Perfil do consumo dos benzodiazepínicos nos anos de 2019 e 2020 no brasil e regiões / Profile of the benzodiazepines in the years 2019 e 2020 in Brazil and regions / Perfil de consume y hospitalizaciones de los benzodiacepinas en los años 2019 y 2020 enBrasil y regiones

Os benzodiazepínicos estão entre os medicamentos mais prescritos, principalmente em países ocidentais, onde estimativas mostram um consumo anual de 1% a 3% da população.Objetivo:Estudar o perfil do consumo dos benzodiazepínicosnos anos de 2019-2020. Metodologia:Foram estudadas a taxa de desocupação segundo o Instituto Brasileiro de Geografia e Estatística, consumo dos benzodiazepínicosa partir do Sistema Nacional de Gerenciamento de Produtos Controlados da Agencia de Vigilância Sanitáriae quantidade de internações por envenenamento com exposição (acidental ou proposital), auto-intoxicação e efeitos adversos aos anticonvulsivantes, sedativos, hipnóticos, antiparkinsonianos e psicotrópicos segundo o Departamento de Informática do Sistema Único de Saúde no Brasil. Resultados:A região Norte e Nordeste apresentou um aumento na taxa de desocupação. O rendimento nominal mensal domiciliar per capitada população residente nas regiões Norte e Nordeste se manteveabaixo de 01 salário-mínimo nos anos de 2019 e 2020. De 2019 para 2020, o princípio ativo mais utilizado dos benzodiazepínicos industrializados foi o Clonazepam com incremento de 9,81% no Brasil e 22,52% na região Nordeste. Todas as formas farmacêuticas manipuladas apresentaram umaredução no consumo de 2019 para 2020, com exceção da forma em mililitros que apresentou um incremento para o bromazepam (42,1%), clonazepam (8,76%) e diazepam (5,27%). De 2020 em relação a 2019, ocorreu um incrementode 119,05% e 25% nas regiões Nordeste e Centro-Oeste, respectivamente, nasinternações por envenenamento [intoxicação] por exposição, a anticonvulsivantes (antiepilépticos), sedativos, hipnóticos, antiparkinsonianos e psicotrópicos não classificados em outra parte, intenção não determinada. Conclusões:Ocorreu um aumento no consumo de benzodiazepínicosindustrial no ano de 2020 sendo o envenenamento [intoxicação] umadas principais causasde internação. Há necessidade de um controle do consumo e vigilância aos psicotrópicos visto que estes fármacos estão dentre aqueles com risco de internações devido àexposição acidental ou não, autointoxicaçãoou efeitos adversos (AU).

Benzodiazepines are among the most prescribed drugs, especially in Western countrieswhere estimates show an annual consumption of 1% to 3% of the population.Objective: To study the profile of benzodiazepinesconsumptionfrom the National Controlled Products Management System of the Sanitary Surveillance Agencyin the years 2019 and 2020.Methodology:The unemployment rate,according to theBrazilian Institute of Geography and Statistics,benzodiazepines consumptionfrom the National Controlled Products Management System of the Sanitary Surveillance Agency, and the number of hospitalizations due to poisoning with exposure (accidental or intentional), self-intoxication, and adverse effects to anticonvulsants, sedatives, hypnotics, antiparkinsonian drugs and psychotropic drugs according to the Department of Informatics of the Unified Health System in Brazil were studied.Results:The North and Northeast regions showed an increase in the unemployment rate. The nominal monthly household income per capita of the population residing in the North and Northeast regions remained below 01 minimum wage in the years 2019 and 2020. From 2019 to 2020, the most used active substanceof industrialized benzodiazepines was Clonazepam with an increase of 9.81% in Brazil and 22.52% in the Northeast region. All compounded pharmaceutical forms showed a reduction in consumption from 2019 to 2020, with the exception of the form in milliliters which showed an increase for bromazepam (42.1%), clonazepam (8.76%) and diazepam (5.27%). In 2020 compared to 2019, there was an increase of 119.05% and 25% in the Northeast and Midwest regions, respectively, in hospitalizations for poisoning[intoxication] due to exposure toanticonvulsants (antiepileptics), sedatives, hypnotics, antiparkinsonian drugs,and psychotropic drugs not elsewhere classified with intent undetermined.Conclusions:There was an increase in the consumption of industrial benzodiazepines in 2020, with poisoning [intoxication] being one of the main causes of hospitalization. There is a need to control the consumption andincrease the surveillance of psychotropic drugs becausethese drugs are among those that involverisk of hospitalization due to accidental or non-accidental exposure, self-intoxication or adverse effects (AU).

