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1.
Article in English | WPRIM | ID: wpr-922567

ABSTRACT

OBJECTIVE@#To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD).@*METHODS@#Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE), the average number of AEs (ANA), and the coverage rate of AEs (CRA). Further comparisons were also conducted, including the drugs with the most reported serious AEs, the AEs with the biggest report number, and the 5 serious AEs of interest (including death, anaphylactic shock, coma, dyspnea and abnormal liver function).@*RESULTS@#The PSE, ANA and CRA of WM were 1.09, 8.23 and 2.35 times higher than those of CM, respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash, pruritus, nausea, dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death, the proportions of WM were 5.47 and 3.00 times higher than those of CM, respectively.@*CONCLUSION@#Based on CSRD, CM was safer than WM at the average level from the perspective of adverse drug reactions.


Subject(s)
China , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Injections , Medicine, Chinese Traditional
2.
Rev. cuba. med ; 60(2): e1507, tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1280344

ABSTRACT

Introducción: Los adultos mayores generalmente presentan diferentes patologías, lo que implica un alto consumo de medicamentos, con lo cual, este grupo poblacional constituye uno de los que mayor cantidad de errores pueden cometer en el uso de fármacos. Objetivo: Evaluar el comportamiento del consumo de fármacos en una población perteneciente a la tercera edad. Métodos: Se realizó un estudio descriptivo de corte transversal en un consultorio médico del municipio Arroyo Naranjo de La Habana en el período entre octubre de 2018 y mayo de 2019. La población estuvo conformada por 365 pacientes geriátricos con diagnóstico de enfermedad crónica no transmisible (ECNT). Se realizó un muestreo al azar para un total de 67 pacientes seleccionados. Las variables analizadas fueron: edad, sexo, ECNT asociada y medicamentos consumidos. Los datos fueron obtenidos mediante revisión de historias clínicas y entrevistas realizadas. Se realizó un análisis porcentual para determinar prevalencia en cada variable analizada. Resultados: Los medicamentos que más destacaron en la muestra fueron los antihipertensivos e hipoglucemiantes. El consumo de medicamentos fue superior en los pacientes de 75 años en adelante y fundamentalmente en las mujeres. Los hombres, por su parte, constituyeron los más irresponsables en la adherencia al tratamiento. Conclusiones: Existió correspondencia entre los tratamientos y las patologías en la mayoría de los casos con excepción de algunos pacientes en los que la relación beneficio-riesgo del tratamiento no se cumplió totalmente. Sin embargo, de manera global, se considera que no existe un adecuado uso de los medicamentos en la muestra(AU)


Introduction: Aged adults generally have different pathologies, which implies high consumption of drugs, with which, this population group is one of those that can make the higher number of errors when using medication drugs. Objective: To evaluate the behavior of drug use in an elderly population. Methods: A descriptive cross-sectional study was carried out in a medical office in Arroyo Naranjo municipality, Havana, from October 2018 to May 2019. 365 geriatric patients made up the population they had diagnosis of chronic non-communicable disease (NCD). A random sampling was carried out for a total of 67 selected patients. The variables analyzed were age, sex, associated NCD, and medications used. The data were obtained by studying medical records and interviews. A percentage analysis was carried out to determine prevalence in each variable analyzed. Results: The drugs that stood out the most in the sample were antihypertensive and hypoglycemic drugs. The consumption of drugs was higher in patients aging 75 years and older and mainly in women. Men were the most irresponsible in adherence to treatment. Conclusions: There was correspondence between the treatments and the pathologies in most cases with the exception of some patients in whom the benefit-risk ratio of the treatment was not fully met. However, generally, it is considered that there is no adequate use of the drugs in the sample(AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Aged , Drug Therapy/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Epidemiology, Descriptive , Cross-Sectional Studies
3.
Ciênc. Saúde Colet ; 26(4): 1245-1257, abr. 2021. tab, graf
Article in Portuguese | LILACS | ID: biblio-1285930

ABSTRACT

Resumo Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latino-americanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.


Abstract The scope of this study was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study comprised three stages. In the first stage, the forms were attributed a score relating to the presence of critical items to generate ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate assessment of causality. In the last stage, hierarchical clustering was used to identify similar forms. The Venezuelan form achieved the highest score (18 points). The median number of variables in the forms of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the variables of the form were classified as life-critical and the majority contribute as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two distinct groups, 1 and 3 respectively. The results of this study indicate the need to change the forms of the different countries studied or even delete some variables, making them more appropriate for the process of assessment of ADR causality.


Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pharmacovigilance , United States , Bolivia , Brazil/epidemiology , Adverse Drug Reaction Reporting Systems
4.
Article in Chinese | WPRIM | ID: wpr-921726

ABSTRACT

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.


