Amamentação e utilização de medicamentos: qual a orientação presente nas bulas de anticoncepcionais e anti-infecciosos? / Breastfeeding and drug use: what is the orientation found in drug package inserts of contraceptives and anti-infective agents?

Resumo O objetivo deste artigo é avaliar a concordância entre bulas e fontes bibliográficas baseadas em evidências científicas quanto à presença de contraindicação do uso de anticoncepcionais e anti-infecciosos durante a amamentação. Foram selecionados medicamentos anticoncepcionais e anti-infecciosos, segundo a ATC, com registro na ANVISA e presentes nas fontes bibliográficas: Manual Amamentação e Uso de Medicamentos e Outras Substâncias, Medications and Mother's Milk, LactMed®, Micromedex® e UpToDate®. As informações foram extraídas das seções "Contraindicações" e "Advertências e precauções" das bulas e comparadas com as informações das fontes. Foi avaliada a presença de informação contraindicando o uso do medicamento durante a amamentação. Em cinco (55,5%) dos nove anticoncepcionais foi verificada contraindicação na bula. Entre as fontes bibliográficas, o percentual variou de 0% a 55,5%, dependendo da fonte. Para os anti-infecciosos, o percentual de contraindicação foi de 46,3% na bula, variando de 0% a 12,9% nas fontes. Existe concordância entre as bulas e as fontes bibliográficas com relação aos anticoncepcionais; no caso dos anti-infecciosos, as bulas apresentam contraindicação para o uso durante a amamentação com mais frequência.

Abstract This article aims to evaluate the conformity between drug package inserts (DPIs) and evidence-based bibliographic sources regarding the presence of contraindications to the use of contraceptives and anti-infective agents during breastfeeding. Contraceptive and anti-infectives were selected, according to ATC, with the updated record in the ANVISA and present in the bibliographic sources Breastfeeding and Use of Medicines and Other Substances, Medications and Mother's Milk, LactMed®, Micromedex® and UpToDate®. Information was extracted from the DPI "Contraindications" and "Warnings and precautions" sections and compared with the information in the bibliographic sources. The contraindication of the drug during breastfeeding was evaluated. Contraindications were found in the DPIs of five (55.5%) of the nine contraceptives. The contraindication percentage ranged from 0 to 55.5% among the bibliographic sources, depending on the source. The percentage was 46.3% in the DPIs, ranging from 0 to 12.9% in the bibliographic sources for anti-infectives. There is an agreement between the DPIs and the bibliographic sources regarding contraceptives; regarding anti-infectives, the DPIs are more often contraindicated for use during breastfeeding.

La trazabilidad en el sistema logístico de medicamentos en Cuba y el uso de las tecnologías de auto-identificación / Traceability in the logistics system of medicines in Cuba, use of auto-identification

La trazabilidad es la capacidad para rastrear la historia, aplicación o ubicación de un objeto bajo consideración. En el ámbito farmacéutico, el rastreo y seguimiento de los medicamentos, incluyendo las vacunas y otros medicamentos biológicos, a lo largo de la cadena de suministro constituye un requisito obligatorio establecido por las autoridades sanitarias a nivel internacional, que se exige en mayor o menor magnitud en las reglamentaciones vigentes. En este artículo se analiza el sistema de codificación y clasificación en el sector de la salud y su estado actual en la cadena de suministro de medicamentos de Cuba. Se presenta un procedimiento para la implementación de las tecnologías de auto-identificación e intercambio electrónico de datos, mediante el uso de GS1 en el sistema de codificación y clasificación empleado en el sector de salud, que permita la trazabilidad en toda la cadena de suministro en Cuba(AU)

Traceability is the capability to track the history, application or location of an object under consideration. In the pharmaceutical field, the tracking and monitoring of medicines, including vaccines and other biological medicines, along the supply chain constitutes a mandatory requirement established by the sanitary authorities at an international level, which is demanded to a greater or lesser extent in the regulations in force. This research was carried out involving different links in the drug supply chain in Cuba, ranging from drug suppliers, drug distribution company, to healthcare centers and pharmacies. An analysis is carried out on the current coding and classification system, detecting the ineffectiveness of the identification of the drugs as the main deficiency. A procedure is proposed for the implementation of the auto-identification and electronic data interchange technologies using GS1 in the coding and classification system used in the health sector that allows traceability throughout the supply chain in Cuba(AU)

