[Profile of clinical trials enrolling Brazilian children]. / Perfil dos ensaios clínicos envolvendo crianças brasileiras.

This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.

[Use of medicines before and during pregnancy: prevalence and associated factors]. / Utilização de medicamentos antes e durante a gestação: prevalência e fatores associados.

This cross-sectional prospective nested cohort study aimed to assess the prevalence of use of medication before and during pregnancy and associated factors in women in a municipality in the countryside of Bahia State, Brazil. Data were collected with a structured questionnaire applied to pregnant women at their prenatal visits at health units. Prevalence rates for use of medication before and during pregnancy were 52.1% and 84.7%, respectively. The following were associated with use of medication before pregnancy: age ≥ 30 years, non-white skin color, first prenatal visit after the 1st trimester, and economic classes C/D/E. There was an increase in medication during pregnancy among women with ≥ 11 years of schooling, women with more than three prenatal visits, and those with some health problem. Pregnant women are exposed to medication before and during pregnancy, notwithstanding the lack of secure information to back the use of medicines during this phase; such use is associated with factors pertaining to prenatal follow-up, suggesting the need for more active participation by pharmacists in orientation and support for rational use of medicines.

Utilização de medicamentos antes e durante a gestação: prevalência e fatores associados / Use of medicines before and during pregnancy: prevalence and associated factors / Utilización de medicamentos antes y durante la gestación: prevalencia y factores asociados

Resumo: Estudo transversal aninhado à coorte prospectiva com o objetivo de avaliar a prevalência e os fatores associados à utilização de medicamentos em gestantes antes e durante a gravidez em município do interior da Bahia, Brasil. As informações foram coletadas mediante um questionário estruturado aplicado às gestantes no momento do acompanhamento pré-natal em unidades de saúde do município. A prevalência para consumo de medicamentos antes e durante a gestação foi 52,1% e 84,7%, respectivamente. Após análise, os seguintes fatores estavam associados à utilização de medicamentos antes da gestação: ≥ 30 anos de idade, as não pretas, as que iniciaram o pré-natal depois do 1º trimestre e as que fazem parte da classe econômica C/D/E. Há um aumento de prevalência de utilização de medicamentos durante a gestação entre as gestantes com escolaridade ≥ 11 anos de estudo, ter feito mais de três consultas pré-natais e ter algum problema de saúde. As gestantes estão expostas ao uso de medicamentos antes e durante a gestação apesar da carência de informações seguras que fundamentem o uso de medicamentos nessa fase, e esse uso está associado a fatores relativos ao acompanhamento pré-natal, sugerindo-se a inclusão mais ativa do farmacêutico na equipe para orientação e apoio ao uso racional de medicamentos.

Abstract: This cross-sectional prospective nested cohort study aimed to assess the prevalence of use of medication before and during pregnancy and associated factors in women in a municipality in the countryside of Bahia State, Brazil. Data were collected with a structured questionnaire applied to pregnant women at their prenatal visits at health units. Prevalence rates for use of medication before and during pregnancy were 52.1% and 84.7%, respectively. The following were associated with use of medication before pregnancy: age ≥ 30 years, non-white skin color, first prenatal visit after the 1st trimester, and economic classes C/D/E. There was an increase in medication during pregnancy among women with ≥ 11 years of schooling, women with more than three prenatal visits, and those with some health problem. Pregnant women are exposed to medication before and during pregnancy, notwithstanding the lack of secure information to back the use of medicines during this phase; such use is associated with factors pertaining to prenatal follow-up, suggesting the need for more active participation by pharmacists in orientation and support for rational use of medicines.

Resumen: Estudio transversal situado en una cohorte prospectiva, con el objetivo de evaluar la prevalencia y factores asociados a la utilización de medicamentos en gestantes antes y durante el embarazo en un municipio del interior de la región de Bahía, Brasil. La información fue recogida mediante un cuestionario estructurado, aplicado a las embarazadas en el momento del seguimiento prenatal en unidades de salud del municipio. La prevalencia para el consumo de medicamentos antes y durante la gestación fue un 52,1% y un 84,7%, respectivamente. Tras el análisis, los siguientes factores estaban asociados a la utilización de medicamentos antes de la gestación: ≥ 30 años de edad; no afro-brasileñas; quienes comenzaron con el seguimiento prenatal tras el 1º trimestre, y las que forman parte de la clase económica C/D/E. Existe un aumento de prevalencia de utilización de medicamentos durante la gestación entre las gestantes con una escolaridad ≥ 11 años de estudio, haber realizado más de tres consultas prenatales y que tengan algún problema de salud. Las gestantes están expuestas al uso de medicamentos antes y durante la gestación, a pesar de la carencia de información segura que fundamente el uso de medicamentos en esa fase, y ese uso está asociado a factores relativos al seguimiento prenatal, sugiriéndose la inclusión más activa del farmacéutico en el equipo para la orientación y apoyo al uso racional de medicamentos.

