Read by QxMD icon Read

Pharmacoepidemiology and Drug Safety

Richard S Swain, Lockwood G Taylor, Tiffany S Woodworth, Candace C Fuller, Andrew B Petrone, Talia J Menzin, Nicole R Haug, Sengwee Toh, Andrew D Mosholder
PURPOSE: Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies. METHODS: To determine if Sentinel contains sufficient all-cause and cause-specific mortality events to power postmarketing safety studies. We calculated crude rates of all-cause mortality and suicide and proportional mortality from suicide from 2004 to 2012 in seven Sentinel data partners...
November 13, 2018: Pharmacoepidemiology and Drug Safety
Andrea L Schaffer, Emily A Karanges, Nicholas A Buckley, Andrew Wilson, Louisa Degenhardt, Briony Larance, Sallie-Anne Pearson
PURPOSE: Despite increasing use of oxycodone/naloxone controlled-release (CR) in Australia, little is known about how it has affected the overall oxycodone CR market since its subsidy in 2011. METHODS: We used Pharmaceutical Benefits Scheme dispensing claims (2006-2016) and interrupted time series analysis to examine changes in the quarterly rates of dispensing of oral oxycodone CR formulations (oxycodone/naloxone CR and single-ingredient oxycodone CR) and new oxycodone CR treatment episodes...
November 13, 2018: Pharmacoepidemiology and Drug Safety
Orwah Al-Khalili, Ted R Mikuls, James R O'Dell, Bryant R England
No abstract text is available yet for this article.
November 13, 2018: Pharmacoepidemiology and Drug Safety
Matthew S Ellis, Theodore J Cicero, Richard C Dart, Jody L Green
PURPOSE: Oral use is the primary route of administration among non-medical prescription opioid users. While progression to non-oral routes and shifts to stronger opioids have been previously studied as ways to cope with tolerance, the prevalence and patterns of those who cope by increasing the number of pills/tablets ingested at one time (ie, multi-pill use) has not been assessed. METHODS: A subset (N = 231) of treatment-seeking opioid users from a national opioid surveillance system, participating in the Researchers and Participants Interacting Directly (RAPID) Program, completed an online survey centered on multi-pill use...
November 9, 2018: Pharmacoepidemiology and Drug Safety
Daniel C Beachler, Cynthia de Luise, Ruihua Yin, Kelsey Gangemi, Philip T Cochetti, Stephan Lanes
PURPOSE: Claims databases offer large populations for research, but lack clinical details. We aimed to develop predictive models to identify estrogen receptor positive (ER+) and human epidermal growth factor negative (HER2-) early breast cancer (ESBC) and advanced stage breast cancer (ASBC) in a claims database. METHODS: Female breast cancer cases in Anthem's Cancer Care Quality Program served as the gold standard validation sample. Predictive models were developed from clinical knowledge and empirically from claims data using logistic and lasso regression...
November 9, 2018: Pharmacoepidemiology and Drug Safety
Pauline Bosco-Lévy, Stéphanie Duret, François Picard, Pierre Dos Santos, Etienne Puymirat, Véronique Gilleron, Patrick Blin, Gilles Chatellier, Vincent Looten, Nicholas Moore
PURPOSE: Heart failure (HF) is a common, serious, and still poorly known illness, which might benefit from studies in claims databases. However, to provide reliable estimates, HF patients must be adequately identified. This validation study aimed to estimate the diagnostic accuracy of the International Classification of Diseases, Tenth Revision (ICD-10) codes I50.x, heart failure, in the French hospital discharge diagnoses database. METHODS: This study was performed in two university hospitals, comparing recorded discharge diagnoses and electronic health records (EHRs)...
November 5, 2018: Pharmacoepidemiology and Drug Safety
Sarah Donald, David Barson, Simon Horsburgh, Katrina Sharples, Lianne Parkin
PURPOSE: The aim of this study was to use national health databases to assemble a pregnancy cohort for undertaking medicine utilisation and safety studies in New Zealand. METHOD: Pregnancies conceived between January 2005 and March 2015 were identified in the National Maternity Collection, the National Minimum Dataset, the Mortality Collection, and the Laboratory Claims Collection. Pregnancy start and end dates were calculated and used in conjunction with the National Health Index number to merge the records from the four collections to create the New Zealand Pregnancy Cohort...
