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Pharmacovigilance

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https://www.readbyqxmd.com/read/28646772/prevalence-of-immune-related-systemic-adverse-events-in%C3%A2-patients-treated-with-anti-programmed-cell-death-1-anti-programmed-cell-death-ligand-1-agents-a-single-centre-pharmacovigilance-database-analysis
#1
Sébastien Le Burel, Stéphane Champiat, Christine Mateus, Aurélien Marabelle, Jean-Marie Michot, Caroline Robert, Rakiba Belkhir, Jean-Charles Soria, Salim Laghouati, Anne-Laure Voisin, Olivier Fain, Arsène Mékinian, Laetitia Coutte, Tali-Anne Szwebel, Laetitia Dunogeant, Bertrand Lioger, Cécile Luxembourger, Xavier Mariette, Olivier Lambotte
AIM: The growing use of immune checkpoint inhibitors (ICIs) is associated with the occurrence of immune-related adverse events (irAEs). Few data are published on systemic, immunohaematological and rheumatic irAEs. In a pharmacovigilance database analysis, we screened for these irAEs and calculated their prevalence. PATIENTS AND METHODS: Participants were recruited via Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie (REISAMIC)(1) a French registry of grade ≥2 irAEs occurring in ICI-treated patients...
June 21, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#2
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28645716/guide-to-active-vaccine-safety-surveillance-report-of-cioms-working-group-on-vaccine-safety-executive-summary
#3
U Heininger, K Holm, I Caplanusi, S R Bailey
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country...
June 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28643275/open-label-single-sequence-crossover-study-evaluating-pharmacokinetics-efficacy-and-safety-of-once-daily-dosing-of-nitisinone-in-patients-with-hereditary-tyrosinemia-type-1
#4
Nathalie Guffon, Anders Bröijersén, Ingrid Palmgren, Mattias Rudebeck, Birgitta Olsson
BACKGROUND: Although nitisinone is successfully used to treat hereditary tyrosinemia type 1 (HT-1) with the recommended twice-daily dosing, data describing a long half-life motivate less frequent dosing. Therefore, in agreement with the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency, this study was performed to investigate the switch to once-daily dosing. METHODS: This open-label, non-randomized, single-sequence crossover study evaluated the pharmacokinetics, efficacy, and safety of once-daily compared to twice-daily dosing of nitisinone in patients with HT-1 (NCT02323529)...
June 23, 2017: JIMD Reports
https://www.readbyqxmd.com/read/28643174/natural-language-processing-for-ehr-based-pharmacovigilance-a-structured-review
#5
REVIEW
Yuan Luo, William K Thompson, Timothy M Herr, Zexian Zeng, Mark A Berendsen, Siddhartha R Jonnalagadda, Matthew B Carson, Justin Starren
The goal of pharmacovigilance is to detect, monitor, characterize and prevent adverse drug events (ADEs) with pharmaceutical products. This article is a comprehensive structured review of recent advances in applying natural language processing (NLP) to electronic health record (EHR) narratives for pharmacovigilance. We review methods of varying complexity and problem focus, summarize the current state-of-the-art in methodology advancement, discuss limitations and point out several promising future directions...
June 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28637743/knowledge-attitude-and-practice-of-healthcare-professionals-towards-infliximab-and-insulin-glargine-biosimilars-result-of-a-uk-web-based-survey
#6
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
OBJECTIVE: To investigate healthcare professionals' knowledge and attitudes towards infliximab and insulin glargine biosimilars and the factors influencing their prescribing. Then, to compare healthcare professionals' attitudes with the utilisation of these biosimilars in UK hospitals. DESIGN: Self-administered, one-time web-based survey and drug utilisation analysis. SETTING AND DATA SOURCES: Professional associations and societies in the field of dermatology, diabetology, gastroenterology and rheumatology in the UK, between 8 August 2016 and 8 January 2017...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28623627/clozapine-induced-gastrointestinal-hypomotility-a-22-year-bi-national-pharmacovigilance-study-of-serious-or-fatal-slow-gut-reactions-and-comparison-with-international-drug-safety-advice
#7
Susanna Every-Palmer, Pete M Ellis
INTRODUCTION: Clozapine is the preferred antipsychotic for treatment-resistant schizophrenia, but has significant adverse effects, including gastrointestinal hypomotility or 'slow gut', which may result in severe constipation, ileus, bowel obstruction, and even death. These gastrointestinal effects remain inadequately recognized. METHODS: We reviewed all reports of serious clozapine-induced gastrointestinal hypomotility (CIGH) submitted to the Australian Therapeutic Goods Administration and New Zealand Pharmacovigilance Centre between 1992 and 2013...