Subject(s)
Adverse Drug Reaction Reporting Systems , Books , Drug-Related Side Effects and Adverse Reactions/epidemiology , European Union , Humans , Medicine, Chinese Traditional , Pharmacovigilance
5.
Article in Chinese | WPRIM | ID: wpr-878898

ABSTRACT

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.


Subject(s)
Case-Control Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drugs, Chinese Herbal/adverse effects , Humans , Injections
6.
Rio de Janeiro; s.n; 2021. 105 p. ilus.
Thesis in Portuguese | LILACS, BDENF | ID: biblio-1366274

ABSTRACT

Introdução: O processo de notificação visa monitorar a ocorrência de incidentes para melhor compreensão e desenvolvimento de estratégias de prevenção e redução de danos, assim como promover a melhoria contínua da qualidade e segurança do cuidado prestado. O presente estudo teve como meta a estruturação de três produtos, a saber: Produto 1 ­ Produto bibliográfico técnico e tecnológico intitulado "Caracterização dos incidentes em um hospital público federal entre os anos 2014 a 2019"; Produto 2 ­ Produto bibliográfico técnico e tecnológico intitulado "Criação de sistema interno online para notificação de incidentes no espaço hospitalar: relato de experiência". Produto 3 ­ Produção técnica intitulada "Guia orientador para o preenchimento adequado dos dados no sistema interno online para notificação de incidentes". Objetivo: Criar um sistema interno online para monitoramento dos incidentes em um hospital federal, a partir do FormSUS, bem como organizar um guia orientador para a sua utilização para auxiliar os profissionais no processo de notificações. Materiais e Métodos: O primeiro produto foi um estudo transversal após pesquisa em base de dados secundários de acesso restrito referente ao período de 2014 a 2019, que identificou 10.837 incidentes classificados segundo as Metas Internacionais de Segurança do Paciente: Eventos Adversos, Incidentes sem Dano, Quase Falhas, Circunstâncias Notificáveis. O sistema de notificação foi construído por meio da plataforma do Departamento de Informática do Sistema Único de Saúde para criação de formulários públicos, conhecida como FormSUS versão 3.0. O instrumento já é existente no Ministério da Saúde com base na interface do FormSUS organizado a partir de dados, tais como: dados da internação, data da ocorrência do incidente, descrição completa do incidente, identificação do profissional notificador, contato por e-mail, telefone ou presencial, cargo e função do profissional notificador. Resultados: Finalmente, foi estruturado um guia orientador para preenchimento das notificações de forma simples, baseado em dúvidas mais frequentes, no qual se explicam detalhadamente os incidentes e a forma de acessar o sistema interno online de notificação para o envio ao Núcleo de Segurança do Paciente. Conclusões: Caracterizar e analisar os dados relacionados aos incidentes ocorridos no hospital é um exercício fundamental, pois auxilia o processo de educação contínua sobre segurança do paciente. A partir desse conhecimento, a criação de um sistema online de notificação, e do manual para o preenchimento correto dos formulários, pode contribuir para aumentar a adesão dos profissionais às notificações e trazer informações fidedignas para o desenvolvimento de estratégias que reduzam os danos ao paciente


Introduction: The notification process aims to monitor the occurrence of incidents in order to better understand and develop strategies for preventing and reducing harm, as well as promoting continuous improvement in the quality and safety of the care provided. The present study aimed at structuring three products, namely: Product 1 ­ Technical and technological bibliographic product entitled "Characterization of incidents in a federal public hospital between the years 2014 and 2019"; Product 2 ­ Technical and technological bibliographic product entitled "Creation of an internal online system for notification of incidents in the hospital space: experience report". Product 3 ­ Technical production entitled "Guiding guide for the proper filling of data in the internal online system for notification of incidents". Objective: Create an internal online system for monitoring incidents in a federal hospital, using FormSUS, as well as organizing a guiding guide for its use to assist professionals in the notification process. Materials and methods: The first product was a cross-sectional study after searching a secondary database with restricted access for the period from 2014 to 2019, which identified 10,837 incidents classified according to the International Patient Safety Goals: Adverse Events, Incidents Without Damage, Almost Failure, Circumstances Notifiable. The notification system was built using the platform of the Informatics Department of the Unified Health System to create public forms, known as FormSUS version 3.0. The instrument already exists at the Ministry of Health based on the FormSUS interface organized from data, such as: hospitalization data, date of the incident, complete description of the incident, identification of the notifying professional, contact by e-mail, telephone or in person, position and function of the notifying professional. Results: Finally, a guiding guide for filling out notifications in a simple way was structured, based on the most frequent doubts, in which the incidents are explained in detail and how to access the internal online notification system for sending to the Patient Safety Center. Conclusions: Characterizing and analyzing the data related to the incidents that occurred in the hospital is a fundamental exercise, as it helps the process of continuous education on patient safety. Based on this knowledge, the creation of an online notification system, and the manual for the correct filling of forms, can contribute to increase the professionals' adherence to the notifications and bring reliable information for the development of strategies that reduce harm to the patient


Subject(s)
Humans , Male , Female , Risk Management/methods , Patient Safety , Health Information Systems/statistics & numerical data , Formularies, Hospital as Topic/standards , Unified Health System , Online Systems , Drug-Related Side Effects and Adverse Reactions/epidemiology
7.
Cad. Saúde Pública (Online) ; 37(1): e00245820, 2021. tab
Article in Portuguese | LILACS | ID: biblio-1153671

ABSTRACT

Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.