ntroducción: Las benzodiacepinas se encuentran entre los fármacos más recetados, especialmente en los países occidentales, donde se estima que de 1% al 3% de la poblaciónde estos países los consumen. Objetivo: Estudiar el perfil del consumo de benzodiacepinas en los años 2019-2020.Metodología: Se midieron la tasa de desempleo según elInstituto Brasileño de Geografía y Estadística, el consumo de benzodiacepinasdel Sistema Nacional de Gestión de Productos Controlados de la Agencia de Vigilancia Sanitariay el número de hospitalizaciones por intoxicación con exposición (accidental o intencional), además se estudiaron autointoxicaciones y efectos adversos a los anticonvulsivos, sedantes, hipnóticos, drogas contra el mal de Parkinsony psicotrópicossegún elDepartamento de Informática del Sistema Único de Salud de Brasil.Resultados: Las regiones Norte y Nordeste presentaron aumento de la tasa de desempleo. El ingreso nominal mensual de los hogares per cápita de la población residente en las regiones Norte y Nordeste se mantuvo por debajo de 01 salario mínimo en los años 2019-2020. De 2019 a 2020, el principio activo más utilizado de las benzodiacepinas industrializadas fue el clonazepam con un aumento de 9,81% en Brasil y de22,52% en la región Nordeste. Todas las formas farmacéuticas compuestas mostraron una reducción en su consumo de 2019-2020, a excepción de la forma en mililitros que mostró un aumento para bromazepam (42,1%), clonazepam (8,76%) y diazepam (5,27%). En 2020 respecto a 2019, hubo un aumento del 119,05% y 25% en las regiones Noreste y Medio Oeste, respectivamente, en las hospitalizaciones por intoxicación por exposición aanticonvulsivos (antiepilépticos), sedantes, hipnóticos, drogas contra el mal de Parkinsony psicofármacos no clasificados en otra parte conintención indeterminada.Conclusiones: Hubo un aumento en el consumo de benzodiacepinas industriales en 2020, siendo las intoxicaciones una de las principales causas de hospitalización. Existe la necesidad de controlar el consumo y vigilancia de los psicofármacos, ya que estos fármacos se encuentran entre los de riesgo de hospitalización por exposición accidental o no accidental, autointoxicación o efectos adversos (AU).

Eventos adversos em uma unidade de internação psiquiátrica / Eventos adversos en una unidad de hospitalización psiquiátrica / Adverse events in a psychiatric hospitalization unit

RESUMO Objetivo descrever os eventos adversos presentes na internação psiquiátrica, analisando-os à luz da teoria do erro humano. Método pesquisa qualitativa, realizada em 2018 em um hospital psiquiátrico. Os dados foram coletados por entrevistas semiestruturadas com 15 profissionais de saúde da equipe multidisciplinar. A análise foi lexical por meio do software Alceste. Resultados evidenciaram-se eventos adversos medicamentosos por erros de administração ou por reações adversas a medicamentos, que produzem danos como impregnação, reações extrapiramidais associadas aos riscos de queda e broncoaspiração pela sonolência e/ou sedação. Outros danos relacionam-se à agressividade do paciente, que produz lesões corporais a si ou a outro, como durante uma tentativa de suicídio ou uso de violência como comportamento de fuga ou defesa. Considerações finais e implicações para a prática existem eventos adversos mais comuns nos ambientes de internação psiquiátrica que precisam ser de conhecimento da equipe de saúde mental porque demandam ações de mitigação por meio do fortalecimento dos sistemas de segurança do paciente. Os dados subsidiam ações para o fortalecimento dos sistemas de segurança nos ambientes de internação psiquiátrica e contribuem à reflexão do conceito de segurança do paciente na psiquiatria.

RESUMEN Objetivo describir los eventos adversos presentes en la hospitalización psiquiátrica, analizándolos a la luz de la teoría del error humano. Método investigación cualitativa, realizada en 2018 en un hospital psiquiátrico. Los datos se recolectaron a través de entrevistas semiestructuradas con 15 profesionales de la salud del equipo multidisciplinario. Se llevó a cabo el análisis léxico por medio del software Alceste. Resultados se evidenciaron eventos adversos por errores de administración o reacciones adversas al fármaco, que producen daños como impregnación y reacciones extrapiramidales asociadas al riesgo de caídas y broncoaspiración por somnolencia y / o sedación. Otros daños se relacionan con agresividad por parte del paciente, que produce daño corporal a sí mismo o a otro, como durante un intento de suicidio o uso de violencia como conducta de fuga o defensa. Conclusión e implicaciones para la práctica hay eventos adversos más comunes en entornos de hospitalización psiquiátrica que deben ser conocidos por el equipo de salud mental porque exigen acciones de mitigación a través del fortalecimiento de los sistemas de seguridad del paciente. Los datos reflejan la necesidad de implementar acciones para fortalecer los sistemas de seguridad en entornos de hospitalización psiquiátrica y contribuyen a la reflexión del concepto de seguridad del paciente en psiquiatría.