June 16, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28622812/clozapine-induced-gastrointestinal-hypomotility-a-potentially-life-threatening-adverse-event-a-review-of-the-literature
#8
REVIEW
Stephen West, David Rowbotham, Glen Xiong, Chris Kenedi
OBJECTIVE: The haematological and cardiac complications of clozapine have been well documented. Recent evidence from pharmacovigilance databases suggests that gastrointestinal (GI) complications are the leading cause of clozapine related deaths. This review aims to describe clinical features along with preventative and treatment options. METHOD: A review of MEDLINE via PubMed searching for all articles published up to February of 2016. Inclusion criteria were articles that provided clinical or epidemiological information relating to the diagnosis, outcome, management or pathophysiology of clozapine related gastrointestinal disorders in humans...
May 2017: General Hospital Psychiatry
https://www.readbyqxmd.com/read/28615765/adverse-drug-reaction-monitoring-in-a-tertiary-care-psychiatry-setting-a-comparative-study-between-inpatients-and-outpatients
#9
Tejaswi Gummadi, Virupaksha Shanmugam Harave, Lakshmi Narayan Aiyar, Saraswathy Ganesan RajaLekshmi, Radhika Kunnavil
BACKGROUND: Psychotropic medications are the mainstay of treatment in psychiatric disorders and are associated with ADRs which affect the compliance and treatment course. Previous studies have looked at the frequency, profile of ADRs and their management aspects. However, the systematic comparison between IP and OP was lacking even though there is a prescription pattern difference. Hence this study was aimed to compare the proportion, pattern, severity and resolution of ADRs once detected...
May 2017: Indian Journal of Psychological Medicine
https://www.readbyqxmd.com/read/28615763/adverse-drug-reactions-and-their-impact-on-quality-of-life-in-patients-on-antipsychotic-therapy-at-a-tertiary-care-center-in-delhi
#10
Shalini Chawla, Shankar Kumar
CONTEXT: Adverse drug reactions (ADR) due to antipsychotic therapy have significant impact on a psychiatric patient's quality of life. Few studies have been conducted in India to monitor adverse drug reactions due to antispsychotics and none has been done to determine their impact on quality of life. AIMS: The present study was conducted to monitor ADRs due to antipsychotics and ascertain the impact of ADRs on quality of life. SETTINGS AND DESIGN: This prospective observational study was conducted in the psychiatry outpatients department in New Delhi for 1 year...
May 2017: Indian Journal of Psychological Medicine
https://www.readbyqxmd.com/read/28603499/campania-preventability-assessment-committee-italy-a-focus-on-the-preventability-of-non-steroidal-anti-inflammatory-drugs-adverse-drug-reactions
#11
Maurizio Sessa, Liberata Sportiello, Annamaria Mascolo, Cristina Scavone, Silvia Gallipoli, Gabriella di Mauro, Daniela Cimmaruta, Concetta Rafaniello, Annalisa Capuano
Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28600751/central-and-peripheral-nervous-system-disorders-following-ivermectin-mass-administration-a-descriptive-study-based-on-the-democratic-republic-of-congo-pharmacovigilance-system
#12
Didier Nzolo, Francis Anto, Sarah Hailemariam, Didier Bakajika, Daniel Muteba, Jean-Claude Makenga, Gautier Mesia, Celestin Nsibu, Samuel Mampunza, Gaston Tona
INTRODUCTION: The mainstay of onchocerciasis control currently is mass administration of ivermectin; however, this may be associated with serious adverse events, including deaths, when administered in areas where onchocerciasis and loiasis are co-endemic. OBJECTIVES: The objective of the current study was to describe the central and peripheral nervous system disorders that occurred after mass administration of ivermectin in Democratic Republic of Congo (DRC). METHODS: This is a retrospective descriptive study involving a review of data on adverse events related to mass administration of ivermectin...
June 9, 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/28600702/hiccups-in-parkinson-s-disease-an-analysis-of-cases-reported-in-the-european-pharmacovigilance-database-and-a-review-of-the-literature
#13
U Lertxundi, A C Marquínez, S Domingo-Echaburu, M Á Solinís, B Calvo, A Del Pozo-Rodríguez, M García, C Aguirre, A Isla
BACKGROUND: Some reports have suggested an association between dopamine agonists and hiccups, involuntary contractions that merit full clinical attention because they can be very debilitating. Many drugs frequently used to treat hiccups are formally contraindicated in Parkinson's disease due to their liability to worsen motor symptoms, making the treatment of hiccups problematic in this disease. The objective of the present study was to analyze all spontaneous reports of hiccups from the European Pharmacovigilance Database in patients with Parkinson's disease and/or on dopaminergic drugs...
