Fatores associados ao controle glicêmico e seu impacto em idosos com diabetes, dados do Estudo SABE (Saúde, Bem-Estar e Envelhecimento) / Factors associated with glycemic control and their impact on older people with diabetes, data from the SABE Study (Health, Well-Being, and Aging)

O rápido envelhecimento populacional observado no Brasil marca a transição demográfica e epidemiológica devido à baixa mortalidade e à alta prevalência de doenças crônicas não transmissíveis, como o diabetes mellitus tipo 2 (DM2). O DM2 é uma doença metabólica caracterizada por elevados níveis de açúcar no sangue e alta morbidade em idosos, associada ao risco cardiovascular. O controle dos níveis glicêmicos é essencial para prevenir complicações agudas e crônicas, evitando prejuízos à capacidade funcional, autonomia e qualidade de vida do indivíduo. As recomendações para o controle glicêmico no DM2 envolvem ações não farmacológicas, como mudanças no estilo de vida (dieta, perda de peso e atividade física regular), e terapia medicamentosa. Os idosos são os maiores consumidores de medicamentos no país, e a polifarmácia, combinada com as mudanças fisiológicas típicas do envelhecimento, torna essa parte da população mais suscetível a problemas relacionados aos medicamentos, que podem afetar o sucesso da terapêutica. Nos últimos anos, estudos em farmacogenômica, uma área que explora a variação interindividual da resposta a medicamentos, demonstraram a associação de variantes em genes com o metabolismo de medicamentos, evidenciando interações farmacogenéticas em diversas classes de antidiabéticos orais. Este estudo buscou compreender os diferentes fatores que influenciam o controle glicêmico em idosos com diabetes referida, residentes no município de São Paulo, participantes do Estudo Saúde, Bem-estar e Envelhecimento (SABE), no período de 2010 a 2015. Foram delineados três artigos que analisaram as características socioeconômicas, aspectos de saúde, estilo de vida e aqueles relacionados ao DM2, como manejo da hiperglicemia e a variabilidade genética na resposta a medicamentos e o controle glicêmico, e seu impacto no desenvolvimento de complicações decorrentes do DM2. O artigo 1 descreve os perfis farmacoepidemiológico e farmacogenético dos idosos. O segundo artigo avalia os fatores associados ao controle glicêmico inadequado, enquanto o artigo 3 estima o risco de desenvolvimento de complicações em 5 anos. A metformina, antidiabético oral da classe das biguanidas e primeira escolha para o tratamento do DM2, foi o medicamento mais utilizado pelos idosos da amostra (61,3%), em monoterapia (35,2%), em mais da metade das associações de 2 AD e em todos os esquemas com 3 AD. Das variantes genéticas associadas à eficácia do tratamento com metformina estudadas, portadores do genótipo TT da variante rs2252281 (SLC47A1) apresentaram maior chance de controle glicêmico inadequado (OR = 4,19 IC 1,22; 14,36). Esse fenômeno foi observado em 32,1% dos idosos e estava associado à utilização de dois ou três antidiabéticos (OR = 2,89 IC 95% 1,47; 5,67), ao tempo de duração do DM2 (OR = 1,46 IC 95% 0,68; 3,12) e à presença de doença cardíaca (OR = 2,02 IC 95% 1,02; 4,01). Problemas nos olhos (RR= 2,13 IC 95% 1,24; 3,66), retinopatia diabética (RR = 3,18 IC 95% 1,05; 9,61) e episódios agudos de hipoglicemia (RR = 2,28 IC 95% 1,49; 3,49) e hiperglicemia (RR = 2,78 IC 95% 1,65; 4,68) tiveram risco aumentado em idosos com controle glicêmico inadequado. Estes resultados reforçam a necessidade de uma abordagem abrangente e individualizada para o manejo da hiperglicemia nos idosos. O controle glicêmico nesta parcela da população é desafiador, e suas implicações no desenvolvimento de complicações do DM2 destacam a importância de manter os níveis de glicose no sangue dentro de faixas saudáveis. A pactuação de metas glicêmicas menos rígidas pode evitar situações adversas, como a hipoglicemia, e a adoção de esquemas terapêuticos menos complexos pode contribuir significativamente para melhora na adesão.

The rapid aging of the population observed in Brazil marks the demographic and epidemiological transition due to low mortality and a high prevalence of noncommunicable chronic diseases, such as type 2 diabetes mellitus (TDM2). TDM2 is a metabolic disease characterized by elevated blood sugar levels and high morbidity in the elderly, associated with cardiovascular risk. Controlling glycemic levels is essential to prevent acute and chronic complications, avoiding impairments to functional capacity, autonomy, and quality of life. Recommendations for glycemic control in TDM2 involve non-pharmacological actions, such as lifestyle changes (diet, weight loss, and regular physical activity), and drug therapy. Elderly individuals are the largest consumers of medications in the country, and polypharmacy, combined with the physiological changes typical of aging, makes this population more susceptible to medication-related problems that can affect the success of therapy. In recent years, studies in pharmacogenomics, an area that explores interindividual variation in drug response, have demonstrated the association of genetic variants with drug metabolism, highlighting pharmacogenetic interactions in various classes of oral antidiabetics. This study aimed to understand the different factors influencing glycemic control in elderly individuals with reported diabetes living in São Paulo city, participants in the Health, Well-being, and Aging Study (SABE) from 2010 to 2015. Three articles were outlined, analyzing socioeconomic characteristics, health aspects, lifestyle, and those related to TDM2, such as hyperglycemia management and genetic variability in drug response and glycemic control, and its impact on the development of complications from TDM2. Article 1 describes the pharmacoepidemiological and pharmacogenetic profiles of the elderly. The second article evaluates factors associated with inadequate glycemic control, while the third article estimates the risk of developing complications over 5 years. Metformin, an oral antidiabetic of the biguanide class and the first choice for TDM2 treatment, was the most used medication by the elderly in the sample (61.3%), either in monotherapy (35.2%) or in more than half of the combinations of 2 antidiabetic drugs and all regimens with 3 drugs. Among the studied genetic variants associated with metformin treatment effectiveness, carriers of the TT genotype of the rs2252281 variant (SLC47A1) had a higher chance of poor glycemic control (OR = 4.19 CI 1.22; 14.36). Poor glycemic control was observed in 32.1% of the elderly and was associated with the use of two or three antidiabetics (OR = 2.89 CI 95% 1.47; 5.67), the duration of TDM2 (OR = 1.46 CI 95% 0.68; 3.12), and the presence of heart disease (OR = 2.02 CI 95% 1.02; 4.01). Problems with eyes (RR = 2.13 CI 95% 1.24; 3.66), diabetic retinopathy (RR = 3.18 CI 95% 1.05; 9.61), and acute episodes of hypoglycemia (RR = 2.28 CI 95% 1.49; 3.49) and hyperglycemia (RR = 2.78 CI 95% 1.65; 4.68) had an increased risk in elderly individuals with poor glycemic control. These results emphasize the need for a comprehensive and individualized approach to hyperglycemia management in the elderly. Glycemic control in this population segment is challenging, and its implications for the development of DM2 complications underscore the importance of maintaining blood glucose levels within healthy ranges. Agreeing on less stringent glycemic targets can prevent adverse situations such as hypoglycemia, and the adoption of less complex therapeutic regimens can significantly contribute to improved adherence.

