A critical review of methods to evaluate the impact of FDA regulatory actions.

abstract：AIM:To determine the contribution of patients' adverse drug reaction (ADR) reports to signals detection, through a study of the signals sent by Lareb to the Dutch Medicines Evaluation Board. METHODS:The percentage of patient's ADR reports contributing to generate signals of adverse drug reactions was determined. A cas...

journal_title：Pharmacoepidemiology and drug safety

authors： van Hunsel F,Talsma A,van Puijenbroek E,de Jong-van den Berg L,van Grootheest K

更新日期：2011-03-01 00:00:00

abstract：PURPOSE:To examine and compare the quality of drug prescribing for older patients in nursing homes and home nursing services. METHODS:Cross-sectional study comprising 11,254 patients aged ≥ 65 years in nursing homes (n = 2986) and home nursing services (n = 8268). Potentially inappropriate medications were identified ...

journal_title：Pharmacoepidemiology and drug safety

authors： Halvorsen KH,Granas AG,Engeland A,Ruths S

更新日期：2012-09-01 00:00:00

abstract：PURPOSE:The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP-National Formulary (USP-NF) quality monographs. Because the veracity of dietary supplement adverse event repor...

journal_title：Pharmacoepidemiology and drug safety

authors： Gardiner P,Sarma DN,Low Dog T,Barrett ML,Chavez ML,Ko R,Mahady GB,Marles RJ,Pellicore LS,Giancaspro GI

更新日期：2008-10-01 00:00:00

abstract：PURPOSE:Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveil...

journal_title：Pharmacoepidemiology and drug safety

authors： Brown JS,Kulldorff M,Chan KA,Davis RL,Graham D,Pettus PT,Andrade SE,Raebel MA,Herrinton L,Roblin D,Boudreau D,Smith D,Gurwitz JH,Gunter MJ,Platt R

更新日期：2007-12-01 00:00:00

abstract：:Denmark has one of the worlds most comprehensive registration of its citizens' use of medical and social services. Most databases are population-based and of very high quality. Virtually all employ a mutual person identifier, which renders it technically possible to link any of them with others. There are two prescrip...

journal_title：Pharmacoepidemiology and drug safety

authors： Hallas J

更新日期：2001-12-01 00:00:00

abstract：PURPOSE:Concomitant use of anti-dementia drugs with psychotropic drugs is potentially problematic in patients with dementia. The aim of this study was to investigate how frequently patients in Norway use anti-dementia drugs concomitantly with psychotropic drugs. METHODS:Analyses are based on data from the Norwegian Pr...

journal_title：Pharmacoepidemiology and drug safety

authors： Langballe EM,Engdahl B,Selbaek G,Nordeng H

更新日期：2011-12-01 00:00:00

abstract：AIM:The aim of the present study was to investigate to what extent patients using prescription antiobesity drugs (orlistat, sibutramine and rimonabant) concomitantly or concurrently used psychotropic drugs and analgesics and the association between this drug use and the patients' gender and age. An additional aim was t...

journal_title：Pharmacoepidemiology and drug safety

authors： Amundsen MO,Engdahl B,Berg C,Nordeng H

更新日期：2010-03-01 00:00:00

abstract：PURPOSE:To study adult height in children that grew up with asthma before inhaled steroids became first-line therapy. METHODS:Data from the Swedish Medical Birth Register (self-reported asthma) and the Hospital Discharge Register (first hospitalization for asthma) were used, to compare adult height for asthmatic and n...

journal_title：Pharmacoepidemiology and drug safety

authors： Norjavaara E,Gerhardsson de Verdier M,Lindmark B

更新日期：2001-03-01 00:00:00

abstract：PURPOSE:Under EU regulations, patient information leaflets (PILs) are required to be clear and understandable. Negations (e.g., not, no) are a linguistic aspect that may impact PIL comprehension, yet go unmentioned in these regulations. We conducted two studies to determine (1) how negations are used in Dutch PILs (stu...

journal_title：Pharmacoepidemiology and drug safety

authors： Burgers C,Beukeboom CJ,Sparks L,Diepeveen V

更新日期：2015-02-01 00:00:00

abstract：OBJECTIVE:As covariates are not always adequately balanced after propensity score matching and double- adjustment can be used to remove residual confounding, we compared the performance of several double-robust estimators in different scenarios. METHODS:We conducted a series of Monte Carlo simulations on virtual obser...