En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.


In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher's chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student's t-test and Mann-Whitney's test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.


Subject(s)
Humans , COVID-19 , Brazil/epidemiology , Cross-Sectional Studies , Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pandemics , Pharmacovigilance , SARS-CoV-2
8.
Arch. cardiol. Méx ; 90(supl.1): 19-25, may. 2020.
Article in Spanish | LILACS | ID: biblio-1152838

ABSTRACT

Resumen La pandemia por COVID-19 ha tenido muy importantes repercusiones negativas, sanitarias, psicológicas, sociales y económicas para las personas, las familias, las comunidades, los países y para las para la humanidad en general. La interrelación con la edad y la presencia de enfermedades crónicas no trasmisibles (hipertensión, diabetes, obesidad, tabaquismo) parece ir mas lejos que lo que explicaría la prevalencia y distribución de ambas. Los medicamentos que actúan sobre el sistema renina-angiotensina-aldosterona, son pilares básicos en el manejo de estas enfermedades. Se sabe de tiempo atrás que estos fármacos aumentan en forma significativa la expresión en el tejido pulmonar de receptores para la enzima de conversión de angiotensina de tipo 2. Este hecho junto con el conocimiento de que la vía de entrada del virus a la célula es precisamente el receptor de ECA-2, inició una hipótesis, basada en evidencia de muy baja calidad, que rápidamente se generalizó en los medios de comunicación, de que el empleo de estos medicamentos podría ser negativo y que deberían suspenderse. La respuesta de prácticamente todas las sociedades científicas fue casi inmediata, con la indicación precisa de que no debería suspenderse el tratamiento con estos fármacos, puesto que la evidencia de su utilidad está basada en una evidencia muy sólida y de gran calidad. Casi simultáneamente también apareció la hipótesis, también basada en evidencia muy preliminar, de que estos medicamentos no solo resultan dañinos sino que son benéficos, tampoco se aceptan todavía como agentes para la prevención o tratamiento de esta enfermedad o sus complicaciones. La presente revisión relata los conocimientos actuales sobre la relación entre COVID-19 y SRAA.


Abstract The COVID-19 pandemic has had major negative health, psychological, social and economic repercussions for individuals, families, communities, countries and for humanity in general. The interrelation with age and the presence of chronic non-communicable diseases (hypertension, diabetes, obesity, smoking) seems to go further than what would be explained by the prevalence and distribution of both. The drugs that act on the renin-angiotensin-aldosterone system are in many cases the backbone for the management of these diseases, it has been known for a long time that these drugs significantly increase the expression of receptors for angiotensin conversion enzyme type 2 in the lung tissue. This fact, together with the knowledge that the route of entry of the virus into the cell is precisely the ACE-2 receptor, initiated a hypothesis, based on very low-quality evidence, which quickly became generalized in the media, that the use of these drugs could be negative and that they should be interrupted immediately. The response of practically all Scientific Societies was almost immediate, with the precise indication that treatment with these drugs should not be discontinued, since the evidence of their usefulness is based on very solid and high-quality evidence. Simultaneously, a different hypothesis also appeared, also based on very preliminary evidence, that these drugs are not only harmful but also beneficial, however these medicaments are not yet accepted as agents for the prevention or treatment of this disease or its complications. This review reports current knowledge on the relationship between COVID-19 and SRAA.


Subject(s)
Humans , Animals , Pneumonia, Viral/virology , Renin-Angiotensin System/physiology , Coronavirus Infections/virology , Pneumonia, Viral/drug therapy , Renin-Angiotensin System/drug effects , Risk Factors , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Peptidyl-Dipeptidase A/metabolism , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pandemics , Angiotensin-Converting Enzyme 2 , COVID-19
9.
Rev. Soc. Bras. Med. Trop ; 53: e20190150, 2020. tab
Article in English | LILACS | ID: biblio-1057268

ABSTRACT

Abstract INTRODUCTION: Benznidazole is used for treating Chagas disease (CD). This cross-sectional study aimed to characterize the adverse drug reactions (ADRs) of benznidazole at a public hospital in Brazil's Federal District. METHODS: Medical records were analyzed and ADRs were categorized by type, intensity, seriousness, and causality. RESULTS: Of the 62 patients who started benznidazole treatment for CD, 41 (66%) presented with 105 ADRs; 23 (37%) discontinued the treatment. Most reactions were classified as probable (81%), severe (63%), serious (67%), and dose-dependent (56%). CONCLUSIONS: The high incidence of ADRs because of treatment withdrawal revealed the need for safer alternatives for CD treatment.


