keyword
MENU ▼
Read by QxMD icon Read
search

Pharmacovigilance

keyword
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#1
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28816174/-adverse-drug-reaction-reports-in-iceland-from-2013-to-2016-a-comparison-with-other-nordic-countries
#2
Sara Skulina Jonsdottir, Sigridur Maria Olafsdottir, Hrefna Gudmundsdottir
INTRODUCTION: Information regarding adverse drug reactions (ADRs) of new medications is based on clinical studies of selected populations. The reporting of ADRs from real-life use following the marketing of new active substances is instrumental for the continuous evaluation of their benefit-risk balance. The aim of this study was to determine the number and nature of ADR reports in Iceland and compare with other Nordic countries. MATERIALS AND METHODS: Reports of ADRs from 2013 to 2016 were examined using the Icelandic Medicines Agency´s database...
July 2017: Læknablađiđ
https://www.readbyqxmd.com/read/28815800/a-method-for-data-driven-exploration-to-pinpoint-key-features-in-medical-data-and-facilitate-expert-review
#3
Kristina Juhlin, Kristina Star, G Niklas Norén
PURPOSE: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28811926/postinjection-delirium-sedation-syndrome-in-patients-with-schizophrenia-receiving-olanzapine-long-acting-injection-results-from-a-large-observational-study
#4
Kristin J Meyers, Himanshu P Upadhyaya, John L Landry, Rashna Chhabra-Khanna, Deborah M Falk, Balasubramanya Seetharama Rao, Meghan E Jones
BACKGROUND: Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. AIMS: The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline...
July 2017: BJPsych Open
https://www.readbyqxmd.com/read/28803714/building-capacity-for-active-surveillance-of-vaccine-adverse-events-in-the-americas-a-hospital-based-multi-country-network
#5
Pamela Bravo-Alcántara, Silvia Pérez-Vilar, Helvert Felipe Molina-León, Miriam Sturkenboom, Steven Black, Patrick L F Zuber, Christine Maure, Jose Luis Castro
New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim was to build capacity for active surveillance of vaccine adverse events in the Americas. We describe the implementation of a proof-of-concept study for the feasibility of an international collaborative hospital-based active surveillance system for vaccine safety. The study was developed and implemented in 15 sentinel sites located in seven countries of the region of the Americas, under the umbrella of the World Health Organization (WHO) Global Vaccine Safety Initiative...
August 10, 2017: Vaccine
https://www.readbyqxmd.com/read/28795368/the-9th-biennial-conference-on-signal-detection-and-interpretation-in-pharmacovigilance
#6
Vicki Osborne, Saad A W Shakir
No abstract text is available yet for this article.
August 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28794523/safety-monitoring-of-local-anaesthetic-drugs-from-the-perspective-of-pharmacovigilance-programme-of-india
#7
Pramod Kumar, Ismeet Kaur, Vivekanandan Kalaiselvan, Abhishank Singh
Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs) to the database and can draw signals for regulatory decisions...
July 2017: Indian Journal of Anaesthesia
https://www.readbyqxmd.com/read/28790833/collaboration-in-pharmacovigilance-lamotrigine-and-fatal-severe-cutaneous-adverse-reactions-a-review-of-spontaneous-reports
#8
Neil Brickel, Haris Shaikh, Andrew Kirkham, Greg Davies, Michelle Chalker, Pascal Yoshida
Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs). Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline's routine pharmacovigilance includes regular reviews of global adverse event (AE) reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28780021/-comparative-relevance-of-declaration-of-side-effects-by-patients-and-health-professionals
#9
Audrey Lagneau, Caroline Vigier, Alexandre Marianna, Rachel Serfaty, Fanny Rocher, Anne Spreux, Milou-Daniel Drici
INTRODUCTION: Drug-induced adverse events have been accessible to patient's spontaneous reporting in France and such notifications have been steadily increasing since 2011. However, these notifications are still shrouded with medical perplexity and are sometimes subjected to partial caution in their interpretation by the patient's physician. We aimed to evaluate and compare prospectively the relevance of such spontaneous notifications with those provided by healthcare professionals to the French Pharmacovigilance Center of Nice-Alpes-Côte d'Azur...