ABSTRACT Objective to describe the adverse events found in psychiatric hospitalization, analyzing them in the light of the human error theory. Method a qualitative research study, carried out in 2018 in a psychiatric hospital. The data were collected through semi-structured interviews with 15 health professionals from the multidisciplinary team. Analysis was of the lexical type using the Alceste software. Results adverse drug events were evidenced due to administration errors or adverse drug reactions, which produce harms such as impregnation and extrapyramidal reactions associated with the risks for falls and bronchoaspiration due to drowsiness and/or sedation. Other harms are related to the patient's aggressiveness, which produce bodily self-harm or harms to another person, such as during a suicide attempt or use of violence as an escape or defense behavior. Conclusion and implications for the practice some adverse events are more frequent in psychiatric hospitalization settings; such events need to be known by the mental health team, as they require mitigation actions through the strengthening of patient safety systems. The data subsidize actions for strengthening safety systems in psychiatric hospitalization settings and contribute to reflecting on the concept of patient safety in Psychiatry.

Interações medicamentosas potenciais em adultos e idosos na atenção primária / Potential drug interactions in adults and the elderly in primary health care

Resumo O objetivo do presente estudo foi caracterizar as interações medicamentosas potenciais (IMP) e avaliar os fatores associados à sua ocorrência em adultos e idosos assistidos pelo Programa Médico de Família de Niterói, Rio de Janeiro. Trata-se de um subestudo do ESTUDO DIGITALIS, que incluiu indivíduos cadastrados no Programa Médico de Família de Niterói (45-99 anos). Foram analisados 341 indivíduos com prescrição de dois ou mais medicamentos. A classificação das IMP seguiu o MICROMEDEX®. Houve 113 interações diferentes. Do total de indivíduos, 63,6% apresentaram pelo menos uma IMP. As variáveis com maior chance de IMP foram: menor escolaridade; renda inferior a R$800,00; ausência de plano de saúde; diagnóstico de hipertensão, diabetes, infarto agudo do miocárdio; e uso de 5 ou mais medicamentos prescritos. Após ajuste, as variáveis diagnóstico anterior de hipertensão e diabetes e uso de 5 ou mais medicamentos prescritos permaneceram significativas estatisticamente. É importante uma gestão cautelosa do tratamento na atenção básica com monitoramento das IMP, especialmente em pacientes mais susceptíveis.

Abstract The objective of the present study was to characterize the potential drug interactions (PDI), estimating the factors associated to their occurrence in adults and the elderly assisted by the Programa Médico de Família de Niterói, Rio de Janeiro. This is a sub-study of STUDY DIGITALIS, which included individuals enrolled in the Niteroi Family Medical Program (45-99 years). In this study, 341 individuals with a prescription of two or more drugs were analyzed. The classification of PDI followed MICROMEDEX. There were 113 different interactions. Of the total number of individuals, 63.6% had at least one PDI. The variables with higher probability of PDI were: lower level of schooling; income less than R$800.00; absence of health plan; previous diagnosis of hypertension and diabetes; use of 5 or more medications prescribed. After adjustment, the variables previous diagnosis of hypertension and diabetes and use of 5 or more prescription drugs remained statistically significant. Careful management of primary care treatment with monitoring is important in patients with PDI, especially in patients who are more susceptible.

Intervenções farmacêuticas em prescrições pediátricas: uma revisão narrativa / Pharmaceutical interventions in pediatric prescriptions: a narrative review