journal_title：Pharmacoepidemiology and drug safety

authors： Nguyen TL,Collins GS,Spence J,Devereaux PJ,Daurès JP,Landais P,Le Manach Y

更新日期：2017-12-01 00:00:00

abstract：PURPOSE:To evaluate the extent, characteristics and determinants of adverse drug reaction (ADR)-related hospitalisations on a population-based level in 2003. METHODS:We performed a cohort study in the Integrated Primary Care Information (IPCI) database, a general practitioners (GPs) research database with longitudinal...

journal_title：Pharmacoepidemiology and drug safety

authors： van der Hooft CS,Dieleman JP,Siemes C,Aarnoudse AJ,Verhamme KM,Stricker BH,Sturkenboom MC

更新日期：2008-04-01 00:00:00

abstract：PURPOSE:Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS:The study was performed in three US managed care o...

journal_title：Pharmacoepidemiology and drug safety

authors： Harrold LR,Patterson MK,Andrade SE,Dube T,Go AS,Buist AS,Chan KA,Weller PF,Wechsler ME,Yood RA,Davis KJ,Platt R,Walker AM

更新日期：2007-06-01 00:00:00

abstract：BACKGROUND:Current guidelines for the empiric treatment of uncomplicated urinary tract infection in women recommend that first-line trimethoprim-sulfamethoxazole (TMP-SMX) or ofloxacin be given for 3 days and nitrofurantoin for 5 days. Increasing the duration of treatment raises costs, and perhaps, the incidence of adv...

journal_title：Pharmacoepidemiology and drug safety

authors： Kahan NR,Chinitz DP,Kahan E

更新日期：2004-04-01 00:00:00

abstract：UNLABELLED:Computerized hospital databases are used for clinical and economic research. In France, the hospital administrative database, Programme de médicalisation des systèmes d'information (PMSI), could be an interesting means for identifying cases of abuse and dependence in hospitals. PURPOSE:To assess the capabil...

journal_title：Pharmacoepidemiology and drug safety

authors： Daveluy A,Miremont-Salamé G,Kostrzewa A,Couret A,Lacoin L,Lecomte C,Moore N,Gilleron V,Haramburu F

更新日期：2012-12-01 00:00:00

abstract：PURPOSE:Quantitative benefit-risk (B-R) assessments are used to characterize treatment by combining key benefits and risks into a single metric but have historically been done for the "average" patient. Our aim was to conduct an individualized assessment for the oral antiplatelet vorapaxar by combining trial and real-w...

journal_title：Pharmacoepidemiology and drug safety

authors： Pinto CA,Tervonen T,Marsh K,Lambrelli D,Schultze A,Tershakovec A,Hyacinthe J,Prawitz T,Hammad TA

更新日期：2019-04-01 00:00:00

abstract：OBJECTIVE:To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS:We used the principal factor analysis to identify the underlying dimensions or domains o...

journal_title：Pharmacoepidemiology and drug safety

authors： Martirosyan L,Haaijer-Ruskamp FM,Braspenning J,Denig P

更新日期：2012-10-01 00:00:00

abstract：OBJECTIVE:Outcome misclassification may occur in observational studies using administrative databases. We evaluated a two-step multiple imputation approach based on complementary internal validation data obtained from two subsamples of study participants to reduce bias in hazard ratio (HR) estimates in Cox regressions....

journal_title：Pharmacoepidemiology and drug safety

authors： Ni J,Leong A,Dasgupta K,Rahme E

更新日期：2017-08-01 00:00:00

abstract：PURPOSE:To identify and quantify risk factors associated with preterm birth, stratified by gestational age at birth. METHODS:Three case-control analyses were done. Controls were pregnancies of > or =37 weeks of gestational age at birth. Cases were defined as: <28, 28-32, 33- <37 weeks of gestational age at birth respe...

journal_title：Pharmacoepidemiology and drug safety

authors： Ofori BD,Le Tiec M,Bérard A

更新日期：2008-06-01 00:00:00

abstract：PURPOSE:We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug lice...

