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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28815982/bridge-the-gap-the-need-for-harmonized-regulatory-and-ethical-standards-for-postmarketing-observational-studies
#1
REVIEW
Hisashi Urushihara, Louise Parmenter, Shimon Tashiro, Kenji Matsui, Nancy Dreyer
Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815803/validity-of-cancer-diagnosis-in-the-national-health-insurance-database-compared-with-the-linked-national-cancer-registry-in-taiwan
#2
Wei-Heng Kao, Ji-Hong Hong, Lai-Chu See, Huang-Ping Yu, Jun-Te Hsu, I-Jun Chou, Wen-Chi Chou, Meng-Jiun Chiou, Chun-Chieh Wang, Chang-Fu Kuo
PURPOSE: We aimed to evaluate the validity of cancer diagnosis in the National Health Insurance (NHI) database, which has routinely collected the health information of almost the entire Taiwanese population since 1995, compared with the Taiwan National Cancer Registry (NCR). METHODS: There were 26,542,445 active participants registered in the NHI database between 2001 and 2012. National Cancer Registry and NHI database records were compared for cancer diagnosis; date of cancer diagnosis; and 1, 2, and 5 year survival...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815800/a-method-for-data-driven-exploration-to-pinpoint-key-features-in-medical-data-and-facilitate-expert-review
#3
Kristina Juhlin, Kristina Star, G Niklas Norén
PURPOSE: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815799/characterization-of-opioid-use-in-sickle-cell-disease
#4
Jin Han, Jifang Zhou, Santosh L Saraf, Victor R Gordeuk, Gregory S Calip
PURPOSE: Opioid analgesics are commonly used to treat vaso-occlusive pain episodes in sickle cell disease (SCD), but comprehensive evidence characterizing opioid use in this patient population is limited. Our objective was to characterize opioid use patterns among SCD patients using a large nationwide database. METHODS: A large, US medical claims database was utilized to identify a cohort of 3882 SCD patients, and characteristics of opioid use were analyzed. Clinical variables including age, gender, medication use, health care utilization, and medical history were evaluated for correlations with opioid use...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815791/risk-of-preeclampsia-after-gestational-exposure-to-selective-serotonin-reuptake-inhibitors-and-other-antidepressants-a-study-from-the-norwegian-mother-and-child-cohort-study
#5
Angela Lupattelli, Mollie Wood, Kate Lapane, Olav Spigset, Hedvig Nordeng
PURPOSE: To describe the risk of early- and late-onset preeclampsia across pregnancies exposed to antidepressants and to evaluate the impact of timing and length of gestational exposure to antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), on preeclampsia. METHODS: The Norwegian Mother and Child Cohort, a prospective population-based study, and the Medical Birth Registry of Norway provided information on antidepressant exposure, depression, and anxiety symptoms in pregnancy, preeclampsia diagnoses, and important covariates...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28812323/a-comparison-of-methods-for-estimating-the-temporal-change-in-a-continuous-variable-example-of-hba1c-in-patients-with-diabetes
#6
Therese Sheppard, Robyn Tamblyn, Michal Abrahamowicz, Mark Lunt, Matthew Sperrin, William G Dixon
PURPOSE: To compare the more complex technique, functional principal component analysis (FPCA), to simpler methods of estimating values of sparse and irregularly spaced continuous variables at given time points in longitudinal data using a diabetic patient cohort from UK primary care. METHODS: The setting for this study is the Clinical Practice Research Datalink (CPRD), a UK general practice research database. For 16,034 diabetic patients identified in CPRD, with at least 2 measures in a 30-month period, HbA1c was estimated after temporarily omitting (i) the final and (ii) middle known values using linear interpolation, simple linear regression, arithmetic mean, random effects, and FPCA...
August 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28809087/spontaneous-reporting-of-suspected-narcolepsy-after-vaccination-against-pandemic-influenza-a-h1n1-in-germany
#7
Doris Oberle, Jutta Pavel, Brigitte Keller-Stanislawski
PURPOSE: We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix® vaccination notified to the Paul-Ehrlich-Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher than expected when compared with the prepandemic background incidence rates. METHODS: ICSR of narcolepsy after vaccination with Pandemrix® notified to the PEI until September 2016 were reviewed and validated according to the criteria of narcolepsy defined by the Brighton Collaboration (BC)...
August 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28809079/changes-in-the-use-of-erythropoiesis-stimulating-agents-esas-and-red-blood-cell-transfusion-in-patients-with-cancer-amidst-regulatory-and-reimbursement-changes
#8
Prasad L Gawade, Jesse A Berlin, David H Henry, Dianne Tomita, Barry D Brooks, Janet Franklin, Brian D Bradbury, Cathy W Critchlow
PURPOSE: Evaluate changes in use of erythropoiesis-stimulating agents (ESAs) and red blood cell transfusion in cancer patients receiving myelosuppressive chemotherapy following regulatory and reimbursement actions. METHODS: Calendar year patient cohorts (2005-2013) with breast, colorectal, lung, multiple myeloma, non-Hodgkin lymphoma, ovarian, or prostate cancer and receiving myelosuppressive chemotherapy were identified within the Marketscan database. Incidence of ESA treatment and transfusion were estimated in each year, as was median number of ESA administrations...
