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Pharmacovigilence

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https://www.readbyqxmd.com/read/28925019/inclusion-of-pregnant-and-breastfeeding-women-in-research-efforts-and-initiatives
#1
Sílvia M Illamola, Christina Bucci-Rechtweg, Maged M Costantine, Katerina Tsilou, Catherine M Sherwin, Anne Zajicek
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labeling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information...
September 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28924350/pharmacovigilance-and-adverse-drug-reaction-reporting-a-perspective-of-community-pharmacists-and-pharmacy-technicians-in-sana-a-yemen
#2
Yaser Mohammed Al-Worafi, Yaman Walid Kassab, Wafa Mohammed Alseragi, Masaad Saeed Almutairi, Ali Ahmed, Long Chiau Ming, Ali Saleh Alkhoshaiban, Muhammad Abdul Hadi
OBJECTIVE: The aim of this study was to compare the knowledge, attitude and barriers of pharmacy technicians and pharmacists toward pharmacovigilance, adverse drug reactions (ADRs) and ADR reporting in community pharmacies in Yemen. METHODS: This cross-sectional survey was conducted among community pharmacists and pharmacy technicians in the capital of Yemen, Sana'a. A total of 289 community pharmacies were randomly selected. The validated and pilot-tested questionnaire consisted of six sections: demographic data, knowledge about pharmacovigilance, experience with ADR reporting, attitudes toward ADR reporting, and the facilitators to improve ADR reporting...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28914115/knowledge-attitudes-and-perspective-on-adverse-drug-reaction-reporting-in-a-public-sector-hospital-in-south-africa-baseline-analysis
#3
Antionette Terblanche, Johanna Catharina Meyer, Brian Godman, Robert Stanley Summers
BACKGROUND AND AIMS: Adverse drug reactions (ADRs) can cause significant harm in patients; however, ADRs are under-reported in many countries, including South Africa, where evidence of a pharmacovigilance (PV) system to monitor and manage ADRs is a requirement for compliance with norms and standards for quality healthcare delivery. We conducted an analysis amongst health care professionals (HCPs) at Sebokeng Hospital to assess the situation there. METHODS: Data were collected using a structured self-administered questionnaire, targeting all medical practitioners, nurses, pharmacists and pharmacist assistants in the hospital...
September 15, 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28913827/when-more-is-less-an-exploratory-study-of-the-precautionary-reporting-bias-and-its-impact-on-safety-signal-detection
#4
Kevin Klein, Joep Hg Scholl, Marie L De Bruin, Eugène P van Puijenbroek, Hubert Gm Leufkens, Pieter Stolk
Concerns have been expressed that large numbers of non-value added reports have been accumulating in ADR databases, for example via patient support programs. We performed an assessment of the impact of such reports, to which we refer to as 'precautionary reports', on safety signal detection in the Netherlands. The case narratives of ADR reports of three case products were screened with text-mining algorithms to identify those reports that lack a causal relationship with the suspected medicinal product. We demonstrate that precautionary reports impede the optimal use of the pharmacovigilance system by, on the one hand, masking safety signals and, on the other hand, creating spurious signals...
September 15, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28904951/diabetic-foot-ulcers-and-epidermal-growth-factor-revisiting-the-local-delivery-route-for-a-successful-outcome
#5
REVIEW
Jorge Berlanga-Acosta, José Fernández-Montequín, Calixto Valdés-Pérez, William Savigne-Gutiérrez, Yssel Mendoza-Marí, Ariana García-Ojalvo, Viviana Falcón-Cama, Diana García Del Barco-Herrera, Maday Fernández-Mayola, Héctor Pérez-Saad, Eulogio Pimentel-Vázquez, Aleida Urquiza-Rodríguez, Moshe Kulikovsky, Gerardo Guillén-Nieto
Soon after epidermal growth factor (EGF) discovery, some in vivo models appeared demonstrating its property to enhance cutaneous wound healing. EGF was the first growth factor (GF) introduced in the clinical arena as a healing enhancer, exerting its mitogenic effects on epithelial, fibroblastoid, and endothelial cells via a tyrosine kinase membrane receptor. Compelling evidences from the 90s documented that, for EGF, locally prolonged bioavailability and hourly interaction with the receptor were necessary for a successful tissue response...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28903545/the-road-from-development-to-approval-evaluating-the-body-of-evidence-to-confirm-biosimilarity
#6
Paul Declerck, Mourad Farouk Rezk
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#7
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28894080/the-portuguese-society-of-rheumatology-position-paper-on-the-use-of-biosimilars-2017-update
#8
Filipe C Araújo, Alexandre Sepriano, Filipa Teixeira, Diogo Jesus, Teresa Martins Rocha, Patrícia Martins, Catarina Tenazinha, Ana Cordeiro, Ana Filipa Mourão, Cândida Silva, Carlos Vaz, Cátia Duarte, Cristina Ponte, Fernando Pimentel Dos Santos, Helena Canhão, Helena Santos, José Bravo Pimentão, José Canas da Silva, Joaquim Pereira, José António Pereira da Silva, Luís Cunha Miranda, Margarida Oliveira, Maria João Saavedra, Pedro Gonçalves, Sandra Falcão, Susana Capela, João Eurico Fonseca
Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements...
