Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France

2002 ◽  
Vol 16 (5) ◽  
pp. 343-346 ◽  
Author(s):  
Jean-Louis Montastruc ◽  
Maryse Lapeyre-Mestre ◽  
Haleh Bagheri ◽  
Atoussa Fooladi
Author(s):  
Ali Awadallah Saeed ◽  
Osman Umballi ◽  
Namareg Ahmed ◽  
Shaza Ali ◽  
Azza Alfaki

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


2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.


2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Ricardo Cruz-Correia

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.


2020 ◽  
Vol 19 (6) ◽  
pp. 763-769
Author(s):  
Diogo Mendes ◽  
Ana Rita Oliveira ◽  
Carlos Alves ◽  
Francisco Batel Marques

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