August 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28799295/application-of-the-stopp-start-criteria-to-a-medical-record-database
#9
Katinka J Nauta, Feikje Groenhof, Jan Schuling, Jacqueline G Hugtenburg, Hein P J van Hout, Flora M Haaijer-Ruskamp, Petra Denig
PURPOSE: The STOPP/START criteria are increasingly used to assess prescribing quality in elderly patients at practice level. Our aim was to test computerized algorithms for applying these criteria to a medical record database. METHODS: STOPP/START criteria-based computerized algorithms were defined using Anatomical-Therapeutic-Chemical (ATC) codes for medication and International Classification of Primary Care (ICPC) codes for diagnoses. The algorithms were applied to a Dutch primary care database, including patients aged ≥65 years using ≥5 chronic drugs...
August 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28799226/educational-intervention-on-medication-reviews-aiming-to-reduce-acute-healthcare-consumption-in-elderly-patients-with-potentially-inappropriate-medicines-a-pragmatic-open-label-cluster-randomized-controlled-trial-in-primary-care
#10
K Schmidt-Mende, M Andersen, B Wettermark, J Hasselström
PURPOSE: Potentially inappropriate medicines (PIMs) may cause 10% of unplanned admissions in elderly people. We performed an educational intervention in primary care to reduce acute health care consumption and PIMs through the promotion of medication reviews (MRs) in elderly patients. METHODS: This cluster-randomized controlled trial was conducted in the context of an official campaign promoting rational drug use in elderly people. Sixty-nine primary health care practices with 119,910 patients aged older than or equal to 65 were randomized, with 1 dropout in the intervention group...
August 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28799214/refill-adherence-and-persistence-to-lipid-lowering-medicines-in-patients-with-type-2-diabetes-a-nation-wide-register-based-study
#11
Sofia Axia Karlsson, Christel Hero, Björn Eliasson, Stefan Franzén, Ann-Marie Svensson, Mervete Miftaraj, Soffia Gudbjörnsdottir, Katarina Eeg-Olofsson, Karolina Andersson Sundell
PURPOSE: This study aimed to describe and compare refill adherence and persistence to lipid-lowering medicines in patients with type 2 diabetes by previous cardiovascular disease (CVD). METHODS: We followed 97 595 patients (58% men; 23% with previous CVD) who were 18 years of age or older when initiating lipid-lowering medicines in 2007-2010 until first fill of multi-dose dispensed medicines, death, or 3 years. Using personal identity numbers, we linked individuals' data from the Swedish Prescribed Drug Register, the Swedish National Diabetes Register, the National Patient Register, the Cause of Death Register, and the Longitudinal Integration Database for Health Insurance and Labour Market Studies...
August 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28799196/combining-evidence-from-multiple-electronic-health-care-databases-performances-of-one-stage-and-two-stage-meta-analysis-in-matched-case-control-studies
#12
Fabiola La Gamba, Giovanni Corrao, Silvana Romio, Miriam Sturkenboom, Gianluca Trifirò, Tania Schink, Maria de Ridder
PURPOSE: Clustering of patients in databases is usually ignored in one-stage meta-analysis of multi-database studies using matched case-control data. The aim of this study was to compare bias and efficiency of such a one-stage meta-analysis with a two-stage meta-analysis. METHODS: First, we compared the approaches by generating matched case-control data under 5 simulated scenarios, built by varying: (1) the exposure-outcome association; (2) its variability among databases; (3) the confounding strength of one covariate on this association; (4) its variability; and (5) the (heterogeneous) confounding strength of two covariates...
August 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28771942/patterns-of-abuse-and-routes-of-administration-for-immediate-release-hydrocodone-combination-products
#13
Theresa A Cassidy, Natasha Oyedele, Travis C Mickle, Sven Guenther, Simon H Budman
PURPOSE: Prescriptions for hydrocodone immediate-release (IR) combination products have recently decreased, yet they represent the majority of opioid prescriptions dispensed and are commonly abused analgesics among both adults and adolescents. Little data exist to understand the contribution of IR products to the problem of prescription opioid abuse. This study aimed to better understand abuse patterns for hydrocodone IR combination products among adult and adolescent substance abusers...
August 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28771933/impact-of-clinical-evidence-communications-and-drug-regulation-changes-concerning-rosiglitazone-on-prescribing-patterns-of-antidiabetic-therapies
#14
Yoojin Noh, Dae Ryong Kang, Dae Jung Kim, Kwang Jae Lee, Sukhyang Lee, Sooyoung Shin
PURPOSE: Cardiovascular safety alerts about rosiglitazone resulted in regulatory actions in several countries in 2010, but the Food and Drug Administration eliminated access restrictions in 2013, reflecting new evidence concerning the drug safety. We investigated the effects of safety signals and regulation shifts concerning rosiglitazone on prescribing of antidiabetic drugs (ADs). METHODS: Patient data were extracted from the Korean health insurance claims database for 2007 to 2015...
