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Pharmacovigilance

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https://www.readbyqxmd.com/read/29045560/inflammatory-gastrointestinal-diseases-associated-with-pd-1-blockade-antibodies
#1
M Collins, Jm Michot, Fx Danlos, C Mussini, E Soularue, C Mateus, D Loirat, A Buisson, I Rosa, O Lambotte, S Laghouati, N Chaput, C Coutzac, Al Voisin, Jc Soria, A Marabelle, S Champiat, C Robert, F Carbonnel
Background: Immune check-point blockade agents have shown clinical activity in cancer patients but are associated with immune-related adverse events that could limit their development. The aim of this study was to describe the gastrointestinal immune-related adverse events (GI-irAE) in patients with cancer treated with anti-PD-1. Methods: this is a retrospective study of consecutive adult patients who had a suspected GI-irAE due to anti-PD-1 antibodies between 2013 and 2016...
October 3, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29040656/barriers-to-the-success-of-an-electronic-pharmacovigilance-reporting-system-in-kenya-an-evaluation-three-years-post-implementation
#2
Oscar O Agoro, Sarah W Kibira, Jenny V Freeman, Hamish S F Fraser
Objective: Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Materials and Methods: Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya...
October 12, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/29040597/mendelian-randomization-a-novel-approach-for-the-prediction-of-adverse-drug-events-and-drug-repurposing-opportunities
#3
Venexia M Walker, George Davey Smith, Neil M Davies, Richard M Martin
Identification of unintended drug effects, specifically drug repurposing opportunities and adverse drug events, maximizes the benefit of a drug and protects the health of patients. However, current observational research methods are subject to several biases. These include confounding by indication, reverse causality and missing data. We propose that Mendelian randomization (MR) offers a novel approach for the prediction of unintended drug effects. In particular, we advocate the synthesis of evidence from this method and other approaches, in the spirit of triangulation, to improve causal inferences concerning drug effects...
October 11, 2017: International Journal of Epidemiology
https://www.readbyqxmd.com/read/29039367/availability-of-computerised-medical-record-system-data-to-compare-models-of-child-health-care-in-primary-care-across-europe
#4
Harshana Liyanage, Uy Hoang, Filipa Ferreira, Denise Alexander, Michael Rigby, Mitch Blair, Simon De Lusignan
Computerised medical record (CMR) system data can be used to compare different models of health care for children. We identified sources of data from the Models of Child Health Appraised (MOCHA) project that compares family doctor led with paediatrician led and mixed models of child care using index conditions. Asthma and immunisation coverage are the first of these. We explored the extent to which an established Patient Registries Initiative (PARENT); MOCHA's own survey (MIROI); the European Centre for Disease Control (ECDC) immunisation information system survey and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) registry of data sources provided data to make comparisons of child health care...
2017: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/29036230/predictors-of-adverse-drug-reaction-related-hospitalisation-in-southwest-ethiopia-a-prospective-cross-sectional-study
#5
Mulugeta Tarekegn Angamo, Colin Michael Curtain, Leanne Chalmers, Daniel Yilma, Luke Bereznicki
BACKGROUND: Adverse drug reactions (ADRs) are important causes of morbidity and mortality in the healthcare system; however, there are no studies reporting on the magnitude and risk factors associated with ADR-related hospitalisation in Ethiopia. OBJECTIVES: To characterise the reaction types and the drugs implicated in admission to Jimma University Specialized Hospital, Southwest Ethiopia, and to identify risk factors associated with ADR-related hospitalisation...
2017: PloS One
https://www.readbyqxmd.com/read/29030411/global-shortage-of-neonatal-and-paediatric-antibiotic-trials-rapid-review
#6
Georgina Thompson, Charlotte I Barker, Laura Folgori, Julia A Bielicki, John S Bradley, Irja Lutsar, Mike Sharland
OBJECTIVES: There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. METHODS: Studies were identified using key word searches of the ClinicalTrials...
October 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/29027336/trends-in-utilization-of-benzodiazepine-and-z-drugs-in-israel
#7
Erez Berman, Sara Eyal, Eli Marom
BACKGROUND: Studies on benzodiazepine (BZDs) as well as Zopiclone and Zolpidem (Z-drugs) utilization are important for estimating the prevalence of medical conditions, providing the basis for pharmacovigilance, and identifying temporal trends of consumption. Such studies that involve the Israeli population have not been conducted yet. PURPOSE: Identify trends over time in utilization of BZDs and Z-drugs in a nationwide population in Israel. METHODS: Data on BZD and Z-drugs utilization (for all indications) for the period 2005 to 2013 were obtained from pharmaceutical companies that distribute BZDs in Israel...