Perfil dos ensaios clínicos envolvendo crianças brasileiras / Profile of clinical trials enrolling Brazilian children / Perfil de los ensayos clínicos involucrando niños brasileños

Resumo: Este estudo visou a caracterizar os ensaios clínicos com medicamentos envolvendo crianças e adolescentes brasileiros, registrados nas bases de dados do Clinical Trials e da Registro Brasileiro de Ensaios Clínicos (ReBEC), entre os anos de 1994 e 2014. Apenas 462 ensaios clínicos envolveram brasileiros nessa faixa etária. A partir de 2003, houve aumento no número de registros, com expressiva queda em 2011. Dentre esses, 35,5% foram sediados no Brasil. Os ensaios clínicos internacionais foram majoritariamente conduzidos por empresas norte-americanas. Em ambos os casos, a indústria multinacional foi a principal fonte de apoio financeiro. Predominaram ensaios clínicos de fase III com antivirais em formas farmacêuticas injetáveis e sólidas orais. Os ensaios clínicos nacionais apresentaram maior variação quanto às formas farmacêuticas e maior porcentual de formulações líquidas investigadas, em comparação aos internacionais. Além da forte dependência externa para a realização dos ensaios clínicos, destacou-se o desafio para o cuidado pediátrico no Brasil, que apresenta peculiaridades epidemiológicas em um ambiente propício ao uso de medicamentos não licenciados para crianças.

Abstract: This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.

Resumen: Este estudio tuvo como objetivo caracterizar los ensayos clínicos con medicamentos, involucrando a niños y adolescentes brasileños, registrados en las bases de datos de Clinical Trials y de la Red Brasileña de Ensayos Clínicos (ReBEC), entre los años de 1994 y 2014. Solamente 462 ensayos clínicos involucraron a brasileños en esa franja de edad. A partir de 2003, hubo un aumento en el número de registros, con una expresiva caída en 2011. Entre ellos, un 35,5% estuvieron ubicados en Brasil. Los ensayos clínicos internacionales fueron mayoritariamente dirigidos por empresas norteamericanas. En ambos casos, la industria multinacional fue la principal fuente de apoyo financiero. Predominaron ensayos clínicos de fase III con antivirales en formas farmacéuticas inyectables y orales sólidas. Los ensayos clínicos nacionales presentaron una mayor variación, en cuanto a las formas farmacéuticas y mayor porcentaje de formulaciones líquidas investigadas, en comparación con los internacionales. Además de la fuerte dependencia externa para la realización de los ensayos clínicos, se destacó el desafío para el cuidado pediátrico en Brasil, que presenta peculiaridades epidemiológicas en un ambiente propicio al uso de medicamentos sin licencia para niños.

Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.

BACKGROUND: Neonates admitted to neonatal intensive care units (NICU) are exposed to a wide variety of drugs, most without any data on safety and efficacy. OBJECTIVE: To describe the drugs prescribed to different groups of neonates hospitalized in a NICU, and to analyze off-label use and harmful potential of drugs, in terms of the potential risks. METHODS: This was a six-month retrospective cohort study of drug use in a NICU, with neonates who were inpatients for a period of over 24 hours, and using prescription data from electronic medical records. Drug information found in the package leaflets, in the British National Formulary for Children 2012-2013, and in the Thomson Micromedex database were compared. Drugs and excipients considered potentially harmful were evaluated according to the literature. RESULTS: One hundred ninety-two neonates were included in the study, with a mean gestational age (GA) of 33.3 weeks (SD ± 4.3), 75.0 % were preterm, with an average of 18.8 days of hospitalization (SD ± 18.1), and a total of 3617 neonates-day. 3290 prescriptions were registered, on average 17.1 prescriptions/neonate (SD ± 17.9) and 8.8 drugs/neonate (SD ± 5.9). The number of prescriptions and drugs was higher in neonates with GA <31 weeks (p <0.05). Anti-infectives for systemic use, blood, alimentary tract and metabolism drug groups were more frequent, varying according to the GA. Neonates (99.5 %) were exposed to unlicensed drugs (UL) and off label use (OL), more frequently in GA <28 weeks (p <0.05). Most OL drugs used were indicated for newborns. 15 potentially harmful drugs were used in more than 70 % of the neonates, and most were OL; exposure to harmful excipients occurred in 91.6 % of the neonates, a percentage even higher when considering immature neonates. CONCLUSIONS: Immature neonates in a Brazilian NICU are exposed to a variety of OL, UL and potentially harmful drugs and excipients.

Clinical and serological evolution in chronic Chagas disease patients in a 4-year pharmacotherapy follow-up: a preliminary study.

INTRODUCTION: The role of trypanocidal therapy in the chronic phase of Chagas disease remains controversial. METHODS: A total of 13 patients with chronic Chagas disease were treated with benznidazole (5mg/kg/day/60 days) and surveyed via antibody measurement and conventional electrocardiogram over the course of 4 years. RESULTS: The antibody titers were significantly reduced after 4 years (p<0.05). Most of the patients showed maintenance of the initial clinical picture (electrocardiographic), with the exception of 4 cases. CONCLUSIONS: Although trypanocidal therapy in the chronic phase of Chagas disease was of limited effectiveness, we believe that it is beneficial in treating these patients.

