Relevant bibliographies by topics / Pharmacovigilance

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Pharmacovigilance'

Author: Grafiati
Published: 4 June 2021
Last updated: 21 December 2024

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Journal articles on the topic "Pharmacovigilance"

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Portela, Maria da Conceição Constantino, Carlos Sinogas, Fernando Albuquerque de Almeida, Ricardo Baptista-Leite, and Alexandre Castro-Caldas. "Medicamentos Biológicos e Biossimilares: Descontinuidades no Sistema de Farmacovigilância em Portugal." Acta Médica Portuguesa 30, no. 3 (March 31, 2017): 205. http://dx.doi.org/10.20344/amp.8079.

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Introduction: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations.Material and Methods: A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted.Results: Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals.Discussion: Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile.Conclusion: The existing pharmacovigilance’s regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.
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Ali, Huma, Farya Zafar, Hina Hasnain, Sana Ahmed, Neelam Mallick, Anum Tariq, Saima Saleem, and Saba Zubair. "PHARMACOVIGILANCE." Professional Medical Journal 23, no. 11 (November 10, 2016): 1298–304. http://dx.doi.org/10.29309/tpmj/2016.23.11.1751.

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The solution for safe and rational medication use to improve patient care aswell as to enhance public health status is Pharmacovigilance (PV). Optimal care of patientand appropriate medication utilization in secure way with respect to various conditions is animperative function of pharmacovigilance system. PV mainly involves in the adverse drugreactions (ADRs) identification, system of reporting, scrutinizes the effectiveness of treatment,reduces the adverse consequences to utmost level and guarantees the patient wellbeing.The safety of drug is highly essential factor when it comes from the healthcare provider to thepatient. For a drug to be successful in market, it is crucial for it to be efficacious as well as safeand secure for the patients. Hence, adherence toward pharmacovigilance activities and systemis now based on a paradigm change from care to safety.
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Jose, Jimmy, Mohammed H. Al Rubaie, Hussain Al Ramimy, and Shirly S. Varughese. "Pharmacovigilance." Sultan Qaboos University Medical Journal [SQUMJ] 21, no. 2 (June 21, 2021): e161-163. http://dx.doi.org/10.18295/squmj.2021.21.02.001.

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Ekobena, Pierre, Anton Ivanyuk, and Françoise Livio. "Pharmacovigilance." Revue Médicale Suisse 17, no. 720-21 (2021): 80–84. http://dx.doi.org/10.53738/revmed.2021.17.720-21.0080.

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Loha, Christopher Abo, and Françoise Livio. "Pharmacovigilance." Revue Médicale Suisse 15, no. 632-33 (2019): 92–95. http://dx.doi.org/10.53738/revmed.2019.15.632-33.0092.

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Livio, Françoise. "Pharmacovigilance." Revue Médicale Suisse 14, no. 588-89 (2018): 81–84. http://dx.doi.org/10.53738/revmed.2018.14.588-89.0081.

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Royer, René Jean. "Pharmacovigilance." Drug Safety 5, Supplement 1 (1990): 137–40. http://dx.doi.org/10.2165/00002018-199000051-00021.

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Sattigeri, BM, and SV Desai. "Pharmacovigilance." Journal of Integrated Health Sciences 3, no. 1 (2015): 1. http://dx.doi.org/10.4103/2347-6486.238513.

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Sattigeri, BM, and SV Desai. "Pharmacovigilance." Journal of Integrated Health Sciences 3, no. 2 (2015): 1. http://dx.doi.org/10.4103/2347-6486.239789.

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Dao, Kim, Haithem Chtioui, Laura E. Rothuizen, Léonore Diezi, Prod’hom Sylvain, Ursula Winterfeld, Thierry Buclin, and Françoise Livio. "Pharmacovigilance." Revue Médicale Suisse 12, no. 500-01 (2016): 75–79. http://dx.doi.org/10.53738/revmed.2016.12.500-01.0075.

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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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Books on the topic "Pharmacovigilance"

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Mann, Ronald D., and Elizabeth B. Andrews, eds. Pharmacovigilance. Chichester, UK: John Wiley & Sons, Ltd, 2006. http://dx.doi.org/10.1002/9780470059210.

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Mann, Ronald D., and Elizabeth B. Andrews, eds. Pharmacovigilance. Chichester, UK: John Wiley & Sons, Ltd, 2002. http://dx.doi.org/10.1002/0470853093.

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Mann, Ronald D., and Elizabeth B. Andrews, eds. Pharmacovigilance. Chichester, UK: John Wiley & Sons, Ltd, 2002. http://dx.doi.org/10.1002/0470853093.

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Edwards, I. Ralph, and Marie Lindquist, eds. Pharmacovigilance. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-40400-4.