October 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29022151/comparative-safety-of-targeted-therapies-for-metastatic-colorectal-cancer-between-elderly-and-younger-patients-a-study-using-the-international-pharmacovigilance-database
#8
Amandine Gouverneur, Pauline Claraz, Marine Rousset, Mickaël Arnaud, Annie Fourrier-Réglat, Antoine Pariente, Thomas Aparicio, Ghada Miremont-Salamé, Pernelle Noize
BACKGROUND: Metastatic colorectal cancer (mCRC) is increasingly treated using targeted therapies. Post-marketing safety of these agents is understudied, especially in the elderly. OBJECTIVE: This study aimed to compare, according to age, the adverse drug reactions (ADRs) of targeted therapies used for mCRC in real life. PATIENTS AND METHODS: An extraction of VigiBase, which contains World Health Organization individual case safety reports (ICSRs), was performed...
October 11, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28989138/knowledge-attitude-and-practices-regarding-pharmacovigilance-and-adverse-drug-reaction-reporting-among-dental-students-in-a-teaching-hospital-jodhpur-india-a-cross-sectional-study
#9
Kumar G Chhabra, Ashish Sharma, Chaya Chhabra, J Jyothirmai Reddy, Shravani G Deolia, Yogesh Mittal
INTRODUCTION: This is a cross-sectional knowledge, attitude, and practices (KAPs) study on pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among dental students in a teaching hospital in India. AIM: The aim of this study was to assess the KAP of dental students regarding PV, ADR reporting, and barriers toward the same. MATERIALS AND METHODS: A cross-sectional survey using a self-administered, investigator-developed, close-ended questionnaire was conducted in an academic dental hospital in India...
October 1, 2017: Journal of Contemporary Dental Practice
https://www.readbyqxmd.com/read/28988943/how-addictive-are-gabapentin-and-pregabalin-a-systematic-review
#10
REVIEW
U Bonnet, N Scherbaum
In the last ten years, gabapentin and pregabalin have been becoming dispensed broadly and sold on black markets, thereby, exposing millions to potential side-effects. Meanwhile, several pharmacovigilance-databases have warned for potential abuse liabilities and overdose fatalities in association with both gabapentinoids. To evaluate their addiction risk in more detail, we conducted a systematic review on PubMed/Scopus and included 106 studies. We did not find convincing evidence of a vigorous addictive power of gabapentinoids which is primarily suggested from their limited rewarding properties, marginal notes on relapses, and the very few cases with gabapentinoid-related behavioral dependence symptoms (ICD-10) in patients without a prior abuse history (N=4)...
October 5, 2017: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28979130/relevance-of-the-weber-effect-in-contemporary-pharmacovigilance-of-oncology-drugs
#11
Ankur Arora, Rajinder K Jalali, Divya Vohora
BACKGROUND: Numerous reporting biases have been known to affect spontaneous reporting databases. The Weber effect, which constitutes a peak in adverse event (AE) reporting of a drug at the end of second year after regulatory approval followed by a continuous decline thereafter, has been considered an important bias for a long time. The existence of this bias in AE reporting of oncology drugs remains an underevaluated area, prompting a targeted examination. METHODS: The US Food and Drug Administration (USFDA) Adverse Event Reporting System (FAERS) was studied for AE reporting patterns of 5 years of 15 new molecular entities (NMEs) and biologics used in oncology...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28976476/comparison-of-unenhanced-t1-weighted-signal-intensities-within-the-dentate-nucleus-and-the-globus-pallidus-after-serial-applications-of-gadopentetate-dimeglumine-versus-gadobutrol-in-a-pediatric-population
#12
Diane M Renz, Stefanie Kümpel, Joachim Böttcher, Alexander Pfeil, Florian Streitparth, Matthias Waginger, Jürgen R Reichenbach, Ulf K Teichgräber, Hans-Joachim Mentzel
OBJECTIVE: The aim of this study was to evaluate and compare changes in T1-weighted signal intensity (SI) within the dentate nucleus (DN) and globus pallidus (GP) in a pediatric population after serial applications of the linear gadolinium-based magnetic resonance contrast medium gadopentetate dimeglumine and the more stable macrocyclic agent gadobutrol. MATERIALS AND METHODS: Institutional review board approval was obtained. Two similar pediatric patient cohorts who underwent at least 3 serial contrast-enhanced magnetic resonance imaging (MRI) examinations with sole application of gadopentetate dimeglumine or gadobutrol were analyzed...
October 2, 2017: Investigative Radiology
https://www.readbyqxmd.com/read/28975584/overview-of-pharmacovigilance-system-in-vietnam-lessons-learned-in-a-resource-restricted-country
#13
Khac-Dung Nguyen, Phuong-Thuy Nguyen, Hoang-Anh Nguyen, Anne Roussin, Jean-Louis Montastruc, Haleh Bagheri, Sten Olsson
Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends...