Simbología gráfica anatómica en el proceso de comunicación / Anatomical graphic symbolism in the communication process

RESUMEN: Las ciencias de la comunicación mejoran la organización de la vida en sociedad. En la interdisciplinaridad que la caracteriza se nutre también de la anatomía. La simbología gráfica anatómica, por ejemplo, la calavera o cabeza ósea, por su carácter universal, facilita el proceso de comunicación y advierte sobre potenciales daños de la salud, a veces de consideraciones mortales. Este artículo destaca la participación de la anatomía en los procesos de comunicación.

SUMMARY: Communication sciences improve the organization of life in society. In the interdisciplinarity that characterizes it, it also draws on anatomy. The anatomical graphic symbology, for example, the skull or bony head, due to its universal nature, facilitates the communication process and warns of potential health damages, sometimes of mortal considerations. This article highlights the participation of anatomy in communication processes.

Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System

PURPOSE: To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.METHODS: Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.RESULTS: A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.CONCLUSION: Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.

Validation of a new tool for evaluating subjects' satisfaction with medicine package leaflets: a cross-sectional descriptive study

ABSTRACT BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.

Evaluation of color-coded drug labeling to identify endovenous medicines / Evaluación de los etiquetados con código de colores para la identificación de medicamentos endovenosos / Avaliação da rotulagem com código de cores para identificação de medicamentos endovenosos

ABSTRACT Objective: To analyze the opinion of nursing professionals on the design, practicality of use and the usefulness of color-coded drug labeling in a pediatric intensive care unit. Methods: A cross-sectional study with 42 nursing professionals. A structured questionnaire was used based on a five-level Likert scale. To assess the proportions, a binomial test was used. Results: Concordance ratio >0.8 for all propositions related to design, practicality and most of the propositions related to error prevention. Conclusion: According to the opinion of the nursing team, the implemented technology has an adequate design, as well as being practical and useful in the prevention of medication errors in the population at the ICU.

RESUMEN Objetivo: Analizar la opinión de los profesionales de Enfermería acerca del diseño, la practicidad del uso y la utilidad de los etiquetados con código de colores en una unidad de terapia intensiva pediátrica. Método: Estudio transversal, realizado con 42 profesionales de enfermería. Se utilizó un cuestionario estructurado basado en una escala Likert de cinco niveles. Para el análisis de las proporciones, se utilizó la prueba binomial. Resultados: Se encontró la proporción de concordancia >0,8 para todas las proposiciones relacionadas con el diseño, la practicidad del uso y la mayoría de las proposiciones relacionadas con la prevención de errores. Conclusión: Según la opinión del equipo de enfermería frente al objeto de estudio, la tecnología implementada tiene un diseño adecuado, además de ser práctica y útil en la prevención de errores de medicamentos en población atendida en la UTI.

RESUMO Objetivo: Analisar a opinião dos profissionais de enfermagem sobre o design, a praticidade do uso e a utilidade da rotulagem com código de cores em uma unidade de terapia intensiva pediátrica. Método: Estudo transversal, realizado com 42 profissionais de enfermagem. Utilizou-se um questionário estruturado com base em uma escala Likert de cinco níveis. Para a análise das proporções, utilizou-se o teste binomial. Resultados: Houve proporção de concordância >0,8 para todas as proposições relacionadas ao design, à praticidade do uso e à maioria das proposições relacionadas à prevenção de erros. Conclusão: De acordo com a opinião da equipe de enfermagem, frente ao objeto de estudo, a tecnologia implementada tem design adequado, além de ser prática e útil na prevenção de erros de medicamentos em população atendida na UTI.