As intervenções farmacêuticas (IFs) são um componente importante no papel do farmacêutico clínico na prevenção de eventos adversos relacionados a medicamentos. A maioria dos estudos aborda as IFs em pacientes adultos e ainda há uma lacuna de informações sobre essas intervenções na população pediátrica. Trata-se de uma revisão narrativa sobre as IFs em prescrições de medicamentos de pacientes pediátricos internados em hospitais. A coleta de dados foi realizada entre julho e agosto de 2018 em três bases de dados e foram selecionados artigos publicados entre janeiro de 2010 a julho de 2018. As IFs apresentaram resultados positivos para os pacientes pediátricos. No total, foram descritos 35700 IFs realizadas com uma taxa de aceitação média de 92% por parte dos prescritores nos estudos que quantificaram a aceitação. A classe de medicamentos mais envolvidas nas IFs foi a de anti-infecciosos. Através dos estudos é possível concluir que as IFs podem beneficiar a segurança do paciente e levar à identificação de potenciais erros, além da prevenção de eventos adversos relacionados a terapia medicamentosa. São necessárias pesquisas contínuas que utilizem métodos padronizados para avaliar desfechos e eventos, permitindo assim a comparação entre resultados. (AU)

Pharmaceutical interventions (PIs) are an important component of the role of the clinical pharmacist in preventing drug-related adverse events. Most studies have addressed PIs in adult patients and there is still a lack of information on these interventions in the pediatric population. This narrative review focuses on PIs in prescriptions of pediatric patients admitted to hospitals. Data collection was performed from July to August 2018 in three databases, and articles published from January 2010 to July 2018 were selected. The reported PIs showed positive results for pediatric patients. In total, 35,700 PIs were performed with an average acceptance rate of 92% by prescribers in the studies that measured acceptance. The most common class of drugs used in PIs was anti-infective drugs. Based on the studies, a possible conclusion is that PIs may contribute to patient safety and lead to identification of potential errors as well as prevention of drug-related adverse events. Further research using standardized methods is required to evaluate outcomes and events, thus allowing a comparison between results. (AU)

Patrones de prescripción de metadona entre médicos colombianos especialistas en manejo del dolor / Methadone Prescription Patterns among Pain Physicians in Colombia

Introducción: el dolor crónico es una enfermedad con graves consecuencias para personas, médicos y sistemas de salud. Una de las estrategias de manejo es el uso prolongado de opioides, y dentro de los disponibles en Colombia se encuentra la metadona, con características farmacológicas únicas y asociación con aumento de mortalidad por sobredosis y complicaciones cardiovasculares. La adecuada prescripción y seguimiento de metadona se relaciona con complicaciones similares al manejo con otros opioides. Objetivo: describir los patrones de prescripción de metadona entre médicos colombianos especialistas en manejo de dolor y comparar estos patrones de prescripción con las recomendaciones mayormente aceptadas por la comunidad científica internacional. Materiales y métodos: se utilizó una encuesta electrónica estructurada aplicada entre médicos especialistas en dolor identificados a través de las principales agremiaciones y programas de formación nacionales. Resultados: los encuestados que respondieron son mayoritariamente experimentados anestesiólogos, con entrenamiento universitario clínico y que trabajan en hospitales universitarios. La mayoría de ellos percibe como efectivo el manejo a largo plazo con opioides para el control analgésico y la mejoría funcional, a pesar de la falta de respaldo empírico. La mayoría no aplica las herramientas recomendadas por guías de práctica clínica, aunque las conocen. Conclusiones: se debe mejorar la educación de prescriptores de metadona para mejorar la seguridad de los pacientes. Se infiere pobre aplicabilidad de herramientas recomendadas por guías de práctica clínica en el medio colombiano. Los resultados de la presente encuesta no son fácilmente generalizables.

Background: Chronic pain is a disease with serious consequences for people, physicians, and health care systems. Chronic opioid usage is one of this therapy strategy. Methadone is among the available opioids in Colombia and it is characterized by unique pharmacological properties and increased mortality reports because of overdose and cardiovascular complications. Appropriate monitoring and prescribing patterns of methadone are associated with complications similar to chronic management with other opioids. Aim: To describe methadone prescribing patterns among Colombian pain physicians and compare them to the accepted recommendations by the international scientific community. Materials and Methods: An electronic structured survey was applied to pain specialist physicians identified through major pain study associations and national training programs. Results: Respondents of the survey are mostly experienced university certified physicians and anesthesiologists with clinical training working at university hospitals. Most of them perceive chronic opioid therapy as an effective strategy for pain relief and functional outcomes despite the lack of empirical support. Most of them know clinical practice guidelines but are not applying them despite this matter. Conclusions: We must enhance education for prescribers in order to improve patient safety. The recommended clinical practice guidelines are poorly applied by Colombian doctors. The results of this study must be cautiously assessed.

Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil / Intercambialidade de medicamentos não-bioequivalentes, segurança do paciente e dinâmica do mercado farmacêutico no Brasil

Abstract Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a "comparable" bioavailability, i.e., an "equivalent" similar drug (EQ). Drugs for chronic diseases and "critical dose medicines" are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.