October 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28971612/adverse-drug-reactions-of-montelukast-in-children-and-adults
#14
Meindina G Haarman, Florence van Hunsel, Tjalling W de Vries
Montelukast, a selective leukotriene receptor antagonist, is recommended in guidelines for the treatment of asthma in both children and adults. However, its effectiveness is debated, and recent studies have reported several adverse events such as neuropsychiatric disorders and allergic granulomatous angiitis. This study aims to obtain more insight into the safety profile of montelukast and to provide prescribing physicians with an overview of relevant adverse drug reactions in both children and adults. We retrospectively studied all adverse drug reactions on montelukast in children and adults reported to the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase(®) until 2016...
October 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28965336/use-and-safety-of-anthroposophic-medicinal-products-an-analysis-of-44-662-patients-from-the-evamed-pharmacovigilance-network
#15
Harald Johan Hamre, Anja Glockmann, Kirsten Heckenbach, Harald Matthes
BACKGROUND: There is a need for data on the clinical safety of anthroposophic medicinal products (AMPs). OBJECTIVES: The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions. METHODS: EvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records...
September 30, 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/28965312/a-comparison-of-adverse-drug-reaction-profiles-in-patients-on-antiretroviral-and-antitubercular-treatment-in-zimbabwe
#16
Josiah T Masuka, Precious Chipangura, Priscilla P Nyambayo, Andy Stergachis, Star Khoza
INTRODUCTION: Few studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries. OBJECTIVES: To describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART). METHODS: We analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016...
September 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28963996/is-acetaminophen-associated-with-a-risk-of-stevens-johnson-syndrome-and-toxic-epidermal-necrolysis-analysis-of-the-french-pharmacovigilance-database
#17
Bénédicte Lebrun-Vignes, Claire Guy, Marie-Josèphe Jean-Pastor, Valérie Gras-Champel, Marie Zenut
AIM: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe mostly drug-induced cutaneous reactions. Acetaminophen is an over the counter drug worldwide used to treat pain and reduce fever. In 2013, the FDA informed the public that acetaminophen was associated with a rare risk of SJS/TEN. The aim of this retrospective study is to analyse reports of acetaminophen as a possible suspect in the development of SJS/TEN from the French Pharmacovigilance Database (FPDB)...
September 30, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28951672/public-awareness-and-perception-toward-adverse-drug-reactions-reporting-in-riyadh-saudi-arabia
#18
Ibrahim Sales, Hisham Aljadhey, Yasser Albogami, Mansour A Mahmoud
Purpose: To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. Method: A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study. Results: A total of 204 questionnaires were collected with a response rate of 68%. Twenty-three percent could correctly define ADRs...
September 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28951666/knowledge-attitude-and-practices-of-pharmacovigilance-and-adverse-drug-reaction-reporting-among-pharmacists-working-in-secondary-and-tertiary-governmental-hospitals-in-kuwait
#19
Fatemah M Alsaleh, Sherifah W Alzaid, Eman A Abahussain, Tania Bayoud, Jacinthe Lemay
Introduction: Pharmacovigilance (PV) is essential to detect and prevent adverse drug reactions (ADR) after a drug is marketed. However, ADRs are significantly underreported worldwide. Objective: The aims of this study were to document the knowledge, attitude and practices (KAP) of pharmacists toward PV and ADR reporting and to explore the barriers to implementing a fully functional PV program in Kuwait. Material and methods: Pharmacists working at governmental hospitals were asked to complete a paper-based 25-item questionnaire...
September 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28951173/signal-management-in-pharmacovigilance-and-human-risk-assessment-of-cpg-7909-integrating-embryo-fetal-and-post-natal-developmental-toxicity-studies-in-rats-and-rabbits
#20
Frédérique Delannois, Camille Planty, Giulia Giordano, Eric Destexhe, Dinesh Stanislaus, Fernanda Tavares Da Silva, Jens-Ulrich Stegmann, Karen Thacker, Lucie Reynaud, Nathalie Garçon, Lawrence Segal
The potential reproductive and developmental toxicity of the synthetic oligodeoxynucleotide (ODN) CpG 7909, a component of GSK's AS15 immunostimulant, was examined in rat and rabbit studies following intermittent intramuscular injections. Previous studies using subcutaneous and intraperitoneal injections in mice, rats and rabbits revealed that CpG ODNs induced developmental effects. To analyze the safety signal, GSK conducted additional animal studies using the intended clinical route of administration. CpG 7909 injections were administered intramuscularly to rats or rabbits 28 and 14days before pairing, on 4 or 5 occasions during gestation, and on lactation day 7...
September 23, 2017: Reproductive Toxicology
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