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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/29143393/an-algorithm-to-detect-unexpected-increases-in-frequency-of-reports-of-adverse-events-in-eudravigilance
#1
Luis C Pinheiro, Gianmario Candore, Cosimo Zaccaria, Jim Slattery, Peter Arlett
PURPOSE: The European Medicines Agency developed an algorithm to detect unexpected increases in frequency of reports, to enhance the ability to detect adverse events that manifest as increases in frequency, in particular quality defects, medication errors, and cases of abuse or misuse. METHODS: An algorithm based on a negative binomial time-series regression model run on 6 sequential observations prior to the monitored period was developed to forecast monthly counts of reports...
November 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29141274/use-of-direct-oral-anticoagulants-in-the-first-year-after-market-entry-of-edoxaban-a-danish-nationwide-drug-utilization-study
#2
Anton Pottegård, Erik L Grove, Maja Hellfritzsch
OBJECTIVES: To describe the early uptake of edoxaban; the fourth direct oral anticoagulant (DOAC) to enter the market. METHODS: Using the Danish nationwide health registries, we identified new users of edoxaban (n = 609) from June 6 (day of marketing) through June 2017. For comparison, we also identified new users of dabigatran (n = 2211), rivaroxaban (n = 19 227), and apixaban (n = 14 736). Users were described regarding indication of use, previous anticoagulant experience, comorbidity, and co-medication...
November 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29141273/antidepressant-use-during-pregnancy-and-childhood-cancer-in-the-offspring
#3
Natalie C Momen, Trine Munk-Olsen, Jiong Li, Katja G Ingstrup, Jørn Olsen, Veerle Bergink, Xiaoqin Liu
PURPOSE: Antidepressant use during pregnancy has been increasing in recent years. We evaluated whether in utero exposure to antidepressants increased the risk of childhood cancer. METHODS: This population-based cohort study using national registers in Denmark comprised 915 128 liveborn singletons during 1998-2012. We categorised children into three mutually exclusive exposure groups according to maternal redemption of an antidepressant prescription from 2 years before pregnancy until delivery of the index child: Unexposed (N = 863 033), prior user (use before but not during pregnancy) (N = 30 607), and use during pregnancy (N = 21 488)...
November 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29108136/application-and-optimisation-of-the-comparison-on-extreme-laboratory-tests-cert-algorithm-for-detection-of-adverse-drug-reactions-transferability-across-national-boundaries
#4
Mun Yee Tham, Qing Ye, Pei San Ang, Liza Y Fan, Dukyong Yoon, Rae Woong Park, Zheng Jye Ling, James W Yip, Bee Choo Tai, Stephen Jw Evans, Cynthia Sung
PURPOSE: The Singapore regulatory agency for health products (Health Sciences Authority), in performing active surveillance of medicines and their potential harms, is open to new methods to achieve this goal. Laboratory tests are a potential source of data for this purpose. We have examined the performance of the Comparison on Extreme Laboratory Tests (CERT) algorithm, developed by Ajou University, Korea, as a potential tool for adverse drug reaction detection based on the electronic medical records of the Singapore health care system...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29108130/comparative-risk-of-serious-hypoglycemia-with-oral-antidiabetic-monotherapy-a-retrospective-cohort-study
#5
Charles E Leonard, Xu Han, Colleen M Brensinger, Warren B Bilker, Serena Cardillo, James H Flory, Sean Hennessy
PURPOSE: To examine and compare risks of serious hypoglycemia among antidiabetic monotherapy-treated adults receiving metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione. METHODS: We performed a retrospective cohort study of apparently new users of monotherapy with metformin, glimepiride, glipizide, glyburide, pioglitazone, rosiglitazone, nateglinide, or repaglinide within a dataset of Medicaid beneficiaries from California, Florida, New York, Ohio, and Pennsylvania...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29108128/safety-assessment-of-niacin-in-the-us-food-and-drug-administration-s-mini-sentinel-system
#6
Joshua J Gagne, Monika Houstoun, Marsha E Reichman, Christian Hampp, James H Marshall, Sengwee Toh
PURPOSE: The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial found higher incidence rates of adverse reactions, including bleeding, in patients receiving the combination of extended-release niacin and laropiprant versus placebo. It is not known whether these adverse events are attributable to laropiprant, not approved in the USA, or to extended-release niacin. We compared rates of major gastrointestinal bleeding and intracranial hemorrhage among initiators of extended-release niacin and initiators of fenofibrate...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29108127/multi-dose-drug-dispensing-as-a-tool-to-improve-medication-adherence-a-study-in-patients-using-vitamin-k-antagonists
#7
Nienke van Rein, Kristel S de Geus, Suzanne C Cannegieter, Pieter H Reitsma, Felix J M van der Meer, Willem M Lijfering
PURPOSE: Multi-dose drug dispensing (MDD) is a dosing aid that provides patients with disposable bags containing all drugs intended for 1 dosing moment. MDD is believed to increase medication adherence, but studies are based on self-reported data, and results may depend on socially desirable answers. Therefore, our purpose was to determine the effect of MDD on medication adherence in non-adherent patients taking vitamin K antagonists (VKAs), and to compare with instructing patients on medication use...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29076208/endings-and-beginnings
#8
Brian L Strom
No abstract text is available yet for this article.
