How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

abstract：:The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable u...

journal_title：Pharmacoepidemiology and drug safety

authors： Califf RM,CERTs Benefit Assessment Workshop Participants.

更新日期：2007-01-01 00:00:00

abstract：PURPOSE:This study aimed to evaluate the risks of upper gastrointestinal (GI) adverse events across a variety of oral and parenteral coxibs and nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in the general population of Taiwan. METHODS:In a case-crossover study, all patients aged ≥20 years who were hospi...

journal_title：Pharmacoepidemiology and drug safety

authors： Chang CH,Chen HC,Lin JW,Kuo CW,Shau WY,Lai MS

更新日期：2011-07-01 00:00:00

abstract：:Analysing duration of treatment episodes has become a standard task in many pharmacoepidemiological studies. However, such analyses are often carried out in a rather simplistic manner and more subtle issues are often ignored. In this paper, methods of analysing duration treatment episodes beyond simple analyses allowi...

journal_title：Pharmacoepidemiology and drug safety

authors： Gichangi A,Andersen M,Kragstrup J,Vach W

更新日期：2006-03-01 00:00:00

abstract：PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...

journal_title：Pharmacoepidemiology and drug safety

authors： Moussally K,Oraichi D,Bérard A

更新日期：2009-06-01 00:00:00

abstract：PURPOSE:First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focu...

journal_title：Pharmacoepidemiology and drug safety

authors： Ikeda J,Kaneko M,Narukawa M

更新日期：2018-12-01 00:00:00

abstract：PURPOSE:To examine whether patient focused drug surveillance was associated with a higher quality of drug treatment at nursing homes. METHODS:An intervention study in four nursing homes in Sweden and four other nursing homes served as controls. At the intervention nursing homes physicians focused on patients' health s...

journal_title：Pharmacoepidemiology and drug safety

authors： Olsson IN,Curman B,Engfeldt P

更新日期：2010-02-01 00:00:00

abstract：PURPOSE:Confounding, a concern in nonexperimental research using administrative claims, is nearly ubiquitous in claims-based pharmacoepidemiology studies. A fixed-length look-back window for assessing comorbidity from claims is common, but it may be advantageous to use all historical claims. We assessed how the strengt...

journal_title：Pharmacoepidemiology and drug safety

authors： Gilbertson DT,Bradbury BD,Wetmore JB,Weinhandl ED,Monda KL,Liu J,Brookhart MA,Gustafson SK,Roberts T,Collins AJ,Rothman KJ

更新日期：2016-03-01 00:00:00

abstract：:Rosiglitazone has previously been widely used to treat patients with type 2 diabetes mellitus, but its safety in terms of cardiovascular morbidity and mortality had been called into question. Recently, there have been doubts raised about the meta-analytic evidence with the regulatory authorities relaxing its restricti...

journal_title：Pharmacoepidemiology and drug safety

authors： Stone JC,Furuya-Kanamori L,Barendregt JJ,Doi SA

更新日期：2015-03-01 00:00:00

abstract：PURPOSE:To investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin-D 24-Hour [C-D 24], the original, round, extended-release formulation) compared to two other tablet formulations of loratadine. METHODS:Pharmacy data of 12 managed care plans were screened...

journal_title：Pharmacoepidemiology and drug safety

authors： Manda B,Drinkard CR,Shatin D,Graham DJ

更新日期：2004-01-01 00:00:00

abstract：PURPOSE:During the past two decades, many novel immunosuppressive drugs have been approved for transplant recipients. Trends in the use of maintenance immunosuppressants after liver transplantation in Asia are unclear. Thus, we aimed to analyze the prescription trends in maintenance immunosuppressive drugs among liver ...

