Effect of European Medicines Agency's restrictions on trimetazidine utilization in Portugal.

abstract：PURPOSE:Under EU regulations, patient information leaflets (PILs) are required to be clear and understandable. Negations (e.g., not, no) are a linguistic aspect that may impact PIL comprehension, yet go unmentioned in these regulations. We conducted two studies to determine (1) how negations are used in Dutch PILs (stu...

journal_title：Pharmacoepidemiology and drug safety

authors： Burgers C,Beukeboom CJ,Sparks L,Diepeveen V

更新日期：2015-02-01 00:00:00

abstract：:Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...

journal_title：Pharmacoepidemiology and drug safety

authors： Bakowski MT,Prescott P

更新日期：1997-09-01 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:To study patterns of antiepileptic drugs (AED) prescribing, particularly valproate, during pregnancy over a 10-year period in the UK, Italy, and France. METHODS:Data on pregnancies conceived after 1 January 2007 with outcomes before 31 December 2016 were extracted from four European electronic health care data...

journal_title：Pharmacoepidemiology and drug safety

authors： Hurault-Delarue C,Morris JK,Charlton R,Gini R,Loane M,Pierini A,Puccini A,Neville A,Snowball J,Damase-Michel C,EUROmediSAFE consortium.

更新日期：2019-11-01 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 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：PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...

journal_title：Pharmacoepidemiology and drug safety

authors： Moussally K,Oraichi D,Bérard A

更新日期：2009-06-01 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：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 review conceptual issues regarding confounding by indication in the context of studies of calcium channel blockers (CCBs). METHODS:Review of literature, with special attention to two articles in the current issue. RESULTS:Conflicting arguments about the presence of uncontrollable confounding by indication ...

journal_title：Pharmacoepidemiology and drug safety

authors： Joffe MM

更新日期：2000-01-01 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：: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：OBJECTIVE:As covariates are not always adequately balanced after propensity score matching and double- adjustment can be used to remove residual confounding, we compared the performance of several double-robust estimators in different scenarios. METHODS:We conducted a series of Monte Carlo simulations on virtual obser...

journal_title：Pharmacoepidemiology and drug safety

authors： Nguyen TL,Collins GS,Spence J,Devereaux PJ,Daurès JP,Landais P,Le Manach Y

更新日期：2017-12-01 00:00:00

abstract：BACKGROUND:Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE:The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug r...

journal_title：Pharmacoepidemiology and drug safety

authors： Tjäderborn M,Jönsson AK,Ahlner J,Hägg S

更新日期：2009-12-01 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：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

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

更新日期：2013-12-01 00:00:00

abstract：PURPOSE:The aims of this study are to examine the validity of diagnostic codes for psoriatic arthritis in The Health Improvement Network (THIN) and to examine the agreement between General Practitioner (GP) report and prescription records for disease modifying antirheumatic drugs (DMARDs). METHODS:Questionnaires were ...

journal_title：Pharmacoepidemiology and drug safety

authors： Ogdie A,Alehashemi S,Love TJ,Jiang Y,Haynes K,Hennessy S,Choi H,Gelfand JM

更新日期：2014-09-01 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:Complex medication management in older people with multiple chronic conditions can introduce practice variation in polypharmacy prevalence. This study aimed to determine the inter-practice variation in polypharmacy prevalence and examine how this variation was influenced by patient and practice characteristics....

journal_title：Pharmacoepidemiology and drug safety

authors： Sinnige J,Braspenning JC,Schellevis FG,Hek K,Stirbu I,Westert GP,Korevaar JC

更新日期：2016-09-01 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:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...

journal_title：Pharmacoepidemiology and drug safety

authors： Trifirò G,Barbui C,Spina E,Moretti S,Tari M,Alacqua M,Caputi AP,UVEC group.,Arcoraci V

更新日期：2007-05-01 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：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：OBJECTIVES:The purpose of this study was to generate data regarding the drug utilization pattern in pediatric population of our tertiary care hospital so that we could generate an essential medicine list (EML). BACKGROUND:Drug therapy accounts for a major portion of expenditure toward health care. Reduction in health ...

journal_title：Pharmacoepidemiology and drug safety

authors： Singh I,Mittal R,Shafiq N,Bharati B,Nigah RK,Pandhi P,Chaudhary RR,Malhotra S

更新日期：2010-04-01 00:00:00

abstract：PURPOSE:This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients. METHODS:We identified potential ONJ cases recorded in 2005-2010 a...

journal_title：Pharmacoepidemiology and drug safety

authors： Ehrenstein V,Gammelager H,Schiødt M,Nørholt SE,Neumann-Jensen B,Folkmar TB,Pedersen L,Svaerke C,Sørensen HT,Ma H,Acquavella J

更新日期：2015-07-01 00:00:00

abstract：BACKGROUND:Raised blood pressure associated with the sodium excipient content of soluble or effervescent analgesic has been previously reported. However, the influence of other anions associated with sodium on blood pressure is still controversial. METHODS:Observational study of elderly hypertensive patients with unco...

journal_title：Pharmacoepidemiology and drug safety

authors： Ubeda A,Llopico J,Sanchez MT

更新日期：2009-05-01 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：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：PURPOSE:To study the association between antibiotic use in early pregnancy and the risk of isolated orofacial clefts. METHODS:We conducted a cohort study of 806,011 live births in Denmark from 1996 through September 2008. Individual-level information on prescribed antibiotics during pregnancy, orofacial cleft diagnosi...

journal_title：Pharmacoepidemiology and drug safety

authors： Mølgaard-Nielsen D,Hviid A

更新日期：2012-03-01 00:00:00

abstract：PURPOSE:Few recent U.S. studies have examined population-based patterns in prescription drug use and even fewer have considered detailed patterns by race/ethnicity. In a representative community sample, our objectives were to determine the most commonly used prescription drug classes, and to describe their use by age, ...

journal_title：Pharmacoepidemiology and drug safety

authors： Hall SA,Chiu GR,Kaufman DW,Kelly JP,Link CL,Kupelian V,McKinlay JB

更新日期：2010-04-01 00:00:00