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 surveillance and (2) identify key methodological issues related to the use of healthcare claims data for real-time drug safety surveillance. METHODS:We assessed the ability to detect ADEs using historical data from nine health plans involved in the HMO Research Network's Center for Education and Research on Therapeutics (CERT). Analyses were performed using a maximized sequential probability ratio test (maxSPRT). Five drug-event pairs representing known associations with an ADE and two pairs representing 'negative controls' were analyzed. RESULTS:Statistically significant (p < 0.05) signals of excess risk were found in four of the five drug-event pairs representing known associations; no signals were found for the negative controls. Signals were detected between 13 and 39 months after the start of surveillance. There was substantial variation in the number of exposed and expected events at signal detection. CONCLUSIONS:Prospective, periodic evaluation of routinely collected data can provide population-based estimates of medication-related adverse event rates to support routine, timely post-marketing surveillance for selected ADEs.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
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 Rdoi
10.1002/pds.1509subject
Has Abstractpub_date
2007-12-01 00:00:00pages
1275-84issue
12eissn
1053-8569issn
1099-1557journal_volume
16pub_type
杂志文章abstract:PURPOSE:The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered d...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2133
更新日期:2011-06-01 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:Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear u...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4394
更新日期:2018-04-01 00:00:00
abstract:PURPOSE:A case-control study is the most powerful design to test the risk of specific congenital malformations associated with a specific drug. However, malformation registries often lack non-malformed controls. For the Dutch EUROCAT, we collected a non-malformed control group: the 'Healthy Pregnant'. The aim of this s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2254
更新日期:2011-11-01 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: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
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.804
更新日期:2003-09-01 00:00:00
abstract:PURPOSE:In pharmacoepidemiology, one of the main concerns is analysis of drug exposure time. However, in real-life settings, patient's behavior is complex and characterized by drug exposure dynamics. Multi-state models allow assessing the probabilities of various patterns, instead of just continuous use and/or disconti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3835
更新日期:2015-09-01 00:00:00
abstract:PURPOSE:Risk assessment for natural health products (NHPs) may not be evaluated similarly to therapeutic products by Health Canada in terms of notification of harms to consumers and health professionals. In this descriptive study, we evaluated risk communications (RCs) issued by Health Canada for NHPs and for therapeut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2137
更新日期:2011-10-01 00:00:00
abstract:PURPOSE:To investigate pattern and extent of adverse drug reactions (ADRs) associated with AEDs and to identify safer options for treatment of epilepsy. METHOD:Study was a retrospective, cross-sectional survey. Data from patients with epilepsy at the out-patient and in-patient of Neurology Department was collected in ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1540
更新日期:2008-08-01 00:00:00
abstract:PURPOSE:To optimize the efficiency of signal detection by maximizing the proportion of true positive (TP) signals among signals detected by a disproportionality algorithm. METHODS:We compared 176 different combinations of stratification factors, sex (S), age (A), region (R) and year of report (Y), and cut-off values o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2013-05-01 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
pub_type: 杂志文章,评审
doi:10.1002/pds.1627
更新日期:2008-10-01 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
pub_type: 杂志文章
doi:10.1002/pds.3767
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:Laboratory technicians, laboratory supervisors, decontamination/remediation workers, and environmental investigators are at increased risk for repeated occupational exposure to Bacillus anthracis. In 2002, the Advisory Committee on Immunization Practices (ACIP) recommended pre-exposure vaccination for these ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1302
更新日期:2006-12-01 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:We aimed to investigate the association between psychotropic treatment and risk of burn injury in individuals with mental illness. METHODS:A nested case-control study was conducted by using the National Health Insurance Research Database in Taiwan. A total of 3187 cases with burn injury under International Cla...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3995
更新日期:2016-08-01 00:00:00
abstract::Adverse drug reaction surveillance conducted by the US Federal Food and Drug Administration (FDA) is important for detecting new safety information about pharmaceuticals. FDA has sought to stimulate reporting of reactions by practitioners and manufacturers. Over the five years from 1989 to 1993, reporting more than do...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199611)5:6<393::AID-PDS235
更新日期:1996-11-01 00:00:00
abstract:PURPOSE:The objective of this study was to quantify rates of adverse events in a high-risk multi-morbid population of institutionalized patients with Alzheimer's disease (AD). METHODS:We conducted a retrospective cohort study among nursing home residents diagnosed with AD and psychosis during January 1998 to October 1...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1274
更新日期:2006-11-01 00:00:00
abstract:PURPOSE:The aim of this study was to estimate the prevalence of first-generation antipsychotics (FGA) prescribed for treatment of psychiatric and neurological conditions and use of benztropine to reduce extrapyramidal side effects (EPS) by patient race/ethnicity in a nationally representative sample of adult outpatient...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3819
更新日期:2015-11-01 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
pub_type: 杂志文章
doi:10.1002/pds.1929
更新日期:2010-05-01 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
pub_type: 杂志文章
doi:10.1002/pds.3369
更新日期:2012-12-01 00:00:00
abstract::Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial inf...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199707)6:4<283::AID-PDS270
更新日期:1997-07-01 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
pub_type: 杂志文章
doi:10.1002/pds.4752
更新日期:2019-04-01 00:00:00
abstract:PURPOSE:To determine healthcare claim patterns associated using nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis (RA). METHODS:The CADEUS study randomly identified NSAID users within the French health insurance database. One-year claims data were extracted, and NSAID indication was obtained from ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.3221
更新日期:2012-06-01 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
pub_type: 撤回出版物
doi:
更新日期:2013-02-01 00:00:00
abstract:PURPOSE:To conduct a systematic review of current evidence regarding the use of health information technology (HIT) interventions to improve drug monitoring in ambulatory care. METHODS:We searched PubMed, CINAHL, the Cochrane Library, and other computerized databases from 1 January 1998 to 30 June 2008 using the key w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1831
更新日期:2009-12-01 00:00:00
abstract:PURPOSE:To determine the validity of pregnancy variables recorded in administrative databases of Quebec using patient medical charts as the gold standard among asthmatic pregnant women. METHODS:Three administrative databases were linked and provided information on maternal, pregnancy and infant characteristics for 726...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.1558
更新日期:2008-04-01 00:00:00
abstract::Schizophrenia is a life-threatening disease associated with mortality rates that are two to three times higher than those expected/observed in the general population. It is associated with high levels of suicide, particularly in young male patients soon after diagnosis. Delays in treating schizophrenia could contribut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1496
更新日期:2007-12-01 00:00:00
abstract:PURPOSE:We evaluated national outpatient antimicrobial prescription trends in relation to the first United States case of inhalational anthrax due to the intentional delivery of Bacillus anthracis (B. anthracis) spores. METHODS:We queried IMS HEALTH's National Prescription Audit Plus7 database for two 6-month periods ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.828
更新日期:2003-04-01 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
pub_type: 杂志文章,评审
doi:10.1002/pds.4004
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:Epidemiological data on adhesion-related complications following intra-abdominal surgery are limited. We tested the accuracy of recording of these surgeries and complications within The Health Improvement Network (THIN), a primary care database within the UK. METHODS:Individuals within THIN from 1995 to 2011 w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3974
更新日期:2016-04-01 00:00:00