. Conclusions: the study of the use of drugs in the Dental Hospital of the City of Formosa allowed us to observe situations where corticosteroids are not indicated. In addition, the excessive prescription of the intramuscular route is pointed out. Based on the results obtained, it is necessary to provide feedback to the prescribers, so it is suggested to continue with different interventions to develop proposals for solutions to the identified problems and formulate drug policies.

Systemic lupus erythematosus: Pharmacological differences between women and men and among age groups and geographical regions

Systemic lupus erythematosus (SLE) is a chronic and potentially fatal autoimmune disease. There are clinical differences between women and men and among age groups. Its treatment involves a heterogeneous group of drugs. The objective was to determine the pharmacological treatment patterns in a group of patients with SLE and compare them according to sex, age group and geographic region. This was a cross-sectional study that identified outpatient drugs used in patients with SLE from a population database of Colombians affiliated with the Colombian Health System. Sociodemographic and pharmacological variables were considered. Descriptive and bivariate analyses were performed. A total of 4307 patients with SLE were identified (median age, 44.2 years; 89.4% women). Disease-modifying antirheumatics were the most prescribed drugs (90.5%), especially chloroquine (54.4%), which predominated in all age groups and geographical regions. Hydroxychloroquine and methotrexate were the predominant prescribed drugs for women, while corticosteroids, chloroquine, azathioprine, and mycophenolate were the predominant prescribed drugs for men. The use of corticosteroids (prednisolone and prednisone) decreased with increasing age. Differences were found in the prescription of drugs for patients with SLE between women and men and among geographic regions and age groups. The use of chloroquine predominated over hydroxychloroquine, contrasting with clinical practice guidelines.

El lupus eritematoso sistémico (LES) es una enfermedad autoinmune crónica y potencialmente mortal. Existen diferencias clínicas entre mujeres y hombres, y entre grupos de edad. Su tratamiento involucra un grupo heterogeneo de medicamentos. El objetivo fue determinar los patrones de tratamiento farmacológico de un grupo de pacientes con LES y compararlos según el sexo, los grupos de edad y las regiones geograficas. Estudio de corte transversal que identifico los medicamentos de uso ambulatorio empleados en pacientes con LES, a partir de una base de datos poblacional de colombianos afiliados al Sistema de Salud de Colombia. Se consideraron variables sociodemográficas y farmacologicas. Se realizo un análisis descriptivo y bivariado. Se identificó a 4.307 pacientes con LES, con una mediana de edad 44,2 an˜ os y un 89,4% mujeres. Los medicamentos modificadores de enfermedad reumatica fueron los mas prescritos (90,5%), en especial cloroquina (54,4%), el cual predomino en todos los grupos de edad y las regiones geográficas. La hidroxicloroquina y el metotrexato predominaron en mujeres, mientras que los corticosteroides, la cloroquina, la azatioprina y el micofenolato, en hombres. Con el aumento de la edad disminuyo el uso de corticoides (prednisolona y prednisona). Se encontraron diferencias en la prescripción de los medicamentos empleados en los pacientes con LES entre mujeres y hombres, regiones geográficas y grupos etarios. El uso de cloroquina predomino sobre la hidroxicloroquina, en contraste con lo recomendado por las guías de practica clínica.

Use of medications by pregnant women in the Family Health Strategy in the Northeast of Brazil / Uso de medicamentos por gestantes da estratégia saúde da família no Nordeste do Brasil

Abstract Objectives: To evaluate the medication use, exposure to potential risks, and associated factors before and during pregnancy of pregnant women receiving care at the Family Health Strategy in a municipality in the Northeast of Brazil. Methods: This is a cross-sectional study of pregnant women receiving care in the municipality of Barreiras, in Bahia, Brazil. In data analysis process, prevalence and frequency of medication use were estimated. To investigate the association between variables, the outcome measure was expressed by the prevalence ratio (crude and adjusted) with a 95% confidence interval via Poisson regression. Results: The prevalence of medication use before pregnancy was 35% and during pregnancy, it was 80.7%. Analgesics and antianemics were the prevalent groups of medications before and during pregnancy, respectively. Family income (≤1 minimum wage; PR=1.62; CI95%=1.02-2.55) showed an association with prior use; health problems (PR=2.3; CI95%=1.27-4.22) and complaints in pregnancy (PR=2.39; CI95%=1.28-4.47) had an association with use during pregnancy. Conclusion: The characterization of a high prevalence of use of medicines by pregnant women, combined with a trend of failures in family planning could demonstrate the exposure of the risks of using some harmful substances in periods close to conception and pregnancy.

