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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/28429612/a-unique-database-for-gathering-data-from-a-mobile-app-and-medical-prescription-software-a-useful-data-source-to-collect-and-analyse-patient-reported-outcomes-of-depression-and-anxiety-symptoms
#1
Yoshinori Watanabe, Yoko Hirano, Yuko Asami, Maki Okada, Kazuya Fujita
A unique database named 'AN-SAPO' was developed by Iwato Corp. and Japan Brain Corp. in collaboration with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes patients' depression/anxiety score data from a mobile app named AN-SAPO and medical records from medical prescription software named 'ORCA'. On the mobile app, depression/anxiety severity can be evaluated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together with the patients' medical records on ORCA...
April 21, 2017: International Journal of Psychiatry in Clinical Practice
https://www.readbyqxmd.com/read/28417321/adjuvanted-as03-a-h1n1-2009-pandemic-influenza-vaccines-and-solid-organ-transplant-rejection-systematic-signal-evaluation-and-lessons-learnt
#2
Gaël Dos Santos, Harry A Seifert, Vincent Bauchau, Vivek Shinde, Dominique M Barbeau, Catherine Cohet
INTRODUCTION: We investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines. METHODS: Potential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored. RESULTS: Overall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients...
April 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28399565/conducting-privacy-preserving-multivariable-propensity-score-analysis-when-patient-covariate-information-is-stored-in-separate-locations
#3
Justin Bohn, Wesley Eddings, Sebastian Schneeweiss
Distributed networks of health-care data sources are increasingly being utilized to conduct pharmacoepidemiologic database studies. Such networks may contain data that are not physically pooled but instead are distributed horizontally (separate patients within each data source) or vertically (separate measures within each data source) in order to preserve patient privacy. While multivariable methods for the analysis of horizontally distributed data are frequently employed, few practical approaches have been put forth to deal with vertically distributed health-care databases...
March 15, 2017: American Journal of Epidemiology
https://www.readbyqxmd.com/read/28398706/can-we-rely-on-pharmacy-claims-databases-to-ascertain-maternal-use-of-medications-during-pregnancy
#4
Jin-Ping Zhao, Odile Sheehy, Jessica Gorgui, Anick Bérard
BACKGROUND: Administrative databases are increasingly used to measure drug exposure in perinatal pharmacoepidemiology. We aimed to estimate the concordance between records of prescriptions filled in pharmacies and self-reported drug use during pregnancy. METHODS: Data on self-reported medication use were collected at each trimester of pregnancy among a sub-sample from the Organization of Teratology Information Specialists Antidepressants in Pregnancy Cohort. Women were eligible if they were Quebec resident and provided their pharmacist's contact information...
April 3, 2017: Birth Defects Res
https://www.readbyqxmd.com/read/28398582/how-to-compare-instrumental-variable-and-conventional-regression-analyses-using-negative-controls-and-bias-plots
#5
Neil M Davies, Kyla H Thomas, Amy E Taylor, Gemma M J Taylor, Richard M Martin, Marcus R Munafò, Frank Windmeijer
There is increasing interest in the use of instrumental variable analysis to overcome unmeasured confounding in observational pharmacoepidemiological studies. This is partly because instrumental variable analyses are potentially less biased than conventional regression analyses. However, instrumental variable analyses are less precise, and regulators and clinicians find it difficult to interpret conflicting evidence from instrumental variable compared with conventional regression analyses. In this paper, we describe three techniques to assess which approach (instrumental variable versus conventional regression analyses) is least biased...
April 7, 2017: International Journal of Epidemiology
https://www.readbyqxmd.com/read/28397412/prevalence-incidence-indication-and-choice-of-antidepressants-in-patients-with-and-without-chronic-kidney-disease-a-matched-cohort-study-in-uk-clinical-practice-research-datalink
#6
Masao Iwagami, Laurie A Tomlinson, Kathryn E Mansfield, Helen I McDonald, Liam Smeeth, Dorothea Nitsch
PURPOSE: People with chronic kidney disease (CKD) have an increased prevalence of depression, anxiety, and neuropathic pain. We examined prevalence, incidence, indication for, and choice of antidepressants among patients with and without CKD. METHODS: Using the UK Clinical Practice Research Datalink, we identified patients with CKD (two measurements of estimated glomerular filtration rate < 60 mL/min/1.73m(2) for ≥3 months) between April 2004 and March 2014...