November 5, 2018: Pharmacoepidemiology and Drug Safety
Noelle M Cocoros, Marc R Larochelle, Jennifer Popovic, Andrew B Petrone, Cynthia Kornegay, Jing Ju, Judith A Racoosin
PURPOSE: Fentanyl transdermal system (FTS) is intended only for patients with prior opioid tolerance. The purpose of this study is to identify the proportion of new FTS users who had evidence of prior opioid tolerance, by dosage strength, in FDA's Sentinel System. METHODS: We identified new FTS episodes (183-day washout) from 2009 through 2013. Members were <65 years and enrolled in medical and pharmacy coverage for 183 days prior to initial FTS dispensing (index)...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Chloé Danet, Mélanie Araujo, Marie-Andrée Bos-Thompson, Ghyslaine Portolan, Sophie Gautier, Laurence Vanlemmens, Sophie Bonenfant, Annie-Pierre Jonville-Béra, Judith Cottin, Thierry Vial, Françoise Bavoux, Jean-Louis Montastruc, Christine Damase-Michel, Justine Benevent, Isabelle Bourgeois-Mondon, Isabelle Lacroix
PURPOSE: There is little data on the effects of cancer chemotherapy in pregnant women. The objective of this study was to describe pregnancy outcomes of women exposed to cancer chemotherapy, recorded in the French Terappel database. METHODS: We performed a descriptive, prospective study of the pregnancies of women exposed to cancer chemotherapy recorded in Terappel between June 1984 and December 2016. Terappel is a French database that has recorded questions of health professionals and/or individuals at the Regional Pharmacovigilance Centres about drugs and pregnancy...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Charles Khouri, Bruno Revol, Marion Lepelley, Michel Mallaret, Jean-Luc Cracowski
No abstract text is available yet for this article.
October 31, 2018: Pharmacoepidemiology and Drug Safety
Julia Spoendlin, Joshua J Gagne, Jennifer J Lewey, Elisabetta Patorno, Sebastian Schneeweiss, Rishi J Desai
PURPOSE: Comparative outcomes of treatment with antiplatelet drugs in patients with acute coronary syndrome (ACS) and co-morbid diabetes mellitus (DM) are not well studied. METHODS: We performed a cohort study using US commercial claims data (2009-2015) and conducted the following pairwise comparisons in ACS patients with DM: prasugrel vs clopidogrel, ticagrelor vs clopidogrel, and prasugrel vs ticagrelor. Outcomes of interest included (1) a composite effectiveness endpoint including myocardial infarction, ischemic stroke, or inpatient mortality; (2) a composite safety endpoint including major bleeding events requiring hospitalization; and (3) pneumonia hospitalizations as a negative control endpoint...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Julijana Dukanovic, Osemeke U Osokogu, Krupa Patel, Carmen Ferrajolo, Miriam C J M Sturkenboom
PURPOSE: The purpose of the study is to assess the current state of the art in pediatric comparative effectiveness research, potential gaps, and areas for improvement. METHODS: Relevant articles from inception to February 2015 were retrieved from Embase and Medline. We sequentially screened titles, abstracts, and full texts, with independent validation. Data regarding general information and study methods including statistical analysis were extracted. Study quality was assessed using Newcastle-Ottawa Scale (NOS)...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Greta A Bushnell, Til Stürmer, Christina Mack, Virginia Pate, Matthew Miller
PURPOSE: To describe how often patients with depression initiating antidepressants receive their depression diagnosis and prescriptions from the same provider and, when simultaneously initiating benzodiazepines, how often both prescriptions come from the same provider. METHODS: Using a US healthcare claims database, we created a cohort of adults (18-64 years) with a depression diagnosis who initiated antidepressants. We examined concordance by provider specialty and provider identifier between (a) the first antidepressant prescription fill and most proximal depression diagnosis, and (b) the initial antidepressant and benzodiazepine prescription fills among simultaneous benzodiazepine and antidepressant initiators...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Dorothea von Bredow, Massoud Toussi, Abdus Samad, Sigal Kaplan, Mónika Domahidy, Hanka de Voogd, Stella Böhmert, Rita Silveira Ramos, Deepa Arora
PURPOSE: In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to "add-on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line therapies." TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM...
