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Dissertations / Theses on the topic 'Pharmacovigilance'
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Scurti, Veronica. "Patients centred pharmacovigilance." Thesis, Open University, 2011. http://oro.open.ac.uk/54505/.
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In recent years, periodically high peaks of attention and publications have documented severe adverse reactions to new molecules, which have raised many questions about the efficacy- efficiency of traditional methodological tools of phannacovigilance, as well as about the role of regulatory systems. Drugs cannot be considered as an independent variable: the evaluation of all of their effects must take into account the real context in which they are used, and in which they are expected have a role, not only in terms of efficacy, but also of tolerability and safety. Specific emphasis is given to recent and promising developments, which are focused on the participation of patient populations as key actors in producing knowledge that can also technically integrate what has been produced so far, and can allow the evolution of surveillance from a role of control to one of the promotion of rights. The replacement of phannacovigilance in an epidemiological context is the main aim of this project. This is applied across the development of various projects realised in different scenarios (e.g. hospital, community) using different methodologies (e.g. administrative database linkage, prospective studies, qualitative projects), and through the direct involvement of all of the actors involved in the process of care (e.g. clinicians, general practitioners, patients). In particular, despite the many recommendations, patient participation can be considered as an exception in the health care setting: for this reason the project was developed with the intention to give voice to patients. Promotion of the use of a more narrative style between health professionals and citizen-patients in phannacovigilance should be considered the most important outcome of a renewed phannacovigilance.
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Maizy, Olivier. "Nécessités de la pharmacovigilance." Paris 5, 1988. http://www.theses.fr/1988PA05P046.
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Tubert-Bitter, Pascale. "Modèles statistiques en pharmacovigilance." Paris 6, 1989. http://www.theses.fr/1989PA066497.
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La decouverte des effets indesirables des medicaments est basee sur les notifications spontanees des medecins. Actuellement, la seule methode d'examen utilisee est leur validation au cas par cas. L'objet de ce travail est de proposer, alors que l'information disponible est incomplete, des traitements statistiques pour ces observations. La premiere partie traite du declenchement de l'alerte, avec la construction du test d'independance entre les variables apparition du symptome et exposition (prise du medicament), lorsque les nombres totaux de personnes traitees ou atteintes du symptome sont mal connus. La table de contingence 22 correspondante est amenagee en considerant des modeles aleatoires pour l'une ou l'autre de ses marges qui n'aura pu etre observee. Pour chacun d'entre eux, lorsque le calcul exact du seuil critique deconditionne de ces observations n'est pas possible, des resultats sur la convergence en loi, du produit des marges vers la loi gamma sous l'hypothese d'independance sont etablis, qui en permettent le calcul approche. Les notifications spontanees sous-estiment l'incidence des effets indesirables. En modelisant le filtrage des accidents par les notifications, une estimation du nombre de cas reellement survenus pendant une periode donnee peut etre obtenue. C'est ce qui constitue la deuxieme partie: la modelisation stochastique du processus des accidents notifies s'effectue en deux temps; le processus de poisson pour la survenue des effets indesirables, et son effacement aleatoire suivant des modeles d'apprentissage pour l'evolution de la detection
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Carteron, Hélène. "Le pharmacien d'officine en pharmacovigilance." Paris 5, 2001. http://www.theses.fr/2001PA05P014.
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Schenkery, Juliette. "Le pharmacien d'officine et la pharmacovigilance." Paris 5, 1992. http://www.theses.fr/1992PA05P067.
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Ekman, Elisabet. "Pharmacovigilance : spontaneous reporting in health care." Doctoral thesis, Linnéuniversitetet, Institutionen för medicin och optometri (MEO), 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-26820.
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Pharmacovigilance in healthcare is essential for safe drug treatment. Spontaneous reporting is the most common source of information in the context of implementing label changes and taking a drug off the market. However, underreporting is found to be very prevalent. One way to decrease underreporting is to include different categories of healthcare professionals in such reporting and to investigate attitudes towards and incentives for reporting adverse drug reaction (ADR)s. As nurses form the largest group of health professionals, a sample of nurses were allowed and encouraged to report ADR during a 12 month period after they had received training in pharmacovigilance. A questionnaire posted to physicians and nurses investigated their knowledge and attitudes towards reporting. Spontaneous reports of torsade de pointes (TdP) and erectile dysfunction (ED) were scrutinized with respect to the reported drugs, risk factors and if the reaction was listed in the summary of product characteristics (SPC). After training, the nurses produced relevant reports and three years after the introduction of nurses in the reporting scheme, more than half of the responding nurses were aware of their role as reporters. Both nurses and physicians stated that the most important factor for reporting a suspected ADR was the severity of the ADR and an ADR arising in response to a newly approved drug. A web-based reporting system was deemed to facilitate the reporting. In spontaneous reports of TdP, citalopram was reported as a suspected drug. However, neither QT prolongations, nor TdP, were labelled in the SPC. ED was reported for all antihypertensive drugs including angiotensin II type I blockers. A positive information component (IC), assessing the disproportionality between the observed and the expected number of reports, was found indicating that ED was reported more often in association with antihypertensive drug classes, except for angiotensinconverting enzyme inhibitors. This thesis demonstrates the importance of pharmacoviglilance in healthcare in terms of capturing new signals. By including nurses as reporters, the overall safety of drugs might improve. Information and education are needed to secure safe treatment when applying drugs.
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Deville, de Périère Gilles. "Réalisation de la première expérience télématique au centre régional de pharmacovigilance du Languedoc-Roussillon." Montpellier 1, 1990. http://www.theses.fr/1990MON11297.
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Alves, Agnès. "Tératovigilance : un des aspects de la pharmacovigilance." Paris 5, 1998. http://www.theses.fr/1998PA05P138.
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Prendergast, Tim. "Interrupted Time Series Analysis Techniques in Pharmacovigilance." Thèse, Université d'Ottawa / University of Ottawa, 2013. http://hdl.handle.net/10393/30291.
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This thesis considers an approach to evaluate the effectiveness of risk communications for prescription drugs by performing interrupted time series analysis of prescription drug volumes prior to and after the risk communication date.
The paper presents methods for detecting change in the presence of autocorrelation and techniques to reduce bias in estimation. Statistical results and data plots are presented for 63 data series. Size and power of the statistical techniques are considered, and a correspondence analysis between these statistical techniques and a small group of physicians is performed.
The methods considered in this thesis correspond weakly with physician sentiment, and exhibit inflated type I errors in the presence of significant autocorrelation.
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Egunsola, Oluwaseun. "Pharmacovigilance of antiepileptic drug toxicity in children." Thesis, University of Nottingham, 2017. http://eprints.nottingham.ac.uk/40058/.