Resumo Objetivos: avaliar o uso de medicamentos, exposição a potenciais riscos e os fatores associados antes e durante a gestação pelas gestantes atendidas na Estratégia Saúde da Família em município do nordeste brasileiro. Métodos: trata-se de um estudo transversal realizado com gestantes atendidas no município de Barreiras, Bahia, Brasil. No processo de análise dos dados, foram estimadas as prevalências e frequências de utilização de medicamentos. Para investigar a associação entre variáveis, a medida do desfecho foi expressa pela razão de prevalência (bruta e ajustada) com intervalo de 95% de confiança pela regressão de Poisson. Resultados: a prevalência do uso de medicamentos antes da gestação foi 35% e durante de 80,7%. Os analgésicos e antianêmicos foram os grupos de medicamentos prevalentes antes e durante a gestação, respectivamente. A renda familiar (≤1 salário mínimo; RP=1,62; IC95%=1,02-2,55), mostrou associação ao uso anterior; problemas de saúde (RP=2,32; IC95%=1,27-4,22) e queixas na gestação (RP=2,39; IC95%=1,28-4,47) tiveram associação para o uso durante. Conclusões: a caracterização de uma alta prevalência do uso de medicamentos por gestantes, aliado a uma tendência de falhas no planejamento familiar pôde demonstrar a exposição dos riscos da utilização de algumas substâncias nocivas em períodos próximos da concepção e na gestação.

Producción científica de la maestría de farmacoepidemiología en Cuba: Revisión de trabajos de tesis / Scientific production of master's degree in pharmacoepidemiology in Cuba: Descriptive review of thesis works

Resumen Objetivo: Caracterizar las investigaciones realizadas en farmacoepidemiología a partir de las tesis de Maestría de Farmacoepidemiología de la Escuela Nacional de Salud Pública, La Habana, Cuba. Materiales y método: Estudio descriptivo; se analizaron 124 tesis defendidas en las cuatro ediciones de la maestría, entre los años 2010 y 2019. Las variables fueron profesión y lugar de residencia de los autores, línea de investigación de la maestría que se abordó, tipo de estudio, tipo de Estudio de Utilización de Medicamentos (EUM), grupos farmacológicos que se investigaron y si los resultados se publicaron en revistas científicas. Los resultados se resumieron en porcentajes. Resultados: La mayoría de los autores eran graduados de Medicina (50.0%) y residían en La Habana 53.2%. Las líneas de investigación más abordadas fueron calidad de la prescripción de medicamentos (43.5%) y farmacovigilancia, 30.6 %. Se identificaron 72 EUM y predominó el tipo prescripción-indicación (27.7%). Predominó el análisis de antimicrobianos (28.5%) y de los fármacos cardiovasculares (29.7%). Fueron publicadas en revistas científicas solo el 22.5% de las investigaciones. Conclusiones: Los temas de tesis de la maestría están en concordancia con las prioridades del sistema sanitario cubano para lograr un uso racional de los medicamentos; los informes de investigación que resultan como trabajo final de la maestría constituyen una referencia de la investigación en ese campo en Cuba. Se debe incentivar la participación de otros profesionales, el diseño de otros tipos de estudios y la publicación de los resultados.

Abstract Objective: To characterize the research carried out in pharmacoepidemiology based on the master's theses in Pharmacoepidemiology of the National School of Public Health, Havana, Cuba. Materials and method: It was done a descriptive study; 124 theses defended in the four editions of the master's degree were analyzed, between 2010 and 2019. The variables were profession and place of residence of authors, line of research of the master's degree that was addressed, type of study, type of Drug Utilization Research (DUR), pharmacological groups that were investigated and whether the results were published in scientific journals. The results were summarized in percentages. Results: Most of the authors were medicine graduates (50.0%) and 53.2% resided in Havana. The researched lines of most addressed were quality of drug prescription (43.5%) and pharmacovigilance, 30.6%. 72 DUR, prescription-indication type prevailed were identified (27.7%). The analysis of antimicrobials (28.5%) and cardiovascular drugs (29.7%) predominated. Only 22.5% of the investigations were published in scientific journals. Conclusions: The topics of the master's thesis are in accordance with the priorities of the Cuban health system to achieve a rational use of medicines; the research reports that result as the final work of the master's degree constitute a reference of the research in that field in Cuba. The participation of other professionals, the design of other types of studies and the publication of the results should be encouraged.