Uso de medicamentos antidepressivos na amamentação: avaliação da conformidade das bulas com fontes bibliográficas baseadas em evidências científicas / Use of antidepressants during breastfeeding: evaluating drug package inserts conformity with science-based bibliographical sources / Uso de medicamentos antidepresivos durante la lactancia: evaluación de la conformidad de los prospectos, respecto a fuentes bibliográficas basadas en evidencias científicas

O objetivo deste artigo foi avaliar a conformidade entre as recomendações de uso de medicamentos antidepressivos durante a amamentação, presentes em bulas, e as recomendações de fontes bibliográficas baseadas em evidências científicas. Foram avaliadas as bulas padrão de 23 antidepressivos com registro ativo no Brasil. A presença de contraindicação do uso do antidepressivo durante a amamentação foi comparada com as informações presentes no manual técnico do Ministério da Saúde, no livro Medications and Mothers' Milk e nas bases de dados LactMed, Micromedex e UpToDate. Na maioria das bulas (62,5%), o antidepressivo é contraindicado na amamentação. Entre as fontes bibliográficas, esse percentual variou de 0% a 25%. O estudo aponta para baixa conformidade entre bulas e fontes bibliográficas, alertando sobre a necessidade de revisão do conteúdo e forma de apresentação das informações presentes nas bulas dos antidepressivos no Brasil.

This article sought to evaluate the conformity between recommendations regarding antidepressant use during breastfeeding found in drug package inserts with recommendations from science-based bibliographic sources. We evaluated the standard drug package inserts of 23 antidepressants with active registration in Brazil. The presence of contraindications of antidepressant use during breastfeeding was compared with information present in the Brazilian Ministry of Health technical manual, the book Medications and Mothers' Milk and on the databases LactMed, Micromedex and UpToDate. In most drug package inserts (62.5%), antidepressants are contraindicated during breastfeeding. Among bibliographical sources, that percentage varied between 0% and 25%. The study shows a low conformity between drug package inserts and bibliographical sources, alerting to the need for revising the content and presentation of information present in antidepressant drug package inserts in Brazil.

El objetivo de este artículo fue evaluar la conformidad entre las recomendaciones de uso de medicamentos antidepresivos durante la lactancia, presentes en prospectos, y las recomendaciones de fuentes bibliográficas, basadas en evidencias científicas. Se evaluaron los prospectos estándar de 23 antidepresivos con registro activo en Brasil. La presencia de contraindicaciones en el consumo de antidepresivos durante la lactancia se comparó con la información presente en el manual técnico del Ministerio de la Salud, en el libro Medications and Mothers' Milk, y en las bases de datos LactMed, Micromedex y UpToDate. En la mayoría de los prospectos (62,5%), el antidepresivo está contraindicado durante la lactancia. Entre las fuentes bibliográficas el porcentaje varió de 0% a 25%. El estudio señala la escasa conformidad entre prospectos y fuentes bibliográficas, alertando sobre la necesidad de revisión del contenido, así como de la forma de presentación de la información que aparece en los prospectos de los antidepresivos en Brasil.

Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation

PURPOSE: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. MATERIALS AND METHODS: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. RESULTS: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA₂DS₂-VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. CONCLUSION: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

Patient Blood Management: An Internist's Perspective / 한양의대학술지

Patient blood management (PBM) is an evidence-based, patient-focused approach to optimize the management of patient and blood transfusion. While PBM is relatively well established in perioperative care, it is not as well established in the medical field. Since anemia in medical patients is heterogeneous and complex in its pathogenesis, the evidence for the threshold of hemoglobin for red blood cell (RBC) transfusion and the use of erythropoiesis-stimulating agents (ESAs) is not strong. While anemia seems to be an adverse risk factor for mortality, it is uncertain if rapid correction of anemia through RBC transfusion can reverse the negative impact of anemia on clinical outcomes. The introduction of ESA is a breakthrough in reducing RBC transfusion and managing anemic patients with renal disease and cancer. Despite promising results from early trials, the United States Food and Drug Administration issued a black box warning for ESAs in 2007 because of concerns about higher mortality, serious cardiovascular and thromboembolic events, and tumor progression. Therefore, the individualized approach to each patient with anemia is recommended in various medical conditions such as acute coronary syndrome, heart failure, chronic kidney disease, and malignancies.

Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database

PURPOSE: To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). MATERIALS AND METHODS: We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. RESULTS: There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. CONCLUSION: We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study / Bulas dos medicamentos mais consumidos em Portugal: aspectos de segurança e de adequação regulamentar. Um estudo descritivo

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines. .

