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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28326633/bias-from-depletion-of-susceptibles-the-example-of-hormone-replacement-therapy-and-the-risk-of-venous-thromboembolism
#1
Christel Renoux, Sophie Dell'Aniello, Benjamin Brenner, Samy Suissa
PURPOSE: The data on the association between hormone replacement therapy and the increased risk of venous thromboembolism (VTE) in postmenopausal women are conflicting. The observed differences between oral estrogen and oral estrogen-progestogen combination formulations may be the result of bias from depletion of susceptibles. METHODS: We used United Kingdom's Clinical Practice Research Datalink to identify the cohort of all women aged 50 to 79 during 1987-2008, with all incident cases of VTE occurring during the study period identified...
March 22, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28317314/assessing-disruptions-in-adherence-to-antidepressant-treatments-after-breast-cancer-diagnosis
#2
Yi-Ting Chou, Aaron N Winn, Donald L Rosenstein, Stacie B Dusetzina
PURPOSE: Long-term treatment with antidepressants can lessen the symptoms of depression, but health-related crises-such as a cancer diagnosis-may disrupt ongoing depression care. The study aims to estimate the effect of receiving a breast cancer diagnosis on antidepressant adherence among women with depression. METHODS: Using SEER-Medicare administrative claims, we identified women aged 65+ with newly diagnosed breast cancer between 2008 and 2011, who were diagnosed with depression and used antidepressants during the year before pre-diagnosis year...
March 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28317274/quality-of-warfarin-therapy-and-risk-of-stroke-bleeding-and-mortality-among-patients-with-atrial-fibrillation-results-from-the-nationwide-finwaf-registry
#3
Mika Lehto, Jussi Niiranen, Pasi Korhonen, Juha Mehtälä, Houssem Khanfir, Fabian Hoti, Riitta Lassila, Pekka Raatikainen
PURPOSE: The most important management strategy in atrial fibrillation (AF) patients is preventing stroke with oral anticoagulants. Warfarin is still used as a first-line anticoagulant, although non-vitamin K antagonist oral anticoagulants are currently recommended to manage AF. Using a large, unselected national sample of AF patients, we evaluated the relationships between quality of warfarin therapy and the risks of thromboembolism, bleeding complications, and mortality. METHODS: The nationwide FinWAF study included 54 568 AF patients taking warfarin...
March 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28295882/identifying-atrial-fibrillation-in-outpatients-initiating-oral-anticoagulants-based-on-medico-administrative-data-results-from-the-french-national-healthcare-databases
#4
Cécile Billionnet, François Alla, Éric Bérigaud, Antoine Pariente, Géric Maura
PURPOSE: Identifying atrial fibrillation (AF) in outpatients treated with oral anticoagulants (OACs) from claims databases is challenging when the outpatient indication is not available, as OACs are also prescribed for deep vein thrombosis/pulmonary embolism (DVT/PE) that may be treated in the ambulatory setting. An algorithm was developed to identify AF in outpatients initiating OAC from medico-administrative data. METHODS: Among patients initiating OAC in 2013 in the French healthcare databases, those treated for orthopaedic indications were excluded...
March 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28295862/sample-size-of-the-reference-sample-in-a-case-augmented-study
#5
Palash Ghosh, Anup Dewanji
The case-augmented study, in which a case sample is augmented with a reference (random) sample from the source population with only covariates information known, is becoming popular in different areas of applied science such as pharmacovigilance, ecology, and econometrics. In general, the case sample is available from some source (for example, hospital database, case registry, etc.); however, the reference sample is required to be drawn from the corresponding source population. The required minimum size of the reference sample is an important issue in this regard...