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1928-, Mann Ronald D., and Andrews Elizabeth B, eds. Pharmacovigilance. Chichester, West Sussex, England: John Wiley & Sons, 2002.

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1928-, Mann Ronald D., and Andrews Elizabeth B, eds. Pharmacovigilance. 2nd ed. Chichester, England: John Wiley & Sons, 2007.

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Andrews, Elizabeth B., and Nicholas Moore, eds. Mann's Pharmacovigilance. Oxford, UK: John Wiley & Sons, Ltd, 2014. http://dx.doi.org/10.1002/9781118820186.

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Nandave, Mukesh, and Anoop Kumar, eds. Pharmacovigilance Essentials. Singapore: Springer Nature Singapore, 2024. http://dx.doi.org/10.1007/978-981-99-8949-2.

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Alghabban, Amer. Dictionary of pharmacovigilance. London: Pharmaceutical Press, 2004.

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Orleans-Lindsay, Justina. Pharmacovigilance Medical Writing. Chichester, UK: John Wiley & Sons, Ltd, 2012. http://dx.doi.org/10.1002/9781118301906.

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Book chapters on the topic "Pharmacovigilance"

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Kaeding, Michael, Julia Schmälter, and Christoph Klika. "Pharmacovigilance." In Pharmacovigilance in the European Union, 11–16. Wiesbaden: Springer Fachmedien Wiesbaden, 2017. http://dx.doi.org/10.1007/978-3-658-17276-3_2.

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Scherf-Clavel, Maike. "Pharmacovigilance." In NeuroPsychopharmacotherapy, 1–15. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-319-56015-1_9-1.

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Nahler, Gerhard. "pharmacovigilance." In Dictionary of Pharmaceutical Medicine, 137–38. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_1054.

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Hobbiger, Stephen F., Bina Patel, and Elizabeth Swain. "Pharmacovigilance." In The Textbook of Pharmaceutical Medicine, 235–53. Oxford, UK: Blackwell Publishing Ltd., 2013. http://dx.doi.org/10.1002/9781118532331.ch11.

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van Grootheest, A. C., and Rachel L. Richesson. "Pharmacovigilance." In Health Informatics, 367–87. London: Springer London, 2012. http://dx.doi.org/10.1007/978-1-84882-448-5_19.

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Scherf-Clavel, Maike. "Pharmacovigilance." In NeuroPsychopharmacotherapy, 85–99. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-62059-2_9.

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Kalb, Robert E. "Pharmacovigilance." In Biologic and Systemic Agents in Dermatology, 73–82. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-66884-0_9.

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Tiwari, Pramil, and Prity Rani Deshwal. "Pharmacovigilance." In Drug Discovery and Development, 435–49. Singapore: Springer Singapore, 2021. http://dx.doi.org/10.1007/978-981-15-5534-3_15.

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Zlotnick, Steve. "Pharmacovigilance." In Clinical Nephrotoxins, 47–50. Dordrecht: Springer Netherlands, 2003. http://dx.doi.org/10.1007/1-4020-2586-6_3.

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Comoglio, Raquel Herrera, and Luis Alesso. "Teaching Pharmacovigilance in University." In Pharmacovigilance, 1–8. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-40400-4_1.

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Conference papers on the topic "Pharmacovigilance"

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Gupta, Anubhav. "Team Yseop at #SMM4H 2024: Multilingual Pharmacovigilance Named Entity Recognition and Relation Extraction." In Proceedings of The 9th Social Media Mining for Health Research and Applications (SMM4H 2024) Workshop and Shared Tasks, 136–41. Stroudsburg, PA, USA: Association for Computational Linguistics, 2024. http://dx.doi.org/10.18653/v1/2024.smm4h-1.32.

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Skali, A. D. "An Epistemological Approach to Risk Assessment in Pharmacovigilance and Mitigation Through Artificial Intelligence." In International e-Health Forum, 29–36. SCITEPRESS - Science and Technology Publications, 2023. http://dx.doi.org/10.5220/0012869800003854.

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Martínez, María Jimena, Silvia N. Schiaffino, Daniela L. Godoy, Ignacio Ponzoni, and Axel J. Soto. "Can Pharmacovigilance Be Performed on Social Media? Mining Adverse Vaccine Reactions From Twitter." In 2024 L Latin American Computer Conference (CLEI), 1–4. IEEE, 2024. http://dx.doi.org/10.1109/clei64178.2024.10700271.

