Read by QxMD icon Read

Pharmacoepidemiology and Drug Safety

Hue-Yu Wang, Ming-Kung Yeh, Chung-Han Ho, Ming-Kuan Hu, Yaw-Bin Huang
PURPOSE: To analyze and characterize data regarding the prevalence and types of outpatient drug-related problems (DRPs) found by clinical pharmacists after implementation of the Virtual Medicine Record in Cloud System (VMRCS). METHODS: A cross-sectional study regarding outpatient pharmaceutical care was conducted at a medical center in Taiwan. Patients aged >20 years old with multiple chronic diseases and polypharmacy were enrolled. In Stage I (1 October-31 December 2014), patients received pharmaceutical care according to prescription data accessed online in the VMRCS...
October 12, 2016: Pharmacoepidemiology and Drug Safety
Joep H G Scholl, Eugène P van Puijenbroek
PURPOSE: In pharmacovigilance, the commonly used disproportionality analysis (DPA) in statistical signal detection is known to have its limitations. The aim of this study was to investigate the value of the time to onset (TTO) of ADRs in addition to DPA. METHODS: We performed a pilot study using individual case safety reports (ICSRs) for three drugs (Cervarix®, nitrofurantoin and simvastatin) from the Lareb spontaneous reporting database. TTO distributions for drug - ADR associations were compared to other ADRs for the same drug and to other drugs for the same ADR using two-sample Anderson-Darling testing...
September 30, 2016: Pharmacoepidemiology and Drug Safety
Paul Brassard, Jennifer W Wu, Pierre Ernst, Sophie Dell'Aniello, Brielan Smiechowski, Samy Suissa
PURPOSE: The effect of statins on cytokine-mediated inflammatory responses may impact on the prognosis of influenza. We assessed whether statin use decreases the incidence of adverse influenza-related outcomes. Additionally, we used a new-user study design to minimize healthy user bias. We further examined the possibility of non-causal associations by using unrelated outcomes. METHODS: We used the UK Clinical Practice Research Datalink to identify all patients aged 30 or older diagnosed with influenza-like illness during 1997-2010...
September 30, 2016: Pharmacoepidemiology and Drug Safety
Henrik Støvring, Anton Pottegård, Jesper Hallas
PURPOSE: The purpose of the study is to develop a method to estimate the duration of single prescriptions in pharmacoepidemiological studies when the single prescription duration is not available. METHODS: We developed an estimation algorithm based on maximum likelihood estimation of a parametric two-component mixture model for the waiting time distribution (WTD). The distribution component for prevalent users estimates the forward recurrence density (FRD), which is related to the distribution of time between subsequent prescription redemptions, the inter-arrival density (IAD), for users in continued treatment...
September 26, 2016: Pharmacoepidemiology and Drug Safety
Karina Jayaputra, Shunsuke Ono
PURPOSE: Our study addresses how the information in the labels differed between United States (US) and Japan, what factors were associated with the decision to place the boxed warning on the label, and the relation of both countries in terms of drug label policy. METHODS: We investigated adverse drug reactions (ADRs) in boxed warnings for 44 oncological drug labels approved from 2004 to 2014 in both Japan and the US. We applied conditional logistic regression to examine how likely it was for each ADR to be included in a boxed warning...
September 26, 2016: Pharmacoepidemiology and Drug Safety
Guttorm Raknes, Lars Småbrekke
PURPOSE: Following a TV documentary in 2013, there was a tremendous increase in low dose naltrexone (LDN) use in a wide range of unapproved indications in Norway. We aim to describe the extent of this sudden and unprecedented increase in LDN prescribing, to characterize patients and LDN prescribers, and to estimate LDN dose sizes. METHODS: LDN prescriptions recorded in the Norwegian Prescription Database (NorPD) in 2013 and 2014, and sales data not recorded in NorPD from the only Norwegian LDN manufacturer were included in the study...
September 26, 2016: Pharmacoepidemiology and Drug Safety
Dan Razavi, Mats Lindblad, Tomas Bexelius, Viktor Oskarsson, Omid Sadr-Azodi, Rickard Ljung
PURPOSE: Drug-induced pancreatitis is receiving increased medical and epidemiological attention. However, as no study has examined the role of polypharmacy per se in the development of acute pancreatitis, we examined the association between polypharmacy and risk of acute pancreatitis. METHODS: A nationwide case-control study was conducted between 2006 and 2008 of Swedish people aged 40-84 years. The Swedish Patient Register was used to identify 6161 cases of first-episode acute pancreatitis...
