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Pharmacovigilance

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https://www.readbyqxmd.com/read/28226033/effectiveness-of-pharmacovigilance-multifaceted-educational-intervention-related-to-the-knowledge-skills-and-attitudes-of-multidisciplinary-hospital-staff
#1
Fabiana Rossi Varallo, Cleopatra S Planeta, Patricia de Carvalho Mastroianni
OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil...
January 1, 2017: Clinics
https://www.readbyqxmd.com/read/28211644/healthcare-professionals-and-pharmacovigilance-of-pediatric-adverse-drug-reactions-a-5-year-analysis-of-adverse-events-reporting-system-database-of-the-food-and-drug-administration
#2
Caterina Bigi, Marco Tuccori, Guido Bocci
BACKGROUND: To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. METHODS: Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis...
February 17, 2017: Minerva Pediatrica
https://www.readbyqxmd.com/read/28203363/an-exploratory-factor-analysis-of-the-spontaneous-reporting-of-severe-cutaneous-adverse-reactions
#3
Manfred Hauben, Eric Hung, Wen-Yaw Hsieh
BACKGROUND: Severe cutaneous adverse reactions (SCARs) are prominent in pharmacovigilance (PhV). They have some commonalities such as nonimmediate nature and T-cell mediation and rare overlap syndromes have been documented, most commonly involving acute generalized exanthematous pustulosis (AGEP) and drug rash with eosinophilia and systemic symptoms (DRESS), and DRESS and toxic epidermal necrolysis (TEN). However, they display diverse clinical phenotypes and variations in specific T-cell immune response profiles, plus some specific genotype-phenotype associations...
January 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28178730/an-overview-of-pharmacoepidemiology-in-new-zealand-medical-databases-registries-and-research-achievements
#4
Prasad Nishtala, Henry Ndukwe, Te-Yuan Chyou, Mohammed Salahudeen, Sujita Narayan
Pharmacoepidemiology is an eclectic blend of epidemiology, clinical pharmacology and biostatistics. In New Zealand there have been recent advances in pharmacoepidemiology to examine drug utilisation, monitor adverse drug events and complement pharmacovigilance. This paper attempts to describe the past, present and future of pharmacoepidemiology, particularly in the area of translational research with a particular focus on medicine use and safety. New Zealand is well-positioned globally to make significant contributions to the knowledge base of drug safety in real-world settings...
January 27, 2017: New Zealand Medical Journal
https://www.readbyqxmd.com/read/28176638/personalized-medicine-and-adverse-drug-reactions-the-experience-of-an-italian-teaching-hospital
#5
Raffaele La Russa, Vittorio Fineschi, Mariantonia Di Sanzo, Vittorio Gatto, Alessandro Santurro, Gabriella Martini, Matteo Scopetti, Paola Frati
The personalized medicine is a model of medicine based on inherent difference given by the genetic heritage that characterizes us, diversity that can affect also our response to administered therapy. Nowadays, the term "adverse drug reaction" is identified with any harmful effect involuntary resulting from the use of a medicinal product; pharmacogenomics, in this field, has the aim to improve the drug response and to reduce the adverse reaction. We analyzed all reports of adverse reaction collected in the Pharmacovigilance Centre database of an Italian University Hospital, at the Sant'Andrea Hospital Sapienza University of Rome, in a period of two years...
February 7, 2017: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/28154326/marketing-approval-of-ethical-kampo-medicines
#6
Takashi Hakamatsuka
 Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28140305/prescribing-cascade-a-proposed-new-way-to-evaluate-it
#7
Marcelo L Ponte, Lionel Wachs, Adolfo Wachs, Héctor A Serra
Prescribing cascade is defined as the situation in which a first drug administered to a patient causes adverse event signs and symptoms, that are misinterpreted as a new condition, resulting in a new medication being prescribed. The cascade may have multiple steps and differ in complexity and severity. Despite being well identified, prescribing cascade is an increasingly common problem in medical practice. It constitutes a warning about irrational use of medicines that puts health at risk and increases treatment costs if it is not taken into account...