Utilización de antidepresivos y prescripción fuera de ficha técnica en atención primaria en España (2013-2018) / Antidepressant use and off-label prescribing in primary care in Spain (2013–2018)

Introducción: Estudios recientes muestran un aumento del uso de antidepresivos en menores de 18 años, aunque pocos de ellos cuentan con indicación en este grupo de edad. El objetivo de este estudio es calcular la prevalencia anual del uso de antidepresivos en niños y adolescentes y revisar la adecuación de la prescripción a las indicaciones actuales. Métodos: Estudio de prevalencia de la utilización de antidepresivos en menores de 18 años a partir de los registros de la Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) durante el periodo 2013-2018, considerando al menos una prescripción por año para un mismo paciente. Resultados: La prevalencia de prescripción de antidepresivos entre los pacientes de la cohorte BIFAP ha aumentado de 2013 (7,97 prescripciones/1.000 pacientes) a 2018 (8,87 prescripciones/1.000 pacientes) en la mayoría de los grupos y en ambos sexos. El sexo femenino suma la mayoría de las prescripciones, superando al masculino en hasta 2,5 puntos en las tasas generales. En menores de 13 años la tendencia se invierte y los antidepresivos predominan en los chicos. La prevalencia de las prescripciones aumenta con la edad de los pacientes, igual que la proporción de tratamientos fuera de ficha técnica. El empleo de fármacos sin indicación disminuye con el transcurso del tiempo. Conclusiones: Observamos un aumento gradual en la prevalencia de prescripción de antidepresivos en menores de 18 años, preponderante en el sexo femenino. La elevada proporción de uso de estos fármacos sin indicación autorizada exige profundizar en el balance beneficio-riesgo y en alternativas de tratamiento más seguras. (AU)

Introduction: Recent studies show an increase in the use of antidepressants in minors (younger than 18 years), although few antidepressants are indicated for this age group. The aim of our study was to calculate the annual prevalence of antidepressant use in children and adolescents and to review the adherence of prescription to current indications. Methods: Study of the prevalence of antidepressant use in minors based on the records of the Electronic Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP) of Spain for the 2013–2018 period, considering at least one prescription per year for each patient. Results: The prevalence of antidepressant prescription in patients from the BIFAP cohort increased between 2013 (7.97 prescriptions per 1000 patients) and 2018 (8.87 prescriptions per 1000 patients), in most groups and in both sexes. In this period, female patients received the most prescriptions, surpassing prescriptions in male patients by up to 2.5 points in the overall rates. In patients younger than 13 years, this trend was inverted and antidepressant use was higher in male patients. The prevalence of prescription rose with increasing patient age, as did the proportion of off-label prescriptions. The use of off-label medication decreased over time. Conclusions: There was a gradual increase in the prevalence of antidepressant prescription in minors younger than 18 years, with a predominance of the female sex. The high proportion of unapproved medication use in this age group calls for more thorough investigation of the risk–benefit balance of these treatments and of safer treatment alternatives. (AU)

For what indications are antidepressants being used in adults in Colombia?

INTRODUCTION: Antidepressants are useful in the pharmacological treatment of different depressive and anxiety disorders, as well as being potentially useful in other indications. The aim of the study was to determine the indications for which antidepressants are being prescribed in patients over 18 years of age registered with the Colombian Health System. METHODS: Retrospective study with data from patients over 18 years old, of either sex, registered with the Colombian Health System, who are prescribed antidepressants. Medical records were reviewed, looking for indications approved and not approved by regulatory agencies. Patients were identified randomly, as well as the sociodemographic, clinical and pharmacological variables that could be associated with prescriptions for unapproved indications. RESULTS: 351 patients were evaluated, with a mean age of 60.4 ± 15.3 years, of whom 72.6% were women. They were attended in 34 cities, with prescriptions mainly by general practitioners (n = 276; 78.6%), and psychiatrists (n = 42; 12.0%). Selective serotonin reuptake inhibitors were the most widely prescribed antidepressants (n = 204; 58.1%), followed by atypicals (n = 76; 21.7%). The most frequent indications were for depression (n = 169; 48.1%), anxiety (n = 48; 13.7%), pain (n = 22; 6.3%) and sleep disorders (n = 17; 4.8%). A total of 188 prescriptions (53.6%) were made for approved indications, and the remaining 163 (46.4%) were classified as unapproved. CONCLUSIONS: Antidepressants are being prescribed for the treatment of depression, anxiety, pain and sleep disorders, especially in older adult women, but almost half of the formulations were for unapproved indications.