October 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29067759/who-benefits-from-fixed-dose-combinations-two-year-statin-adherence-trajectories-in-initiators-of-combined-amlodipine-atorvastatin-therapy
#9
Andrea L Schaffer, Nicholas A Buckley, Sallie-Anne Pearson
PURPOSE: We compared statin adherence in individuals initiating combined amlodipine/atorvastatin therapy as a fixed-dose (FDC) or free combination and identified subgroups benefiting most from FDCs. METHODS: We used a 10% sample of Australian Pharmaceutical Benefits Scheme dispensing data (2005-2015) to identify individuals initiating amlodipine and atorvastatin as an FDC (n = 3996) or free combination (n = 5434), with or without prior statin dispensing. We measured the proportion of days covered in each 30-day period over 24 months and classified patterns of statin adherence using group-based trajectory models...
October 25, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29047196/to-what-extent-do-data-from-pharmaceutical-claims-under-estimate-opioid-analgesic-utilisation-in-australia
#10
Natasa Gisev, Sallie-Anne Pearson, Emily A Karanges, Briony Larance, Nicholas A Buckley, Sarah Larney, Timothy Dobbins, Bianca Blanch, Louisa Degenhardt
PURPOSE: Although pharmaceutical claims are an essential data source for pharmacoepidemiological studies, these data potentially under-estimate opioid utilisation. Therefore, this study aimed to quantify the extent to which pharmaceutical claims from Australia's national medicines subsidy programs (Pharmaceutical Benefits Scheme [PBS] and Repatriation Schedule of Pharmaceutical Benefits [RPBS]) under-estimate prescription-only and total national opioid utilisation across time and for different opioids...
October 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29047193/unlicensed-pharmaceutical-preparations-for-clinical-patient-care-ensuring-safety
#11
REVIEW
Sofieke de Wilde, Maria G H de Jong, Paul P H Le Brun, Henk-Jan Guchelaar, Kirsten J M Schimmel
Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient...
October 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29044735/making-fair-comparisons-in-pregnancy-medication-safety-studies-an-overview-of-advanced-methods-for-confounding-control
#12
REVIEW
Mollie E Wood, Kate L Lapane, Marleen M H J van Gelder, Dheeraj Rai, Hedvig M E Nordeng
Understanding the safety of medication use during pregnancy relies on observational studies: However, confounding in observational studies poses a threat to the validity of estimates obtained from observational data. Newer methods, such as marginal structural models and propensity calibration, have emerged to deal with complex confounding problems, but these methods have seen limited uptake in the pregnancy medication literature. In this article, we provide an overview of newer advanced methods for confounding control and show how these methods are relevant for pregnancy medication safety studies...
October 17, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29027336/trends-in-utilization-of-benzodiazepine-and-z-drugs-in-israel
#13
Erez Berman, Sara Eyal, Eli Marom
BACKGROUND: Studies on benzodiazepine (BZDs) as well as Zopiclone and Zolpidem (Z-drugs) utilization are important for estimating the prevalence of medical conditions, providing the basis for pharmacovigilance, and identifying temporal trends of consumption. Such studies that involve the Israeli population have not been conducted yet. PURPOSE: Identify trends over time in utilization of BZDs and Z-drugs in a nationwide population in Israel. METHODS: Data on BZD and Z-drugs utilization (for all indications) for the period 2005 to 2013 were obtained from pharmaceutical companies that distribute BZDs in Israel...