Doença de Chagas: situação vetorial no município de Limoeiro do Norte – CE, no período de 2006 a 2009 / Chagas Disease: vector status in the city of Limoeiro do Norte – CE, during the period from 2006 to 2009

Entre as doenças transmitidas por vetores no Brasil, a doença de Chagas é uma das mais importantes como problemas de saúde pública. Neste estudo foi estimada a prevalência de triatomíneos infectados por Trypanosoma cruzi no município de Limoeiro do Norte-CE, por meio de consulta aos arquivos do Programa de Controle da Doença de Chagas deste Distrito Sanitário no período de 2006 a 2009. Na análise foram incluídos os triatomíneos adultos e ninfas, mortos ou vivos, capturados durante o período investigado. Durante os quatro anos de estudo foram capturados 2.863 exemplares de triatomíneos, ninfase adultos distribuídos no intradomicílio e peridomicílio; e examinados 2.756 (96,3 %) exemplares. O índice de infecção dos triatomíneos foi de 7,9 % nos quatros anos de estudo. O número de ninfas capturadas foi cerca de três vezes maior que o número de adultos; no entanto, o número de ninfas infectadas pelo flagelado (5,30 %) foi inferior aos adultos (15,85 %). O distrito de Limoeiro do Norte apresenta alto risco de transmissão para doença de Chagas e, portanto, sugere-se que as ações de controle sejam intensificadas neste município para evitar a ocorrência de transmissão da doença e dispersão do vetor.

In Brazil, among the endemic vector-borne diseases, Chagas disease has been considered one of the mostimportant public health problems. The present study aimed at estimating the prevalence of triatominesinfected with Trypanosoma cruzi in the city of Limoeiro do Norte, CE, Brazil. This investigation was conductedby consulting the archives of the Chagas disease control program of the Health District of Limoeiro do Nortefor the period from 2006 to 2009. The study included dead or alive, adults and nymphs triatomines, whichwhere captured during the investigated period. During the four-year study, 2,863 specimens of nymphs andadults insects were captured from the domestic and peridomestic areas; 2,756 were examined, representing96.3 % of collected specimens. The insect infection rate was 7.9 % in four-year study. The number of capturednymphs was nearly three times higher than the number of adults; however the number of nymphs infectedwith the flagellate (5.30 %) was lower than the number of adults form (15.85 %). Limoeiro do Norte showeda high risk for Chagas disease transmission, suggesting that the control actions should be intensified in thiscity to prevent the disease transmission and the vector spread.

Pattern of asthma medication use among children from a large urban center in Brazil.

PURPOSE: Despite the advances in asthma therapeutics, there are few data on the use and determinants of anti-asthmatic drugs in the general population of children. This study describes the use of asthma medications among children in the general population and in children with current asthma, living in a large urban center in Brazil. METHODS: A population-based cross-sectional survey, aimed at analyzing asthma determinants, was conducted with 1,382 children aged 4-11 years, between February and May 2006, in Salvador, Brazil. At baseline, an extensive questionnaire was applied, including questions about the use of asthma medications in the last 12 months. RESULTS: In all studied children (n = 1,382) aged 4-11 years, oral beta2-agonists were the drugs most frequently used (9.8%), followed by short-acting inhaled beta2-agonists (4.3%) and systemic corticosteroids (1.6%). Anti-asthmatic drug use was higher among males than females, and it significantly decreased with age in both genders. A total of 312 children (22.6%) reported current asthma, and 62% of them were not being treated with any anti-asthmatic drugs. Of all those who reported following a certain type of treatment, 20% used oral beta2-agonists alone; 6.1%, short-acting inhaled beta2-agonists alone; and 4.8%, a combination of both drugs. Anti-asthmatic drug use did not differ according to socioeconomic status, except for the use of inhaled beta2-agonists and systemic corticosteroids. CONCLUSIONS: An overwhelming majority of asthmatic children were not using long-term medications for asthma, in particular inhaled corticosteroids, regardless of the severity of their disease. This result points to the deficiencies of the Brazilian public health system in recognizing this important pharmacological need for child care and thereby limiting the access of these children to a group of efficacious, available, and low risk therapeutic medications.

Use of prescribed and non-prescribed medications among children living in poor areas in the city of Salvador, Bahia State, Brazil.

A cross-sectional study of children living in poor areas in the city of Salvador, Bahia State, Brazil, was carried out in 2006 to investigate the prevalence of use of prescribed and non-prescribed medication. This population-based study included 1,382 children aged 4-11 years. The use prescribed and non-prescribed medication during the 15 day period preceding the interview was adopted as the dependent variable. Of the 1,382 children, 663 (48%) had used at least one type of medication in the 15 days prior to the interview: in 267 cases (40.3%), mothers reported that the child had taken prescribed medication, while in 396 cases (59.7%), the child had taken medication that had not been prescribed by a physician. The most commonly prescribed drugs were analgesics (42.3%), systemic antibiotics (21.3%) and antiasthmatic (16.5%). With respect to non-prescribed drugs, the most common were analgesics (65.2%), antitussives (15.7%) and vitamins (9.3%). The results show a high prevalence of the use of non-prescription drugs among poor children, and large drug purchases of drugs by the head of household, highlighting deficiencies in coverage of the health system.