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G. A, Senthil, Geerthik S, Jasphin Vijay J, and Mohanakrishnan K. "A Novel Pharmacovigilance Strategy for Detecting Adverse Drug Reactions in Healthcare Using Machine Learning and Blockchain." In 2024 Second International Conference on Intelligent Cyber Physical Systems and Internet of Things (ICoICI), 763–67. IEEE, 2024. http://dx.doi.org/10.1109/icoici62503.2024.10696339.

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Raithel, Lisa, Philippe Thomas, Bhuvanesh Verma, Roland Roller, Hui-Syuan Yeh, Shuntaro Yada, Cyril Grouin, et al. "Overview of #SMM4H 2024 – Task 2: Cross-Lingual Few-Shot Relation Extraction for Pharmacovigilance in French, German, and Japanese." In Proceedings of The 9th Social Media Mining for Health Research and Applications (SMM4H 2024) Workshop and Shared Tasks, 170–82. Stroudsburg, PA, USA: Association for Computational Linguistics, 2024. http://dx.doi.org/10.18653/v1/2024.smm4h-1.39.

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Zheng, Yifan, Jun Gong, Shushun Ren, Dalton Simancek, and V. G. Vinod Vydiswaran. "LHS712_ADENotGood at #SMM4H 2024 Task 1: Deep-LLMADEminer: A deep learning and LLM pharmacovigilance pipeline for extraction and normalization of adverse drug event mentions on Twitter." In Proceedings of The 9th Social Media Mining for Health Research and Applications (SMM4H 2024) Workshop and Shared Tasks, 130–32. Stroudsburg, PA, USA: Association for Computational Linguistics, 2024. http://dx.doi.org/10.18653/v1/2024.smm4h-1.30.

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Cunha, Alexandre M. R., Kele T. Belloze, and Gustavo P. Guedes. "Recognizing pharmacovigilance named entities in Brazilian Portuguese with CoreNLP." In XIII Brazilian e-Science Workshop. Sociedade Brasileira de Computação - SBC, 2019. http://dx.doi.org/10.5753/bresci.2019.6314.

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Textual data sources may assist in the detection of adverse events not predicted for a particular drug. However, given the amount of information available in several sources, it is reasonable to adopt a computational approach to analyze these sources to search for adverse events. In this scenario, we created an extension of CoreNLP to process Brazilian Portuguese texts from pharma- covigilance area. We trained three natural language models: a Part-of-speech tagger, a parser and a Named Entity Recognizer. Preliminary results indicate success in generating a dependency tree for phrases in the pharmacovigilance area and in identifying pharmacovigilance named entities.
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Sernadela, Pedro, Pedro Lopes, and Jose Luis Oliveira. "Exploring nanopublications integration in pharmacovigilance scenarios." In 2013 IEEE 15th International Conference on e-Health Networking, Applications and Services (Healthcom 2013). IEEE, 2013. http://dx.doi.org/10.1109/healthcom.2013.6720773.

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Sai Prakash, Mukkamala Venkata, Ganesh Parab, Meghana Veeramalla, Siddartha Reddy, Varun V, Saisubramaniam Gopalakrishnan, Vishal Pagidipally, and Vishal Vaddina. "Accelerating Pharmacovigilance using Large Language Models." In WSDM '24: The 17th ACM International Conference on Web Search and Data Mining. New York, NY, USA: ACM, 2024. http://dx.doi.org/10.1145/3616855.3635741.

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dos Santos, Adriano, Silvana Andreia Molina Lima, Marcia Cercal Fernandes, and Simone Fernanda Gonçalves. "The importance of pharmacovigilance notifications in a teaching hospital: Experience report." In VI Seven International Multidisciplinary Congress. Seven Congress, 2024. http://dx.doi.org/10.56238/sevenvimulti2024-087.

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Pharmacovigilance is an important activity for society. It contains a complex regiment in the hospital environment that aims at total patient safety as well as the analysis of problems related to the use of medications, risks that can be harmful to health during the hospitalization process. There are numerous errors in the use of medications, so applying the risk management tool in the establishment can be an alternative to ensure a safe process. In order to create risk prevention strategies, it is important to identify and analyze the causes of events and implement preventive actions before and after the occurrence. The objective of this work is to describe the importance of pharmacovigilance notifications for patient safety during the period of hospitalization in a teaching hospital. This is a qualitative, descriptive research of the actions developed by the hospital clinical pharmacist together with the multidisciplinary team to promote safe practices for the prevention of medication errors and reduction of harm. A well-developed and implemented management system in the service ended up generating the actions developed such as: review and training of the prescription, dispensing and administration protocol of medication; technical notes; implementation of the protocol based on the visual identification of medications; standardization of drug identification labels; change in electronic medical prescription of drugs, visual identification on packaging, training on pharmacovigilance; annual training with new residents and prescribing physicians. The strategic actions developed and implemented by the team served to create a safer environment, thus promoting safe processes and safe practices during the hospitalization period. The team's performance in creating strategies was important and enriching, pharmacovigilance is an important instrument in preventing any adverse events, encouraging reporting is extremely relevant and a key element in patient safety.
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Reports on the topic "Pharmacovigilance"

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Apiyo, Eric, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Improving Pharmacovigilliance Quality Management System in the Pharmacy and Poisions Board of Kenya. Purdue University, December 2021. http://dx.doi.org/10.5703/1288284317444.

