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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/28649864/the-french-addictovigilance-network-clinical-assessment-z-drugs-true-false-twins
#1
Morgane Rousselet, Fanny Feuillet, Marie Gerardin, Pascale Jolliet, Jean-Benoit Hardouin, Caroline Victorri-Vigneau
INTRODUCTION: In France, an addictovigilance network is responsible for evaluating drug dependence, by drawing on pharmacoepidemiological studies, clinical studies and by assessing healthcare professionals' reports on problematic consumption. METHODS: The aim of this study was to determine whether zolpidem and zopiclone have different dependence profiles, based on healthcare professionals' reports, and to identify various consumer dependence profiles among zolpidem users and among zopiclone users...
June 26, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28623627/clozapine-induced-gastrointestinal-hypomotility-a-22-year-bi-national-pharmacovigilance-study-of-serious-or-fatal-slow-gut-reactions-and-comparison-with-international-drug-safety-advice
#2
Susanna Every-Palmer, Pete M Ellis
INTRODUCTION: Clozapine is the preferred antipsychotic for treatment-resistant schizophrenia, but has significant adverse effects, including gastrointestinal hypomotility or 'slow gut', which may result in severe constipation, ileus, bowel obstruction, and even death. These gastrointestinal effects remain inadequately recognized. METHODS: We reviewed all reports of serious clozapine-induced gastrointestinal hypomotility (CIGH) submitted to the Australian Therapeutic Goods Administration and New Zealand Pharmacovigilance Centre between 1992 and 2013...
June 16, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28608510/agreement-and-validity-of-electronic-health-record-prescribing-data-relative-to-pharmacy-claims-data-a-validation-study-from-a-us-electronic-health-record-database
#3
Christopher G Rowan, James Flory, Tobias Gerhard, John K Cuddeback, Nikita Stempniewicz, James D Lewis, Sean Hennessy
BACKGROUND: Granular clinical and laboratory data available in electronic health record (EHR) databases provide researchers the opportunity to conduct investigations that would not be possible in insurance claims databases; however, for pharmacoepidemiology studies, accurate classification of medication exposure is critical. OBJECTIVE: The aim of this study was to evaluate the validity of classifying medication exposure using EHR prescribing (EHR-Rx) data. METHODS: We conducted a retrospective cohort study among patients with linked claims and EHR data in OptumLabs™ Data Warehouse...
June 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28603009/graphic-report-of-the-results-from-propensity-score-method-analyses
#4
Ian Shrier, Menglan Pang, Robert W Platt
OBJECTIVE: To increase transparency in papers reporting propensity scores by using graphical methods that clearly illustrate 1) the number of participant exclusions that occur as a consequence of the analytic strategy, and 2) whether treatment effects are constant or heterogeneous across propensity scores. STUDY DESIGN AND SETTING: We applied graphical methods to a real-world pharmacoepidemiologic study that evaluated the effect of initiating statin medication on the 1-year all-cause mortality post-myocardial infarction...
June 8, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28597251/occurrence-of-multiple-sclerosis-after-drug-exposure-insights-from-evidence-mapping
#5
Ippazio Cosimo Antonazzo, Emanuel Raschi, Luca Vignatelli, Elisa Baldin, Trond Riise, Roberto D'Alessandro, Fabrizio De Ponti, Elisabetta Poluzzi
INTRODUCTION: The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. OBJECTIVE: The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. METHODS: A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS...
June 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28579364/false-positive-results-in-pharmacoepidemiology-and-pharmacovigilance
#6
Julien Bezin, Pauline Bosco-Levy, Antoine Pariente
False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing...
May 8, 2017: Thérapie
https://www.readbyqxmd.com/read/28578178/frequency-and-correlates-of-anticholinergic-use-among-patients-with-schizophrenia-in-denmark-a-nation-wide-pharmacoepidemiological-study
#7
S G Pristed, C U Correll, J Nielsen
Anticholinergic medications are used to treat extrapyramidal adverse effects induced by antipsychotics. Anticholinergics are associated with adverse effects: constipation, dry mouth and worsening of cognitive function. Anticholinergics have potential for abuse and are not recommended for long term-treatment. We aimed to investigate the use of anticholinergics in patients with schizophrenia. The national health registers in Denmark were used to examine: The prevalence of anticholinergics in 1996-2012 using a cross-sectional design; geographic variations in the prescription of anticholinergics in 2012; correlates of treatment with anticholinergics...