Use of prescribed and non-prescribed medications among children living in poor areas in the city of Salvador, Bahia State, Brazil / Consumo de medicamentos prescritos e não prescritos entre crianças residentes em áreas pobres de Salvador, Bahia, Brasil

A cross-sectional study of children living in poor areas in the city of Salvador, Bahia State, Brazil, was carried out in 2006 to investigate the prevalence of use of prescribed and non-prescribed medication. This population-based study included 1,382 children aged 4-11 years. The use prescribed and non-prescribed medication during the 15 day period preceding the interview was adopted as the dependent variable. Of the 1,382 children, 663 (48 percent) had used at least one type of medication in the 15 days prior to the interview: in 267 cases (40.3 percent), mothers reported that the child had taken prescribed medication, while in 396 cases (59.7 percent), the child had taken medication that had not been prescribed by a physician. The most commonly prescribed drugs were analgesics (42.3 percent), systemic antibiotics (21.3 percent) and antiasthmatic (16.5 percent). With respect to non-prescribed drugs, the most common were analgesics (65.2 percent), antitussives (15.7 percent) and vitamins (9.3 percent). The results show a high prevalence of the use of non-prescription drugs among poor children, and large drug purchases of drugs by the head of household, highlighting deficiencies in coverage of the health system.

A prevalência de uso de medicamentos prescritos e não prescritos foi investigada por intermédio dum estudo transversal, em crianças que vivem em áreas pobres da cidade de Salvador, Bahia, Brasil, em 2006. Estudo de base populacional que incluiu 1.382 crianças entre 4 e 11 anos de idade. O consumo de medicamentos prescritos e não prescritos nos 15 dias anteriores à entrevista foi considerado a variável dependente. Das 1.382 crianças, 663 (48 por cento) haviam consumido ao menos um medicamento nos últimos 15 dias: 267 (40,3 por cento) referidas pela mãe haviam consumido medicamentos prescritos e 396 (59,7 por cento) consumiram medicamentos não prescritos. Os grupos farmacológicos prescritos mais consumidos foram analgésicos (42,3 por cento), antibacterianos sistêmicos (21,3 por cento) e antiasmáticos (16,5 por cento). Os grupos farmacológicos não prescritos mais consumidos foram analgésicos (65,2 por cento), antitussígenos (15,7 por cento) e vitaminas (9,3 por cento). Os resultados mostram uma alta prevalência do uso de medicamentos sem prescrição em crianças pobres, bem como elevada compra de medicamentos pelas famílias, evidenciando deficiências de cobertura do sistema de saúde.

[Adverse reactions in Chagas disease patients treated with benznidazole, in the State of Ceará]. / Reações adversas em pacientes com doença de Chagas tratados com benzonidazol, no Estado do Ceará.

INTRODUCTION: Chagas disease is caused by Trypanosoma cruzi and treated with benznidazole (BNZ). This drug has the troublesome features of presenting partial effectiveness and high toxicity ranging from hypersensitivity reactions to medullary aplasia. The objective here was to describe and evaluate the occurrence of adverse reactions in Chagas disease patients treated with benznidazole in Fortaleza, Ceará. METHODS: This was a prospective descriptive study involving 32 chronic Chagas patients treated with benznidazole between January 2005 and April 2006. Sociodemographic and clinical data were collected through questionnaires, interviews and laboratory tests. Blood samples were collected before treatment and after 30 and 60 days of treatment. RESULTS: Adverse reactions were reported in 28 patients (87.5%) patients and the most frequent of these were pruritus (50%), prickling (43.8%), muscle weakness (37.5%) and skin rash (31.3%). Out of the 28 patients with adverse reactions, eight (28.57%) discontinued their treatment. The adverse reactions that culminated with discontinuation of the treatment were prickling (7; 87.5%) or skin eruptions (5; 62.5%). There was a slight increase in aminotransferase levels during the treatment in 9.4% of the patients. CONCLUSIONS: Following up the drug therapy administered to Chagas patients is of great importance for prevention and early detection of adverse reactions to drugs.

