Abstract:
:Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors. The aim of pharmacovigilance is not only a bureaucratic exercise in public health norms, but is mainly concerned with small minorities of statistical outliers-and even individuals-whose experiences from harms may together form messages about causation that will prevent further at-risk patients from exposure, or at least assist with earlier recognition of drug-related harm and better management of such harm. This requires more time, more data, more analysis and more patient and clinical involvement in reporting useful clinical detail. The paradigm shift back towards gathering more case data relating to possible causation can be selective and would not be just retrogressive, nor necessarily too costly. Greater transparency of hypotheses and availability of anonymised case data will enrol more expertise into evaluations and hypothesis testing, and the provision of more complete and useful information should reduce clinical burdens from bad patient outcomes as well as their overall costs to society.
journal_name
Drug Safjournal_title
Drug safetyauthors
Ralph Edwards Idoi
10.1007/s40264-017-0509-2subject
Has Abstractpub_date
2017-05-01 00:00:00pages
365-372issue
5eissn
0114-5916issn
1179-1942pii
10.1007/s40264-017-0509-2journal_volume
40pub_type
杂志文章相关文献
DRUG SAFETY文献大全abstract:INTRODUCTION:While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM:The aim of this study was to describe the landscape of technolo...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-019-00838-x
更新日期:2019-09-01 00:00:00
abstract::Paraquat is a bipyridyl compound with no known chronic toxicity or teratogenicity. It is poorly absorbed when inhaled, but causes severe illness when ingested orally, death usually occurring within 2 days of ingestion of 50 mg/kg. At lower doses death may be delayed for several weeks. The toxic compound accumulates in...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199005040-00002
更新日期:1990-07-01 00:00:00
abstract::An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. Since 1998, Bayesian Confidence Propagation Neural Network (BCPNN) data mining has been in routine use for screening of the WHO adverse reaction database, Vigibas...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200730070-00014
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:Gastric acid-related symptoms are highly prevalent in the general population (21-40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH). OBJECTIVE:We hypothesized that medicatio...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0488-8
更新日期:2017-03-01 00:00:00
abstract::Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclo...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199410040-00002
更新日期:1994-04-01 00:00:00
abstract:BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200831030-00007
更新日期:2008-01-01 00:00:00
abstract::Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-020-00926-3
更新日期:2020-05-01 00:00:00
abstract::This review evaluates the benefits and potential health risks of the currently used drugs that are approved for the pharmacological treatment of obesity. Analysis of several long term clinical trials indicates that all of these drugs are efficient in reducing excess bodyweight, and that the majority of them allow the ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199920020-00003
更新日期:1999-02-01 00:00:00
abstract:INTRODUCTION:Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current pra...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-020-00959-8
更新日期:2020-10-01 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:INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-019-00809-2
更新日期:2019-07-01 00:00:00
abstract::Older people in the UK receive a disproportionate amount of medication. They comprise 18% of the population but receive 45% of all prescription items. Not surprisingly they experience drug-related illnesses - in 1980, 1 in 10 admissions to acute geriatric units were wholly or partly due to adverse drug reactions. Drug...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199819040-00001
更新日期:1998-10-01 00:00:00
abstract::Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-016-0469-y
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-014-0142-2
更新日期:2014-03-01 00:00:00
abstract::Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescrib...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-013-0020-3
更新日期:2013-03-01 00:00:00
abstract::Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-015-0347-z
更新日期:2015-12-01 00:00:00
abstract::Monobactams and carbapenems are 2 classes of beta-lactam antibiotics that were introduced in the 1980s. This review considers the monobactam aztreonam and the carbapenems imipenem and meropenem. Imipenem is administered together with cilastatin, which inhibits the enzymatic breakdown of imipenem in the kidney. The ant...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199512050-00003
更新日期:1995-05-01 00:00:00
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::Current antiretroviral therapy has lead to longer survival in patients infected with HIV, but it is also associated with new and important problems. Body fat redistribution and metabolic abnormalities, the so-called lipodystrophy syndrome, are among the most prevalent and worrisome ones. While an increasing number of ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124030-00001
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200427130-00006
更新日期:2004-01-01 00:00:00
abstract::Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199207040-00004
更新日期:1992-07-01 00:00:00
abstract::Anaemia is common in patients with haematological malignancy, occurring in the majority of patients with malignant disease who are treated with chemotherapy. Most patients will have their anaemia attributed to the cytokine-mediated anaemia of chronic disease. Many of these patients with anaemia will be symptomatic wit...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225070-00006
更新日期:2002-01-01 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::It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstra...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-016-0446-5
更新日期:2016-11-01 00:00:00
abstract::The biochemistry of vitamin K metabolism and the role of vitamin K-dependent gamma-carboxylation of the vitamin K-dependent coagulation factors are now well understood. Likewise, there is a clear understanding of the role of oral anticoagulants in the inhibition of these coagulation factors. However, the effect of ora...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199309040-00004
更新日期:1993-10-01 00:00:00
abstract::Cirrhosis encompasses a range of pathophysiological changes that may alter drug disposition. Drugs that are dependent primarily on the liver for their systemic clearance are more likely to be subject to reduced elimination and subsequent accumulation. Drug accumulation may lead to excessive plasma drug concentrations ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199717010-00004
更新日期:1997-07-01 00:00:00
abstract:BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombi...
journal_title:Drug safety
pub_type: 杂志文章,随机对照试验
doi:10.2165/00002018-200831080-00008
更新日期:2008-01-01 00:00:00
abstract::As the variety and range of pharmaceutical agents available to the medical profession continues to expand, one unavoidable effect will be an increase in drug-induced disease, including cardiovascular disorders. However, given the high rates of cardiovascular disease and prevalence of recognised cardiovascular risk fac...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730090-00005
更新日期:2007-01-01 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:INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-020-00998-1
更新日期:2021-02-01 00:00:00