Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

OBJECTIVES: In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. STUDY DESIGN: Qualitative study design. METHODS: Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. RESULTS: Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. CONCLUSIONS: The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended.

Use of plant residues on growth of mycorrhizal seedlings of neem (Azadirachta indica A. Juss.).

BACKGROUND: Owing to its multiple uses in veterinary medicine, biofertilizers, pest control, etc., the commercial cultivation of neem (Azadirachta indica) has been increasing in various countries. The use of arbuscular mycorrhizal fungi (AMF) and plant by-products (composted leaves and residues of neem and sugarcane) for the propagation of seedlings can be an efficient alternative to stimulate plant growth, reducing the propagation time and conferring increased tolerance of plants to biotic and abiotic stresses. Therefore this study aimed to evaluate the effect of plant substrates and inoculation with AMF on the production of neem seedlings. RESULTS: Beneficial effects of the application of neem by-products to neem seedlings were observed on most of the variables analysed. However, the treatment with sugarcane cake did not improve the growth of neem seedlings. In general, the inoculation treatments using Glomus etunicatum in the composted neem substrates improved seedling growth. CONCLUSION: Neem by-products benefit the growth of seedlings of this plant under greenhouse conditions. Inoculation with G. etunicatum enhances plants growth mainly in substrates with residues of neem leaves, providing an alternative for the production of seedlings of this crop under nursery conditions, which can reduce the need for chemical fertilizers that impact the environment.

Charge carriers injection/extraction at the metal-polymer interface and its influence in the capacitive microelectromechanical systems-switches actuation voltage.

Opposite results concerning the sign of the parasitic charge accumulated at the metal dielectric contact in RF microelectromechanical systems (MEMS) capacitive switches are found in the literature. The mechanism concerning charge injection/extraction at the metal-dielectric contact and its influence on the pull-in voltage needs to be further clarified. A model-switch, for which only one dimension is in the microns range, is used to study the behaviour of a capacitive RF MEMS switch. The aim is to analyze how the electric charge is injected/extracted into or from the dielectric material under the applied field and to obtain realistic data to understand how this parasitic charge influences the pull-in voltage Vpi and the pull-off voltage Vpo. A triangle voltage is employed to measure Vpi and Vpo, by measuring the isothermal charging/discharging currents. Our results demonstrate that Vpi is strongly dependent on the injected/extracted charge on the free surface of the dielectric. The charge injected/extracted at the bottom side of the dielectric has no influence on the actuation voltage. The charge injected/extracted on the free surface of the dielectric determines an increase of the modulus of Vpi and, eventually, the switch can fail to actuate. An estimation of the charge stored into the material was obtained (i) by measuring the charging current and the discharging current and (ii) from the value of the Vpi. The parasitic charge necessary to keep the bridge stick to the insulator is 5.3 x 10(-4) C m(-2) for our experimental conditions. The modification of the Vpi determined by the stored charge in the dielectric is analyzed. An increase of the relative dielectric permittivity by a factor of 2 produces a decrease of the actuation voltage of 10%. A variation of 30% in the elastic constant determines a variation of about 20% in the Vpi. A voltage threshold for charge injection/extraction was not observed.

[On the sidelines of society: crack use, deviation, criminalization and social exclusion - a narrative review]. / À margem: uso de crack, desvio, criminalização e exclusão social ­ uma revisão narrativa.

The article comprises a narrative review of the scientific literature, aiming to identify and discuss the contexts of vulnerability and social exclusion faced by users of crack cocaine and other substances who live on the sidelines of society in the Brazilian and international context. The paper summarizes insights from different theoretical frameworks, focusing on an integrated perspective of substance use and abuse, with an emphasis on the use of crack and its inter-relationships with social vulnerability, marginalization, social exclusion and deviation. In a first step, broad aspects of qualitative research on drugs are outlined. The subsequent section highlights issues associated with exclusion and social vulnerability of crack users, followed by an assessment of the main associations mentioned in the literature on drug use and criminal involvement. Finally, the concept of "sidelines of society" is discussed, as exemplified by situations and events experienced by users of crack and other substances, as mentioned in the literature.

Challenges and perspectives of academic evaluation.