March 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28295821/economic-impact-of-medication-error-a-systematic-review
#6
Elaine K Walsh, Christina Raae Hansen, Laura J Sahm, Patricia M Kearney, Edel Doherty, Colin P Bradley
PURPOSE: Medication error is a significant source of morbidity and mortality among patients. Clinical and cost-effectiveness evidence are required for the implementation of quality of care interventions. Reduction of error-related cost is a key potential benefit of interventions addressing medication error. The aim of this review was to describe and quantify the economic burden associated with medication error. METHODS: PubMed, Cochrane, Embase, CINAHL, EconLit, ABI/INFORM, Business Source Complete were searched...
March 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28266748/immeasurable-time-bias-due-to-hospitalization-in-medico-administrative-databases-which-impact-for-pharmacoepidemiological-studies
#7
Aurore Palmaro, Quentin Boucherie, Julie Dupouy, Joëlle Micallef, Maryse Lapeyre-Mestre
PURPOSE: Drugs administered to hospitalized patients are not available within almost all health insurance databases. However, this unobservable exposure time bias is very rarely taken into account in pharmacoepidemiology. The objective was to model unobservable periods due to hospitalization and to assess their impact on risk estimates in the context of the association between benzodiazepines and mortality. METHODS: A cohort study was identified using the General Sample of Beneficiaries in France for the period 2006-2012...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28266092/six-year-multi-centre-observational-post-marketing-surveillance-of-the-safety-of-the-hpv-16-18-as04-adjuvanted-vaccine-in-women-aged-10-25%C3%A2-years-in-korea
#8
Chul-Jung Kim, Rok Song, Jing Chen, Fernanda Taveres Da Silva, Kusuma B Gopala, Joon Hyung Kim, Dan Bi, Jong Sup Park
PURPOSE: To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. METHODS: A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28266090/trends-in-antipsychotic-prescriptions-for-japanese-outpatients-during-2006-2012-a-descriptive-epidemiological-study
#9
Kenji Kochi, Izumi Sato, Chika Nishiyama, Sachiko Tanaka-Mizuno, Yuko Doi, Masaru Arai, Yosuke Fujii, Toshiyuki Matsunaga, Yusuke Ogawa, Toshi A Furukawa, Koji Kawakami
PURPOSE: This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized. METHODS: This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and receiving their initial antipsychotic prescription during 2006-2012 were evaluated. The annual trends were reported for monotherapies, polypharmacy, antipsychotic doses, and the concurrent prescription of psychotropic medications...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28247528/ace-inhibitors-and-the-risk-of-acute-pancreatitis-a-population-based-case-control-study
#10
Jaana Kuoppala, Hannes Enlund, Jukka Pulkkinen, Helena Kastarinen, Johanna Jyrkkä, Pertti Happonen, Hannu Paajanen
PURPOSE: The aim of this study was to examine the association between angiotensin converting enzyme (ACE) inhibitor use and the risk of acute pancreatitis. METHODS: Information on all 4966 cases hospitalized in 2008-2010 for acute pancreatitis was retrieved from the Finnish national registers on hospital discharges and prescriptions. A total of 24 788 age and sex-matched population-based controls were randomly selected using density sampling. ACE inhibitor use between 1 January 2003 and the index date were determined by the date of hospitalization for acute pancreatitis among the cases...
March 1, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28239929/a-tutorial-on-the-use-of-instrumental-variables-in-pharmacoepidemiology
#11
REVIEW
Ashkan Ertefaie, Dylan S Small, James H Flory, Sean Hennessy
PURPOSE: Instrumental variable (IV) methods are used increasingly in pharmacoepidemiology to address unmeasured confounding. In this tutorial, we review the steps used in IV analyses and the underlying assumptions. We also present methods to assess the validity of those assumptions and describe sensitivity analysis to examine the effects of possible violations of those assumptions. METHODS: Observational studies based on regression or propensity score analyses rely on the untestable assumption that there are no unmeasured confounders...
February 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28239922/diverging-approaches-of-pharmacovigilance-and-pharmacoepidemiology-to-assessing-drug-safety-epistemological-and-ethical-implications
#12
Joël Coste
No abstract text is available yet for this article.
