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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28101968/defined-daily-doses-ddd-do-not-accurately-reflect-opioid-doses-used-in-contemporary-chronic-pain-treatment
#1
Suzanne Nielsen, Natasa Gisev, Raimondo Bruno, Wayne Hall, Milton Cohen, Briony Larance, Gabrielle Campbell, Marian Shanahan, Fiona Blyth, Nicholas Lintzeris, Sallie Pearson, Richard Mattick, Louisa Degenhardt
OBJECTIVE: To assess how well the defined daily dose (DDD) metric reflects opioid utilisation among chronic non-cancer pain patients. DESIGN: Descriptive, cross-sectional study, utilising a 7-day medication diary. SETTING: Community-based treatment settings, Australia. SUBJECTS: A sample of 1101 people prescribed opioids for chronic non-cancer pain. METHODS: Opioid dose data was collected via a self-completed 7-day medication diary capturing names, strengths and doses of each medication taken in the past week...
January 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28097730/exposure-to-reactive-intermediate-inducing-drugs-during-pregnancy-and-the-incident-use-of-psychotropic-medications-among-children
#2
Yen-Hao Tran, Henk Groen, Jorieke E H Bergman, Eelko Hak, Bob Wilffert
PURPOSE: Our study aimed to investigate the association between prenatal exposure to reactive intermediate (RI)-inducing drugs and the initiation of psychotropic medications among children. METHODS: We designed a cohort study using a pharmacy prescription database. Pregnant women were considered exposed when they received a prescription of RI-inducing drugs. These drugs could be either used alone (RI+/FAA-) or combined with drugs exhibiting folic acid antagonism (FAA, RI+/FAA+)...
January 18, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28083980/increased-availability-of-paracetamol-in-sweden-and-incidence-of-paracetamol-poisoning-using-laboratory-data-to-increase-validity-of-a-population-based-registry-study
#3
Rolf Gedeborg, Bodil Svennblad, Lennart Holm, Hans Sjögren, Carola Bardage, Mark Personne, Gunilla Sjöberg, Nils Feltelius, Björn Zethelius
PURPOSE: To estimate the incidence trend and outcome of paracetamol poisoning, in relation to increased availability of paracetamol from non-pharmacy outlets in 2009. METHOD: Patients' serum paracetamol results over 14 years (2000-2013) from 20 (out of 21) regions in Sweden were linked to national registers of hospital care, cause of death, and prescriptions. Paracetamol poisonings were defined by serum paracetamol levels, hospital diagnoses, or cause of death...
January 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28083936/adhd-medications-and-cardiovascular-adverse-events-in-children-and-adolescents-cross-national-comparison-of-risk-communication-in-drug-labeling
#4
Jan Sieluk, Brittany Palasik, Susan dosReis, Peter Doshi
PURPOSE: Regulators approve written medical information for healthcare professionals and consumers, but the consistency of these sources has not been studied. We investigated the consistency of information regarding four cardiovascular risks of attention-deficit/hyperactivity disorder (ADHD) medications approved in four countries. METHODS: Professional and consumer product labeling for five ADHD medications approved in Australia, Canada, the UK, and the USA were obtained in March/April 2016...
January 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28083935/propacetamol-poses-a-potential-harm-of-adverse-hypotension-in-male-and-older-patients
#5
Hyun-Young Lee, Ga-Young Ban, Chang-Gyu Jeong, Ji-Ho Lee, Seung-Hee Park, Sang-Hee Kim, Young-Hee Lee, Young-Min Ye
PURPOSE: Researchers recently suggested intravenous paracetamol as a potential cause of hypotension. We aimed to investigate risk factors of paracetamol- and propacetamol-associated adverse drug reactions (ADRs) in Korean individuals. METHODS: All adverse hypotension cases, regardless of suspected drug, and all ADRs associated with paracetamol and propacetamol use were collected from the Korea Adverse Event Reporting System database between 2011 and 2014. The seriousness, causality, and type of ADR were classified...
January 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28083886/incidence-and-risk-estimate-of-drug-induced-agranulocytosis-in-hong-kong-chinese-a-population-based-case-control-study
#6
Chor-Wing Sing, Ian C K Wong, Bernard M Y Cheung, Johnny C Y Chan, Jody K P Chu, Ching-Lung Cheung
PURPOSE: Drug-induced agranulocytosis is a rare but life-threatening adverse drug reaction. Its epidemiology in Chinese is largely unknown. This study aimed to estimate the incidence, mortality, and risk of the drugs associated with agranulocytosis in Hong Kong Chinese. METHODS: A population-based case-control study was conducted using the Clinical Data Analysis and Reporting System, a database managed by the Hong Kong Hospital Authority. Patients with drug-induced agranulocytosis from 1 January 2004 to 31 December 2013 were identified...