Antidepressant use and off-label prescribing in primary care in Spain (2013-2018).

INTRODUCTION: Recent studies show an increase in the use of antidepressants in minors (younger than 18 years), although few antidepressants are indicated for this age group. The aim of our study was to calculate the annual prevalence of antidepressant use in children and adolescents and to review the adherence of prescription to current indications. METHODS: Study of the prevalence of antidepressant use in minors based on the records of the Electronic Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP) of Spain for the 2013-2018 period, considering at least one prescription per year for each patient. RESULTS: The prevalence of antidepressant prescription in patients from the BIFAP cohort increased between 2013 (7.97 prescriptions per 1000 patients) and 2018 (8.87 prescriptions per 1000 patients), in most groups and in both sexes. In this period, female patients received the most prescriptions, surpassing prescriptions in male patients by up to 2.5 points in the overall rates. In patients younger than 13 years, this trend was inverted and antidepressant use was higher in male patients. The prevalence of prescription rose with increasing patient age, as did the proportion of off-label prescriptions. The use of off-label medication decreased over time. CONCLUSIONS: There was a gradual increase in the prevalence of antidepressant prescription in minors younger than 18 years, with a predominance of the female sex. The high proportion of unapproved medication use in this age group calls for more thorough investigation of the risk-benefit balance of these treatments and of safer treatment alternatives.

Prevalência de uso de medicamentos em população rural brasileira / Prevalence of medication use in a rural Brazilian population

Resumo Introdução Apesar da vulnerabilidade social existente na população rural brasileira, o uso de medicamentos entre agricultores é um tema ainda pouco estudado no país. Objetivo Analisar o uso de medicamentos e sua associação com características sociodemográficas, laborais, comportamentais e autoavaliação do estado de saúde em agricultores. Método Estudo epidemiológico transversal com 790 agricultores de 18 a 59 anos, de ambos os sexos, do município de Santa Maria de Jetibá. Os medicamentos foram agrupados segundo o Sistema de Classificação Anatômico-Terapêutico-Químico (ATC) nos níveis 1 e 2. Foram realizadas análise descritiva (frequências absolutas e relativas) e associações entre as variáveis e o uso de medicamentos pelo teste de qui-quadrado. As variáveis que se mostraram associadas com o desfecho com nível de significância de 5% no teste de qui-quadrado foram testadas por regressão logística binária. Resultados A prevalência de uso de medicamentos foi de 44,2%, sendo menor no sexo masculino (30,3%) do que no feminino (59,4%). Após a análise ajustada, o uso de medicamentos esteve associado ao sexo feminino, à faixa etária de 40 anos ou mais e à pior autoavaliação do estado de saúde. A prevalência de polifarmácia foi de 6,6%. Os medicamentos mais utilizados foram os anti-hipertensivos (19,3%). Conclusão O estudo evidenciou a importância de se avaliar populações rurais a fim de subsidiar políticas e recursos em saúde pública.

Abstract Background Despite the social vulnerability that exists in the Brazilian rural population, the drug use is a topic still little studied in the country. Objective The present work aims to analyze drug use and its association with sociodemographic, occupational, behavioral, and self-rated health characteristics in farmers. Method A cross-sectional epidemiological study of 790 male and female farmers from 18 to 59 years old, from Santa Maria de Jetibá. The drugs were grouped according to the Anatomical Therapeutic Classification System (ATC) at levels 1 and 2. Descriptive analysis of the data was performed (in absolute and relative frequencies) and associations between study variables and drug use by the chi-square test. The variables that were associated with the outcome with a significance level of 5% in the chi-square test were tested by binary logistic regression. Results The prevalence of drug utilization was 44.2%, being lower in males (30,3%) than in females (59,4%). After adjusted analysis, the drug use was associated with female gender, age 40 years and older and worse self-rated health status. The prevalence of polypharmacy was 6,6%. The most used drugs were antihypertensive (19,3%). Conclusion The study showed the importance of evaluating rural populations to subsidize policies and resources in Public Health.

