Abstract:
PURPOSE:The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailored to the different roles and responsibilities of the various staff involved. PROPOSAL:We describe a simple theoretical model of functional and behavioural competencies that is based on an organisation with three levels of staff: evidence collectors and gatherers, evidence processors and distillers, and decision makers. CONCLUSIONS:To stimulate discussion about how to enhance the progress already being made in pharmacovigilance and patient risk management, we have proposed functional and behavioural competencies for pharmacovigilance as a way of identifying and measuring scientific and personal skills pertinent to pharmacovigilance. Competencies should, we believe, be agreed and adopted by all those seeking to improve pharmacovigilance. We invite discussion of these proposals.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Edwards B,Tilson HH,West SLdoi
10.1002/pds.1153keywords:
subject
Has Abstractpub_date
2006-03-01 00:00:00pages
193-8issue
3eissn
1053-8569issn
1099-1557journal_volume
15pub_type
杂志文章abstract:PURPOSE:Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3902
更新日期:2016-05-01 00:00:00
abstract:PURPOSE:The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS:The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during th...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2169
更新日期:2012-02-01 00:00:00
abstract::Schizophrenia is a life-threatening disease associated with mortality rates that are two to three times higher than those expected/observed in the general population. It is associated with high levels of suicide, particularly in young male patients soon after diagnosis. Delays in treating schizophrenia could contribut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1496
更新日期:2007-12-01 00:00:00
abstract::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.699
更新日期:2002-06-01 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
pub_type: 杂志文章
doi:10.1002/pds.5006
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs. METHODS:We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3389
更新日期:2013-03-01 00:00:00
abstract:OBJECTIVE:To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN:Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS:There were 56.8 million prescriptions for oral contrace...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199605)5:3<141::AID-PDS221
更新日期:1996-05-01 00:00:00
abstract:PURPOSE:We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. METHODS:In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Prima...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3926
更新日期:2016-04-01 00:00:00
abstract:PURPOSE:The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP-National Formulary (USP-NF) quality monographs. Because the veracity of dietary supplement adverse event repor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1627
更新日期:2008-10-01 00:00:00
abstract::Rosiglitazone has previously been widely used to treat patients with type 2 diabetes mellitus, but its safety in terms of cardiovascular morbidity and mortality had been called into question. Recently, there have been doubts raised about the meta-analytic evidence with the regulatory authorities relaxing its restricti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,meta分析
doi:10.1002/pds.3736
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:The abuse and nonmedical use of prescription opioids and its subsequent consequences are an important public health concern. This phenomenon has paralleled the increase in the therapeutic use of opioids for pain management. There is thus a need to measure prescription opioid abuse to understand trends over time...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3711
更新日期:2014-12-01 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
pub_type: 杂志文章
doi:10.1002/pds.1988
更新日期:2010-08-01 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
pub_type: 杂志文章
doi:10.1002/pds.1542
更新日期:2008-03-01 00:00:00
abstract:PURPOSE:Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods curre...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3966
更新日期:2016-03-01 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
pub_type: 杂志文章
doi:10.1002/pds.1458
更新日期:2007-10-01 00:00:00
abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4646
更新日期:2018-11-01 00:00:00
abstract:BACKGROUND AND AIMS:Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the as...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.1810
更新日期:2009-11-01 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
pub_type: 杂志文章
doi:10.1002/pds.1838
更新日期:2009-12-01 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
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199711/12)6:6<399::AID-PDS
更新日期:1997-11-01 00:00:00
abstract::It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regardi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.650
更新日期:2002-01-01 00:00:00
abstract:AIMS:To evaluate the pattern of prescribing of angiotensin-converting enzyme (ACE) inhibitors in general practice, related to the primary clinical diagnosis and concomitant medication. DESIGN:A descriptive survey of general practitioners' prescribing habits, presumptive diagnosis and patient demography over a period o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199809/10)7:5<331::AID-PDS
更新日期:1998-09-01 00:00:00
abstract:PURPOSE:To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. METHODS:We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were m...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4362
更新日期:2018-02-01 00:00:00
abstract:PURPOSE:Longitudinal data on prescriptions of antidepressants (AD) in children and adolescents depression are scarce. This study aimed to examine AD prescription trends in children and adolescents in Germany. METHODS:Data of a large statutory health insurance company were analyzed for the period 2005-2012, and outpati...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 历史文章,杂志文章
doi:10.1002/pds.3649
更新日期:2014-12-01 00:00:00
abstract:PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4948
更新日期:2020-03-01 00:00:00
abstract::Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial inf...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199707)6:4<283::AID-PDS270
更新日期:1997-07-01 00:00:00
abstract:PURPOSE:Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear u...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4394
更新日期:2018-04-01 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
pub_type: 杂志文章
doi:10.1002/pds.4092
更新日期:2017-02-01 00:00:00
abstract:PURPOSE:We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug lice...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1695
更新日期:2009-02-01 00:00:00
abstract:PURPOSE:This study was performed to evaluate the change of prescribing patterns after the regulatory action regarding fluoroquinolones in pediatric patients. METHODS:We conducted a time series analysis using the Korea Health Insurance Review and Assessment Service National Patients Sample database. Study subjects cons...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3696
更新日期:2014-12-01 00:00:00
abstract:PURPOSE:The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered d...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2133
更新日期:2011-06-01 00:00:00