Abstract：
PURPOSE:Spontaneous reporting systems in European countries are crucial for collecting adverse drug reaction (ADR) reports. The aim of this study was to evaluate reporting activity among countries and their strategy to increase the number of reports. We also established the best measure for assessment quantity of reports. METHODS:This was a retrospective observational study based on questionnaires and annual reports. The most reliable measure of reporting was determined by Spearman correlation coefficients. RESULTS:Data collected in spontaneous reporting systems in 26 European countries were analysed. In 2007, 2008 and 2009, the average value of reports per year per million inhabitants based on the safety databases of countries was 208, 236, 286, respectively; in comparison, that of Eudra- Vigilance was 311, 453 and 435, respectively. Twelve countries reached a significant level for signal detection of ADRs in 2009. The population-based reporting ratio (PBRR) was correlated to the total expenditure on health (ρ=0.499, p=0.023, n=21), public expenditure on health (ρ=0.477, p=0.035, n=20), density of physicians (ρ=0.336, p=0.136, n=21) and expenditure on pharmaceuticals (ρ=0.365, p=0.114, n=20). Strategies of regulatory authorities to increase reporting were determined. CONCLUSIONS:The results of this study make several noteworthy contributions regarding national spontaneous reporting systems. The relevance of the PBRR for the measurement reporting activity is clearly supported by the current findings. This study also shows that there is a general trend towards increased reporting activity. This is maintained by regional centres and encouragement of reporting. A further study would be helpful to assess the effectiveness of reporting systems at both the national and European level.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Srba J,Descikova V,Vlcek Jdoi
10.1007/s00228-012-1219-4subject
Has Abstractpub_date
2012-07-01 00:00:00pages
1057-63issue
7eissn
0031-6970issn
1432-1041journal_volume
68pub_type
杂志文章abstract：:Factors influencing the disposition of clotiazepam in man were evaluated in a series of pharmacokinetic studies in healthy volunteers given a single 5 mg dose. Old age caused an increased volume of distribution of clotiazepam in women, and its clearance tended to be reduced in elderly men. Use of oral contraceptives, ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00546709
更新日期：1984-01-01 00:00:00
abstract：:The pharmacokinetics of i.v. chloramphenicol succinate and oral chloramphenicol palmitate were studied in Ethiopian children with different nutritional states. In children with kwashiorkor the plasma clearance of chloramphenicol was significantly lower than in children of normal weight (4.16 ml/min/kg versus 7.53 ml/m...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00607094
更新日期：1983-01-01 00:00:00
abstract：OBJECTIVE:Nafamostat mesilate, a potent protease inhibitor, is widely used for the treatment of pancreatitis, disseminated intravascular coagulation and as an anticoagulant in haemodialysis. However, hyperkalaemia associated with nafamostat mesilate has been reported. It is thought to be due to decreased urinary potass...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280050176
更新日期：1996-01-01 00:00:00
abstract：:The four sulphonamides studied--furosemide, tolbutamide, sulfafurazole and sulfonamidochlorobenzoic acid--bind to human albumin at the same sites but with decreasing affinity. These sites are also common to other drugs, namely acenocoumarin, chlorophenoxyisobutyric acid, phenylbutazone and warfarin. In plasma, the fou...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00609473
更新日期：1976-06-15 00:00:00
abstract：PURPOSE:To assess the influence of the P450 oxidoreductase 28 SNP (POR 28) on tacrolimus pharmacokinetics in the Chinese population. METHODS:Seventy-one healthy Chinese volunteers enrolled in the study received an oral dose of 2 mg of tacrolimus after providing written informed consent. CYP3A5 3 was genotyped by polym...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-012-1432-1
更新日期：2013-04-01 00:00:00
abstract：:Human calcitonin (hCT) injected into the lumen of the descending colon of normal human subjects was absorbed within minutes and could be recognized intact in plasma as shown by RIA in combination with reverse-phase HPLC. The absorption was low and variable, with bioavailabilities ranging from 0.01% to 2.7% relative to...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF02285096
更新日期：1992-01-01 00:00:00
abstract：:Effects on psychomotor and cognitive performance of adinazolam (15 or 30 mg), alone and in combination with ethanol (0.8 g/kg), were studied in healthy male volunteers and compared to effects of 10 mg diazepam. Adinazolam 30 mg produced relatively long-lasting impairments on tests of tracking, attention, verbal and no...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00315578