Subject(s)
Humans , Male , Female , Adult , Trypanocidal Agents/adverse effects , Chagas Disease/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Nitroimidazoles/adverse effects , Socioeconomic Factors , Trypanocidal Agents/therapeutic use , Severity of Illness Index , Brazil/epidemiology , Hemagglutination Tests , Incidence , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions , Hospitals, Public , Middle Aged , Nitroimidazoles/therapeutic use
10.
Rev. Soc. Bras. Med. Trop ; 53: e20190207, 2020. tab
Article in English | LILACS | ID: biblio-1057305

ABSTRACT

Abstract INTRODUCTION: Adverse drug reactions can develop when using anti-tuberculosis medication, and the effects of the drugs can also significantly hinder the treatment of patients. METHODS: A cross-sectional survey was conducted in 73 patients using two standardized questionnaires and the World Health Organization Quality of Life-Bref. RESULTS: All patients reported the presence of adverse drug reactions, 71.6% of which are minor and 28.3% both major and minor. The global quality of life analysis showed that patients with tuberculosis have a good average (67.3%). CONCLUSIONS: There is an association between quality of life and adverse drug reaction, educational level, and vulnerability.


Subject(s)
Humans , Male , Female , Aged , Quality of Life/psychology , Tuberculosis/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Antitubercular Agents/adverse effects , Socioeconomic Factors , Tuberculosis/psychology , Cross-Sectional Studies , Surveys and Questionnaires , Drug-Related Side Effects and Adverse Reactions/psychology , Tertiary Care Centers , Middle Aged , Antitubercular Agents/administration & dosage
11.
Rev. Soc. Bras. Med. Trop ; 53: e20190443, 2020. tab
Article in English | LILACS | ID: biblio-1101452

ABSTRACT

Abstract INTRODUCTION: Herein, we aimed to identify the factors associated with adverse drug events (ADEs) in chronic Chagas disease (CD) patients. METHODS: We analyzed 320 medical notes from 295 patients. The Naranjo algorithm was applied to determine the cause of ADEs. Mixed effects logistic regression was performed to evaluate the factors associated with ADEs. RESULTS: ADEs were described in 102 medical notes (31.9%). Captopril was most frequently associated with ADEs. Age (RR 0.96; 95%CI 0.94-0.99) and cardiac C/D stages (RR 3.24; 95%CI 1.30-4.58) were the most important clinical factors associated with ADEs. CONCLUSIONS: Close follow-up is warranted for CD patients.


Subject(s)
Humans , Male , Female , Aged , Chagas Disease/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Socioeconomic Factors , Severity of Illness Index , Algorithms , Brazil/epidemiology , Chronic Disease , Middle Aged
12.
J. pediatr. (Rio J.) ; 95(6): 682-688, Nov.-Dec. 2019. tab, graf
Article in English | LILACS | ID: biblio-1056659

ABSTRACT

ABSTRACT Objective: To assess spontaneous reports of suspected adverse drug reactions in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. Methods: A cross-sectional study on suspected adverse drug reactions reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (World Health Organization). Results: A total of 3330 adverse drug reactions were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected adverse drug reactions reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. Conclusions: The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.


RESUMO Objetivo: Analisar relatos espontâneos de suspeitas de Reação Adversa a Medicamento (RAM) em crianças de 0 a 12 anos notificadas pela Agência Nacional de Vigilância Sanitária entre 2008 e 2013. Métodos: Um estudo transversal a partir de notificações de suspeitas de RAM relacionadas a medicamentos e produtos para a saúde em crianças foi realizado por um período de seis anos (2008-2013). O ano da notificação, a origem do relato por estado brasileiro, sexo, idade, o medicamento suspeito, a descrição da reação adversa e a gravidade foram incluídos na análise, bem como o número de leitos nos serviços de saúde e dados global da VigiBase. Resultados: Um total de 3330 reações adversas foram relatadas em crianças no Brasil no período investigado (54% em meninos). Cerca de 28% dos relatos de suspeitas de RAM envolveram crianças de 0 a 1 ano de idade. Quase 40% dos relatos vieram da região Sudeste. Aproximadamente 60% foram classificados como eventos graves. Houve ocorrência de morte em 75 casos. Quase 30% das mortes envolveram o uso off-label dos medicamentos. Um total de 3875 medicamentos (465 substâncias ativas) foram considerados fármacos suspeitos. Medicamentos anti-infecciosos (vancomicina, ceftriaxona, oxacilina e anfotericina), com ação no sistema nervoso (dipirona) e no trato digestivo foram os mais frequentemente notificados. Conclusões: As notificações de suspeitas de RAM por sexo e faixa etária corresponderam ao perfil de crianças hospitalizadas no Brasil. Os dados sobre gravidade e medicamentos relatados podem ser úteis para encorajar ações reguladoras e melhorar o uso seguro de medicamentos em crianças.


Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Databases, Factual/statistics & numerical data , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Brazil/epidemiology , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/classification , Sex Factors , Cross-Sectional Studies , Age Factors , Age Distribution
13.
Rev. Assoc. Med. Bras. (1992) ; 65(5): 611-617, May 2019. tab
Article in English | LILACS | ID: biblio-1012956

ABSTRACT

SUMMARY INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients.


RESUMO INTRODUÇÃO: Interação medicamentosa é uma importante causa de morbidade mundial. Apresenta especial importância em pacientes oncológicos, pois esses frequentemente estão em uso de polifarmácia, podendo haver interações entre os medicamentos e os quimioterápicos utilizados. OBJETIVO: Avaliar a interação medicamentosa entre a quimioterapia e outros medicamentos em pacientes oncológicos. MÉTODOS: Estudo transversal realizado em serviço ambulatorial de oncologia de um hospital público terciário. Foram incluídos 235 pacientes, identificando-se quais medicamentos eram utilizados por eles. Por meio do auxílio do banco de dados do MedScape e Epocrates, avaliaram-se as interações entre as medicações e os quimioterápicos, definindo sua frequência e dividindo sua gravidade da interação em leve, monitorização próxima e grave. RESULTADOS: Do total estudado, 161 pacientes apresentavam alguma interação medicamentosa, sendo nove tipos de interações leves, 23 tipos de interações com necessidade de monitorização próxima e dois tipos de interações graves. As interações mais frequentes foram entre fluoracil e leucovorin (32 casos) e ciclofosfamida e doxorrubicina (19 casos). As interações sérias foram entre aspirina e pemetrexed; e leucovorim e bactrim. CONCLUSÃO: No presente trabalho, interações medicamentosas foram frequentes, incluindo interações graves com potencial aumento de morbimortalidade. Assim, faz-se necessário que oncologistas tracem um plano terapêutico levando em consideração as possíveis interações medicamentosas entre a quimioterapia prescrita e demais medicações em uso pelos pacientes.


Subject(s)
Humans , Male , Female , Adult , Aged , Aged, 80 and over , Drug Interactions , Drug-Related Side Effects and Adverse Reactions/epidemiology , Antineoplastic Agents/adverse effects , Severity of Illness Index , Brazil/epidemiology , Cross-Sectional Studies , Risk Factors , Polypharmacy , Tertiary Care Centers , Hospitals, Public , Middle Aged
14.
Rev. méd. Chile ; 147(4): 416-425, abr. 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-1014242

ABSTRACT

Background: Medication related adverse events are an important cause of hospital admission or prolonged stay. Aim: To assess medication related adverse events in a hospital discharge database. Material and Methods: Revision of the Chilean hospital discharge database from 2010 to 2017 searching for ICD- 10 diagnostic codes corresponding to medication related adverse events. Results: The number of medication related adverse events was stable across the studied time lapse, but admission length increased. Between 34 and 111 people died every year due to medication related adverse events. Lactating babies, toddlers, adolescents and people over 80 years of age are at greater risk of experiencing these events. Conclusions: Medication related adverse events are more common than expected.


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Drug-Related Side Effects and Adverse Reactions/epidemiology , Hospitalization/statistics & numerical data , Time Factors , Chile/epidemiology , Sex Factors , Prevalence , Retrospective Studies , Risk Factors , Age Factors , Sex Distribution , Age Distribution
15.
Ciênc. Saúde Colet ; 24(2): 573-587, Feb. 2019. tab, graf
Article in Portuguese | LILACS | ID: biblio-984213

ABSTRACT

Resumo A amamentação desempenha um papel fundamental nos benefícios para a saúde do recém-nascido e da nutriz. O uso de fármacos durante a amamentação é um tema relevante, visto a frequente necessidade de tratamento farmacológico no período pós-parto. O presente artigo teve como objetivo realizar revisão bibliográfica sobre a eficácia e a segurança dos medicamentos utilizados durante o período de amamentação. Foram consultadas as bases de dados PubMed (National Library of Medicine), Science Direct e Biblioteca Virtual em Saúde (BVS), nas línguas portuguesa, inglesa e espanhola, em artigos publicados no período de 1981-2016. Esta revisão discute o risco do uso de medicamentos na lactação e os efeitos que podem causar no lactente. Poucos fármacos são contraindicados e outros requerem cuidados devido ao risco de efeitos adversos em lactentes ou ainda na supressão do volume de leite materno. Portanto, a divulgação de informações atualizadas para o profissional de saúde avaliar adequadamente os riscos e os benefícios do uso de fármacos durante a amamentação é de vital importância e, dessa forma, contribui para evitar o desmame precoce.


