Active involvement of the general public in pharmacovigilance

The importance of direct patient reporting has been highlighted by recent European legislation on pharmacovigilance, and in addition, there is also an increasing attention worldwide for this subject. In Europe, the legislation directs member states to take all appropriate measures to encourage patients to report suspected adverse drug reactions (ADR) to the relevant national authorities. The introduction of patient reporting in pharmacovigilance indicates a change in attitude in which patient reporting is valued due to their potential to contribute useful information on drug safety. The aim of this project is to give a better understanding of the role of patients in pharmacovigilance systems. The chosen approach during this project intended to lead to a better understanding of the awareness and perception of the risk involved with medicine use and how patients and healthcare professionals can contribute to optimize the current pharmacovigilance system. For the purpose of this study, the project was divided in several parts, for which specific objectives were designed and described below, together with main results of the thesis. The first study described in Chapter 2 discusses the experiences of patient reporting to pharmacovigilance in Portugal and quantifies consumers motivation for reporting ADRs, investigating patient opinions about reporting with a quantitative analysis in a large group of consumers. The objective was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers adverse drug reaction underreporting. The study reveals that consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Also, more altruistic motives as the contribution to research and knowledge, the contribution to improvement of drugs and prevent harm to other people are seen as motives to report ADRs by patients. These motives can be classified in reporting for oneself (severity, worried, problems), reporting for others (share experiences, preventing harm, feeling responsible) or reporting for improvement (research and knowledge, patient information leaflet). It appeared that multiple patient characteristics (gender, age and level of education) had an effect on the motives of patients to report their ADR. In Chapter 3 were described the attitudes toward patient reporting systems, and progress toward implementing such systems among national competent authorities participating in the World Health Organization Programme for International Drug Monitoring. The study shows that most countries accept ADR reports from patients by an official reporting system designed for patients or through the existing system for Healthcare Professionals (HCPs). The main reasons for not having a Patient Reporting System (PRS) are financial restraints and a lack of information/education of patients. Attitudes toward a PRS are positive, but some countries fear 181 that they will not be able to handle an increase in reports. Most countries accept ADR reports from the general public. The lack of resources/budget and the lack of information/education for patients are highlighted as the major obstacles to the implementation of PRS. Chapter 4 focused on patient organizations role to promote patient reporting. In Chapter 4.1, it was studied the role of European patient organizations with the objective of understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. There is a wide range of interest in drug safety issues among patient organizations, which appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. A lack of resources, budget, and support from National Competent Authorities (NCAs) are seen as the main barriers to being involved in pharmacovigilance. On the other hand, an important part of the organizations appears to not have any activities or involvement related to pharmacovigilance. Bringing pharmacovigilance stakeholders and patient organizations together could create a more optimal patient reporting culture. Members of a patient organization showed more positive opinions related to pharmacovigilance. They would like to have more information about ADRs related to their medication and a higher intention to have information on how to report when compared to other patients. The other study in Chapter 4 described medicines and attitudes and opinions regarding pharmacovigilance in people with diabetes. The study explored the impact of the patient reports being followed by a patient diabetes association. The objective was to assess risk perception of developing adverse drug reactions and knowledge, attitudes and opinions regarding pharmacovigilance in patients with diabetes and to investigate whether being a member of a patient organization for diabetes had an effect on these factors. Patients followed in a diabetes patient association presented a higher score of risk perception, experiences using the medicines, but also by the information received from the patient organization. Being a member of a patient organization seems to have an important