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Pharmacovigilance; Contents; Contributors; Preface; Foreword; Part I. The Basis of Pharmacovigilance; 1. Introduction; 2. Legal Basis -- EU; 3. Legal Basis -- United States; 4. Ethical Oversight, Consent and Confidentiality; 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation; 6. Periodic Safety Update Reports; 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials; 8. Mechanisms of Adverse Drug Reactions; 9. Micturin and Torsades de Pointes; 10. Withdrawal of Terodiline: A Tale of Two Toxicities.

Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world

Pharmacovigilance is growing in India. Given the size of the pharmaceutical market in India, it is important to understand how pharmacovigilance impacts the pharmaceutical products. Pharmacovilance leads to the safe usage of the pharmaceutical drugs but under reporting is a major issue in India mainly due to lack of awareness or feeling of fear. In order to build a robust pharmacovigilance system in India, active participation would be required from the Indian pharma sector as well as the government. Initiatives that can assist the small privatized generic companies to cope with the evolving regulations given their limited budget, are necessary. This paper provides an overview about the current pharmacovigilance system in India, its problems and how the problems can be solved provided India follows the pharmacovigilance practices practiced by other developed and developing nations.

Introduction: Various authors have described the challenges associated with African pharmacovigilance systems. However, the last decades have seen growth of these systems. The thesis provides insight into the emergence and growth of African pharmacovigilance systems by looking at different elements of the system. Focus will be on examining the role of the national pharmacovigilance centre, the participation and awareness of reporters and evaluators and lastly, the feasibility of generating evidence on the safety and use of medicines in low resource settings in Africa. Results:Chapter 2.1 characterized Adverse Drug Reaction (ADR) reporting activities in Africa and compared them with the rest of the world. We found that ADR reporting in Africa has grown from 25,000 in 2010to 103,499 in 2015. The characteristics of African ADRs are different from the rest of the world in terms of products and ADRs reported. In Chapter 2.2 we provided a broader view on the functioning of national pharmacovigilance centres in Africa by examining their resources, relationships and organisational capacity. We found that strategic leaders of national centres often attributed successful pharmacovigilance activities to availability of political and technical resources, while unsuccessful activities were often attributed to a lack of financial and human resources. In order to increase reporting of ADRs to the national centre, we assessed the awareness of Ghanaian patients about ADRs and ADR reporting (Chapter 3.1) which revealed that of the 491 participants in our study, 38% had experienced an ADR of which 67% reported the ADR to someone, 68% of them reported it to a doctor. However, only 3% of the 491 participants were aware of the Ghana-Food and Drug Authority's patient reporting system. There is limited knowledge on the use of local data for decision making in Africa. In Chapter 3.2 through literature review we showed that no major drug safety decisions have been taken by public health programmes based on data collected in Africa. Data ...

Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making

Background: Adverse drug reactions (ADRs) can be a big threat to the health of people in Nepal as a variety of medicines are consumed in the country. Involving consumers in pharmacovigilance can strengthen ADR reporting. The study aims to find out knowledge, attitude and practice regarding pharmacovigilance and consumer pharmacovigilance among consumers at Lalitpur district, NepalMethods: It was carried out in outpatients visiting in KIST Medical College and Teaching Hospital, Lalitpur, Nepal. Participant's knowledge, attitude and practice were measured by noting their agreement with a set of 21 statements along with multiple choice and open ended questions.Results: A total of 157 outpatients were surveyed. The knowledge scores for males (12) was better compared to the females (11), but the scores for attitude and practice were same for both groups. The maximum score for knowledge was 29, attitude was 6 and practice was 10. The overall KAP scores was 45. The total scores for knowledge, attitude and practice for males (24) were better compared to female (22) respondents. Seventy-one patients (68%) who participated in this study favoured establishing a consumer centre for obtaining information about ADRs.Conclusions: Knowledge scores among consumers regarding pharmacovigilance is low and require advocacy and improvement.

