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Pharmacoepidemiology and Drug Safety

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
Joshua J Gagne
No abstract text is available yet for this article.
February 21, 2017: Pharmacoepidemiology and Drug Safety
Xavier Kurz
No abstract text is available yet for this article.
February 21, 2017: Pharmacoepidemiology and Drug Safety
Michael Fralick, Aaron S Kesselheim
No abstract text is available yet for this article.
February 15, 2017: Pharmacoepidemiology and Drug Safety
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
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
Alfred Mahr, Clara Golmard, Emilie Pham, Laura Iordache, Laure Deville, Pierre Faure
PURPOSE: Scarce studies analyzing adverse event (AE) data from randomized placebo-controlled clinical trials (RPCCTs) of selected illnesses suggested that a substantial proportion of collected AEs are unrelated to the drug taken. This study analyzed the nonspecific AEs occurring with active-drug exposure in RPCCTs for a large range of medical conditions. METHODS: Randomized placebo-controlled clinical trials published in five prominent medical journals during 2006-2012 were searched...
February 7, 2017: Pharmacoepidemiology and Drug Safety
Anders Engeland, Tone Bjørge, Kari Klungsøyr, Svetlana Skurtveit, Kari Furu
PURPOSE: To explore associations between preterm birth and use of medications in young adulthood as a proxy for different diseases. METHODS: We linked data on birth characteristics from the Medical Birth Registry of Norway (1967-1999) and the Norwegian Prescription Database (2004-2015). Individuals born as singletons during 1974-1984 and alive at the age of 31 were included (main analyses) (n = 450 555). Relative risks (RRs) with 95% confidence intervals (CIs) of using different medications were estimated by log-binomial regression...
February 7, 2017: Pharmacoepidemiology and Drug Safety
Eva Skovlund, Marte Handal, Randi Selmer, Ragnhild Eek Brandlistuen, Svetlana Skurtveit
PURPOSE: An increasing consumption of opioids in the general population has been reported in several countries also among pregnant women. Limited information is available regarding the effect of prenatal exposure to analgesic opioids on long-term neurocognitive function in children. The primary aim of the study was to determine the association between prenatal exposure to analgesic opioids and language competence and communication skills at 3 years of age. METHODS: The Norwegian Mother and Child Cohort Study (MoBa) prospectively included pregnant women during the period from 1999 to 2008...
February 7, 2017: Pharmacoepidemiology and Drug Safety
Andreia Leite, Nick J Andrews, Sara L Thomas
PURPOSE: Near real-time vaccine safety surveillance (NRTVSS) is an option for post-licensure vaccine safety assessment. NRTVSS requires timely recording of outcomes in the database used. Our main objective was to examine recording delays in the Clinical Practice Research Datalink (CPRD) for outcomes of interest for vaccine safety to inform the feasibility of NRTVSS using these data. We also evaluated completeness of recording and further assessed reporting delays for hospitalized events in CPRD...
February 3, 2017: Pharmacoepidemiology and Drug Safety
Jordi Castellsague, Susana Perez-Gutthann, Brian Calingaert, Christine Bui, Cristina Varas-Lorenzo, Alejandro Arana, Alexandra Prados-Torres, Beatriz Poblador-Plou, Francisca Gonzalez-Rubio, Maria Giner-Soriano, Albert Roso-Llorach, Marie Linder, Anna Citarella, Oliver Scholle, Tilo Blenk, Edeltraut Garbe
PURPOSE: To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS: New users of cilostazol were identified in populations enrolled in five European health automated databases in the UK (The Health Improvement Network [THIN]), Spain (EpiChron cohort and Information System for the Improvement of Research in Primary Care [SIDIAP]), Sweden (National Registers), and Germany (German Pharmacoepidemiological Research Database [GePaRD]) between 2002 and 2012...
January 30, 2017: Pharmacoepidemiology and Drug Safety
Julien Bezin, Rolf H H Groenwold, M Sanni Ali, Régis Lassalle, Philip Robinson, Anthonius de Boer, Nicholas Moore, Olaf H Klungel, Antoine Pariente
PURPOSE: The secondary prevention treatment for acute coronary syndrome (ACS) is based on the combined use of drugs from four therapeutic classes (beta-blockers, antiplatelet agents, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers). The objective of this study was to compare the long-term effectiveness of the recommended therapeutic combination with those of incomplete combinations in secondary prevention of ACS. METHODS: This cohort study used data from a representative sample of the French national healthcare insurance system database...
January 26, 2017: Pharmacoepidemiology and Drug Safety
Maria Soledad Cepeda, Daniel Fife, Michel Denarié, Dan Bradford, Stephanie Roy, Yingli Yuan
PURPOSE: This study aims to quantify the magnitude of missed dispensings in commercial claims databases. METHODS: A retrospective cohort study has been used linking PharMetrics, a commercial claims database, to a prescription database (LRx) that captures pharmacy dispensings independently of payment method, including cash transactions. We included adults with dispensings for opioids, diuretics, antiplatelet medications, or anticoagulants. To determine the degree of capture of dispensings, we calculated the number of subjects with the following: (1) same number of dispensings in both databases; (2) at least one dispensing, but not all dispensings, missed in PharMetrics; and (3) all dispensings missing in PharMetrics...