journal_title：Pharmacoepidemiology and drug safety

authors： Huang YY,Hsu CC,Chou CL,Loong CC,Wu MS,Chou YC

更新日期：2016-06-01 00:00:00

abstract：PURPOSE:To define periods of acceptable mortality reporting in primary care and to demonstrate through examples the implication for research using automated medical data. METHODS:Annual death counts were obtained for each primary care practice participating in The Health Improvement Network "THIN" (UK). Expected count...

journal_title：Pharmacoepidemiology and drug safety

authors： Maguire A,Blak BT,Thompson M

更新日期：2009-01-01 00:00:00

abstract：:Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....

journal_title：Pharmacoepidemiology and drug safety

authors： Slattery J,Kurz X

更新日期：2020-10-01 00:00:00

abstract：BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...

journal_title：Pharmacoepidemiology and drug safety

authors： Delaney JA,McClelland RL,Furberg CD,Cooper R,Shea S,Burke G,Psaty BM

更新日期：2009-09-01 00:00:00

abstract：PURPOSE:This paper introduces an improved tool for designing matched-pairs randomized trials. The tool allows the incorporation of clinical and other knowledge regarding the relative importance of variables used in matching and allows for multiple types of missing data. The method is illustrated in the context of a clu...

journal_title：Pharmacoepidemiology and drug safety

authors： Greevy RA Jr,Grijalva CG,Roumie CL,Beck C,Hung AM,Murff HJ,Liu X,Griffin MR

更新日期：2012-05-01 00:00:00

abstract：PURPOSE:Following safety concerns regarding trimetazidine, the European Medicines Agency (EMA) recommended restrictions on its use. Our objective was to determine the impact of regulatory actions on trimetazidine utilization in Portugal. METHODS:Retrospective interrupted time-series analysis of monthly ambulatory phar...

journal_title：Pharmacoepidemiology and drug safety

authors： Pinto D,Silva A,Heleno B,Rodrigues DS,Santos I,Caetano PA

更新日期：2018-09-01 00:00:00

abstract：PURPOSE:The Canadian Network for Observational Drug Effect Studies (CNODES), a network of pharmacoepidemiologists and other researchers from seven provincial sites, provides evidence on the benefits and risks of drugs used by Canadians. The Knowledge Translation Team, one of CNODES' four main teams, evaluates the impac...

journal_title：Pharmacoepidemiology and drug safety

authors： Sketris IS,Carter N,Traynor RL,Watts D,Kelly K,following contributing members of the CNODES Knowledge Translation Team: Pierre Ernst, JM Gamble, Brenda Hemmelgarn, Colleen Metge, Michael Paterson, Robert Platt W. and Gary Teare.

更新日期：2020-01-01 00:00:00

abstract：PURPOSE:The thorough analysis of special drug characteristics requires information on the specific brand of a drug. This information is often not sought in pharmacoepidemiologic surveys although in many countries packages are labelled with an unequivocal code (in Germany called Pharmazentralnummer (PZN)). We aimed to a...

journal_title：Pharmacoepidemiology and drug safety

authors： Quinzler R,Schmitt SP,Szecsenyi J,Haefeli WE

更新日期：2007-09-01 00:00:00

abstract：BACKGROUND:Studies demonstrate the potential for statins to prevent dementia and Alzheimer's disease (AD), but the evidence is inconclusive. OBJECTIVE:Conduct a meta-analysis to estimate any benefit of statins in preventing dementia and examine the potential effect of study design and confounding on the benefit of sta...

journal_title：Pharmacoepidemiology and drug safety

authors： Wong WB,Lin VW,Boudreau D,Devine EB

更新日期：2013-04-01 00:00:00

abstract：PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...

journal_title：Pharmacoepidemiology and drug safety

authors： Pradel V,Tardieu S,Micallef J,Signoret A,Villano P,Gauthier L,Vanelle P,Blin O,Albumin Study Group.