July 21, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28887902/atropinic-anticholinergic-burden-in-antipsychotic-treated-patients
#9
François Montastruc, Justine Benevent, Anthony Touafchia, Leila Chebane, Mélanie Araujo, Emmanuelle Guitton-Bondon, Geneviève Durrieu, Christophe Arbus, Laurent Schmitt, Bernard Begaud, Jean-Louis Montastruc
Antipsychotic drugs possess side atropinic (anticholinergic) properties that may induce several adverse drug reactions (ADRs), such as memory loss or cognitive impairment. The aim of the present study was investigating anticholinergic burden in patients treated with antipsychotic drugs. All ADR reports including at least one antipsychotic and registered between 2000 and 2015 in the Midi-Pyrénées PharmacoVigilance Database were extracted and analyzed using the Anticholinergic Duran's list. The primary objective of this cross-sectional study was to calculate anticholinergic burden in antipsychotic-treated patients; the secondary one was to investigate associated factors...
September 9, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/28885222/opinions-of-maltese-doctors-and-pharmacists-on-medication-errors
#10
Amy Tanti, Miriam Camilleri, Andrew A Borg, Benjamin Micallef, Gavril Flores, Anthony Serracino-Inglott, John Joseph Borg
BACKGROUND: Pharmacovigilance directive 2010/84/EU focused attention on medication errors and encouraged regulators to identify causing and contributing factors. OBJECTIVES: (1) To study opinions of doctors/pharmacists on factors bearing a causal link to MEs as well as ways to minimise MEs (2) to test whether differences in opinion exist between subgroups of doctors and pharmacists working in community, hospital or office settings. METHODS: Different questionnaires were circulated to doctors and pharmacists...
2017: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/28882026/epidemiology-and-risk-factors-of-voluntary-poisoning-by-pesticides-in-2008-2014-morocco
#11
Zineb Nabih, Latifa Amiar, Zakaria Abidli, Maria Windy, Abdelmajid Soulaymani, Abdelrhani Mokhtari, Rachida Soulaymani Bencheikh
Objectives: To determine the epidemiological profile of voluntary poisoning by pesticides, and determine the risk factors that may affect the life of patients. Methods: A retrospective analysis using all cases of voluntary poisoning by pesticides collected at the Antipoison and Pharmacovigilance Center of Morocco between January 2008 and December 2014. Results: During the study period, 2 690 acute pesticides poisoning cases were collected...
September 1, 2017: Epidemiology and Health
https://www.readbyqxmd.com/read/28880141/-clioquinol-use-for-dientamoeba-fragilis-infections-is-questionable
#12
F van Hunsel, C van Nieuwkoop, B H Ch Stricker
Clioquinol is used for treatment of amoebiasis and infection with Dientamoeba fragilis. In a guideline of the Dutch Working Party on Antibiotic Policy, clioquinol is recommended as a first-choice treatment for Dientamoeba fragilis. This drug, however, is associated with subacute myelo-optico-neuropathy (SMON). It was withdrawn from the market worldwide in 1985 by manufacturer Ciba-Geigy. Although the Dutch Medicines Evaluation Board has registered no products for systemic use of clioquinol since then, the drug is available as a pharmacy-compounded drug and the last few years the use of clioquinol in the Netherlands has risen again...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28867897/extrapyramidal-symptoms-probably-related-to-risperidone-treatment-a-case-series
#13
Sereen Rose Thomson, Bharti Chogtu, Dipanjan Bhattacharjee, Saurabh Agarwal
BACKGROUND: Atypical antipsychotics, like risperidone purportedly, score over their typical counterparts in terms of their lower propensity toward producing extrapyramidal symptoms (EPS). However, recent studies have furnished evidence to the contrary. Hereby, we present a case series implicating risperidone as the causative agent for EPS. METHODS: As a part of the pharmacovigilance programme of India, the authors have assessed 10 physician-reported cases of EPS among the 1,830 patients who were prescribed risperidone within the time period of January 2012-December 2014 in a tertiary care hospital in South India...