Iron salt supplementation during gestation and gestational diabetes mellitus

ABSTRACT OBJETIVE To evaluate the association between the use of iron salts during the first two trimesters of gestation in non-anemic women and the development of gestational diabetes mellitus. METHODS The study used maternal data from the 2015 Pelotas Birth Cohort. All non-anemic women at the 24th week of gestation (n = 2,463) were eligible for this study. Gestational diabetes mellitus was self-reported by women. Crude and adjusted logistic regression were performed considering level of significance = 0.05. RESULTS Among the women studied, 69.7% were exposed to prophylactic iron supplementation in the first two trimesters of gestation. The prevalence of gestational diabetes mellitus among those exposed was 8.7% (95%CI: 7.4-10.1) and 9.3% (95%CI: 7.4-11.6) among those who were not exposed. Iron supplementation was not associated with increased risk of gestational diabetes mellitus in crude (OR = 0.9; 95%CI: 0,7-1,3) and adjusted analysis (OR = 1.1; 95%CI :0,8-1,6). CONCLUSIONS The results suggest that routine iron use in non-anemic pregnant women does not increase the risk of developing gestational diabetes. This evidence supports the existing national and international guidelines, in which prophylactic iron supplementation is recommended for all pregnant women as soon as they initiate antenatal care in order to prevent iron deficiency anemia.

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.

High-risk pregnancy: characterization of medication use profile and association with clinical and sociodemographic factors / Gestação de alto risco: caracterização do perfil de utilização de medicamentos e associação com fatores clínicos e sociodemográficos

Abstract Objectives: describe the profile of medication use and adherence, and the association with clinical and sociodemographic characteristics of high-risk pregnant women attended at a university hospital. Methods: cross-sectional study with data collected through a questionnaire applied on 386 pregnant women. Results: most participants were seen only by the gynecologist (75.1%), started prenatal in the first gestational trimester (86.8%), did not plan the pregnancy (61.9%), and performed an average of 8.2 (SD=4.4) prenatal consultations. The most frequent diagnoses were arterial hypertension (20.5%) and diabetes mellitus (19.7%). Prevalence of medication use was 99.7%, with an average of 5.1 (SD=2.1) medication per woman and 12.7% self-medication. Antianemics (88.9%) and analgesics (63.2%) were the most prevalent classes and 17.9% of the women reported the use of medication with significant gestational risk. Only 36.5% were considered adherent, 32.9% declared they were unaware of the indication of the medication in use and 42% did not receive guidance on the use of the medication during pregnancy. There is no evidence of association between the number of the medication used and clinical and sociodemographic aspects. Conclusions: there is a need to develop strategies to improve the care of this population, with emphasis on strengthening multi-professional care.

Resumo Objetivos: descrever o perfil de utilização de medicamentos e de adesão, e a associação com as características clínicas e sociodemográficas de gestantes de alto risco atendidas em um hospital universitário. Métodos: trata-se de um estudo transversal com dados coletados mediante um questionário estruturado aplicado à 386 gestantes. Resultados: a maior parte das participantes era acompanhada apenas pelo ginecologista (75,1%), iniciou o pré-natal no primeiro trimestre gestacional (86,8%), não planejou a gravidez (61,9%) e realizou em média 8,2 (DP=4,4) consultas de pré-natal. Os diagnósticos mais frequentes foram hipertensão arterial (20,5%) e diabetes mellitus (19,7%). A prevalência de uso de medicamentos foi 99,7%, com média de 5,1 (DP=2,1) medicamentos por mulher e 12,7% de automedicação. Os antianêmicos (88,9%) e analgésicos (63,2%) foram as classes farmacológicas mais prevalentes e 17,9% das gestantes referiram uso de fármacos com risco gestacional relevante. Apenas 36,5% das gestantes foram consideradas aderentes ao tratamento, 32,9% declararam desconhecer a indicação dos medicamentos em uso e 42% não receberam orientações sobre o uso de medicamentos durante a gestação. Não há evidências de associação entre o número de medicamentos utilizados e os aspectos clínicos e sociodemográficos. Conclusão: é necessário desenvolver estratégias para melhorar o atendimento desta população e o uso racional de medicamentos, com ênfase no fortalecimento do cuidado multiprofssional.

Indicación y prescripción de macrólidos en una población colombiana / Study of the indications for macrolide prescriptions in a Colombian population