Reações adversas em pacientes com doença de Chagas tratados com benzonidazol, no Estado do Ceará / Adverse reactions in Chagas disease patients treated with benznidazole, in the State of Ceará

INTRODUÇÃO: A doença de Chagas, causada pelo Trypanosoma cruzi, é tratada com benzonidazol, tendo o inconveniente de apresentar efetividade parcial e alta toxicidade, que varia desde reações de hipersensibilidade a aplasia medular. O objetivo foi descrever e avaliar a ocorrência de reações adversas em pacientes chagásicos em tratamento com benzonidazol em Fortaleza, Ceará. MÉTODOS: Estudo descritivo prospectivo envolvendo 32 pacientes chagásicos crônicos tratados com benzonidazol entre janeiro de 2005 e abril de 2006. Dados sociodemográficos e clínicos foram coletados de questionários, entrevistas e exames laboratoriais. As amostras de sangue foram coletadas antes, com 30 e 60 dias de tratamento. RESULTADOS: Reações adversas foram relatadas em 28 (87,5 por cento) pacientes tratados, tendo sido as mais frequentes: prurido (50 por cento), formigamento (43,8 por cento), fraqueza muscular (37,5 por cento) e rash cutânea (31,3 por cento). Dos 28 pacientes com reações adversas, oito (28,57 por cento) interromperam o tratamento. Reações adversas que culminaram com a suspensão do tratamento foram formigamento sete (87,5 por cento) ou erupção cutânea cinco (62,5 por cento). Observou-se aumento discreto dos níveis de aminotransferases durante o tratamento em (9,4 por cento) pacientes. CONCLUSÕES: Concluindo, o acompanhamento farmacoterapêutico dos pacientes chagásicos é de grande relevância na prevenção e detecção precoce das reações adversas a medicamentos.

INTRODUCTION: Chagas disease is caused by Trypanosoma cruzi and treated with benznidazole (BNZ). This drug has the troublesome features of presenting partial effectiveness and high toxicity ranging from hypersensitivity reactions to medullary aplasia. The objective here was to describe and evaluate the occurrence of adverse reactions in Chagas disease patients treated with benznidazole in Fortaleza, Ceará. METHODS: This was a prospective descriptive study involving 32 chronic Chagas patients treated with benznidazole between January 2005 and April 2006. Sociodemographic and clinical data were collected through questionnaires, interviews and laboratory tests. Blood samples were collected before treatment and after 30 and 60 days of treatment. RESULTS: Adverse reactions were reported in 28 patients (87.5 percent) patients and the most frequent of these were pruritus (50 percent), prickling (43.8 percent), muscle weakness (37.5 percent) and skin rash (31.3 percent). Out of the 28 patients with adverse reactions, eight (28.57 percent) discontinued their treatment. The adverse reactions that culminated with discontinuation of the treatment were prickling (7; 87.5 percent) or skin eruptions (5; 62.5 percent). There was a slight increase in aminotransferase levels during the treatment in 9.4 percent of the patients. CONCLUSIONS: Following up the drug therapy administered to Chagas patients is of great importance for prevention and early detection of adverse reactions to drugs.

[Evaluation of the teratogenic risks in gestations exposed to misoprostol]. / Avaliação de riscos teratogênicos em gestações expostas ao misoprostol.

PURPOSE: failed attempted abortions with the use of misoprostol (Cytotec(R)) without medical indication have been associated with the occurrence of congenital malformations. The objective of the present study was to identify, in newborns with malformations and in normal controls, the frequency of exposure to misoprostol and the spectrum of associated malformations. METHODS: this was a case-control study involving a daily survey at four public maternities in Fortaleza (CE) for the identification of newborns with malformations and paired controls (1:1) during the period from July to November 2005. The sample comprised 252 parturients interviewed by a trained team by means of a structured questionnaire based on the Latin American Collaborative Study of Congenital Malformations (Estudo Colaborativo Latino-Americano de Malformações Congênitas, ECLAMC). The questionnaire was used to obtain sociodemographic data and a family history of malformations, as well as to identify diverse forms of exposure during pregnancy, including misoprostol. Bivariate analysis and the chi-square test were used to compare cases and controls regarding their characteristics and factors associated with malformation, and the Odds Ratio was calculated to determine the chance of the Case Group to present malformations as compared to the Control Group after exposure to misoprostol. RESULTS: there were no significant differences between groups regarding most of the risk factors for malformations investigated. Attempted abortion was reported by 6.8% of the mothers, with a higher exposure to misoprostol during pregnancy resulting in a greater proportion of malformed newborns, Odds Ratio (OR)=3.65 (95%CI=0.74-17.91). The spectrum of congenital defects encountered with exposure to misoprostol included defects of the central nervous, musculoskeletal, urogenital and cardiovascular systems, in agreement with literature data. CONCLUSION: the findings of this study suggest that fetuses exposed to misoprostol tend to be at higher risk of developing congenital malformations in comparison to non-exposed fetuses. Other studies should be encouraged for a better identification of the damage caused by the improper use of misoprostol, especially in countries where the control of medication is inadequate.

