scholarly journals Pharmacovigilance of Antiretroviral Drugs at B.P. Koirala Institute of Health sciences

2021 ◽  
Vol 18 (4) ◽  
pp. 596-603
Author(s):  
Deependra Prasad Sarraf ◽  
Gajendra Prasad Rauniar ◽  
Roshan Chhetri ◽  
Shyam Prasad Kafle ◽  
Suchana Marahatta ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Health Sciences ◽  
Antiretroviral Drugs ◽  
Drug Reactions ◽  
Third Line ◽  
Hiv Drugs ◽  
Living With Hiv

Background: Antiretroviral drugs are lifeline for patients living with HIV. Adverse drug reactions can compromise the compliance to antiretroviral therapy. The objectives of the study were to estimate the prevalence of adverse drug reactions and to assess its risk factors in patients living with HIV and receiving antiretroviral therapy.Methods: A prospective cohort study was conducted among 496 patients living with HIV at B.P. Koirala Institute of Health Sciences for a period of one year. Adverse drug reactions were evaluated based upon clinical history, clinical examination and investigations. Results: Majority of patients were of 31-45 year age group (58.1%) and on first-line antiretroviral therapy regimen (94.3%). Total of 240 adverse drug reactions were documented. Prevalence of adverse drug reaction was 34.7%. Skin rash, anemia and nausea and vomiting were the three most common adverse drug reactions. The adverse drug reactions were more common in patients having non-communicable diseases, chronic co-infections, taking more than 3 non-HIV drugs, second and third-line antiretroviral regimen and it was statistically significant (P-value < 0.05). Conclusions: Prevalence of adverse drug reaction was high in the patients living with HIV. Age, gender, co-infections, non-communicable diseases, taking more than three non-HIV drugs and second and third-line antiretroviral regimen were identified as possible risk factor for occurrence of adverse drug reactions and their prior identification is important to optimize the best suited antiretroviral regimen.Keywords: Adverse drug reactions; antiretroviral therapy; pharmacovigilance

scholarly journals Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

2019 ◽  
Author(s):  
Getiye Dejenu Kibret ◽  
Tadesse Awoke Ayele ◽  
Adino Tesfahun
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Catchment Area ◽  
Referral Hospital ◽  
Drug Reactions ◽  
Immunodeficiency Virus ◽  
Debre Markos

Abstract Background Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. Objective The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.

scholarly journals Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

2019 ◽  
Author(s):  
Getiye Dejenu Kibret ◽  
Tadesse Awoke Ayele ◽  
Adino Tesfahun
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Catchment Area ◽  
Referral Hospital ◽  
Drug Reactions ◽  
Immunodeficiency Virus ◽  
Debre Markos

Abstract Background: Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods: Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results: Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion: The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.

scholarly journals Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

2019 ◽  
Author(s):  
Getiye Dejenu Kibret ◽  
Tadesse Awoke Ayele ◽  
Adino Tesfahun
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Catchment Area ◽  
Referral Hospital ◽  
Drug Reactions ◽  
Immunodeficiency Virus ◽  
Debre Markos

Abstract Background Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. Objective The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.

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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