July 8, 2017: Thérapie
https://www.readbyqxmd.com/read/28777129/aripiprazole-and-impulse-control-disorders-higher-risk-with-the-intramuscular-depot-formulation
#10
Unax Lertxundi, Rafael Hernandez, Juan Medrano, Saioa Domingo-Echaburu, Montserrat Garcia, Carmelo Aguirre
Dopamine agonists have been associated with an increased risk of developing impulse control disorders (ICDs). The US Food and Drug Administration (FDA) issued a safety warning in 2016 of a possible association between ICDs and aripiprazole. Recently, one large epidemiological study has confirmed this risk. In the present study, we aim to determine whether the safety signal of ICDs associated with aripiprazole detected by the FDA is replicated in the European pharmacovigilance database (EudraVigilance). We searched for all suspected spontaneous cases of ICDs associated with aripiprazole in EudraVigilance up to 23 February 2017...
August 2, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28776442/structure-and-activities-of-pharmacy-and-therapeutics-committees-among-public-hospitals-in-south-africa-findings-and-implications
#11
Moliehi Matlala, Andries Gs Gous, Brian Godman, Johanna C Meyer
The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used...
August 16, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28774564/risk-of-bursitis-and-other-injuries-and-dysfunctions-of-the-shoulder-following-vaccinations
#12
REVIEW
L H Martín Arias, R Sanz Fadrique, M Sáinz Gil, M E Salgueiro-Vazquez
While vaccination injection site adverse reactions are usually mild and transient in nature, several cases of bursitis and other shoulder injuries have been reported in the medical literature. However, these lesions are not included in vaccine label inserts. To identify the characteristics of post-vaccination shoulder injuries and those of patients and involved vaccines, as well as their potential causes, a systematic review of the cases of vaccination-related bursitis and other shoulder injuries reported in the literature and notified to the Spanish Pharmacovigilance System database (FEDRA) have been conducted...
July 31, 2017: Vaccine
https://www.readbyqxmd.com/read/28772094/pharmacovigilance-in-hospice-palliative-care-net-effect-of-haloperidol-for-nausea-or-vomiting
#13
Madeline Digges, Akram Hussein, Andrew Wilcock, Gregory B Crawford, Jason W Boland, Meera R Agar, Aynharan Sinnarajah, David C Currow, Miriam J Johnson
BACKGROUND: Haloperidol is widely prescribed as an antiemetic in patients receiving palliative care, but there is limited evidence to support and refine its use. OBJECTIVE: To explore the immediate and short-term net clinical effects of haloperidol when treating nausea and/or vomiting in palliative care patients. DESIGN: A prospective, multicenter, consecutive case series. SETTING/SUBJECTS: Twenty-two sites, five countries: consultative, ambulatory, and inpatient services...
August 3, 2017: Journal of Palliative Medicine
https://www.readbyqxmd.com/read/28771763/farmarel-an-italian-pharmacovigilance-project-to-monitor-and-evaluate-adverse-drug-reactions-in-haematologic-patients
#14
Nicola S Fracchiolla, Silvia Artuso, Agostino Cortelezzi, Anna M Pelizzari, Paola Tozzi, Maurizio Bonfichi, Federica Bocchio, Livio Gargantini, Elisa De Rosa, Giuseppe D Vighi, Lucia Prestini, Simona Sammassimo, Niccolò Frungillo, Maria C Pasquini, Alessandra Ragazzi, Daniele Boghi, Alessia Pastore, Eraldo Lanzi, Giuseppe Gritti, Giulia Quaresmini, Simone Voltolini, Roberta Gaiardoni, Consuelo Corti, Maria C Vilardo, Maria L La Targia, Giacomo Berini, Massimo Magagnoli, Claudia Bacci, Dario Consonni, Alma L Rivolta, Giuliana Muti
Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned...