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Several of the available antiepileptic drugs (AEDs) were approved in the last 25 years. These new generation AEDs have not been shown to be more effective than the old ones and their safety profile have not been explored sufficiently in pharmacovigilance studies. As reported in chapter 2, prospective cohort studies are the most common pharmacovigilance study methods, with adverse drug reactions (ADRs) often elicited with questionnaires or checklists. A systematic review to identify all published AED side effects rating scales, reported in chapter 3, identified nine AED ADR rating scales. Two of these, The Hague Side Effect Scale (HASES) and the Paediatric Side Effect Questionnaire (PESQ), are paediatric specific. A systematic review of AED utilisation rate reported in chapter 4, shows an increasing utilisation of levetiracetam and lamotrigine reported as the most frequently utilised new generation AED in paediatrics. Systematic reviews of the safety of both drugs in children, reported in chapters 5 and 6, identified rash (7.3%) and behavioural problems (10.9%) as the most common ADRs associated with lamotrigine and levetiracetam respectively. They were also the most common reasons for the discontinuation of treatment. In chapter 7, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) risks are reported to be significantly higher when lamotrigine was co-prescribed with sodium valproate (43%) than when either carbamazepine (8%) or phenobarbital (8%) were co-prescribed with sodium valproate. SJS/TEN also occurred more frequently with sodium valproate and lamotrigine co-medication than other non-cutaneous ADRs (19%). Being the more recent paediatric AED ADR rating scale, the PESQ was selected for the elicitation of ADRs in a prospective cohort study of AED safety in children reported in chapter 8. Half of the 124 participants in the study received levetiracetam, either as monotherapy or polytherapy. There were significantly fewer ADRs with levetiracetam than either carbamazepine or sodium valproate monotherapy. The risks of drowsiness, fatigue and weight gain were significantly higher with levetiracetam polytherapy than monotherapy (p < 0.05). Attention difficulties, aggression and decreased concentration were significantly lower with valproate polytherapy (p < 0.05). The common ADRs associated with AEDs are discussed in chapter 9. In conclusion, lamotrigine and levetiracetam are increasingly being used for the treatment of epilepsy in children. Lamotrigine may cause severe rash, especially when co-administered with valproate; while levetiracetam is a common cause of behavioural problems. In order to compare the safety profile of AEDs adequately, large multicentre paediatric safety studies are required.
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NGUYEN-HUU, THIEN-AN. "Un essai de pharmacovigilance en medecine hospitaliere." Toulouse 3, 1994. http://www.theses.fr/1994TOU31004.
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Jorge, Pedro André Alves. "Internship report: experience in Bluepharma's pharmacovigilance sector." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/13590.
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Mestrado em Biomedicina FarmacêuticaThe present report is intended to describe a ten-month internship for the master degree in Pharmaceutical Medicine in University of Aveiro performed in the pharmacovigilance sector of the pharmaceutical company Bluepharma – Indústria Farmacêutica, S.A. Pharmaceutical Medicine professionals, based on their background, have knowledge about theoretical and procedural concepts related to pharmacovigilance (the science responsible for the study of safety of medicinal products). The objectives of this internship forecasted the application of this knowledge, as well the acquisition and improvement of knowledge related to the pharmacovigilance and medicinal products’ safety in a professional setting. This report is divided in four sections. In section one a description of internship objectives and current state-of-art of pharmacovigilance is presented. The activities performed during this internship are described on section two, followed by their discussion on section three. Finally, section four presents a conclusion analysing the main skills and knowledge gained during this internship and their relevance for complementing academic experience.
O presente relatório descreve um estágio curricular no âmbito do mestrado em Biomedicina Farmacêutica da Universidade de Aveiro realizado ao longo de dez meses no sector de farmacovigilância da empresa farmacêutica Bluepharma – Indústria Farmacêutica, S.A. Os profissionais da Biomedicina Farmacêutica, no âmbito da sua formação, desenvolvem conhecimentos de conceitos teóricos e processuais associados à farmacovigilância (ciência relacionada com a segurança de medicamentos). Os objetivos deste estágio previam a colocação em prática desses conhecimentos, bem como a aquisição e aprofundamento de conhecimentos relacionados com as matérias de farmacovigilância e segurança de medicamentos de uso humano em contexto profissional. O relatório encontra-se dividido em quatro partes. Numa primeira parte são descritos os objetivos deste estágio e o estado-de-arte da farmacovigilância. Uma descrição das atividades envolvidas neste estágio é apresentada na segunda parte, seguida da sua discussão na terceira parte. Por fim, é apresentada uma conclusão onde são discutidos os principais conhecimentos adquiridos e qual importância da experiência académica para complemento da formação.
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Phillips, Anastasia. "Evolution and Opportunities: Vaccine Pharmacovigilance in Australia." Thesis, The University of Sydney, 2021. https://hdl.handle.net/2123/27202.
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Immunisation has an immense impact on preventing morbidity and mortality worldwide. Although vaccine safety is demonstrated in pre-licensure clinical trials, post-marketing surveillance is essential to ensure an ongoing, positive benefit-risk profile in the population. In Australia, a safety issue was identified after febrile seizures were associated with one brand of influenza vaccine in 2010. These events prompted the modification and strengthening of vaccine pharmacovigilance systems; however, additional pharmacovigilance opportunities exist.
This thesis hypothesises that multi-faceted and adaptive vaccine pharmacovigilance methods, implemented strategically, are necessary to monitor vaccine safety in Australia and to inform ongoing benefit–risk assessment for vaccines and immunisation programs. Further, this thesis proposes that Australia can contribute to an international body of evidence through strengthening its own systems.
This thesis assesses the value of current vaccine pharmacovigilance systems through analysis of cumulative data from multiple sources, including passive and active surveillance data, and a novel primary care data source. These analyses affirm the safety profile of the vaccines under investigation and highlight the validity of the systems and methods used. The limitations of individual systems are identified, including the challenges in ascertainment of hospitalised events and in making comparisons to unvaccinated populations. A final qualitative evaluation draws on the perspectives of expert informants to consider progress since 2010 and whether current systems are sufficiently robust to detect and investigate a potential safety signal, including for COVID-19 vaccines. The thesis concludes with five recommendations to strengthen Australia’s country-level systems and enhance its global contribution to vaccine pharmacovigilance.
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Perdiz, Daniel. "Harmonisation européenne en pharmacovigilance, implication du pharmacien." Paris 5, 1995. http://www.theses.fr/1995PA05P243.
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Tang, Amy. "Evaluating the evidence base in pharmacovigilance decision making." Thesis, University of Portsmouth, 2010. https://researchportal.port.ac.uk/portal/en/theses/evaluating-the-evidence-base-in-pharmacovigilance-decision-making(e2ef5638-ca08-44fc-8586-23d88e012430).html.