A vigilancia farmacológica no cenário brasileiro do sáculo 21 / Pharmacological surveillance in the Brazilian scenario of the 21st century / La vigilancia farmacológica en el escenario brasileño del siglo XXI

Resumo Os estudos em vigilancia farmacológica e ecofarmacológicas possibilitam o monitoramento, identificagao e minimi-zagao de efeitos nocivos advindos do uso de medicamentos. Diante disso, o presente estudo teve como objetivo descrever o cenário atual da farmacoepidemiologia e ecofarmacovigilancia no Brasil, no que se refere a produgao, registro, comerciali-zagao e uso de medicamentos. Foi realizado um levantamento sistemático, através dos bancos de dados PubMed/Medline, Lilacs e SciELO, cuja temática envolveu pesquisas em farmacoeconomia, farmacovigilancia, ecofarmacovigilancia e estudo da utilizagao de medicamentos no Brasil de 2001 a 2019. As publicagóes distribuíram-se de forma desigual entre as regióes brasileiras. Pacientes hipertensos, oncológicos e as gestantes foram os grupos de risco mais citados e os antimicrobianos, psicotrópicos e antineoplásicos os grupos farmacológicos mais discutidos. Custo de cuidados em saúde foi a temática mais abordada no contexto da farmacoeconomia e grande parte dos trabalhos destinou-se a análise e obtengao de dados referentes ao uso de medicamentos e suas reagóes adversas. Em relagao a ecofarmacovigilancia nao foram encontradas publicagóes no Brasil que contemplem essa área. Apesar dos avangos da legislagao farmacoepidemiológica e melhorias nos processos de fiscalizagao, no que tange a vigilancia da produgao, registro, comercializagao e uso de medicamentos, ainda permanecem carencias, quanto ao aporte de uma visao científica direcionada, sobretudo ao gerenciamento e diferentes usos dos recursos terapéuticos, e económicos do sistema de saúde brasileiro, bem como uma visao ambiental referente ao uso de medicamentos.

Abstract Studies in pharmacological and ecopharmacological surveillance make it possible to monitor, identify and minimize harmful effects arising from the use of drugs. Therefore, the present study aimed to describe the current scenario of pharmacoepidemiology and ecopharmacovigilance in Brazil, about the production, registration, marketing, and use of medicines. A systematic survey was carried out through the PubMed/Medline, Lilacs, and SciELO databases, whose theme involved research in pharmacoeconomics, pharmacovigilance, ecopharmacovigilance, and the study of drug use in Brazil from 2001 to 2019. Publications were unevenly distributed between Brazilian regions. Hypertensive patients, cancer patients, and pregnant women were the most cited risk groups, and antimicrobials, psychotropics, and antineoplastics were the most discussed pharmacological groups. Cost of health care was the most discussed topic in the context of pharmacoeconomics and most of the work was aimed at analyzing and obtaining data regarding the use of drugs and their adverse reactions. Regarding ecopharmacovigilance, no publications were found in Brazil covering this area. Despite advances in pharmacoepidemiological legislation and improvements in inspection processes, regarding the surveillance of the production, registration, commercialization, and use of medicines, there are still gaps regarding the contribution of a directed scientific vision, especially to the management and different uses of resources. therapeutic and economic aspects of the Brazilian health system, as well as an environmental vision regarding the use of medicines.

Resumen Los estudios de vigilancia farmacológica y ecofarmacológica permiten controlar, identificar y minimizar los efectos nocivos derivados del uso de los medicamentos. Ante esto, el presente estudio tuvo como objetivo describir el escenario actual de la farmacoepidemiología y la ecofarmacovigilancia en Brasil, en relación con la producción, el registro, la comercialización y el uso de los medicamentos. Se realizó una encuesta sistemática, a través de las bases de datos PubMed/Medline, Lilacs y SciELO, cuya temática involucró investigaciones sobre farmacoepidemiología, farmacovigilancia, ecofarmacovigilancia y estudio del uso de medicamentos en Brasil desde 2001 hasta 2019. Las publicaciones se distribuyeron de forma desigual entre las regiones brasileñas. Los pacientes hipertensos, los pacientes oncológicos y las mujeres embarazadas fueron los grupos de riesgo más citados y los antimicrobianos, los psicotrópicos y los antineoplásicos fueron los grupos farmacológicos más discutidos. El coste de la asistencia sanitaria fue el tema más abordado en el contexto de la farmacoeconomía y la mayoría de los trabajos estaban dirigidos a analizar y obtener datos sobre el uso de los medicamentos y sus reacciones adversas. En cuanto a la ecofarmacovigilancia, no se encontraron publicaciones en Brasil que aborden esta área. A pesar de los avances en la legislación farmacoepidemiológica y de las mejoras en los procesos de inspección, en lo que respecta a la vigilancia de la producción, registro, comercialización y uso de los medicamentos, todavía falta una visión científica dirigida, sobre todo, a la gestión y a los diferentes usos de los recursos terapéuticos y económicos del sistema de salud brasileño, así como una visión ambiental en cuanto al uso de los medicamentos.

