Systems for evaluation of new drugs in the United Kingdom.

abstract：PURPOSE:We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD). METHODS:Using a retrospective, observational cohort s...

journal_title：Pharmacoepidemiology and drug safety

authors： Hermos JA,Quach L,Gagnon DR,Weber HC,Altincatal A,Cho K,Lawler EV,Grotzinger KM

更新日期：2014-05-01 00:00:00

abstract：PURPOSE:Lack of control for time-varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an overview and guidance on some of the available methodologies used to address problems related to time-varying exposure and confounding in pharmacoepidemiology and oth...

journal_title：Pharmacoepidemiology and drug safety

authors： Pazzagli L,Linder M,Zhang M,Vago E,Stang P,Myers D,Andersen M,Bahmanyar S

更新日期：2018-02-01 00:00:00

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

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

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: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

authors： Schuerch M,Gasse C,Robinson NJ,Alvarez Y,Walls R,Mors O,Christensen J,Hesse U,de Groot M,Schlienger R,Reynolds R,Klungel O,de Vries F

更新日期：2016-03-01 00:00:00

abstract：PURPOSE:The aim of this work was to study the use of systemic antibacterials and its possible determinants in Hungarian intensive care units (ICUs). METHODS:Hospital pharmacy. departments provided package level dispensing data for their corresponding ICU (2006). Data were converted into defined daily doses (DDDs) and ...

journal_title：Pharmacoepidemiology and drug safety

authors： Benko R,Matuz M,Peto Z,Bogár L,Viola R,Doró P,Soós G,Hajdú E

更新日期：2012-01-01 00:00:00

abstract：PURPOSE:The decision whether to continue antidepressant use for depression during pregnancy requires weighing maternal and child risks and benefits. Little is known about the effectiveness of antidepressant therapy during pregnancy. The goal of this study is to evaluate whether standard administrative claims data can b...

journal_title：Pharmacoepidemiology and drug safety

authors： Swanson SA,Hernandez-Diaz S,Palmsten K,Mogun H,Olfson M,Huybrechts KF

更新日期：2015-09-01 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

authors： Zenut M,Fialip J,Lavarenne J

更新日期：1998-08-01 00:00:00

abstract：OBJECTIVE:To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates. METHODS:A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health for antidepressants and lithium was carried out for the period ...

journal_title：Pharmacoepidemiology and drug safety

authors： Arias LH,Lobato CT,Ortega S,Velasco A,Carvajal A,del Pozo JG

更新日期：2010-09-01 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

abstract：:Dr. Walker asserts that a hypothesis always can be tested using the same data source that generated the data if the test data are independent of the data generating the hypothesis. One way to do this is to use part of the totality of data to generate the hypothesis and the other to test the hypothesis. The validity of...

journal_title：Pharmacoepidemiology and drug safety

authors： Gould AL

更新日期：2010-05-01 00:00:00

abstract：PURPOSE:Although a series of serious adverse events have continually raised concerns about the potential toxicity of traditional Chinese medicine injections (TCM injections), studies on this subject are still sparse. We conducted a descriptive analysis of a spontaneous reporting system in China to describe the safety p...

journal_title：Pharmacoepidemiology and drug safety

authors： Li H,Deng J,Deng L,Ren X,Xia J

更新日期：2019-07-01 00:00:00

abstract：AIM:To determine the appropriate size of risk windows in both exposed and unexposed sub-cohorts. METHOD:Data was taken from a previous study of upper gastrointestinal haemorrhage and perforation. The length of each prescription for NSAIDs was estimated. The risk was calculated for the duration of a prescription plus i...

journal_title：Pharmacoepidemiology and drug safety

authors： McMahon AD,Evans JM,McGilchrist MM,McDevitt DG,MacDonald TM

更新日期：1998-07-01 00:00:00

abstract：PURPOSE:Opioid analgesic use in chronic non-cancer pain (CNCP) is increasingly prevalent, but the benefits and risks are inadequately understood. In France, tramadol is one of the most used prescription opioids, but studies on its misuse liability in CNCP are still lacking. The aim was to assess the incidence of tramad...

journal_title：Pharmacoepidemiology and drug safety

authors： Chenaf C,Kabore JL,Delorme J,Pereira B,Mulliez A,Roche L,Eschalier A,Delage N,Authier N

更新日期：2016-09-01 00:00:00

abstract：PURPOSE:To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France. METHODS:A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by r...

journal_title：Pharmacoepidemiology and drug safety

authors： Laroche ML,Perault-Pochat MC,Ingrand I,Merle L,Kreft-Jais C,Castot-Villepelet A,Durrieu G,Gras V,Guy C,Jean-Pastor MJ,Jonville-Béra AP,Merlet-Chicoine I,Miremont-Salamé G,Nourhashemi F,Charmes JP,French Centres of Pharmacov