January 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28074520/assessing-the-accuracy-of-opioid-overdose-and-poisoning-codes-in-diagnostic-information-from-electronic-health-records-claims-data-and-death-records
#7
Carla A Green, Nancy A Perrin, Shannon L Janoff, Cynthia I Campbell, Howard D Chilcoat, Paul M Coplan
PURPOSE: The purpose of this study is to assess positive predictive value (PPV), relative to medical chart review, of International Classification of Diseases (ICD)-9/10 diagnostic codes for identifying opioid overdoses and poisonings. METHODS: Data were obtained from Kaiser Permanente Northwest and Northern California. Diagnostic data from electronic health records, submitted claims, and state death records from Oregon, Washington, and California were linked. Individual opioid-related poisoning codes (e...
January 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28071845/influence-of-age-sex-and-seriousness-on-reporting-of-adverse-drug-reactions-in-sweden
#8
Lennart Holm, Elisabet Ekman, Kerstin Jorsäter Blomgren
PURPOSE: To investigate how reporting of adverse drug reactions (ADRs) among adults in Sweden is associated to age and sex, in addition to seriousness of the reaction and drug utilisation. METHODS: Individual case safety reports (ICSRs) reported by healthcare professionals to the national pharmacovigilance database 2008-2011 were related to defined daily dose (DDD) in the Swedish Prescribed Drug Register (SPDR) for individual's ≥20 years. Data were stratified into five age groups...
January 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28067454/concomitant-use-of-calcium-channel-blockers-with-dual-antiplatelet-therapy-and-re-hospitalization-for-acute-coronary-syndrome
#9
Chen-Yu Wang, Zhen-Fang Lin, Chii-Ming Lee, Yi-Wen Tsai, Ting-Ying Huang, Li-Jiuan Shen, Fei-Yuan Hsiao
BACKGROUND: Existing studies suggested that concomitant use of calcium channel blockers (CCBs) may interfere with the antiplatelet effect of clopidogrel. The objective of this study was to examine the effect of concomitant use of CCBs and clopidogrel on risks of acute coronary syndrome (ACS) re-hospitalization in patients receiving percutaneous coronary intervention. METHODS: Using the Taiwan National Health Insurance Research Database, we identified 51 925 patients who were admitted for newly diagnosed ACS, received percutaneous coronary intervention, and used clopidogrel within 1 year after discharge...
January 9, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28067434/pioglitazone-and-bladder-cancer-fda-s-assessment
#10
Christian Hampp, Jennifer Pippins
No abstract text is available yet for this article.
January 9, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28054412/identifying-birth-defects-in-automated-data-sources-in-the-vaccine-safety-datalink
#11
Elyse Olshen Kharbanda, Gabriela Vazquez-Benitez, Paul A Romitti, Allison L Naleway, T Craig Cheetham, Heather S Lipkind, Shanthi Sivanandam, Nicola P Klein, Grace M Lee, Michael L Jackson, Simon J Hambidge, Avalow Olsen, Natalie McCarthy, Frank DeStefano, James D Nordin
PURPOSE: The Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations, aims to monitor safety of vaccines administered in the USA. We present definitions and prevalence estimates for major structural birth defects to be used in studies of maternal vaccine safety. METHODS: In this observational study, we created and refined algorithms for identifying major structural birth defects from electronic healthcare data, conducted formal chart reviews for severe cardiac defects, and conducted limited chart validation for other defects...
January 4, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28052554/antiepileptic-drugs-and-risk-of-suicide-attempts-a-case-control-study-exploring-the-impact-of-underlying-medical-conditions
#12
Lamiae Grimaldi-Bensouda, Clementine Nordon, Michel Rossignol, Vincent Jardon, Virginie Boss, Frédérique Warembourg, Robert Reynolds, Xavier Kurz, Frédéric Rouillon, Lucien Abenhaim
PURPOSE: Randomized-controlled trials and claims databases suggest that antiepileptic drug (AED) use may increase the risk of suicide attempts (SA). The present case-control study explores the impact of underlying indications on this potential association. METHODS: Physicians collected the medical history; prior 12-month drug use was obtained from standardized telephone interviews with patients. The association between AED use and SA was explored using multivariate conditional logistic regression...
January 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28052483/natural-language-processing-to-ascertain-two-key-variables-from-operative-reports-in-ophthalmology
#13
Liyan Liu, Neal H Shorstein, Laura B Amsden, Lisa J Herrinton
PURPOSE: Antibiotic prophylaxis is critical to ophthalmology and other surgical specialties. We performed natural language processing (NLP) of 743 838 operative notes recorded for 315 246 surgeries to ascertain two variables needed to study the comparative effectiveness of antibiotic prophylaxis in cataract surgery. The first key variable was an exposure variable, intracameral antibiotic injection. The second was an intraoperative complication, posterior capsular rupture (PCR), which functioned as a potential confounder...