February 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28233421/burden-of-hospitalizations-related-to-adverse-drug-events-in-the-usa-a-retrospective-analysis-from-large-inpatient-database
#13
Dilli Ram Poudel, Prakash Acharya, Sushil Ghimire, Rashmi Dhital, Rajani Bharati
PURPOSE: Adverse drug events (ADEs) represent medication-related patient harm, which is associated with significant patient morbidity and mortality. This study was conducted to determine the rate, specific causes, and outcomes of ADE-related hospitalization in the USA. METHODS: We used the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample dataset for the years 2008 to 2011. We selected patients with ADE based on 537 Classification of Diseases-9 codes...
February 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28233367/medical-specialists-attitudes-to-prescribing-biosimilars
#14
Amy Hemmington, Nicola Dalbeth, Paul Jarrett, Alan G Fraser, Reuben Broom, Peter Browett, Keith J Petrie
PURPOSE: Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acceptance of biosimilars. METHODS: A national sample of 110 of 327 medical specialists working in the areas of rheumatology, dermatology, gastroenterology, oncology and haematology completed an online questionnaire examining attitudes towards prescribing biosimilars, indication extrapolation and switching patients to a biosimilar...
February 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28220993/antiemetic-use-among-pregnant-women-in-the-united-states-the-escalating-use-of-ondansetron
#15
Lockwood G Taylor, Steven T Bird, Leyla Sahin, Melissa S Tassinari, Patty Greene, Marsha E Reichman, Susan E Andrade, Katherine Haffenreffer, Sengwee Toh
PURPOSE: To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births. METHODS: We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes...
February 21, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28220982/new-user-designs-with-conditional-propensity-scores-a-unified-complement-to-the-traditional-active-comparator-new-user-approach
#16
Joshua J Gagne
No abstract text is available yet for this article.
February 21, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28220974/advancing-regulatory-science-advancing-regulatory-practice
#17
Xavier Kurz
No abstract text is available yet for this article.
February 21, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28198116/periodic-benefit-risk-evaluation-reports-have-substantial-promise-to-guide-patient-care-and-should-be-made-publicly-available
#18
Michael Fralick, Aaron S Kesselheim
No abstract text is available yet for this article.
February 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28198064/real-life-practices-for-preventing-venous-thromboembolism-in-multiple-myeloma-patients-a-cohort-study-from-the-french-health-insurance-database
#19
Aurore Palmaro, Marie-Eve Rougé-Bugat, Martin Gauthier, Fabien Despas, Guillaume Moulis, Maryse Lapeyre-Mestre
PURPOSE: The risk of venous thromboembolic event (VTE) in multiple myeloma is particularly increased. Current guidelines recommend systematic VTE prophylaxis with vitamin K antagonists (VKA) or low weight molecular heparin (LWMH) or unfractionated heparin (UFH) in high-risk patients, based on treatment received [e.g. use of IMiDs (thalidomide, lenalidomide and pomalidomide), alkylating agents or erythropoietin] and individual risk factors (e.g. history of VTE). The aim of this study was to describe strategy of VTE prophylaxis and prescribing of other antithrombotic agents during the first 6 months of multiple myeloma therapy, with stratification on IMiD-based regimens and drug and disease-related risk factors...
February 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28176447/statins-during-pregnancy-a-cohort-study-using-the-general-practice-research-database-to-investigate-pregnancy-loss
#20
Anita McGrogan, Julia Snowball, Rachel A Charlton
PURPOSE: The aim of this study was to determine if there are any differences between the types of pregnancy loss experienced by women who have been prescribed a statin just before or early in pregnancy compared with those who have not. METHODS: A retrospective cohort study using the General Practice Research Database was carried out. Women aged 10-49 years at pregnancy start who received a prescription for a statin in the 3 months before and/or during the first trimester of pregnancy were matched to up to 10 pregnancies on age at start date, diabetes and hypertension status before pregnancy...
February 8, 2017: Pharmacoepidemiology and Drug Safety
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