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Pharmacoepidemiology and Drug Safety

Fenglong Xie, Lisandro D Colantonio, Jeffrey R Curtis, Meredith L Kilgore, Emily B Levitan, Keri L Monda, Monika M Safford, Ben Taylor, Mark Woodward, Paul Muntner
BACKGROUND: Cause of death is often not available in administrative claims data. OBJECTIVE: To develop claims-based algorithms to identify deaths due to fatal cardiovascular disease (CVD; ie, fatal coronary heart disease [CHD] or stroke), CHD, and stroke. METHODS: Reasons for Geographic and Racial Differences in Stroke (REGARDS) study data were linked with Medicare claims to develop the algorithms. Events adjudicated by REGARDS study investigators were used as the gold standard...
March 14, 2018: Pharmacoepidemiology and Drug Safety
Michael James Zoorob
BACKGROUND: Although polydrug incidents comprise a substantial proportion of overdose deaths, scholarly and popular focus has centered on prescription opiates. This study examines the role of benzodiazepine and opioid prescriptions on overdose-both individually and synergistically-using data from Medicare Part D, a source of prescription drug claims for about 35 million Americans. METHODS: Prescribing data from the Medicare Part D Public Use Files for 2013, 2014, and 2015 (approximately 3...
March 14, 2018: Pharmacoepidemiology and Drug Safety
Ryan M Carnahan, Jennifer L Kuntz, Shirley V Wang, Candace Fuller, Joshua J Gagne, Charles E Leonard, Sean Hennessy, Tamra Meyer, Patrick Archdeacon, Chih-Ying Chen, Catherine A Panozzo, Sengwee Toh, Hannah Katcoff, Tiffany Woodworth, Aarthi Iyer, Sophia Axtman, Elizabeth A Chrischilles
PURPOSE: The Food and Drug Administration's Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non-user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users...
March 13, 2018: Pharmacoepidemiology and Drug Safety
Onyekachukwu A Illoh, Sengwee Toh, Susan E Andrade, Christian Hampp, Leyla Sahin, Kate Gelperin, Lockwood Taylor, Steven T Bird
PURPOSE: To describe the utilization of drugs with pregnancy exposure registries by trimester during pregnancy, in comparison with matched nonpregnant episodes and a pre-pregnancy period. METHODS: We identified live-born deliveries from women aged 10 to 54 years and matched the pregnancies 1:1 with nonpregnant episodes from a comparator cohort not delivering live-born infants, using data from 2001 to 2013 in the Sentinel Distributed Database. We evaluated the utilization of 34 drugs with pregnancy exposure registries, comparing utilization during pregnancy to the matched nonpregnant episodes, and to the 90 days before pregnancy...
March 8, 2018: Pharmacoepidemiology and Drug Safety
Wei Liu, Patrick J Antonelli, Philipp Dahm, Tobias Gerhard, Joseph A C Delaney, Richard Segal, Stephen Crystal, Almut G Winterstein
PURPOSE: The objective of the study was to determine the risk of sudden sensorineural hearing loss (SNHL) associated with use of phosphodiesterase type 5 (PDE5) inhibitors. METHODS: We conducted a retrospective cohort study in the MarketScan Commercial Claims and Encounters Database including adult men who initiated a PDE5 inhibitor (n = 377,722) and 1,957,233 nonusers between 1998 and 2007. Periods of drug exposure were assessed on a weekly basis based on pharmacy billing records, assuming use of 1 dose per week (current use)...
March 7, 2018: Pharmacoepidemiology and Drug Safety
David Martin, Joshua J Gagne, Susan Gruber, Rima Izem, Jennifer C Nelson, Michael D Nguyen, Rita Ouellet-Hellstrom, Sebastian Schneeweiss, Sengwee Toh, Alexander M Walker
No abstract text is available yet for this article.
March 5, 2018: Pharmacoepidemiology and Drug Safety
Jonathan Brett, Andrea Schaffer, Timothy Dobbins, Nicholas A Buckley, Sallie-Anne Pearson
PURPOSE: To evaluate the impact of 2 policy changes on quetiapine dispensing in Australia: removal of prior authorisation for prescribing (policy 1: July 2007) and removal of repeat prescriptions for 25-mg quetiapine (policy 2: January 2014). METHODS: We performed an interrupted time series analysis using Pharmaceutical Benefits Scheme claims data (July 2005 to December 2015). We assessed the impact of both policies on monthly quetiapine dispensing (25 mg and >25 mg) and the impact of policy change 2 on monthly rates of 25-mg discontinuation and switching from 25 mg to other quetiapine strengths...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Barbara N Harding, Noel S Weiss, Rod L Walker, Eric B Larson, Sascha Dublin
PURPOSE: The purpose of the study is to determine if the use of a proton pump inhibitor (PPI) is associated with an increased fracture risk, as some prior studies have suggested. METHODS: This retrospective cohort study included data on 4438 participants aged 65 and older who had no fracture in the year prior to baseline and had ≥5 years of enrollment history in Kaiser Permanente Washington, an integrated healthcare delivery system in Seattle, WA, during 1994 to 2014...
