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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/28811926/postinjection-delirium-sedation-syndrome-in-patients-with-schizophrenia-receiving-olanzapine-long-acting-injection-results-from-a-large-observational-study
#1
Kristin J Meyers, Himanshu P Upadhyaya, John L Landry, Rashna Chhabra-Khanna, Deborah M Falk, Balasubramanya Seetharama Rao, Meghan E Jones
BACKGROUND: Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. AIMS: The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline...
July 2017: BJPsych Open
https://www.readbyqxmd.com/read/28792563/-initiating-an-antipsychotic-drug-treatment-for-schizophrenia-the-situation-in-quebec-canada-from-1998-to-2006
#2
Jean-Daniel Carrier, Lucie Blais, Alan Cohen, Josiane Courteau, Pasquale Roberge, Annie Larouche, Sylvain Grignon, Marie-Josée Fleury, Alain Lesage, Marie-France Demers, Marc-André Roy, André Delorme, Alain Vanasse
Objectives To describe factors associated with the following characteristics of the first prescription of an antipsychotic drug treatment (ADT): 1) prescribing physician type (psychiatrist vs. general practitioner); 2) second-generation vs. first-generation antipsychotic drug; 3) in conjunction with at least one additional antipsychotic drug (multitherapy); 4) never renewed by the patient.Methods This is a pharmacoepidemiologic study using administrative data from the Régie de l'assurance maladie du Québec (RAMQ), the public healthcare insurer in Quebec, Canada...
2017: Santé Mentale Au Québec
https://www.readbyqxmd.com/read/28777918/the-importance-of-pharmacoepidemiology-in-pregnancy-implications-for-safety
#3
Justine Benevent, Francois Montastruc, Christine Damase-Michel
Prescription of medications to pregnant women is usually a challenge as the drug benefit has to be considered regarding its potential adverse effects. As medication use is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiologic studies. Area covered: Data sources are numerous. Some of them have been created for the particular purpose of assessing medications during pregnancy. Augmented databases enable the study of delayed effects in late childhood and provide information on potential confounders...
August 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28766108/a-pharmacoepidemiology-database-system-for-monitoring-risk-due-to-the-use-of-medicines-by-new-zealand-primary-care-patients
#4
Andrew M Tomlin, David M Reith, David J Woods, Hywel S Lloyd, Alesha Smith, John S Fountain, Murray W Tilyard
INTRODUCTION: The use of large record-linked healthcare databases for drug safety research and surveillance is now accepted practice. New Zealand's standardized national healthcare datasets provide the potential to automate the conduct of pharmacoepidemiological studies to provide rapid validation of medicine safety signals. OBJECTIVES: Our objectives were to describe the methodology undertaken by a semi-automated computer system developed to rapidly assess risk due to drug exposure in New Zealand's population of primary care patients and to compare results from three studies with previously published findings...
August 1, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28765823/past-present-and-future-of-pharmacovigilance-in-korea
#5
REVIEW
Dong Yoon Kang, Kyung-Min Ahn, Hye-Ryun Kang, Sang-Heon Cho
As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status...
July 2017: Asia Pacific Allergy
https://www.readbyqxmd.com/read/28761650/pioglitazone-and-risk-of-mortality-in-patients-with-type-2-diabetes-results-from-a-european-multidatabase-cohort-study
#6
Helen Strongman, Pasi Korhonen, Rachael Williams, Shahram Bahmanyar, Fabian Hoti, Solomon Christopher, Maila Majak, Leanne Kool-Houweling, Marie Linder, Paul Dolin, Edith M Heintjes
OBJECTIVES: Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. DESIGN: Retrospective cohort study. SETTING: Pooled analysis of clinical data collected from primary and/or secondary care settings in four European countries: Finland, The Netherlands, Sweden and the UK . PARTICIPANTS: 56 337 patients with type 2 diabetes mellitus first prescribed pioglitazone between 2000 and 2011, and 56 337 patients never prescribed pioglitazone matched by treatment stage, history of diabetes, diabetes complications and cardiovascular disease, and year of cohort entry using exact and propensity score matching...
2017: BMJ Open Diabetes Research & Care
https://www.readbyqxmd.com/read/28755801/international-trends-in-antipsychotic-use-a-study-in-16-countries-2005-2014
#7
Óskar Hálfdánarson, Helga Zoëga, Lise Aagaard, Miquel Bernardo, Lena Brandt, Anna Coma Fusté, Kari Furu, Kristina Garuoliené, Falk Hoffmann, Krista F Huybrechts, Luuk J Kalverdijk, Koji Kawakami, Helle Kieler, Takuya Kinoshita, Melisa Litchfield, Soffy C López, Jorge E Machado-Alba, Manuel E Machado-Duque, Mufaddal Mahesri, Prasad S Nishtala, Sallie-Anne Pearson, Johan Reutfors, Leena K Saastamoinen, Izumi Sato, Catharina C M Schuiling-Veninga, Yu-Chiau Shyu, Svetlana Skurtveit, Hélène Verdoux, Liang-Jen Wang, Corinne Zara Yahni, Christian J Bachmann
The objective of this study was to assess international trends in antipsychotic use, using a standardised methodology. A repeated cross-sectional design was applied to data extracts from the years 2005 to 2014 from 16 countries worldwide. During the study period, the overall prevalence of antipsychotic use increased in 10 of the 16 studied countries. In 2014, the overall prevalence of antipsychotic use was highest in Taiwan (78.2/1000 persons), and lowest in Colombia (3.2/1000). In children and adolescents (0-19 years), antipsychotic use ranged from 0...