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Introduction It has been said that through monitoring of drug safety, pharmacovigilance (PV) systems have been instrumental in assisting regulatory decisions on product safety. However, there has been no, systematic, in-depth study of this role. This thesis reports such a study conducted in the UK. On the basis of the results, suggestions are made on how PV data might be produced and used more effectively. Methods In Phase 1, a scoping study was conducted to document all changes made to UK product labelling on safety grounds over a 10 year period (September 1st 1995 to August 31st 2005). In Phase 2, all product withdrawals and major labelling changes made during the 10 year study above, were investigated in depth to determine the therapeutic group, source of ADR data cited as the reason for the change; and product survival probability, using Kaplan-Meier modelling. Phase 3, informed by Phases 1 and 2, used a web-based survey (150 respondents) and structured interviews (13 subjects) with healthcare professionals and scientists with a PV role in the NHS, pharmaceutical companies and the UK regulator, to gain views on the current procedures for handling safety issues in the UK and how these might be improved. Inferences were drawn using interpretative henomenological analysis with NVivo 8 software. Key findings Phases 1 and 2 revealed the fragmentary nature of information in the public domain and the difficulties of obtaining unpublished information. Based on public information, Phase 1 showed that 2,630 safety notices were issued affecting 688 individual products. The two main safety notice categories were drug interactions (841;32%) and side effects (537;20%). The rank order of the four most common therapeutic areas in which safety notices occurred was: CNS (23.5%)> anti-infectives (21.6%) > cardiovascular (15.2%) > cancer chemotherapy (10.8%). The ratio of Type A : Type B side effects (ADRs) was 1:3.3. Phase 2 found that of 518 eligible products launched during the study period, 9 (1.7%) were licensed and withdrawn for safety reasons. The ten-year Kaplan-Meier probability of adverse drug reactions causing the withdrawal of a new product, postmarketingwas 2.2%. All decisions were based on more than one safety data type and all involved UK yellow cards. One decision considered prescription event monitoring (PEM) data. A total of 164 important safety notices affecting 818 individual products were identified. Of 518 products launched during the study period, 56 experienced at least one major labelling change for safety reasons. The ten-year Kaplan-Meier risk of a product experiencing at least one major labelling change on safety grounds was 13.8%. As with product withdrawals, safety decisions were based on a wide range of data sources of variable quality and quantity. Variation in dissemination of the new safety information was observed. Only one fifth of safety notices warranting a ‘Dear Healthcare Professional’ letter or a monograph in ‘Current Problems in Pharmacovigilance’, were accompanied by a boxed warning in the BNF, representing an important inconsistency in notifying prescribers. As with interview participants, respondents to the on-line questionnaire had difficulties placing the yellow card reports in a formal hierarchy of evidence whilst acknowledging that the data were valuable in the decision making process. Suggested ways of improving the quality of such reports included making the reporting more accessible and training all those eligible to report. PEM studies were cited by the majority of respondents as a means of generating credible safety data and raising the general quality of the drug safety database. In terms of dissemination and education about ADRs, Drug Safety Updates (which replaced the ‘Current Problems’ publication from the MHRA in August 2007) were highly thought of; they appeared to be more popular than ‘Dear Healthcare Professional’ letters and because they were web-based, ought to be accessible by a wider audience. Conclusions Safeguarding public health is of utmost importance when making a decision whether or not to withdraw a product or amend its labelling upon the emergence of new safety data. Labelling changes should be made only on the best evidence available at the time and appropriate risk management strategies should be instigated where feasible; not only when a safety signal arises post-marketing, but when a drug is first granted a marketing authorisation. There is no general consensus on what constitutes ‘best evidence’ and rating evidence using traditional hierarchies is problematic, The GRADE hierarchy may be an exception. Improving ADR reporting should lead to improved data bases from which to draw safety conclusions. Methods of improving reporting include early instigation and enforcement of risk management plans by the regulator, education of all those eligible to report, greater transparency of regulatory decisions and better and more rapid dissemination of safety change information.
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Meyboom, Ronald Hubert Boudewijn. "Detecting adverse drug reactions : pharmacovigilance in the Netherlands /." 's-Hertogenbosch : LAREB, 1998. http://www.gbv.de/dms/bs/toc/280331320.pdf.
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Sun, Pei-Chen Angela. "Paediatric pharmacovigilance : utility of routinely acquired healthcare data." Thesis, University of Aberdeen, 2014. http://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=225729.
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Castro, Luísa Margarida Narciso Alves Tavares de. "Pharmacovigilance and the safety of veterinary medicinal products." Master's thesis, Universidade de Lisboa, Faculdade de Medicina Veterinária, 2018. http://hdl.handle.net/10400.5/16693.
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Dissertação de Mestrado Integrado em Medicina VeterináriaPharmacovigilance in veterinary medicine has developed considerably in the recent years. The increase in legislation in the area of veterinary medicinal products, as well as the increased awareness of the veterinarian regarding the need to report the adverse events observed during the use of the medicines in the animals in his care, has led to an increase in the number of cases reported at European level. For the preparation of this master's dissertation, a review was made of the existing published references on the subject of pharmacovigilance, namely the legal framework, the requirements for the marketing authorization holder of the veterinary medicinal product as well as for the veterinarian prescribing the medicines to the animals which are under her/his responsibility and treatment. Signal management is currently considered the best way to carry out drug surveillance and it follows a specific methodology. Signal management is the pillar of the future legislation on veterinary medicinal products as well as human medicines. In this study the European pharmacovigilance systems, France, Portugal, Spain, UK, are analysed and compared because although having the same legislative frame, each one has different particularities. There is also a reflection about the underreporting of adverse events by veterinarians and some measures that can improve notification, such as use of new technologies and improvement in the feedback to reporter, among others. Whether as a clinician, as veterinarian working in the pharmaceutical industry as well as in the competent authorities, the veterinary professional is essential in the veterinary pharmacovigilance system, the continuous monitoring of veterinary medicinal products, maintaining the positive benefit-risk balance and in the protection of animal health and food safety.
RESUMO - Farmacovigilância e a segurança dos medicamentos veterinários - A farmacovigilância em medicina veterinária tem-se desenvolvido bastante nos últimos anos. O aumento de legislação na área do medicamento veterinário, bem como a maior sensibilização do médico veterinário para a necessidade de reportar os eventos adversos observados aquando da utilização do medicamento veterinário nos animais que estão a seu cuidado, têm resultado num aumento no número de casos reportados a nível europeu. Para a elaboração desta dissertação de mestrado foi feita uma revisão das publicações existentes sobre o assunto da farmacovigilância nomeadamente o enquadramento legal, os requisitos para o titular de autorização de introdução no mercado do medicamento veterinário, bem como para o médico veterinário que prescreve os medicamentos aos animais que tem sob sua responsabilidade e tratamento. Atualmente considera-se que a gestão de sinais é a melhor forma para realizar a vigilância dos medicamentos e esta segue uma metodologia específica. A gestão de sinais dos eventos adversos é o pilar da futura legislação quer do medicamento veterinário, quer do medicamento de uso humano. Neste estudo os sistemas de farmacovigilância europeus, como de Espanha, França, Portugal e Reino Unido, são analisados e comparados, pois tendo como base a mesma moldura legislativa europeia, cada um deles tem as suas particularidades. Também se faz uma reflexão sobre a subnotificação de eventos adversos por parte dos veterinários e algumas medidas que podem melhorar a notificação, como a utilização das novas tecnologias e uma melhoria nas respostas que se dão aos notificantes, entre outras. Seja como médico veterinário clínico, como médico veterinário profissional do sector farmacêutico, bem como membro nas autoridades competentes, a figura do médico veterinário é fundamental no sistema de farmacovigilância veterinária, na monitorização contínua dos medicamentos veterinários, na manutenção do benefício-risco positivo e na proteção da saúde animal e segurança alimentar.
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Fernandes, Nádia Libânia Lopes. "Internship report: a 11-month experience in pharmacovigilance." Master's thesis, Universidade de Aveiro, 2013. http://hdl.handle.net/10773/11518.
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Mestrado em Biomedicina FarmacêuticaO presente relatório propõe relatar a minha experiência de 11 meses em farmacovigilância na Bluepharma - Indústria Farmacêutica, S.A. O estágio foi realizado no âmbito do mestrado em Biomedicina Farmacêutica e teve como objetivos a aquisição de competências técnicas e de experiência em farmacovigilância e a consolidação de conhecimentos. No primeiro capítulo é feita uma introdução ao estágio curricular, seguindo-se uma descrição do estado da arte da indústria farmacêutica, focando-se no mercado farmacêutico e no seu ambiente regulamentar na União Europeia, em especial na área da farmacovigilância. Neste capítulo é ainda apresentada a empresa de acolhimento e os objetivos do estágio. No capítulo seguinte são descritas as formações multidisciplinares, bem como as tarefas e atividades desempenhadas durante o período de estágio. No final é apresentada uma discussão e conclusão, incluindo uma análise das atividades desenvolvidas, principais dificuldades sentidas bem como das competências adquiridas durante esta experiência profissional.
