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International Journal of Risk & Safety in Medicine

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https://www.readbyqxmd.com/read/27662283/letter-to-the-editor
#1
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September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27662282/letter-to-the-editor
#2
(no author information available yet)
No abstract text is available yet for this article.
September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27662281/letter-to-the-editor
#3
(no author information available yet)
No abstract text is available yet for this article.
September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27662280/adverse-event-reporting-and-patient-safety-at-a-university-hospital-mapping-correlating-and-associating-events-for-a-data-based-patient-risk-management
#4
Alessandra Buja, Anna Maria Saieva, Angela Vinelli, Rosaria Manola Cacco, Ketty Ottolitri, Elisa De Battisti, Claudio Dario, Vincenzo Baldo
BACKGROUND: Reporting adverse events (AE) with a bearing on patient safety is fundamentally important to the identification and mitigation of potential clinical risks. OBJECTIVE: The aim of this study was to analyze the AE reporting systems adopted at a university hospital for the purpose of enhancing the learning potential afforded by these systems. RESEARCH DESIGN: Retrospective cohort study METHODS: Data were collected from different information flows (reports of incidents and falls, patients' claims and complaints, and cases of hospital-acquired infection [HAI]) at an university hospital...
September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27662279/study-329-continuation-phase-safety-and-efficacy-of-paroxetine-and-imipramine-in-extended-treatment-of-adolescent-major-depression
#5
Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude
OBJECTIVE: This is an analysis of the unpublished continuation phase of Study 329, the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The objectives of the continuation phase were to assess safety and relapse rates in the longer term. The objective of this publication, under the Restoring Invisible and Abandoned Trials (RIAT) initiative, was to see whether access to and analysis of the previously unpublished dataset from the continuation phase of this randomized controlled trial would have clinically relevant implications for evidence-based medicine...
September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27662278/links-between-serotonin-reuptake-inhibition-during-pregnancy-and-neurodevelopmental-delay-spectrum-disorders-a-systematic-review-of-epidemiological-and-physiological-evidence
#6
D Healy, J Le Noury, D Mangin
OBJECTIVE: To investigate possible linkages between neurodevelopmental delay and neurodevelopmental spectrum disorders and exposure to medication with effects on serotonin reuptake inhibition during pregnancy. METHODS: We systematically reviewed the epidemiological literature for studies bearing on this relationship in children born with neurodevelopmental spectrum disorder and related conditions, as well as animal studies giving serotonin reuptake inhibitors to pregnant animals and in addition reviewed the literature for proposals as to possible mechanisms that might link effects on serotonin reuptake with cognitive changes post-partum...
September 17, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27567768/actions-in-response-to-drug-safety-signals%C3%A2-arising-from-a-spontaneous-reporting%C3%A2-system-retrospective-study%C3%A2-in%C3%A2-the%C3%A2-netherlands
#7
Leàn Rolfes, Judith Kolfschoten, Florence van Hunsel, Michel Kooijman, Eugène van Puijenbroek
BACKGROUND: There is limited information on actions taken in response to drug safety signals originating from a spontaneous reporting system (SRS) in pharmacovigilance. In The Netherlands the Pharmacovigilance Centre Lareb is an independent organization that works in close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB). OBJECTIVE: The objective of this study is to gain insight in steps undertaken on signals originating from the SRS and disseminated by Lareb from 2008-2012...
August 22, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27567767/adverse-event-assessment-methods-in%C3%A2-published-trials-of-psychotropic-drugs-poor-reporting-and-neglect-of-emerging-safety-concerns
#8
Shannon Hughes, David Cohen, Rebekah Johnson
BACKGROUND: Actual assessment methods for identifying adverse events (AEs) in clinical trials have received less scrutiny than underreporting of AEs. OBJECTIVE: To investigate whether AE assessment has changed over time for three psychotropic drugs with turbulent histories of safety concerns since their U.S. approval. METHODS: From industry-funded published trials of atomoxetine, duloxetine, and olanzapine retrieved from PubMed for 1996-2004 (n = 33) and 2009-2014 (n = 40), verbatim AE assessment and numbers of words describing efficacy and safety assessment were extracted...