September 21, 2016: Pharmacoepidemiology and Drug Safety
Gillian C Hall, Robert Mr Tulloh, Louise E Tulloh
PURPOSE: To provide expected incidence rates of Kawasaki disease after vaccination in routine clinical practice and as recommended within a pre-school National Immunisation Programme (NIP). METHODS: A post-immunisation risk period when Kawasaki disease onset might be associated with vaccination was defined as 28 days. Immunisation records for children under 6 years were identified from The Health Improvement Network (THIN) database of electronic UK primary health care records (2008-2012) and linked to previously validated cases of Kawasaki disease with an assigned date of onset...
September 21, 2016: Pharmacoepidemiology and Drug Safety
Preeti Datta-Nemdharry, Andrew Thomson, Julie Beynon, Katherine Donegan
PURPOSE: The purpose of this study is to characterise how Type 2 Diabetes Mellitus (T2DM) is treated in England and Wales and whether this adheres to 2009 National Institute for Health and Care Excellence (NICE) guidance on management of T2DM. METHODS: Data for T2DM patients aged 18+ years prescribed at least one anti-diabetic drug between 01/01/2000-30/06/2012 were extracted from the Clinical Practice Research Datalink. We examined the sequences in which anti-diabetic drugs were prescribed and, for patients on the most common anti-diabetic drug pathways, evaluated average HbA1c values at treatment initiation and at progression to a second or third-line anti-diabetic drug class, including insulin...
September 19, 2016: Pharmacoepidemiology and Drug Safety
Andreas D Meid, Dirk Heider, Jürgen-Bernhard Adler, Renate Quinzler, Herrmann Brenner, Christian Günster, Hans-Helmut König, Walter E Haefeli
PURPOSE: The purpose of this study was to compare the predictive accuracy of different methods suggested for approximation of drug prescription durations in claims data. METHODS: We expanded a well-established modeling and simulation framework to compare approximated drug prescription durations with 'true' (i.e., simulated) durations. Real claims data of persons aged ≥65 years insured by the German nationwide 'Statutory Health Insurance Fund' AOK between 2010 and 2012 provided empiric input parameters that were completed with missing information on actual dosing patterns from an observational cohort...
September 16, 2016: Pharmacoepidemiology and Drug Safety
Chao-Chin Lu, Jianwei Leng, Grant W Cannon, Xi Zhou, Marlene Egger, Brett South, Zach Burningham, Qing Zeng, Brian C Sauer
PURPOSE: Medications with non-standard dosing and unstandardized units of measurement make the estimation of prescribed dose difficult from pharmacy dispensing data. A natural language processing tool named the SIG extractor was developed to identify and extract elements from narrative medication instructions to compute average weekly doses (AWDs) for disease-modifying antirheumatic drugs. The goal of this paper is to evaluate the performance of the SIG extractor. METHOD: This agreement study utilized Veterans Health Affairs pharmacy data from 2008 to 2012...
September 16, 2016: Pharmacoepidemiology and Drug Safety
Veena Hoffman, Nicholas J Everage, Scott C Quinlan, Kathleen Skerry, Daina Esposito, Nicolas Praet, Dominique Rosillon, Crystal N Holick, David D Dore
PURPOSE: We validated procedure codes used in health insurance claims for reimbursement of rotavirus vaccination by comparing claims for monovalent live-attenuated human rotavirus vaccine (RV1) and live, oral pentavalent rotavirus vaccine (RV5) to medical records. METHODS: Using administrative data from two commercially insured United States populations, we randomly sampled vaccination claims for RV1 and RV5 from a cohort of infants aged less than 1 year from an ongoing post-licensure safety study of rotavirus vaccines...
September 13, 2016: Pharmacoepidemiology and Drug Safety
Samy Suissa, Erica E M Moodie, Sophie Dell'Aniello
PURPOSE: Studies of the real-world comparative effectiveness of drugs conducted using computerized healthcare databases typically involve an incident new-user cohort design for head-to-head comparisons between two medications, using exclusively treatment-naïve patients. However, the desired contrast often involves one new drug compared with an older drug, of which many users of the new drug may have switched from, seriously restricting the scope of incident new-user studies. METHODS: We introduce prevalent new-user cohort designs for head-to-head comparative drug effect studies, where incident new users are scarce...