role in increasing risk perception since they presented the highest risk perception scores for medicines related to their disease. Those patients affirmed that their doctor explained the possible ADRs of their medication and they have higher intention to report ADRs in the future if they are serious or unexpected. Patient organizations are well positioned to be a source where patients can obtain reliable information, changing their attitudes and perceptions about the disease and drug treatments. An additional chapter was provided, related with HCPs role as active agents to improve the involvement of patients in pharmacovigilance. Chapter 5.1 objective was to describe the attitudes and knowledge of different community pharmacy professional groups regarding the spontaneous reporting of adverse drug reactions to identify the factors that can influence adverse drug reaction under-reporting. Despite HCPs knowledge of the pharmacovigilance system, only a small 182 percentage of Community pharmacy professionals had reported ADRs, and approximately half did not usually encourage consumers to report possible ADRs. In Chapter 5.2, the objective was to evaluate community pharmacy professionals as role players . Reporting of ADRs is fundamental to pharmacovigilance, and consumer reporting is a significant contribution to creating useful information on drug safety. Community pharmacy professionals can play a major role in pharmacovigilance by reporting ADRs directly or encouraging consumers to report them. Measures to overcome under-reporting as encouraging HCPs and consumers to play an active role in pharmacovigilance, namely continuous education and training should be incorporated to increase the level of risk perception and encourage a better attitude about reporting for both HCPs and consumers. Chapter 6 presents a general discussion about the role of general public in pharmacovigilance, providing recommendations that arose from the results with different points of view of patient participation in pharmacovigilance (national competent authorities, HCPs, patient organizations and patients themselves). In conclusion, this thesis has focused on an overview of the participation of different stakeholders in pharmacovigilance, including HCPs, NCAs, Patient Organizations and patients themselves. Further research and developments for pharmacovigilance systems and for patients themselves arose from the results provided.Recientemente, la legislación europea sobre farmacovigilancia ha resaltado la importancia de la participación de los ciudadanos en la notificación espontánea de sospechas de reacciones adversas (RAMs), siendo este asunto objeto de atención creciente en todo el mundo. En Europa, la legislación establece que los Estados miembros deben tomar las medidas apropiadas para alentar a los pacientes a notificar las de sospechas de RAMs a las autoridades nacionales competentes. La introducción de esta posibildad, indica un cambio de actitud en el que se valora el informe del paciente debido a su potencial para aportar información útil sobre la seguridad de los medicamentos. El objetivo de esta tesis es comprender mejor el papel de los pacientes en los sistemas de farmacovigilancia. El enfoque elegido pretende describir la conciencia y la percepción del riesgo por parte de los pacientes en relación con el uso de medicamentos y cómo tanto ellos, como los profesionales de la salud (PS) pueden contribuir a optimizar el sistema actual de farmacovigilancia. Con este propósito, la tesis se dividió en varias partes, cuyos objetivos específicos y principales resultados, se describen a continuación. En el primer estudio descrito en el Capítulo 2, se discuten las experiencias de la notificacion ciudadana al sistema de farmacovigilancia en Portugal y cuantifica la motivación de los consumidores, investigando sus opiniones a través de un análisis cuantitativo llevado a cabo en un gran grupo de usuarios. El objetivo de este estudio es describir las actitudes y el conocimiento de los ciudadanos en general con respecto a las notificaciones espontáneas y las razones y opiniones que pueden influir en la escasa notificación de RAMs por su parte. El estudio revela que es más probable la notificación espontánea por parte de los ciudadanos, cuando se trate de reacciones graves o si existiera preocupación por los síntomas generados por la RAM. Además, otros motivos más altruistas como la contribución a la investigación y al conocimiento, la contribución a la mejora de los fármacos y la prevención del daño en otras personas, también fueron considerados por los pacientes como motivos para notificar RAM. Estas motivaciones pueden clasificarse en: notificar para uno mismo (gravedad, preocupación, problemas), para otros (compartir experiencias, prevenir daños, sentirse responsable) o para la mejora (investigación y conocimiento, hoja de información para el paciente). Asimismo, diferentes características del paciente como género, edad y nivel de educación, tenían influencia en sus motivos para notificar sus RAMs. El Capítulo 3 describe las actitudes de las autoridades nacionales de los participantes en el Programa de la Organización Mundial de la Salud de Vigilancia Farmacéutica Internacional acerca de la notificación ciudadana de sospechas de RAM y del progreso en su implementación. 