August 22, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27567766/obligation-towards-medical-errors-disclosure-at-a-tertiary-care-hospital-in%C3%A2-dubai-uae
#9
Ashraf Ahmad Zaghloul, Syed Azizur Rahman, Nagwa Younes Abou El-Enein
OBJECTIVE: The study aimed to identify healthcare providers' obligation towards medical errors disclosure as well as to study the association between the severity of the medical error and the intention to disclose the error to the patients and their families. DESIGN: A cross-sectional study design was followed to identify the magnitude of disclosure among healthcare providers in different departments at a randomly selected tertiary care hospital in Dubai. SETTING AND PARTICIPANTS: The total sample size accounted for 106 respondents...
August 22, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27567765/medication-errors-among-health-professionals-in-nigeria-a-national-survey
#10
Olayinka O Ogunleye, Ibrahim A Oreagba, Catherine Falade, Ambrose Isah, Okezie Enwere, Sunday Olayemi, Sunday O Ogundele, Reginald Obiako, Rachel Odesanya, Peter Bassi, John Obodo, Jelili Kilani, Mathew Ekoja
BACKGROUND: Medication errors are preventable causes of patient harm with significant contributions to adverse drug events but they remain understudied in Nigeria. OBJECTIVES: To estimate the prevalence of self-reported medication errors among health professionals and examine their knowledge of medication errors with the hope of identifying appropriate measures to promote medication safety. METHODS: A cross sectional survey among doctors, pharmacists and nurses in 10 tertiary hospitals...
August 22, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27567764/effect-of-patient-safety-incident-review-and%C3%A2-reflection-in-an-extended-morbidity-and%C3%A2-mortality-meeting
#11
Saurabh Mehta, Harvinder Pal Singh, Joseph J Dias
BACKGROUND: We modified the departmental mortality and morbidity (M&M) meetings to evaluate whether patient safety incident review as a part of this meeting was associated with reduced patient safety incidents. METHOD: A pilot programme of peer review of patient safety incidents (PSI) supported by education relevant to that event and follow-on action plan was introduced as a part of an extended morbidity and mortality meeting in a university hospital orthopaedic department...
August 22, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176757/front-office-staff-as-medical-educators-risk-creators-and-risk-managers
#12
Marshall B Kapp
The author describes his own negative series of encounters with the front office staff of a large specialty medical practice during a recent lengthy episode of significant medical distress. The author suggests several reasons, including legal risk management, that medical students should be exposed as part of their education to the interactions of patients with front office staffs (not just physicians) to get a fuller picture of patients' actual experiences with the health care system.
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176756/biosimilar-medicines-review
#13
Camila Dos Reis, Ricardo Teixo, Fernando Mendes, Rui Santos Cruz
INTRODUCTION: By definition, biosimilars are similar to a biological reference that has already received marketing authorization for biologic drugs.The purpose of biosimilars is reducing costs, thus increasing access to this treatment, however, the concerns of health professionals and users refer to the fact that to reduce costs will not neglecting the quality, effectiveness and especially security. OBJECTIVE: The aim of this study is then to assess the degree of similarity between the biosimilar and its reference biopharmaceuticals, trying to understand the production process, requirements necessary for approval, and its impact on the quality, safety, efficacy and costs...
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176755/the-citalopram-cit-md-18-pediatric-depression-trial-deconstruction-of-medical-ghostwriting-data-mischaracterisation-and-academic-malfeasance
#14
Jon N Jureidini, Jay D Amsterdam, Leemon B McHenry
OBJECTIVE: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States. METHODS: Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed. RESULTS: The published article contained efficacy and safety data inconsistent with the protocol criteria...