Introducción. El uso inadecuado de antibióticos se asocia con aumento de la resistencia antimicrobiana, mayores costos de atención médica, más efectos adversos y peores resultados clínicos. Objetivo. Determinar los patrones de prescripción y las indicaciones aprobadas y no aprobadas para macrólidos en un grupo de pacientes en Colombia. Materiales y métodos. Se hizo un estudio de corte transversal sobre las indicaciones de uso de macrólidos en pacientes ambulatorios a partir de una base de datos de dispensación de medicamentos de 8,5 millones, aproximadamente, de personas afiliadas al sistema de salud de Colombia. Se consideraron variables sociodemográficas, farmacológicas y clínicas. Resultados. Se encontraron 9.344 pacientes que habían recibido prescripción de macrólidos; su mediana de edad era de 40,1 años (rango intercuartílico: 27,1-53,3 años) y el 58,3 % correspondía a mujeres. El macrólido más prescrito fue la azitromicina (38,8 %) y los usos más frecuentes fueron el tratamiento de la infección por Helicobacter pylori (15,9 %) y la neumonía (15,8 %). El 31,3 % de las prescripciones correspondía a indicaciones no aprobadas, destacándose el resfriado común (7,8 %), la Covid-19 (4,0 %) y la bronquitis aguda (3,5 %). La residencia en la región Caribe (OR=1,17; IC95% 1,05-1,31), las prescripciones odontológicas (OR=2,75; IC95% 1,91-3,96), las comorbilidades respiratorias crónicas (OR=1,30; IC95% 1,08-1,56), y la prescripción de eritromicina (OR=3,66; IC95% 3,24-4,14) o azitromicina (OR=2,15; IC95% 1,92 2,41), se asociaron con una mayor probabilidad de recibir macrólidos para indicaciones no aprobadas, en tanto que tener entre 18 y 64 años (OR=0,81; IC95% 0,71-0,93), 65 o más años (OR=0,77; IC95% 0,63-0,94) y residir en Bogotá-Cundinamarca (OR=0,74; IC95% 0,65 0,85) reducían dicho riesgo. Conclusiones. La mayoría de los pacientes recibieron macrólidos para infecciones del sistema respiratorio; la eritromicina y la azitromicina se prescribieron en indicaciones no aprobadas en menores de 18 años y en quienes presentaban enfermedades respiratorias crónicas.

Introduction: The inappropriate use of antibiotics is associated with a greater risk for antimicrobial resistance, high health care costs, adverse events, and worse clinical outcomes. Objective: To determine the prescription patterns and approved and nonapproved indications for macrolides in a group of patients from Colombia. Materials and methods: This was a cross-sectional study on the indications for the use of macrolides in outpatients registered in a drug-dispensing database of approximately 8.5 million people affiliated with the Colombian health system. Sociodemographic, pharmacological, and clinical variables were considered. Results: A total of 9.344 patients had received a macrolide prescription; their median age was 40.1 years (interquartile range: 27.1-53.3 years) and 58.3% were women. The most commonly prescribed macrolide was azithromycin (38.8%) most frequently for Helicobacter pylori infection (15.9%) and pneumonia treatment (15.8%). A total of 31.3% of the prescriptions were used for unapproved indications: common cold (7.8%), COVID-19 (4.0%), and acute bronchitis (3.5%). Residence in the Caribbean region (OR=1.17; 95%CI 1.05-1.31), dental prescriptions (OR=2.75; 95%CI 1.91-3.96), presence of chronic respiratory comorbidities (OR=1.30; 95%CI 1.08-1.56), and prescription of erythromycin (OR=3.66; 95%CI 3.24-4.14) or azithromycin (OR=2.15; 95%CI 1,92-2.41) were associated with a higher probability of macrolide use for unapproved indications while being 18-64 years old (OR=0.81; 95%CI 0.71-0.93) or 65 years or older (OR=0.77; 95%CI 0.63-0.94) and residing in Bogotá-Cundinamarca (OR=0.74; 95%CI 0.65-0.85) were associated with reduced risk. Conclusions: Most patients received macrolides for respiratory tract infections; erythromycin and azithromycin were used for unapproved indications in people under 18 years of age and those with chronic respiratory diseases.

Competencias profesionales del farmacólogo en farmacoepidemiología / The pharmacologist's professional competences in pharmacoepidemiology

Introducción: Los retos y las exigencias del mundo contemporáneo requieren de profesionales de la salud con una formación académica basada en competencias. La especialidad de Farmacología en Cuba no ha definido sus competencias profesionales. Objetivo: Definir las competencias profesionales de los especialistas en Farmacología para su desempeño como farmacoepidemiólogos. Métodos: Estudio de desarrollo en el que se obtuvieron las competencias profesionales genéricas y específicas que los especialistas en Farmacología debían alcanzar para desempeñarse como farmacoepidemiólogos. El trabajo se realizó en La Habana entre marzo de 2018 y febrero de 2019. Se aplicaron técnicas cualitativas y revisiones documentales sobre las temáticas relacionadas con el objeto de la investigación. Se trabajó con dos grupos de expertos en dos etapas. Se empleó la metodología Delphi. Resultados: Se construyeron 24 competencias, genéricas y específicas, de las áreas funcionales asistencial, investigativa, docente y gerencial, que los especialistas en Farmacología debían alcanzar para desempeñarse como farmacoepidemiólogos. Conclusiones: Las competencias definidas permiten al farmacoepidemiólogo lograr un uso racional de los medicamentos, lo cual tributa a su propósito clave: una atención de calidad durante el proceso salud-enfermedad(AU)

Introduction: The challenges and demands of the contemporary world require health professionals with competency-based academic training. The specialty of pharmacology in Cuba has not defined its professional competencies. Objective: To define the professional competences of pharmacology specialists for their performance as pharmacoepidemiologists. Methods: Development study that allowed obtaining the generic and specific professional competences that pharmacology specialists should reach to practice as pharmacoepidemiologists. The work was carried out in Havana between March 2018 and February 2019. Qualitative techniques were applied, together with documental reviews on the topics related to the research object. Two groups of experts participated in the work during two stages. The Delphi methodology was used. Results: Twenty-four competencies, either generic or specific, were determined, belonging to the functional areas of care, research, teaching and management, which pharmacology specialists should achieve to practice as pharmacoepidemiologists. Conclusions: The competencies defined allow the pharmacoepidemiologist to achieve a rational use of drugs, which contributes to the key purpose of the specialized profession: quality care during the health-disease process(AU)

Sociodemographic and pharmacoepidemiological profile of people on antiretroviral therapy in the coast of the state of Paraná

The aim of this study was to investigate possible factors related to antiretroviral therapy (ART) that contribute to the understanding of the highest rate of Aids detection on the coast of the state of Paraná, a port region identified administratively as the 1stRegional Health Division (1stHD) in the state of Paraná. Data on the sociodemographic profile of the population undergoing antiretroviral treatment (ART), medication changes, dropout of therapy, proportion of the population undergoing treatment and viral load were obtained through computerized systems. Between July 1, 2018 and June 31, 2019, 1,393 people were on ART in the 1stRS. Of these, 57.6% were male. During this period, 110 people started ART with a predominance of the age group between 30 and 39 years old. ART was switched for169 people and 211 patient dropouts were detected. The proportion of people diagnosed with HIV without treatment (gap) is still high, however 92.7% people on ART have suppressed viral load. It can be concluded that the lower educational level of the population undergoing treatment, the late diagnosis of those infected and the treatment gapprobably contribute to the highest rate of Aids detection in the 1stRS.