187 El estudio muestra que la mayoría de los países aceptan notificaciones de sospechas de RAMs de los ciudadanos mediante un sistema oficial diseñado especialmente para ellos, o bien mediante el sistema existente para PS. Las principales razones para no disponer de un Sistema de Notificación de sospechas de RAM para Ciudadanos (SNRC) son las restricciones económicas y la falta de información / educación de los pacientes. Las actitudes acerca de los SNRC son positivas, aunque algunos países temen no poder manejar un aumento de las notificaciones de sospechas. La falta de recursos y la falta de información/educación de los pacientes se destacan como los principales obstáculos para la implementación del SNRC. El Capítulo 4 se centró en el papel de las organizaciones de pacientes para promover la notificación. En el Capítulo 4.1 se estudió el papel de las organizaciones europeas de pacientes como partes interesadas en optimizar la participación del paciente en la farmacovigilancia. Existe un amplio interés en los problemas de seguridad de los medicamentos entre las organizaciones de pacientes. Estas organizaciones parecen tener un papel importante alentando a los pacientes a hablar con sus médicos / farmacéuticos sobre las RAM experimentadas, o ayudándolo a informar las sospechas de RAM a los sistemas de farmacovigilancia. La falta de recursos y apoyo de las Autoridades Nacionales Competentes se consideran las principales barreras para participar en la farmacovigilancia. Por otro lado, una parte importante de las organizaciones parece no tener ninguna actividad relacionada con la farmacovigilancia. Reunir a las partes interesadas en farmacovigilancia con las organizaciones de pacientes podría crear una cultura de notificaciones de sospechas por los pacientes optimizada. De un estudio realizado en una organización de pacientes de pacientes diabéticos (Capítulo 4.2) sabemos que sus miembros mostraron opiniones positivas relacionadas con la farmacovigilancia. En general, a los pacientes asociados les gustaría tener más información sobre las RAMs de sus medicación y tenían mayor interés en disponer de información sobre cómo notificar que los pacientes diabéticos que no formaban parte de la asociación. El capítulo 5.1 se centró en el papel de los PS como agentes activos para mejorar la participación de los pacientes en la farmacovigilancia. El objetivo del Capítulo 5.1 era describir las actitudes y el conocimiento de los diferentes grupos profesionales de Farmacias Comunitarias con respecto a la notificación espontánea de RAM para identificar los factores que puedan influir en la falta de notificación. A pesar de que los PS conocen el sistema de farmacovigilancia, solo un pequeño porcentaje de los profesionales de Farmacia Comunitaria ha informado de RAMs, y aproximadamente la mitad no suele alentar a los ciudadanos a informar sospechas de RAMs. En el Capítulo 5.2, el objetivo fue evaluar a los profesionales de Farmacia Comunitaria como actores en la mejora de la participación de los ciudadanos en la farmacovigilancia y describir sus actitudes en relación con el sistema de farmacovigilancia y la notificación ciudadana de sospechas de RAMs. Las notificaciones de RAMs son fundamentales para la farmacovigilancia, y los informes de los ciudadanos son una contribución significativa a la creación de información útil sobre la seguridad de los medicamentos. Los profesionales de la Farmacia Comunitaria pueden desempeñar un papel importante en la farmacovigilancia notificando directamente o 188 alentando a los ciudadanos. Se deben implementar medidas como estrategias de educación y capacitación continua para superar la falta de información de los ciudadanos y alentar a los profesionales sanitarios a desempeñar un papel activo en la farmacovigilancia, mejorando su nivel de percepción de riesgo y promoviendo una mejor actitud. El Capítulo 6 presenta una discusión general sobre el papel del ciudadano en la farmacovigilancia, brindando recomendaciones surgidas de los resultados de los estudios sobre los diferentes puntos de vista (autoridades nacionales competentes, profesionales sanitarios, organizaciones de pacientes y los propios pacientes) acerca de la participación del paciente en la farmacovigilancia. En conclusión, esta tesis se ha centrado en una visión general de la participación de diferentes partes interesadas en la farmacovigilancia, incluidos los PS, las autoridades nacionales competentes, las organizaciones de pacientes y los propios pacientes. De los resultados proporcionados, surge la necesidad de un desarrollo adicional de medidas dirigidas a los PS, pacientes y a los propios sistemas de farmacovigilancia para mejorar la participación de los ciudadanos en los sistemas de farmacovigilancia

