scholarly journals Adverse reactions to fluoroquinolones in the Nigerian population: an audit of reports submitted to the National Pharmacovigilance Centre from 2004 to 2016

2017 ◽  
Vol 5 (2) ◽  
pp. e00297 ◽  
Author(s):  
Ibrahim A. Oreagba ◽  
Kazeem A. Oshikoya ◽  
Comfort Ogar ◽  
Abiodun O. Adefurin ◽  
Ali Ibrahim ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Pharmacovigilance Centre ◽  
National Pharmacovigilance Centre ◽  
Nigerian Population

scholarly journals A qualitative study to analyse adverse drug reaction reporting forms

2016 ◽  
Vol 4 (2) ◽  
pp. 208
Author(s):  
Thamizhvani D ◽  
Keerthana Brattiya. R ◽  
Ramachandra Bhat.C ◽  
Stalin C
Keyword(s):  
Adverse Reactions ◽  
Hospital Admissions ◽  
Causality Assessment ◽  
Adverse Drug Reaction Reporting ◽  
Pharmacovigilance Centre ◽  
Adr Reporting ◽  
Clinical Events ◽  
Incomplete Filling ◽  
Financial Burdens ◽  
Assessment Scales

Introduction: Adverse reactions to drugs cause increase in the hospital admissions. They also cause increased financial burdens to the patients. They can be reduced by increasing the awareness about adverse drug reactions. ADR reporting can create a database help in this regard. To make ADR reporting effective, good ADR reporting form is needed. This study was started to analyse the existing ADR forms of different countries and identify the possible improvements that can be made.Material and methods: ADR Reporting forms submitted to the Regional Pharmacovigilance Centre were analysed to identify the difficulties faced by the reporters while filling them. ADR reporting forms of different countries were also collected and analysed. Adequacies of these forms were analysed. Based on this qualitative analysis, areas for improvement were identified.Results: Use of generic names, use of abbreviations and incomplete filling up of the details were observed. Options for causality assessment scales, colouring of mandatory details, categorising ADRs as new or old, dates of intake of concomitant drugs were identified as items to be included in the ADR reporting forms in future.Conclusion: As per the study’s findings and other similar studies , dates of the concomitant drugs, categorisation of ADRs (as known or new ), different colours for the mandatory fields, options for causality assessment scales , whether the ADR is medically confirmed , exact chronology of clinical events are the items which can be included in ADR reporting forms in future. Need for more training for primary reporters in filling up of the ADR reporting form is recognized in this study.

scholarly journals Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapies: extent, associated factors, challenges and solutions to reporting

2020 ◽  
Author(s):  
Ronald Kiguba ◽  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
...  
Keyword(s):  
Associated Factors ◽  
Healthcare Professionals ◽  
Pharmacovigilance Centre ◽  
Combination Therapies ◽  
Public And Private ◽  
Factors Associated ◽  
Adr Reporting ◽  
National Pharmacovigilance Centre ◽  
Reporting Procedures

Abstract Background: This study aimed to determine the extent and associated factors of past 6-month reporting of artemisinin-based combination therapy (ACT)-failure by healthcare professionals (HCPs); and difficulties and solutions to the pharmacovigilance (PV) of ACT therapeutic ineffectiveness.Methods: Survey of 685 HCPs from June to July 2018 in purposively selected public and private health facilities in Uganda.Results: One in five [20%, 137/685; 95% confidence intervals (CI) 17% to 23%] HCPs reported ACT-failure to any authority in the previous 6-months. HCPs commonly reported ACT-failure to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever reported a written ACT-failure to Uganda’s National Pharmacovigilance Centre. Common difficulties to reporting ACT-failure were; unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT-failure in past 6-months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41 to 4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29 to 3.76), suspicion of ACT-failure in past 4-weeks (OR = 2.3, 95% CI, 1.29 to 3.92), receipt of patient-complaint(s) of ACT-failure in past 4-weeks (OR = 2.9, 95% CI, 1.62 to 5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28 to 0.93) and western (vs central; OR = 0.4, 95% CI, 0.17 to 0.77) parts of Uganda.Conclusion: One in five HCPs reported ACT-failure, mostly verbally to supervisors. The existing ADR-reporting infrastructure should be leveraged to promote the PV of ACT therapeutic ineffectiveness.

scholarly journals A study of serious adverse drug reactions with antiepileptic drugs: a pharmacovigilance study

