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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/29349834/drug-adherence-in-treatment-resistant-and-in-controlled-hypertension-results-from-the-swedish-primary-care-cardiovascular-database-spccd
#1
Lina Holmqvist, Kristina Bengtsson Boström, Thomas Kahan, Linus Schiöler, Miriam Qvarnström, Björn Wettermark, Per Hjerpe, Jan Hasselström, Karin Manhem
PURPOSE: To assess drug adherence in patients treated with ≥3 antihypertensive drug classes, with both controlled and uncontrolled blood pressure and describe associated factors for nonadherence. METHODS: Patients with hypertension, without cardiovascular comorbidity, aged >30 years treated with ≥3 antihypertensive drug classes were followed for 2 years. Both patients with treatment resistant hypertension (TRH) and patients with controlled hypertension were included...
January 19, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29349833/a-systematic-assessment-of-key-design-and-performance-characteristics-of-drug-exposure-registries-requested-by-the-u-s-food-and-drug-administration
#2
Yanling Zhao, Ellen Pinnow, Jacqueline M Major
PURPOSE: The purpose of the study is to evaluate contributions to postmarket safety assessments and identify potential factors for enhancing implementation and utilization of registries in regulatory decision-making. METHODS: Registry documents (e.g., protocols, reports) submitted to the FDA were identified up to January 2016 through an extensive, systematic review of internal records and resources. We characterized nonpregnancy drug exposure registries based on prespecified design elements, performance, and regulatory impact...
January 19, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29341340/bias-from-restricting-to-live-births-when-estimating-effects-of-prescription-drug-use-on-pregnancy-complications-a-simulation
#3
Elizabeth A Suarez, Suzanne N Landi, Mitchell C Conover, Michele Jonsson Funk
PURPOSE: Administrative claim databases are increasingly being used to study the safety of medication exposures during pregnancy. These studies are restricted to live births due to a reliance on algorithms for estimating gestational age that are based on codes associated with live delivery. Conditioning on live birth may induce selection bias when studying the effect of a drug on a pregnancy complication if fetal death is a competing risk for the complication or is caused by the complication...
January 17, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29341324/beta-testing-the-potential-link-between-the-alpha-antagonist-tamsulosin-and-dementia
#4
Sudeep S Gill, Anthony D Bai
No abstract text is available yet for this article.
January 17, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29327451/strengthening-standards-transparency-and-collaboration-to-support-medicine-evaluation-ten-years-of-the-european-network-of-centres-for-pharmacoepidemiology-and-pharmacovigilance-encepp
#5
Xavier Kurz, Susana Perez-Gutthann
No abstract text is available yet for this article.
January 11, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29318705/relevance-of-frailty-to-mortality-associated-with-the-use-of-antipsychotics-among-community-residing-older-adults-with-impaired-cognition
#6
Colleen J Maxwell, Michael A Campitelli, David B Hogan, Christina Diong, Peter C Austin, Joseph E Amuah, Kate Lapane, Dallas P Seitz, Sudeep S Gill, Andrea Gruneir, Walter P Wodchis, Susan E Bronskill
PURPOSE: To examine the association between new antipsychotic use and mortality over 6 months among community-based older adults with cognitive impairment, and variation in risk by frailty and sex. METHODS: We conducted a retrospective cohort study of older (aged 66+) home care clients in Ontario, Canada, using linked administrative health and clinical databases. Included were clients with dementia and/or significant cognitive impairment assessed during April 2008 to March 2013...
January 10, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29318704/use-of-antihypertensive-drugs-and-risk-of-keratinocyte-carcinoma-a-meta-analysis-of-observational-studies
#7
Huilin Tang, Shuangshuang Fu, Suodi Zhai, Yiqing Song, Maryam M Asgari, Jiali Han
PURPOSE: Current epidemiologic evidence on the association between antihypertensive drugs and keratinocyte carcinoma (KC) risk is inconsistent. We sought to quantify this association by meta-analysis of observational studies. METHODS: We systematically reviewed observational studies published through August 2016 and reported the KC risk (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) associated with antihypertensive drugs, including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-adrenergic blocking agents (β-blockers), and calcium channel blockers (CCBs)...
January 10, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29318695/risk-factors-for-medication-errors-at-admission-in-preoperatively-screened-patients
#8
Marieke M Ebbens, Kim B Gombert-Handoko, Muhammad Al-Dulaimy, Patricia M L A van den Bemt, Elsbeth J Wesselink
BACKGROUND: Preoperative screening (POS) may help to reduce medication errors at admission (MEA). However, due to the time window between POS and hospital admission, unintentional medication discrepancies may still occur and thus a second medication reconciliation at hospital admission can be necessary. Insight into potential risk factors associated with these discrepancies would be helpful to focus the second medication reconciliation on high-risk patients. OBJECTIVE: To determine the proportion of POS patients with MEA and to identify risk factors for MEA...