Are patients ready to take part in pharmacovigilance system : a Portuguese preliminary study concerning ADR reporting

Background: New Pharmacovigilance legislation allows patients to report adverse drug reactions (ADRs) directly to competent authorities in all European Union (EU) member states. Patient reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n=50) were reported by patients. Underreporting remains a reality in Portugal, although patient reporting could be one of the measures to reduce the rate of underreporting by healthcare professionals (HCP). Objectives: The aim of this study was to describe the attitudes and knowledge of the patients regarding spontaneous reporting and the reasons and opinions that can influence patients ADR underreporting. Methods: A descriptive-correlational study was performed looking for patients’ attitudes and knowledge regarding spontaneous reporting. A 6-months survey was conducted from June to November 2013 in general adult patients from a community pharmacy in Coimbra, Portugal, that used prescribed medicines or OTC-drugs. Attitudes and opinions were surveyed in a closedanswer questionnaire using a Likert scale. Incomplete questionnaires and answers from healthcare professionals were excluded from data analysis. The data were analyzed using descriptive statistics, χ2 tests and Spearman’s correlation coefficients. Results: A total of 1084 questionnaires were collected with a response rate of 81,1% and 948 completed questionnaires were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only 1 patient had previously reported an ADR directly to SNF. Reporting ADRs indirectly through an HCP was preferred by 62.4%. The main reasons for patients reporting spontaneous ADR would be the severity of the reaction (81,1% agreed or strongly agreed) and worries about their own situation (73,4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements. Conclusions: Patients are most likely to do a spontaneous report about a severe reaction or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on patients could increase the number of reports from patients in Portugal

Attitudes and knowledge of community pharmacy professionals regarding the spontaneous reporting of adverse drug reactions: a preliminary study in Coimbra, Portugal

Background Spontaneous reporting of adverse drug reactions (ADRs) remains one of the most efficient methods to detect new, unusual, and severe ADRs. Community pharmacy professionals (CPPs) play a fundamental role in the reporting of spontaneous ADRs. The aim of this study was to describe the attitudes and knowledge of different CPP groups regarding the spontaneous reporting of ADRs and to identify the factors that can influence ADR under-reporting. Methods A cross-sectional descriptive study was conducted in CPPs (156 pharmacists and 40 pharmacy technicians) working in 49 pharmacies in Coimbra, Portugal. A survey of the knowledge and attitudes of CPPs towards reporting ADRs and the factors that encourage and discourage ADR reporting was constructed and personally delivered to the pharmacies. Results The response rate was 82.0%. The seriousness and the unusualness of the reaction were the most important motives to report ADRs (98.0 and 97.4% of respondents, respectively). CPPs also considered ADR reporting to be a professional obligation (96.4%), but “don’t feel the need to report well-known ADRs” (54.1%). Other attitudes associated with under-reporting were lack of time (50.0%), method of reporting (38.3%), and fear of legal liability (29.6%). Conclusions CPPs’ knowledge and behavior play a significant role in ADR reporting. Despite the differences in their educational syllabus, there were no statistical differences between pharmacists and pharmacy technicians with regard to their perception of the importance of ADR reports or the factors that affect their reporting. It may be possible to reduce the under-reporting of ADRs by introducing educational interventions based on the attitudes related to under-reporting that have been identified in this study.info:eu-repo/semantics/publishedVersio

Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.info:eu-repo/semantics/publishedVersio

Literatura infanto-juvenil e censura consequencias do pós-golpe

Orientador: Fábio de Carvalho MessaMonografia (graduação) - Universidade Federal do Paraná, Setor de Litoral, Curso de Licenciatura em Linguagem e ComunicaçãoInclui referênciasResumo: Este trabalho pretende verificar os equívocos de leitura e interpretação sobre textos infanto-juvenis - A Semente do Nicolau, de Chico Alencar; Meninos Sem Pátria, de Luiz Puntel; e A Bolsa Amarela, de Lygia Bojunga Nunes - que protagonizaram polêmicas e/ou conflitos no contexto escolar, no período da eleição do novo presidente do Brasil em 2018. A partir da seleção dessas manifestações, passamos à etapa de tentativa de compreensão do material produzido nas mídias (impressas e digitais) sobre as polêmicas envolvendo essas obras. Para isso foi preciso realizar uma leitura analítica integral das obras envolvidas para, então, contrastar com os enunciados das matérias geradas. Delimitamos, também, os temas que foram evidenciados como: doutrinação, comunismo, gênero e ideologia. Procuramos uma fundamentação para essas concepções, a fim de desfazer equívocos e banalizações. Mostramos, portanto, que as polêmicas são infundadas e que as obras têm muitas características interessantes e significativas para fins paradidáticos