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The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow and delayed system that captures the data much later after the fact and the agency will always be behind the curve in controlling the adverse incidents and events. This means that the incidences might continue to arise or go out of control. This project attempts to develop a system that would be more proactive in the collection of pharmacovigilance data and more predictive of pharmacovigilance incidences. The pharmacovigilance system should have the capacity to detect and analyze subtle changes in reporting frequencies and in patterns of clinical symptoms and signs that are reported as suspected adverse drug reactions. The method involved carrying out a thorough literature review of the latest trends in pharmacovigilance employed by different regulatory agencies across the world, especially the more stringent regulatory authorities. A review of the system employed by the Pharmacy and Poisons Board of Kenya was also done. Pharmacovigilance data, both primary and secondary, were collected and reviewed. Media reports on adverse drug reactions and poor-quality medicines over the period were also collected and reviewed. An appropriate predictive pharmacovigilance tool was also researched and identified. It was found that the Pharmacy and Poisons Board had a robust system of collecting historical pharmacovigilance data both from the healthcare workers and the general public. However, a more responsive data collection and evaluation system is proposed that will help the agency achieve its pharmacovigilance objectives. On analysis of the data it was found that just above half of all the product complaints, about 55%, involved poor quality medicines; 15% poor performance, 13% presentation, 8% adverse drug reactions, 7% market authorization, 2% expired drugs and 1% adulteration complaints. A regulatory pharmacovigilance prioritization tool was identified, employing a risk impact analysis was proposed for regulatory action.
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2

Zhang, Huiyun. Cutaneous adverse events in patients treated with ICIs monotherapy and combination therapy: A pharmacovigilance and meta-analysis study. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, July 2022. http://dx.doi.org/10.37766/inplasy2022.7.0069.

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3

CIOMS Cumulative Pharmacovigilance Glossary. Council for International Organizations of Medical Sciences (CIOMS), March 2021. http://dx.doi.org/10.56759/gjej7050.

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Since its inception, CIOMS has published over 10 reports on various topics in the field of pharmacovigilance, and this CIOMS Cumulative Pharmacovigilance Glossary compiles all the definitions within these reports. The current SARS-CoV-2 pandemic seems to be a particularly appropriate time to publish this glossary, given the increased interest in pharmacovigilance globally to address the safety and effectiveness of medicinal products for prevention and treatment of COVID-19. The CIOMS Cumulative Pharmacovigilance Glossary does not cover CIOMS reports on the subjects of ethics, clinical pharmacology, product development, the Medical Dictionary for Regulatory Activities (MedDRA), or publications resulting from CIOMS Roundtable Discussions. Including terms and definitions on the subject of vaccines is currently under discussion.
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4

CIOMS Cumulative Pharmacovigilance Glossary. Council for International Organizations of Medical Sciences (CIOMS), June 2021. http://dx.doi.org/10.56759/simv6903.

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This glossary compiles the terms and definitions from published CIOMS pharmacovigilance reports. Version 1.1 newly includes the terms and definitions from three vaccine-related and two pharmacovigilance-related CIOMS Working Group reports. It does not cover CIOMS reports on the subjects of ethics, clinical pharmacology, product development, the Medical Dictionary for Regulatory Activities (MedDRA), or publications resulting from CIOMS Roundtable Discussions.
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CIOMS Cumulative Glossary, with a focus on pharmacovigilance. Council for International Organizations of Medical Sciences (CIOMS), September 2022. http://dx.doi.org/10.56759/ocef1297.

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Since its inception, CIOMS has published numerous reports on pharmaco¬vigilance and related fields, and this CIOMS Cumulative Pharmacovigilance Glossary compiles all the definitions within these reports. Version 1.1 newly includes the terms and definitions from the report of CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. Reflecting the fact that recent CIOMS Working Groups have been dealing with topics that extend beyond pharmacovigilance, the title of Version 2.0 has been adapted to read ‘CIOMS Cumulative glossary, with a focus on pharmacovigilance terms’. The CIOMS Glossary does not cover CIOMS reports on the subjects of ethics, clinical pharmacology, product development, the Medical Dictionary for Regulatory Activities (MedDRA), or publications resulting from CIOMS Roundtable Discussions.
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