May 23, 2017: Psychiatry Research
https://www.readbyqxmd.com/read/28575313/power-calculator-for-instrumental-variable-analysis-in-pharmacoepidemiology
#8
Venexia M Walker, Neil M Davies, Frank Windmeijer, Stephen Burgess, Richard M Martin
Background: Instrumental variable analysis, for example with physicians' prescribing preferences as an instrument for medications issued in primary care, is an increasingly popular method in the field of pharmacoepidemiology. Existing power calculators for studies using instrumental variable analysis, such as Mendelian randomization power calculators, do not allow for the structure of research questions in this field. This is because the analysis in pharmacoepidemiology will typically have stronger instruments and detect larger causal effects than in other fields...
May 30, 2017: International Journal of Epidemiology
https://www.readbyqxmd.com/read/28574195/pharmacoepidemiology-of-tacrolimus-in-pediatric-liver-transplantation
#9
Natalia Riva, Paula Schaiquevich, Paulo Cáceres Guido, Esteban Halac, Marcelo Dip, Oscar Imventarza
AEs during immunosuppressive treatment with tacrolimus are very common. We retrospectively evaluated FK safety and efficacy in a large pediatric liver transplant cohort in Latin America. During 2-year follow-up, we analyzed data from patients who underwent liver transplantation over the period 2010-2012 and recorded FK exposure, AEs, and AR episodes. AEs were classified according causality and severity. Tacrolimus exposure before and during AE was compared using Wilcoxon matched-pairs test. Kaplan-Meier curves were used for survival analysis...
June 2, 2017: Pediatric Transplantation
https://www.readbyqxmd.com/read/28566573/from-a-viewpoint-of-clinical-settings-pharmacoepidemiology-as-reverse-translational-research-rtr
#10
Junichi Kawakami
 Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28552095/abdominal-aortic-aneurysms-pharmacoepidemiological-studies
#11
Holger Wemmelund
An abdominal aortic aneurysm (AAA) is an enlargement of the abdominal aorta. It is a common disease in the elderly, with a prevalence of 1-5%. An AAA is normally asymptomatic, and the diagnosis is often incidental, identified when a patient is examined for other conditions. The major risk of having an AAA is sudden rupture and death caused by massive hemorrhaging. As rupture risk increases with increasing AAA diameter, the current management strategies include regular imaging surveillance and elective repair before rupture occurs...
May 2017: Danish Medical Journal
https://www.readbyqxmd.com/read/28544284/the-national-healthcare-system-claims-databases-in-france-sniiram-and-egb-powerful-tools-for-pharmacoepidemiology
#12
Julien Bezin, Mai Duong, Régis Lassalle, Cécile Droz, Antoine Pariente, Patrick Blin, Nicholas Moore
The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information of reimbursed claims from all these plans, linked to the national hospital-discharge summaries database system (PMSI) and the national death registry. It now covers 98.8% of the French population, over 66 million persons, from birth (or immigration) to death (or emigration), making it possibly the world's largest continuous homogeneous claims database...
May 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28497594/the-impact-of-regulatory-action-on-the-co-prescribing-of-renin-angiotensin-system-blockers-in-uk-primary-care
#13
Craig Allen, Katherine Donegan
PURPOSE: The aim of this study was to assess the impact of regulatory action taken in June 2014 on the co-prescribing of renin-angiotensin system (RAS) blockers in UK primary care. METHODS: RAS blocker prescriptions, issued between 01/01/2009-30/06/2015, were extracted from the Clinical Practice Research Datalink to estimate the quarterly prevalence (number of patients with at least one co-prescription) and incidence (number of patients first receiving a RAS blocker co-prescription) of co-prescribing...
May 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28495861/testosterone-treatment-and-cardiovascular-and-venous-thromboembolism-risk-what-is-new
#14
G Corona, M Dicuio, G Rastrelli, E Maseroli, F Lotti, A Sforza, M Maggi
In men, testosterone (T) production declines as a function of ageing. Late-onset hypogonadism (LOH) is the most commonly used term to indicate this age-related condition. In LOH, the relative clinical significance and the potential benefit of testosterone treatment (TTh) are still the subject of strong criticisms in the scientific community. The debate is further complicated by the recent position statement of the US Food and Drug Administration (FDA) emphasizing that, in LOH, the benefits and safety of TTh have not been fully established...
May 10, 2017: Journal of Investigative Medicine: the Official Publication of the American Federation for Clinical Research
https://www.readbyqxmd.com/read/28490702/-status-for-self-medication-based-on-bibliometric-study-in-china
#15
Zhuqing Zhong, Zhiying Shen, Siqing Ding, Feng Zheng, Yinglong Duan, Aijing Luo
To figure out problems through analyzing the status for self-medication in China and to provide references for further research.