Abstract Breastfeeding plays a fundamental role in the benefits for the health of the newborn child and the nursing mother. The use of medications during breastfeeding is a relevant issue, by virtue of the frequent need for pharmacological treatment in the postpartum period. The scope of this article was to conduct a review of the literature regarding the efficacy and safety of medications used during the breastfeeding period. A search was conducted in the PubMed (National Library of Medicine), ScienceDirect and Biblioteca Virtual em Saúde (BVS) databases for articles published in Portuguese, English and Spanish in the period from 1981 to 2016. This review discusses the risk of the use of medications during lactation and the effects that they may have on the breastfed infant. Few medications are contraindicated and others require care due the risk of adverse effects on breastfed infants or in the suppression of breast milk volume. Therefore, the dissemination of updated information for the health professional to adequately assess the risks and the benefits of the use of medications during breastfeeding is of vital importance, thereby contributing to avoid early weaning.


Subject(s)
Humans , Female , Infant, Newborn , Infant , Breast Feeding , Drug-Related Side Effects and Adverse Reactions/epidemiology , Milk, Human/metabolism , Lactation , Drug-Related Side Effects and Adverse Reactions/prevention & control , Mothers
16.
Einstein (Säo Paulo) ; 17(3): eAO4521, 2019. tab, graf
Article in English | LILACS | ID: biblio-1011989

ABSTRACT

ABSTRACT Objective: To characterize severe potential drug interactions in maternal intensive care, and to determine their frequency, risk factors and potential risk medications. Methods: An observational and longitudinal study conducted between December 2014 and December 2015 in a maternal intensive care unit. Clinical data were collected and severe potential drug interactions were identified on pregnant inpatients. The drug interactions were classified by type, prevalence and exposure rate. A multivariate logistic regression model was used to identify the severe potential drug interactions and the related drugs (p<0.05). Results: A total of 95.1% of patients were exposed to, at least, one potential drug interaction; in that, 91.7% 33.9% were related to, respectively, moderate and severe potential drug interactions. The patients were exposed, on average, on 69.2% of days they were in the intensive care unit. The main drugs involved in more severe drug interactions were magnesium sulfate, metoclopramide, propranolol and diazepam. Conclusion: The severe potential drug interactions were observed in almost all patients of the study, and, approximately one third of those interactions were related to greater severity and resulted in exposure during long hospital stay. The higher number of prescribed drugs and its previous use of medications at home increase the occurrence of severe potential drug interactions.


RESUMO Objetivo: Caracterizar as interações medicamentosas potenciais graves em terapia intensiva materna, e determinar sua frequência, os fatores e os medicamentos de risco associados à ocorrência dessas interações. Métodos: Estudo observacional e longitudinal executado entre dezembro de 2014 a dezembro de 2015, conduzido em uma unidade de terapia intensiva materna. Foram coletados dados clínicos e identificadas interações medicamentosas potenciais graves de gestantes admitidas. As interações medicamentosas foram caracterizadas quanto ao tipo, à prevalência e à taxa de exposição. Um modelo multivariado de regressão logística foi utilizado para identificação de fatores associados à ocorrência de interações medicamentosas potenciais graves e os medicamentos implicados (p<0,05). Resultados: Um total de 95,1% das pacientes foi exposto a, no mínimo, uma interação medicamentosa potencial, com 91,7% delas envolvidas com interações medicamentosas potenciais moderadas e 33,9% com as interações graves. As pacientes ficaram expostas, em média, em 69,2% dos dias que estiveram sob terapia intensiva. Os principais medicamentos implicados em interações medicamentosas de maior gravidade foram sulfato de magnésio, metoclopramida, propranolol e diazepam. Conclusão: As interações medicamentosas potenciais graves ocorreram na maioria das pacientes avaliadas. Aproximadamente um terço das interações foram graves e levaram à maior exposição por um longo período de internação. Maior número de fármacos prescritos e uso prévio domiciliar de medicamentos elevam a ocorrência de interações medicamentosas potenciais graves.


Subject(s)
Humans , Female , Child , Adolescent , Adult , Young Adult , Risk Assessment/methods , Drug Interactions , Intensive Care Units/statistics & numerical data , Metoclopramide/pharmacology , Propranolol/pharmacology , Severity of Illness Index , Brazil/epidemiology , Pregnancy/drug effects , Logistic Models , Serial Cross-Sectional Studies , Prevalence , Multivariate Analysis , Risk Factors , Diazepam/pharmacology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Hospitalization/statistics & numerical data , Magnesium Sulfate/pharmacology
17.
Rev. bras. enferm ; 72(supl.2): 345-353, 2019. tab, graf
Article in English | LILACS, BDENF | ID: biblio-1057643