April 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28397352/effects-of-expanding-the-look-back-period-to-all-available-data-in-the-assessment-of-covariates
#7
Sonja S Nakasian, Jeremy A Rassen, Jessica M Franklin
BACKGROUND: A fixed baseline period has been a common covariate assessment approach in pharmacoepidemiological studies from claims but may lead to high levels of covariate misclassification. Simulation studies have recommended expanding the look-back approach to all available data (AAD) for binary indicators of diagnoses, procedures, and medications, but there have been few real data analyses using this approach. OBJECTIVE: The objective of the study is to explore the impact on treatment effect estimates and covariate prevalence of expanding the look-back period within five validated studies in the Aetion system, a rapid cycle analytics platform...
April 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28397317/evaluating-the-effectiveness-of-risk-minimisation-measures-the-application-of-a-conceptual-framework-to-danish-real-world-dabigatran-data
#8
REVIEW
Martin Erik Nyeland, Mona Vestergaard Laursen, Torbjörn Callréus
PURPOSE: For both marketing authorization holders and regulatory authorities, evaluating the effectiveness of risk minimization measures is now an integral part of pharmacovigilance in the European Union. The overall aim of activities in this area is to assess the performance of risk minimization measures implemented in order to ensure a positive benefit-risk balance in patients treated with a medicinal product. METHODS: Following a review of the relevant literature, we developed a conceptual framework consisting of four domains (data, knowledge, behaviour and outcomes) intended for the evaluation of risk minimization measures put into practice in the Danish health-care system...
April 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28392715/positive-predictive-values-of-international-classification-of-diseases-10th-revision-codes-for-dermatologic-events-and-hypersensitivity-leading-to-hospitalization-or-emergency-room-visit-among-women-with-postmenopausal-osteoporosis-in-the-danish-and-swedish
#9
Kasper Adelborg, Lotte Brix Christensen, Troels Munch, Johnny Kahlert, Ylva Trolle Lagerros, Grethe S Tell, Ellen M Apalset, Fei Xue, Vera Ehrenstein
BACKGROUND: Clinical epidemiology research studies, including pharmacoepidemiology and pharmacovigilance studies, use routinely collected health data, such as diagnoses recorded in national health and administrative registries, to assess clinical effectiveness and safety of treatments. We estimated positive predictive values (PPVs) of International Classification of Diseases, 10th revision (ICD-10) codes for primary diagnoses of dermatologic events and hypersensitivity recorded at hospitalization or emergency room visit in the national patient registries of Denmark and Sweden among women with postmenopausal osteoporosis (PMO)...
2017: Clinical Epidemiology
https://www.readbyqxmd.com/read/28389679/erratum-to-changes-in-utilisation-of-antiepileptic-drugs-in-epilepsy-and-non-epilepsy-disorders-a-pharmacoepidemiological-study-and-clinical-implications
#10
Arton Baftiu, Cecilie Johannessen Landmark, Ida Rudberg Rusten, Silje Andrea Feet, Svein I Johannessen, Pål G Larsson
No abstract text is available yet for this article.
April 7, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28381721/regulatory-science-in-practice-pharmaceuticals-and-medical-devices-agency
#11
Taisuke Hojo
 Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28370857/gastrointestinal-toxicity-among-patients-taking-selective-cox-2-inhibitors-or-conventional-nsaids-alone-or-combined-with-proton-pump-inhibitors-a-case-control-study
#12
Mohammad Bakhriansyah, Patrick C Souverein, Anthonius de Boer, Olaf H Klungel
PURPOSE: To assess the risk of gastrointestinal perforation, ulcers, or bleeding (PUB) associated with the use of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) with proton pump inhibitors (PPIs) and selective COX-2 inhibitors, with or without PPIs compared with conventional NSAIDs. METHODS: A case-control study was performed within conventional NSAIDs and/or selective COX-2 inhibitors users identified from the Dutch PHARMO Record Linkage System in the period 1998-2012...
March 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28370746/low-dose-naltrexone-and-opioid-consumption-a-drug-utilization-cohort-study-based-on-data-from-the-norwegian-prescription-database
#13
Guttorm Raknes, Lars Småbrekke
PURPOSE: Low-dose naltrexone (LDN) is used in a wide range of conditions, including chronic pain and fibromyalgia. Because of the opioid antagonism of naltrexone, LDN users are probably often warned against concomitant use with opioids. In this study, based on data from the Norwegian prescription database, we examine changes in opioid consumption after starting LDN therapy. METHODS: We included all Norwegian patients (N = 3775) with at least one recorded LDN prescription in 2013 and at least one dispensed opioid prescription during the 365 days preceding the first LDN prescription...
March 29, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28365198/-how-to-act-when-an-alpha-blocker-is-associated-with-a-potent-inhibitor-of-cyp3a4
#14
N Bensalah, S Garcia, F X Rose, P Bedouch, O Conort, M Juste, R Roubille, B Allenet, M Tod, B Charpiat
OBJECTIVE: Combination of alpha-blockers with potent CYP3A4 inhibitors is either contra-indicated or not recommended. We searched data supporting this classification and guiding prescribers when such an interaction occurs. METHODS: We analyzed reports published by the French agency for drug safety, reference books and performed search in databases of pharmacokinetics studies and case or case series related with these interactions. RESULTS: The classification of the potential severity of these interactions defined by the French agency for drug safety evolved over time...
