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ADR identification and reporting

Ar Kar Aung, Mei Jie Tang, Nikki Rae Adler, Sara Lee de Menezes, Michelle Sue Yen Goh, Hui Wen Tee, Jason Anthony Trubiano, Robert Puy, Celia Mary Zubrinich, Linda Velta Graudins
We describe adverse drug reaction (ADR) reporting characteristics and factors contributing to length of time to report by healthcare professionals. This is a retrospective study of voluntary reports to an Australian healthcare ADR Review Committee over a 2-year period (2015-2016). Descriptive and univariate models were used for outcomes, employing standardized ADR definitions. Hospital pharmacists reported 84.8% of the 555 ADRs: 70.3% were hospital onset reactions, and 71.7% were at least of moderate severity...
May 7, 2018: Journal of Clinical Pharmacology
Anthony Marius Smith, Shannon Lucrecia Smouse, Nomsa Pauline Tau, Colleen Bamford, Vineshree Mischka Moodley, Charlene Jacobs, Kerrigan Mary McCarthy, Adré Lourens, Karen Helena Keddy
BACKGROUND: Workers in clinical microbiology laboratories are exposed to a variety of pathogenic microorganisms. Salmonella species is among the most commonly reported bacterial causes of laboratory-acquired infections. We report on three cases of laboratory-acquired Salmonella enterica serotype Typhi (Salmonella Typhi) infection which occurred over the period 2012 to 2016 in South Africa. METHODS: Laboratory investigation included phenotypic and genotypic characterization of isolates...
September 29, 2017: BMC Infectious Diseases
Cedric Bousquet, Badisse Dahamna, Sylvie Guillemin-Lanne, Stefan J Darmoni, Carole Faviez, Charles Huot, Sandrine Katsahian, Vincent Leroux, Suzanne Pereira, Christophe Richard, Stéphane Schück, Julien Souvignet, Agnès Lillo-Le Louët, Nathalie Texier
BACKGROUND: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture...
September 21, 2017: JMIR Research Protocols
Paulo Henrique Santos Andrade, Adriano da Silva Santos, Carlos Adriano Santos Souza, Iza Maria Fraga Lobo, Wellington Barros da Silva
BACKGROUND: The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. METHODS: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle-Ottawa scale for cohort studies...
June 2017: Therapeutic Advances in Drug Safety
Kaarina Kowalec, Elaine Kingwell, Robert Carruthers, Ruth Ann Marrie, Sasha Bernatsky, Anthony Traboulsee, Colin J D Ross, Bruce Carleton, Helen Tremlett
INTRODUCTION: Adverse drug reactions (ADRs) are a global public health issue. The potential for pharmacogenomic biomarkers has been demonstrated in several therapeutical areas, including HIV infection and oncology. Dimethyl fumarate (DMF) is a licensed disease-modifying therapy for the treatment of multiple sclerosis (MS). The use of DMF in MS has been associated with a severe reduction in lymphocyte counts and reports of progressive multifocal leukoencephalopathy. Here, we outline the protocol for a case-control study designed to discover genomic variants associated with DMF-induced lymphopenia...
June 2, 2017: BMJ Open
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)...
June 15, 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...
July 18, 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
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