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International Journal of Risk & Safety in Medicine

Joakim Börjesson, Peter C Gøtzsche
OBJECTIVE: To assess if lithium treatment in patients with mood disorders, for instance depression, bipolar disorders and schizoaffective disorders has an effect on total mortality and suicide. DESIGN: Systematic review and meta-analysis. MAIN OUTCOME MEASURE: Total mortality. Secondary outcome was suicide. DATA SOURCES: PubMed and Eligible trials were randomized double-blind trials comparing lithium with placebo in patients with mood disorders who were not already on lithium before randomization in order to avoid withdrawal effects in the placebo group...
July 31, 2019: International Journal of Risk & Safety in Medicine
Preshit Nemdas Ambade, Chinmayee Katragadda, Diana Sun, J Lyle Bootman, Ivo Abraham
 This paper argues that health policies should transcend national boundaries yet should not reach the supranational level. Along with multinational global health efforts, such cross-national health policies are essential to leverage joint efforts by countries learning from their peers that experience similar health system challenges. In our analysis, we used World Bank Health, Nutrition, and Population (HNP) data from 1995 to 2014 for East Asia Pacific (EAP) countries to explore health system comparability across member nations...
June 29, 2019: International Journal of Risk & Safety in Medicine
Anuj Chhabra, C Nidhi, Anurag Jain
BACKGROUND: There has been increasing need to examine undergraduate dental education in prescribing to confirm whether it is establishing the goal of producing safe and rational prescribers. Prescribing by dental doctors after graduation is influenced by a variety of factors: the different teaching approaches of the professors at the clinics and in the pharmacology course, fellow colleagues and even the information provided by the pharmaceutical industry. OBJECTIVE: The aim of this study was to assess the prescription knowledge, attitude, preference and common errors made by junior resident dental doctors in the dental department of two medical college and hospital, India...
June 22, 2019: International Journal of Risk & Safety in Medicine
P B Danborg, M Valdersdorf, P C Gøtzsche
BACKGROUND: Millions of people are treated with antidepressants like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This clinical practice is based on short-term trials that have exaggerated the benefits and underestimated the harms. We also know too little about long-term harms. AIM: To assess harms of SSRIs and SNRIs that persist after end of drug intake. METHODS: Systematic review of placebo-controlled randomised trials of any length in patients with a psychiatric diagnosis and a follow-up of at least six months...
January 28, 2019: International Journal of Risk & Safety in Medicine
Kannan Sridharan, Gowri Sivaramakrishnan, Steve Kanters
BACKGROUND: Data regarding the relative safety profile of anti-malarial drugs in pregnancy is sparse mainly limited by the absence of head-to-head clinical trials. The present study is a network meta-analysis of safety of anti-malarial drugs used to treat malaria in pregnant women. METHODS: A thorough literature search using the search strategy "Malaria [tiab] AND (Pregnant [tiab] OR Pregnancy [tiab])" was carried out for either randomized controlled trials or prospective cohort studies in pregnant malarial women prescribed any of the recommended anti-malarial drugs by World Health Organization (WHO) and that have reported adverse pregnancy outcomes such as miscarriage, still birth, and neonatal deaths...
January 28, 2019: International Journal of Risk & Safety in Medicine
Leila Omidi, Reihane Akbari, Esmaeil Hadavandi, Esmaeil Zarei
BACKGROUND: Patient safety culture (PSC) as a main component of the organizational culture plays a key role in providing safe, effective and economic cares and services in healthcare organizations. PSC provides a way to assist hospitals in order to improve patient safety and prevent medical errors. OBJECTIVE: The present study aimed to measure PSC and healthcare professionals' attitude towards voluntary reporting of adverse events in two hospitals in Iran and to develop a hybrid intelligent approach for modeling PSC grades...
2019: International Journal of Risk & Safety in Medicine
Rubina Mulchandani, Ashish Kumar Kakkar
Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs...
2019: International Journal of Risk & Safety in Medicine
Yasutaka Konishi, Yoshinori Nakata, Asuka Nemoto, Masaru Ushijima, Masaaki Matsuura
OBJECTIVE: Self-extubation of tubes and catheters causes various adverse events in postoperative patients. We investigated preoperative risk factors associated with self-extubation. DESIGN: A matched case-control study. SETTING: Teikyo University Hospital. PARTICIPANTS: Postoperative patients over 50 years old. METHODS: Sixty-five patients with a comment in the incident report about self-extubation within 7 postoperative days were recruited for the case group...
2019: International Journal of Risk & Safety in Medicine
Lotta Schepel, Lasse Lehtonen, Marja Airaksinen, Raimo Ojala, Jouni Ahonen, Outi Lapatto-Reiniluoto
BACKGROUND: 10-30% of hospital stays by older patients are drug-related. The admission phase is important for identifying drug-related problems, but taking an incorrect medication history often leads to medication errors. OBJECTIVES: To enhance medication history recording and identify drug-related problems (DRPs) of older patients admitted to emergency departments (EDs). METHODS: DRPs were identified by pharmacists-led medication reconciliation and review procedures in two EDs in Finland; Helsinki University Hospital (HUS), and Kuopio University Hospital (KUH)...
2019: International Journal of Risk & Safety in Medicine
David Healy, Joanna Le Noury, Jon Jureidini
The data supporting the use of "antidepressants" in children and adolescents is largely unavailable. Academic publications give a different picture as regards benefits and harms to publications from regulatory other sources. Despite disagreements about the data driving use of these medicines, in practice "antidepressants" may now be the most commonly used drugs by adolescent girls, and children's mental health services are attracting increasing attention.This paper reviews the difficulties surrounding the data...