The present report intends to describe my 11-month experience in pharmacovigilance at Bluepharma - Indústria Farmacêutica, S.A. The internship was performed within the scope of the Master’s Degree in Pharmaceutical Biomedicine, aiming to acquire technical skills and experience in pharmacovigilance, as well as to consolidate previous knowledge. The first chapter introduces the internship and describes the state of the art in the pharmaceutical industry focusing on the pharmaceutical market and regulatory environment in the European Union, especially in the pharmacovigilance area. This chapter also includes a description of the host company and the internship objectives. The subsequent chapter presents a description of the multidisciplinary experience as well as the tasks and activities developed during the internship period. Finally, it is presented a discussion and conclusion, which include a critical analysis of the tasks developed, main difficulties and skills acquired during this professional experience.
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Qin, Xiao. "Sequential Data Mining and its Applications to Pharmacovigilance." Digital WPI, 2019. https://digitalcommons.wpi.edu/etd-dissertations/515.
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With the phenomenal growth of digital devices coupled with their ever-increasing capabilities of data generation and storage, sequential data is becoming more and more ubiquitous in a wide spectrum of application scenarios. There are various embodiments of sequential data such as temporal database, time series and text (word sequence) where the first one is synchronous over time and the latter two often generated in an asynchronous fashion. In order to derive precious insights, it is critical to learn and understand the behavior dynamics as well as the causality relationships across sequences. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADR) or other drug-related problems. In the post-marketing phase, the effectiveness and the safety of drugs is monitored by regulatory agencies known as post-marketing surveillance. Spontaneous Reporting System (SRS), e.g., U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), collects drug safety complaints over time providing the key evidence to support regularity actions towards the reported products. With the rapid growth of the reporting volume and velocity, data mining techniques promise to be effective to facilitating drug safety reviewers performing supervision tasks in a timely fashion. My dissertation studies the problem of exploring, analyzing and modeling various types of sequential data within a typical SRS: Temporal Correlations Discovery and Exploration. SRS can be seen as a temporal database where each transaction encodes the co-occurrence of some reported drugs and observed ADRs in a time frame. Temporal association rule learning (TARL) has been proven to be a prime candidate to derive associations among the objects from such temporal database. However, TARL is parameterized and computational expensive making it difficult to use for discovering interesting association among drugs and ADRs in a timely fashion. Worse yet, existing interestingness measures fail to capture the significance of certain types of association in the context of pharmacovigilance, e.g. drug-drug interaction (DDI) related ADR. To discover DDI related ADR using TARL, we propose an interestingness measure that aligns with the DDI semantics. We propose an interactive temporal association analytics framework that supports real-time temporal association derivation and exploration. Anomaly Detection in Time Series. Abnormal reports may reveal meaningful ADR case which is overlooked by frequency-based data mining approach such as association rule learning where patterns are derived from frequently occurred events. In addition, the sense of abnormal or rareness may vary in different contexts. For example, an ADR, normally occurs to adult population, may rarely happen to youth population but with life threatening outcomes. Local outlier factor (LOF) is identified as a suitable approach to capture such local abnormal phenomenon. However, existing LOF algorithms and its variations fail to cope with high velocity data streams due to its high algorithmic complexity. We propose new local outlier semantics that leverage kernel density estimation (KDE) to effectively detect local outliers from streaming data. A strategy to continuously detect top-N KDE-based local outliers over streams is also designed, called KELOS -- the first linear time complexity streaming local outlier detection approach. Text Modeling. Language modeling (LM) is a fundamental problem in many natural language processing (NLP) tasks. LM is the development of probabilistic models that are able to predict the next word in the sequence given the words that precede it. Recently, LM is advanced by the success of the recurrent neural networks (RNNs) which overcome the Markov assumption made in the traditional statistical language models. In theory, RNNs such as Long Short-Term Memory (LSTM) and Gated Recurrent Unit (GRU) can “remember� arbitrarily long span of history if provided with enough capacity. However, they do not perform well on very long sequences in practice as the gradient computation for RNNs becomes increasingly ill-behaved as the expected dependency becomes longer. One way of tackling this problem is to feed succinct information that encodes the semantic structure of the entire document such as latent topics as context to guide the modeling process. Clinical narratives that describe complex medical events are often accompanied by meta-information such as a patient's demographics, diagnoses and medications. This structured information implicitly relates to the logical and semantic structure of the entire narrative, and thus affects vocabulary choices for the narrative composition. To leverage this meta-information, we propose a supervised topic compositional neural language model, called MeTRNN, that integrates the strength of supervised topic modeling in capturing global semantics with the capacity of contextual recurrent neural networks (RNN) in modeling local word dependencies.
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Constantin, Valérie. "La pharmacovigilance à l'A. P-. H. P : bilan et perspectives." Paris 5, 1998. http://www.theses.fr/1998PA05P165.
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Chassagne, Isabelle. "La pharmacovigilance industrielle : structures types, politique d'action et de développement." Bordeaux 2, 1993. http://www.theses.fr/1993BOR2PE72.
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Rassier, Sylvie. "Gestion des appels de tératovigilance : expérience du C.R.P.V. de Montpellier." Montpellier 1, 1993. http://www.theses.fr/1993MON11170.
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Morange-Sala, Sophie. "Les aromatisants : faut-il en tenir compte en pharmacovigilance ?" Aix-Marseille 2, 1989. http://www.theses.fr/1989AIX20833.
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Naina, Mohamed Isa. "Novel approaches to pharmacovigilance : exploiting routinely acquired healthcare data." Thesis, University of Aberdeen, 2010. http://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=165979.
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Introduction: The main pharmacovigilance system in the United Kingdom is the ‘Yellow Card’ spontaneous reporting system which suffers from low reporting rate, and long lag time between drug launch and ADR recognition. Aim: The aim of this study is to develop a pharmacovigilance system to permit the early detection of adverse drug reactions using routinely acquired NHS health data with minimal cost and resources. Methods: There are 2 methods for this study; Phase 1: The extraction of drug persistence data from routinely acquired NHS health data, and Phase 2: Identifying the exact reason(s) for patient discontinuation of drug therapy within 6 months of the index prescription. Results: Phase1: During the study period 4243 patients were initiated on ramipril, 8849 patients on simvastatin, 3242 patients on ARBs, 3646 patients on amlodipine and 269 patients on lercanidipine. The 1, 2-3 and 4-6 month discontinuation rates were 9.9%, 4.9% and 4.2% respectively for ramipril, 9.5%, 3.4% and 3.2% for simvastatin, 8.7%, 2.9% and 2.5% for ARBs, 16.2%, 6.3% and 4.8% for amlodipine, and 17.8%, 3.7% and 3.7% for lercanidipine. Drug discontinuation rates determined agree closely with published data from trials and post marketing surveys in terms of the peak time at which ADRs and discontinuations occur (1 month), the populations most frequently affected (females and the young or elderly depending on drug), and the relationship between the frequency of ADRs and discontinuations relative to the drug of interest, especially for antihypertensive (CCBs>ACEIs>ARBs). Phase 2: Six (20%) of 30 participating primary care practices, contributing to the PTI database, agreed to be approached directly. Completed data was returned for 98% of patients whom discontinued amlodipine due to a specific ADR. Conclusions: Drug discontinuation rates obtained from health care databases is a good surrogate for ADR/E rates. Specific reasons for discontinuation, such as adverse drug reactions, can be identified directly from such electronic databases or more effectively from the primary care medical records held in primary care practices.
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Teng, Lida. "Pharmacovigilance of traditional Chinese herbal medicine in the UK." Thesis, University College London (University of London), 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.499080.