Resumo A partir da vigência da lei dos genéricos (1999), três tipos de produtos farmaceuticamente equivalentes são comercializados no Brasil: o medicamento inovador de refência (REF), o produto "similar" (S), e o genérico (G). O similar (nome de fantasia) e o genérico (nome genérico) tomam de empréstimo do REF (nome de fantasia) os dados clínicos de segurança e eficácia e a posologia. G (mas não S) é bioequivalente ao, e intercambiável com REF. Desde 2003, a Agência Nacional de Vigilância Sanitária (Anvisa) exige dados de testes de biodisponibilidade relativa para registrar (ou renovar o registro de) medicamentos S. Em 2014, a Anvisa estendeu o conceito de intercambialidade aos medicamentos similares com biodisponibilidade "comparável", i.e., um medicamento similar "equivalente" (EQ). Medicamentos para doenças crônicas e "fármacos de dose crítica" estão listados entre os produtos EQ aprovados. A intercambialidade de medicamentos não-bioequivalentes suscita grande preocupação quanto a falhas terapêuticas e eventos adversos. Os receios são ainda maiores se os pacientes trocam um medicamento por outro durante o tratamento de doenças como epilepsia, insuficiência cardíaca, hipertensão, diabetes e/ou os produtos farmacêuticos substituídos tem um índice terapêutico estreito.

Errores en las recetas médicas y en la preparación de estas en farmacia de pacientes ambulatorios: El caso del Hospital de Nueva Imperial / Errors in prescriptions and their preparation at the outpatient pharmacy of a regional hospital

Background: Adverse effects of medications are an important cause of morbidity and hospital admissions. Errors in prescription or preparation of medications by pharmacy personnel are a factor that may influence these occurrence of the adverse effects Aim: To assess the frequency and type of errors in prescriptions and in their preparation at the pharmacy unit of a regional public hospital. Material and Methods: Prescriptions received by ambulatory patients and those being discharged from the hospital, were reviewed using a 12-item checklist. The preparation of such prescriptions at the pharmacy unit was also reviewed using a seven item checklist. Results: Seventy two percent of prescriptions had at least one error. The most common mistake was the impossibility of determining the concentration of the prescribed drug. Prescriptions for patients being discharged from the hospital had the higher number of errors. When a prescription had more than two drugs, the risk of error increased 2.4 times. Twenty four percent of prescription preparations had at least one error. The most common mistake was the labeling of drugs with incomplete medical indications. When a preparation included more than three drugs, the risk of preparation error increased 1.8 times. Conclusions: Prescription and preparation of medication delivered to patients had frequent errors. The most important risk factor for errors was the number of drugs prescribed.

Clinical Features of Drug-induced Liver Injury According to Etiology

Drug-induced liver injury (DILI) is an increasingly common cause of acute hepatitis. We examined clinical features and types of liver injury of 65 affected patients who underwent liver biopsy according DILI etiology. The major causes of DILI were the use of herbal medications (43.2%), prescribed medications (21.6%), and traditional therapeutic preparations and dietary supplements (35%). DILI from herbal medications, traditional therapeutic preparations, and dietary supplements was associated with higher elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels than was DILI from prescription medications. The types of liver injury based on the R ratio were hepatocellular (67.7%), mixed (10.8%), and cholestatic (21.5%). Herbal medications and traditional therapeutic preparations were more commonly associated with hepatocellular liver injury than were prescription medications (P = 0.002). Herbal medications and traditional therapeutic preparations induce more hepatocellular DILI and increased elevations in AST and ALT than prescribed medications.

Programas de monitoreo de medicamentos de prescripción en los Estados Unidos de América / Prescription drug monitoring programs in the United States of America

Desde finales de la década de los años noventa, el número de muertes por sobredosis que involucran analgésicos opioides se ha cuadriplicado en los Estados Unidos de América (de 4 030 muertes en 1999 a 16 651 en 2010). Los objetivos de este artículo son proporcionar una visión general del problema de sobredosis de medicamentos de prescripción en los Estados Unidos y discutir las acciones que podrían ayudar a reducir el problema, abordando en forma directa las características de los Programas de monitoreo de medicamentos de prescripción (PDMP). Estos programas están compuestos de bases de datos a nivel estatal que vigilan las sustancias controladas. La información recopilada en las bases de datos está a disposición de las personas autorizadas por el Estado (por ejemplo, los médicos, los farmacéuticos y otros proveedores de cuidado médico) y debe ser utilizada solo con propósitos profesionales. Los proveedores pueden utilizar dicha información para evitar la interacción con otros medicamentos, la duplicación terapéutica o la identificación de conductas de búsqueda de drogas. Las agencias del orden público pueden utilizar estos programas para identificar patrones de prescripción inadecuada, dispensación o desviación.