CONTEXTO E OBJETIVO: As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes. TIPO DE ESTUDO E LOCAL: Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa. MÉTODOS: Utilização de uma checklist para recolher os dados. A checklist foi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem. RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos. CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos. .

Does Maintaining a Bottle of Adhesive Without the Lid Significantly Reduce the Solvent Content?

This study aimed to evaluate the effect of maintaining a bottle of adhesive without its lid on the solvent loss of the etch-and-rinse adhesive systems. Three 2-step etch-and-rinse adhesives with different solvents (acetone, ethanol or butanol) were used in this study. Drops of each adhesive were placed on an analytical balance and the adhesive mass was recorded until equilibrium was achieved (no significant mass alteration within time). The solvent content of each adhesive and evaporation rate of solvents were measured (n=3). Two bottles of each adhesive were weighted. The bottles were maintained without their lids for 8 h in a stove at 37 ºC, after which the mass loss was measured. Based on mass alteration of drops, acetone-based adhesive showed the highest solvent content (46.5%, CI 95%: 35.8-54.7) and evaporation rate (1.11 %/s, CI95%: 0.63-1.60), whereas ethanol-based adhesive had the lowest values (10.1%, CI95%: 4.3-16.0; 0.03 %/s CI95%: 0.01-0.05). However, none of the adhesives bottles exhibited significant mass loss after sitting for 8 h without their lids (% from initial content; acetone - 96.5, CI 95%: 91.8-101.5; ethanol - 99.4, CI 95%: 98.4-100.4; and butanol - 99.3, CI 95%: 98.1-100.5). In conclusion, maintaining the adhesive bottle without lid did not induce significant solvent loss, irrespective the concentration and evaporation rate of solvent.

Este estudo avaliou o efeito da manutenção do frasco do adesivo sem sua tampa na perda de solvente de sistemas adesivos convencionais. Três adesivos convencionais de 2 passos com diferentes solventes (acetona, etanol ou butanol) foram usados neste estudo. Gotas de cada adesivo foram colocadas em uma balança analítica e a massa dos adesivos foi registrada até a obtenção do equilíbrio (nenhuma alteração significativa com o tempo). O conteúdo de solvente de cada adesivo e a taxa de evaporação dos solventes foram mensurados (n=3). Dois frascos de cada adesivo foram pesados. Os frascos foram mantidos sem suas tampas por 8 h em uma estufa a 37 ºC, seguido pela mensuração da pera de massa. Baseado na alteração de massa das gotas, o adesivo a base de acetona demonstrou o maior conteúdo de solvente (46,5%, IC 95%: 35,8-54,7) e de taxa de evaporação (1,11 %/s, IC95%: 0,63-1,60), enquanto que o adesivo à base de etanol teve os menores valores (10,1%, IC95%: 4,3-16,0; 0,03 %/s IC95%: 0,01-0,05). Entretanto, nenhum dos frascos dos adesivos exibiu perda significante de massa após ficar por 8 h sem suas tampas (% do conteúdo inicial; acetona - 96,5, IC95%: 91,8-101,5; etanol - 99,4, IC95%: 98,4-100,4; e butanol - 99,3, IC95%: 98,1-100,5). Em conclusão, a manutenção do frasco do adesivo sem tampa não induziu perda significante de solvente independente da concentração e da taxa de evaporação do solvente.

An assessment of Pakistani pharmacy and medical students’ knowledge of black box warnings / Una evaluación del conocimiento de estudiantes de medicina y de farmacia en Pakistán sobre alertas de medicamentos / Uma avaliação sobre o acesso de estudantes paquistaneses de medicina e farmácia ao conhecimento das advertências das caixas de tarja preta

Food and Drug Administration delivers the black box warnings (BBW) which should appear on the leaflets of medicines for patient awareness and the prescription of drugs indicating its highly fatal adverse effects to human body. The aim of this study was to assess the knowledge of Pakistani pharmacy and medical students about BBW. A questionnaire containing contents about BBW was given to the 1st, 2nd and 3rd professional year pharmacy and medical students from different pharmacy and medical institutes. A 76 percent survey response rate was observed. It was observed that student’s knowledge about BBW improves in association with the promotion in professional years of pharmacy and medical education. The results indicate that student’s knowledge about black box increases with the study level. Training in black box warnings should be implemented in pharmacy and medical institutions influencing the meaningful ways to educate and train pharmacy and medical students, and help these students to get recent knowledge about black box warnings so that, in future, they may perform an ethical practice in their respective fields.