 Methods: Papers related to self-medication were collected from Chinese journal net database, Wanfang database, VIP database and China biomedical literature database (CBMDisc). A literature metrology analysis was carried out by NoteExpress 2.0 and Excel.
 Results: A total of 161 papers were included in this study, while 33 papers belong to Hubei and Jiangsu Province, accounting for 20...
April 28, 2017: Zhong Nan da Xue Xue Bao. Yi Xue Ban, Journal of Central South University. Medical Sciences
https://www.readbyqxmd.com/read/28490262/methods-for-safety-signal-detection-in-healthcare-databases-a-literature-review
#16
REVIEW
Mickael Arnaud, Bernard Bégaud, Nicolas Thurin, Nicholas Moore, Antoine Pariente, Francesco Salvo
With increasing availability, the use of healthcare databases as complementary data source for drug safety signal detection has been explored to circumvent the limitations inherent in spontaneous reporting. Areas covered: To review the methods proposed for safety signal detection in healthcare databases and their performance. Expert opinion: Fifteen different data mining methods were identified. They are based on disproportionality analysis, traditional pharmacoepidemiological designs (e.g. self-controlled designs), sequence symmetry analysis (SSA), sequential statistical testing, temporal association rules, supervised machine learning (SML), and the tree-based scan statistic...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28489008/-do-opioids-sedatives-and-proton-pump-inhibitors-increase-the-risk-of-fractures
#17
Gudlaug Thorsdottir, Elisabet Benedikz, Sigridur A Thorgeirsdottir, Magnus Johannsson
INTRODUCTION: A pharmacoepidemiological study was conducted to analyse the relationship between bone fracture and the use of certain drugs. MATERIAL/METHODS: The study includes patients 40 years and older, diagnosed with bone fractures in the Emergency Department of Landspitali University Hospital in Reykjavik, Iceland, during a 10-year period (2002-2011). Also were included those who picked up from a pharmacy 90 DDD or more per year of the drugs included in the study in the capital region of Iceland during same period...
May 2017: Læknablađiđ
https://www.readbyqxmd.com/read/28474439/estimating-medication-stopping-fraction-and-real-time-prevalence-of-drug-use-in-pharmaco-epidemiologic-databases-an-application-of-the-reverse-waiting-time-distribution
#18
Henrik Støvring, Anton Pottegård, Jesper Hallas
PURPOSE: To introduce the reverse waiting time distribution (WTD) and show how it can be used to estimate stopping fractions and real-time prevalence of treatment in pharmacoepidemiological studies. METHODS: The reverse WTD is the distribution of time from the last dispensed prescription of each patient within a time window to the end of it. It is a mirrored version of the ordinary WTD, which considers the first dispensed prescription of patients within a time window...
May 4, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28468629/a-methodological-protocol-for-selecting-and-quantifying-low-value-prescribing-practices-in-routinely-collected-data-an-australian-case-study
#19
Jonathan Brett, Adam G Elshaug, R Sacha Bhatia, Kelsey Chalmers, Tim Badgery-Parker, Sallie-Anne Pearson
BACKGROUND: Growing imperatives for safety, quality and responsible resource allocation have prompted renewed efforts to identify and quantify harmful or wasteful (low-value) medical practices such as test ordering, procedures and prescribing. Quantifying these practices at a population level using routinely collected health data allows us to understand the scale of low-value medical practices, measure practice change following specific interventions and prioritise policy decisions. To date, almost all research examining health care through the low-value lens has focused on medical services (tests and procedures) rather than on prescribing...
May 3, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28466973/refining-estimates-of-prescription-durations-by-using-observed-covariates-in-pharmacoepidemiological-databases-an-application-of-the-reverse-waiting-time-distribution
#20
Henrik Støvring, Anton Pottegård, Jesper Hallas
PURPOSE: The study aimed to develop an automated method to estimate prescription durations in pharmacoepidemiological studies that may depend on patient and redemption characteristics. METHODS: We developed an estimation algorithm based on maximum likelihood estimation for the reverse waiting time distribution (WTD), which is the distribution of time from the last prescription of each patient within a time window to the end of the time window. The reverse WTD consists of two distinctly different components: one component for prevalent users and one for patients stopping treatment...
May 3, 2017: Pharmacoepidemiology and Drug Safety
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