Since the late 1990s, the number of opioid analgesic overdose deaths has quadrupled in the United States of America (from 4 030 deaths in 1999 to 16 651 in 2010). The objectives of this article are to provide an overview of the problem of prescription drug overdose in the United States and to discuss actions that could help reduce the problem, with particular attention to the characteristics of prescription drug monitoring programs (PDMPs). These programs consist of state-level databases that monitor controlled substances. The information compiled in the databases is at the disposal of authorized persons (e.g., physicians, pharmacists, and other health-care providers) and may be used only for professional purposes. Suppliers can use such information to prevent interaction with other drugs or therapeutic duplication, or to identify drug-search behavior. Law enforcement agencies can use these programs to identify improper drug prescription or dispensing patterns, or drug diversion.

Características de las interacciones farmacológicas en una unidad de cuidados intensivos de pediatría / Characteristics of drug interactions in a pediatric intensive care unit

Introduction: The aim of this study is to calculate the theoretical frequency of potential drug interactions (PDI) and their characteristics in the therapeutic plan of hospitalized patients in a Pediatric Intensive Care Unit (PICU). Patients and Methods: An observational study was conducted which analyzed PICU prescriptions between September and November 2011. The inclusion criteria included to be hospitalized in a PICU, requirements of at least 3 drugs, except those topically applied, either gender, no age limit, no hospital stay required. The Micromedex ® 2.0 program was used to detect and classify PDI. Results: Of 223 patients, 100 met inclusion criteria, 610 prescriptions were analyzed and 815 drugs were prescribed. 1,240 PDI were detected in 44 patients; 12 patients received more than 10 drugs each, presenting 1,162 PDI (93.7% of total PDI). 8 patients were hospitalized for more than 10 days, presenting 1,035 PDI (83.5% of total PDI). According to PDI theoretical severity, 37.5% were high, 51.7% moderate, 6.7% low and 4.1% contraindicated. The therapeutic group most involved was antimicrobials (17.6%) and the most frequently involved individual drugs were chloral hydrate (15.9%), midazolam (14.1%) and vecuronium (13.4%). Conclusion: PDI were more frequent in patients associated with major polypharmacy and longer hospital stay.

Introducción: El objetivo de éste estudio fue medir la frecuencia teórica de interacciones farmacológicas probables (IF) y sus características en los esquemas terapéuticos de los pacientes hospitalizados una Unidad de Cuidados Intensivos Pediátricos (UCIP). Pacientes y Método: Estudio observacional que analizó las prescripciones médicas en UCIP entre septiembre y noviembre del año 2011. Criterios de inclusión fueron estar hospitalizados en la UCIP, tener prescripciones que incluyan a lo menos 3 medicamentos, excepto aquellos de aplicación tópica, ambos sexos, sin límite de edad, ni estadía hospitalaria. Se utilizó el programa Micromedex 2.0® para la detección y clasificación de las IF. Resultados: De 223 pacientes, 100 cumplieron criterio de inclusión, en quienes se analizaron 610 prescripciones médicas, donde se indicaron 815 fármacos. Se detectaron 1.240 IF en 44 pacientes. Doce pacientes recibieron más de 10 fármacos cada uno, registrándose en ellos 1.162 IF (93,7% de las IF). Ocho pacientes estuvieron más de 10 días hospitalizados, concentrando 1.035 IF (83,5% de las IF). Según severidad teórica de las IF, se encontró 37,5% mayores, 51,7% moderadas, 6,7% menores y 4,1% contraindicadas. El grupo terapéutico más implicado fueron los antimicrobianos (17,6%) y los fármacos individuales más frecuentemente involucrados fueron hidrato de cloral (15,9%), midazolam (14,1%) y vecuronio (13,4%). Conclusión: Las IF fueron más frecuentes en pacientes con mayor polifarmacia y estadía más prolongada.