Avaliação de riscos teratogênicos em gestações expostas ao misoprostol / Evaluation of the teratogenic risks in gestations exposed to misoprostol

OBJETIVOS: a tentativa de aborto mal sucedida com o uso do misoprostol (Cytotec®) sem indicação médica tem sido associada a malformações congênitas. Este estudo teve por objetivo identificar, em recém-nascidos malformados e controles normais, a frequência de exposição ao misoprostol e o espectro de malformações associadas. MÉTODOS: estudo de caso-controle desenvolvido em 2005 nas quatro principais maternidades públicas de Fortaleza (CE). Através de busca ativa diária, foram identificados recém-nascidos com diagnóstico de malformação fetal (caso) e controles saudáveis de mesmo sexo nascidos em seguida na mesma maternidade (pareamento 1:1). A amostra foi de 252 parturientes entrevistadas por equipe treinada utilizando questionário estruturado com base no Estudo Colaborativo Latino-Americano de Malformações Congênitas (ECLAMC). Além de abordar questões sociodemográficas e histórico familiar de malformação, o questionário objetivou identificar exposições diversas durante a gestação, incluindo o misoprostol. A análise bivariada com teste do χ2 comparou os grupos quanto às características e fatores associados à malformação e foi calculada a Odds Ratio para verificar a razão de chances de o Grupo Caso apresentar malformação em relação ao Grupo Controle com relação à exposição ao misoprostol. RESULTADOS: não houve diferenças significativas entre os grupos caso e controle quanto à maioria dos fatores de riscos investigados para malformações. O relato de tentativa de aborto foi de 6,8 por cento, havendo uma maior exposição ao misoprostol durante a gestação em neonatos malformados comparados a saudáveis, Odds Ratio (OR)=3,65 (IC95 por cento=0,74-17,91). O espectro de malformações encontradas entre os recém-nascidos expostos ao misoprostol foi compatível com a literatura, como os decorrentes de defeitos do tubo neural e disrupção vascular. CONCLUSÕES: os achados deste estudo, apesar de não apresentarem significância estatística, sugerem que ...

PURPOSE: failed attempted abortions with the use of misoprostol (Cytotec®) without medical indication have been associated with the occurrence of congenital malformations. The objective of the present study was to identify, in newborns with malformations and in normal controls, the frequency of exposure to misoprostol and the spectrum of associated malformations. METHODS: this was a case-control study involving a daily survey at four public maternities in Fortaleza (CE) for the identification of newborns with malformations and paired controls (1:1) during the period from July to November 2005. The sample comprised 252 parturients interviewed by a trained team by means of a structured questionnaire based on the Latin American Collaborative Study of Congenital Malformations (Estudo Colaborativo Latino-Americano de Malformações Congênitas, ECLAMC). The questionnaire was used to obtain sociodemographic data and a family history of malformations, as well as to identify diverse forms of exposure during pregnancy, including misoprostol. Bivariate analysis and the chi-square test were used to compare cases and controls regarding their characteristics and factors associated with malformation, and the Odds Ratio was calculated to determine the chance of the Case Group to present malformations as compared to the Control Group after exposure to misoprostol. RESULTS: there were no significant differences between groups regarding most of the risk factors for malformations investigated. Attempted abortion was reported by 6.8 percent of the mothers, with a higher exposure to misoprostol during pregnancy resulting in a greater proportion of malformed newborns, Odds Ratio (OR)=3.65 (95 percentCI=0.74-17.91). The spectrum of congenital defects encountered with exposure to misoprostol included defects of the central nervous, musculoskeletal, urogenital and cardiovascular systems, in agreement with literature data. CONCLUSION: the findings of this study suggest ...

Problemas relacionados a medicamentos em pacientes com doença de Chagas durante tratamento com benzonidazol em Fortaleza - CE. / Drug-related problems in patients with Chagas disease under treatment with benzonidazole in Fortaleza - CE.

A Doença de Chagas não tem uma terapia medicamentosa satisfatória. A toxicidade dos tratamentos existentes limita a tolerabilidade e a adesão, configurando situaçõesproblema que podem inviabilizar a cura dos pacientes. Analisar os PRM durante o tratamento em pacientes com Doença de Chagas tratados com benzonidazol (BNZ) em Fortaleza ? CE. Estudo descritivo observacional de seguimento, acompanhando-se 19 pacientes em uso de BNZ atendidos pelo ambulatório no Hospital Universitário Walter Cantídio (HUWC), durante o período de novembro de 2006 a outubro de 2007. Utilizou-se o método Dáder de Seguimento Farmacoterapêutico para acompanhar o tratamento dos pacientes. Os PRM foram classificados de acordo com o II Consenso de Granada (2002). Observou-se que os pacientes apresentaram um total de 148 PRM, somando-se as três avaliações. Destes 41,9% (62) estavam relacionados à necessidade, 33,1% (49) à efetividade e 25% (37) à segurança. Constatou-se que os PRM estavam significantemente correlacionados com o número de medicamentos (Teste de Kendall: Coeficiente de Correlação = 0,438; p-valor bicaudal = 0,018). Problemas relacionados à necessidade de uso de medicamento e de segurança, expressos pela ocorrência de reações adversas, comprometeram a adesão ao tratamento e a qualidade de vida dos pacientes usuários de BNZ.