2017: Medicina
https://www.readbyqxmd.com/read/28139283/advantages-and-limitations-of-online-communities-of-patients-for-research-on-health-products
#8
Sophie Ravoire, Marie Lang, Elena Perrin
The way patients and their caregivers share information on various online platforms about health topics and their own experiential knowledge presents new potential environments for research, particularly as concerns health products. The information provided individually and voluntarily by patients who are members of these online communities is a new resource for identifying and understanding precisely how health products are used, assessing their effectiveness, quantifying potential adverse effects in real-life situations, detecting subtle signs that are significant for experts in pharmacovigilance and addiction studies, and developing new assessment tools to help form new working hypotheses...
January 3, 2017: Thérapie
https://www.readbyqxmd.com/read/28134712/diagnosis-and-monitoring-of-hiv-programmes-to-support-treatment-initiation-and-follow-up-and-improve-programme-quality
#9
Willem Daniel Francois Venter, Nathan Ford, Marco Vitoria, Wendy Stevens
PURPOSE OF REVIEW: The HIV 'cascade of care' breaks down at several points, with delayed HIV diagnosis, late treatment initiation, or interruption, leading to new morbidity and mortality and loss of prevention effects. New approaches are needed at each step. RECENT FINDINGS: HIV testing is still not reaching certain communities, resulting in late presentation. Creative ways to reach these communities is being explored, including with self-testing. HIV misdiagnosis is increasingly recognized as undermining testing programmes, highlighting the need for better quality control...
March 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28132566/long-term-comparative-pharmacovigilance-of-orally-transmitted-chagas-disease-first-report
#10
Belkisyolé Alarcón de Noya, Raiza Ruiz-Guevara, Oscar Noya, Julio Castro, John Ossenkopp, Zoraida Díaz-Bello, Cecilia Colmenares, José Antonio Suárez, Oscar Noya-Alarcón, Laura Naranjo, Humberto Gutiérrez, Giuseppa Quinci, Jaime Torres
BACKGROUND: Two old drugs are the only choice against Trypanosoma cruzi and little is known about their secondary effects in the acute stage of oral-transmitted Chagas disease (ChD). METHODS: A cross-sectional analytical surveillance study was conducted in a sizable cohort of patients seen during the largest acute foodborne ChD microepidemic registered so far. Individuals were treated with benznidazole (BNZ) or nifurtimox (NFX). "Common Terminology Criteria for Adverse Events" was assessed to categorize side effects according to severity...
January 30, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28130773/identification-of-substandard-medicines-via-disproportionality-analysis-of-individual-case-safety-reports
#11
Zahra Anita Trippe, Bruno Brendani, Christoph Meier, David Lewis
INTRODUCTION: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28123291/the-need-for-greater-opioid-pharmacovigilance-in-copd
#12
COMMENT
Nicholas T Vozoris
No abstract text is available yet for this article.
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28120270/feasibility-and-educational-value-of-a-student-run-pharmacovigilance-programme-a-prospective-cohort-study
#13
Tim Schutte, Jelle Tichelaar, Michael O Reumerman, Rike van Eekeren, Leàn Rolfes, Eugène P van Puijenbroek, Milan C Richir, Michiel A van Agtmael
INTRODUCTION: Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme. METHODS: In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre...
January 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28115678/elimination-of-kala-azar-from-the-southeast-asia-region
#14
Sujit K Bhattacharya, Aditya Prasad Dash
Visceral leishmaniasis (VL), popularly known as kala-azar, is essentially a disease of poverty. Kala-azar is caused by a parasite, Leishmania donovani Recent review indicates that worldwide 98 countries are endemic for kala-azar. Approximately 0.2-0.4 million new VL cases occur each year worldwide. More than 90% of global VL cases occur in Bangladesh, Brazil, Ethiopia, India, South Sudan, and Sudan. This trend is slowly changing due to the progress in kala-azar elimination in southeast Asia, where Bangladesh has reported an average of some 600 new cases in 2014-2015...
