Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance.

abstract：:Narcolepsy is a life-long central nervous system (CNS) syndrome characterised by excessive sleepiness, cataplexy, sleep paralysis, hypnagogic hallucinations and disturbed night-time sleep. Unsuccessfully treated narcolepsy confers increased risks on patients and on society due to the patient's increased chance of beco...

journal_title：Drug safety

authors： Mitler MM,Hayduk R

更新日期：2002-01-01 00:00:00

abstract：BACKGROUND:A number of published studies compare adverse event rates for drugs on the basis of reports in the US FDA Adverse Event Reporting System (AERS). While the AERS data have the advantage of timely availability and a large capture population, the database is subject to many significant biases, and lacks complete...

journal_title：Drug safety

authors： Hochberg AM,Pearson RK,O'Hara DJ,Reisinger SJ

更新日期：2009-01-01 00:00:00

abstract：:The generation of autoantibodies and autoimmune diseases such as systemic lupus erythematosus has been associated with the use of certain drugs in humans. Early reports suggested that procainamide and hydralazine were associated with the highest risk of developing lupus, quinidine with a moderate risk and all other dr...

journal_title：Drug safety

authors： Chang C,Gershwin ME

更新日期：2011-05-01 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

authors： van Eekeren R,Rolfes L,Koster AS,Magro L,Parthasarathi G,Al Ramimmy H,Schutte T,Tanaka D,van Puijenbroek E,Härmark L

更新日期：2018-11-01 00:00:00

abstract：BACKGROUND:Hepatic dysfunction, manifested as liver enzyme elevations, occurs frequently in patients who are treated with interferon, however, data for patients with multiple sclerosis are limited. OBJECTIVE:To retrospectively assess the safety profile of interferon-beta-1a therapy with respect to liver function durin...

journal_title：Drug safety

authors： Francis GS,Grumser Y,Alteri E,Micaleff A,O'Brien F,Alsop J,Stam Moraga M,Kaplowitz N

更新日期：2003-01-01 00:00:00

abstract：INTRODUCTION:The case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate...

journal_title：Drug safety

authors： Théophile H,Moore N,Robinson P,Bégaud B,Pariente A

更新日期：2016-12-01 00:00:00

abstract：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 00:00:00

abstract：:Since 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical pat...

journal_title：Drug safety

authors： Raschi E,Bianchin M,Ageno W,De Ponti R,De Ponti F

更新日期：2016-12-01 00:00:00

abstract：:To determine the pattern of and the risk factors for adverse drug reactions (ADRs) in Hong Kong, a prospective study of acute admissions to 2 general medical wards at the Prince of Wales Hospital was undertaken. Of the 1701 admissions included in this study, 74 (4.4%) were attributed to ADRs. Sulphonylureas, nonsteroi...

journal_title：Drug safety

authors： Chan TY,Chan JC,Tomlinson B,Critchley JA

更新日期：1992-05-01 00:00:00

abstract：:In the US, adverse drug reactions (ADRs) rank between the fourth to sixth leading cause of death, ahead of pneumonia and diabetes mellitus. An important reason for the high incidence of serious and fatal ADRs is that the existing drug development paradigms do not generate adequate information on the mechanistic source...

journal_title：Drug safety

authors： Ozdemir V,Shear NH,Kalow W

更新日期：2001-01-01 00:00:00

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

authors： Straub L,Gagne JJ,Maro JC,Nguyen MD,Beaulieu N,Brown JS,Kennedy A,Johnson M,Wright A,Zhou L,Wang SV

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION:Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES:The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and altern...

journal_title：Drug safety

authors： Webster RK,Weinman J,Rubin GJ

更新日期：2017-08-01 00:00:00

abstract：:Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

journal_title：Drug safety

authors： Inokuma Y

更新日期：2017-06-01 00:00:00

abstract：:The New Zealand Medicines Adverse Reactions Committee has been monitoring reports of adverse drug reactions (ADRs) since 1965. We wished to determine the numbers of voluntary reports of different types of ADR to all nonsteroidal anti-inflammatory drugs (NSAIDs) over a long time period and relate these to age. As the e...

