Abstract:
INTRODUCTION:Pharmacovigilance includes analysis of large databases of information on drugs and events using algorithms that detect disproportional frequencies of associations. In order to test such algorithms, attempts have been made to provide canonical reference lists of so-called 'positive controls' and 'negative controls'. Reference sets with even modest levels of misclassification may result in under- or overstatement of the performance of algorithms. AIM:We sought to determine the extent to which 'negative control' drug-event pairs in the Observational Medical Outcomes Partnership (OMOP) database are misclassified METHODS:We searched the medical literature for evidence of associations between drugs and events listed by OMOP as negative controls. RESULTS:The criteria used in OMOP to classify positive and negative controls are asymmetric; drug-event associations published only as case series or case reports are classified as positive controls if they are cited in Drug-Induced Diseases by Tisdale and Miller, but as negative controls if case series or case reports exist but are not cited in Tisdale and Miller. Of 233 drug-event pairs classified in the 2013 version of OMOP as negative controls, 21 failed to meet pre-specified OMOP adjudication criteria; in another 19 cases we found case reports, case series, or observational evidence that the drug and event are associated. Overall, OMOP misclassified, or may have misclassified, 40 (17 %) of all 'negative controls.' CONCLUSIONS:Results from studies of the performance of signal-detection algorithms based on the OMOP gold standard should be viewed with circumspection, because imperfect gold standards may lead to under/overstatement of absolute and relative signal detection algorithm performance. Improvements to OMOP would include omitting misclassified drug-event pairs, assigning more specific event labels, and using more extensive sources of information.
journal_name
Drug Safjournal_title
Drug safetyauthors
Hauben M,Aronson JK,Ferner REdoi
10.1007/s40264-016-0392-2subject
Has Abstractpub_date
2016-05-01 00:00:00pages
421-32issue
5eissn
0114-5916issn
1179-1942pii
10.1007/s40264-016-0392-2journal_volume
39pub_type
杂志文章相关文献
DRUG SAFETY文献大全abstract::The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...
journal_title:Drug safety
pub_type: 已发布勘误
doi:10.1007/s40264-019-00803-8
更新日期:2019-06-01 00:00:00
abstract::Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy f...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629030-00004
更新日期:2006-01-01 00:00:00
abstract::Zopiclone is a cyclopyrrolone hypnosedative that is chemically unrelated to the benzodiazepines but nevertheless potentiates gamma-aminobutyric acid-mediated neuronal inhibition, and has demonstrated proven efficacy and good tolerability in the treatment of insomnia over 15 years of use. Zopiclone is indicated for sho...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199921060-00003
更新日期:1999-12-01 00:00:00
abstract::After 2002, an association between stroke and antipsychotic use was reported in clinical trials and large database studies. This review considers previous quantitative reviews, newly published clinical trials, and recent observational cohort and case-control studies, and focuses on the clinical significance of the ris...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/11319120-000000000-00000
更新日期:2010-04-01 00:00:00
abstract::Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currentl...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629120-00005
更新日期:2006-01-01 00:00:00
abstract::Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200023010-00002
更新日期:2000-07-01 00:00:00
abstract::Linezolid is an oxazolidinone, a new class of antibacterial with a unique mechanism of action, namely inhibition of the formation of a functional 70S initiation complex in the 50S bacterial ribosomal subunit. Linezolid is highly active against multidrug-resistant Gram-positive cocci, including meticillin-resistant Sta...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200831090-00004
更新日期:2008-01-01 00:00:00
abstract::Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepi...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200528040-00003
更新日期:2005-01-01 00:00:00
abstract::Methylphenidate is the most widely use psychotropic medication in children in the US. It is both well tolerated and efficacious in the treatment of attention deficit hyperactivity disorder, and is associated with few serious adverse effects. However, the abuse of methylphenidate for the purpose of experiencing a 'high...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199717030-00001
更新日期:1997-09-01 00:00:00
abstract::In this narrative review, a brief summary of theoretical approaches to risk perception is followed by an analysis of some of the special factors influencing risk perception and risk communication in sub-Saharan Africa. Examples of recent and emergent local medicines and vaccine controversies in several countries are g...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/BF03261990
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospi...