January 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28028867/the-clinical-status-and-economic-savings-associated-with-remission-among-patients-with-rheumatoid-arthritis-leveraging-linked-registry-and-claims-data-for-synergistic-insights
#14
Jeffrey R Curtis, Lang Chen, Jeffrey D Greenberg, Leslie Harrold, Meredith L Kilgore, Joel M Kremer, Daniel H Solomon, Huifeng Yun
INTRODUCTION: Treat to target guidelines recommend achieving remission or low disease activity in rheumatoid arthritis (RA). However, the reduction in adverse events and costs associated with lower disease activity is unclear. METHODS: We used Corrona linked to Medicare data to identify RA patients. Time varying disease activity was measured using Clinical Disease Activity Index (CDAI); outcomes included all-cause hospitalization, a composite of hospitalization or emergency department (ED) visits, mortality, and medical costs...
December 28, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28028914/a-systematic-review-of-pregnancy-exposure-registries-examination-of-protocol-specified-pregnancy-outcomes-target-sample-size-and-comparator-selection
#15
Kate Gelperin, Hoda Hammad, Kira Leishear, Steven T Bird, Lockwood Taylor, Christian Hampp, Leyla Sahin
PURPOSE: Our study sought to systematically evaluate protocol-specified study methodology in prospective pregnancy exposure registries including pre-specified pregnancy outcomes, power calculations for sample size, and comparator group selection. METHODS: U.S. pregnancy exposure registries designed to evaluate safety of drugs or biologics were identified from www.clinicaltrials.gov, the FDA's Office of Women's Health website, and the FDA's list of postmarketing studies...
December 27, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28000298/the-feasibility-of-using-multiple-databases-to-study-rare-outcomes-the-potential-effect-of-long-acting-beta-agonists-with-inhaled-corticosteroid-therapy-on-asthma-mortality
#16
Catherine B Johannes, Lisa J McQuay, Kirk D Midkiff, Brian Calingaert, Elizabeth B Andrews, Patricia Tennis, Jeffrey S Brown, Carlos A Camargo, Rachael L DiSantostefano, Kenneth J Rothman, Til Stürmer, Stephan Lanes, Kourtney J Davis
PURPOSE: Long-acting beta agonists (LABAs) when used without concomitant inhaled corticosteroids (ICS) increase the risk of asthma-related deaths, but the effect on asthma-related death of LABA used in combination with ICS therapy is unknown. To address this question, we explored the feasibility of conducting an observational study using multiple US health care data sources. METHODS: Retrospective cohort study to evaluate the likelihood of getting an upper 95% confidence limit ≤1...
December 21, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28000295/drug-availability-adjustments-in-population-based-studies-of-prescription-opioid-abuse
#17
Alex Secora, James Phillip Trinidad, Rongmei Zhang, Rajdeep Gill, Gerald Dal Pan
PURPOSE: Population-based prescription opioid abuse studies in which one drug is compared to another, or drugs are compared across time, often account for the availability of those drugs in the community. The objective of this investigation is to assess consistency in the relative abuse ratios (RARs) across different approaches for adjusting for drug availability. METHODS: For the years 2004 through 2010, RARs for each of four prescription opioids (hydrocodone, oxycodone, hydromorphone, and morphine) were calculated using negative binomial regression...
December 21, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27935151/patient-related-characteristics-associated-with-non-persistence-with-statin-therapy-in-elderly-patients-following-an-ischemic-stroke
#18
Martin Wawruch, Dusan Zatko, Gejza Wimmer, Jan Luha, Vasil Hricak, Jan Murin, Peter Kukumberg, Tomas Tesar, Adam Hloska, Rashmi Shah
PURPOSE: This study was aimed at evaluating the extent of non-persistence with statin therapy in elderly patients after an ischemic stroke and identifying patient-related characteristics that are risk factors for non-persistence. METHODS: The evaluable study cohort (n = 2748) was derived from the database of the largest health insurance provider in the Slovak Republic. Patients aged ≥65 years who were initiated on statin therapy following the diagnosis of an ischemic stroke during one full year (1 January 2010 to 31 December 2010) constituted this cohort...
December 9, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27935150/trends-in-potentially-inappropriate-medication-prescribing-to-nursing-home-patients-comparison-of-three-cross-sectional-studies
#19
Kjell H Halvorsen, Geir Selbaek, Sabine Ruths
PURPOSE: The aim of this study was to examine trends in potentially inappropriate medication (PIM) prescribing in Norwegian nursing homes. METHODS: Patients aged ≥70 years were included from three cross-sectional studies conducted in 1997, 2005 and 2011. PIMs were analyzed according to the Norwegian General Practice-Nursing Home criteria (NORGEP-NH), use of single substances to avoid, combinations to avoid, and deprescribing items. Associations between sample and use of PIMs were examined by logistic regression, adjusted for age, gender, and ward...
December 9, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27921360/mortality-in-patients-who-discontinue-low-dose-acetylsalicylic-acid-therapy-after-upper-gastrointestinal-bleeding
#20
Antonio González-Pérez, María Eugenia Sáez, Saga Johansson, Péter Nagy, Luis A García Rodríguez
PURPOSE: Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS: ASA users at the time of UGIB and who were alive 30 days after were selected using The Health Improvement Network. Predictors of survival were assessed using adjusted Cox proportional hazards regression models...
December 6, 2016: Pharmacoepidemiology and Drug Safety
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