scholarly journals Spontaneous Reporting of Adverse Drug Reactions

2018 ◽  
Vol 2 (1) ◽  
pp. 3
Author(s):  
Jagminder Kaur Bajaj ◽  
Satinder Jeet Singh
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Drug Event ◽  
Drug Reactions ◽  
Comprehensive Health Care ◽  
Unexpected Event ◽  
Comprehensive Health

Drugs are used for the benefit of the patient however drugs also produce adverse drug reactions. Adverse drug reaction is an adverse drug event that results in undesirable or unexpected event that requires some changes in the clinician's care of the patient, modifying a dosage, prolonging hospitalization or administering supportive treatment. Monitoring and Reporting of adverse drug reaction should be a part of comprehensive health care provided to the patients. This letter stresses on the need for the health care professional to report and monitor the adverse drug reactions.

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.

scholarly journals Adverse Drug Reaction Reporting in Ethiopia: Systematic Review

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Abel Demerew Hailu ◽  
Solomon Ahmed Mohammed
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

Adverse drug reactions are major global public health problems and an important cause of mortality. Problems related to medicines safety can emerge from real-life medication use due to increasing access to complex treatment of concomitant infectious and noncommunicable diseases, hence leading to a higher prevalence of drug-related problems. The objective of this review was to assess the knowledge, attitude, and practice of adverse drug reaction reporting among health care professionals in Ethiopia. Relevant literatures were searched from Google Scholar, PubMed, Hinari, Web of Science, Scopus, and Science Direct using inclusion and exclusion criteria. From 133 searched studies, 13 studies were reviewed. The knowledge and attitude of health care professionals towards adverse drug reaction reporting ranged from 22.68% -60.33% and 47.22% -67.14%, with averages of 41.50% and 57.18%, respectively. While 46.93% encountered adverse drug reactions and 41.8% reported in the last 12 months. One-third (34.15%) of health care professionals do not know how to report adverse drug reactions. Fearing to report, uncertainty about the adverse drug reaction, concern about reporting generating extra work, thinking that one report does not make any difference, nonavailability of reporting forms, and lack of feedback from regulatory authority were the stated reasons for underreporting. We conclude that the knowledge, attitude, and practice of health care professionals towards spontaneous ADR reporting were low. Conducting awareness and educational training and implementation of electronic reporting can improve the ADR reporting practice.

scholarly journals The era of pharmacovigilance and the need of pharmacovigilance in psychiatry: A review

2019 ◽  
Vol 9 (1-s) ◽  
pp. 449-452
Author(s):  
Dhanya Dharman ◽  
Parimala Krishnan ◽  
K G Ravikumar ◽  
Shaiju S Dharan
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Physiological Function ◽  
Drug Reactions ◽  
Care Community ◽  
Considerable Morbidity

According to WHO, Adverse drug reaction (ADR) is defined as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function”. Adverse drug reactions occur almost daily in every health care institution and can adversely affect a patient’s quality of life (QOL), often causing considerable morbidity and mortality. With the setting up of the Pharmacovigilance Program in India, it is important for all psychiatrists, pharmacist and nurses to familiarize themselves with the key principles of this science, and to apply the principle of Pharmacovigilance for the welfare of our patients and the entire health care community. Keywords: Adverse drug reaction (ADR), prophylaxis, diagnosis, patient’s quality of life (QOL)

scholarly journals Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

2014 ◽  
Vol 4 (2) ◽  
pp. 120-125 ◽  
Author(s):  
Maša Amrain ◽  
Fahir Bečić
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Bosnia And Herzegovina ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Adr Reporting

Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR) reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87%) completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH). Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4%) of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

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.

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.

The role of electronic records in reporting adverse drug reactions.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 309-309
Author(s):  
Alanna M. Poirier ◽  
Paul Nachowicz ◽  
Subhasis Misra
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Drug Reactions ◽  
Improve Patient Safety ◽  
Cancer Center ◽  
Health Record ◽  
Drug Reactions ◽  
History Of ◽  
Electronic Health

309 Background: The Pharmacy and Therapeutics committee at a regional cancer center is responsible to report and trend existing adverse drug reactions. The electronic health record did not have an option to document the history of an event or have an alert function if a medication was re-ordered. The frequency of documented adverse drug reactions did not correlate to what was being observed on the units with the use of a paper document. Methods: InAugust 2010 a Lean Six Sigma project was initiated to improve adverse drug reaction reporting. An adverse drug reaction document along with standard work instructions was completed by March 2011. A report was built in the electronic health record and a computer based learning module was created and rolled out to clinical staff by October 2011. Results: The turn-around time in days to document an adverse drug reaction in the patients chart decreased from 6.8 days to 0.7 days. The documented adverse drug reactions increased by 37%; verified by the use of supportive medications. Conclusions: The root cause for under-reporting was attributed to lack of knowledge, process, and automation. The history of an adverse drug reaction can now be viewed and an automatic alert is produced requiring physician acknowledgement decreasing the chance of repeated discomfort or harm to the patient. Adverse drug reaction documentation can be retrieved within 24 hours, analyzed, trended, and used for educational purposes to improve patient safety. [Table: see text]

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