There is no satisfactory drug treatment for Chagas disease. The high toxicity of the existent drugs for specific treatment decreases the tolerability and adherence, a problem that can impair the curing of patients. The aim of this study is to assess the occurrence of drug-related problems (DRP) during treatment with benzonidazole (BNZ) in Chagas disease patients (CDP) in Fortaleza ? CE. It is a descriptive observational follow-up, monitoring 19 patients in use of BNZ under clinical treatment at Walter Cantídio University hospital (HUWC) from November 2006 to October 2007. The Dader method was used to follow the patients up. DRPs were classified according to the Second Granada Consensus (2002). During three evaluations, it was identified a total of 148 DRPs, being 41,9% (62) related to the need, 33.1% (49) to the effectiveness, and 25% (37) to the safety. The DRPs were significantly correlated with the number of drugs (Kendall Test: Correlation coefficient = 0.438; bi-tail p-value = 0.018). Problems related to the need to use drugs and safety, expressed by the occurrence of adverse reactions, compromised the adherence to treatment and life quality of patients under use of BNZ.

Drug use and associated factors in children living in poor areas.

OBJECTIVE: To describe drug use profile in children living in poor areas and associated factors. METHODS: Population-based, cross-sectional study, including 1,382 children aged between four and 11 years. These children were selected by random sampling of 24 micro-areas, representative of the poorest segments of the population living in the city of Salvador, Northeastern Brazil, in 2006. The dependent variable was drug use in the 15 days preceding the surveys. A total of three groups of explanatory variables were considered: socioeconomic variables, child health status, and use of health services. Adjusted analysis used Poisson regression, following a hierarchical conceptual model. RESULTS: Drug use prevalence in children was 48%. Female children showed higher drug use prevalence than males, 50.9% and 45.4%, respectively (p=0.004). Drug use prevalence decreased significantly with age (p<0.001) in both sexes. Most used pharmacological groups were: analgesics/antipyretics (25.5%), systemic antibiotics (6.5%), and anti-cough /expectorant drugs (6.2%). In the multivariate analysis, factors determining greater drug use were: age (four to five, six, seven to eight years); female sex; white mother; poorer health perception; interruption of activities due to health problems and health care, whether ill or not, in the last 15 days; drug spending in the last month; and medical visits in the last three months. CONCLUSIONS: Drug use prevalence in the poor children studied was below that observed in other population-based studies in Brazil, yet similar to that of adults. The identification of groups most subject to excessive drug use may serve as the basis for strategies to promote their rational use.

Utilização de medicamentos e fatores associados entre crianças residentes em áreas pobres / Utilización de medicamentos y factores asociados entre niños residentes en áreas pobres / Drug use and associated factors in children living in poor areas

OBJETIVO: Descrever o perfil de uso de medicamentos entre crianças residentes em áreas pobres e fatores associados. MÉTODOS: Estudo transversal de base populacional que incluiu 1.382 crianças entre quatro e 11 anos de idade, selecionadas por amostragem aleatória de 24 micro-áreas representativas das zonas mais pobres da população residente no município de Salvador, BA, em 2006. A variável dependente foi o consumo de medicamentos nos 15 dias anteriores à realização dos inquéritos. Foram considerados três grupos de variáveis explanatórias: socioeconômicas, estado de saúde da criança e utilização dos serviços de saúde. A análise ajustada utilizou regressão de Poisson seguindo um modelo conceitual hierarquizado. RESULTADOS: A prevalência de consumo de medicamentos em crianças foi de 48 por cento. As crianças do sexo feminino apresentaram prevalência de utilização de medicamentos superior ao sexo masculino, 50,9 por cento e 45,4 por cento, respectivamente (p=0,004). A prevalência de uso de medicamentos diminuiu significativamente com a idade (p<0,001) em ambos os sexos. Os grupos farmacológicos mais utilizados foram os analgésicos/antitérmicos (25,5 por cento), antibacterianos sistêmicos (6,5 por cento) e antitussígenos/expectorantes (6,2 por cento). Na análise multivariada os fatores determinantes de maior utilização de medicamentos foram: idade (quatro a cinco, seis, sete a oito anos), sexo feminino, mães de cor da pele branca, pior percepção de saúde, interrupção de atividades por problemas de saúde e atendimento de saúde independentemente de estar doente nos últimos 15 dias, gasto com medicamentos no último mês e realização de consultas ao médico nos últimos três meses. CONCLUSÕES: A prevalência de uso de medicamentos entre crianças pobres estudadas foi inferior à verificada em outros estudos populacionais no Brasil, mas semelhante à de adultos. A identificação de grupos mais sujeitos ao uso excessivo de medicamentos pode embasar estratégias ...