Academic evaluation has been an essential component of modern science since its inception, as science has moved away from personalized patronage toward its contemporary role as an essential enterprise of contemporary, democratic societies. In recent years, Brazil has experienced sustained growth in its scientific output, which is nowadays fully compatible with its status as a high middle-income country striving to become a fully developed, more equitable country in the years to come. Growth usually takes place amidst challenges and dilemmas and, in Brazil as elsewhere, academic evaluation is not exempt from such difficulties. In a large, profoundly heterogeneous country with a national evaluation system and nationwide on-line platforms disseminating information on the most disparate fields of knowledge, the main challenges refer to how to pay attention to detail without losing sight of comprehensiveness and how to handle social and regional diversity while preserving academic excellence as the fundamental benchmark.

À margem: uso de crack, desvio, criminalização e exclusão social - uma revisão narrativa / On the sidelines of society: crack use, deviation, criminalization and social exclusion - a narrative review

Resumo O artigo faz uma revisão narrativa da literatura científica visando identificar e discutir os contextos de vulnerabilidade e exclusão social que situam os usuários de crack e outras drogas à margem da norma social no contexto brasileiro e internacional. Lança-se mão de uma variedade de marcos teóricos de modo a integrar as áreas temática do uso de drogas, com ênfase no de crack e sua inter-relação com vulnerabilidade social, marginalidade, exclusão social e desvio. Inicialmente são discutidos aspectos gerais da pesquisa qualitativa em drogas. Em seguida são pontuadas questões acerca da exclusão e vulnerabilidade social dos usuários de crack, seguido das principais associações descritas na literatura sobre uso de drogas e envolvimento criminal. Por fim, o conceito de “margens do Estado” é discutido através do exemplo de situações vivenciadas pelos usuários de crack e outras drogas, como relatado pela literatura.

Abstract The article comprises a narrative review of the scientific literature, aiming to identify and discuss the contexts of vulnerability and social exclusion faced by users of crack cocaine and other substances who live on the sidelines of society in the Brazilian and international context. The paper summarizes insights from different theoretical frameworks, focusing on an integrated perspective of substance use and abuse, with an emphasis on the use of crack and its inter-relationships with social vulnerability, marginalization, social exclusion and deviation. In a first step, broad aspects of qualitative research on drugs are outlined. The subsequent section highlights issues associated with exclusion and social vulnerability of crack users, followed by an assessment of the main associations mentioned in the literature on drug use and criminal involvement. Finally, the concept of “sidelines of society” is discussed, as exemplified by situations and events experienced by users of crack and other substances, as mentioned in the literature.

Perfil de prescritores e prescrição de antimicrobianos nas infecções das vias aéreas superiores em pediatria / Profile of prescribers and prescription of antibiotics in upper respiratory infections in pediatrics / Perfil de prescriptores y prescripción de antimicrobianos en las infecciones de vías aéreas superiores en pediatría

OBJETIVO: Traçar um perfil dos médicos que atendem crianças nos sistemas público (Sistema Único de Saúde) e privado de saúde e verificar como são prescritos antimicrobianos nas infecções das vias aéreas superiores. MÉTODOS: Médicos de algumas cidades do interior do Estado de São Paulo receberam via correio ou nas Unidades Básicas de Saúde uma carta explicativa sobre a pesquisa e o questionário, com perguntas sobre: tempo de graduação, residência médica, carga horária e local de trabalho, forma de atualização, fatores que consideram ao prescrever antimicrobianos e casos clínicos sobre as infecções das vias aéreas superiores. Os dados pessoais dos médicos foram relacionados com as respostas aos casos clínicos. Para análise estatística, foram aplicados os testes Z e de Tukey-Kramer, sendo p<0,05 significante. RESULTADOS: A amostra foi composta por 170 prescritores: 86,5% possuíam residência em Pediatria, 75% trabalhavam no Sistema Único de Saúde e 71% tinham carga horária superior a 40 horas semanais. Os formados há menos de dez anos valorizaram mais os laboratórios farmacêuticos como forma de atualização do que os graduados há mais de 30 anos; 33% dos médicos do Sistema Único de Saúde atendem mais de cinco pacientes por hora. A média de acerto nos casos clínicos foi de 87%. O uso das entidades médicas como forma de atualização foi associado a respostas corretas, enquanto o uso de materiais de laboratório estava ligado a respostas incorretas (p<0,05). Houve clara tendência de diminuição dos acertos conforme o número de pacientes atendidos por hora aumentava. CONCLUSÕES: Educação adequada sobre o tema e melhora nas condições de trabalho podem ser eficientes para reduzir a prescrição de antibióticos para infecções das vias aéreas superiores em crianças.