更新日期：2007-01-01 00:00:00

abstract：BACKGROUND:Despite numerous clinical guidelines on asthma management, patients often receive suboptimal drug therapy. This study identified patients who received suboptimal regimens according to the National Heart, Lung and Blood Institute (NHLBI) Guidelines for the Diagnosis and Management of Asthma in a complete popu...

journal_title：Pharmacoepidemiology and drug safety

authors： Zhang T,Smith MA,Camp PG,Carleton BC

更新日期：2013-07-01 00:00:00

abstract：PURPOSE:Residual confounding is a potential limitation of pharmacoepidemiologic studies, and in particular, studies based on administrative claims data that do not capture lifestyle and clinical confounders. We describe an application of the case-cohort design to assess residual confounding by thromboembolic risk facto...

journal_title：Pharmacoepidemiology and drug safety

authors： Eng PM,Seeger JD,Loughlin J,Clifford CR,Mentor S,Walker AM

更新日期：2008-03-01 00:00:00

abstract：PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...

journal_title：Pharmacoepidemiology and drug safety

authors： Hirota S,Yamaguchi T

更新日期：2018-11-01 00:00:00

abstract：:Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strategies to seek signals. In our more familiar 'reactive' mode, we...

journal_title：Pharmacoepidemiology and drug safety

authors： Bortnichak EA,Wise RP,Salive ME,Tilson HH

更新日期：2001-05-01 00:00:00

abstract：BACKGROUND:Current methods for prospective drug safety monitoring focus on determining whether and when to generate safety alerts indicating that a new drug may be less safe than a comparator. Approaches are needed to develop safety thresholds that can be used to define whether a new drug is no less than or equally saf...

journal_title：Pharmacoepidemiology and drug safety

authors： Wangge G,Schneeweiss S,Glynn RJ,Gagne JJ

更新日期：2016-07-01 00:00:00

abstract：:There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in commun...

journal_title：Pharmacoepidemiology and drug safety

authors： Bourke A,Bate A,Sauer BC,Brown JS,Hall GC

更新日期：2016-07-01 00:00:00

abstract：BACKGROUND:The Epidemiologic Registry of Cystic Fibrosis (ERCF) was a multicentre, longitudinal follow-up project of cystic fibrosis patients enrolled at some 200 centres in nine European countries between 1994 and 1999. PURPOSE:We aimed to assess and improve the quality of a subset of data from the ERCF relating to s...

journal_title：Pharmacoepidemiology and drug safety

authors： Strobl J,Enzer I,Bagust A,Haycox A,Smyth R,Ashby D,Walley T

更新日期：2003-09-01 00:00:00

abstract：PURPOSE:De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claim...

journal_title：Pharmacoepidemiology and drug safety

authors： Lund JL,Kuo TM,Brookhart MA,Meyer AM,Dalton AF,Kistler CE,Wheeler SB,Lewis CL

更新日期：2019-05-01 00:00:00

abstract：:When a biological hypothesis of causal effect can be inferred, the hypothesis can sometimes be tested in the selfsame database that gave rise to the study data from which the hypothesis grew. Valid testing happens when the inferred biological hypothesis has scientific implications that predict new relations between ob...

journal_title：Pharmacoepidemiology and drug safety

authors： Walker AM

更新日期：2010-05-01 00:00:00

abstract：PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...

journal_title：Pharmacoepidemiology and drug safety

authors： Trifirò G,Barbui C,Spina E,Moretti S,Tari M,Alacqua M,Caputi AP,UVEC group.,Arcoraci V

更新日期：2007-05-01 00:00:00

abstract：PURPOSE:In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. METHODS:Aggregated demographic, clinical, and prescription data from eight databases in four countri...

journal_title：Pharmacoepidemiology and drug safety

authors： Coloma PM,Schuemie MJ,Trifirò G,Gini R,Herings R,Hippisley-Cox J,Mazzaglia G,Giaquinto C,Corrao G,Pedersen L,van der Lei J,Sturkenboom M,EU-ADR Consortium.

更新日期：2011-01-01 00:00:00