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Johansson-Pajala, Rose-Marie. "Pharmacovigilance in municipal elderly care : From a nursing perspective." Doctoral thesis, Mälardalens högskola, Akademin för hälsa, vård och välfärd, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-34750.
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Medication management constitutes a large part of registered nurses' (RNs) daily work in municipal elderly care. They are responsible for monitoring multimorbid older persons with extensive treatments, and they often work alone, without daily access to physicians. RNs’ drug monitoring is, in this thesis, based on the concept of pharmacovigilance. Pharmacovigilance is about the science and the activities that aim to improve patient care and safety in drug use, that is, to detect, assess, understand and prevent drug-related problems. The overall aim was to explore conditions for pharmacovigilance from a nursing perspective, focusing on implications of RNs’ competence and use of a computerized decision support system (CDSS). Both quantitative and qualitative research methods were used, including a questionnaire (I), focus group discussions (II), individual interviews (III) and an intervention study (IV). In total 216 RNs and 54 older persons participated from 13 special accommodations, located in three different regions. RNs who had completed further training in pharmacovigilance rated their medication competence higher than those who had not. However, there was no difference between groups in the number of pharmacovigilant activities they performed in clinical practice (I). The RNs appeared to act as “vigilant intermediaries” in drug treatment. They depended on the nursing staff's observations of drug-related problems. The RNs continuously controlled the work of staff and physicians, and attempted to compensate for shortcomings in competence, accessibility and continuity (II). RNs’ use of a CDSS was found to affect drug monitoring, including aspects of time, responsibility, standardization of the work, as well as access to knowledge and opportunities for evidence-based care (III). The CDSS detected significantly more drug-related problems when conducting medication reviews, than the RNs did. Nevertheless, this did not result in any significant improvement in the quality of drug use in the follow up, three and six months later (IV). This thesis contributes to the recognition of pharmacovigilance from a nursing perspective. Increased medication competence seems to be insufficient to generate pharmacovigilant activities. RNs depend on other health care professionals and organizational conditions in order to perform their work. A CDSS has the potential to support RNs, both in structured medication reviews and in daily clinical practice. Inter-professional collaboration is crucial, with or without a CDSS, and the entire team needs to be aware of and take responsibility. Other important conditions is the existence of well-functioning communication channels, competence across the team, and established procedures based on current guidelines.
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ZEMMOUR, MARIE-CHRISTINE. "Pharmacovigilance : enquete intensive dans un service de medecine interne." Toulouse 3, 1989. http://www.theses.fr/1989TOU31173.
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Tavassoli, Neda. "Nouvelles méthodes de mesure du risque médicamenteux en pharmacovigilance." Toulouse 3, 2010. http://thesesups.ups-tlse.fr/924/.
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Ce travail de thèse a pour objectif d'utiliser et de développer de nouvelles méthodes en pharmacovigilance pour étudier et mesurer le risque médicamenteux. Nous pouvons classer les travaux réalisés dans le cadre de cette thèse en 2 catégories : 1) Exploitations innovantes de la Base Nationale de PharmacoVigilance (BNPV), 2) Développement de nouvelles méthodes de détection des effets indésirables (EIs) en milieu hospitalier. Dans un premier temps, nous avons exploité la BNPV dans le but d'identifier les cas d'interactions médicamenteuses des anticholinestérasiques parmi les notifications spontanées enregistrées dans cette base et de définir la responsabilité de ces interactions médicamenteuses dans la survenue des EIs. Ce travail a montré qu'un tiers des notifications spontanées enregistrées dans la BNPV impliquant un anticholinestérasique contenait au moins une interaction médicamenteuse. Parmi elles, un tiers des interactions étaient la cause des EIs fréquemment " graves ". Dans un deuxième temps, nous avons comparé le taux de notification des EIs au système français de PV et enregistrées dans la BNPV avec les trois analgésiques du pallier II (dextropropoxyphène, tramadol et codéine) en association avec le paracétamol, pour identifier l'association qui entraîne le moins d'EIs. Ce travail a montré que le taux de notifications spontanées et la "gravité" des EIs étaient les plus élevés avec tramadol+paracétamol et les moins élevés avec codéine+paracétamol. Pour la deuxième partie du travail de thèse, nous avons d'abord réalisé un travail, à partir des signaux générés par des laboratoires d'hématologie, pour identifier des cas d'agranulocytoses médicamenteuses et estimer son incidence au CHU de Toulouse et au CHU de Pampelune (Espagne). Ce travail a montré un taux d'incidence deux fois plus élevé en Espagne qu'en France ainsi qu'un taux très élevé de sous-notification de cet EI rare mais " grave " au système de pharmacovigilance. Malgré le développement de différentes méthodes en pharmacovigilance pour identifier les EIs, il y a toujours un doute sur l'exhaustivité des bases de données. Aucune des sources utilisées (la notification spontanée ou les bases de données médicales informatisées) pour estimer l'incidence des EIs ne sont pas exhaustives. Au final, nous avons donc décidé d'appliquer la méthode "capture-recapture ", à partir de quatre sources, pour la première fois dans le domaine de pharmacovigilance, afin de comparer la performance et l'exhaustivité de chacune des sources disponibles pour estimer l'incidence des atteintes hépatiques médicamenteuses au CHU de Toulouse. .The objective of this thesis work is to use and to develop the new methods in pharmacovigilance and pharmacoepidemiology for evaluation and assessment of drug risks. We can class the studies realized on the occasion of this thesis in two categories: - Innovative exploitations of French PharmacoVigilance Database (FPVD) - Development of new methods of drug risks detection in hospital Innovative exploitations of FPVD First, we performed an analysis in the FPVD to identify spontaneous notifications containing drug-drug interactions with the 3 cholinesterase inhibitors marketed in France and to determine the responsibility of these interactions in inducing adverse drug reactions (ADRs). Drug-drug interactions were present in more than one third of spontaneous notifications involving cholinesterase inhibitors registered in FPVD. Approximately, one third of these interactions were the cause of ADRs frequently " serious ". Secondly, we compared the reporting rate of ADRs to the French system of pharmacovigilance, between three step II analgesic combinations (tramadol/paracetamol, codeine/paracetamol and dextropropoxyphene/paracetamol) to determine the safest combination. The results show that among these combinations, reporting rate and "seriousness" of reported ADRs are the highest with tramadol/paracetamol and the lowest with codeine/paracetamol. Development of new methods of drug risks detection in hospital Then, we performed a prospective study at Toulouse University Hospital (France) and Navarra University Hospital (Spain) during 1 year to assess the detection and incidence of drug-induced agranulocytosis using hematology laboratory data. The annual incidence of drug-induced agranulocytosis was 2 fold higher in Navarra University Hospital than in Toulouse University hospital. We also noted an important underreporting rate of this serious adverse drug reaction to the official French Pharmacovigilance system. Despite the development of different methods in pharmacovigilance for identifying ADRs, there is always uncertainty about the exhaustiveness of databases. .
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MANEVAL, GUY. "Vers l'evaluation cout/benefice d'un centre regional de pharmacovigilance." Nice, 1988. http://www.theses.fr/1988NICE6513.
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Arimone, Yannick. "Elaboration et validation d'une nouvelle méthode d'imputabilité en pharmacovigilance." Bordeaux 2, 2004. http://www.theses.fr/2004BOR21158.