OBJECTIVE: To describe the profile of physicians that care for children in Brazilian public and private health systems, and to verify how antimicrobials for upper respiratory airway infections are prescribed. METHODS: Physicians in some cities of the state of São Paulo (Southeast Brazil) received an explanatory letter by mail or at the Primary Health Care Units about the research and a form with questions concerning: time of graduation, medical residency, workload and workplace, how they update their medical knowledge, factors considered when prescribing antimicrobials, and clinical cases on upper respiratory infections. Personal information was related to the answers of the clinical cases. For statistical analysis, the Z and Tukey-Kramer tests were applied, being significant p<0.05. RESULTS: The sample included 170 prescribers, out of whom 87% had medical residence in Pediatrics, 75% worked for the Public Health System, and 71% worked more than 40 hours per week. Physicians who graduated in the past ten years emphasized the pharmaceutical industry as a way of keeping themselves updated in comparison to the ones who had been graduated for more than 30 years; 33% of the public health system physicians cared for more than five patients per hour. Regarding clinical cases, the correct answers averaged 87%. Consulting medical entities as a way of continuous medical education was associated with correct answers, while using materials from the pharmaceutical industry was associated with the incorrect ones (p<0.05). There was a clear trend towards decreasing the quality of the prescription as the number of patients per hour increased. CONCLUSIONS: Efficient education and improvement of work load could reduce the prescription of antibiotics for upper airway infections in children.

Objetivo: Esbozar un perfil de los médicos que atienden a niños en el sistema público (SUS) y privado de salud y ve­rificar cómo se prescriben antimicrobianos en las infecciones de vías aéreas superiores (IVAS). Métodos: Los médicos de algunas ciudades del interior de la Provincia de São Paulo recibieron por correo o en las Unidades Básicas de Salud una carta explicativa sobre la in­vestigación y cuestionario con preguntas sobre: hace cuánto tiempo se ha graduado, internado, carga horaria y local de trabajo, forma de actualización, factores que tienen en cuenta al prescribir antimicrobianos y casos clínicos sobre IVAS. Los datos personales de los médicos fueron relacionados a las respuestas a los casos clínicos. Para el análisis estadístico, se aplicó la prueba Z y prueba de Tukey-Kramer, siendo significante p<0,05. Resultados: La muestra fue de 170 prescriptores: 86,5% realizaron internado en pediatría, 75% trabajaban en el SUS y 70,8% tenían carga horaria superior a 40 horas semanales. Los que se graduaron hace menos de 10 años valorizaron más los laboratorios farmacéuticos como forma de actualización que los graduados hace más de 30 años; el 33% de los mé­dicos del SUS atienden a más de cinco pacientes por hora. El promedio de acierto en los casos clínicos fue de 86,6%. El uso de las entidades médicas como forma de actualización fue asociado a respuestas correctas, mientras que el uso de materiales de laboratorio, a respuestas incorrectas (p<0,05). Hubo clara tendencia a la reducción de los aciertos conforme aumentaba el número de pacientes atendidos por hora. Conclusiones: Educación adecuada sobre el tema y me­jora en las condiciones de trabajo pueden ser eficientes para reducir la prescripción de antibióticos en IVAS.

Perfil de usuários de drogas: danos à integridade física e psicossocial: estudo de características de pacientes do NEPAD/UERJ - 1986 / Profile of drug users: physical and psychosocial damages; study in outpatients characteristics at Nucleous of Study and Research in Care of Drug Abuse, Rio de Janeiro State University (NEPAD/UERJ)

Dando prosseguimento a publicaçäo de resultados obtidos a partir dos levantamentos feitos com a clientela de usuários de drogas que procuraram o ambulatório do NEPAD/UERJ no ano de 1986, os autores apresentam e discutem os itens referentes aos danos a integridade física e psicossocial dos usuários. Estes resultados foram extraídos da análise de um instrumento de pesquisa (questionário) elaborado pela equipe de epidemiologia do NEPAD/UERJ e aplicado a 100 pacientes. Foram abordados especificamente: complicaçöes infecto-clínicas, síndrome de abstinência, envolvimento em acidentes automobilísticos, tendência ao suicídio e problemas com a justiça