La Agencia Reguladora de Alimentos y Medicamentos comunica alertas sobre medicamentos (AM), que debieran aparecer en los prospectos de medicinas, para el conocimiento de los pacientes y la prescripción de medicamentos, indicando sus efectos adversos fatales para el cuerpo humano. El objetivo de este estudio es averiguar el conocimiento de estudiantes de medicina y de farmacia sobre AM. Se entregó un cuestionario con contenidos sobre AM a estudiantes de farmacia y de medicina de primero a tercer año de diferentes institutos médicos y farmacéuticos. Se obtuvo un 76 por ciento de respuesta. Se observó que el conocimiento de los estudiantes sobre AM mejora asociado a la promoción en años profesionales de medicina y farmacia. Los resultados indican que el conocimiento de los estudiantes sobre alerta de medicamentos aumenta con el nivel de estudio. Debería implementarse la formación sobre alerta de medicamentos en farmacia y medicina y ayudar a los estudiantes a tener conocimiento actual sobre alerta de medicamentos de forma que, en el futuro, puedan realizar prácticas éticas en sus campos respectivos.

A Food and Drug Administration disponibiliza as advertências das caixas de tarja preta (BBW) que devem aparecer em bulas de medicamentos para conscientização de pacientes e a prescrição de drogas, indicando seus efeitos adversos altamente fatais para o corpo humano. O propósito deste estudo foi o de de inteirar a cerca do conhecimento de estudantes de medicina e farmácia sobre BBW. Um questionário com conteúdos sobre BBW foi dado a estudantes de farmácia e medicina, do 1º, 2º e 3º ano de diferentes instituições de ensino em farmácia e medicina. Foi observada uma taxa de 76 por cento de resposta dos pesquisados. Observou-se que o conhecimento de estudantes sobre BBW melhora quando se associa à promoção para anos seguintes da educação nas faculdades de farmácia e medicina. Os resultados indicam que o conhecimento dos estudantes sobre as caixas de tarja preta aumenta com o nível de estudo. Treinamento com caixas de tarja preta pode ser implementado em instituições de ensino de farmácia e medicina, influenciando de modo significativo as formas de educação e treinamento de estudantes de farmácia e medicina, e,assim, ajudar estes estudantes a obter conhecimentos recentes sobre medicamentos de tarja preta de modo que, no futuro, elas possam exercer uma prática ética em seus respectivos campos de atuação profissional.

Sistema Braille para la identificación de medicamentos comercializados en la República Bolivariana de Venezuela / Braille system for the identification of drugs marketed in the Bolivarian Republic of Venezuela

El desarrollo de la presente investigación constituye la propuesta de un capítulo para Las Normas de la Junta Revisora de Productos Farmacéuticos que incluya el sistema Braille como método de identificación de medicamentos comercializados y distribuidos en la República Bolivariana de Venezuela. Para lograr el objetivo planteado fue necesaria la revisión internacional de leyes y normas que involucren el sistema Braille como requisito en la identificación de medicamentos, también fue necesario realizar un análisis de estas leyes y normas a nivel internacional con la finalidad de establecer las fortalezas; adicionalmente se verificaron las leyes venezolanas que justifiquen y que ofrezca soporte legal a la investigación. El presente estudio se justifica como medio de inclusión social para el sector de la población que tiene discapacidad visual, también como mecanismo para al acceso a los bienes y servicios en el sector salud, por otro lado, dispone una mayor independencia y/o autonomía en lo que respecta al uso racional y seguridad al momento del consumo de medicamento a las personas con ceguera, por último esta investigación puede ser útil en la reducción de ilícitos farmacéuticos, debido a la posibilidad de detectar los medicamentos ilícitos que tengan una identificación errónea del sistema Braille. Metodológicamente el estudio se aborda desde la perspectiva del tipo de investigación exploratoria y descriptiva con la aplicación de un diseño documental y cuyas fases de estudios son: la búsqueda documental y como segunda fase: el análisis. Las técnicas empleadas son la elaboración de fichas y el análisis DOFA de las normas internacionales.