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Nous proposons une nouvelle approche pour évaluer la responsabilité d'un médicament dans la survenue d'un événement indésirable. Cette approche est basée sur la fonction logistique, dans laquelle 7 critères d'imputabilité sont pondérés dans un modèle de régression utilisant un consensus d'expert comme référence. Un échantillon de 30 observations d'événements indésirables (32 couples médicament-effet indésirable) a été sélectionné dans les données de la base de la Pharmacovigilance Française. La probabilité de responsabilité de chaque médicament a été évaluée par un premier groupe d'experts (référence). Un second groupe d'experts a évalué les sept critères d'imputabilité. La pondération statistique a été réalisée en utilisant un modèle de régression linéaire avec le logit(p) comme variable dépendante et les critères d'imputabilité comme variables explicatives. Après s'être assuré de la validité et de la fiabilité de la nouvelle méthode, une version finale et opérationnelle a été proposéeWe propose a new approach for the assessment of adverse drug reactions (ADRs), based on the logistic function, in which seven operational criteria were weighted in a regression model by using a consensus of experts as gold standard. A sample of 30 ADRs involving to 32 suspect drugs was randomly selected from the French pharmacovigilance database. The probability of drug causation was assessed by consensus by a first group of five senior experts using global introspection. This probability was used as gold standard. A second group of five senior experts assessed the seven criteria for each case. The statistical weighting was performed by using a multi-linear regression with logit(p) as dependent variable and the 7 seven judgement as independent variables. After assessment of the validity and reliability of the new method, a final and operational version was retained and proposed as routine tool
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Theophile, Hélène. "Etude de la causalité en pharmacovigilance et pharmaco-épidémiologie." Thesis, Bordeaux 2, 2011. http://www.theses.fr/2011BOR21898/document.
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L’analyse de la causalité, qui consiste à déterminer si la prise d’un médicament est la cause de la survenue d’un événement, est la problématique centrale de la pharmacovigilance et de la pharmaco-épidémiologie.La première partie de ce travail aborde l’étude de la causalité au plan individuel, au travers des méthodes d’imputabilité. Nous avons d’abord comparé une méthode d’imputabilité récemment développée, la méthode logistique, et la méthode d’imputabilité officiellement utilisée en France à un jugement consensuel d’experts pris comme référence. Les résultats montrent que la méthode française d’imputabilité tend à sous-coter la responsabilité du médicament (faible sensibilité) alors que la méthode logistique tend à la surestimer (faible spécificité). Par la suite, une nouvelle version de la méthode française d’imputabilité visant à améliorer sa sensibilité et son pouvoir discriminant a été proposée. Le travail de validation portant sur cette méthode réactualisée montre une amélioration de sa sensibilité et des résultats se rapprochant plus du jugement consensuel d’experts. Pour la méthode logistique, les critères d’imputabilité et leurs poids ont été réévalués sur un échantillon plus important d’observations que celui ayant servi à la pondération initiale. La validité de cette nouvelle version et celle de l’un des algorithmes les plus couramment utilisés en pharmacovigilance, la méthode Naranjo, ont été comparées à un jugement consensuel d’experts. Les résultats concernant la validité interne et les qualités prédictives de la méthode Naranjo ne sont pas satisfaisants alors que la méthode logistique présente une spécificité améliorée ainsi qu’une bonne sensibilité et valeurs prédictives. Cette dernière méthode présente donc des caractéristiques qui devraient améliorer l’évaluation de la responsabilité des médicaments dans la survenue des événements indésirables. La mise en place de méthode d’imputabilité spécifique à une classe thérapeutique et/ou à un type d’événement indésirable pourrait aussi améliorer l’évaluation des événements indésirables. Nous proposons une grille d’imputabilité adaptée aux accidents hémorragiques sous antithrombotique. Dans la deuxième partie de cette thèse, l’analyse épidémiologique de la causalité est abordée en proposant deux méthodes : l’analyse populationnelle des cas individuels, en particulier leur délai de survenue après exposition médicamenteuse, et l’approche cas-population. Bien que beaucoup moins robustes que les méthodes classiques, elles sont testées sur des problématiques réelles de pharmacovigilance et les résultats montrent qu’elles peuvent être utiles pour une première exploration d’une association causale potentielle. En conclusion, ce travail méthodologique pourrait aider à mieux évaluer la responsabilité des médicaments dans la survenue d’événements indésirables après leurs autorisations de mise sur le marchéThe analysis of causality, which consists of determining if drug intake is the cause of the event occurrence, is the central issue of pharmacovigilance and pharmacoepidemiology. The first part of this work deals with the study of causality assessment methods at the level of individual cases. We first compared the recently developed logistic causality assessment method and the method officially used in France, to consensusual expert judgement taking as a reference. The results showed that the French causality assessment method tended to underestimate the responsibility of the drug (low sensitivity) whereas the logistic method tended to overestimate it (low specificity). Subsequently a new version of the French causality assessment method aiming to improve its sensitivity and discriminating power was proposed. The validation phase of this updated method showed improved sensitivity and a performance closer to consensual expert judgement. For the logistic method, the criteria of causality assessment and their weights were re-evaluated on a larger sample of drug-event pairs that had been used in the initial weighting. The validity of this method and that of one of the most commonly used algorithms in pharmacovigilance, the Naranjo method, were compared to consensual expert judgement. Results concerning the internal validity and the predictive qualities of the Naranjo method were not satisfactory while the logistic method presented an improved specificity and good sensitivity and predictive values. The logistic method now presents characteristics that should improve the assessment of drug responsibility in the occurrence of adverse events. The implementation of causality assessment method specific to a therapeutic class and / or to a type of adverse event could also improve the assessment of adverse events. We proposed a scale adapted to hemorrhages with antithrombotics and derived from the French causality assessment method. In the second part of this thesis, the epidemiological analysis of causality was tackled by proposing two methods: the populational analysis of individual cases, in particular their time to onset after drug exposure, and the case-population approach. Although less robust than the conventional methods, these were tested on real problems of pharmacovigilance and the results indicate that they may be useful for an initial exploration of a potential causal association. In conclusion, this methodological work could help to better assess drug causality in the occurrence of adverse event in post maketing surveillance
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MERIUS, CHRISTIAN. "Pharmacovigilance et banques de donnees medicamenteuses : etude de l'isaxonine." Strasbourg 1, 1987. http://www.theses.fr/1987STR10770.
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Abraham, Erick. "Correspondants du centre de pharmacovigilance de Bordeaux entre 1986 et 1991." Bordeaux 2, 1992. http://www.theses.fr/1992BOR23070.
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ERTLEN, PHILIPPE. "Famotidine : etude de pharmacovigilance intensive : analyse de 200 observations et revue de la litterature." Nice, 1989. http://www.theses.fr/1989NICE6582.
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Ginies, Emmanuelle. "Mesure et surveillance de la clozapinémie : vers un dosage thérapeutique de routine." Montpellier 1, 1998. http://www.theses.fr/1998MON11097.
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DROUET, GROSS GENEVIEVE. "A propos de l'automedication." Aix-Marseille 2, 1990. http://www.theses.fr/1990AIX20257.
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Pajot, François Jolliet Pascale. "Objectifs et méthodes du suivi post-commercialisation d'un médicament." [S.l.] : [s.n.], 2005. http://theses.univ-nantes.fr/thesemed/PHpajot.pdf.
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Olowofela, Abimbola. "Évaluation de la performance du système de pharmacovigilance au Sud-Sud du Nigéria." Thesis, Bordeaux, 2018. http://www.theses.fr/2018BORD0456/document.