Perceptions by pregnant and childbearing-age women in southern Brazil towards teratogenic risk from medicines and radiotherapy / Percepções de risco teratogênico de medicamentos e radioterapia por gestantes e mulheres em idade fértil no Sul do Brasil / Percepciones de riesgo teratogénico de medicamentos y radioterapia en mujeres embarazadas y en edad fértil en el sur de Brasil

Mistaken perception of teratogenic risk can keep pregnant women from using safe medicines. The current study analyzed women’s concepts and perceptions towards teratogenic risk from medicines and exposure to radiotherapy during pregnancy. The quantitative data resulted from interviews with 287 pregnant and non-pregnant women. Two qualitative focus groups were conducted. No significant differences were observed between the two groups in terms of perceptions of teratogenic risk. Median perceptions of non-teratogenic exposures (paracetamol and metoclopramide) were close to the expected values, while higher values were found for teratogenic exposures (misoprostol and radiotherapy). The logic women used to estimate risk was classification of medicines as “strong” or “weak”. Medicines perceived as “weak” by the women do not pose any teratogenic risk, as shown by the median perceptions close to the true values. Meanwhile, “strong” medicines were viewed as dangerous, thus explaining the high median perceptions of teratogenic exposures.

Percepção de risco teratogênico equivocada pode privar a gestante do uso de medicamentos seguros. O estudo analisou concepções e percepções de risco teratogênico de mulheres sobre o uso de medicamentos e exposição à radioterapia durante a gestação. Dados quantitativos resultaram da realização de entrevistas com 287 gestantes e não gestantes. Qualitativamente, dois grupos focais foram realizados. Não se observaram diferenças significativas nas percepções de risco teratogênico entre grupos. As medianas das percepções para as exposições não teratogênicas – paracetamol e metoclopramida – foram próximas do valor esperado, e para as exposições teratogênicas – misoprostol e radioterapia – valores maiores foram encontrados. A lógica acionada pelas mulheres na estimação do risco é a da classificação dos medicamentos em fortes e fracos. Medicamentos percebidos pelas mulheres como fracos não apresentam risco, evidenciado pela aproximação das medianas ao valor esperado. Já medicamentos fortes são vistos como perigosos, justificando as altas medianas das exposições teratogênicas.

Percepción equivocada del riesgo teratogénico puede privar a las embarazadas de la utilización de medicamentos seguros. En este estudio se analizan las concepciones y la percepción de riesgo teratogénico de mujeres con respecto al uso de medicamentos y exposición a la radioterapia durante el embarazo. Los datos cuantitativos resultan de la administración de entrevistas a 287 mujeres embarazadas y no embarazadas; los cualitativos, de dos grupos focales. No se encontraron diferencias significativas en la percepción de riesgo entre los grupos. Las medianas para la percepción de riesgo a las exposiciones no teratogénicas resultaron cerca del valor esperado, mientras que para las exposiciones teratogénicas se encontraron valores más altos. La lógica usada por las mujeres para estimar el riesgo clasifica los medicamentos en fuertes y débiles. Aquellos percibidos como débiles no suponen riesgo (lo que se evidencia por la aproximación de las medianas al valor real). Por otra parte, los fuertes son vistos como peligrosos, lo que justifica las medianas altas para los riesgos teratogénicos.

Adverse drug reactions & their risk factors among Indian ambulatory elderly patients.

Background & objectives: Several studies have reported adverse drug events ranging from 5 to 35 per cent in all age group from outpatient setting. However, adverse drug reactions (ADRs) particularly among a large sample of ambulatory elderly patients in India has not been reported. This study has attempted to identify ADRs and assessed their causality, preventability and severity, and also their risk factors in Indian ambulatory elderly patients. Methods: A 2 year long term prospective study included 4005 ambulatory elderly patients (60 yr or above; either sex) at a public teaching hospital. Suspected ADRs were assessed for causality, preventability and severity using Naranjo's probability scale, modified Schumock and Thornton's criteria, and modified Hartwig's criteria, respectively. Results: Of the total 4005 prescriptions, 406 were identified with ADRs, giving the occurrence of 10 per cent ADRs in elderly. The total number of ADRs was 422 in 406 prescriptions. Type A ADRs accounted for 46 per cent of the total ADRs. Majority of the ADRs (88.6%) were classified as ‘probable’. The definitely preventable reactions were 22 per cent. The percentage of moderate reaction was 16 per cent. Only 1.6 per cent ADRs was severe in nature. The most common type of ADR was peripheral oedema. The most commonly offending class of drug was cardiovascular drugs (57.6%). Using logistic regression analysis, the risk factors which contributed to ADRs were age above 80 yr (OR=1.7), prescription of multiple drugs (OR=1.8), longer duration of treatment (OR=2.28) and multiple diagnoses (OR=1.8). Interpretation & conclusions: In this study, 10 per cent ambulatory elderly patients were found to have ADRs. This indicates that the elderly patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of risk factors of ADRs would help physicians to identify elderly patients with greater risk of ADRs and, therefore, might benefit from ADRs monitoring and reporting programme.