Para qué indicaciones se están utilizando los antidepresivos en adultos de Colombia / For What Indications are Antidepressants Being Used in Adults in Colombia?

RESUMEN Introducción: Los antidepresivos son útiles en el tratamiento farmacológico de diferentes trastornos depresivos y de ansiedad, además de su potencial utilidad para otras indicaciones. El objetivo del estudio es determinar las indicaciones para las que se están prescribiendo los antidepresivos a pacientes mayores de 18 años afiliados al Sistema de Salud de Colombia. Métodos: Estudio retrospectivo con datos de pacientes mayores de 18 años, de cualquier sexo, afiliados al Sistema de Salud de Colombia, a los que se prescriben antidepresivos; se revisaron las historias clínicas buscando indicaciones aprobadas y no aprobadas por agencias reguladoras. Se identificó a los pacientes aleatoriamente, así como las variables sociodemográficas, clínicas y farmacológicas que se pudieran asociar con prescripciones para indicaciones no aprobadas. Resultados: Se evaluó a 351 pacientes, con una media de edad de 60,4 ± 15,3 años; el 72,6% eran mujeres; se atendieron en 34 ciudades, y los prescriptores principalmente fueron médico general (n = 276; 78,6%) y psiquiatra (n = 42; 12,0%). Los inhibidores selectivos de la recaptación de serotonina fueron los antidepresivos más prescritos (n = 204; 58,1%), seguidos de los atípicos (n = 76; 21,7%). Las indicaciones más frecuentes fueron depresión (n = 169; 48,1%), ansiedad (n = 48; 13,7%), dolor (n = 22; 6,3%) y trastornos del sueño (n = 17; 4,8%). Un total de 188 prescripciones (53,6%) se hicieron para indicaciones aprobadas y las 163 (46,4%) restantes se catalogaron como no aprobadas. Conclusiones: Los antidepresivos se están prescribiendo para tratar depresión, ansiedad, analgesia y trastornos del sueño, especialmente a mujeres adultas mayores, pero casi la mitad de las formulaciones fueron para indicaciones no aprobadas.

ABSTRACT Introduction: Antidepressants are useful in the pharmacological treatment of different depressive and anxiety disorders, as well as being potentially useful in other indications. The aim of the study was to determine the indications for which antidepressants are being prescribed in patients over 18 years of age registered with the Colombian Health System. Methods: Retrospective study with data from patients over 18 years old, of either sex, registered with the Colombian Health System, who are prescribed antidepressants. Medical records were reviewed, looking for indications approved and not approved by regulatory agencies. Patients were identified randomly, as well as the sociodemographic, clinical and pharmacological variables that could be associated with prescriptions for unapproved indications. Results: 351 patients were evaluated, with a mean age of 60.4 ± 15.3 years, of whom 72.6% were women. They were attended in 34 cities, with prescriptions mainly by general practitioners (n = 276; 78.6%), and psychiatrists (n = 42; 12.0%). Selective serotonin reuptake inhibitors were the most widely prescribed antidepressants (n = 204; 58.1%), followed by atypicals (n = 76; 21.7%). The most frequent indications were for depression (n = 169; 48.1%), anxiety (n = 48; 13.7%), pain (n = 22; 6.3%) and sleep disorders (n = 17; 4.8%). A total of 188 prescriptions (53.6%) were made for approved indications, and the remaining 163 (46.4%) were classified as unapproved. Conclusions: Antidepressants are being prescribed for the treatment of depression, anxiety, pain and sleep disorders, especially in older adult women, but almost half of the formulations were for unapproved indications.