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVE:To search for ethnic variability in the impact of cytochrome P450 2C9 (CYP2C9) polymorphism. METHODS:CYP2C9 allelic variants related to impaired CYP2C9 metabolism were analysed in genomic DNA from 157 Spanish healthy subjects using amplification-restriction and sequencing procedures. RESULTS:The frequency f...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/s002280100264
更新日期：2001-04-01 00:00:00
abstract：PURPOSE:The objective of this study was to appraise the safety profiles of HES preparations and to find out which HES preparation was the most acceptable in cardiovascular surgery through a comparison with control solutions. METHODS:Pertinent randomized controlled trials were selected through a search of Pubmed, Embas...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,meta分析,评审
doi：10.1007/s00228-011-1008-5
更新日期：2011-08-01 00:00:00
abstract：PURPOSE:The aim of this study was to add to the body of evidence on statin-induced gynecomastia based on data retrieved from the Italian spontaneous adverse drug reaction (ADR) reporting database. METHODS:Spontaneous ADR reports collected in the Italian database up to 31 December 2010 were assessed on a case-by-case b...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-012-1218-5
更新日期：2012-06-01 00:00:00
abstract：BACKGROUND:Anti-tumor necrosis factor-alpha (TNF-α) agents have considerable advances in treating inflammatory bowel disease (IBD). These drugs carry possible risk of adverse symptoms, and no meta-analysis has examined this issue and the potential duration-response relationship. PURPOSE:The purpose of this study was t...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,meta分析,评审
doi：10.1007/s00228-015-1877-0
更新日期：2015-08-01 00:00:00
abstract：:The effect of menstrual cycle on the pharmacokinetics of theophylline has been studied in 9 female asthmatic patients. At three different times during the cycle (first, tenth and twentieth days) each subject received an i.v. infusion of 240 mg theophylline. Significant changes were found in the kinetics of theophyllin...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF02657059
更新日期：1990-01-01 00:00:00
abstract：PURPOSE:Perhexiline is a prophylactic anti-ischaemic agent with weak calcium antagonist effect which has been increasingly utilised in the management of refractory angina. The metabolic clearance of perhexiline is modulated by CYP2D6 metaboliser status and stereoselectivity. The current study sought to (1) determine wh...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-015-1934-8
更新日期：2015-12-01 00:00:00
abstract：:The pharmacokinetics of temocapril hydrochloride, a novel prodrug-type angiotensin-I converting enzyme (ACE) inhibitor, has been studied in patients with mild (Group II) to severe (Group III) renal insufficiency in comparison with subjects with normal renal function (Group I). The pharmacokinetic parameters of the act...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF02284968
更新日期：1992-01-01 00:00:00
abstract：PURPOSE:To develop a limited sampling strategy (LSS) to predict area under the concentration-time curve (AUC) ratios of omeprazole (AUC(OPZ)) to its metabolites 5-hydroxyomeprazole (AUC(5OH)) and omeprazole sulfone (AUC(SUL)) as phenotyping parameters for cytochrome P450 (CYP) 2C19 and 3A. METHODS:Data were obtained f...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-011-1136-y
更新日期：2012-04-01 00:00:00
abstract：OBJECTIVE:To evaluate the effect of the CYP2D6 genotype on the pharmacokinetics of tropisetron in healthy Korean subjects. METHODS:A single 5-mg capsule of tropisetron was administered orally to 13 healthy subjects. Plasma concentrations were determined by validated HPLC procedures and data were analyzed by using nonc...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-003-0595-1
更新日期：2003-06-01 00:00:00
abstract：PURPOSE:The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are not similar to those obtained in the other sex. Therefore, results obtained in studies including only mal...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/s00228-019-02632-1
更新日期：2019-06-01 00:00:00
abstract：:The pharmacodynamic actions and disposition of diuretic and antihypertensive agents may be significantly modified in subjects with renal disease. Most studies on this question have dealt with alterations in the elimination kinetics of these drugs and, while they generate descriptive data, minimal insight about change...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00561487
更新日期：1980-07-01 00:00:00