Free acquisition of psychotropic drugs by the Brazilian adult population and presence on the National List of Essential Medicines

Abstract The aims of the present study were to estimate the free-of-charge acquisition of psychotropic drugs among Brazilian adults; analyze the distribution of psychotropics according to their presence on the Relação Nacional de Medicamentos Essenciais (RENAME [National List of Essential Medicines]) and acquisition according to the source of funding (free of charge or direct payment); and estimate the proportion of free-of-charge psychotropic drugs according to therapeutic class and presence on the RENAME. This study involved the analysis of data from the 2014 National Survey on the Accessibility, Use and Promotion of the Rational Use of Medicines considering psychotropic drugs used by the adult population (≥20 years; n = 32,348). The prevalence of the acquisition of free-of-charge psychotropic drugs was 53.3% and 64.6% of these drugs were on the RENAME. Among the psychotropic drugs acquired by direct payment, 70.8% were not on the national list. Regarding free-of-charge acquisition according to the therapeutic class and presence on the RENAME, differences were found for antidepressants, anxiolytics and antipsychotics (p <0.05). In conclusion, the most used psychotropic medicines were listed in the RENAME, but free-of-charge acquisition was not provided for all of them

Prevalência e fatores associados à polifarmácia e potenciais interações medicamentosas em adultos na cidade de Manaus: estudo transversal de base populacional, 2019 / Prevalencia y factores asociados a la polifarmacia y posibles interacciones farmacológicas en adultos en la ciudad de Manaus, Amazonas, Brasil: estudio transversal poblacional, 2019 / Prevalence and factors associated with polypharmacy and potential drug interactions in adults in Manaus, Amazonas state, Brazil: a cross-sectional population-based study, 2019

Objetivo: Analisar a prevalência e fatores associados à polifarmácia e a presença de potenciais interações medicamentosas em Manaus, estado do Amazonas, Brasil, em 2019. Métodos: Estudo transversal de base populacional, com adultos de ≥ 18 anos. Entre pessoas em polifarmácia (≥ 5 medicamentos), pesquisou-se a presença de interações medicamentosas na base Micromedex. Razões de prevalências (RP) com intervalos de confiança de 95% (IC95%) foram calculadas por regressão de Poisson com variância robusta, seguindo análise hierárquica e considerando o delineamento amostral complexo. Resultados: Dos 2.321 participantes, 2,8% (IC95% 2,1;3,6) estavam em polifarmácia e, destes, 74,0% apresentaram interações, sendo mais frequentes quatro ou mais interações por pessoa (40,4%) e gravidade alta (59,5%). Polifarmácia foi maior entre idosos (RP = 3,24; IC95% 1,25;8,42), pessoas com saúde ruim (RP = 2,54; IC95% 1,14;5,67), hospitalização prévia (RP = 1,90; IC95% 1,09;3,32) e multimorbidade (RP = 3,20; IC95% 1,53;6,67). Conclusão: A polifarmácia foi mais frequente entre idosos e pessoas com problemas de saúde, que tiveram mais interações medicamentosas.

Objetivo: Analizar la prevalencia y factores asociados a la polifarmacia y la presencia de posibles interacciones farmacológicas en Manaus, estado de Amazonas, Brasil, en 2019. Métodos: Estudio poblacional transversal realizado con adultos con edad ≥ 18 años. Entre personas en polifarmacia (≥ 5 medicamentos), se investigó la presencia de interacciones farmacológicas en Micromedex. Las razones de prevalencia (RP) con intervalos de confianza de 95% (IC95%) se calcularon mediante la regresión de Poisson con varianza robusta, siguiendo análisis jerárquico y considerando el diseño de muestra complejo. Resultados: De los 2.321 participantes, 2,8% (IC95% 2,1;3,6) se encontraban en polifarmacia, de los cuales 74,0% presentaban interacciones, siendo más frecuentes cuatro o más interacciones por persona (40,4%) y de alta gravedad (59,5%). La polifarmacia fue mayor entre los ancianos (RP = 3,24; IC95% 1,25;8,42), personas con mala salud (RP = 2,54; IC95% 1,14;5,67), hospitalización previa (RP = 1,90; IC95% 1,09;3,32) y multimorbilidade (RP = 3,20; IC95% 1,53;6,67). Conclusión: La polifarmacia fue más frecuente entre los ancianos y personas con problemas de salud, que potencialmente tenían más interacciones farmacológicas.

Objective: To assess the prevalence and factors associated with polypharmacy and the presence of potential drug interactions in Manaus, Amazonas state, Brazil, in 2019. Methods: This was a population-based cross-sectional study conducted with adults aged ≥ 18 years. The presence of drug interactions among people on a polypharmacy regimen (≥ 5 drugs) was investigated on the Micromedex database. Prevalence ratios (PR) with 95% confidence intervals (95%CI) were calculated using Poisson regression model with robust variance, following hierarchical analysis and considering the complex sample design. Results: Of the 2,321 participants, 2.8% (95%CI 2.1;3.6) were on polypharmacy regimen, of whom, 74.0% presented drug interactions, usually with four or more drug interactions per person (40.4%) and high severity (59.5%). Polypharmacy was higher among older adults (PR = 3.24; 95%CI 1.25;8.42), people with poor health (PR = 2.54; 95%CI 1.14;5.67), previous hospitalization (PR = 1.90; 95%CI 1.09;3.32) and multimorbidity (PR = 3.20; 95%CI 1.53;6.67). Conclusion: Polypharmacy was more frequent among older adults and people with medical problems, who presented more drug interactions.