January 23, 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28104709/utility-of-social-media-and-crowd-sourced-data-for-pharmacovigilance-a-scoping-review-protocol
#15
Andrea C Tricco, Wasifa Zarin, Erin Lillie, Ba Pham, Sharon E Straus
INTRODUCTION: Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products...
January 19, 2017: BMJ Open
https://www.readbyqxmd.com/read/28101815/developing-a-crowdsourcing-approach-and-tool-for-pharmacovigilance-education-material-delivery
#16
Andrew Bate, Jürgen Beckmann, Alexander Dodoo, Linda Härmark, Kenneth Hartigan-Go, Anna Hegerius, Marie Lindquist, Eugène van Puijenbroek, Marco Tuccori, Ulrich Hagemann
The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product...
January 18, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28098949/identification-of-cellular-targets-involved-in-cardiac-failure-caused-by-pki-in-oncology-an-approach-combining-pharmacovigilance-and-pharmacodynamics
#17
E Patras de Campaigno, E Bondon-Guitton, G Laurent, F Montastruc, J L Montastruc, M Lapeyre-Mestre, F Despas
AIMS: To evaluate the risk of cardiac failure (CF) of 15 anticancer protein kinase inhibitors (PKIs) through a case/non-case analysis and to identify which PK(s) and pathways are involved in PKI-induced CF. METHODS: To evaluate the risk of CF, adjusted reporting odds ratios (aRORs) were calculated for the 15 anticancer PKIs in the WHO safety report database (VigiBase®). We realised a literature review to identify 21 PK possibly involved in CF caused by PKIs. Pearson's correlation coefficients (r) between aROR and affinity data of the 15 PKIs for the 21 PKs were calculated to identify the cellular target most likely involved in PKI-induced CF...
January 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28094583/signal-detection-activity-on-eudravigilance-data-analysis-of-the-procedure-and-findings-from-an-italian-regional-centre-for-pharmacovigilance
#18
Luca Monaco, Mauro Melis, Chiara Biagi, Monia Donati, Ester Sapigni, Alberto Vaccheri, Domenico Motola
BACKGROUND: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. METHOD: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28090715/health-care-professionals-knowledge-and-perception-of-pharmacovigilance-in-a-tertiary-care-teaching-hospital-in-amman-jordan
#19
Khawla Abu Hammour, Faris El-Dahiyat, Rana Abu Farha
RATIONALE, AIMS, AND OBJECTIVES: Underreporting of adverse drug reactions (ADRs) by health care professionals is a common inherent health problem encountered in many countries. This could be explained by the lack of awareness and knowledge about the guidelines to follow to identify and report ADRs. Thus, this study aimed to evaluate the awareness, knowledge, and perceptions among medical doctors and nurses regarding their role as ADRs reporters in Jordan. METHODS: A cross-sectional study was conducted between September 2015 to January 2016 at the Jordan University Hospital in Amman...
January 16, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28087585/standard-based-comprehensive-detection-of-adverse-drug-reaction-signals-from-nursing-statements-and-laboratory-results-in-electronic-health-records
#20
Suehyun Lee, Jiyeob Choi, Hun-Sung Kim, Grace Juyun Kim, Kye Hwa Lee, Chan Hee Park, Jongsoo Han, Dukyong Yoon, Man Young Park, Rae Woong Park, Hye-Ryun Kang, Ju Han Kim
OBJECTIVE: We propose 2 Medical Dictionary for Regulatory Activities-enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. MATRIALS AND METHODS: This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)-based pharmacovigilance method, called CLEAR...
January 13, 2017: Journal of the American Medical Informatics Association: JAMIA
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