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ADR identification and reporting

Yanni Lv, Jia Fu, Xianpeng Shi, Zhiwei Yang, Shengli Han
Yejuhua (YJH) injection is a traditional Chinese medicine (TCM) injection and has a widely application in clinical practice. However, adverse drug reactions (ADRs) caused by YJH injection, majorly manifested as allergic reactions, have been reported. Hence, Effective and practical method for allergen screening and identification is needed. In this work, a LAD2/CMC model coupled online with HPLC-IT-TOF-MS system was developed to screen, analyze, and identify the allergenic components of YJH injection. A fraction was retained on the LAD2/CMC column, and identified as linarin (LN)...
April 27, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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...
May 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Nidhi S Patel, Tejas K Patel, Parvati B Patel, Viren N Naik, C B Tripathi
PURPOSE: The study aimed to measure the percentage of preventable adverse drug reactions that lead to the hospitalization (PADRAd) and to explore the heterogeneity in its estimation through subgroup analysis of study characteristics. METHODS: Two investigators independently searched in electronic databases and related bibliography for prospective studies involving PADRAd. We excluded studies investigating medication errors and spontaneous and retrospective reporting...
April 2017: European Journal of Clinical Pharmacology
Kinjal Prajapati, Mira Desai, Samidh Shah, Jigar Panchal, Jigar Kapadia, Ramkumar Dikshit
OBJECTIVE: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs) such as clinical presentation, causality, severity, and preventability occurring in a hospital setting. MATERIALS AND METHODS: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC) criteria...
October 2016: Perspectives in Clinical Research
Narumol Jarernsiripornkul, Arunrot Patsuree, Janet Krska
PURPOSE: The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public's awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting. METHODS: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015...
February 2017: European Journal of Clinical Pharmacology
Vassilis G Koutkias, Agnès Lillo-Le Louët, Marie-Christine Jaulent
OBJECTIVE: Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. METHODS: Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data...
February 2017: Expert Opinion on Drug Safety
Geneviève Durrieu, Julien Jacquot, Mathilde Mège, Emmanuelle Bondon-Guitton, Vanessa Rousseau, François Montastruc, Jean-Louis Montastruc
INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment. OBJECTIVE: The primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports...
December 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Wen-Yang Lin, Duen-Chuan Yang, Jie-Teng Wang
BACKGROUND: To facilitate long-term safety surveillance of marketing drugs, many spontaneously reporting systems (SRSs) of ADR events have been established world-wide. Since the data collected by SRSs contain sensitive personal health information that should be protected to prevent the identification of individuals, it procures the issue of privacy preserving data publishing (PPDP), that is, how to sanitize (anonymize) raw data before publishing. Although much work has been done on PPDP, very few studies have focused on protecting privacy of SRS data and none of the anonymization methods is favorable for SRS datasets, due to which contain some characteristics such as rare events, multiple individual records, and multi-valued sensitive attributes...
2016: BMC Medical Informatics and Decision Making
Juan M Banda, Lee Evans, Rami S Vanguri, Nicholas P Tatonetti, Patrick B Ryan, Nigam H Shah
Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results...
May 10, 2016: Scientific Data
Rebecca S Bejhed, Mohammad Kharazmi, Pär Hallberg
BACKGROUND: Atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ) are well-known adverse drug reactions (ADRs) associated with bisphosphonates. To prevent these ADRs and to aid in the search for pathogenic mechanisms, knowledge of risk factors can be helpful. OBJECTIVE: To identify risk factors for bisphosphonate-related ONJ and AF. METHODS: In this case-control study of reports of bisphosphonate-related ADRs from February 16, 1984, to October 16, 2013, in the Swedish national database of ADRs, we compared characteristics for cases of ONJ (n = 167) and AF (n = 55) with all other bisphosphonate-related ADRs (n = 565) with regard to demographic variables, clinical characteristics, and concomitant drug treatments...
August 2016: Annals of Pharmacotherapy
Min Kyoung Kim, Hyeong Sim Choi, Sung-Gook Cho, Yong Cheol Shin, Seong-Gyu Ko
Cancer cells can acquire an anticancer, drug-resistant phenotype following chemotherapy, which is tightly linked to cancer malignancy and patient survival rates. Therefore, the identification of options to treat chemotherapy‑resistant cancer cells is an urgent requirement. Rubus coreanus Miquel (RCM) has long been used as a source of food. In addition, it has been reported that RCM has effective functions against particular diseases, including cancer and inflammation. In the present study, it was demonstrated that RCM extract caused the apoptotic cell death of doxorubicin‑resistant NCI/ADR‑RES ovarian cancer cells by phosphorylating c‑Jun N‑terminal kinase (JNK)...
May 2016: Molecular Medicine Reports
Anne Laure Bourgeois, Pascal Auriche, Aurore Palmaro, Jean Louis Montastruc, Haleh Bagheri
OBJECTIVE: After the diagnosis of transsexualism, hormone therapy is an established stage of gender identity disorder treatment for inducing secondary sex characteristic development of the target gender while reducing that of the birth sex. The aim of this study was to review existing data about the risk of hormone therapy in transsexual people. METHODS: A PubMed search was done to identify relevant data about adverse drug reactions (ADRs) and mortality associated to hormones exposure...
