scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Suspected Adverse Drug Reaction ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Risk Minimization ◽  
Drug Reactions ◽  
Medicinal Products

Abstract Background: Signals of adverse drug reactions are the basis of some regulatory risk-minimization actions in pharmacovigilance, such as changes to the section of undesirable effects in Summaries of Products Characteristics (SmPCs). Reviews of the evidence of signals have highlighted that these are mostly supported by reports of adverse drug reactions or multiple types of evidence, but have so far been limited to specific medicinal products, time intervals, groups of adverse drug reactions and specific countries. The time that elapses between a report of a suspected adverse drug reaction and the communication of a signal has not been systematically investigated. Furthermore, difficulties in causally linking medicinal products to adverse events have been highlighted, but the elements of reports of suspected ADRs that authors used to support putative causal relationships have been rarely characterized.Methods: We plan a scoping review to chart the evidence underpinning signals in pharmacovigilance and the time that it takes to communicate a signal. We shall retrieve records from electronic databases, without language or publication restrictions; we shall apply backward and forward citation to adjust for variations in database indexing. We shall also hand-search the websites of 35 regulatory agencies/authorities, restricted publications from Uppsala Monitoring Centre, and drug bulletins in the list of International Society of Drug Bulletins. If websites do not report signals, signals will be requested from the competent stakeholder. We shall use the Oxford Centre for Evidence-Based Medicine Levels of Evidence to chart and summarize evidence. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the date of reporting for reports of adverse drug reactions. Plots, or pictograms (if appropriate), will be used to represent the time from the first report of a suspected adverse drug reaction to a signal.Discussion: We expect that the findings from this exploratory investigation will be useful in better understanding global patterns of similarities or differences in regulatory decision-making in terms of evidence and timing of communications, and in identifying relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals Reporting Adverse Drug Reactions Among Hospitalized Medical Patients: A Prospective Study From Tertiary Care Hospital in Western Nepal

2014 ◽  
Vol 4 (1) ◽  
pp. 330-336 ◽  
Author(s):  
Kadir Alam ◽  
R Shakya ◽  
P Ojha
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Uppsala Monitoring Centre ◽  
Care Hospital ◽  
Medical Patients ◽  
Drug Reactions ◽  
Online Data ◽  
General Medical Ward

Background    The risk of adverse drug reaction ranges nearly from zero to high level depending upon the drug itself and the patient factor. The process of detection, assessment, monitoring and reporting of adverse drug reaction is necessary to prevent its occurrence in future. Materials and Methods Information related to suspected Adverse Drug Reactions(ADRs) were collected by pharmacists from general medical ward using ADRs reporting form from Manipal Teaching Hospital (MTH)during ward rounds. The details of suspected drug, drug reaction and all related data were documented. Naranjo Algorithm, modified Hartwig and Siegel and modified Shumock and Thornton scale were used for assessment of causality, severity and preventability respectively. All suspected ADRs were reported to National Pharmacovigilance Center and then to Uppsala Monitoring centre through the electronic online data base named Vigiflow.  Results Among 1,105 patients, 51 patients experienced ADR (4.61%). Incidents of ADRs were higher with antibiotics (47.06%) and Ceftriaxone was at top of list (15.69 %). Dermatological system (25.49%) and gastrointestinal system (19.61%) were affected more. About 33.33% of suspected drugs were discontinued. About 41.18% of ADRs required medical treatment where antihistaminic (24.32%) and antipruritic (21.62%) were most commonly used to treat ADRs. To sum up, 64.71% of ADRs were probable, 62.75% were mild in nature and 60.78% were probably preventable. Conclusion Finding of the study suggests that ADRs still pose serious health threat among hospitalized patients and as a matter of fact over 60% of them are preventable. Reporting of ADR scan provide effective measures to prevent the occurrence in the future in which the role of pharmacist is vital.DOI: http://dx.doi.org/10.3126/nje.v4i1.10135 Nepal Journal of Epidemiology 2014;4 (1): 330-336

scholarly journals Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics & Pharmacodynamics with Side Effects & Adverse Drug Reactions: Updated Systematic Review Article

2020 ◽  
Vol 10 (1) ◽  
pp. 163-172
Author(s):  
Rohit Bangwal ◽  
Shivam Bisht ◽  
Saurabh Saklani ◽  
Shobit Garg ◽  
Mohan Dhayani
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Common Property ◽  
Antipsychotic Drugs ◽  
Psychotic Disorders ◽  
World Health ◽  
Drug Reactions ◽  
Wide Range