June 9, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28599142/opioid-pharmacovigilance-a-clinical-social-history-of-the-changes-in-opioid-prescribing-for-patients-with-co-occurring-chronic-non-cancer-pain-and-substance-use
#14
Kelly R Knight, Margot Kushel, Jamie S Chang, Kara Zamora, Rachel Ceasar, Emily Hurstak, Christine Miaskowski
There is growing concern among US-based clinicians, patients, policy makers, and in the media about the personal and community health risks associated with opioids. Perceptions about the efficacy and appropriateness of opioids for the management of chronic non-cancer pain (CNCP) have dramatically transformed in recent decades. Yet, there is very little social scientific research identifying the factors that have informed this transformation from the perspectives of prescribing clinicians. As part of an on-going ethnographic study of CNCP management among clinicians and their patients with co-occurring substance use, we interviewed 23 primary care clinicians who practice in safety-net clinical settings...
May 23, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/28597531/attitudes-in-australia-on-the-upscheduling-of-over-the-counter-codeine-to-a-prescription-only-medication
#15
Jacqui McCoy, Raimondo Bruno, Suzanne Nielsen
INTRODUCTION AND AIMS: In December 2016, the Australian Therapeutic Goods Administration announced that over-the-counter (OTC) codeine would be available by prescription-only in February 2018. Prior to this announcement, the authors aimed to evaluate attitudes among Australian codeine consumers, pharmacists and general medical practitioners (GP) towards the proposed upscheduling of OTC codeine. DESIGN AND METHODS: Public Therapeutic Goods Administration submissions on codeine upscheduling were assessed, and a brief questionnaire was developed to assess the common issues raised...
June 8, 2017: Drug and Alcohol Review
https://www.readbyqxmd.com/read/28597251/occurrence-of-multiple-sclerosis-after-drug-exposure-insights-from-evidence-mapping
#16
Ippazio Cosimo Antonazzo, Emanuel Raschi, Luca Vignatelli, Elisa Baldin, Trond Riise, Roberto D'Alessandro, Fabrizio De Ponti, Elisabetta Poluzzi
INTRODUCTION: The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. OBJECTIVE: The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. METHODS: A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS...
June 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28588760/the-impact-of-database-restriction-on-pharmacovigilance-signal-detection-of-selected-cancer-therapies
#17
Manfred Hauben, Eric Hung, Jennifer Wood, Amit Soitkar, Daniel Reshef
BACKGROUND: The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. METHODS: We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes...
May 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28579364/false-positive-results-in-pharmacoepidemiology-and-pharmacovigilance
#18
Julien Bezin, Pauline Bosco-Levy, Antoine Pariente
False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing...
May 8, 2017: Thérapie
https://www.readbyqxmd.com/read/28572733/the-jordan-food-and-drug-administration-comparison-of-its-registration-process-with-australia-canada-saudi-arabia-and-singapore
#19
Wesal Salem Al Haqaish, Hayel Obeidat, Prisha Patel, Stuart Walker
OBJECTIVE: This study outlines the current regulatory review process and good review practices (GRevPs) at the Jordan Food and Drug Administration (JFDA) and compares them with those of regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to gauge how well the JFDA is performing. We identify opportunities for further development of the JFDA as a key global reference agency. METHODS: Personnel within the JFDA completed a questionnaire comprising four sections: organisation, key milestones, review timelines, and GRevPs...
2017: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/28571501/ct-p13-in-the-treatment-of-rheumatoid-arthritis
#20
Dae Hyun Yoo
The first biosimilar infliximab, CT-P13 infliximab-dyyb was approved in 2013 by the European Medicines Agency (EMA) and in 2016 by the United States Food and Drug Administration (FDA) and has been used for the treatment of rheumatoid arthritis (RA) for 4 years. Areas covered: CT-P13 with the three brand names on the market has highly similar efficacy and safety profiles but lower price than originator infliximab and are approved in more than 80 countries. One of the most important determinants of the implementation of CT-P13 in the treatment of RA is scientific evidence from clinical studies and real-world pharmacovigilance data...
July 2017: Expert Review of Clinical Immunology
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