journal_title：Drug safety

authors： Clark DW,Ghose K

更新日期：1992-11-01 00:00:00

abstract：BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

journal_title：Drug safety

authors： Bailey S,Singh A,Azadian R,Huber P,Blum M

更新日期：2010-02-01 00:00:00

abstract：:Gastroesophageal reflux is one of the most common reasons for referrals to paediatricians or paediatric gastroenterologists. Gastric acid-buffering agents, mucosal surface barriers and gastric anti-secretory agents are the main groups of medications currently used for treating gastroesophageal reflux disease (GERD) in...

journal_title：Drug safety

authors： Kierkus J,Oracz G,Korczowski B,Szymanska E,Wiernicka A,Woynarowski M

更新日期：2014-05-01 00:00:00

abstract：:Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

journal_title：Drug safety

authors： Fox AM,Rieder MJ

更新日期：1993-07-01 00:00:00

abstract：:Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials...

journal_title：Drug safety

authors： Ioannidis JP,Lau J

更新日期：2002-01-01 00:00:00

abstract：:Postoperative nausea and vomiting (PONV) is an age-old problem; more so since the blooming of ambulatory or day surgery centres within the last 2 decades. The aetiology of PONV is multifactorial. The incidence of PONV is usually higher in women and children than in men. PONV not only causes patient discomfort, anxiety...

journal_title：Drug safety

authors： Sung YF

更新日期：1996-03-01 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

authors： Golder S,Smith K,O'Connor K,Gross R,Hennessy S,Gonzalez-Hernandez G

更新日期：2021-02-01 00:00:00

abstract：BACKGROUND:Pharmacists have an essential role in improving drug usage and preventing prescribing errors (PEs). PEs at the interface of care are common, sometimes leading to adverse drug events (ADEs). This was the first study to investigate, using a computerized search method, the number, types, severity, pharmacists' ...

journal_title：Drug safety

authors： Abdel-Qader DH,Harper L,Cantrill JA,Tully MP

更新日期：2010-11-01 00:00:00

abstract：BACKGROUND:Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. OBJECTIVE:The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic prep...

journal_title：Drug safety

authors： Bar-Oz B,Weber-Schoendorfer C,Berlin M,Clementi M,Di Gianantonio E,de Vries L,De Santis M,Merlob P,Stahl B,Eleftheriou G,Maňáková E,Hubičková-Heringová L,Youngster I,Berkovitch M

更新日期：2012-07-01 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

authors： Barbera J,Shapiro C

更新日期：2005-01-01 00:00:00

abstract：BACKGROUND:The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. The task of evaluating information relating to safety lies with national agencies and, for international data, with the World Health Organization Programme for I...

journal_title：Drug safety

authors： Lindquist M,Ståhl M,Bate A,Edwards IR,Meyboom RH

更新日期：2000-12-01 00:00:00

abstract：:The WHO World Alliance on Patient Safety is a new, all encompassing project to improve medical care. Individual patients are the focus and all countries are encouraged to develop systems in which medical error, therapeutic accidents and failures are minimised. The potential for adverse events is present at all levels ...

journal_title：Drug safety

authors： Edwards IR

更新日期：2005-01-01 00:00:00

abstract：:The New Zealand Intensive Medicines Monitoring Programme (IMMP) undertakes prospective observational cohort studies on selected new drugs in the early postmarketing period using prescription-event monitoring (PEM) methodology with the purpose of identifying signals of previously unrecognised ADRs and establishing risk...

journal_title：Drug safety

authors： Coulter DM

更新日期：2002-01-01 00:00:00

abstract：BACKGROUND:Fatal venous thromboembolism (VTE) is a rare complication of combined oral contraceptive (COC) treatment. This study aims to determine incidences of fatal VTE in relation to the type of COC and the percentage of cases reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). A further aim i...

journal_title：Drug safety

authors： Hedenmalm K,Samuelsson E

更新日期：2005-01-01 00:00:00

abstract：:Regular treatment with both long- and short-acting beta 2-agonists results in tolerance to their bronchoprotective effects, although the relevance of this phenomenon in terms of long term asthma control remains unclear. However, there appears to be no appreciable difference between the 2 long-active beta 2-agonists, s...

journal_title：Drug safety

authors： Lipworth BJ

更新日期：1997-05-01 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

authors： McLernon DJ,Bond CM,Hannaford PC,Watson MC,Lee AJ,Hazell L,Avery A,Yellow Card Collaboration.

更新日期：2010-09-01 00:00:00

abstract：BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

journal_title：Drug safety

authors： Ramaswamy K,Kozma CM,Nasrallah H

更新日期：2007-01-01 00:00:00