October 31, 2018: Pharmacoepidemiology and Drug Safety
Yong Chen, Jianqiao Wang, Jessica Chubak, Rebecca A Hubbard
PURPOSE: Many outcomes derived from electronic health records (EHR) not only are imperfect but also may suffer from exposure-dependent differential misclassification due to variability in the quality and availability of EHR data across exposure groups. The objective of this study was to quantify the inflation of type I error rates that can result from differential outcome misclassification. METHODS: We used data on gold-standard and EHR-derived second breast cancers in a cohort of women with a prior breast cancer diagnosis from 1993 to 2006 enrolled in Kaiser Permanente Washington...
October 30, 2018: Pharmacoepidemiology and Drug Safety
Sascha Dublin, Rod L Walker, Susan M Shortreed, Evette J Ludman, Karen J Sherman, Ryan N Hansen, Manu Thakral, Kathleen Saunders, Michael L Parchman, Michael Von Korff
PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed)...
October 30, 2018: Pharmacoepidemiology and Drug Safety
Rory J Ferguson, Daniel Prieto-Alhambra, Christine Walker, Dahai Yu, Jose M Valderas, Andrew Judge, John Griffiths, Kelvin P Jordan, George Peat, Sion Glyn-Jones, Alan J Silman
PURPOSE: The diagnosis of hip osteoarthritis is subject to several uncertainties, especially in primary care. The aims of this study were to determine (i) the diagnostic accuracy of coding of hip osteoarthritis by primary care physicians in the UK Clinical Practice Research Datalink (CPRD), (ii) the relative influence of radiographic and clinical parameters on diagnostic accuracy, and (iii) the accuracy of the diagnosis date. METHODS: An extract of all patients aged over 65 years, with a Read code for hip osteoarthritis listed between January 1995 and December 2014, was obtained from CPRD...
October 30, 2018: Pharmacoepidemiology and Drug Safety
Chisato Fukazawa, Yasushi Hinomura, Masayuki Kaneko, Mamoru Narukawa
PURPOSE: Data mining has been introduced as one of the most useful methods for signal detection by spontaneous reports, but data mining is not always effective in detecting all safety issues. To investigate appropriate situations in which data mining is effective in routine signal detection activities, we analyzed the characteristics of signals that the US Food and Drug Administration (FDA) identified from the FDA Adverse Event Reporting System (FAERS). METHODS: Among the signals that the FDA identified from the FAERS between 2008 1Q and 2014 4Q, we selected 233 signals to evaluate in this study...
October 15, 2018: Pharmacoepidemiology and Drug Safety
Jody L Green, Victoria Anderson, Richard C Dart, Kennon Heard
PURPOSE: Accurate capture of medication use is important for high quality research. For epidemiologic studies, medication histories are the most common measure of exposure when trying to identify associations between medications and outcomes. Concomitant medications can alter the efficacy or safety of study drugs in clinical trials. However, there are few studies evaluating the accuracy and efficiency of methods to collect these histories. The objective of this study is to compare the accuracy of medication histories collected by structured interview to histories captured using a tablet-based application...
October 5, 2018: Pharmacoepidemiology and Drug Safety
Jennifer W Wu, Laurent Azoulay, Anjie Huang, Michael Paterson, Fangyun Wu, Matthew H Secrest, Kristian B Filion
PURPOSE: To validate three approaches for identifying incident cases of pancreatic cancer in Ontario administrative claims data. METHODS: We created a cohort using Ontario (Canada) administrative health data from 2002 to 2012 and identified cases of pancreatic cancer with three approaches, using the Ontario Cancer Registry (OCR) as the reference standard. In the any diagnosis approach, cases were defined by primary or secondary diagnostic codes for pancreatic cancer in outpatient or inpatient records...
October 4, 2018: Pharmacoepidemiology and Drug Safety
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"