September 9, 2016: Pharmacoepidemiology and Drug Safety
Mei Sheng Duh, Pierre Cremieux, Marc Van Audenrode, Francis Vekeman, Paul Karner, Haimin Zhang, Paul Greenberg
PURPOSE: To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor(®) ) and sibutramine (Meridia(®) ) in social media ( versus the FDA Adverse Event Reporting System (FAERS). METHODS: We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports...
September 7, 2016: Pharmacoepidemiology and Drug Safety
Corinne Willame, Laurence Baril, Judith van den Bosch, Germano L C Ferreira, Rachael Williams, Dominique Rosillon, Catherine Cohet
PURPOSE: Investigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data...
September 7, 2016: Pharmacoepidemiology and Drug Safety
Jacob N Hunnicutt, Christine M Ulbricht, Stavroula A Chrysanthopoulou, Kate L Lapane
PURPOSE: We systematically reviewed pharmacoepidemiologic and comparative effectiveness studies that use probabilistic bias analysis to quantify the effects of systematic error including confounding, misclassification, and selection bias on study results. METHODS: We found articles published between 2010 and October 2015 through a citation search using Web of Science and Google Scholar and a keyword search using PubMed and Scopus. Eligibility of studies was assessed by one reviewer...
September 5, 2016: Pharmacoepidemiology and Drug Safety
Andrea Arfè, Federica Nicotra, Arianna Ghirardi, Monica Simonetti, Francesco Lapi, Miriam Sturkenboom, Giovanni Corrao
PURPOSE: The effect of drug exposure misclassification generally receives little attention in pharmacoepidemiological research. In this paper, we illustrate a probabilistic bias analysis approach for misclassified categorical exposures and apply it in a database study of oral anti-hyperglycaemic drugs (OADs). METHODS: A cohort study based on the Health Search Database general-practice database was carried out by including 12 640 adult (≥40 years) patients newly treated with OADs during 2003-2010...
September 4, 2016: Pharmacoepidemiology and Drug Safety
Johannes T H Nielen, Pieter C Dagnelie, Pieter J Emans, Nicole Veldhorst-Janssen, Arief Lalmohamed, Tjeerd-Pieter van Staa, Annelies E R C H Boonen, Bart J F van den Bemt, Frank de Vries
BACKGROUND: There has been much debate recently on the best type of thromboprophylaxis following elective total joint replacement surgery. OBJECTIVE: This study aims to compare rates of venous thromboembolism (VTE), gastro-intestinal (GI) bleeding and mortality events, with use of new oral anticoagulants (NOAC) or low-molecular-weight heparins (LMWHs) compared with aspirin in patients undergoing total joint replacement. METHODS: A population-based retrospective cohort study was performed using the Clinical Practice Research Datalink...
September 4, 2016: Pharmacoepidemiology and Drug Safety
Theodore J Cicero, Matthew S Ellis, Zachary A Kasper
PURPOSE: Although differences in the pharmacological properties of immediate-release (IR) and extended-release (ER) opioid formulations have been reported, there are few studies comparing the real world abuse and relative preferences for these formulations. METHODS: To examine drug preferences, we used a structured survey of 8304 individuals entering treatment (2011-2014) for opioid use disorder followed by a more focused online survey (2014-2015) with a subset of these patients (N = 301)...
September 4, 2016: Pharmacoepidemiology and Drug Safety
Stephen E Kimmel, Andrea B Troxel, Benjamin French, George Loewenstein, Jalpa A Doshi, Todd E H Hecht, Mitchell Laskin, Colleen M Brensinger, Chris Meussner, Kevin Volpp
BACKGROUND: Previous research has suggested that daily lottery incentives could improve medication adherence. Such daily incentives include implicit reminders. However, the comparative effectiveness of reminders alone versus daily incentives has not been tested. METHODS: A total of 270 patients on warfarin were enrolled in a four-arm, multi-center, randomized controlled trial comparing a daily lottery-based incentive, a daily reminder, and a combination of the two against a control group (usual care)...
September 4, 2016: 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"