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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/29776419/introduction-of-national-guidelines-for-restrictive-blood-transfusion-threshold-for-hip-fracture-patients-a-consecutive-cohort-study-based-on-complete-follow-up-in-national-databases
#1
Bjarke Viberg, Per Hviid Gundtoft, Jesper Schønnemann, Lasse Pedersen, Lis Røhl Andersen, Kjell Titlestad, Carsten Fladmose Madsen, Jens Lauritsen, Søren Overgaard
BACKGROUND: Randomized controlled trials have demonstrated that a restrictive red blood cell (RBC) transfusion strategy lowers transfusion frequency without affecting mortality. However, the external validity of these trials has not been tested in a large cohort. The purpose was to estimate the effect of introducing a National Clinical Guideline (NCG) for a restrictive hemoglobin transfusion threshold on transfusion frequency and mortality in hip fracture patients > 65 years old...
May 18, 2018: Journal of Orthopaedic Surgery and Research
https://www.readbyqxmd.com/read/29755992/the-first-euro-asian-congress-of-pharmacoepidemiology-a-real-instance-for-a-multidisciplinary-approach
#2
EDITORIAL
Ali Mohammad Sabzghabaee
No abstract text is available yet for this article.
January 2018: Journal of Research in Pharmacy Practice
https://www.readbyqxmd.com/read/29750409/implications-of-the-propensity-score-matching-paradox-in-pharmacoepidemiology
#3
John E Ripollone, Krista F Huybrechts, Kenneth J Rothman, Ryan E Ferguson, Jessica M Franklin
Recent work demonstrated that propensity score matching may lead to increased covariate imbalance, even with the corresponding decrease in propensity score distance between matched units. The extent to which this paradoxical phenomenon might harm causal inference in real epidemiologic studies has not been explored. We evaluated the effect of this phenomenon using insurance claims data from the Pharmaceutical Assistance Contract for the Elderly (1999-2002) and Medicaid Analytic eXtract (2000-2007) databases...
May 10, 2018: American Journal of Epidemiology
https://www.readbyqxmd.com/read/29733448/real-world-evidence-what-it-is-and-what-it-can-tell-us-according-to-the-international-society-for-pharmacoepidemiology-ispe-comparative-effectiveness-research-cer-special-interest-group-sig
#4
Hongbo Yuan, M Sanni Ali, Emily S Brouwer, Cynthia J Girman, Jeff J Guo, Jennifer L Lund, Elisabetta Patorno, Jonathan L Slaughter, Xuerong Wen, Dimitri Bennett
On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns...
May 7, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29725942/exploring-the-potential-routine-use-of-electronic-healthcare-record-data-to-strengthen-early-signal-assessment-in-uk-medicines-regulation-proof-of-concept-study
#5
Katherine Donegan, Rebecca Owen, Helena Bird, Brian Burch, Alex Smith, Phil Tregunno
INTRODUCTION: Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform...
May 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29716850/methylphenidate-induced-hepatotoxicity-in-rats-and-its-reduction-by-buspirone
#6
Nausheen Alam, Rahila Ikram
Methylphenidate is commonly use for the treatment of attention deficit hyperactivity disorder (ADHD), but its long term use was found to produce hepatic necrosis in mice. Purpose of this study was to investigate that co-administration of buspirone (drug which attenuates methylphenidate induced sensitization) may attenuate methylphenidate-induced hepatotoxic effects and to determine the effect of challenge dose of haloperidol (D2 antagonist that blocks the effects of methylphenidate in case of intoxication) on SGPT and SGOT levels in methylphenidate treated rats...
May 2018: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29712429/in-silico-pharmacoepidemiologic-evaluation-of-drug-induced-cardiovascular-complications-using-combined-classifiers
#7
Chuipu Cai, Jiansong Fang, Pengfei Guo, Qi Wang, Huixiao Hong, Javid Moslehi, Feixiong Cheng
Drug-induced cardiovascular complications are the most common adverse drug events and account for the withdrawal or severe restrictions on use of multitudinous post-marketed drugs. In this study, we developed new in silico models for systematic identification of drug-induced cardiovascular complications in drug discovery and post-marketing surveillance. Specifically,we collected drug-induced cardiovascular complications covering five most common types of cardiovascular outcomes (hypertension, heart block, arrhythmia, cardiac failure, and myocardial infarction) from four publicly available data resources: Comparative Toxicogenomics Database, SIDER, Offsides, and MetaADEDB...
April 30, 2018: Journal of Chemical Information and Modeling
https://www.readbyqxmd.com/read/29703384/risk-undermined-in-the-bilateral-pharmaceutical-regulatory-system-in-taiwan
#8
REVIEW
Hui-Po Wang, Chun-Li Wang
The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM)...
