scholarly journals Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

2019 ◽  
Vol 85 (7) ◽  
pp. 1507-1515 ◽  
Author(s):  
Sieta T. Vries ◽  
Petra Denig ◽  
Corine Ekhart ◽  
Jako S. Burgers ◽  
Nanno Kleefstra ◽  
...  
Keyword(s):  
Sex Differences ◽  
The Netherlands ◽  
Observational Study ◽  
Adverse Drug Reactions ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
National Pharmacovigilance Centre

Adverse drug reactions of systemic antihistamines in children in the Netherlands

2016 ◽  
Vol 101 (10) ◽  
pp. 968-970 ◽  
Author(s):  
Tjalling W de Vries ◽  
Florence van Hunsel
Keyword(s):  
Central Nervous System ◽  
Allergic Rhinitis ◽  
Nervous System ◽  
The Netherlands ◽  
Adverse Drug Reactions ◽  
Allergic Conjunctivitis ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Malignant Neuroleptic Syndrome ◽  
Neuroleptic Syndrome

BackgroundAntihistamines are used for the treatment of allergic rhinitis, allergic conjunctivitis, chronic spontaneous urticaria and atopic eczema.ObjectiveTo study the reports of adverse drug reactions (ADRs) in children using antihistamines to provide prescribers with an overview of the possible toxicity.DesignWe studied ADRs in children reported to the Netherlands Pharmacovigilance Centre Lareb in the years 1991–2014, assessed the Naranjo score and, when possible, computed the reporting OR.ResultsSerious ADRs included one death (malignant neuroleptic syndrome), cardiac arrhythmia (one case) and convulsions (three cases). Skin eruptions, headache and somnolence were the most frequently reported ADRs. Aggression and agitation were also reported.ConclusionsToxicity can occur with second-generation antihistamines. The main toxicity relates to skin eruptions and central nervous system problems.

Adverse Drug Reactions to Radiographic Contrast Media in a Teaching Hospital in North India: An Observational Study

2019 ◽  
Vol 14 (2) ◽  
pp. 122-126
Author(s):  
Deepti Chopra ◽  
Abhinav Jain ◽  
Richa Garg ◽  
Shreya Dhingra
Keyword(s):  
Observational Study ◽  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Adverse Reactions ◽  
North India ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Radiographic Contrast ◽  
Radiographic Contrast Media

Background: Radiocontrast media are used extensively nowadays to visualize internal organs. Currently, non-ionic iodinated contrast media are used which are generally considered to be safe but some adverse reactions have been reported. Thus, the present study was carried out to analyze the nature and incidence of adverse drug reactions (ADRs) to radiographic contrast media in a teaching hospital. Methods:An observational study carried out for a period of six months in a teaching hospital. Contrast media induced adverse reactions were analyzed in terms of affected organs, rate, causality assessment, severity and preventability. The treatment and outcomes of adverse events were also recorded. Naranjo Probability Scale was used to evaluate the relationship between the contrast agent used and the suspected ADR. The severity of the suspected ADRs was determined using Hartwig Scale and preventability was assessed using modified Schumock and Thornton criterion. Results:A total of 15 suspected ADRs occurred in 11 patients with an incidence of 1.4%. It included 5 (45.4%) males and 6 (54.5%) females (p < 05). The highest percentage (72.7 %) of ADRs was seen in adult patients, the mean age being 40.8 years. Vomiting (33.3%) was the most common ADR noted followed by severe nausea and rashes. 64.7 % of ADRs were categorized as probable and 35.3 % were possible. Adverse reactions required treatment in 46.6% patients. There was no fatality reported. Conclusion:The reactions observed were mild to moderate in severity and occurred within 30 minutes of the administration of the contrast.

Sex Differences in the Risk of Cutaneous Adverse Drug Reactions Induced by Antiseizure Medications: A Systematic Review and Meta-analysis

CNS Drugs ◽  
2021 ◽  
Vol 35 (2) ◽  
pp. 161-176
Author(s):  
Israa Alfares ◽  
Muhammad Shahid Javaid ◽  
Zhibin Chen ◽  
Alison Anderson ◽  
Ana Antonic-Baker ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sex Differences ◽  
Adverse Drug Reactions ◽  
Meta Analysis ◽  
Drug Reactions

ASSESSMENT OF COMMUNITY PHARMACIST AWARENESS ON ADVERSE DRUG REACTION (ADR) AND PHARMACOVIGILANCE REPORTING SYSTEM IN KHARTOUM LOCALITY, SUDAN

2021 ◽  
Author(s):  
Ali Awadallah Saeed ◽  
Osman Umballi ◽  
Namareg Ahmed ◽  
Shaza Ali ◽  
Azza Alfaki
Keyword(s):  
Peer Review ◽  
Adverse Drug Reactions ◽  
Community Pharmacists ◽  
Total Sample ◽  
Cross Sectional Study ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Positive Attitudes ◽  
National University