July 2017: Annals of Neurosciences
https://www.readbyqxmd.com/read/28867862/good-pharmacovigilance-practice-accountability-of-ayurvedic-pharmaceutical-companies
#14
Rohit Sharma, R Galib, P K Prajapati
No abstract text is available yet for this article.
January 2017: Ancient Science of Life
https://www.readbyqxmd.com/read/28867440/etonogestrel-implant-migration-to-the-vasculature-chest-wall-and-distant-body-sites-cases-from-a-pharmacovigilance-database
#15
Sarah Kang, Ali Niak, Neha Gada, Allen Brinker, S Christopher Jones
OBJECTIVE: To describe clinical outcomes of etonogestrel implant patients with migration to the vasculature, chest wall, and other distant body sites spontaneously reported to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. STUDY DESIGN: We performed a standardized Medical Dictionary for Regulatory Activities (MedDRA) query in the FAERS database (through November 15, 2015) with reports coded with one or more MedDRA preferred terms (PTs) that indicate complications with device placement or migration of the device from the original site of insertion to the vasculature, chest wall and other distant body sites...
August 31, 2017: Contraception
https://www.readbyqxmd.com/read/28864818/the-italian-pharmacovigilance-program-an-observational-study-of-adverse-effects-of-natalizumab-in-multiple-sclerosis-therapy
#16
Sabrina Giacoppo, Maria Ruscica, Luigi Maria Grimaldi, Placido Bramanti, Emanuela Mazzon
BACKGROUND This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. MATERIAL AND METHODS The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy...
September 2, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28863867/results-on-exposure-during-pregnancy-from-a-pregnancy-registry-for-as04-hpv-16-18-vaccine
#17
Marta López-Fauqued, Julia Zima, Maria-Genalin Angelo, Jens-Ulrich Stegmann
OBJECTIVE: To assess pregnancy outcomes after exposure to AS04-HPV-16/18 vaccine (Cervarix, GSK, Belgium) prior to, or during pregnancy, as reported to a pregnancy registry. METHODS: A pregnancy exposure registry was established to collect data in the United Kingdom and the United States. Exposure was defined as vaccination with AS04-HPV-16/18 within 60days before the estimated conception date and delivery. Reporting was voluntary. RESULTS: Between September 2007 and November 2015, 306 pregnancy exposure reports were received of which 181 were prospective, evaluable reports...
September 25, 2017: Vaccine
https://www.readbyqxmd.com/read/28857309/impact-of-the-black-triangle-label-on-prescribing-of-new-drugs-in-the-united-kingdom-lessons-for-the-united-states-at-a-time-of-deregulation
#18
Daniel B Horton, Tobias Gerhard, Amy Davidow, Brian L Strom
PURPOSE: Newly approved novel drugs in Europe receive a black triangle label to promote pharmacovigilance. With growing momentum for earlier drug approvals and reliance on real-world evidence, we studied if the black triangle label promotes more judicious prescribing. METHODS: We examined whether general practitioners prescribed escitalopram, tadalafil, and vardenafil with a black triangle more cautiously than the same or similar drugs without a black triangle in The Health Improvement Network (UK)...
August 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28856572/safety-of-antiplatelet-agents-analysis-of-real-world-data-from-the-italian-national-pharmacovigilance-network
#19
Lucia Gozzo, Andrea Navarria, Giuseppe Benfatto, Laura Longo, Silvana Mansueto, Laura Sottosanti, Luca Pani, Salvatore Salomone, Filippo Drago
INTRODUCTION: According to the Italian National Report on drug use, thienopyridines (ticlopidine, clopidogrel and prasugrel) and ticagrelor represent the most prescribed antiplatelet agents, beside aspirin. The aim of this study was to analyse the safety profile of these drugs using data from spontaneous reporting of suspected adverse reactions (ADRs). METHODS: Suspected ADRs for ticlopidine, clopidogrel, prasugrel and ticagrelor, reported on the Italian National Pharmacovigilance Network between January 2009 and December 2016, were included in the analysis...
August 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28855012/tamoxifen-pharmacovigilance-implications-for-safe-use-in-the-future
#20
Demetra Antimisiaris, Ki-Hwan Gabriel Bae, Laura Morton, Zahara Gully
OBJECTIVE: To survey the status of current tamoxifen pharmacovigilance documentation reflecting tamoxifen use in an academic outpatient multispecialty practice in older adults. This data will help provide information to develop improved pharmacovigilance for a growing cohort of older adult users. The data will be utilized by an interdisciplinary team developing new methods of identifying factors for individualized pharmacovigilance in older adults. DESIGN: Retrospective chart review to gather descriptive and quantitative data on tamoxifen pharmacovigilance...
September 1, 2017: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
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