Psychosis is a mental disorder characterized by a disconnection from reality. Psychosis is a group of disorder characterized by thought disorder, abnormal behaviour, defective cognition, delusion and hallucination. Adverse drug reaction is defined as any undesired or unintended effects of drugs treatment. According to the World Health Organization (WHO)- “adverse drug reaction (ADRs) has been defined one which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or modification of physiological function”. Adverse drug reactions are the most important causes of the mortality and morbidity. Antipsychotics are the most effective drugs which are used in the psychiatry in the maintenance therapy of mania, psychoses and schizophrenia. The antipsychotics drugs are chemically disparate but have the common property of alleviating the symptoms of organic as well as functional psychosis. But they also have a capacity to cause a wide range of potential adverse drug reactions that can lead to non-compliance that can impair quality of life, may cause the extra pyramidal symptoms which can lead to discontinuation of therapy and in extreme cases it may be fatal. Knowledge of assessment of ADRs due to different antipsychotics is necessary. It helps to choose to safe treatment and reduce the risk of occurrence of ADRs by the clinicians. ADR are often poorly identified and reported in day to day medical practice. As we collect more and more information about ADRs, we need an active surveillance system regarding identification and reporting of ADRs with antipsychotic drugs.  On many review articles are read & ward round participation experiences we find that antipsychotic drugs can have shown a various kind of ADRs. Psychiatrist and clinical pharmacist are need to be made aware of these potentially fatal adverse effects associated with antipsychotic drugs via conduction of patients counseling regarding (drugs, disease, doses & side effects), quality-based seminars, published medical literature, conferences, learning programs and health care camps. Keywords: Antipsychotic Drugs, WHO, Adverse Drug Reactions, Pharmacovigilance, Psychiatrist.

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reactions ◽  
Systematic Reviews ◽  
Scoping Review ◽  
Data Retrieval ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Data Repository ◽  
Supporting Evidence ◽  
Causal Relationships ◽  
Drug Reactions

Abstract Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. . The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither have the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting signals, and the time that it takes to communicate a signal.Methods: . We shall retrieve records from PubMed, EMBASE, Web of Science, PsycINFO (from inception onwards), without language/design restrictions and apply backward citation screening . We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the dates on which ADRs were reported . We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal.Discussion: We expect the findings from this review will allow better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications, and identify relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals The class imbalance problem detecting adverse drug reactions in electronic health records

2018 ◽  
Vol 25 (4) ◽  
pp. 1768-1778 ◽  
Author(s):  
Sara Santiso ◽  
Arantza Casillas ◽  
Alicia Pérez
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Records ◽  
Adverse Drug Reactions ◽  
Class Imbalance ◽  
Drug Reactions ◽  
Class Imbalance Problem ◽  
Health Records ◽  
Imbalance Problem ◽  
Electronic Health

This work focuses on adverse drug reaction extraction tackling the class imbalance problem. Adverse drug reactions are infrequent events in electronic health records, nevertheless, it is compulsory to get them documented. Text mining techniques can help to retrieve this kind of valuable information from text. The class imbalance was tackled using different sampling methods, cost-sensitive learning, ensemble learning and one-class classification and the Random Forest classifier was used. The adverse drug reaction extraction model was inferred from a dataset that comprises real electronic health records with an imbalance ratio of 1:222, this means that for each drug–disease pair that is an adverse drug reaction, there are approximately 222 that are not adverse drug reactions. The application of a sampling technique before using cost-sensitive learning offered the best result. On the test set, the f-measure was 0.121 for the minority class and 0.996 for the majority class.

Cutaneous Adverse Drug Reactions

2018 ◽  
Author(s):  
Neil H. Shear ◽  
Sandra Knowles ◽  
Lori Shapiro
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Toxic Epidermal Necrolysis ◽  
Adverse Drug Reactions ◽  
Skin Necrosis ◽  
Drug Eruption ◽  
Hypersensitivity Syndrome ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Cutaneous Eruption

An adverse drug reaction is defined as any noxious, unintended, and undesired effect of a drug that occurs at doses used in humans for prophylaxis, diagnosis, or therapy. A cutaneous eruption is one of the most common manifestations of an adverse drug reaction. This chapter reviews the epidemiology, etiology, diagnosis, clinical manifestations, and differential diagnosis of adverse drug reactions, as well as laboratory tests for them. Also discussed are the types of cutaneous eruption: exanthematous eruption, urticarial eruption, blistering eruption, pustular eruption, and others. The simple and complex forms of each type of eruption are reviewed. The chapter includes 4 tables and 12 figures. Tables present the warning signs of a serious drug eruption, clinical features of hypersensitivity syndrome reaction and serum sickness-like reaction, characteristics of Stevens-Johnson Syndrome and toxic epidermal necrolysis, and clinical pearls to identify anticoagulant-induced skin necrosis. Figures illustrate hypersensitivity syndrome reaction, a fixed drug eruption from tetracycline, pseudoporphyria from naproxen, linear immunoglobulin A disease induced by vancomycin, pemphigus foliaceus from taking enalapril, pemphigus vulgaris from taking penicillamine, toxic epidermal necrolysis after starting phenytoin therapy, acneiform drug eruption due to gefitinib, acute generalized exanthematous pustulosis from cloxacillin, coumarin-induced skin necrosis, a lichenoid drug eruption associated with ramipril, and leukocytoclastic vasculitis from hydrochlorothiazide. This chapter contains 106 references.

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.

scholarly journals Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Lense Temesgen Gurmesa ◽  
Mohammed Gebre Dedefo
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Drug Reactions ◽  
Reaction Reporting ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%), 56 (42.1%), and 13 (9.8%) health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.

Myopathy with Ezetimibe Monotherapy; Statin-Associated Pancreatitis; Linezolid Associated Toxic Optic Neuropathy; Hiccups and Dopamine Agonists; SIADH and Seizures in a Patient Treated with Duloxetine; Prevention of a Well-Known Adverse Drug Reaction

2006 ◽  
Vol 41 (5) ◽  
pp. 408-488
Author(s):  
Joel Shuster
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Optic Neuropathy ◽  
Dopamine Agonists ◽  
Drug Reactions ◽  
Toxic Optic Neuropathy

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

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