February 2016: Annales D'endocrinologie
Stefan Wimmer, Antje Neubert, Wolfgang Rascher
BACKGROUND: 1.7% of children taking medication on an outpatient basis in Germany have at least one adverse drug reaction (ADR). The corresponding figure for hospitalized children is estimated at 10% . METHODS: This review is based on pertinent literature retrieved by a selective search in PubMed. RESULTS: According to reports submitted to the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ), serious ADRs can arise, for example, after the administration of dimenhydrinate, α-adrenergic nose drops, enemas containing phosphate, ACE inhibitors, angiotensin-2-receptor antagonists (sartans), and methylphenidate...
November 13, 2015: Deutsches Ärzteblatt International
Rion Brattig Correia, Lang Li, Luis M Rocha
Much recent research aims to identify evidence for Drug-Drug Interactions (DDI) and Adverse Drug reactions (ADR) from the biomedical scientific literature. In addition to this "Bibliome", the universe of social media provides a very promising source of large-scale data that can help identify DDI and ADR in ways that have not been hitherto possible. Given the large number of users, analysis of social media data may be useful to identify under-reported, population-level pathology associated with DDI, thus further contributing to improvements in population health...
2016: Pacific Symposium on Biocomputing
Niels S Vermeer, Hans C Ebbers, Sabine M J M Straus, Hubert G M Leufkens, Toine C G Egberts, Marie L De Bruin
BACKGROUND AND OBJECTIVE: The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge between products containing the same active substance. In spontaneous adverse drug reaction (ADR) reports, drug exposure may, however, be misclassified, that is, attributed to the incorrect product. The aim of this study was to explore the effect of exposure misclassification on the time to detection of product-specific risks in spontaneous reporting systems...
March 2016: Pharmacoepidemiology and Drug Safety
Olga Morales Ríos, Luis Jasso Gutiérrez, Juan O Talavera, Martha María Téllez-Rojo, Víctor Olivar López, Juan Garduño Espinosa, Onofre Muñoz Hernández
BACKGROUND: Physicians identify from 45.7 to 96.2 % of Adverse Drug Reactions (ADRs) in their patients, with under-reporting ranging from 6 to 100 %. In order to improve ADR reporting, several interventions have been evaluated in different studies, but not with regard to ADR identification. In addition, it is not known whether some patient characteristics might influence on ADR identification and reporting by physicians. OBJECTIVES: (a) To assess the effectiveness of a comprehensive intervention directed to Emergency Department physicians and coordinated by a pharmacist in a tertiary care pediatric hospital on ADR identification and reporting...
February 2016: International Journal of Clinical Pharmacy
Yen S Low, Ola Caster, Tomas Bergvall, Denis Fourches, Xiaoling Zang, G Niklas Norén, Ivan Rusyn, Ralph Edwards, Alexander Tropsha
OBJECTIVE: Quantitative Structure-Activity Relationship (QSAR) models can predict adverse drug reactions (ADRs), and thus provide early warnings of potential hazards. Timely identification of potential safety concerns could protect patients and aid early diagnosis of ADRs among the exposed. Our objective was to determine whether global spontaneous reporting patterns might allow chemical substructures associated with Stevens-Johnson Syndrome (SJS) to be identified and utilized for ADR prediction by QSAR models...
September 2016: Journal of the American Medical Informatics Association: JAMIA
Maximilian Gahr, René Zeiss, Dirk Lang, Bernhard J Connemann, Christoph Hiemke, Carlos Schönfeldt-Lecuona
Drug-induced liver injury is a major problem of pharmacotherapy and is also frequent with antidepressive psychopharmacotherapy. However, there are only few studies using a consistent methodologic approach to study hepatotoxicity of a larger group of antidepress ants. We performed a quantitative signal detection analysis using data from the Uppsala Monitoring Centre from the WHO that records adverse drug reaction (ADR) data from worldwide sources; we retrieved substance- and country-specific (Australia, France, Germany, Italy, Spain, the United Kingdom, and the United States) ADR data and calculated reporting odds ratios as measures for disproportionality within a case/noncase approach...
June 2016: Journal of Clinical Pharmacology
Alexandra C Pacurariu, Sabine M Straus, Gianluca Trifirò, Martijn J Schuemie, Rosa Gini, Ron Herings, Giampiero Mazzaglia, Gino Picelli, Lorenza Scotti, Lars Pedersen, Peter Arlett, Johan van der Lei, Miriam C Sturkenboom, Preciosa M Coloma
BACKGROUND AND OBJECTIVE: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection. METHODS: A signal detection strategy, focused on a limited set of adverse events deemed important in pharmacovigilance, was performed retrospectively in two data sources-(1) the Exploring and Understanding Adverse Drug Reactions (EU-ADR) database network and (2) the EudraVigilance database-using data between 2000 and 2010...
December 2015: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Simran D S Maggo, Ruth L Savage, Martin A Kennedy
It is well established that variations in genes can alter the pharmacokinetic and pharmacodynamic profile of a drug and immunological responses to it. Early advances in pharmacogenetics were made with traditional genetic techniques such as functional cloning of genes using knowledge gained from purified proteins, and candidate gene analysis. Over the past decade, techniques for analysing the human genome have accelerated greatly as knowledge and technological capabilities have grown. These techniques were initially focussed on understanding genetic factors of disease, but increasingly they are helping to clarify the genetic basis of variable drug responses and adverse drug reactions (ADRs)...
April 2016: Clinical Pharmacokinetics
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