Introduction: Adverse drug reactions resulting from the use of a medicinal product and were harmful or unpleasant reaction. Pharmacovigilance is related pharmaceuticals product after marketing and associated with collection, detection, assessment, monitoring and prevention of adverse effects. The aim of study is to recognize the awareness of pharmacists regarding pharmacovigilance and adverse drug reactions reporting. Methodology: Descriptive cross-sectional study conducted to 237 pharmacists working in Khartoum’s locality pharmacies from August 2019 to March 2020 selected by simple randomization. The data were collected by face to face interview using self-administrated Questionnaire and analyzed by SPSS version 23. Results: 57.4% from the total sample size never seen adverse drug reactions reporting form, 76.4% never receive training on how to report it and only 10.5% from the pharmacists in the study report it to pharmacovigilance center. 79% from pharmacists in the study were not aware about existence of pharmacovigilance program in Sudan. 51.5 % from pharmacists have good attitude about adverse drug reactions and pharmacovigilance in Sudan while 48.5% had poor attitude. Difficulty in communicating with pharmacovigilance centre in Sudan and how to write the report were the factors discourage pharmacists from reporting of adverse drug reactions. Conclusion: Community pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting while they had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting, this can be strengthened by educational trainings and workshops.                   Peer Review History: Received: 4 September 2021; Revised: 9 October; Accepted: 29 October, Available online: 15 November 2021 Academic Editor:  Dr. Jennifer Audu-Peter, University of Jos, Nigeria, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.  Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Neelam H. Zaidi, Fiji National University, Fiji, [email protected] Dr. U. S. Mahadeva Rao, Universiti Sultan Zainal Abidin, Terengganu Malaysia, [email protected] Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] Dr. Andrzej Szymański, Poznan University of Technology, Poland, [email protected] Similar Articles: AWARENESS OF PHARMACISTS TOWARDS ASPARTAME SIDE EFFECTS IN KHARTOUM CITY, SUDAN ASSESSMENT OF THE ROLE OF COMMUNITY PHARMACISTS IN MANAGEMENT OF HIV-POSITIVE INDIVIDUALS IN THE SOUTHERN REGION OF NIGERIA

scholarly journals INTRAVENOUS APPLICATION OF HELIXOR® IN GYNECOLOGICAL ONCOLOGY: IS IT SAFE?

2017 ◽  
Vol 5 (10) ◽  
pp. 307-312
Author(s):  
Yong-Il Ji
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Gynecological Cancer ◽  
Viscum Album ◽  
University Hospital ◽  
Drug Reactions ◽  
Gynecological Oncology ◽  
Patients With Cancer ◽  
Therapeutic Outcomes ◽  
Efficacy Studies

Background: Traditional mistletoe (Viscum album L.) therapy has been frequently used in patients with cancer in Europe. The different mistletoe formulations available for oncological use are Iscador®, Iscucin®, AbnovaViscum®, and Lektinol®, as well as Helixor®, which may improve therapeutic outcomes following intravenous (i.v.) administration and therefore, is becoming more commonly used. Method: I conducted an observational study in four different University Hospital Centers and the frequency of adverse drug reactions (ADRs) induced by the i.v. infusion of Helixor® was determined. Result: of the 108 patients with gynecological cancer who received i.v. infusions of Helixor®, 10 (9.3%) reported mild ADRs, and no serious ADRs were reported. Conclusion: Therefore, i.v. infusion of Helixor® was determined to be safe, and prospective efficacy studies are recommended.

scholarly journals NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Philip A. Kalra ◽  
Sunil Bhandari ◽  
Michael Spyridon ◽  
Rachel Davison ◽  
Sarah Lawman ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Observational Study ◽  
Adverse Drug Reactions ◽  
Real World ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Drug Reactions ◽  
Deficiency Anaemia

Abstract Background Intravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients. Methods This real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ≥12 months. Iron dose and the need for retreatment were determined at the investigators’ discretion. The primary study outcome was the need for retreatment at 52 weeks compared between patients who received >1000 mg of iron during Course 1 and those who received ≤1000 mg. Safety was evaluated through adverse drug reactions. Results The probability of retreatment at Week 52 was significantly lower in the >1000 mg iron group (n = 58) versus the ≤1000 mg group (n = 198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p = 0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ≤1000 mg group and by 10.59 (7.52, 13.66) g/L in the >1000 mg group (p = 0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000 mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ≤1000 mg. No serious adverse drug reactions were reported. Of the patients who received ≤1000 mg of iron in this study, 82.3% were eligible for a dose >1000 mg. Conclusions The >1000 mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ≤1000 mg regimen. Many of the patients who received ≤1000 mg of iron were eligible for >1000 mg, indicating that there was considerable underdosing in this study. Trial registration ClinicalTrials.gov NCT02546154, 10 September 2015.

scholarly journals Promoting adverse drug reaction reporting: comparison of different approaches

2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Ricardo Cruz-Correia
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Cost Effectiveness ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Educational Approach ◽  
Reaction Reporting

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

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