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L’évolution du système de pharmacovigilance au Nigéria a été associée à une croissance modeste et les hôpitaux universitaires ont été identifiés comme des partenaires importants du système de pharmacovigilance. Cependant, aucune étude n'a encore été réalisée sur les performances du système de pharmacovigilance dans les hôpitaux universitaires nigérians. Cette étude visait à évaluer l'état de la pharmacovigilance, en particulier les réactions indésirables aux médicaments dans le sud et le sud du Nigéria, en se référant à des médicaments sélectionnés. Le système de pharmacovigilance ainsi que le schéma posologique des médicaments ont été évalués à l'aide des indicateurs de pharmacovigilance de base de l'OMS et des indicateurs de prescription de base de l'OMS, respectivement. Cela a été suivi d'une intervention éducative avec des messages texte envoyés via le système de messagerie courte (SMS) pour améliorer les connaissances, l'attitude et la pratique de la pharmacovigilance parmi les professionnels de la santé. Le nombre, la qualité et le profil des effets indésirables du médicament ont également été évalués avant et après l'intervention. Les facteurs probables susceptibles de contribuer à une mauvaise notification des problèmes de pharmacovigilance ont été recherchés en effectuant une enquête sur les connaissances, la sensibilisation et les pratiques des professionnels de la santé travaillant dans la zone. Ces faiblesses de la pharmacovigilance étaient essentiellement. Les résultats ont montré que des structures étaient en place pour les activités de pharmacovigilance, même si certaines étaient peu fonctionnelles. Les indicateurs de processus et de résultat / impact ont révélé des systèmes de santé faibles et une attention générale insuffisante à la pharmacovigilance dans les hôpitaux. Il a également montré que, même si le groupe possédait une connaissance modeste et une perception juste de la pharmacovigilance, la pratique était médiocre et peu de réactions indésirables au médicament étaient répertoriées dans les bases de données des hôpitaux locaux. Celles-ci ont été attribuées à une connaissance insuffisante de la pharmacovigilance sur ce qui peut être signalé, à des processus de notification médiocres, à de fausses croyances selon lesquelles leur notification ne fera aucune différence et à la difficulté de déterminer les éléments à signaler. Une perception insuffisante de l’intérêt de la notification des effets indésirables. Les connaissances et les pratiques en matière de pharmacovigilance se sont améliorées, de même que le nombre de déclarations d'effets indésirables au médicament suite à une intervention éducative. Cette étude a également mis en évidence le profil des effets indésirables associés aux médicaments couramment utilisés dans la zone et les problèmes inhérents à la notification spontanée. Il souligne également que la pharmacovigilance, discipline en pleine croissance, peut être améliorée par des évaluations fréquentes du système, la formation des professionnels de la santé et le renforcement général du système de santé nigérian. Des études plus approfondies seraient nécessaires pour mieux évaluer la sécurité des médicaments dans cette population noire homogèneThe evolution of the pharmacovigilance system in Nigeria has been associated with modest growth and teaching hospitals have been identified as important partners in the pharmacovigilance mechanism. However, there have been no studies evaluating the performance of the pharmacovigilance system in Nigerian Teaching hospitals prior to this time. This study set out to evaluate the state of pharmacovigilance specifically adverse drug reactions in South-South Nigeria. The pharmacovigilance system as well as the prescribing pattern of medicines was evaluated using the WHO Core Pharmacovigilance indicators and WHO Core Prescribing indicators respectively. This was followed by an educational intervention with text messages sent via the Short Messaging System (SMS) to improve the knowledge, attitude and practice of pharmacovigilance amongst healthcare professionals. The number, quality and profile of Adverse Drug Reactions (ADRs) were also assessed before and after the intervention. Factors likely to contribute to poor reporting of pharmacovigilance issues were sought by conducting knowledge, awareness, and practice survey of healthcare professionals working in the zone.The findings showed that of the six teaching hospitals assessed, only three could be described as functional or partly functional although all had some structures in place for pharmacovigilance activities. The process and outcome/impact indicators revealed weak health systems and overall insufficient attention to pharmacovigilance in the hospitals as only one centre had committed their ADR reports to the National Pharmacovigilance Centre and there were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 admissions. It further showed that although a modest knowledge and fair perception of pharmacovigilance existed among the group, practice was poor as only 12% of the 811 healthcare Professionals had ever used the national ADR reporting form and there were few adverse drug reaction reports in the local hospital databases. These were attributed to insufficient awareness of pharmacovigilance on what can be reported, poor reporting processes, wrong beliefs that their reporting will not make a difference and difficulty in determining what to report. There was an improvement in the knowledge and practice of pharmacovigilance, with a 31.6% increase in the number of adverse drug reaction reports following an educational intervention. This study also highlighted the ADR profile to commonly used medicines in the zone and the inherent problems associated with spontaneous reporting. It further highlights that the growing discipline of pharmacovigilance can be improved through frequent assessments of the system, training of the healthcare professionals and general strengthening of the Nigerian healthcare system. More in-depth studies would be required to further evaluate the safety of medicines in the Nigerian population
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Iannucci, Raphae͏̈le. "Adaptation des rapports périodiques de pharmacovigilance à la vaccino-vigilance." Paris 5, 1997. http://www.theses.fr/1997PA05P167.
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TAUPIN, SCHWETTERLE MARTINE. "Etude de pharmacovigilance de quatre fluoroquinolones : pefloxacine, norfloxacine, ofloxacine, ciprofloxacine." Reims, 1990. http://www.theses.fr/1990REIMM067.
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Bate, Andrew. "The use of Bayesian confidence propagation neural network in pharmacovigilance." Doctoral thesis, Umeå University, Pharmacology and Clinical Neuroscience, 2003. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-83.
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The WHO database contains more than 2.8 million case reports of suspected adverse drug reactions reported from 70 countries worldwide since 1968. The Uppsala Monitoring Centre maintains and analyses this database for new signals on behalf of the WHO Programme for International Drug Monitoring. A goal of the Programme is to detect signals, where a signal is defined as "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously."
The analysis of such a large amount of data on a case by case basis is impossible with the resources available. Therefore a quantitative, data mining procedure has been developed to improve the focus of the clinical signal detection process. The method used, is referred to as the BCPNN (Bayesian Confidence Propagation Neural Network). This not only assists in the early detection of adverse drug reactions (ADRs) but also further analysis of such signals. The method uses Bayesian statistical principles to quantify apparent dependencies in the data set. This quantifies the degree to which a specific drug- ADR combination is different from a background (in this case the WHO database). The measure of disproportionality used, is referred to as the Information Component (IC) because of its' origins in Information Theory. A confidence interval is calculated for the IC of each combination. A neural network approach allows all drug-ADR combinations in the database to be analysed in an automated manner. Evaluations of the effectiveness of the BCPNN in signal detection are described.
To compare how a drug association compares in unexpectedness to related drugs, which might be used for the same clinical indication, the method is extended to consideration of groups of drugs. The benefits and limitations of this approach are discussed with examples of known group effects (ACE inhibitors - coughing and antihistamines - heart rate and rhythm disorders.) An example of a clinically important, novel signal found using the BCPNN approach is also presented. The signal of antipsychotics linked with heart muscle disorder was detected using the BCPNN and reported.
The BCPNN is now routinely used in signal detection to search single drug - single ADR combinations. The extension of the BCPNN to discover 'unexpected' complex dependencies between groups of drugs and adverse reactions is described. A recurrent neural network method has been developed for finding complex patterns in incomplete and noisy data sets. The method is demonstrated on an artificial test set. Implementation on real data is demonstrated by examining the pattern of adverse reactions highlighted for the drug haloperidol. Clinically important, complex relationships in this kind of data are previously unexplored.