journal_title:Drug safety
pub_type: 杂志文章,meta分析,评审
doi:10.2165/11598050-000000000-00000
更新日期:2012-03-01 00:00:00
abstract:BACKGROUND:In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. OBJECTIVE:To compare patient characteristics, suspected ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11536510-000000000-00000
更新日期:2010-09-01 00:00:00
abstract::The risks and adverse effects of the low dose, new generation progestogen combined oral contraceptives (COCs) are much lower than original studies involving pills containing 50 micrograms estrogen. The main effects are those on the cardiovascular system, lipid and glucose metabolism and cancer. Any effect of the COC o...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199512020-00002
更新日期:1995-02-01 00:00:00
abstract::The development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-016-0440-y
更新日期:2016-10-01 00:00:00
abstract::The prevalence of pain is high in multimorbid patients and they can experience a multitude of painful conditions. The changes in physiology and homeostasis associated with multimorbidity and increasing age and the immature metabolism of neonates all increase the risk of toxicity from analgesics. Altered pharmacokineti...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199818060-00006
更新日期:1998-06-01 00:00:00
abstract::Misoprostol, a prostaglandin E(1) analogue, is widely used in the US and other countries for cervical ripening and labour induction. Its use for these indications is not approved by the US Food and Drug Administration (FDA). The manufacturer of misoprostol issued a letter to American healthcare providers in August 200...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225090-00005
更新日期:2002-01-01 00:00:00
abstract::Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0681-z
更新日期:2018-11-01 00:00:00
abstract:BACKGROUND:Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE:The aim of this pilot study was to assess the e...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11319170-000000000-00000
更新日期:2010-05-01 00:00:00
abstract:BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-013-0069-z
更新日期:2013-07-01 00:00:00
abstract:INTRODUCTION:The nature of medication errors (MEs) and the frequency of identified or intercepted MEs are not being scrutinized in daily practice in Japan. OBJECTIVES:The aim of this study was to clarify the epidemiology of MEs and the risk factors for non-intercepted and unidentified MEs. METHODS:The Japan Adverse D...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0458-1
更新日期:2016-11-01 00:00:00
abstract::The introduction of MedDRA, the Medical Dictionary for Regulatory Activities, as a standardised terminology may have a major impact on the performance of risk management. Thus, MedDRA is likely to have an important effect on the analysis of clinical trial safety data. Review of the most commonly used terms in clinical...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427080-00010
更新日期:2004-01-01 00:00:00
abstract::It is a major clinical and public health problem that there is no clear strategy as to how we best make use of information obtained when pregnant women take drugs. For this reason, some pregnant women are not treated as they should be and some are given drugs they should not use. We suggest a monitoring system that co...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200225010-00003
更新日期:2002-01-01 00:00:00
abstract:INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0424-y
更新日期:2016-08-01 00:00:00
abstract::Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-017-0625-z
更新日期:2018-04-01 00:00:00
abstract::In general, the selective estrogen receptor modulators (SERMs) currently indicated for the treatment and prevention of breast cancer, i.e. tamoxifen and toremifene, are fairly well tolerated. However, tamoxifen has been shown to induce hepatocellular carcinomas in rats, but not in humans, and can increase the risk of ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124140-00003
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND:Eosinophilic pneumonia (EP) has been noted in association with daptomycin use. The product labelling was recently updated to include EP in the Warnings and Precautions and Post-Marketing Experience sections. OBJECTIVE:The objective of this study was to analyse adverse event (AE) reports submitted to the US ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/11597460-000000000-00000
更新日期:2012-06-01 00:00:00
abstract::Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-012-0012-8
更新日期:2013-02-01 00:00:00
abstract::The complications of failure, neural injury and local anaesthetic toxicity are common to all regional anaesthesia techniques, and individual techniques are associated with specific complications. All potential candidates for regional anaesthesia should be thoroughly evaluated and informed of potential complications. I...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124060-00002
更新日期:2001-01-01 00:00:00
abstract::Aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) cause deterioration in respiratory function in approximately 10% of adults with asthma and a smaller proportion of children with asthma. We propose evidence-based guidelines for the safe use of NSAIDs in individuals with asthma foll...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124110-00004
更新日期:2001-01-01 00:00:00
abstract:INTRODUCTION:The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Ap...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-017-0630-2
更新日期:2018-05-01 00:00:00