The development of this research is the proposal one chapter for The Standards Review Board Pharmaceutical Products that include Braille as a method of identifying drugs marketed and distributed in the Bolivarian Republic of Venezuela. To achieve the objective international review of laws and regulations involving Braille requirement in identifying medicinal raised was necessary, it was also necessary to perform an analysis of these laws and regulations at the international level in order to establish the strengths; further justifying Venezuelan law and offers legal support research verified. This study is justified as a means of social inclusion for the sector of the population with visual impairment, also as a mechanism to access to goods and services in the health sector, on the other hand, have greater independence and / or autonomy in regarding the rational use and safety when drug consumption to the blind, finally this research may be useful in reducing illicit pharmaceuticals, due to the possibility of detecting illicit drugs with misidentification system Braille. Methodologically the study is approached from the perspective of the type of exploratory and descriptive research with the application of a documentary and the phases of design studies are: document retrieval as second phase analysis. The techniques used are the development of chips and the SWOT analysis of international standards.

Optimization condition in labeling of ofloxacin with [99m]Tc and its biological evaluation in Staphylococcus aureus and Escherichia coli for infection imaging

The use of radiopharmaceuticals is a powerful tool in the management of patients with infectious or inflammatory diseases in nuclear medicine. In this study ofloxacin as a second-generation fluoroquinolone is used to design a desired infection imaging agent after labeling with [99m]Tc via direct labeling. Ofloxacin was radiolabeled with [99m]Tc using different concentrations of ligand, stannous chloride, sodium pertechnetate and at different pH. Then labeling yield, stability in saline and serum, lipophilicity, binding with Staphylococcus aureus and Escherichia coli and biodistribution in infected mice for labeled compound were studied. The final complex was characterized by TLC and HPLC and radiochemical purity of >90% was obtained when 1.5 mg ofloxacin in presence of 75 micro g SnCl2 was labeled with 370 MBq sodium pertechnetate. The complex showed specific binding to Staphylococcus aureus and Escherichia coli. Biodistribution results showed that radioligand had high affinity in the infected site in mice. The uptake for Staphylococcus aureus induced infections [T/NT = 2.33 +/- 0.17 at 1 h post injection] was higher than that was for Escherichia coli [T/NT = 1.96 +/- 0.13 at 1 h post injection]. This complex may lead to further development of a radiotracer for imaging of infections induced by grampositive or gram-negative bacteria

Survey on common pediatric drugs for renal diseases / 中华儿科杂志

<p><b>OBJECTIVE</b>Development and use of better medicine for children is a worldwide problem recently, especially in China. The current situation of drugs for children's renal diseases is far from well-understood now. This survey focused on drugs for pediatric renal diseases including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents.Information regarding the dosage, form, precaution, usage and administration in inserts was collected in this study.</p><p><b>METHOD</b>Drugs for pediatric renal diseases were selected according to the guidelines established by the Chinese Society of Pediatric Nephrology. The detailed information about the dosage, form of drugs was searched on the website of China-State Food and Drug (SFDA). The information of the precaution, usage and administration was obtained from the China Pharmaceutical Reference, the first edition.</p><p><b>RESULT</b>In this study, there were 5 categories of medicine including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents, and 89 kinds of medicine for renal diseases. Among these medicines, 65.2% were found not suitable for children in terms of drug dosage and form, 19.1% did not indicate the precaution, 51.7% did not indicate clearly the safety and effectiveness for children, and 56.2% lacked the detailed information about the usage and administration for children. There were only 4 kinds of these medicines which were studied via clinical trials in children population.</p><p><b>CONCLUSION</b>There is a lack of drugs for children with renal diseases. Most of the time, the medicines used by doctors are not specially manufactured for children. The safety and efficacy of drugs that are currently used to treat pediatric renal diseases are not clear and definite.In addition, few clinical trials have been conducted for evaluation of drugs for pediatric renal diseases.In clinic, the situation of off-label drug treatment is very serious.</p>