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

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

Automedicação entre estudantes de graduação do interior do Amazonas / Automedicación entre estudiantes universitarios del interior del estado de Amazonas / Self-medication among undergraduate students from the countryside of Amazonas

Resumo Objetivo Estimar a prevalência e fatores associados à automedicação entre estudantes de cursos de graduação do interior do Amazonas. Métodos Estudo transversal com 694 estudantes de uma universidade pública do interior do Amazonas, entre março a julho de 2018. Definiu-se automedicação como uso de, no mínimo, um medicamento sem prescrição. Estimaram-se Odds Ratio (OR) e Intervalos de Confiança de 95% (IC 95%) pela Regressão Logística. Resultados Dos 694 graduandos, 483 indicaram consumo medicamentoso. Destes, 80,1% referiram automedicação. Os analgésicos foram os mais utilizados (51,8%) e os motivos que mais levaram a se automedicarem foram os problemas álgicos (54,3%). As variáveis "ter filhos" (OR: 1,83; IC 95%: 1,06-3,16) e "ter a prática de indicar medicamentos para terceiros" (OR: 2,38; IC 95%: 1,47-3,86) permaneceram independentemente associadas à automedicação. Conclusão Observou-se alta prevalência da automedicação entre os estudantes, evidenciando a necessidade de discussão sobre o uso racional de medicamentos no ambiente universitário.

Resumen Objetivo Estimar la prevalencia y factores asociados con la automedicación entre estudiantes de cursos universitarios del interior del estado de Amazonas. Métodos Estudio transversal con 694 estudiantes de una universidad pública del interior del estado de Amazonas, entre marzo a julio de 2018. Se definió la automedicación como el uso de, como mínimo, un medicamento sin prescripción. Se estimaron Odds Ratio (OR) e Intervalos de Confianza del 95 % (IC 95 %) por Regresión Logística. Resultados De los 694 estudiantes universitarios, 483 indicaron un consumo medicamentoso. De estos, 80,1 % mencionaron automedicación. Los analgésicos fueron los más utilizados (51,8 %) y los motivos que más llevaron a la automedicación fueron los problemas álgicos (54,3 %). Las variables "tener hijos" (OR: 1,83; IC 95 %: 1,06-3,16) y "tener la práctica de indicar medicamentos a terceros" (OR: 2,38; IC 95 %: 1,47-3,86) permanecieron independientemente asociadas a la automedicación. Conclusión Se observó alta prevalencia de automedicación entre los estudiantes, evidenciando la necesidad de discusión sobre el uso racional de medicamentos en el ambiente universitario.

Abstract Objective To estimate the prevalence and factors associated with self-medication among undergraduate students in the countryside of Amazonas. Methods Cross-sectional study with a total of 694 students from a public university in the countryside of Amazonas, between March and July 2018. Self-medication was defined as the use of at least one medication without a prescription. Odds Ratio (OR) and 95% Confidence Intervals (95% CI) were estimated by Logistic Regression. Results Of the 694 undergraduate students, 483 indicated drug use. Of these, 80.1% reported self-medication. Analgesics were the most used (51.8%) and the reasons that most led to self-medicating were pain problems (54.3%). The variables "having children" (OR: 1.83; 95% CI: 1.06-3.16) and "having the practice of recommending medication to other people" (OR: 2.38; 95% CI: 1.47 -3.86) remained independently associated with self-medication. Conclusion There was a high prevalence of self-medication among students, highlighting the need for discussion about the rational use of medication in the university environment.

Profile of pharmaceutical interventions of a pharmacotherapeutic follow-up model for diabetic patients in a community pharmacy

Abstract The insertion of Pharmaceutical Care in Primary Health Care (PHC) improves patients' clinical outcomes and quality of life. Pharmacotherapeutic follow-up can contribute to the management of chronic diseases such as diabetes, promoting better glycemic control and adherence to therapy. This study aimed to assess the Drug-therapy Problems (DTPs) and Pharmacist Interventions (PIs) on the pharmacotherapeutic management in patients with type 2 diabetes mellitus (T2DM) in a community pharmacy. A quantitative, retrospective, and cross-sectional study was conducted in a Pharmaceutical Care Program within the PHC in Juiz de Fora (Minas Gerais, Brazil). Inclusion criteria were patients with T2DM above 18, who attended at least three pharmaceutical consultations between July 2016 and October 2018 and presented two or more glycated hemoglobin tests. The study group (n = 17) was largely composed of women (65%), elderly (76%), sedentary (72%), and obese people (52%). The resolution was achieved in 79% of the DTPs identified (n = 115). Most of DTPs were related to administration and adherence to pharmacotherapy (46%). 60% of the 437 PIs involved the provision of information and counseling. In other words, accessible interventions lead to high resolvability. Therefore, clinical actuation of pharmacists could improve the prognosis in diabetes treatment

Psychoactive drugs in the Brazilian public health system: Use profile and associated factors

Abstract The purpose of this study is to estimate the prevalence of and characterize the use of psychoactive drugs among drug users in a Brazilian municipality, relating the findings to factors associated with the consumption of these substances. Through a cross-sectional design, 1,355 drug users from the public health systems community pharmacies were interviewed. Sociodemographic and health-related data were collected, as well as any other prescribed drugs. The prevalence of psychoactive drug use within the last month was 31.0%, with antidepressants and benzodiazepines being the most prescribed (53.5% and 24.6% respectively). Most psychoactive drug users were female (81.9%), lived with a partner (52.6%), had private health insurance (69.2%) and a monthly per-capita income up to one minimum wage (54.0%). The adjusted Odds Ratio (OR) confirmed the following factors to be positively associated with the use of psychoactive drugs: female gender (OR=2.06; 95% CI 1.44; 2.95), age ≥60 years old (OR=1.77; 95% CI 1.26; 2.48), follow-up with a psychologist (OR=4.12; 95% CI 1.84; 5.25), absence of regular physical activity (OR=1.59; 95% CI 1.13; 2.23), and smokers (OR=1.94; 95% CI 1.26; 2.97). Approximately one out of three individuals used at least one psychoactive drug. Health managers should focus the planning and actions aimed at their rational use for these groups, leading to increased overall treatment success

Use of medication and associated factors in adults living in Rio Branco, Acre. Use of medication in adults

Abstract We analyzed use of medication and associated factors in adults aged 18-59 years living in Rio Branco, Acre. This is a cross-sectional and population-based study that used a probabilistic sample of the population from rural and urban areas of the city of Rio Branco, Acre. The Prevalence Ratio (PR) was calculated with 95% confidence intervals and associations were estimated by Poisson regression. This study found a 29.4% prevalence ratio of use of medication among individuals aged from 18 to 59 years (685 adults: 473 women and 212 men; producing estimates for 211,902 adults: 110,769 women and 101,133 men). After adjusted analysis, their use was associated with: age (50-59 years, PR: 2.36; 95%CI: 2.29-2.43); women (PR: 1.25; 95%CI: 1.23-1.27); up to elementary school (PR: 1.13; 95%CI: 1.11-1.15); and poor or very poor self-rated health (PR: 1.47; 95%CI: 1.43-1.51). The health conditions associated with use of medication were: number of comorbidities, hypertension, diabetes, insomnia, depression, number of health complaints and use of health services. The most frequently used drugs were those belonging to the following ATC categories: alimentary tract and metabolism, cardiovascular system, nervous system, and the musculoskeletal system.