abstract：PURPOSE:The aim of our study was to evaluate the impact of CYP3A4, CYP3A5, and ABCB1 polymorphisms on donepezil disposition and clinical outcome. METHODS:Fifty-four Italian patients diagnosed with probable mild to moderate Alzheimer's disease, treated with donepezil (37 patients 5 mg/day, 17 patients 10 mg/day) were g...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-010-0883-5
更新日期：2011-01-01 00:00:00
abstract：PURPOSE:To investigate if the ordinary use of a vaginal suppository containing miconazole results in systemic absorption that is sufficient to affect the activities of CYP1A2 and CYP3A4, which are major drug- and steroid-metabolising enzymes. METHODS:In 20 healthy non-pregnant women aged 18-45 years, the serum concent...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-010-0906-2
更新日期：2010-12-01 00:00:00
abstract：:The pharmacokinetics of theophylline was investigated in five hyperthyroid, five hypothyroid, and five euthyroid patients, all with chronic obstructive pulmonary disease. Wide individual variability was found in theophylline kinetics, but the rate of elimination of theophylline was significantly higher in hyperthyroid...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00544240
更新日期：1987-01-01 00:00:00
abstract：:General well-being, adverse effects and anti-hypertensive efficacy have been investigated in a double blind, parallel-group, dose-response multicentre study of diltiazem and metoprolol monotherapy for hypertension. 128 patients with primary hypertension were included from 10 participating centres. The patients were ra...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1007/BF00315222
更新日期：1991-01-01 00:00:00
abstract：OBJECTIVE:Because of the risk of haemorrhagic disease of the newborn as a result of a deficit in vitamin K, it is generally agreed that newborns should receive vitamin K. However, there is no consensus concerning the route of administration, dose, number of doses, or dose frequency. METHODS:We studied patterns of vita...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280050297
更新日期：1997-01-01 00:00:00
abstract：BACKGROUND:Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in the elderly. NSAIDs may cause a series of adverse drug reactions, of which gastrointestinal, renovascular/cardiovascular and bleeding complications are of particular concern. Concomitant use of several other drugs may further increase the risk...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-010-0825-2
更新日期：2010-08-01 00:00:00
abstract：PURPOSE:The aims of this study were to characterise the population pharmacokinetics of oxypurinol in patients receiving haemodialysis and to compare oxypurinol exposure in dialysis and non-dialysis patients. METHODS:Oxypurinol plasma concentrations from 6 gout people receiving haemodialysis and 19 people with gout not...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-016-2133-y
更新日期：2017-01-01 00:00:00
abstract：:Repeated doses of a 1,5 benzodiazepine, clobazam, were administered to a group of consenting volunteers. Performance on a psychomotor performance task was not impaired by repeated doses of the drug. Subjective assessments of anxiety were reduced commensurate with an increase in the level of cortical integration, measu...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00644961
更新日期：1979-08-01 00:00:00
abstract：PURPOSE:Pharmacology and pharmacotherapy education is being increasingly integrated in medical curricula, which might lead to a specific loss of knowledge in these subjects. This, in turn, could lead to harmful prescribing errors, especially in vulnerable older patients. METHODS:Teachers who coordinated education in D...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-015-1830-2
更新日期：2015-05-01 00:00:00
abstract：:Investigations were undertaken to evaluate which uraemic solutes decrease drug protein binding. This was done by performing HPLC-fractionation of uraemic biological fluids and studying the effect of addition of a lyophilisate of each fraction to normal plasma containing standard quantities of radiolabelled drugs. From...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/BF01428386
更新日期：1993-01-01 00:00:00
abstract：OBJECTIVES:Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands. METHODS:In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigilance Centre Lareb. ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-006-0102-6
更新日期：2006-05-01 00:00:00
abstract：:The kinetics of triamterene and its active phase II metabolite were studied in 32 patients with various degrees of impaired renal function; the creatinine clearances ranged from 135 to 10 ml/min. The area under the plasma concentration-time curves (AUC) for triamterene were not influenced by kidney function, but the A...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00609885
更新日期：1983-01-01 00:00:00