August 3, 2017: Hematological Oncology
https://www.readbyqxmd.com/read/28770283/the-key-role-of-clinical-and-community-health-nurses-in-pharmacovigilance
#15
REVIEW
Caterina Bigi, Guido Bocci
PURPOSE: The reporting of suspected adverse drug reactions (ADRs) is starting to become routine to nurses. The aim of this review is to underline the role of clinical and community health nurses in pharmacovigilance and to promote their effective participation in ADR reporting in different countries and for patients of different ages. METHODS: The PubMed, Scopus and ISI Web of Science databases were searched for research articles published between January 1985 and April 2017 using the search items "pharmacovigilance" AND "nurse;" "adverse drug reaction report" AND "nurse;" "community health nurse" AND "adverse drug reaction...
August 2, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28770276/a-comparative-study-of-qt-prolongation-with-serotonin-reuptake-inhibitors
#16
Ana Ojero-Senard, Justine Benevent, Emmanuelle Bondon-Guitton, Geneviève Durrieu, Leila Chebane, Melanie Araujo, Francois Montastruc, Jean-Louis Montastruc
BACKGROUND: QT interval prolongations were described with citalopram and escitalopram. However, the effects of the other serotonin reuptake inhibitors (SRIs) remained discussed. In order to identify a putative signal with other SRIs, the present study investigates the reports of QT interval prolongation with SRIs in two pharmacovigilance databases (PVDB). METHODS: Two kinds of investigations were performed: (1) a comparative study in VigiBase®, the WHO PVDB, where notifications of QT prolongation with six SRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) were selected...
August 3, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28766184/frequency-and-nature-of-adverse-drug-reactions-due-to-non-prescription-drugs-in-children-a-retrospective-analysis-from-the-french-pharmacovigilance-database
#17
Geneviève Durrieu, Mathieu Maupiler, Vanessa Rousseau, Leila Chebane, François Montastruc, Emmanuelle Bondon-Guitton, Jean-Louis Montastruc
INTRODUCTION: Studies that evaluate the safety of non-prescription drugs in children remain scarce. OBJECTIVES: The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. METHODS: We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France)...
August 1, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28765823/past-present-and-future-of-pharmacovigilance-in-korea
#18
REVIEW
Dong Yoon Kang, Kyung-Min Ahn, Hye-Ryun Kang, Sang-Heon Cho
As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status...
July 2017: Asia Pacific Allergy
https://www.readbyqxmd.com/read/28764191/knowledge-and-perception-about-pharmacovigilance-among-pharmacy-students-of-universities-in-sana-a-yemen
#19
Gamil Qasem Othman, Mohamed Izham Mohamed Ibrahim, Mohammed Alshakka, Mukhtar Ansari, Farouk Al-Qadasi, Abdulsalam M Halboup
INTRODUCTION: Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. AIM: To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana'a Yemen. MATERIALS AND METHODS: A cross-sectional study design was conducted among 385 final year pharmacy students...
June 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28761650/pioglitazone-and-risk-of-mortality-in-patients-with-type-2-diabetes-results-from-a-european-multidatabase-cohort-study
#20
Helen Strongman, Pasi Korhonen, Rachael Williams, Shahram Bahmanyar, Fabian Hoti, Solomon Christopher, Maila Majak, Leanne Kool-Houweling, Marie Linder, Paul Dolin, Edith M Heintjes
OBJECTIVES: Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. DESIGN: Retrospective cohort study. SETTING: Pooled analysis of clinical data collected from primary and/or secondary care settings in four European countries: Finland, The Netherlands, Sweden and the UK . PARTICIPANTS: 56 337 patients with type 2 diabetes mellitus first prescribed pioglitazone between 2000 and 2011, and 56 337 patients never prescribed pioglitazone matched by treatment stage, history of diabetes, diabetes complications and cardiovascular disease, and year of cohort entry using exact and propensity score matching...
2017: BMJ Open Diabetes Research & Care
keyword
keyword
17961
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"