Aspects épidémiologiques et thérapeutiques de la maladie de Kawasaki à Libreville de 2014 à 2021

Introduction.Kawasaki disease (KD) is an acute multi-systemic vasculitis of young children and infants. It is the first cause of acquired cardiac disease in children and remains poorly described in Gabon. We therefore wanted to describe the epidemiological and therapeutic aspects of this disease in two hospitals in Libreville. Patients and methods.We conducted a retrospective, descriptive study from 2014 to 2021 at the Akanda University Hospital and the El Rapha polyclinic in Libreville. All records of patients hospitalised in paediatrics for MK were included. Results.Thirty three cases of MK were retrieved, giving ahospital prevalence of0.6%. The mean age of patients was 20.4 months, the proportion of patients <18 months was 60.6% and the sex ratio was 1.7. The symptoms were observed mainly during the dry season (69.7%). Fever (100%), conjunctivitis (78.8%) and desquamation (72.7%) were the main reasons for consultation. In 24.2% of cases, a traditional medicine was administered. The average time between the onset of symptoms and hospitalization was 11 days. Once hospitalized, the diagnosis of MK was evoked within an average of 3 days. The typical form was observed in 57.6% of cases. In 100% of cases, the hemoglobin level was <12g/dl and the CRP was >15mg/l. Echocardiography was abnormal in 5 patients. Acetylsalicylic acid was the only treatment with a mean time to apyrexia of 3 days after administration. No deaths were recorded. Conclusion:the MK is relatively present in Libreville. It is important to mention it in the event of a fever of more than 5 days.

International Classification of Diseases Codes as screeners for Adverse Drug Events

Códigos da Classificação Internacional de Doenças como Rastreadores de Eventos Adversos a MedicamentosARTIGO DE REVISÃOJosé Romério Rabelo Melo1,2 , Elisabeth Carmen Duarte,3 Silvia Maria de Freitas4 , Eduardo Gabriel Pinheiro5 , Eudiana Vale Francelino6,7 , Paulo Sergio Dourado Arrais7 Introdução: Os Eventos Adversos a Medicamentos-EAM representam riscos à saúde e sua subnotificação representa um desafio para a saúde pública. A busca ativa de casos suspeitos de EAM nos bancos de dados de saúde utilizando a Classificação Internacional de Doenças-CID é uma das estratégias que pode reduzir as subnotificações desses eventos. Objetivo: O objetivo desse estudo é identificar os códigos da CID mais usados como rastreadores de EAM e avaliar a sua concordância entre os pesquisadores. Métodos: Foi realizada uma revisão sistemática da literatura utilizando as bases de dados PubMed, Scopus, Web of Science, MEDLINE e LILACS com os descritores "Classificação Internacional de Doenças", "CID-10", "Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos", "Envenenamento", "Erros de Medicação". Os artigos incluídos tiveram seus códigos CID identificados, comparados e sua qualidade avaliada. A análise de concordância dos códigos foi feita usando o modelo de ensaios de Bernoulli, testes de proporções binomial exata e a técnica de false discovery rate para analisar as hipóteses postas. A análise estatística foi feita com o software R. O estudo está registrado no PROSPERO sob n.º CRD42019120694. Resultados: Foram identificados 5.167 artigos e após os critérios de seleção, 33 foram incluídos nessa revisão. Foram identificados 1.105 códigos da CID. O coeficiente de prevalência dos EAM variou entre 0,18% e 18,4% em internações hospitalares e a taxa de mortalidade variou entre 0,12 a 45,9 óbitos por 100 mil óbitos. Somente 195 (17,7%) códigos tiveram alta concordância entre os pesquisadores. Muitos códigos CID utilizados para detectar EAM possuem baixa concordância entre os pesquisadores e produziram diferentes taxas do evento. Conclusão: Os códigos rastreadores de EAM identificados representam um método simples e eficiente para captação de eventos adversos em grandes bancos de dados em saúde, contribuindo na redução da subnotificação nos tradicionais sistemas de notificações de EAM.Palavras-chave: Informática médica, Farmacoepidemiologia, Segurança do paciente, Classificação internacional de doenças, Efeitos colaterais e reações adversas relacionadas a medicamentos. (AU)

International Classification of Diseases Codes as screeners for Adverse Drug EventsREVIEW ARTICLEJosé Romério Rabelo Melo1,2 , Elisabeth Carmen Duarte,3 Silvia Maria de Freitas4 , Eduardo Gabriel Pinheiro5 , Eudiana Vale Francelino6,7 , Paulo Sergio Dourado Arrais7 1. Agência Nacional de Vigilância Sanitária/Gerência Geral de Inspeção e Fiscalização, Brasília, (DF), Brasil2. Universidade Federal do Ceará-UFC. Programa de Pós-Graduação de Ciências Farmacêuticas, Fortaleza, (CE), Brasil3. Universidade de Brasília-UnB. Faculdade de Medicina. Núcleo de Medicina Tropical, (DF), Brasil4. Universidade Federal do Ceará-UFC. Departamento de Estatística e Matemática Aplicada. Fortaleza, (CE), Brasil5. Instituto de Matemática, Estatística e Computação Científica (IMECC). Programa de Pós-Graduação em Estatística, UNICAMP. Campinas, (SP), Brasil6. Universidade Federal do Ceará-UFC. Faculdade de Farmácia, Odontologia e Enfermagem. Grupo de Prevenção ao Uso Indevido de Medicamentos-GPUIM. Departamento de Farmácia, Fortaleza, (CE), Brasil7. Universidade Federal do Ceará-UFC. Faculdade de Farmácia, Odontologia e Enfermagem. Departamento de Farmácia, Fortaleza, (CE), Brasilhttps://doi.org/10.11606/issn.2176-7262.rmrp.2021.178993Introduction: Adverse drug events (ADEs) represent health risks and their underreporting represents a challenge to public health. The active search for suspected cases of ADE in health databases using the International Classification of Diseases-CID is one of the strategies that can reduce underreporting of these events. Objective: The aim of this study is to identify the ICD codes most commonly used as tracers of ADE and to assess their concordance among researchers. Methods: A systematic literature review was conducted using the PubMed, Scopus, Web of Science, MEDLINE and LILACS databases with the descriptors "International Classification of Diseases", "ICD-10", "Drug-Related Side Effects and Adverse Reactions", "Poisoning", "Medication Errors". The included articles had their ICD codes identified, compared and their quality assessed. The analysis of concordance of the codes was done using Bernoulli's test model, exact binomial proportions tests and the false discovery rate technique to analyze the hypotheses posed. Statistical analysis was done using R software. The study is registered in PROSPERO under CRD42019120694. Results: A total of 5,167 articles were identified and after the selection criteria, 33 were included in this review. A total of 1,105 ICD codes were identified. The prevalence coefficient of ADEs ranged from 0.18% to 18.4% in hospital admissions and the mortality rate ranged from 0.12 to 45.9 deaths per 100,000 deaths. Only 195 (17.7%) codes had high concordance among researchers. Many ICD codes used to detect ADEs have low inter-rater concordance and produced different event rates. Conclusion: The identified ADE tracking codes represent a simple and efficient method for capturing adverse events in large healthcare databases, contributing to the reduction of underreporting in traditional ADE reporting systems. (AU)

