A computerized system for signal detection in spontaneous reporting system of Shanghai China.

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 licensing with minimum patient exposure. METHODS:This system was developed by Microsoft visual basic (VB) 6.0. Data preprocessing, data cleaning, and data mining were based upon visual basic for application (VBA) in Microsoft Excel 2003. Database of drug generic name and adverse drug reaction (ADR) standard dictionary were set up initially for data cleaning and coding. Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR), measure used by the Medicines and Healthcare Products Regulatory Agency (MHRA), Bayesian confidence propagation neural network (BCPNN) were employed in this system. Crude ADR reports submitted to Shanghai ADR SRS from December 2003 to April 2007 were used as a material in this study to test the feasibility and flexibility of this system. RESULTS:Thirty two thousand seven hundred and fourty six crude ADR reports were acquired from the SRS automatically. Two thousand one hundred and fourty seven drug generic name and 621 ADR name were kept in the database after data preprocessing and cleaning. A total of 1430, 1419, 868 and 997 possible drug-ADR signals were generated by ROR, PRR, BCPNN and MHRA, respectively. CONCLUSIONS:The results indicate that this computerized system is a flexible one that can help to detect possible drug-ADR signals intelligently in SRS of Shanghai now. It is a promising system for post-marketing surveillance on both chemical medicine and Chinese traditional medicine.

authors

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

doi

10.1002/pds.1695

subject

Has Abstract

pub_date

2009-02-01 00:00:00

pages

154-8

issue

2

eissn

1053-8569

issn

1099-1557

journal_volume

18

pub_type

杂志文章
  • Bias from restricting to live births when estimating effects of prescription drug use on pregnancy complications: A simulation.

    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

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

    更新日期:2018-03-01 00:00:00

  • The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour--original formulation).

    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

    pub_type: 杂志文章

    doi:10.1002/pds.816

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

    更新日期:2004-01-01 00:00:00

  • Adverse events among nursing home residents with Alzheimer's disease and psychosis.

    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

    authors: Oliveria SA,Liperoti R,L'italien G,Pugner K,Safferman A,Carson W,Lapane K

    更新日期:2006-11-01 00:00:00

  • Personalized benefit-risk assessments combining clinical trial and real-world data provide further insights into which patients may benefit most from therapy: Demonstration for a new oral antiplatelet therapy.

    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

    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

  • Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.

    abstract:PURPOSE:To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation i...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1991

    authors: McMahon AW,Pratt RG,Hammad TA,Kozlowski S,Zhou E,Lu S,Kulick CG,Mallick T,Dal Pan G

    更新日期:2010-09-01 00:00:00

  • Domperidone, cytochrome P450 3A4 isoenzyme inhibitors and ventricular arrhythmia: a nationwide case-crossover study.

    abstract:BACKGROUND:Recent evidence suggested that oral form of domperidone may possess pro-arrhythmic effects and increase the risk of ventricular arrhythmia. The concomitant use of cytochrome P450 (CYP) 3A4 isoenzyme inhibitors may further potentiate this association. Nevertheless, empirical data supporting these associations...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3814

    authors: Chen HL,Hsiao FY

    更新日期:2015-08-01 00:00:00

  • Acute kidney injury during concomitant use of valacyclovir and loxoprofen: detecting drug-drug interactions in a spontaneous reporting system.

    abstract:PURPOSE:Little is known about the effects of drug-drug interactions between valacyclovir and non-steroidal anti-inflammatory drugs (NSAIDs). In this study, we analysed the adverse event 'acute kidney injury (AKI)' resulting from a possible interaction between loxoprofen (a non-selective NSAID) and valacyclovir in repor...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3626

    authors: Yue Z,Shi J,Jiang P,Sun H

    更新日期:2014-11-01 00:00:00

  • Impact of cancer-related fatigue on chemotherapy-induced nausea and vomiting in Asian cancer patients.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.3516

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

    更新日期:2013-12-01 00:00:00

  • Prescribed daily doses and 'risk factors' associated with the use of benzodiazepines in primary care.