February 28, 2018: Pharmacoepidemiology and Drug Safety
I-Kuan Wang, Cheng-Li Lin, Tzung-Hai Yen, Shih-Yi Lin, Liu Yao-Lung, Fung-Chang Sung
PURPOSE: Icodextrin can enhance ultrafiltration and consequently improve fluid balance and can control blood pressure and reduce left ventricular mass for peritoneal dialysis (PD) patients. This study investigated whether icodextrin use could reduce the risk of congestive heart failure (CHF) for PD patients. METHODS: From the Taiwan National Health Insurance database, we identified 5462 newly diagnosed end-stage renal disease patients undergoing PD from 2005 to 2010...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Hsien-Yen Chang, Irene Murimi, Mark Faul, Lainie Rutkow, G Caleb Alexander
PURPOSE: We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. METHODS: We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Jacqueline M Cohen, Mollie E Wood, Sonia Hernandez-Diaz, Hedvig Nordeng
PURPOSE: Father's medication use is of interest in fertility studies and as negative control exposures in pregnancy medication safety studies. We sought to compare self-report to prescription records to understand how reliably each of these sources of information may be used. METHODS: We compared self-reported medication use in the 6 months prior to pregnancy from fathers participating in the Norwegian Mother and Child Cohort Study to records of dispensed prescriptions from the Norwegian Prescription Database that overlapped in time...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Kristin Palmsten, Matthieu Rolland, Mary F Hebert, Megan E B Clowse, Michael Schatz, Ronghui Xu, Christina D Chambers
PURPOSE: To characterize prednisone use in pregnant women with rheumatoid arthritis using individual-level heat-maps and clustering individual trajectories of prednisone dose, and to evaluate the association between prednisone dose trajectory groups and gestational length. METHODS: This study included pregnant women with rheumatoid arthritis who enrolled in the MotherToBaby Autoimmune Diseases in Pregnancy Study (2003-2014) before gestational week 20 and reported prednisone use without another oral glucocorticoid during pregnancy (n = 254)...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Alexander M Ponizovsky, Eli Marom, Abraham Weizman, Eyal Schwartzberg
PURPOSE: The purpose of the study is to assess opioid (morphine, methadone, oxycodone, pethidine, and fentanyl) consumption in Israel during 2009 to 2016 and identify recent trends. METHODS: Data for all treatment settings, private and public, for the years 2009 to 2016, were extracted from the Israel Ministry of Health's Pharmaceutical Administration database. The data were used to calculate defined daily doses (DDD) per 1000 inhabitants per day, of the various drugs...
February 28, 2018: Pharmacoepidemiology and Drug Safety
Xiaojuan Li, Stephen R Cole, Daniel Westreich, M Alan Brookhart
No abstract text is available yet for this article.
February 19, 2018: Pharmacoepidemiology and Drug Safety
Peter Malfertheiner, Claudio Ripellino, Nazarena Cataldo
PURPOSE: The angiotensin II receptor blocker (ARB) olmesartan has been recently associated with sprue-like enteropathy (SLE), a gastrointestinal condition characterized by intestinal malabsorption (IM) and severe diarrhea. Whether the increased risk of SLE is substance-specific or a class effect involving all ARBs is uncertain. The aim of this study is to assess the risk of enteropathy associated with ARBs and angiotensin converting enzyme inhibitors (ACE-i) by using data from large administrative and claim databases...
February 19, 2018: Pharmacoepidemiology and Drug Safety
Eric M Ammann, Marin L Schweizer, Jennifer G Robinson, Jayasheel O Eschol, Rami Kafa, Saket Girotra, Scott K Winiecki, Candace C Fuller, Ryan M Carnahan, Charles E Leonard, Cole Haskins, Crystal Garcia, Elizabeth A Chrischilles
BACKGROUND: The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases. PURPOSE: In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410...
February 15, 2018: Pharmacoepidemiology and Drug Safety
Rongxia Li, Eric Weintraub, Michael M McNeil, Martin Kulldorff, Edwin M Lewis, Jennifer Nelson, Stanley Xu, Lei Qian, Nicola P Klein, Frank Destefano
PURPOSE: The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting. METHODS: Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre-defined sets of conditions or diagnoses...
February 15, 2018: Pharmacoepidemiology and Drug Safety
Shirley V Wang, Abdurrahman Abdurrob, Julia Spoendlin, Edwin Lewis, Sophia R Newcomer, Bruce Fireman, Matthew F Daley, Jason M Glanz, Jonathan Duffy, Eric S Weintraub, Martin Kulldorff
PURPOSE: The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of Medicine and Department of Health and Human Services. The recommended childhood immunization schedule includes multiple vaccines in a visit. A key concern is safety of concomitant (same day) versus separate day vaccination. This paper addresses a methodological challenge for observational studies using a self-controlled design to investigate the safety of concomitant vaccination...
February 13, 2018: Pharmacoepidemiology and Drug Safety
Kandace L Amend, Muhammad Younus, Kenneth R Petronis, Jingping Mo, John D Seeger, Robert Gately, Xiangmei Gu, Cheryl Enger
PURPOSE: To evaluate the Risk Evaluation and Mitigation Strategies (REMS) for varenicline by assessing patients' understanding of the varenicline medication guide (MG) at pre-specified time points: 18 months, 3 years, and 7 years after the REMS approval. METHODS: Self-administered surveys were mailed to people who received varenicline based on a pharmacy dispensing. Survey questions assessed understanding of potential risks outlined in the MG: neuropsychiatric symptoms, skin reactions, allergic reactions, and cardiovascular risks...
February 6, 2018: Pharmacoepidemiology and Drug Safety
Denis Talbot, Joseph A Chris Delaney, Veit Sandfort, David M Herrington, Robyn L McClelland
PURPOSE: Estimating how much of the impact of statins on coronary heart diseases (CHD), cardiovascular disease (CVD), and mortality risk is attributable to their effect on low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglycerides. METHODS: A semi-parametric g-formula estimator together with data from the Multi-Ethnic Study of Atherosclerosis (a prospective multi-center cohort study) was utilized to perform a mediation analysis...
February 6, 2018: Pharmacoepidemiology and Drug Safety
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