July 27, 2017: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28748718/diabetes-drugs-and-the-incidence-of-solid-cancers-a-survey-of-the-current-evidence
#8
Marco Tuccori, Irma Convertino, Maria Teresa Galiulo, Alessandra Marino, Alice Capogrosso-Sansone, Corrado Blandizzi
The evaluation of the relationship between the use of antidiabetic drug and the occurrence of cancer is extremely challenging, both from the clinical and pharmacoepidemiological standpoint. This narrative review described the current evidence supporting a relationship between the use of antidiabetic drugs and the incidence of solid cancers. Areas Covered: Data from pharmacoepidemiological studies on cancer incidence were presented for the main antidiabetic drugs and drug classes, including human insulin and insulin analogues, metformin, sulfonylureas, glinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin mimetics, and sodium glucose co-transporter 2 inhibitors...
July 27, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28713660/a-cross-sectional-pharmacoepidemiological-study-of-the-utilization-pattern-of-pre-anesthetic-medications-in-major-surgical-procedures-in-a-tertiary-care-hospital
#9
Madhuri Kulkarni, Anant Patil
OBJECTIVE : A study of the utilization pattern of pre-anesthetic medications in major surgical procedures. MATERIAL AND METHODS : A cross-sectional, pharmacoepidemiological study was conducted among patients undergoing surgical procedures in routine or emergency conditions under general anesthesia. The utilization of pre-anesthetic medicines in all patients was reported. RESULTS: A total of 110 patients (mean age - 42.36 years; 57.27% males) were enrolled...
June 13, 2017: Curēus
https://www.readbyqxmd.com/read/28698923/sequence-symmetry-analysis-in-pharmacovigilance-and-pharmacoepidemiologic-studies
#10
REVIEW
Edward Chia-Cheng Lai, Nicole Pratt, Cheng-Yang Hsieh, Swu-Jane Lin, Anton Pottegård, Elizabeth E Roughead, Yea-Huei Kao Yang, Jesper Hallas
Sequence symmetry analysis (SSA) is a method for detecting adverse drug events by utilizing computerized claims data. The method has been increasingly used to investigate safety concerns of medications and as a pharmacovigilance tool to identify unsuspected side effects. Validation studies have indicated that SSA has moderate sensitivity and high specificity and has robust performance. In this review we present the conceptual framework of SSA and discuss advantages and potential pitfalls of the method in practice...
July 11, 2017: European Journal of Epidemiology
https://www.readbyqxmd.com/read/28676983/non-steroidal-anti-inflammatory-drug-use-and-the-risk-of-acute-myocardial-infarction-in-the-general-german-population-a-nested-case-control-study
#11
Kathrin Thöne, Bianca Kollhorst, Tania Schink
INTRODUCTION: Use of non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with an increased relative risk of acute myocardial infarction (AMI), but the label warnings refer particularly to patients with cardiovascular risk factors. The magnitude of relative AMI risk for patients with and without cardiovascular risk factors varies between studies depending on the drugs and doses studied. OBJECTIVES: The aim of our study was to estimate population-based relative AMI risks for individual and widely used NSAIDs, for a cumulative amount of NSAID use, and for patients with and without a prior history of cardiovascular risk factors...
July 4, 2017: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/28667742/gingival-bleeding-a-possible-serious-adverse-drug-reaction-an-observational-study-in-the-french-pharmacovigilance-database
#12
Emmanuelle Bondon-Guitton, Thibaut Mourgues, Vanessa Rousseau, Sarah Cousty, Judith Cottin, Guillaume Drablier, Joëlle Micallef, Jean-Louis Montastruc
INTRODUCTION: Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. AIM: We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. MATERIAL AND METHODS: We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database...
July 1, 2017: Journal of Clinical Periodontology
https://www.readbyqxmd.com/read/28653488/drugs-for-rare-disorders
#13
EDITORIAL
Serge Cremers, Jeffrey K Aronson
Estimates of the frequencies of rare disorders vary from country to country; the global average defined prevalence is 40 per 100 000 (0.04%). Some occur in only one or a few patients. However, collectively rare disorders are fairly common, affecting 6-8% of the US population, or about 30 million people, and a similar number in the European Union. Most of them affect children and most are genetically determined. Diagnosis can be difficult, partly because of variable presentations and partly because few clinicians have experience of individual rare disorders, although they may be assisted by searching databases...
August 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28649864/the-french-addictovigilance-network-clinical-assessment-z-drugs-true-false-twins
#14
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 28, 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
#15
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...
August 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
#16
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...
August 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28603009/graphic-report-of-the-results-from-propensity-score-method-analyses
#17
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
#18
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
#19
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
#20
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...
September 2017: Psychiatry Research
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