OBJECTIVE: To describe drug use profile in children living in poor areas and associated factors. METHODS: Population-based, cross-sectional study, including 1,382 children aged between four and 11 years. These children were selected by random sampling of 24 micro-areas, representative of the poorest segments of the population living in the city of Salvador, Northeastern Brazil, in 2006. The dependent variable was drug use in the 15 days preceding the surveys. A total of three groups of explanatory variables were considered: socioeconomic variables, child health status, and use of health services. Adjusted analysis used Poisson regression, following a hierarchical conceptual model. RESULTS: Drug use prevalence in children was 48 percent. Female children showed higher drug use prevalence than males, 50.9 percent and 45.4 percent, respectively (p=0.004). Drug use prevalence decreased significantly with age (p<0.001) in both sexes. Most used pharmacological groups were: analgesics/antipyretics (25.5 percent), systemic antibiotics (6.5 percent), and anti-cough /expectorant drugs (6.2 percent). In the multivariate analysis, factors determining greater drug use were: age (four to five, six, seven to eight years); female sex; white mother; poorer health perception; interruption of activities due to health problems and health care, whether ill or not, in the last 15 days; drug spending in the last month; and medical visits in the last three months. CONCLUSIONS: Drug use prevalence in the poor children studied was below that observed in other population-based studies in Brazil, yet similar to that of adults. The identification of groups most subject to excessive drug use may serve as the basis for strategies to promote their rational use.

OBJETIVO: Describir el perfil de uso de medicamentos entre niños residentes en áreas pobres y factores asociados. MÉTODOS: Estudio transversal de base poblacional que incluyó 1.382 niños entre cuatro y 11 años de edad, seleccionadas por muestreo aleatorio de 24 micro-áreas representativas de las zonas más pobres de la población residente en el municipio de Salvador, Noreste de Brasil, en 2006. La variable dependiente fue el consumo de medicamentos en los 15 días anteriores a la realización de las pesquisas. Fueron considerados tres grupos de variables explicatorios: socioeconómicas, estado de salud del niño y utilización de los servicios de salud. El análisis ajustado utilizó regresión de Poisson siguiendo un modelo conceptual jerarquizado. RESULTADOS: La prevalencia de consumo de medicamentos en niños fue de 48 por ciento. Los niños del sexo femenino presentaron prevalencia de utilización de medicamentos superior al sexo masculino, 50,9 por ciento y 45,4 por ciento, respectivamente (p=0,004). La prevalencia de uso de medicamentos disminuyó significativamente con la edad (<0,001) en ambos sexos. Los grupos farmacológicos más utilizados fueron los analgésicos/antitérmicos (25,5 por ciento), antibacterianos sistémicos (6,5 por ciento) y antitusígenos/expectorantes (6,2 por ciento). En el análisis multivariado los factores determinantes de mayor utilización de medicamentos fueron: edad (cuatro a cinco, seis, siete a ocho años), sexo femenino, madres de color de piel blanca, peor percepción de salud, interrupción de actividades por problemas de salud y atención de salud independientemente de estar enfermo en los últimos 15 días, gasto con medicamentos en el último mes y realización de consultas con médico en los últimos tres meses. CONCLUSIONES: La prevalencia de uso de medicamentos entre niños pobres estudiados fue inferior a la verificada en otros estudios poblacionales en Brasil, pero semejante a la de adultos. La identificación de grupos ...

Utilização de medicamentos e fatores associados entre crianças residentes em áreas pobres / Drug use and associated factors in children living in poor areas

OBJETIVO: Descrever o perfil de uso de medicamentos entre crianças residentes em áreas pobres e fatores associados. MÉTODOS: Estudo transversal de base populacional que incluiu 1.382 crianças entre quatro e 11 anos de idade, selecionadas por amostragem aleatória de 24 micro-áreas representativas das zonas mais pobres da população residente no município de Salvador, BA, em 2006. A variável dependente foi o consumo de medicamentos nos 15 dias anteriores à realização dos inquéritos. Foram considerados três grupos de variáveis explanatórias: socioeconômicas, estado de saúde da criança e utilização dos serviços de saúde. A análise ajustada utilizou regressão de Poisson seguindo um modelo conceitual hierarquizado. RESULTADOS: A prevalência de consumo de medicamentos em crianças foi de 48 por cento. As crianças do sexo feminino apresentaram prevalência de utilização de medicamentos superior ao sexo masculino, 50,9 por cento e 45,4 por cento, respectivamente (p=0,004). A prevalência de uso de medicamentos diminuiu significativamente com a idade (p<0,001) em ambos os sexos. Os grupos farmacológicos mais utilizados foram os analgésicos/antitérmicos (25,5 por cento), antibacterianos sistêmicos (6,5 por cento) e antitussígenos/expectorantes (6,2 por cento). Na análise multivariada os fatores determinantes de maior utilização de medicamentos foram: idade (quatro a cinco, seis, sete a oito anos), sexo feminino, mães de cor da pele branca, pior percepção de saúde, interrupção de atividades por problemas de saúde e atendimento de saúde independentemente de estar doente nos últimos 15 dias, gasto com medicamentos no último mês e realização de consultas ao médico nos últimos três meses. CONCLUSÕES: A prevalência de uso de medicamentos entre crianças pobres estudadas foi inferior à verificada em outros estudos populacionais no Brasil, mas semelhante à de adultos. A identificação de grupos mais sujeitos ao uso excessivo de medicamentos pode embasar estratégias ...(AU)