ABSTRACT

ABSTRACT Objective: To identify the knowledge produced on Medication-Related Problems in the transitional care of the elderly from hospital to home. Method: Integrative review of the literature data, organized in six stages: guiding question; establishment of inclusion and exclusion criteria; extraction of data; analyze; interpretation of results; and presentation of the review. Articles were considered among 2002 and 2017, in Portuguese, English, and Spanish, in the databases LILACS, MEDLINE, CINAHL and EMBASE. Results: 10 studies were selected and analyzed. They were categorized by subject and identified in three themes: Medication Discrepancy and Reconciliation (40%); Adhesion to Medication (30%); and Adverse Drug Events (30%). Final considerations: Drug-Related Problems in the transitional care of the elderly from hospital to home, were presented as a relevant theme for nursing, involving complex issues related to care. Drug reconciliation was evidenced as a coherent and effective strategy in home care transitions for the elderly.


RESUMEN Objetivo: identificar el conocimiento producido sobre Problemas Relacionados con los Medicamentos en la transición de ancianos del hospital a casa. Método: la revisión integrativa de la literatura, organizada en seis etapas: pregunta orientadora; establecimiento de criterios de inclusión y exclusión; extracción de datos; análisis; interpretación de los resultados; y presentación de la revisión. Se consideraron los artículos entre 2002 y 2017, en portugués, inglés y español, en las bases de datos LILACS, MEDLINE, CINAHL y EMBASE. Resultados: se seleccionaron y analizaron 10 estudios. Se clasificaron por tema y se identificaron tres temas: Discrepancia y Reconciliación de Medicamentos (40%); Adhesión al Medicamento (30%); y Eventos Adversos a los Medicamentos (30%). Consideraciones finales: los Problemas Relacionados con los Medicamentos en la transición de ancianos del hospital a casa, se presentó como un tema relevante para la enfermería, involucrando cuestiones complejas relacionadas con el cuidado. La reconciliación de medicamentos fue evidenciada como estrategia coherente y eficaz en las transiciones de cuidado del anciano a casa.


RESUMO Objetivo: identificar o conhecimento produzido sobre Problemas Relacionados a Medicamentos na transição de idosos do hospital para casa. Método: revisão integrativa da literatura, organizada em seis etapas: pergunta norteadora; estabelecimento de critérios de inclusão e exclusão; extração dos dados; análise; interpretação dos resultados; e apresentação da revisão. Consideraram-se artigos entre 2002 e 2017, nos idiomas português, inglês e espanhol, nas bases de dados LILACS, MEDLINE, CINAHL e EMBASE. Resultados: foram selecionados e analisados 10 estudos. Categorizaram-se por assunto e identificaram-se três temas: Discrepância e Reconciliação de Medicamentos (40%); Adesão ao Medicamento (30%); e Eventos Adversos a Medicamentos (30%). Considerações finais: os Problemas Relacionados a Medicamentos na transição de idosos do hospital para casa, apresentou-se como um tema relevante para a Enfermagem, envolvendo questões complexas relacionadas ao cuidado. A reconciliação de medicamentos foi evidenciada como estratégia coerente e eficaz nas transições de cuidado do idoso para casa.


Subject(s)
Humans , Male , Female , Aged , Drug-Related Side Effects and Adverse Reactions/diagnosis , Transitional Care/standards , Drug-Related Side Effects and Adverse Reactions/epidemiology , Transitional Care/trends , Hospitals/standards , Hospitals/trends , Middle Aged
18.
Rev. bras. epidemiol ; 22: e190018, 2019. tab, graf
Article in Portuguese | LILACS | ID: biblio-990747

ABSTRACT

RESUMO: Introdução: Os eventos toxicológicos relacionados a medicamentos têm alto impacto na morbimortalidade, representando a primeira causa de intoxicação no Brasil. Objetivo: Descrever as tendências de casos de eventos toxicológicos relacionados a medicamentos atendidos por um Centro de Informações Toxicológicas. Método: Estudo com abordagem quantitativa (transversal e de tendência), com análise dos dados referentes aos casos de eventos toxicológicos relacionados a medicamentos atendidos pelo Centro de Informações Toxicológicas do Hospital Universitário da Universidade Estadual de Londrina. Os dados foram coletados das fichas de atendimento, referentes ao período de 1985 a 2014. Para a análise estatística, utilizou-se um modelo de regressão linear simples. Resultados: Dos 36.707 casos atendidos pelo serviço, 22,5% (n = 8.608) foram eventos toxicológicos relacionados a medicamentos. Houve um aumento da proporção de casos em ambos os sexos (R2 = 0,195; p = 0,014) e no sexo masculino (R2 = 0,403; p < 0,001). Detectou-se tendência de elevação da proporção de casos envolvendo a classe de analgésicos, anti-inflamatórios e imunossupressores (R2 = 0,521; p = 0,018), antidepressivos (R2 = 0,923; p < 001) e antipsicóticos (R2 = 0,869; p < 0,001). Os antimicrobianos apresentaram tendência de redução da proporção de casos (R2 = 0,773; p = 0,001). Conclusões: Observou-se tendência de aumento da proporção de casos de eventos toxicológicos relacionados a medicamentos no sexo masculino. Também houve aumento nas tendências envolvendo analgésicos/anti-inflamatórios/imunossupressores, antidepressivos e antipsicóticos.