January 25, 2017: Pharmacoepidemiology and Drug Safety
Ricky Camplain, Anna Kucharska-Newton, Carmen C Cuthbertson, Jacqueline D Wright, Alvaro Alonso, Gerardo Heiss
PURPOSE: The aim of this study was to quantify the influence of the length of the look-back period on misclassification of heart failure (HF) incidence in Medicare claims available for participants of a population-based cohort. METHODS: Atherosclerosis Risk in Communities participants with ≥3 years of continuous fee-for-service Medicare enrollment from 2000 to 2012 was assigned an index date 36 months after enrollment separating the time-in-observation period into the look-back and the incidence periods...
January 25, 2017: Pharmacoepidemiology and Drug Safety
Suzanne Nielsen, Natasa Gisev, Raimondo Bruno, Wayne Hall, Milton Cohen, Briony Larance, Gabrielle Campbell, Marian Shanahan, Fiona Blyth, Nicholas Lintzeris, Sallie Pearson, Richard Mattick, Louisa Degenhardt
OBJECTIVE: To assess how well the defined daily dose (DDD) metric reflects opioid utilisation among chronic non-cancer pain patients. DESIGN: Descriptive, cross-sectional study, utilising a 7-day medication diary. SETTING: Community-based treatment settings, Australia. SUBJECTS: A sample of 1101 people prescribed opioids for chronic non-cancer pain. METHODS: Opioid dose data was collected via a self-completed 7-day medication diary capturing names, strengths and doses of each medication taken in the past week...
January 19, 2017: Pharmacoepidemiology and Drug Safety
Yen-Hao Tran, Henk Groen, Jorieke E H Bergman, Eelko Hak, Bob Wilffert
PURPOSE: Our study aimed to investigate the association between prenatal exposure to reactive intermediate (RI)-inducing drugs and the initiation of psychotropic medications among children. METHODS: We designed a cohort study using a pharmacy prescription database. Pregnant women were considered exposed when they received a prescription of RI-inducing drugs. These drugs could be either used alone (RI+/FAA-) or combined with drugs exhibiting folic acid antagonism (FAA, RI+/FAA+)...
January 18, 2017: Pharmacoepidemiology and Drug Safety
Rolf Gedeborg, Bodil Svennblad, Lennart Holm, Hans Sjögren, Carola Bardage, Mark Personne, Gunilla Sjöberg, Nils Feltelius, Björn Zethelius
PURPOSE: To estimate the incidence trend and outcome of paracetamol poisoning, in relation to increased availability of paracetamol from non-pharmacy outlets in 2009. METHOD: Patients' serum paracetamol results over 14 years (2000-2013) from 20 (out of 21) regions in Sweden were linked to national registers of hospital care, cause of death, and prescriptions. Paracetamol poisonings were defined by serum paracetamol levels, hospital diagnoses, or cause of death...
January 13, 2017: Pharmacoepidemiology and Drug Safety
Jan Sieluk, Brittany Palasik, Susan dosReis, Peter Doshi
PURPOSE: Regulators approve written medical information for healthcare professionals and consumers, but the consistency of these sources has not been studied. We investigated the consistency of information regarding four cardiovascular risks of attention-deficit/hyperactivity disorder (ADHD) medications approved in four countries. METHODS: Professional and consumer product labeling for five ADHD medications approved in Australia, Canada, the UK, and the USA were obtained in March/April 2016...
January 13, 2017: Pharmacoepidemiology and Drug Safety
Hyun-Young Lee, Ga-Young Ban, Chang-Gyu Jeong, Ji-Ho Lee, Seung-Hee Park, Sang-Hee Kim, Young-Hee Lee, Young-Min Ye
PURPOSE: Researchers recently suggested intravenous paracetamol as a potential cause of hypotension. We aimed to investigate risk factors of paracetamol- and propacetamol-associated adverse drug reactions (ADRs) in Korean individuals. METHODS: All adverse hypotension cases, regardless of suspected drug, and all ADRs associated with paracetamol and propacetamol use were collected from the Korea Adverse Event Reporting System database between 2011 and 2014. The seriousness, causality, and type of ADR were classified...
January 13, 2017: Pharmacoepidemiology and Drug Safety
Chor-Wing Sing, Ian C K Wong, Bernard M Y Cheung, Johnny C Y Chan, Jody K P Chu, Ching-Lung Cheung
PURPOSE: Drug-induced agranulocytosis is a rare but life-threatening adverse drug reaction. Its epidemiology in Chinese is largely unknown. This study aimed to estimate the incidence, mortality, and risk of the drugs associated with agranulocytosis in Hong Kong Chinese. METHODS: A population-based case-control study was conducted using the Clinical Data Analysis and Reporting System, a database managed by the Hong Kong Hospital Authority. Patients with drug-induced agranulocytosis from 1 January 2004 to 31 December 2013 were identified...
January 13, 2017: Pharmacoepidemiology and Drug Safety
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