Responsabilidade civil dos notários e dos registradores

Os serviços notariais e de registro são exercidos em caráter privado mediante delegação do Poder Público. Os responsáveis pela execução dos serviços de nota e de registro são os tabeliães e os oficiais de registro, e estes os executam nas dependências dos cartórios extrajudiciais. Embasando-se na doutrina, na jurisprudência e na lei, procura-se entender a quem cabe a responsabilidade civil por atos lesivos causados por tabeliães e registradores. Entre os entendimentos divergentes apresentam-se três correntes, a primeira defende a responsabilidade objetiva do Estado e subjetiva dos notários e registradores, a segunda defende a responsabilidade objetiva e direta do Estado e a terceira defende a responsabilidade objetiva e direta dos notários e registradores. A partir da análise das três correntes procurarse-á demonstrar qual a mais adequada para unificar o entendimento no ordenamento jurídico brasileiro

Spectral Analysis of Marine Debris in Simulated and Observed Sentinel-2/MSI Images using Unsupervised Classification

Marine litter poses significant threats to marine and coastal environments, with its impacts ever-growing. Remote sensing provides an advantageous supplement to traditional mitigation techniques, such as local cleaning operations and trawl net surveys, due to its capabilities for extensive coverage and frequent observation. In this study, we used Radiative Transfer Model (RTM) simulated data and data from the Multispectral Instrument (MSI) of the Sentinel-2 mission in combination with machine learning algorithms. Our aim was to study the spectral behavior of marine plastic pollution and evaluate the applicability of RTMs within this research area. The results from the exploratory analysis and unsupervised classification using the KMeans algorithm indicate that the spectral behavior of pollutants is influenced by factors such as the type of polymer and pixel coverage percentage. The findings also reveal spectral characteristics and trends of association and differentiation among elements. The applied methodology is strongly dependent on the data, and if reapplied in new, more diverse, and detailed datasets, it can potentially generate even better results. These insights can guide future research in remote sensing applications for detecting marine plastic pollution.Comment: Manuscript submitted to Ocean and Coastal Research journa

Knowledge and consumption of emergency contraception pills in a tertiary education student population

Introduction According to the World Health Organization (WHO), every year there are 200 million pregnancies, of which 75 million are unintended. Emergency contraception pills (ECPs) are one of the available methods to prevent an unintended pregnancy, after unprotected sexual intercourse or contraceptive failure. The aim of this study was to quantify the consumption, characterize the level of knowledge, and understand the factors that induce the use of ECPs in tertiary students. Methods An observational, cross-sectional, and retrospective survey was conducted at two tertiary education institutions (Coimbra Health School and Coimbra Education School) between January and April 2015. A written survey was applied to a convenience sample of female and male students at these schools. The survey questions comprised three areas: sociodemographic indicators; knowledge of ECPs; and previous consumption of ECPs (females only). Descriptive statistics and chi-square of independence test were used. Results Most of the students had heard about ECPs and used them mainly for “forgetfulness or contraceptive failure” (63.8%) or “sex without using a contraceptive” (22.4%). Students’ main information sources were school, friends, and the internet. There was a higher level of knowledge in female students, students from the Coimbra Health School (vs students from the Coimbra Education School), and students who had received healthcare professional counseling (p < 0.01). Regarding consumption, the majority (74.1%) were first-time users of ECPs and almost all ECPs were obtained in the pharmacy (91.4%). Conclusions In Portugal, ECPs are available over the counter, which facilitates their obtainment. There was some knowledge among students, however lack of information about this subject should be taken into account in further studies. Communication with the students to improve their risk perception and knowledge is key to improving the safer use of ECPs.info:eu-repo/semantics/publishedVersio