ABSTRACT: Introduction: Drug-related poisonings have a high impact on morbidity and mortality, representing the first cause of intoxication in Brazil. Objective: To describe the trends of cases of drug-related poisonings attended to by a poison control center. Method: A quantitative approach (cross-sectional trend study) with data analysis of cases of drug-related poisonings attended to at the Poison Control Center of University Hospital of the State University of Londrina. Data were collected from service notification records for the period 1985 to 2014. For statistical analysis, a simple linear regression model was used. Results: Of the 36,707 cases attended to by the service, 22.5% (n = 8,608) were drug-related poisonings. There was an increase in the proportion of cases for both sexes (R2 = 0.195, p = 0.014) and males (R2 = 0.403, p < 0.001). There was a trend towards a higher proportion of cases involving the analgesic, anti-inflammatory and immunosuppressive drug classes (R2 = 0.521, p = 0.018), antidepressants (R2 = 0.923, p < 0.001) and antipsychotics (R2 = 0.869; p < 0.001). Antibiotics showed a trend toward a lower proportion of cases (R2 = 0.773, p = 0.001). Conclusions: There was a trend for a higher proportion of cases of drug-related poisonings in males. Also, there was an increased trend towards cases involving analgesics/anti-inflammatories/immunosuppressants, antidepressants and antipsychotics.


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Adolescent , Adult , Young Adult , Poisoning/etiology , Poisoning/epidemiology , Pharmaceutical Preparations , Drug-Related Side Effects and Adverse Reactions/epidemiology , Poison Control Centers , Brazil , Linear Models , Sex Factors , Cross-Sectional Studies , Age Factors , Drug-Related Side Effects and Adverse Reactions/classification , Middle Aged
19.
Cad. Saúde Pública (Online) ; 35(8): e00148818, 2019. tab, graf
Article in Portuguese | LILACS | ID: biblio-1019624

ABSTRACT

Resumo: Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.


Abstract: The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.


Resumen: El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.


Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Adult , Aged , Aged, 80 and over , Young Adult , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Brazil/epidemiology , Pharmacovigilance , Government Agencies , Middle Aged
20.
Rev. medica electron ; 40(6): 2053-2070, nov.-dic. 2018.
Article in Spanish | LILACS, CUMED | ID: biblio-978717

ABSTRACT

RESUMEN La polifarmacia, definida como el consumo más de tres fármacos simultáneamente, constituye una de las situaciones más frecuentes con implicaciones relacionadas con la morbimortalidad en el adulto mayor, provocado por cambios fisiológicos que afectan la distribución de medicamentos: alteraciones en la motilidad intestinal, aumento del pH gástrico, disminución del flujo esplácnico y del transporte activo intestinal de sustancias como hierro o vitamina B12, cambios en la distribución por disminución de agua corporal total , reducción de la masa magra corporal y de las proteínas totales que afecta el transporte ligado a ellas, de ahí la necesidad de su atención por un profesional suficientemente capacitado. Ante esta situación se realizó una revisión bibliográfica en bases de datos de Infomed y se seleccionaron 46 artículos científicos que cumplieron con los criterios de búsqueda, se obtuvieron 29 referencias bibliográficas y el 79.32 % de la bibliografía correspondió a los últimos cinco años. Con ello los autores pretenden contribuir en las buenas prácticas clínicas de los facultativos encargados de la atención del adulto mayor (AU).


ABSTRACT Polipharmacy, defined as the consumption of more than three medicinal products, is one of the most frequent situations with implications related to morbi-mortality in elder people due to physiological changes affecting the medicinal product distribution: alterations of the intestinal motility, gastric pH intensification, decrease of the esplacnic flow and active intestinal transportation of substances like iron or B12 vitamins, changes in the distribution due to decrease of total body water, reduction of the body lean mass and total proteins affecting the transportation linked to them; therefore the necessity of a highly trained professional care. For all that we carried out a bibliographic review in Infomed databases and chose 46 scientific articles fulfilling the search criteria, finding 29 bibliographic references; 79.32 % of the bibliography corresponded to the last five years. The authors pretend make their contributions to the good clinical practices of the professionals involved in elder people care (AU).


Subject(s)
Humans , Aged , Aging , Population Dynamics , Frail Elderly , Polypharmacy , Drug Interactions , Drug-Related Side Effects and Adverse Reactions/epidemiology , Self Medication , Health Programs and Plans , Life Expectancy , Morbidity , Mortality , eHealth Strategies , Health Services for the Aged
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