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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28449404/changes-in-prescribing-and-healthcare-resource-utilization-after-fda-drug-safety-communications-involving-zolpidem-containing-medications
#1
Aaron S Kesselheim, Macarius Donneyong, Gerald J Dal Pan, Esther H Zhou, Jerry Avorn, Sebastian Schneeweiss, John D Seeger
PURPOSE: Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next-morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing-pattern changes between January 2011 and December 2013. METHODS: We assessed overall dispensings of zolpidem-containing products between January 2011 and December 2013 by conducting a time-series analysis...
April 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28449197/safety-profile-of-medication-used-during-pregnancy-results-of-a-multinational-european-study
#2
Johanne N Trønnes, Angela Lupattelli, Hedvig Nordeng
PURPOSE: The present study describes the safety profile of medications used during pregnancy across European countries and examines maternal factors associated with the use of risky medications during pregnancy. METHODS: This study is based on a multinational, web-based study conducted in 15 European countries from October 2011 to February 2012. Information about maternal demographics, illnesses, and medication use during pregnancy was collected via an electronic questionnaire...
April 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28422339/prenatal-exposure-to-%C3%AE-2-adrenoreceptor-agonists-and-the-risk-of-autism-spectrum-disorders-in-offspring
#3
XiuJuan Su, Wei Yuan, JianPing Chen, MaoHua Miao, Jørn Olsen, Lars Henning Pedersen, Hong Liang, Jiong Li
PURPOSE: We aimed to examine the risk of autism spectrum disorders (ASDs) in the offspring who were exposed to maternal use of β2-adrenoreceptor agonist (β2AA) during pregnancy. METHODS: This is a population-based cohort study including all live singleton births in Denmark from 1 January 1997 to 31 December 2008. Children born to mothers who used β2AA during pregnancy were categorized as exposed, and all other children were included in the unexposed group. Cases of ASDs were identified from the Danish Psychiatric Central Register and the Danish Patient Register...
April 19, 2017: Pharmacoepidemiology and Drug Safety
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
#4
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
#5
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
#6
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/28371079/validity-of-major-osteoporotic-fracture-diagnosis-codes-in-the-clinical-data-analysis-and-reporting-system-in-hong-kong
#7
Chor-Wing Sing, Yu-Cho Woo, Alan C H Lee, Joanne K Y Lam, Jody K P Chu, Ian C K Wong, Ching-Lung Cheung
PURPOSE: Large medical record databases facilitate epidemiology research in fracture. However, the validity of fracture in the databases is needed to ensure the reliability of data. We aimed to assess the validity of International Classification of Diseases, 9th Revision (ICD-9) code algorithms for identifying major osteoporotic fracture in the Clinical Data Analysis and Reporting System (CDARS) in Hong Kong. METHODS: The CDARS is a database developed by the Hong Kong Hospital Authority for research purpose...
April 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28370875/adherence-to-disease-modifying-therapies-for-multiple-sclerosis-and-subsequent-hospitalizations
#8
Charity Evans, Ruth Ann Marrie, Feng Zhu, Stella Leung, Xinya Lu, Elaine Kingwell, Yinshan Zhao, Helen Tremlett
PURPOSE: The aim of this study was to examine the association between optimal adherence to first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) and hospitalizations. METHODS: We used population-based administrative data from three Canadian provinces. All individuals receiving DMT (interferon-B-1b, interferon-B-1a, or glatiramer acetate) between January 1, 1996, and December 31, 2011 (British Columbia); March 31, 2012 (Manitoba); or March 31, 2014, (Saskatchewan) were included...
April 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28370905/exposure-to-statins-is-associated-to-fracture-risk-reduction-in-elderly-people-with-cardiovascular-disease-evidence-from-the-aifa-i-grade-observational-project
#9
Federico Rea, Stefano Bonassi, Cristiana Vitale, Gianluca Trifirò, Silvia Cascini, Giuseppe Roberto, Alessandro Chinellato, Ersilia Lucenteforte, Alessandro Mugelli, Giovanni Corrao
PURPOSE: Conflicting findings were observed from clinical trials and observational studies evaluating the association between the use of statins and the risk of fracture. A case-control study nested into a cohort of elderly patients on treatment with statins for cardiovascular secondary prevention was performed on this issue. METHODS: The cohort was formed by 13 875 individuals aged ≥65 years from several Italian health units receiving statins after hospital discharge for cardiovascular outcomes...
March 31, 2017: Pharmacoepidemiology and Drug Safety
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
#10
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/28370652/do-patients-trust-the-fda-a-survey-assessing-how-patients-view-the-generic-drug-approval-process
#11
Aaron S Kesselheim, Joshua J Gagne, Jessica M Franklin, Wesley Eddings, Lisa A Fulchino, Eric G Campbell
PURPOSE: Skepticism about the safety and effectiveness of certain generic drugs remains, particularly related to generic drugs that are approved by the Food and Drug Administration (FDA) using product-specific bioequivalence studies that differ from the standard testing pathway. The current study was designed to assess patient knowledge and perceptions of the generic drug approval process. METHODS: We conducted a survey of patients with 10 different chronic diseases...