Errores de medicación en pacientes críticos adultos de un hospital universitario: Estudio prospectivo y aleatorio / Prospective assessment of medication errors in critically ill patients in a university hospital

Background: Critically ill patients are especially vulnerable to medication errors (ME) due to their severe clinical situation and the complexities of their management. Aim: To determine the frequency and characteristics of ME and identify shortcomings in the processes of medication management in an Intensive Care Unit. Patients and Methods: During a 3 months period, an observational prospective and randomized study was carried out in the ICU of a university hospital. Every step of patient's medication management (prescription, transcription, dispensation, preparation and administration) was evaluated by an external trained professional. Steps with higher frequency of ME and their therapeutic groups involved were identified. Medications errors were classified according to the National Coordinating Council for Medication Error Reporting and Prevention. Results: In 52 of 124 patients evaluated, 66 ME were found in 194 drugs prescribed. In 34% of prescribed drugs, there was at least 1 ME during its use. Half of ME occurred during medication administration, mainly due to problems in infusion rates and schedule times. Antibacterial drugs had the highest rate of ME. Conclusions: We found a 34% rate of ME per drug prescribed, which is in concordance with international reports. The identification of those steps more prone to ME in the ICU, will allow the implementation of an intervention program to improve the quality and security of medication management.

Critérios de Beers-Fick e medicamentos genéricos no Brasil / Beer-Fick criteria and generic drugs in Brazil

OBJETIVO: Determinar a prevalência de fármacos potencialmente inapropriados para idosos em medicamentos genéricos brasileiros pelos critérios de Beers-Fick. MÉTODOS: Análise da lista de medicamentos genéricos publicada no Diário Oficial da União de 12 de julho de 2004 e copiada da página da Agência Nacional de Vigilância Sanitária (ANVISA) - www.anvisa.gov.br, utilizando-se os critérios de Beers-Fick. RESULTADOS: Contendo 299 produtos e/ou apresentações, a lista analisada apresentava 20 deles (6,7 por cento do total) incluídos nos critérios de Beers-Fick, concentrados nas categorias de ansiolíticos, antiagregantes plaquetários, antialérgicos, antiangionosos e vasodilatadores, antiarrítmicos, antidepressivos, antiespasmódicos, anti-hipertensivos, antiinflamatórios não esteroidais, antiulcerosos e glicosídeos cardíacos. Esses critérios não incluem fármacos como antitussígenos, cinarizina, diltiazem, piracetam, quinolonas, xantinas, cremes, pomadas e colírios que fazem parte dessa lista de medicamentos genéricos. CONCLUSÃO: Critérios de Beers-Fick são úteis para a prevenção do uso de fármacos potencialmente inapropriados em idosos, com a ressalva de que não são completos para medicamentos genéricos brasileiros.

BACKGROUND: Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. METHODS: Analysis of the list of generic medications issued by " Dißrio Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA) - www.anvisa.gov.br, using the Beers-Fick criteria. RESULTS: From the list of 299 products 20 (6.7 percent of the total) included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid antinflammatories, antiulceratives and cardiac glycosides. These criteria do not include drugs such as cough suppressants, cinnarizine, diltiazem, piracetam, quinolones, xanthines, creams, ointments and ophthalmic solutions which are also present in the list of generic medication. CONCLUSION: The Beers-Fick criteria may prevent use of drugs potentially inappropriate for the elderly, however, it should be stressed that these criteria are not complete for Brazilian generic medications.

Anaphylaxis: lesson learned from five cases.

Anaphylaxis is a severe hypersensitivity reaction. Its clinical manifestations vary, affecting several organs at once. Skin symptom is the most frequent manifestation; however, diagnosis of anaphylaxis will only be established when involving one or both vital organs, which are cardiovascular and respiratory system. Other symptom, such as that involving central nervous system or gastrointestinal tract, may accompany. We present five cases of anaphylaxis which vary in onset of symptoms, allergen, degree of severity, therapeutic response and clinical manifestation. Anaphylactic reaction to drugs in these cases is mainly manifested as anaphylactic shock and reaction to food allergen causing obstruction of respiratory tract. Four anaphylactic events occurred at home and only one occurred in a hospital, thus education on anaphylaxis to general community is very important, especially for the patients and their families. Prompt medical assistance in patients with anaphylactic symptoms determines their therapeutic response. Skin test prior to administration of cephalosporin does not give negative predictive value toward anaphylactic event.