Desempeño profesional de egresados de la maestría en Farmacoepidemiología / Professional performance of graduates from the Pharmacoepidemiology Master's Degree Course

Introducción: El seguimiento de los egresados permite conocer su desempeño profesional. Este aspecto no se ha tenido en cuenta en la maestría en Farmacoepidemiología. Objetivo: Caracterizar el desempeño profesional de los egresados de las tres primeras ediciones de la maestría en Farmacoepidemiología entre 2010 y 2018. Métodos: Estudio descriptivo y transversal. El universo estuvo constituido por 73 egresados. Se midieron las variables: cargo relacionado con la farmacoepidemiología antes y después de la maestría, competencias en el área del conocimiento del programa, realización de actividades de farmacoepidemiología, promoción de cargo, categoría docente y científica, entre otras. Los egresados fueron encuestados por correo electrónico. Resultados: Respondieron la encuesta 52 egresados de los cuales el 57,7 por ciento residía en La Habana. Predominaron las mujeres (69,2 por ciento), la edad entre 41 y 50 años (53,8 por ciento) y los médicos (52 por ciento). La mayoría reconoció la influencia de la maestría para comunicar temas científicos y realizar investigaciones. El 46,2 por ciento trabajaba en farmacoepidemiología después del egreso; el 42,3 por ciento realizaba actividades de farmacoepidemiología como expertos del programa nacional de medicamentos, integraba los comités farmacoterapéuticos en su institución y desarrollaba estudios de utilización de medicamentos, entre otras; el 53,8 por ciento promovió de cargo; el 46,2 por ciento publicó los resultados de su tesis de maestría; y el 38,5 por ciento adquirió categorías docentes. Conclusiones: El desempeño profesional se caracterizó por cambios positivos, de magnitud heterogénea, sobre todo en actividades investigativas, lo que permitió considerar que existió impacto formativo en los egresados. La mayoría no trabajaba en farmacoepidemiología ni realizaba actividades relacionadas, lo que denotó incoordinación entre su formación y su vinculación con áreas de trabajo acordes con su capacitación(AU)

Introduction: Follow-up of graduates allows knowing their professional performance. This aspect has not been taken into account in the Master's Degree Course in Pharmacoepidemiology. Objective: To characterize professional performance of the graduates of the first three editions, between 2010 and 2018, of the Master's Degree Course in Pharmacoepidemiology. Methods: A descriptive and cross-sectional study was carried out, with a universe of 73 graduates. The following variables were measured: position related to pharmacoepidemiology before and after the Master's Degree Course, competences in the program's area of knowledge, carrying out pharmacoepidemiology activities, promotion of position, teaching and scientific rank, among others. Graduates were surveyed by email. Results: Fifty-two graduates answered the survey, 57.7 percent of whom live in Havana. There was a predominance of women (69.2 percent), the age group 41-50 years (53.8 percent) and of doctors (52 percent). Most of the respondents recognized the influence of the Master's Degree Course in communicating scientific topics and conducting research. 46.2 percent worked in pharmacoepidemiology after completing the Master's Degree Course; 42.3 percent carried out pharmacoepidemiology activities as experts in the National Drug Program, were members of the pharmacotherapeutic committees at their institution, and developed studies on drug use, among others. 53.8 percent promoted from their positions; 46.2 percent published the results of their master's thesis; and 38.5 percent acquired teaching ranks. Conclusions: Professional performance was characterized by positive changes, of heterogeneous magnitude, especially in research activities, which allowed to consider that there was a training impact on graduates. Most of them did not work in pharmacoepidemiology nor carried out related activities, which denoted lack of coordination between their training and their connection with working areas consistent with their training(AU)

Manejo de la hiperglicemia en un hospital de primer nivel de atención / Management of hyperglycemia in a first level care hospital

Resumen Objetivo: Describir el tratamiento en un hospital de primer nivel de pacientes que consultaron el servicio de urgencias por hiperglucemia, el manejo previo y su probable relación con nuevas hiperglucemias. Materiales y métodos: Estudio observacional de corte transversal con seguimiento de un año en pacientes mayores de 18 años con hiperglucemia que consultaron en el servicio de urgencias entre septiembre-2016 y agosto-2017. Se revisaron las historias clínicas y se establecieron variables sociodemográficas, clínicas, y farmacológicas. Se empleó estadística descriptiva, X 2 y modelos de regresión logística binaria (P<0.05). Resultados: Se presentaron 86 pacientes con hiperglucemia (edad media de 52.1±14.93 años). Se encontró que en el 58,1% de casos había un diagnóstico previo de diabetes mellitus; 87,2% fueron tratados con insulina cristalina y el 47,0% de los pacientes consultaron nuevamente por una crisis de hiperglucemia en los seis meses posteriores al egreso. Conclusión: Existe alta proporción de pacientes con hiperglucemias no cetónicas, no hiperosmolares que desconocían presentar diabetes mellitus. Además, casi la mitad de los pacientes consultan nuevamente por crisis de hiperglucemia en los siguientes seis meses después del alta.