March 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28370596/identifying-rare-diseases-using-electronic-medical-records-the-example-of-allergic-bronchopulmonary-aspergillosis
#12
Andrew Maguire, Michelle E Johnson, David W Denning, Germano L C Ferreira, Adrian Cassidy
PURPOSE: The purpose of the study is to evaluate whether primary care electronic medical records (EMRs) from patients with severe asthma can be used to identify allergic bronchopulmonary aspergillosis (ABPA) cases. METHODS: This cross-sectional feasibility study was conducted in adults with active and severe asthma registered with the Clinical Practice Research Datalink. A set of keywords flagged terms potentially indicative of ABPA in free-text comments of patients' EMRs to produce a grid on the basis of keywords' hit or miss...
March 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28370798/differential-use-of-screening-mammography-in-older-women-initiating-metformin-versus-sulfonylurea
#13
Jin-Liern Hong, Louise M Henderson, Michele Jonsson Funk, Jennifer L Lund, John B Buse, Virginia Pate, Til Stürmer
PURPOSE: Differential use of screening mammography may lead to biased detection of breast cancer. This study aimed to compare receipt of screening mammography and the incidence of screen-detected breast cancer between metformin and sulfonylurea initiators. METHODS: We used 2006-2014 US Medicare claims to identify initiators of metformin or sulfonylurea aged 65+ years continuously enrolled in Parts A/B for ≥2 years pre-initiation and ≥2 years post-initiation...
March 29, 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
#14
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/28345306/the-burden-and-management-of-cytochrome-p450-2d6-cyp2d6-mediated-drug-drug-interaction-ddi-co-medication-of-metoprolol-and-paroxetine-or-fluoxetine-in-the-elderly
#15
Muh Akbar Bahar, Eelko Hak, Jens H J Bos, Sander D Borgsteede, Bob Wilffert
PURPOSE: Metoprolol and paroxetine/fluoxetine are inevitably co-prescribed because cardiovascular disorders and depression often coexist in the elderly. This leads to CYP2D6-mediated drug-drug interactions (DDI). Because systematic evaluations are lacking, we assessed the burden of metoprolol-paroxetine/fluoxetine interaction in the elderly and how these interactions are managed in Dutch community pharmacies. METHOD: Dispensing data were collected from the University of Groningen pharmacy database (IADB...
March 26, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28345245/pain-depressive-symptoms-and-medication-in-german-patients-with-rheumatoid-arthritis-results-from-the-linking-patient-reported-outcomes-with-claims-data-for-health-services-research-in-rheumatology-proclair-study
#16
Kathrin Jobski, Andres Luque Ramos, Katinka Albrecht, Falk Hoffmann
PURPOSE: Pain and depressive symptoms are common in patients with rheumatoid arthritis (RA). Information on the prevalence and treatment of both conditions in German RA patients is scarce. METHODS: Using data from a nationwide statutory health insurance fund (BARMER GEK), 6193 RA patients aged 18 to 79 years were provided with a questionnaire covering a variety of items such as demographics, medical condition and quality of life in 2015. Pain caused by the joint disorder (11-point scale) was classified as none existent/mild, moderate or severe...
March 26, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28345151/registries-in-european-post-marketing-surveillance-a-retrospective-analysis-of-centrally-approved-products-2005-2013
#17
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/28337823/interest-of-the-trajectory-method-for-the-evaluation-of-outcomes-after-in-utero-drug-exposure-example-of-anxiolytics-and-hypnotics
#18
Caroline Hurault-Delarue, Cécile Chouquet, Nicolas Savy, Isabelle Lacroix, Anna-Belle Beau, Jean-Louis Montastruc, Christine Damase-Michel
PURPOSE: The aim of this study was to examine the potential benefit to take into account duration and intensity of drug exposure using the recently published method based on individual drug trajectories. This approach was used to define profiles of exposure to anxiolytics/hypnotics during pregnancy and to evaluate the potential effect on newborn health. METHODS: The study was performed in EFEMERIS database (54 918 mother-children pairs). An estimation of adaptation to extrauterine life was assessed using several criteria especially cardio-respiratory symptoms...
March 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28326633/bias-from-depletion-of-susceptibles-the-example-of-hormone-replacement-therapy-and-the-risk-of-venous-thromboembolism
#19
Christel Renoux, Sophie Dell'Aniello, Benjamin Brenner, Samy Suissa
PURPOSE: The data on the association between hormone replacement therapy and the increased risk of venous thromboembolism (VTE) in postmenopausal women are conflicting. The observed differences between oral estrogen and oral estrogen-progestogen combination formulations may be the result of bias from depletion of susceptibles. METHODS: We used United Kingdom's Clinical Practice Research Datalink to identify the cohort of all women aged 50 to 79 during 1987-2008, with all incident cases of VTE occurring during the study period identified...
March 22, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28317314/assessing-disruptions-in-adherence-to-antidepressant-treatments-after-breast-cancer-diagnosis
#20
Yi-Ting Chou, Aaron N Winn, Donald L Rosenstein, Stacie B Dusetzina
PURPOSE: Long-term treatment with antidepressants can lessen the symptoms of depression, but health-related crises-such as a cancer diagnosis-may disrupt ongoing depression care. The study aims to estimate the effect of receiving a breast cancer diagnosis on antidepressant adherence among women with depression. METHODS: Using SEER-Medicare administrative claims, we identified women aged 65+ with newly diagnosed breast cancer between 2008 and 2011, who were diagnosed with depression and used antidepressants during the year before pre-diagnosis year...
March 19, 2017: Pharmacoepidemiology and Drug Safety
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