The BCPNN method has been shown and tested for use in routine signal detection, refining signals and in finding complex patterns. The usefulness of the output is influenced by the quality of the data in the database. Therefore, this method should be used to detect, rather than evaluate signals. The need for clinical analyses of case series remains crucial.
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Kirby, Bradley. "Data linkage for pharmacovigilance using routinely acquired electronic health data." Thesis, University of Aberdeen, 2014. http://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=215567.
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Introduction: Despite the establishment of pharmacovigilance systems, there is a recognised paucity of information specifically on the safety of paediatric medicines. Data linkage techniques offer real potential for linking routinely collected population based primary and secondary care datasets, using the Community Health Index (CHI) as a patient linkage key, to monitor the safety of new drugs and treatments. Aim: To explore the validity of routinely acquired NHS data and the utility of linking this data to support a routine mechanism for post-marketing surveillance of paediatric medicines. Methods: The internal and external validity of the Scottish national Prescribing Information System (PIS) was assessed using retrospective cohort studies combined with data linkage techniques. This PhD programme assesses the consistency of unique patient identifiers; the completeness and accuracy of the data; and the extent to which well established associations between drugs and adverse events can be reproduced using routinely collected NHS data. Results: For routine prescribing data a CHI number was found present on nearly 95% of dispensed items. In the first cohort study, insulin prescriptions within PIS were identified for 96% (95% CI 0.96-0.97) of children hospitalised for type 1 diabetes (SMR01). The rates of newly prescribed insulin were concordant with published rates in both Scottish and non-Scottish populations. In the second study asthma prescribing in children was observed to be complete (sensitivity 0.96 (95% CI 0.95-0.98)) and accurate (PPV 0.87 (95% CI 0.83-0.9)) when compared with a gold standard patient registry. Finally, patients newly prescribed NSAID therapy were observed to be 1.51 (95% CI 1.24-1.85) to 3.97 (95% CI 1.27 – 12.46) times more likely to experience first time hospitalisation for a gastrointestinal event than unexposed. Significant risk factors for a GI event were age and concurrent use of antiplatelet and anticoagulant therapy. These results are concordant with the published literature. Conclusions: Routine Scottish prescribing data is consistent, complete and accurate; however several key variables such as indication, dose and frequency, which are essential for robust pharmacovigilance, are currently missing from routinely collected data.
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Liu, Xiao, and Xiao Liu. "Health Data Analytics: Data and Text Mining Approaches for Pharmacovigilance." Diss., The University of Arizona, 2016. http://hdl.handle.net/10150/620913.
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Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug events (WHO 2004). Post-approval adverse drug events are a major health concern. They attribute to about 700,000 emergency department visits, 120,000 hospitalizations, and $75 billion in medical costs annually (Yang et al. 2014). However, certain adverse drug events are preventable if detected early. Timely and accurate pharmacovigilance in the post-approval period is an urgent goal of the public health system. The availability of various sources of healthcare data for analysis in recent years opens new opportunities for the data-driven pharmacovigilance research. In an attempt to leverage the emerging healthcare big data, pharmacovigilance research is facing a few challenges. Most studies in pharmacovigilance focus on structured and coded data, and therefore miss important textual data from patient social media and clinical documents in EHR. Most prior studies develop drug safety surveillance systems using a single data source with only one data mining algorithm. The performance of such systems is hampered by the bias in data and the pitfalls of the data mining algorithms adopted. In my dissertation, I address two broad research questions: 1) How do we extract rich adverse drug event related information in textual data for active drug safety surveillance? 2) How do we design an integrated pharmacovigilance system to improve the decision-making process for drug safety regulatory intervention? To these ends, the dissertation comprises three essays. The first essay examines how to develop a high-performance information extraction framework for patient reports of adverse drug events in health social media. I found that medical entity extraction, drug-event relation extraction, and report source classification are necessary components for this task. In the second essay, I address the scalability issue of using social media for pharmacovigilance by proposing a distant supervision approach for information extraction. In the last essay, I develop a MetaAlert framework for pharmacovigilance with advanced text mining and data mining techniques to provide timely and accurate detection of adverse drug reactions. Models, frameworks, and design principles proposed in these essays advance not only pharmacovigilance research, but also more broadly contribute to health IT, business analytics, and design science research.
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PAULVAICHE, OLIVIER. "Enquete prospective de pharmacovigilance dans un service de medecine interne." Lille 2, 1992. http://www.theses.fr/1992LIL2M272.
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Moinard, Valérie. "Etude comparative de la qualité des observations recueillies au Centre régional de pharmacovigilance de Bordeaux en 1988 et 1994." Bordeaux 2, 1995. http://www.theses.fr/1995BOR2P073.
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Guibaud, Corinne. "Analyse de la notification spontanée au centre régional de pharmacovigilance de Bordeaux de juillet 1986 à juin 1990." Bordeaux 2, 1994. http://www.theses.fr/1994BOR2M110.
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Sophie, Hamel. "Cardiovascular Effects and Pattern of Use of Antineoplastic Therapies in Female Breast Cancer Patients." Thesis, Université d'Ottawa / University of Ottawa, 2014. http://hdl.handle.net/10393/31523.
Full textAbstract:
Cancer survivors are at greater risk of cardiovascular diseases in comparison to the
general population. Cardiovascular disorders are among the most prominent comorbidities in breast cancer patients. In order to gain a better understanding of the prescribing practices and cardiovascular risks associated with oncology drugs, this thesis encompasses a detailed review of the molecular and physiological mechanisms leading to drug‐induced cardiotoxicity and an evaluation of the cardiovascular risks associated with cancer drug therapies. Using a nested case‐control design, we evaluated whether these cancer drugs were associated with adverse cardiovascular outcomes under real‐world conditions of use. Although only few oncology drugs are indicated for breast cancer treatment, we were interested in prescribing practices and whether breast cancer treatments are restricted to labelled indications. The characterization of prescribing practices provides insights on the range of antineoplastic agents that should be considered in the evaluation of treatmentrelated
adverse reactions such as cardiotoxicity.
We found that selective estrogen receptor modulators demonstrated a better
safety profile than aromatase inhibitors based on their mechanism of action on the
cardiovascular system. These observations were corroborated by our findings from logistic regression analyses where aromatase inhibitors were associated with a higher risk of heart failure in a heterogeneous population of breast cancer patients. We reported that off‐label prescribing is common strategy in breast cancer treatment. While this practice tends to be associated with specific socio‐demographic and disease characteristics, the majority of off-label encounters are evidence‐based decisions. Because these off‐label treatments have their own inherent safety profiles, a comprehensive approach, covering all antineoplastic agents administered should be adopted in the evaluation of breast cancer treatment-induced cardiotoxicity. Careful monitoring of patients is crucial for the early detection of warning signs of cardiotoxicity to prevent long‐term deleterious effects.
The information contained in this thesis provides useful considerations for the
prospective surveillance of cancer drug‐induced cardiac events. These findings point to the need for a multi‐disciplinary approach to facilitate the rapid diagnosis and treatment of cardiac complications secondary to cancer therapy and to ensure that treatment decisions will maximize tumor response while minimizing adverse outcomes.
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Grosdidier, Régis. "Concept d'allergovigilance : application a la pathologie medicamenteuse." Nancy 1, 1988. http://www.theses.fr/1988NAN11212.
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Owen, Thomas. "Un essai de pharmacovigilance en medecine rurale : nogaro en gascogne du 1er janvier au 30 juin 1991 ; a propos de 49 observations." Toulouse 3, 1992. http://www.theses.fr/1992TOU31009.
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