January 10, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29318683/prospective-surveillance-pilot-of-rivaroxaban-safety-within-the-us-food-and-drug-administration-sentinel-system
#9
Elizabeth A Chrischilles, Joshua J Gagne, Bruce Fireman, Jennifer Nelson, Sengwee Toh, Azadeh Shoaibi, Marsha E Reichman, Shirley Wang, Michael Nguyen, Rongmei Zhang, Rima Izem, Margie R Goulding, Mary Ross Southworth, David J Graham, Candace Fuller, Hannah Katcoff, Tiffany Woodworth, Catherine Rogers, Ryan Saliga, Nancy D Lin, Cheryl N McMahill-Walraven, Vinit P Nair, Kevin Haynes, Ryan M Carnahan
PURPOSE: The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. METHODS: In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. RESULTS: Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin...
January 10, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29316005/tamsulosin-and-the-risk-of-dementia-in-older-men-with-benign-prostatic-hyperplasia
#10
Yinghui Duan, James J Grady, Peter C Albertsen, Z Helen Wu
PURPOSE: Clinicians use tamsulosin, an α1-adrenoceptor antagonist, to manage symptomatic benign prostatic hyperplasia (BPH). Because α1-adrenoceptors are also present in the brain, the potential exists for adverse effects on cognitive functions. We explored the association between tamsulosin use and dementia risk. METHODS: We used Medicare data (2006-2012) to conduct a cohort study among patients aged ≥65 years and diagnosed with BPH. Men taking tamsulosin (n = 253 136) were matched at a 1:1 ratio using propensity-scores to each of 6 comparison cohorts: patients who used no BPH-medication (n = 180 926), and patients who used the following alternative-BPH-medications: doxazosin (n = 28 581), terazosin (n = 23 858), alfuzosin (n = 17 934), dutasteride (n = 34 027), and finasteride (n = 38 767)...
January 9, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29316026/treatment-dynamics-of-bone-targeting-agents-among-men-with-bone-metastases-from-prostate-cancer-in-the-united-states
#11
Anne M Butler, Karynsa Cetin, Rohini K Hernandez, B Diane Reams, Robert A Overman, Jung I Kim, Bradford R Hirsch, Amy P Abernethy, Alexander Liede, M Alan Brookhart
PURPOSE: To examine the dynamics of treatment with 2 bone-targeting agents (BTAs)-denosumab and zoledronic acid-among men with bone metastases from prostate cancer. METHODS: Using electronic health record data from oncology practices across the US, we identified prostate cancer patients diagnosed with bone metastasis in 2012/2013 without evidence of BTA use within 6 months prior to diagnosis. We examined the risk and predictors of BTA initiation, interruption, and re-initiation...
January 7, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29292555/validation-of-an-algorithm-for-identifying-type-1-diabetes-in-adults-based-on-electronic-health-record-data
#12
Emily B Schroeder, William T Donahoo, Glenn K Goodrich, Marsha A Raebel
PURPOSE: Algorithms using information from electronic health records to identify adults with type 1 diabetes have not been well studied. Such algorithms would have applications in pharmacoepidemiology, drug safety research, clinical trials, surveillance, and quality improvement. Our main objectives were to determine the positive predictive value for identifying type 1 diabetes in adults using a published algorithm (developed by Klompas et al) and to compare it to a simple requirement that the majority of diabetes diagnosis codes be type 1...
January 2, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29292551/bias-from-outcome-misclassification-in-immunization-schedule-safety-research
#13
Sophia R Newcomer, Martin Kulldorff, Stan Xu, Matthew F Daley, Bruce Fireman, Edwin Lewis, Jason M Glanz
PURPOSE: The Institute of Medicine recommended conducting observational studies of childhood immunization schedule safety. Such studies could be biased by outcome misclassification, leading to incorrect inferences. Using simulations, we evaluated (1) outcome positive predictive values (PPVs) as indicators of bias of an exposure-outcome association, and (2) quantitative bias analyses (QBA) for bias correction. METHODS: Simulations were conducted based on proposed or ongoing Vaccine Safety Datalink studies...
