Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: A cohort study focused on first-in-class drugs.

abstract：PURPOSE:To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS:Eighty-four qual...

journal_title：Pharmacoepidemiology and drug safety

authors： Mazor KM,Sabin JE,Goff SL,Smith DH,Rolnick S,Roblin D,Raebel MA,Herrinton LJ,Gurwitz JH,Boudreau D,Meterko V,Dodd KS,Platt R

更新日期：2009-07-01 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: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

authors： Van Holle L,Bauchau V

更新日期：2013-05-01 00:00:00

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

authors： Yue Z,Shi J,Jiang P,Sun H

更新日期：2014-11-01 00:00:00

abstract：PURPOSE:Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identi...

journal_title：Pharmacoepidemiology and drug safety

authors： Lin YL,Kung MF

更新日期：2009-03-01 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:This study examined recent trends and correlates of prescription opioid use and long-term use in the United States. METHODS:Data were from 47 356 adult participants of National Health and Nutrition Survey from 1999-2000 to 2013-2014. Participants were asked about prescription medications used in the past 30 da...

journal_title：Pharmacoepidemiology and drug safety

authors： Mojtabai R

更新日期：2018-05-01 00:00:00

abstract：PURPOSE:To examine the association between the use of psychotropic drugs and fatal pulmonary embolism. METHODS:We conducted a national case-control study of fatal pulmonary embolism. Cases were 75 New Zealand men and women aged 15-59 years who died between 1 January 1990 and 31 December 1998, where the underlying caus...

journal_title：Pharmacoepidemiology and drug safety

authors： Parkin L,Skegg DC,Herbison GP,Paul C

更新日期：2003-12-01 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

authors： Meijer WM,Cornel MC,Dolk H,de Walle HE,Armstrong NC,de Jong-van den Berg LT,EUROCAT Working Group.

更新日期：2006-09-01 00:00:00

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

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

更新日期：2018-12-01 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

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:Following approval in the EU in 2002 and the USA in 2003, an Intensive Safety Surveillance Scheme (IS(3) ) was initiated to educate prescribers on the appropriate use of miglustat for the treatment of type I Gaucher disease (GD1), and to actively solicit safety-relevant information. This report summarises da...

journal_title：Pharmacoepidemiology and drug safety

authors： Brand M,Muller A,Alsop J,van Schaik IN,Bembi B,Hughes D

更新日期：2015-03-01 00:00:00

abstract：PURPOSE:Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS:The study was performed in three US managed care o...

journal_title：Pharmacoepidemiology and drug safety

authors： Harrold LR,Patterson MK,Andrade SE,Dube T,Go AS,Buist AS,Chan KA,Weller PF,Wechsler ME,Yood RA,Davis KJ,Platt R,Walker AM

更新日期：2007-06-01 00:00:00

abstract：PURPOSE:The objective of this study was to evaluate the prevalence of potential drug-drug interactions (DDIs) in hospitalised patients in correlation with patient's age and number of drugs prescribed and to determine the prevalence of inappropriate drugs prescribed to elderly patients. METHODS:Drugs prescribed during ...

journal_title：Pharmacoepidemiology and drug safety

authors： Radosević N,Gantumur M,Vlahović-Palcevski V

更新日期：2008-07-01 00:00:00

abstract：PURPOSE:To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand. SETTING:Tertiary teaching hospital, North-East Thailand. METHODS:Over a 6-month period doctors w...

journal_title：Pharmacoepidemiology and drug safety

authors： Jarernsiripornkul N,Kakaew W,Loalukkana W,Krska J

更新日期：2009-03-01 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：PURPOSE:To determine prescribing patterns by general physicians working in primary care (GPs) in Iran for the elderly and the prevalence of inappropriate prescribing. METHODS:We collected information about prescribed medicines for 10% of patients in primary care aged 65 years or above in six cities in one province dur...

journal_title：Pharmacoepidemiology and drug safety

authors： Ghadimi H,Esmaily HM,Wahlstrom R

更新日期：2011-05-01 00:00:00

abstract：PURPOSE:To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. MET...

journal_title：Pharmacoepidemiology and drug safety

authors： Bergman U,Risinggård H,Vlahović-Palcevski V,Ericsson O

更新日期：2004-07-01 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

authors： Fowler GL,Baggs JM,Weintraub ES,Martin SW,McNeil MM,Gust DA

更新日期：2006-12-01 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

authors： Chang CM,Wu KY,Chiu YW,Wu HT,Tsai YT,Chau YL,Tsai HJ

更新日期：2016-08-01 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:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequen...

journal_title：Pharmacoepidemiology and drug safety

authors： Pane J,Francisca RDC,Verhamme KMC,Orozco M,Viroux H,Rebollo I,Sturkenboom MCJM

更新日期：2019-09-01 00:00:00

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: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

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

abstract：PURPOSE:Type 2 diabetes is associated with increased cardiovascular risk. The comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in reducing risk of cardiovascular disease in real-world settings is unknown. METHODS:A retrospective database analysis was performed using a large m...

journal_title：Pharmacoepidemiology and drug safety

authors： Suh HS,Hay JW,Johnson KA,Doctor JN

更新日期：2012-05-01 00:00:00

abstract：PURPOSE:Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may "mask" signals. METHODS:We analyzed the masking effect of vaccines in pediatrics in the EudraVigilance database by...

journal_title：Pharmacoepidemiology and drug safety

authors： Dodd C,Pacurariu A,Osokogu OU,Weibel D,Ferrajolo C,Vo DH,Becker B,Kors JA,Sturkenboom M

更新日期：2018-11-01 00:00:00

abstract：PURPOSES:The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activi...

journal_title：Pharmacoepidemiology and drug safety

authors： Alshammari TM,Alenzi KA,Ata SI

更新日期：2020-09-01 00:00:00

abstract：PURPOSE:The use of granulocyte colony-stimulating factor (G-CSF) in the treatment of non-chemotherapy drug- induced agranulocytosis is controversial. We aimed at assessing the effect of G-CSF on the duration of agranulocytosis. METHODS:To assess the effect of G-CSF on the duration of agranulocytosis, a Cox proportiona...

journal_title：Pharmacoepidemiology and drug safety

authors： Ibáñez L,Sabaté M,Ballarín E,Puig R,Vidal X,Laporte JR,Agranulocytosis and Aplastic Anaemia Study Group of Barcelona.

更新日期：2008-03-01 00:00:00

abstract：PURPOSE:To assess the effectiveness of additional risk minimization measures (aRMMs) implemented in Europe for colistimethate sodium (CMS) among healthcare professionals (HCPs) and patients/caregivers following safety concerns regarding incorrect use of CMS delivered via Turbospin inhaler. METHODS:A cross-sectional st...

journal_title：Pharmacoepidemiology and drug safety

authors： Kaplan S,Patino O,Rainville C,Madison T

更新日期：2020-02-01 00:00:00