更新日期：2013-09-01 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

authors： Daveluy A,Miremont-Salamé G,Kostrzewa A,Couret A,Lacoin L,Lecomte C,Moore N,Gilleron V,Haramburu F

更新日期：2012-12-01 00:00:00

abstract：:In Slovenia, the national health insurance system covers almost the whole population. The average patient receives six to seven prescriptions per year with an average value of 15 USD per prescription. This paper presents the systemic conditions necessary for the performance of pharmacoepidemiologic studies. A recent s...

journal_title：Pharmacoepidemiology and drug safety

authors： Primozic S,Kos M,Mrhar A,Ravnik I

更新日期：2001-12-01 00:00:00

abstract：:Analysing duration of treatment episodes has become a standard task in many pharmacoepidemiological studies. However, such analyses are often carried out in a rather simplistic manner and more subtle issues are often ignored. In this paper, methods of analysing duration treatment episodes beyond simple analyses allowi...

journal_title：Pharmacoepidemiology and drug safety

authors： Gichangi A,Andersen M,Kragstrup J,Vach W

更新日期：2006-03-01 00:00:00

abstract：PURPOSE:The purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. METHODS:Using a large integrated healthcare system innovative infrastructure in...

journal_title：Pharmacoepidemiology and drug safety

authors： Paxton EW,Ake CF,Inacio MC,Khatod M,Marinac-Dabic D,Sedrakyan A

更新日期：2012-05-01 00:00:00

abstract：PURPOSE:Medicaid programs are concerned about inappropriate, potentially hazardous, and costly off-label use of second-generation antipsychotics (SGAs). Several states are exploring policies aimed at managing low-dose quetiapine, commonly prescribed for off-label conditions. This study aimed to characterize longitudina...

journal_title：Pharmacoepidemiology and drug safety

authors： Hartung DM,Zerzan J,Yamashita T,Tong S,Morden NE,Libby AM

更新日期：2014-01-01 00:00:00

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

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

abstract：PURPOSE:The purpose of this study is to characterise how Type 2 Diabetes Mellitus (T2DM) is treated in England and Wales and whether this adheres to 2009 National Institute for Health and Care Excellence (NICE) guidance on management of T2DM. METHODS:Data for T2DM patients aged 18+ years prescribed at least one anti-d...

journal_title：Pharmacoepidemiology and drug safety

authors： Datta-Nemdharry P,Thomson A,Beynon J,Donegan K

更新日期：2017-02-01 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：:Data regarding the total number of anti-asthma drugs dispensed via community pharmacies within Northern Ireland from 1980 to 1997 were collected and analysed. The use of anti-asthma drugs within this population increased markedly over the study period from 19.84 DDDs/1000/day to 84.07 DDDs/1000/day. With the exception...

journal_title：Pharmacoepidemiology and drug safety

authors： Bell HM,McElnay JC,Hughes CM

更新日期：1999-10-01 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: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：PURPOSE:Administration of pegylated interferon-alpha (IFN-alpha) and ribavirin in adults with chronic hepatitis C (CHC) is a recommended therapeutic standard. Nevertheless, this therapeutic regimen rises numerous controversies. The aim of this study was to analyze adverse effects during the treatment with pegylated IFN...

journal_title：Pharmacoepidemiology and drug safety

authors： Kowala-Piaskowska A,Mozer-Lisewska I,Figlerowicz M,Słuzewski W

更新日期：2007-10-01 00:00:00

abstract：PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...

journal_title：Pharmacoepidemiology and drug safety

authors： Requena G,Wolf A,Williams R,Dedman D,Quint JK,Murray-Thomas T,Pimenta JM

更新日期：2020-12-27 00:00:00

abstract：PURPOSE:We aimed to describe time-trends in the use of NOACs among a group of ambulatory patients with nonvalvular atrial fibrillation (NVAF) in Colombia and to describe treatment patterns and user characteristics. METHODS:Using the Audifarma S.A administrative healthcare database in Colombia, we identified 10 528 pat...

journal_title：Pharmacoepidemiology and drug safety

authors： Machado-Alba JE,Gaviria-Mendoza A,Machado-Duque ME,Tovar-Yepes C,Ruigómez A,García Rodríguez LA

更新日期：2020-10-15 00:00:00

abstract：AIM:To study the influence of media attention about statins and ADRs on the level of disproportionality, expressed as the reporting odds ratio (ROR) for statins in the Lareb database, based on patients' reports. METHODS:Patient reports about statins, before and after the broadcast of a consumer programme about statins...

journal_title：Pharmacoepidemiology and drug safety

authors： van Hunsel F,van Puijenbroek E,de Jong-van den Berg L,van Grootheest K

更新日期：2010-01-01 00:00:00