October 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29027301/challenges-of-post-authorization-safety-studies-lessons-learned-and-results-of-a-french-study-of-fentanyl-buccal-tablet
#14
REVIEW
Natalie Gavrielov-Yusim, Ilda Bidollari, Sigal Kaplan, Netta Bartov
PURPOSE: Recruiting and retaining participants in real-world studies that collect primary data are challenging. This article illustrates these challenges using a post-authorization safety study (PASS) to assess adverse events (AEs) experienced with fentanyl buccal tablet (FBT) over 3 months of treatment. METHODS: This was an observational, prospective, multicenter study in France conducted over 1 year. The study employed primary data collection in FBT-treated patients and their treating physicians via a site qualification questionnaire and patient log completed by physicians and a questionnaire and pain diary completed by patients...
October 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29027300/pattern-of-in-hospital-changes-in-drug-use-in-the-older-people-from-2010-to-2016
#15
C Franchi, I Ardoino, A Nobili, L Pasina, P M Mannucci, A Maregoni, F Perticone
PURPOSE: To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS: People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from 2010 to 2016 were selected. Drugs use were categorized as 0 to 1 drug (very low drug use), 2 to 4 drugs (low drug use), 5 to 9 drugs (polypharmacy), and 10 or more drugs (excessive polypharmacy)...
October 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29024286/modelling-cumulative-exposure-for-inference-about-drug-effects-in-observational-studies
#16
Bassam Farran, Stuart McGurnaghan, Helen C Looker, Shona Livingstone, Eva Lahnsteiner, Helen M Colhoun, Paul M McKeigue
PURPOSE: To demonstrate a modelling approach that controls for time-invariant allocation bias in estimation of associations of outcome with drug exposure. METHODS: We show that in a model that includes terms for both ever-exposure versus never-exposure and cumulative exposure, the parameter for ever-exposure represents the effect of time-invariant allocation bias, and the parameter for cumulative exposure represents the effect of the drug after adjustment for this unmeasured confounding...
October 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29024218/using-probability-of-drug-use-as-independent-variable-in-a-register-based-pharmacoepidemiological-cause-effect-study-an-application-of-the-reverse-waiting-time-distribution
#17
Jesper Hallas, Anton Pottegård, Henrik Støvring
BACKGROUND: In register-based pharmacoepidemiological studies, each day of follow-up is usually categorized either as exposed or unexposed. However, there is an underlying continuous probability of exposure, and by insisting on a dichotomy, researchers unwillingly force a nondifferential misclassification into their analyses. We have recently developed a model whereby probability of exposure can be modeled, and we tested this on an empirical case of nonsteroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal bleeding (UGIB)...
October 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28994158/the-myths-of-medication-adherence
#18
Walid F Gellad, Carolyn T Thorpe, John F Steiner, Corrine I Voils
No abstract text is available yet for this article.
October 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28984052/patterns-of-long-term-use-of-non-vitamin-k-antagonist-oral-anticoagulants-for-non-valvular-atrial-fibrillation-quebec-observational-study
#19
Antonios Douros, Christel Renoux, Janie Coulombe, Samy Suissa
PURPOSE: Studies on long-term utilization of non-vitamin K antagonist oral anticoagulants (NOACs) in non-valvular atrial fibrillation (NVAF) are scarce. We evaluated predictors of use and long-term persistence of NOACs in a real-world setting. METHODS: This population-based cohort study used the computerized databases of the Canadian Province of Quebec's health insurance. Patients with a first NVAF diagnosis from 2011 until 2014 were included. A logistic regression model yielded adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for predictors of treatment initiation with NOACs versus VKAs...
October 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28984050/comparison-of-the-ability-of-double-robust-estimators-to-correct-bias-in-propensity-score-matching-analysis-a-monte-carlo-simulation-study
#20
Tri-Long Nguyen, Gary S Collins, Jessica Spence, Philip J Devereaux, Jean-Pierre Daurès, Paul Landais, Yannick Le Manach
OBJECTIVE: As covariates are not always adequately balanced after propensity score matching and double- adjustment can be used to remove residual confounding, we compared the performance of several double-robust estimators in different scenarios. METHODS: We conducted a series of Monte Carlo simulations on virtual observational studies. After estimating the propensity scores by logistic regression, we performed 1:1 optimal, nearest-neighbor, and caliper matching...
October 6, 2017: Pharmacoepidemiology and Drug Safety
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