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 examine hypotheses from inquiries or publicity. Such responsive evaluations remain essential but may miss latent information on unsuspected risks. Efficient techniques to disclose hidden clusters and associations may emerge through adaptation of approaches from industrial quality control and other disciplines. Data-driven techniques like exploratory analysis, control charts, and time series modeling may help in sifting through accumulated data and in screening consecutive submissions to discern hints of new product hazards or of more specific understanding about previously identified potential side effects. We also need to cultivate non-spontaneous data for hypothesis generation as well as testing, the systematic epidemiologic evaluation of questions and concerns. This hypothesis testing function will assume greater importance if proactive safety surveillance methods yield larger numbers of putatively positive findings. Whether from spontaneous reports or other sources, signals that could have arisen by chance alone usually represent only clues to potential hazards until or unless they can be verified through independent studies.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Bortnichak EA,Wise RP,Salive ME,Tilson HHdoi
10.1002/pds.587keywords:
subject
Has Abstractpub_date
2001-05-01 00:00:00pages
191-6issue
3eissn
1053-8569issn
1099-1557journal_volume
10pub_type
杂志文章,评审abstract:PURPOSE:We developed an adverse events (AEs) reporting form for Korean folk medicine. METHODS:The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. RESULTS:We devel...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4077
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than 1 million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1265
更新日期:2006-09-01 00:00:00
abstract:PURPOSE:Proton pump inhibitor (PPI) may suppress adrenal cortical steroid synthesis and release, thereby leading to electrolyte disturbances. Both hyponatremia and hyperkalemia in the setting of PPI therapy have been documented in case reports. The objective of this study was to examine the association between serum po...
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pub_type: 杂志文章
doi:10.1002/pds.1795
更新日期:2009-09-01 00:00:00
abstract:PURPOSE:Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case-control studies. Recently, pregnancy cohort...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4789
更新日期:2019-07-01 00:00:00
abstract:PURPOSE:We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS:A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3896
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE:The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1838
更新日期:2009-12-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2016-07-01 00:00:00
abstract:OBJECTIVES:The purpose of this study was to generate data regarding the drug utilization pattern in pediatric population of our tertiary care hospital so that we could generate an essential medicine list (EML). BACKGROUND:Drug therapy accounts for a major portion of expenditure toward health care. Reduction in health ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1832
更新日期:2010-04-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1144
更新日期:2005-10-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5088
更新日期:2020-12-01 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
pub_type: 杂志文章
doi:10.1002/pds.1788
更新日期:2009-09-01 00:00:00
abstract:PURPOSE:To examine and compare risks of serious hypoglycemia among antidiabetic monotherapy-treated adults receiving metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione. METHODS:We performed a retrospective cohort study of apparently new users of monotherapy with metformin, glimepiride, glipizide, glyburi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4337
更新日期:2018-01-01 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
pub_type: 杂志文章
doi:10.1002/pds.1896
更新日期:2010-03-01 00:00:00
abstract: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...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4187
更新日期:2017-06-01 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
pub_type: 杂志文章
doi:10.1002/pds.3444
更新日期:2013-07-01 00:00:00
abstract::We review the concept of time-dependent confounding by using the example in paper "Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure" by Desai et al. and illustrate how to adjust for it by using inverse probability of treatment weighting t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
doi:10.1002/pds.2306
更新日期:2012-03-01 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
pub_type: 杂志文章
doi:10.1002/pds.4738
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:To develop a method for identifying the beginning and ending records of pregnancies in the automated medical records of the General Practice Research Database (GPRD). METHODS:Women's records from 1991 to 1999 were searched for codes from 17 pregnancy marker and 7 pregnancy outcome categories. Using the retriev...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.935
更新日期:2004-11-01 00:00:00
abstract:PURPOSE:The objectives of this study were to characterize the validity of algorithms to identify AF from electronic health data through a systematic review of the literature and to identify gaps needing further research. METHODS:Two reviewers examined publications during 1997-2008 that identified patients with atrial ...
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pub_type: 杂志文章,评审
doi:10.1002/pds.2317
更新日期:2012-01-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.816
更新日期:2004-01-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199907)8:4<275::AID-PDS427
更新日期:1999-07-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1778
更新日期:2009-09-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2017
更新日期:2010-11-01 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
pub_type: 杂志文章
doi:10.1002/pds.4387
更新日期:2018-03-01 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
pub_type: 杂志文章
doi:10.1002/pds.1303
更新日期:2007-05-01 00:00:00
abstract:PURPOSE:To determine patterns of United Arab Emirates (UAE) citizen herbal medicine taking. METHODS:Questionnaire survey of UAE citizens attending a primary healthcare clinic in Abu Dhabi. RESULTS:Three hundred and thirty surveys were analysed. Seventy-six per cent (250/330) had previously used herbal products, and o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1591
更新日期:2008-07-01 00:00:00
abstract:PURPOSE:Longitudinal data on prescriptions of antidepressants (AD) in children and adolescents depression are scarce. This study aimed to examine AD prescription trends in children and adolescents in Germany. METHODS:Data of a large statutory health insurance company were analyzed for the period 2005-2012, and outpati...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 历史文章,杂志文章
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更新日期:2014-12-01 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
pub_type: 杂志文章
doi:10.1002/pds.3928
更新日期:2016-03-01 00:00:00
abstract: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 receiv...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4161
更新日期:2017-03-01 00:00:00
abstract::In 1978, a systematic collection of adverse drug reactions (ADRs) was set up in a hospital including several departments and continued for more than 18 years. Quarterly meetings were organized gathering clinicians, students, nurses and pharmacologists to discuss the clinical cases collected each quarter. Approximately...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(sici)1099-1557(199808)7:1+
更新日期:1998-08-01 00:00:00