Abstract Objective: Describe the treatment in a first-level hospital of patients who consulted the emergency department for hyperglycemia, the previous management and its probable relationship with new hyperglycemia. Materials and methods: Observational cross-sectional study with a one-year follow-up in patients over 18 years of age with hyperglycemia who consulted in the emergency department between September-2016 and August-2017. The medical records were reviewed and sociodemographic, clinical, and pharmacological variables were established. Descriptive statistics, X2 and binary logistic regression models (P <0.05) were used. Results: There were 86 patients with hyperglycemia (mean age 52.1 ± 14.93 years). It was found that in 58.1% of cases there was a previous diagnosis of diabetes mellitus; 87.2% were treated with crystalline insulin and 47.0% of the patients consulted again for a hyperglycemic crisis in the six months after discharge. Conclusion: There is a high proportion of patients with non-ketonic, non-hyperosmolar hyperglycemia who were unaware of having diabetes mellitus. In addition, almost half of the patients consult again for a hyperglycemic attack in the following six months after discharge.

Utilización y farmacovigilancia de inmunoglobulina G endovenosa en un hospital pediátrico de alta complejidad / Intravenous immunoglobulin G use and pharmacovigilance in a tertiary care children's hospital

Introducción. La inmunoglobulina G endovenosa (IGEV) es un medicamento hemoderivado de inmunoglobulina G polivalente y policlonal. Posee un amplio espectro de indicaciones como inmunomodulador o como terapia de reemplazo. Asimismo, si bien se considera un tratamiento seguro, la incidencia de reacciones adversas reportadas en la literatura varía del 1 % al 81 %. Este trabajo tuvo como objetivo evaluar la utilización de IGEV y describir los acontecimientos adversos por la medicación en un hospital pediátrico de alta complejidad.Población y métodos. Se realizó un estudio de farmacoepidemiología, observacional y prospectivo. Se evaluaron pacientes que recibieron IGEV durante 7 meses, en 6 áreas de un hospital pediátrico de alta complejidad de la Ciudad Autónoma de Buenos Aires. La unidad de análisis fue cada infusión de IGEV, y la principal variable de estudio fue la presencia de reacciones adversas.Resultados. Se analizaron 305 infusiones en 111 pacientes. El 81,6 % de las indicaciones fueron de tipo supletorio. La dosis máxima utilizada fue 1 g/kg. En el 99,6 % de las infusiones, se indicó algún tipo de premedicación; la difenhidramina fue la droga más utilizada, aunque con diferentes posologías. Se registraron 12 reacciones adversas (el 3,9 % de las infusiones), tres de las cuales se consideraron graves: dos meningitis asépticas y una crisis comicial. Todas se resolvieron ad integrum.Conclusiones. La tasa de reacciones adversas de la IGEV en nuestro medio fue baja, con mayoría de reacciones leves e inmediatas y evolución favorable en todos los pacientes.

Introduction. Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is considered a safe therapy, the incidence of adverse reactions reported in the bibliography ranges from 1 % to 81 %. The objective of this study was to assess IVIG use and describe related adverse events in a tertiary care children's hospital.Population and methods. This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children's hospital in the Autonomous City of Buenos Aires were assessed. The analysis unit was each IVIG infusion, and the main variable was the presence of adverse reactions.Results. A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedication was indicated; diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal.Conclusions. The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients

Criterios de realización y evidencias para la formación por competencias del farmacólogo en Farmacoepidemiología / Performance criteria and evidence for using the competencies approach in providing the pharmacologist with pharmacoepidemiological training

Introducción: La aplicación del enfoque de competencias incluye los procesos de identificación, normalización, evaluación y certificación. Una vez definidas las competencias deben ser evaluadas. Una investigación realizada en la Escuela Nacional de Salud Pública definió las competencias profesionales de los especialistas de Farmacología en Farmacoepidemiología. Se conoce que a los especialistas de Farmacología no se les realiza examen de competencias. Objetivos: Determinar los criterios de realización requeridos para alcanzar las competencias profesionales del especialista de Farmacología en Farmacoepidemiología y las evidencias correspondientes para su evaluación. Métodos: Estudio de desarrollo en el que se obtuvieron como producto los criterios de realización necesarios para lograr las competencias profesionales que los especialistas de Farmacología debían alcanzar para desempeñarse como farmacoepidemiólogos y las evidencias para su evaluación posterior. El trabajo se realizó en La Habana entre marzo de 2018 y febrero de 2019. Se aplicaron técnicas cualitativas y revisiones documentales sobre las temáticas relacionadas con el objeto de la investigación. Se trabajó con dos grupos de expertos en dos etapas. Se empleó la metodología Delphi. Resultados: Se pudieron definir y validar los criterios de realización necesarios para alcanzar las competencias profesionales del especialista de Farmacología para su desempeño como farmacoepidemiólogo y se construyeron las evidencias correspondientes para su evaluación. Conclusiones: La definición de los criterios de realización y la construcción de las evidencias respectivas viabilizan la evaluación del desempeño del farmacólogo en Farmacoepidemiología(AU)

Introduction: The application of the competencies approach includes the identification, standardization, evaluation and certification processes. Once defined, competencies must be evaluated. A research carried out at the National School of Public Health defined the professional competencies in pharmacoepidemiology of Pharmacology specialists. It is known that Pharmacology specialists do not take a competency test. Objective: To determine the performance criteria required to achieve the professional competencies in pharmacoepidemiology of the Pharmacology specialist and the corresponding evidence for their evaluation. Methods: This was a development study in which the necessary performance criteria were obtained as a product for achieving the professional competencies that Pharmacology specialists had to achieve to perform as pharmacoepidemiologists, together with the evidence for their subsequent evaluation. The work was carried out in Havana, between March 2018 and February 2019. Qualitative techniques and document reviews were applied with regard to the topics related to the research object. The research work included two groups of experts in two stages. The Delphi methodology was used. Results: It was possible to define and validate the performance criteria necessary to achieve the professional competencies of the Pharmacology specialist for their performance as pharmacoepidemiologists. Also, the corresponding evidence was constructed for their evaluation. Conclusions: The definition of the performance criteria and the construction of the respective evidences permit the evaluation of the pharmacologist's performance in pharmacoepidemiology(AU)