INTRODUCTION: The pharmacovigilance system is playing a vital role in the process of patient safety through reporting of ADRs and other drug-related problems. Although, the. Pharmacovigilance system is well established in other Gulf Cooperation Countries (GCC). In Kingdom of Bahrain, the Pharmacovigilance system is still in its early stages. Establishing a successful Pharmacovigilance system in Bahrain requires a collective effort from various stakeholders such as the ministry of health and the National Health Regulatory Authority (NHRA). AIM: To assess the current status of the Pharmacovigilance system in Bahrain and the feasibility of its development. OBJECTIVES: To investigate the current Pharmacovigilance activities in Bahrain, to explore the attitude / knowledge of healthcare providers towards PV systems and to identify the limitations, and barriers of the PV system in Bahrain. METHODOLOGY: This was a descriptive cross-sectional study utilising an online survey composed of 24 questions. It was distributed to pharmacists, physicians, and nurses working at government and private hospitals in Bahrain through emails and social media. In addition, a telephone interview was performed with a pharmacist working for NHRA in Bahrain. Ethics approval was prior to commencing the study. RESULTS: More than half of the respondents (69.8%) did not report any ADRs so far in their practice, whereas 30.2% had done so. A total of 95.8% of those who have never reported before were willing to report in the future. Participants who received training regarding reporting ADRs reported lower positive attitudes (3.3 ± 0.8 vs 3.6 ± 0.6). In addition, the participants were more knowledgeable about the ADRs reporting process than the PV system. The results showed the absence of an active PV program. The activity of PV in Bahrain is limited to receiving notifications and periodic safety update records from manufactures or the GHC. Conclusion: Despite the average level of knowledge of healthcare providers towards the PV system, the ...

The legal regulation of pharmacovigilance is overviewed in this master thesis. In the first part the concept, sorts and history of pharmacovigilance are analysed. In the second part the current European Union legislation on pharmacovigilance is analysed, comparing it to legislation that will come into force in july, 2012, pointing to the main changes and its meaning to the European Union system of pharmacovigilance. In the third part Lithuanian legislation on pharmacovigilance is analysed and the efficiency of national system of pharmacovigilance is assessed.

The legal regulation of pharmacovigilance is overviewed in this master thesis. In the first part the concept, sorts and history of pharmacovigilance are analysed. In the second part the current European Union legislation on pharmacovigilance is analysed, comparing it to legislation that will come into force in july, 2012, pointing to the main changes and its meaning to the European Union system of pharmacovigilance. In the third part Lithuanian legislation on pharmacovigilance is analysed and the efficiency of national system of pharmacovigilance is assessed.

BACKGROUND: National pharmacovigilance centres (national centres) are gradually gaining visibility as part of the healthcare delivery system in Africa. As does happen in high-income countries, it is assumed that national centres can play a central coordinating role in their national pharmacovigilance (PV) systems. However, there are no studies that have investigated whether national centres in Africa have sufficient organizational capacity to deliver on this mandate and previous studies have reported challenges such as lack of funding, political will and adequate human resources. We conducted interviews with strategic leaders in national centres in 18 African countries, to examine how they link the capacity of their organization to the outcomes of activities coordinated by their centres. Strategic leaders were asked to describe three situations in which activities conducted by their centre were deemed successful and unsuccessful. We analyzed these experiences for common themes and examined whether strategic leaders attributed particular types of resources and relationships with stakeholders to successful or unsuccessful activities. RESULTS: We found that strategic leaders most often attributed successful experiences to the acquisition of political (e.g. legal mandate) or technical (e.g. active surveillance database) resources, while unsuccessful experiences were often attributed to the lack of financial and human resources. Stakeholders that were most often mentioned in association with successful experiences were national government and development partners, whereas national government and public health programmes (PHPs) were often mentioned in unsuccessful experiences. All 18 centres, regardless of maturity of their PV systems had similar challenges. CONCLUSIONS: The study concludes that national centres in Africa are faced with 3 core challenges: (1) over-reliance on development partners, (2) seeming indifference of national governments to provide support after national centres have gained membership of the ...

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.