2019: International Journal of Risk & Safety in Medicine
Leemon B McHenry
OBJECTIVE: Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company's efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate. METHODS: A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined. RESULTS: The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a front for the defense of Monsanto products...
2018: International Journal of Risk & Safety in Medicine
Saeed Yari, Hesam Akbari, Mohammad Gholami Fesharaki, Omid Khosravizadeh, Mohammad Ghasemi, Yalda Barsam, Hamed Akbari
BACKGROUND: Paying attention to the safety of hospitals, as the most crucial institute for providing medical and health services wherein a bundle of facilities, equipment, and human resource exist, is of significant importance. OBJECTIVE: The present research aims at developing a model for assessing hospitals' safety based on principles of inherent safety design. METHODS: Face validity (30 experts), content validity (20 experts), construct validity (268 examples), convergent validity, and divergent validity have been employed to validate the prepared questionnaire; and the items analysis, the Cronbach's alpha test, ICC test (to measure reliability of the test), composite reliability coefficient have been used to measure primary reliability...
2018: International Journal of Risk & Safety in Medicine
Fernando Oscar Ramos, Roberto Ariel Abeldaño Zuñiga
BACKGROUND: An adverse event is defined as any unintentional harm that results in temporary or permanent disability and/or prolongation of hospitalization time, or death of a patient; as a consequence of health care provided by any staff member of the health institution. OBJECTIVES: The aim was to describe the adverse events that affect patient safety, reported in 2015 in a private hospital in the city of Córdoba, Argentina. METHODS: We analyzed 678 events reported through the computer system on the hospital's intranet...
2018: International Journal of Risk & Safety in Medicine
Mario Ćurković, Dražen Gorjanski
OBJECTIVE: To examine primary care patients' knowledge and attitudes on off-label treatment. METHODS: In 47 primary care offices in Osijek-Baranja County, 1300 patients were given questionnaires about their knowledge and attitudes on off-label treatment. Questionnaires were completed voluntarily and anonymously. RESULTS: Majority of patients (96.3%) had no knowledge about off-label treatment, and upon having it explained, 42.3% would not accept such treatment under any circumstances, while 54...
2018: International Journal of Risk & Safety in Medicine
Tom Stockmann, Dolapo Odegbaro, Sami Timimi, Joanna Moncrieff
BACKGROUND: Antidepressant withdrawal symptoms are well-recognised, but their potential duration remains uncertain. OBJECTIVE: We aimed to describe the characteristics of withdrawal associated with two popular classes of antidepressants, including duration. METHODS: We analysed the content of a sample of posts on an antidepressant withdrawal website. We compared the characteristics of withdrawal associated with SSRIs and SNRIs, including time of onset, duration and nature of symptoms...
2018: International Journal of Risk & Safety in Medicine
Hesty Utami Ramadaniati, Jeffery David Hughes, Ya Ping Lee, Lynne Maree Emmerton
OBJECTIVE: To determine multi-disciplinary perceptions of the clinical significance of medication errors (MEs), the responsible health professional(s), the contributing factors and potential preventive strategies. METHODS: The five simulated ME cases represented errors from five wards at a children's hospital in Australia. Pre-determined answers for each case were developed through consensus among the researchers. The root cause analysis (RCA) was undertaken via a questionnaire disseminated to physicians, nurses and pharmacists at the study hospital to seek their opinions on the ME cases...
2018: International Journal of Risk & Safety in Medicine
David Healy
No abstract text is available yet for this article.
2018: International Journal of Risk & Safety in Medicine
David Healy, Joanna Le Noury, Derelie Mangin
OBJECTIVE: To investigate clinical reports of post-SSRI sexual dysfunction (PSSD), post-finasteride syndrome (PFS) and enduring sexual dysfunction following isotretinoin. METHODS: Data from, a global adverse event reporting website, have been used to establish the clinical features, demographic details and clinical trajectories of syndromes of persistent sexual difficulties following three superficially different treatment modalities.RESULTSWe report on 300 cases of enduring sexual dysfunction from 37 countries following 14 different drugs comprised of serotonin reuptake inhibiting antidepressants, 5α-reductase inhibitors and isotretinoin...
2018: International Journal of Risk & Safety in Medicine
Pia Brandt Danborg, Anders Lykkemark Simonsen, Peter C Gøtzsche
BACKGROUND: Few studies have reported on long-term harms caused by ADHD drugs but they are known to impair growth. OBJECTIVE: To assess whether ADHD drugs impair reproduction in mammals. METHODS: Systematic review of reproduction in studies of animals treated with ADHD drugs. DATA SOURCES: PubMed, Biosis and EMBASE. RESULTS: We included 17 studies. The studies were generally of poor quality or poorly reported...
2017: International Journal of Risk & Safety in Medicine
Khalid Ahmed Jassim Al Khaja, Sindhan Veeramuthu, Husain Ahmed Isa, Reginald Paul Sequeira
BACKGROUND: The use of non-steroidal anti-inflammatory drug (NSAIDs) is deemed a major risk factor for peptic ulcer disease in elderly population that requires concomitant therapy with gastroprotective agents (GPAs). OBJECTIVE: This study evaluated the rational prescribing of NSAIDs and GPAs, and extent of adherence to the guideline recommendations in primary care. METHODS: Nationwide audit of prescriptions issued to elderly patients (≥65 years) with hypertension or diabetic hypertension in primary care...
2017: International Journal of Risk & Safety in Medicine
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