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176754/knowledge-attitude-and-practice-of-general-practitioners-towards-adverse-drug-reaction-reporting-in-south-of-iran-shiraz-pharmacoepidemiology-report
#15
Payam Peymani, Reza Tabrizi, Saba Afifi, Soha Namazi, Seyed Taghi Heydari, Mohammad Khabaz Shirazi, Hasti Nouraei, Elham Sadeghi, Kamran B Lankarani, Najmeh Maharlouei
BACKGROUND: An adverse drug reaction (ADRs) is linked with the use of medications and unpredictable negative consequences. The Iranian Pharmacovigilance center (IPC) has reported that the rate of ADR is very low. OBJECTIVE: Thus, this study was performed to find the reasons for this under-reporting, and investigate the level of knowledge, attitude and practice (KAP) of General Practitioners (GPs) about spontaneous reporting system in Shiraz. METHODS: The present cross-sectional study was conducted on 350 general practitioners (GPs) working in Shiraz, Iran from Oct 2014 to March 2015...
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176753/patterns-of-adverse-drug-reaction-signals-in-nafdac-pharmacovigilance-activities-from-september-to-november-2014
#16
Olufunsho Awodele, Ali Ibrahim, Paul Orhii
BACKGROUND: Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. OBJECTIVE: Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals...
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/27176752/persistent-sexual-dysfunction-after-early-exposure-to-ssris-systematic-review-of-animal-studies
#17
Anders Lykkemark Simonsen, Pia Brandt Danborg, Peter Christian Gøtzsche
BACKGROUND: Sexual dysfunction is a common adverse effect of selective serotonin reuptake inhibitors (SSRIs) and there is a concern that the sexual harms might persist after discontinuation of therapy. OBJECTIVE: To assess whether the use of SSRIs in animals can lead to persistent sexual dysfunction. METHODS: Systematic review of animal studies measuring sexual behaviour after end of treatment with SSRIs or serotonin norepinephrine reuptake inhibitors...
March 16, 2016: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/26756896/performance-assessment-of-the-thai-national-center-for-pharmacovigilance
#18
Wanida Kaewpanukrungsi, Puree Anantachoti
BACKGROUND: The Thai National Pharmacovigilance Center (NPVC) has operated since 1983, but its performance has never been formally assessed. OBJECTIVE: The paper aimed to present the main findings of performance assessment of the Thai NPVC. METHODS: A survey was conducted. Data from January 2011-December 2013 were collected. The performance was assessed through four indicator domains. RESULTS: The NPVC has a clear mission to guide its roles and responsibilities...
2015: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/26756895/knowledge-and-perception-of-off-label-drug-use-amongst-prescribing-physicians-in-a-tertiary-care-hospital
#19
S Kannan, A Bahl, P P Khosla
INTRODUCTION: Off-label drug use is commonly reported in various disciplines of medicine. Considering the lacunae of studies from prescribers in the Indian subcontinent, the present study was conducted to explore their awareness and views of off-label drug use. METHODS: A validated questionnaire was administered to interns, junior residents and faculty members who were recruited in the present study of various medical and surgical departments of Subharti Medical College, Meerut, India, a tertiary care teaching hospital...
2015: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/26756894/evidence-based-information-leads-to-reduction-in-inappropriate-drug-prescribing-results-from-indian-older-inpatients
#20
Mandavi Kashyap, Sanjay D'Cruz, Atul Sachdev, Pramil Tiwari
BACKGROUND: Although several guidelines for appropriate prescribing are available, inappropriate drug prescription remains noteworthy problem among older adults. Indian older patients are also not spare from this issue and existing literature indicates a fair level of inappropriate drug use (IDU). OBJECTIVES: Identified potentially IDU and documented their reduction based on provided evidence-based information and also identified possible predictors of IDU in older inpatients...
2015: International Journal of Risk & Safety in Medicine
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