Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System.

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: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：: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

authors： Dunn NR,Thorogood M,de Caestecker L,Mann RD

更新日期：1997-07-01 00:00:00

abstract：PURPOSE:Our study addresses how the information in the labels differed between United States (US) and Japan, what factors were associated with the decision to place the boxed warning on the label, and the relation of both countries in terms of drug label policy. METHODS:We investigated adverse drug reactions (ADRs) in...

journal_title：Pharmacoepidemiology and drug safety

authors： Jayaputra K,Ono S

更新日期：2017-02-01 00:00:00

abstract：PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...

journal_title：Pharmacoepidemiology and drug safety

authors： Cavadino A,Prieto-Merino D,Morris JK

更新日期：2020-03-01 00:00:00

abstract：PURPOSE:Increased post-marketing reports of 'interstitial pneumonia' as an adverse drug reaction (ADR) from the use of gefitinib, irinotecan, or leflunomide among patients in Japan have not been noted in other countries. The WHO International Drug Monitoring Database was analyzed to examine Japan's pattern of reporting...

journal_title：Pharmacoepidemiology and drug safety

authors： Koo LC,Clark JA,Quesenberry CP,Higenbottam T,Nyberg F,Wolf MK,Steinberg MH,Forsythe BH

更新日期：2005-11-01 00:00:00

abstract：BACKGROUND:Cause of death is often not available in administrative claims data. OBJECTIVE:To develop claims-based algorithms to identify deaths due to fatal cardiovascular disease (CVD; ie, fatal coronary heart disease [CHD] or stroke), CHD, and stroke. METHODS:Reasons for Geographic and Racial Differences in Stroke ...

journal_title：Pharmacoepidemiology and drug safety

authors： Xie F,Colantonio LD,Curtis JR,Kilgore ML,Levitan EB,Monda KL,Safford MM,Taylor B,Woodward M,Muntner P

更新日期：2018-07-01 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:Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. METHODS:A MEDLINE search of English language literature was performed to identify studies published between Janua...

journal_title：Pharmacoepidemiology and drug safety

authors： Andrade SE,Kahler KH,Frech F,Chan KA

更新日期：2006-08-01 00:00:00

abstract：:The cost of drugs represents 10% of the National Health Service (NHS) budget in the UK and this fraction is increasing. Because the NHS is centrally funded and because there is a budgetary limit, prioritization in health care is required. The National Institute for Clinical Excellence in England and Wales and the Heal...

journal_title：Pharmacoepidemiology and drug safety

authors： Beard K

更新日期：2001-08-01 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：PURPOSE:To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database. METHODS:We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were ...

journal_title：Pharmacoepidemiology and drug safety

authors： Cea Soriano L,Soriano-Gabarró M,García Rodríguez LA

更新日期：2016-04-01 00:00:00

abstract：:The General Practice Research Database (GPRD) is the world's largest computerized database of anonymized longitudinal patient records from general practice and is a unique public health research tool. Several issues have threatened the viability of the database in recent years; in April 1999 responsibility for its man...

journal_title：Pharmacoepidemiology and drug safety

authors： Wood L,Coulson R

更新日期：2001-08-01 00:00:00

abstract：PURPOSE:To develop and test an algorithm that translates total dose and daily regimen, inputted as 'free text' on a prescription, into numerical values to calculate the prescribed treatment duration. METHOD:The algorithm was developed using antibiotic prescriptions (n = 711,714) from multiple primary care computer sys...

journal_title：Pharmacoepidemiology and drug safety

authors： Brooks CJ,Lyons RA,Jones KH,Hutton AJ,Walker R,Evans KA,Lloyd K,Ford DV

更新日期：2010-09-01 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

authors： Bernard MA,Bénichou J,Blin P,Weill A,Bégaud B,Abouelfath A,Moore N,Fourrier-Réglat A,CADEUS Team.