August 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28771890/metamizole-use-during-first-trimester-a-prospective-observational-cohort-study-on-pregnancy-outcome
#15
Katarina Dathe, Stephanie Padberg, Stefanie Hultzsch, Katja Meixner, Tatjana Tissen-Diabaté, Reinhard Meister, Evelin Beck, Christof Schaefer
INTRODUCTION: The analgesic metamizole (dipyrone) is not recommended during pregnancy due to limited experience. In several countries, metamizole has no market authorization because of agranulocytosis as a rare but severe adverse effect. However, in others, metamizole is available and widely used as a pain reliever, and its use occurs also during pregnancy, often followed by fears of potential teratogenic risk. METHODS: This prospective observational cohort study compared pregnancy outcomes of 446 women exposed with metamizole in the first trimester with a randomly selected control cohort comprising 887 women not exposed to metamizole...
August 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28771878/national-trends-in-use-and-costs-of-oral-anticancer-drugs-in-france-an-8-year-population-based-study
#16
Pauline Bosco-Lévy, Paul de Boissieu, Amandine Gouverneur, Pernelle Noize, Mathieu Molimard, Annie Fourrier-Réglat, Julien Bezin
PURPOSE: During the last decade, many oral anticancer drugs (OAcDs) have been marketed, providing interesting but potentially costly pharmaceutical alternatives to intravenous treatments. This study aims to provide updated information on their use and costs. METHODS: A cross-sectional yearly repeated study was conducted from 2006 to 2014 using the representative sample of the French national health care insurance system claims database (EGB). OAcD use was described for each year, among prevalent (ie, patients with at least 1 OAcD reimbursement) and incident users (ie, patients with no OAcD reimbursement within the prior year) and according to their pharmacological classes (Hormone Therapy [HT], Cytotoxic Therapy [CT], Targeted Therapy [TT], and others)...
August 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28758289/changes-in-misuse-and-abuse-of-prescription-opioids-following-implementation-of-extended-release-and-long-acting-opioid-analgesic-risk-evaluation-and-mitigation-strategy
#17
Becki Bucher Bartelson, M Claire Le Lait, Jody L Green, M Soledad Cepeda, Paul M Coplan, Jean-Yves Maziere, Gregory P Wedin, Richard C Dart
PURPOSE: An unintended consequence of extended-release (ER) and long-acting (LA) prescription opioids is that these formulations can be more attractive to abusers than immediate-release (IR) formulations. The US Food and Drug Administration recognized these risks and approved the ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (ER/LA REMS), which has a goal of reducing opioid misuse and abuse and their associated consequences. The primary objective of this analysis is to determine whether ER/LA REMS implementation was associated with decreased reports of misuse and abuse...
July 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28758284/new-oral-anticoagulant-prescription-rate-and-risk-of-bleeding-in-an-italian-region
#18
Francesca Valent
PURPOSE: The purpose of this study was to measure the prescription rate of new oral anticoagulants (NOACs) and to investigate whether there is an increased risk of bleeding associated with these medications in the 1 220 000-inhabitant Italian region Friuli Venezia Giulia. METHODS: The administrative data of the Regional Health Information System, linkable with each other at the individual patient level through an anonymous stochastic key, were used as the source of information...
July 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28758274/pregnancy-and-infant-outcomes-including-major-congenital-malformations-among-women-with-chronic-inflammatory-arthritis-or-psoriasis-with-and-without-etanercept-use
#19
Wendy J Carman, Neil A Accortt, Mary S Anthony, Janet Iles, Cheryl Enger
PURPOSE: Objectives were to quantify prevalence estimates of pregnancy and infant outcomes including major congenital malformations (MCMs) by etanercept (ETN) exposure among infants born to women with chronic inflammatory arthritis (cIA) or psoriasis (PsO). METHODS: Claims-based data delineated pregnancy exposures and outcomes of live or nonlive births among women with cIA and PsO (ETN exposed, unexposed) and general population (GP) comparators. Infant outcomes were determined for live-born infants covered by the mother's insurer...
July 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28758270/prescription-drug-use-during-pregnancy-in-france-a-study-from-the-national-health-insurance-permanent-sample
#20
Romain Demailly, Sylvie Escolano, Catherine Quantin, Pascale Tubert-Bitter, Ismaïl Ahmed
PURPOSE: To provide an up-to-date account of drug prescription during pregnancy in France from 2011 to 2014 using the permanent sample of the French national computerized healthcare database and with a focus on recommended supplementations, fetotoxic drugs and teratogenic drugs. METHODS: All pregnancies identified by the International Classification of Diseases, 10th Revision codes list in the hospitalization database, lasting more than 9 weeks of amenorrhea and whose delivery occurred between 01/01/2011 and 12/31/2014, were included...
July 30, 2017: Pharmacoepidemiology and Drug Safety
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