Data sources on drug safety evaluation: a review of recent published meta-analyses.

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

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

更新日期：2017-08-01 00:00:00

abstract：PURPOSE:Fear of discontinuing concomitant anti-epileptic drugs (AEDs) may lead to potentially unnecessary and perhaps unsafe polypharmacy. The effect of withdrawing concomitant AEDs on epilepsy control was therefore studied in long-term users of levetiracetam. METHODS:The EULEV cohort followed patients initiating leve...

journal_title：Pharmacoepidemiology and drug safety

authors： Droz-Perroteau C,Marchal C,Dureau-Pournin C,Lassalle R,Jové J,Robinson P,Lavernhe G,Vespignani H,Moore N,Fourrier-Réglat A,Eulev Study Group.

更新日期：2012-11-01 00:00:00

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

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

更新日期：2019-02-01 00:00:00

abstract：PURPOSE:We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS:A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies includ...

journal_title：Pharmacoepidemiology and drug safety

authors： Durán CE,Christiaens T,Acosta Á,Vander Stichele R

更新日期：2016-01-01 00:00:00

abstract：PURPOSE:Early detection of risky behaviors involving prescription opioids can assist prescribers in implementing safer prescribing. Patient-to-prescriber travel patterns may indicate potential opioid misuse. We introduce doctor hopping, patients bypassing nearby prescribers in favor of more distant ones, as a new spati...

journal_title：Pharmacoepidemiology and drug safety

authors： Young SG,Hayes CJ,Aram J,Tait MA

更新日期：2019-08-01 00:00:00

abstract：PURPOSE:Concomitant use of anti-dementia drugs with psychotropic drugs is potentially problematic in patients with dementia. The aim of this study was to investigate how frequently patients in Norway use anti-dementia drugs concomitantly with psychotropic drugs. METHODS:Analyses are based on data from the Norwegian Pr...

journal_title：Pharmacoepidemiology and drug safety

authors： Langballe EM,Engdahl B,Selbaek G,Nordeng H

更新日期：2011-12-01 00:00:00

abstract：:An information-theoretic definition of similarity proposed by Dekang Lin in 1998 appears to have attractive properties for identifying medically similar cases in a large database. Examination of similar cases that appear following vaccination may provide a way of detecting previously unexpected associations. A key ele...

journal_title：Pharmacoepidemiology and drug safety

authors： Walker AM

更新日期：2010-03-01 00:00:00

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

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

abstract：PURPOSE:To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example. METHODS:We compared self-reported triptan use durin...

journal_title：Pharmacoepidemiology and drug safety

authors： Harris GE,Wood M,Nordeng H

更新日期：2020-09-01 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

authors： Hayward GL,Parnes AJ,Simon SR

更新日期：2009-12-01 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:Hydroxyzine is indicated for the management of anxiety, skin and sleep disorders. In 2015, the European Medicines Agency (EMA) concluded that hydroxyzine was pro-arrhythmogenic and changes to the product information were implemented in Europe. This study aimed to evaluate their impact in Denmark, Scotland, E...

journal_title：Pharmacoepidemiology and drug safety

authors： Morales DR,Macfarlane T,MacDonald TM,Hallas J,Ernst MT,Herings RMC,Smits E,Overbeek JA,Mitchell L,Morant S,Mackenzie I,Doney ASF,Robertson C,Bennie M,Wei L,Nicholson L,Morris C,Flynn RWF

更新日期：2021-01-01 00:00:00

abstract：PURPOSE:Oral morphine is the first-choice opioid for moderate to severe cancer pain. Transdermal fentanyl is an alternative in patients with stable requirements of high-potency opioids (HPO) or if drugs cannot be taken orally. Drug regulatory authorities have issued several alerts to use transdermal fentanyl only for c...

journal_title：Pharmacoepidemiology and drug safety

authors： Garbe E,Jobski K,Schmid U

更新日期：2012-02-01 00:00:00

abstract：:Pharmaceutical manufacturers are faced with the challenge of when and how to conduct pharmacoeconomic (PE) evaluations to satisfy formulary decision-makers. To illustrate the usefulness of decision analysis for strategic planning in drug development, a model was created to compare the cost-benefit of three PE design o...

journal_title：Pharmacoepidemiology and drug safety

authors： Ungar W

更新日期：1997-11-01 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:Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS:ASA users...

journal_title：Pharmacoepidemiology and drug safety

authors： González-Pérez A,Sáez ME,Johansson S,Nagy P,García Rodríguez LA

更新日期：2017-02-01 00:00:00

abstract：PURPOSE:This study aims to examine the associations between proton pump inhibitors (PPIs), traditional nonsteroidal anti-inflammatory drugs (tNSAIDs), PPI + tNSAID co-exposure, and the development of the following: (i) acute interstitial nephritis (AIN), a specific kidney injury often attributed to these drugs, and (ii...

journal_title：Pharmacoepidemiology and drug safety

authors： Leonard CE,Freeman CP,Newcomb CW,Reese PP,Herlim M,Bilker WB,Hennessy S,Strom BL

更新日期：2012-11-01 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：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：:Meloxicam (Mobic((R))) was introduced in the UK in 1996 as a nonsteroidal anti-inflammatory drug (NSAID). To help evaluate the postmarketing experience with meloxicam in the UK, we used the General Practitioners Research Database (GPRD) to characterize the baseline risk of an upper gastrointestinal (GI) event among ne...

journal_title：Pharmacoepidemiology and drug safety

authors： Lanes SF,Rodrígeuz LA,Hwangg E

更新日期：2000-03-01 00:00:00

abstract：AIM:To determine the contribution of patients' adverse drug reaction (ADR) reports to signals detection, through a study of the signals sent by Lareb to the Dutch Medicines Evaluation Board. METHODS:The percentage of patient's ADR reports contributing to generate signals of adverse drug reactions was determined. A cas...

journal_title：Pharmacoepidemiology and drug safety

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

更新日期：2011-03-01 00:00:00

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

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

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: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:The aim of this study was to examine trends in potentially inappropriate medication (PIM) prescribing in Norwegian nursing homes. METHODS:Patients aged ≥70 years were included from three cross-sectional studies conducted in 1997, 2005 and 2011. PIMs were analyzed according to the Norwegian General Practice-Nur...

journal_title：Pharmacoepidemiology and drug safety

authors： Halvorsen KH,Selbaek G,Ruths S

更新日期：2017-02-01 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：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

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

更新日期：2018-03-01 00:00:00

abstract：PURPOSE:Most epidemiologic studies have detected no association between prior use of antidepressant medications and breast cancer risk. Despite the uniform conclusion, there is a continuous rise in the proportion of women using antidepressants, lending support to further monitoring of disease effects. METHODS:We condu...

journal_title：Pharmacoepidemiology and drug safety

authors： Wernli KJ,Hampton JM,Trentham-Dietz A,Newcomb PA

更新日期：2009-04-01 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

authors： Jentink J,Zetstra-van der Woude AP,Bos J,de Jong-van den Berg LT

更新日期：2011-11-01 00:00:00

abstract：PURPOSE:In epidemiological studies, non-response may introduce bias and limit generalizability. In genetic pharmacoepidemiological research, collection of DNA might be a major reason for non-response. We determined reasons for non-response and compared characteristics of non-responders and responders in a pharmacogenet...

journal_title：Pharmacoepidemiology and drug safety

authors： van Wieren-de Wijer DB,Maitland-van der Zee AH,de Boer A,Kroon AA,de Leeuw PW,Schiffers P,Janssen RG,Psaty BM,van Duijn CM,Stricker BH,Klungel OH

更新日期：2009-08-01 00:00:00