April 2018: Journal of Food and Drug Analysis
https://www.readbyqxmd.com/read/29694288/predicting-adherence-to-chronic-disease-medications-in-patients-with-long-term-initial-medication-fills-using-indicators-of-clinical-events-and-health-behaviors
#9
Julie C Lauffenburger, Jessica M Franklin, Alexis A Krumme, William H Shrank, Olga S Matlin, Claire M Spettell, Gregory Brill, Niteesh K Choudhry
BACKGROUND: Efforts at predicting long-term adherence to medications have been focused on patients filling typical month-long supplies of medication. However, prediction remains difficult for patients filling longer initial supplies, a practice that is becoming increasingly common as a method to enhance medication adherence. OBJECTIVES: To (a) extend methods involving short-term filling behaviors and (b) develop novel variables to predict adherence in a cohort of patients receiving longer initial prescriptions...
May 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29694286/primary-nonadherence-to-oral-anticoagulants-in-patients-with-atrial-fibrillation-real-world-data-from-a-population-based-cohort
#10
Clara L Rodriguez-Bernal, Salvador Peiró, Isabel Hurtado, Aníbal García-Sempere, Gabriel Sanfélix-Gimeno
BACKGROUND: Primary nonadherence (not filling a first prescription) is an important yet unstudied aspect of adherence to oral anticoagulant (OAC) therapy. OBJECTIVE: To estimate the rates of primary nonadherence to OACs and determine associated factors in real-world practice. METHODS: This population-based retrospective cohort study set in the Valencia region of Spain (about 5 million inhabitants) included all patients with atrial fibrillation who were newly prescribed OACs during 2011-2014 (N = 18,715)...
May 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29667263/assumptions-made-when-preparing-drug-exposure-data-for-analysis-have-an-impact-on-results-an-unreported-step-in-pharmacoepidemiology-studies
#11
Stephen R Pye, Thérèse Sheppard, Rebecca M Joseph, Mark Lunt, Nadyne Girard, Jennifer S Haas, David W Bates, David L Buckeridge, Tjeerd P van Staa, Robyn Tamblyn, William G Dixon
PURPOSE: Real-world data for observational research commonly require formatting and cleaning prior to analysis. Data preparation steps are rarely reported adequately and are likely to vary between research groups. Variation in methodology could potentially affect study outcomes. This study aimed to develop a framework to define and document drug data preparation and to examine the impact of different assumptions on results. METHODS: An algorithm for processing prescription data was developed and tested using data from the Clinical Practice Research Datalink (CPRD)...
April 17, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29665426/human-papillomavirus-vaccine-and-demyelinating-diseases-a-systematic-review-and-meta-analysis
#12
Julie Mouchet, Francesco Salvo, Emanuel Raschi, Elisabetta Poluzzi, Ippazio Cosimo Antonazzo, Fabrizio De Ponti, Bernard Bégaud
Approved in 2006, human papillomavirus (HPV) vaccines were initially targeted for girls aged 9-14 years. Although the safety of these vaccines has been monitored through post-licensure surveillance programmes, cases of neurological events have been reported worldwide. The present study aimed to assess the risk of developing demyelination after HPV immunization by meta-analysing risk estimates from pharmacoepidemiologic studies. A systematic review was conducted in Medline, Embase, ISI Web of Science and the Cochrane Library from inception to 10 May 2017, without language restriction...
April 14, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29649695/doctor-shopping-of-opioid-analgesics-relative-to-benzodiazepines-a-pharmacoepidemiological-study-among-11-7-million-inhabitants-in-the-french-countries
#13
Camille Ponté, Marion Lepelley, Quentin Boucherie, Michel Mallaret, Maryse Lapeyre Mestre, Vincent Pradel, Joëlle Micallef
BACKGROUND: The abuse of prescription opioids and its subsequent consequences is an important public concern particularly in the USA. The literature on opioid analgesic abuse is scarce. OBJECTIVE: We assess the extent and risk of opioid analgesics abuse relative to benzodiazepines (BZD) using the doctor shopping method, taken into account the pharmacological characteristics (dosage, route of administration, extended or immediate release). METHODS: We used SNIIRAM database covering 11...
April 4, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29628219/psychiatrists-and-dentists-knowledge-and-attitudes-regarding-adverse-drug-reactions-of-psychotropic-drugs
#14
Maximilian Gahr, Bernhard J Connemann, Carlos Schönfeldt-Lecuona, Roland W Freudenmann, Jamal M Stein, Anna-Katharina Hawlik
Psychotropic drugs may induce impairments in the mouth, jaw and face area. Currently, appropriate pharmacoepidemiologic data are missing. Therefore, a questionnaire-based telephone survey of two non-representative samples of psychiatrists and dentists was conducted. Most of the psychiatrists (79.7%) and dentists (76.5%) indicated that psychotropic drugs may induce dental adverse drug reactions (ADR); in both samples there was an approximately equally sized, relevant proportion of participants who did not believe in the risk of dental ADR of psychotropic drugs (psychiatrists 20...