March 29, 2017: Progrès en Urologie
https://www.readbyqxmd.com/read/28363921/evidence-of-potential-bias-in-a-comparison-of-%C3%AE-blockers-and-calcium-channel-blockers-in-patients-with-chronic-obstructive-pulmonary-disease-and-acute-coronary-syndrome-results-of-a-multinational-study
#15
Yaa-Hui Dong, Matthew Alcusky, Vittorio Maio, Jun Liu, Mengdan Liu, Li-Chiu Wu, Chia-Hsuin Chang, Mei-Shu Lai, Joshua J Gagne
OBJECTIVES: A number of observational studies have reported that, in patients with chronic obstructive pulmonary disease (COPD), β blockers (BBs) decrease risk of mortality and COPD exacerbations. To address important methodological concerns of these studies, we compared the effectiveness and safety of cardioselective BBs versus non-dihydropyridine calcium channel blockers (non-DHP CCBs) in patients with COPD and acute coronary syndromes (ACS) using a propensity score (PS)-matched, active comparator, new user design...
March 31, 2017: BMJ Open
https://www.readbyqxmd.com/read/28348181/trajectories-of-ckd-mbd-biochemical-parameters-over-a-2-year-period-following-diagnosis-of-secondary-hyperparathyroidism-a-pharmacoepidemiological-study
#16
Pierre Filipozzi, Carole Ayav, Willy Ngueyon Sime, Emmanuelle Laurain, Michèle Kessler, Laurent Brunaud, Luc Frimat
OBJECTIVES: To define groups of patients according to the changes of biochemical parameters, that is, serum calcium, phosphate and parathyroid hormone (PTH), over a 2-year follow-up period using group-based multi-trajectory modeling (GBMM) among a cohort of dialysis patients with newly diagnosed secondary hyperparathyroidism (SHPT) (ie, PTH≥500 ng/L for the first time) and to compare their patient characteristics and treatments. DESIGN: Pharmacoepidemiological study...
March 27, 2017: BMJ Open
https://www.readbyqxmd.com/read/28347475/current-trends-in-vasopressor-use-to-the-operating-room-a-pharmacoepidemiologic-study-in-french-teaching-and-military-hospitals
#17
M Bauducel, V Piriou, C Dussart, G Aulagner, X Armoiry
OBJECTIVES: Phenylephrine, ephedrine and norepinephrine are the vasopressors most commonly used in the operating room to treat anaesthesia-induced hypotension. Two new diluted forms of phenylephrine were released in 2011 (500μg/10mL and 500μg/5mL). We initiated a study to evaluate trends in the use of vasopressors in the operating room in French hospitals over the period 2011-2014. METHODS: We conducted a longitudinal, retrospective, observational study between 2011 and 2014 in French teaching and military hospitals...
March 24, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28345151/registries-in-european-post-marketing-surveillance-a-retrospective-analysis-of-centrally-approved-products-2005-2013
#18
Jacoline C Bouvy, Kevin Blake, Jim Slattery, Marie L De Bruin, Peter Arlett, Xavier Kurz
PURPOSE: Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. METHODS: European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation...
March 26, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28332362/signal-detection-of-imipenem-compared-to-other-drugs-from-korea-adverse-event-reporting-system-database
#19
Kyounghoon Park, Mick Soukavong, Jungmee Kim, Kyoung Eun Kwon, Xue Mei Jin, Joongyub Lee, Bo Ram Yang, Byung Joo Park
PURPOSE: To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). MATERIALS AND METHODS: We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem...
May 2017: Yonsei Medical Journal
https://www.readbyqxmd.com/read/28301639/association-of-repeated-intravitreous-bevacizumab-injections-with-risk-for-glaucoma-surgery
#20
Brennan D Eadie, Mahyar Etminan, Bruce C Carleton, David A Maberley, Frederick S Mikelberg
Importance: Intravitreous injections of anti-vascular endothelial growth factor (VEGF) agents are associated with a sustained increase in intraocular pressure. This sustained elevated intraocular pressure could lead to higher rates of glaucoma surgery to lower this pressure. Objective: To determine the risk of glaucoma surgery following repeated intravitreous bevacizumab injections. Design, Setting, Participants: This nested, case-control study acquired and analyzed data from large, population-based, linked health databases supported by the British Columbia Ministry of Health in Canada...
March 16, 2017: JAMA Ophthalmology
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