更新日期：2012-06-01 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:Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States poison centers. METHODS:This retrospective database study utilized the National Poison Data System to compare the ...

journal_title：Pharmacoepidemiology and drug safety

authors： Leonard JB,Seung H,Klein-Schwartz W

更新日期：2021-01-01 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:The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillanc...

journal_title：Pharmacoepidemiology and drug safety

authors： Li R,Stewart B,McNeil MM,Duffy J,Nelson J,Kawai AT,Baxter R,Belongia EA,Weintraub E

更新日期：2016-08-01 00:00:00

abstract：:The UK Drug Utilization Research Group's (DURG) Regional Meeting 'New Horizons: Pharmacovigilance' was hosted by the Drug Safety Research Unit (DSRU) at Southampton on 19 May 2000. Opening the meeting, Dr Keith Beard, UK DURG chairman, welcomed delegates and speakers and thanked the DSRU team for hosting the meeting. ...

journal_title：Pharmacoepidemiology and drug safety

authors： Barnes J

更新日期：2000-09-01 00:00:00

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

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

更新日期：2002-04-01 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：PURPOSE:Generic substitution (GS) is an important way to decrease medical costs. We aimed to study the opinions and attitudes of Finnish people about GS five years after it was introduced, the reasons for substituting and what people think about generic medicines. METHODS:We sent a postal survey to a random stratified...

journal_title：Pharmacoepidemiology and drug safety

authors： Heikkilä R,Mäntyselkä P,Ahonen R

更新日期：2011-02-01 00:00:00

abstract：:The article is devoted to the establishment and development of the National Pharmacovigilance system in Ukraine. A drug safety centre of Ukraine started to form a pharmacovigilance system in 1996. It has been operating on a regular basis since 2000 and now provides the regulatory services that include data collection ...

journal_title：Pharmacoepidemiology and drug safety

authors： Stefanov O,Sharayeva M,Jajtchenja V

更新日期：2004-03-01 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：BACKGROUND AND AIMS:Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the as...

journal_title：Pharmacoepidemiology and drug safety

authors： van Bruggen R,Gorter K,Stolk RP,Zuithoff P,Klungel OH,Rutten GE

更新日期：2009-11-01 00:00:00

abstract：PURPOSE:To investigate suicide-related over-the-counter (OTC) analgesic medication exposures among individuals ≥6 years old reported to United States (US) poison control centers. METHODS:Data from the National Poison Data System for the years 2000-2018 were retrospectively analyzed. RESULTS:From 2000 to 2018, US pois...

journal_title：Pharmacoepidemiology and drug safety

authors： Hopkins AG,Spiller HA,Kistamgari S,Zhu M,Michaels NL,Funk AR,Smith GA

更新日期：2020-09-01 00:00:00

abstract：PURPOSE:The objective of this study was to evaluate the level of use and therapy profile of antibacterial agents in hospitals. Further to explore whether type, size or geographical situation influenced antibacterial agents used. METHODS:Antibacterial use during 1998-1999, in 13 hospitals, including emergency, referral...

journal_title：Pharmacoepidemiology and drug safety

authors： Blix HS,Hartug S

更新日期：2005-09-01 00:00:00

abstract：PURPOSE:To determine the effectiveness of quality circles on prescribing patterns of primary care physicians in Germany and to explore the influence of specific factors on changes. METHODS:Three large non-randomised comparative studies were performed in primary care in Germany, with baseline measurements in 2001 and f...

journal_title：Pharmacoepidemiology and drug safety

authors： Wensing M,Broge B,Riens B,Kaufmann-Kolle P,Akkermans R,Grol R,Szecsenyi J

更新日期：2009-09-01 00:00:00

abstract：PURPOSE:To examine the association between use of methylphenidate and the risk for valvular heart disease (VHD) in the Spanish primary care database BIFAP. METHODS:Case-control study nested in a cohort of patients aged 5 to 25 years between 2002 and 2014, based in a general practice research database. Cases were peopl...

journal_title：Pharmacoepidemiology and drug safety

authors： Saiz LC,Gil M,Alonso A,Erviti J,Garjón J,Martínez M

更新日期：2020-03-01 00:00:00