March 17, 2018: Psychiatry Research
https://www.readbyqxmd.com/read/29627803/danish-centre-for-strategic-research-in-type-2-diabetes-dd2-project-cohort-of-newly-diagnosed-patients-with-type-2-diabetes-a-cohort-profile
#15
Diana Hedevang Christensen, Sia Kromann Nicolaisen, Klára Berencsi, Henning Beck-Nielsen, Jørgen Rungby, Søren Friborg, Ivan Brandslund, Jens Sandahl Christiansen, Allan Vaag, Henrik Toft Sørensen, Jens Steen Nielsen, Reimar Wernich Thomsen
PURPOSE: The aim of this article is to provide a detailed description of the ongoing nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project cohort and biobank. The DD2 cohort continuously enrols newly diagnosed patients with type 2 diabetes (T2D) throughout Denmark. The overall goal of the DD2 project is to establish a large and data-rich T2D cohort that can serve as a platform for exhaustive T2D research including (1) improved genotypic and phenotypic characterisation of T2D, (2) intervention studies of more individualised T2D treatment, (3) pharmacoepidemiological studies and (4) long-term follow-up studies on predictors of T2D complications and prognosis...
April 7, 2018: BMJ Open
https://www.readbyqxmd.com/read/29621836/a-systematic-review-of-coding-systems-used-in-pharmacoepidemiology-and-database-research
#16
Yong Chen, Marko Zivkovic, Tongtong Wang, Su Su, Jianyi Lee, Edward A Bortnichak
BACKGROUND: Clinical coding systems have been developed to translate real-world healthcare information such as prescriptions, diagnoses and procedures into standardized codes appropriate for use in large healthcare datasets. Due to the lack of information on coding system characteristics and insufficient uniformity in coding practices, there is a growing need for better understanding of coding systems and their use in pharmacoepidemiology and observational real world data research. OBJECTIVES: To determine: 1) the number of available coding systems and their characteristics, 2) which pharmacoepidemiology databases are they adopted in, 3) what outcomes and exposures can be identified from each coding system, and 4) how robust they are with respect to consistency and validity in pharmacoepidemiology and observational database studies...
February 2018: Methods of Information in Medicine
https://www.readbyqxmd.com/read/29621057/controlling-for-frailty-in-pharmacoepidemiologic-studies-of-older-adults-validation-of-an-existing-medicare-claims-based-algorithm
#17
Carmen C Cuthbertson, Anna Kucharska-Newton, Keturah R Faurot, Til Stürmer, Michele Jonsson Funk, Priya Palta, B Gwen Windham, Sydney Thai, Jennifer L Lund
BACKGROUND: Frailty is a geriatric syndrome characterized by weakness and weight loss, and is associated with adverse health outcomes. It is often an unmeasured confounder in pharmacoepidemiologic and comparative effectiveness studies using administrative claims data. METHODS: Among the Atherosclerosis Risk in Communities (ARIC) Study Visit 5 participants (2011-2013; n=3146), we conducted a validation study to compare a Medicare claims-based algorithm of dependency in activities of daily living (or dependency) developed as a proxy for frailty with a reference standard measure of phenotypic frailty...
April 4, 2018: Epidemiology
https://www.readbyqxmd.com/read/29598957/pharmacovigilance-in-pediatrics
#18
Émilie Bouquet, Kristina Star, Annie Pierre Jonville-Béra, Geneviève Durrieu
The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs)...
February 16, 2018: Thérapie
https://www.readbyqxmd.com/read/29588074/use-of-french-healthcare-insurance-databases-in-pediatric-pharmacoepidemiology
#19
Florentia Kaguelidou, Agnes Sommet, Maryse Lapeyre-Mestre
The French healthcare insurance databases have proven to be valuable tools for the conduct of pharmaco-epidemiological studies with regards to the size of the population covered and that of the available information. Their wider use in the field of pediatric pharmacoepidemiology is of paramount importance given the existing gap of knowledge in the use and effects of many drugs in children and adolescents as well as the difficulties to conduct clinical research studies in this age population. However, because of the architectural complexity of these databases and their specificities, specific expertise should be developed in order to ensure the reliability of studies based on these data...
February 16, 2018: Thérapie
https://www.readbyqxmd.com/read/29580613/pharmacoepidemiology-in-pediatrics-needs-challenges-and-future-directions-for-research
#20
Osemeke U Osokogu, Katia Verhamme, Miriam Sturkenboom, Florentia Kaguelidou
Despite international initiatives to promote clinical research in pediatrics, there are still many gaps of knowledge in the use of drugs to treat this specific population. When important information cannot be derived only from clinical trials, use of available observational research tools is required. In this paper, we provide an overview of the particular interest of pharmacoepidemiological research into the evaluation of drug effects in children and adolescents. We also sought to underline the unique challenges and specific needs regarding this research...
February 21, 2018: Thérapie
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