journal_title：Pharmacoepidemiology and drug safety

authors： Ye X,Fu Z,Wang H,Du W,Wang R,Sun Y,Gao Q,He J

更新日期：2009-02-01 00:00:00

abstract：PURPOSE:Determining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-depend...

journal_title：Pharmacoepidemiology and drug safety

authors： Austin PC,Park-Wyllie LY,Juurlink DN

更新日期：2014-08-01 00:00:00

abstract：PURPOSE:The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS:Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate an...

journal_title：Pharmacoepidemiology and drug safety

authors： Schuerch M,Gasse C,Robinson NJ,Alvarez Y,Walls R,Mors O,Christensen J,Hesse U,de Groot M,Schlienger R,Reynolds R,Klungel O,de Vries F

更新日期：2016-03-01 00:00:00

abstract：:The following article from Pharmacoepidemiology and Drug Safety, “Epidemiological evaluation of intraoperative antibiosis as a protective agent against endophthalmitis after cataract surgery” by F. Krummenauer, S. Kurz and H.B. Dick, published online on July 11 2006 inWiley Online Library (wileyonlinelibrary.com), has...

journal_title：Pharmacoepidemiology and drug safety

authors：

更新日期：2013-02-01 00:00:00

abstract：PURPOSE:To determine the risk factors and rate of medication administration error (MAE) alerts by analyzing large-scale medication administration data and related error logs automatically recorded in a closed-loop medication administration system using radio-frequency identification and barcodes. METHODS:The subject h...

journal_title：Pharmacoepidemiology and drug safety

authors： Hwang Y,Yoon D,Ahn EK,Hwang H,Park RW

更新日期：2016-12-01 00:00:00

abstract：PURPOSE:Because health insurance claims lack clinical information, comparative effectiveness research studies that rely on these data may be challenging to interpret and may result in biased inference. We conducted an exploratory study to determine if medical information contained in patient charts could offer clinical...

journal_title：Pharmacoepidemiology and drug safety

authors： Croghan TW,Esposito D,Daniel G,Wahl P,Stoto MA

更新日期：2010-08-01 00:00:00

abstract：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 ma...

journal_title：Pharmacoepidemiology and drug safety

authors： Suarez EA,Landi SN,Conover MM,Jonsson Funk M

更新日期：2018-03-01 00:00:00

abstract：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 oth...

journal_title：Pharmacoepidemiology and drug safety

authors： Pazzagli L,Linder M,Zhang M,Vago E,Stang P,Myers D,Andersen M,Bahmanyar S

更新日期：2018-02-01 00:00:00

abstract：PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...

journal_title：Pharmacoepidemiology and drug safety

authors： Qureshi ZP,Seoane-Vazquez E,Rodriguez-Monguio R,Stevenson KB,Szeinbach SL

更新日期：2011-07-01 00:00:00

abstract：PURPOSE:The use of prescription opioid analgesics has been increasing over the last few decades in Australia. In particular, oxycodone and fentanyl have increased substantially. We examined the gender and age trends in the prescribing of subsidised opioid analgesics in the Australian population for non-palliative care ...

journal_title：Pharmacoepidemiology and drug safety

authors： Hollingworth SA,Gray PD,Hall WD,Najman JM

更新日期：2015-06-01 00:00:00

abstract：INTRODUCTION:Cancer-related fatigue (CRF) has been suggested to be associated with the occurrence of chemotherapy-induced nausea and vomiting (CINV). This study aims to evaluate the potential of CRF in predicting the occurrence of CINV. METHOD:This is a prospective, observational study. Recruited patients received mod...

journal_title：Pharmacoepidemiology and drug safety

authors： Poon KS,Un MK,Low XH,Cheung YT,Yap KY,Chan A

更新日期：2013-12-01 00:00:00

abstract：PURPOSE:To evaluate the frequency, severity and preventability of warfarin-induced cerebral haemorrhages due to warfarin and warfarin-drug interactions in patients living in the county of Ostergötland, Sweden. METHODS:All patients with a diagnosed cerebral haemorrhage at three hospitals during the period 2000-2002 wer...

journal_title：Pharmacoepidemiology and drug safety

authors： Jönsson AK,Spigset O,Jacobsson I,Hägg S

更新日期：2007-03-01 00:00:00