January 2, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29285840/methods-for-time-varying-exposure-related-problems-in-pharmacoepidemiology-an-overview
#14
REVIEW
Laura Pazzagli, Marie Linder, Mingliang Zhang, Emese Vago, Paul Stang, David Myers, Morten Andersen, Shahram Bahmanyar
PURPOSE: Lack of control for time-varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an overview and guidance on some of the available methodologies used to address problems related to time-varying exposure and confounding in pharmacoepidemiology and other observational studies. The methods are explored from a conceptual rather than an analytical perspective. METHODS: The methods described in this study have been identified exploring the literature concerning to the time-varying exposure concept and basing the search on four fundamental pharmacoepidemiological problems, construction of treatment episodes, time-varying confounders, cumulative exposure and latency, and treatment switching...
December 28, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29280228/an-update-on-medication-guides
#15
Linda M Park, Paul R Jones, Bryon M Pearsall, Richardae T Araojo
No abstract text is available yet for this article.
December 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29280224/trends-in-opioid-utilisation-in-australia-2006-2015-insights-from-multiple-metrics
#16
Emily A Karanges, Nicholas A Buckley, Jonathan Brett, Bianca Blanch, Melisa Litchfield, Louisa Degenhardt, Sallie-Anne Pearson
PURPOSE: Population-based observational studies have documented global increases in opioid analgesic use. Many studies have used a single population-adjusted metric (number of dispensings, defined daily doses [DDDs], or oral morphine equivalents [OMEs]). We combine these volume-based metrics with a measure of the number of persons dispensed opioids to gain insights into Australian trends in prescribed opioid use. METHODS: We obtained records of prescribed opioid dispensings (2006-2015) subsidised under Australia's Pharmaceutical Benefits Scheme...
December 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29278866/is-patient-exposure-preapproval-and-postapproval-a-determinant-of-the-timing-and-frequency-of-occurrence-of-safety-issues
#17
Alexandra C Pacurariu, Christina E Hoeve, Peter Arlett, Georgy Genov, Jim Slattery, Miriam C J M Sturkenboom, Sabine M J M Straus
BACKGROUND: The amount of drug exposure, pre and post approval, is considered to be a direct determinant of knowledge about the safety of a drug. A larger pre-approval exposed population is supposed to reduce the risk of unanticipated safety issues post-approval. The amount of use in the postapproval population is also expected to influence the occurrence and timing of safety issues. We investigated how the amount of pre and post approval exposure influences the detection of post-approval safety issues...
December 26, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29271049/decline-in-opioid-prescribing-after-federal-rescheduling-of-hydrocodone-products
#18
Mukaila A Raji, Yong-Fang Kuo, Deepak Adhikari, Jacques Baillargeon, James S Goodwin
PURPOSE: To examine differences in opioid prescribing by patient characteristics and variation in hydrocodone combination product (HCP) prescribing attributed to states, before and after the 2014 Drug Enforcement Administration's reclassification of HCP from schedule III to the more restrictive schedule II. METHODS: We used 2013 to 2015 data for 9 202 958 patients aged 18 to 64 from a large nationally representative commercial health insurance program to assess the temporal trends in the monthly rate of opioid prescribing...
December 21, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29271017/a-prediction-model-based-algorithm-for-computer-assisted-database-screening-of-adverse-drug-reactions-in-the-netherlands
#19
Joep H G Scholl, Florence P A M van Hunsel, Eelko Hak, Eugène P van Puijenbroek
PURPOSE: The statistical screening of pharmacovigilance databases containing spontaneously reported adverse drug reactions (ADRs) is mainly based on disproportionality analysis. The aim of this study was to improve the efficiency of full database screening using a prediction model-based approach. METHODS: A logistic regression-based prediction model containing 5 candidate predictors was developed and internally validated using the Summary of Product Characteristics as the gold standard for the outcome...
December 21, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29250905/validity-of-diagnostic-codes-to-identify-hospitalizations-for-infections-among-patients-treated-with-oral-anti-diabetic-drugs
#20
M Elle Saine, Mona Gizaw, Dena M Carbonari, Craig W Newcomb, Jason A Roy, Serena Cardillo, Daina B Esposito, Harshvinder Bhullar, Arlene M Gallagher, Brian L Strom, Vincent Lo Re
PURPOSE: Identification of hospitalizations for infection is important for post-marketing surveillance of drugs, but the validity of using diagnosis codes to identify these events is unknown. Differentiating between hospitalization for and with infection is important, as the latter is common and less likely to arise from pre-admission exposure to drugs. We determined positive predictive values (PPVs) of diagnostic coding-based algorithms to identify hospitalization for infection among patients prescribed oral anti-diabetic drugs (OADs)...
December 18, 2017: Pharmacoepidemiology and Drug Safety
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