    abstract:OBJECTIVE:To assess the extent, characteristics and determinants of benzodiazepine prescription in outpatient Primary Health Care. METHODS:A clinical audit of a stratified random sample of Primary Health Care Centres in the seven islands and 1.6 million inhabitants region of 'Canarias' in Spain was carried out. From t...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199905/06)8:3<207::AID-PDS

    authors: de las Cuevas C,Sanz E,de la Fuente JA,Cabrera C,Mateos A

    更新日期:1999-05-01 00:00:00

  • Who are we missing? Underrepresentation of data sources used for pharmacoepidemiology research in the United States.

    abstract:PURPOSE:Research using healthcare databases often includes patients frequently excluded from clinical trials; yet it is not known whether commonly used data represents the overall population or specific sub-populations of interest. We aimed to examine population representativeness from data sources in recent research s...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5087

    authors: Kaviani P,Landi SN,McKethan A,Brookhart MA,McGrath LJ

    更新日期:2020-11-01 00:00:00

  • Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

    abstract:PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveil...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2336

    authors: Curtis LH,Weiner MG,Boudreau DM,Cooper WO,Daniel GW,Nair VP,Raebel MA,Beaulieu NU,Rosofsky R,Woodworth TS,Brown JS

    更新日期:2012-01-01 00:00:00

  • Trends in rates of acetaminophen-related adverse events in the United States.

    abstract:PURPOSE:The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality. METHODS:A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings,...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3906

    authors: Major JM,Zhou EH,Wong HL,Trinidad JP,Pham TM,Mehta H,Ding Y,Staffa JA,Iyasu S,Wang C,Willy ME

    更新日期:2016-05-01 00:00:00

  • vigiRank for statistical signal detection in pharmacovigilance: First results from prospective real-world use.

    abstract:PURPOSE:vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggeste...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4247

    authors: Caster O,Sandberg L,Bergvall T,Watson S,Norén GN

    更新日期:2017-08-01 00:00:00

  • Pattern of in-hospital changes in drug use in the older people from 2010 to 2016.

    abstract:PURPOSE:To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS:People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4330

    authors: Franchi C,Ardoino I,Nobili A,Pasina L,Mannucci PM,Marengoni A,Perticone F,REPOSI investigators.

    更新日期:2017-12-01 00:00:00

  • Risk of hospitalization for upper gastrointestinal adverse events associated with nonsteroidal anti-inflammatory drugs: a nationwide case-crossover study in Taiwan.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.2140

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

    更新日期:2011-07-01 00:00:00

  • An algorithm to identify preterm infants in administrative claims data.

    abstract:PURPOSE:To develop and validate an algorithm to identify preterm infants in the absence of birth certificates within Medicaid data. METHODS:Medicaid fee-for-service claims data from Florida (FL) and Texas (TX) were linked to vital statistics data for infants who were continuously eligible during the first 3 months fol...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3264

    authors: Eworuke E,Hampp C,Saidi A,Winterstein AG

    更新日期:2012-06-01 00:00:00

  • The negative effect of red tape on research.

    abstract:PURPOSES:To describe the kind of the difficulties encountered when seeking research governance approval for a nationwide public health and genetic study-the Drug-Induced Arrhythmia Risk Evaluation study-in England. METHODS:Description of the processes followed when seeking research governance approval for the Drug-Ind...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.1116

    authors: Boshier A,Shakir SA,Telfer P,Behr E,Pakrashi T,Camm AJ

    更新日期:2005-06-01 00:00:00

  • Adverse drug reaction-related hospitalisations: a population-based cohort study.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.1565

    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

  • The importance of defining periods of complete mortality reporting for research using automated data from primary care.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.1688

    authors: Maguire A,Blak BT,Thompson M

    更新日期:2009-01-01 00:00:00

  • Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain.

    abstract:PURPOSE:Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of informat...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5006

    authors: Maciá-Martínez MA,Gil M,Huerta C,Martín-Merino E,Álvarez A,Bryant V,Montero D,BIFAP Team.

    更新日期:2020-10-01 00:00:00

  • Drug prescribing patterns in Parkinson's disease: a pharmacoepidemiological survey in a cohort of ambulatory patients.

    abstract:PURPOSE:Drug treatment of idiopathic Parkinson's disease (IPD) is a difficult task, and comorbidity and comedication add to its complexity. Since in IPD there is little information about drug use, this study investigated drug prescribing and indications in IPD patients. METHODS:From June 1997 to April 1998, a cross-se...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.682

    authors: Leoni O,Martignoni E,Cosentino M,Michielotto D,Calandrella D,Zangaglia R,Riboldazzi G,Oria C,Lecchini S,Nappi G,Frigo G

    更新日期:2002-03-01 00:00:00

  • Agreement and validity of electronic health record prescribing data relative to pharmacy claims data: A validation study from a US electronic health record database.

    abstract:BACKGROUND:Granular clinical and laboratory data available in electronic health record (EHR) databases provide researchers the opportunity to conduct investigations that would not be possible in insurance claims databases; however, for pharmacoepidemiology studies, accurate classification of medication exposure is crit...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4234

    authors: Rowan CG,Flory J,Gerhard T,Cuddeback JK,Stempniewicz N,Lewis JD,Hennessy S

    更新日期:2017-08-01 00:00:00

  • Validity and completeness of the General Practice Research Database for studies of inflammatory bowel disease.

    abstract:PURPOSE:The objective of this study was to evaluate the validity and completeness of the General Practice Research Database (GPRD) as a tool for research into inflammatory bowel disease epidemiology. METHODS:Patients diagnosed with inflammatory bowel disease were identified from GPRD. Mailed surveys were sent to the g...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.698

    authors: Lewis JD,Brensinger C,Bilker WB,Strom BL

    更新日期:2002-04-01 00:00:00

  • Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany.

    abstract:PURPOSE:To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS:New users of cilostazol were identified in pop...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4167

    authors: Castellsague J,Perez-Gutthann S,Calingaert B,Bui C,Varas-Lorenzo C,Arana A,Prados-Torres A,Poblador-Plou B,Gonzalez-Rubio F,Giner-Soriano M,Roso-Llorach A,Linder M,Citarella A,Scholle O,Blenk T,Garbe E

    更新日期:2017-06-01 00:00:00

  • A systematic review of validated methods for identifying atrial fibrillation using administrative data.

    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 ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.2317

    authors: Jensen PN,Johnson K,Floyd J,Heckbert SR,Carnahan R,Dublin S

    更新日期:2012-01-01 00:00:00

  • Treatment with montelukast and antidepressive medication-a symmetry analysis.

    abstract:PURPOSE:Leukotriene receptor antagonists are used in asthma and rhinitis treatment. Pharmacovigilance data have suggested an association between montelukast and depression, but the association has not been established in controlled study designs. We described the association between initiation of montelukast and depres...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4638

    authors: Winkel JS,Damkier P,Hallas J,Henriksen DP

    更新日期:2018-12-01 00:00:00

  • Correcting hazard ratio estimates for outcome misclassification using multiple imputation with internal validation data.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.4223

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

    更新日期:2017-08-01 00:00:00

  • Validation studies of claims data in the Asia-Pacific region: A comprehensive review.

    abstract:PURPOSE:To describe published validation studies of administrative health care claims data in the Asia-Pacific region. METHODS:A comprehensive literature search was conducted in PubMed for English language articles published through 31-Oct-2017 in humans from 10 Asian-Pacific countries or regions (Japan, Australia, Ne...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.4616

    authors: Koram N,Delgado M,Stark JH,Setoguchi S,de Luise C

    更新日期:2019-02-01 00:00:00

  • Weaknesses of goodness-of-fit tests for evaluating propensity score models: the case of the omitted confounder.

    abstract:PURPOSE:Propensity scores are used in observational studies to adjust for confounding, although they do not provide control for confounders omitted from the propensity score model. We sought to determine if tests used to evaluate logistic model fit and discrimination would be helpful in detecting the omission of an imp...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.986

    authors: Weitzen S,Lapane KL,Toledano AY,Hume AL,Mor V

    更新日期:2005-04-01 00:00:00

  • Short-term safety and tolerability of antihypertensive agents in Korean patients: an observational study.

    abstract:PURPOSE:In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out. METHODS:A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monoth...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.554

    authors: Kim YS,Park HS,Sunwoo S,Byeon JJ,Song YM,Seo HG,Kim CH,Cheon KS,Yoo SM,Lee JK,Korea Post-Marketing Surveillance Research Group.

    更新日期:2000-12-01 00:00:00