2018 ◽  
Vol 7 (5) ◽  
pp. 922 ◽  
Author(s):  
Shaima Zafer Khan ◽  
Mohammed Abid Ali ◽  
Ghulam Subhani ◽  
T. Ushasree
Keyword(s):  
Antiepileptic Drugs ◽  
Adverse Reactions ◽  
Neurological Diseases ◽  
Tertiary Care ◽  
Similar Efficacy ◽  
Tolerability Profile ◽  
Pharmacovigilance Centre ◽  
Johnson Syndrome ◽  
Clinically Significant ◽  
Steven Johnson Syndrome

Background: Approximately 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. There are currently more than 25 drugs in the market for the treatment of epilepsy, many of which have similar efficacy but differ in their tolerability profile. Besides unmatched beneficial potential of antiepileptic drugs, it is associated with many adverse reactions too. This study aims to identify the serious adverse reactions caused by prescribed antiepileptics, reported at the pharmacovigilance centre of government tertiary care centre.Methods: This is a retrospective, pharmacovigilance study of the antiepileptic drugs adverse reactions reported over a period of 1 year at a tertiary care centre.Results: A total of 120 ADRs of antiepileptic drugs were reported and collected at the pharmacovigilance centre. According to the WHO-ART system organ classification of ADRs, 78% of ADRs belonged to skin and appendages disorder. Based on the modified Hartwig and Siegel scale of severity, 60.8% ADRs were mild, 18.5% were moderate and 20.8 % were severe ADRs. The severe ADRs included: Steven-Johnson syndrome, Toxic epidermal necrolysis, Erythroderma, DRESS syndrome and Acute pancreatitis. Phenytoin has been found to be the antiepileptic drug causing the most number of severe ADRs amongst the prescribed antiepileptics. According to the modified Schumock and Thornton criteria most of the severe ADRs were not preventable.Conclusions: This study analyses the ADRs associated with antiepileptics reported at the pharmacovigilance centre. 20.8% ADRS were severe, this indicates that the epileptic patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of ADRs would help physicians to identify patients with greater risk of ADRs and therefore, might benefit from ADRs monitoring and reporting programmes.

scholarly journals Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting

2020 ◽  
Author(s):  
Ronald Kiguba ◽  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Associated Factors ◽  
Sub Saharan Africa ◽  
Pharmacovigilance Centre ◽  
Public And Private ◽  
Logistic Regression Models ◽  
The Past ◽  
National Pharmacovigilance Centre ◽  
Nationally Representative ◽  
Sub Saharan

Abstract Background Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.Methods Survey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness.Results One in five (20%, 137/685; 95% CI: 17-23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41-4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29-3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI, 1.29-3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI, 1.62-5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28-0.93) and western (vs central; OR = 0.4, 95% CI, 0.17-0.77) parts of Uganda.Conclusion One in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

scholarly journals Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001) : special report

2001 ◽  
Vol 72 (3) ◽  
Author(s):  
R. Gehring
Keyword(s):  
Adverse Effects ◽  
Adverse Reactions ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Special Report ◽  
Inappropriate Use ◽  
Different Types ◽  
Formal Procedure ◽  
Suspected Adverse Reactions ◽  
Suspected Adverse Drug Reactions

The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

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

Evaluation of Completeness of Suspected Adverse Drug Reaction Reports Submitted to the Mexican National Pharmacovigilance Centre

Drug Safety ◽  
2012 ◽  
Vol 35 (10) ◽  
pp. 837-844 ◽  
Author(s):  
Betsabé Sánchez-Sánchez ◽  
Marina Altagracia-Martínez ◽  
Jaime Kravzov-Jinich ◽  
Consuelo Moreno-Bonett ◽  
Everardo Vázquez-Moreno ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Suspected Adverse Drug Reaction ◽  
Pharmacovigilance Centre ◽  
National Pharmacovigilance Centre

scholarly journals Strengthening adverse drug reaction reporting in Nepal

2015 ◽  
Vol 6 (4) ◽  
pp. 9-13 ◽  
Author(s):  
Nisha Jha ◽  
Devendra Singh Rathore ◽  
Pathiyil Ravi Shankar ◽  
Sudesh Gyawali ◽  
Mohamed Azmi Hassali ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Community Pharmacists ◽  
Current Status ◽  
Pharmacovigilance Centre ◽  
Adr Reporting ◽  
National Pharmacovigilance Centre ◽  
National Regulatory Authority

Pharmacovigilance in Nepal is still in infancy. Till date only healthcare professionals are involved and the problem of underreporting is seen. The national pharmacovigilance centre is located in the national regulatory authority of Nepal, i.e. Department of Drug Administration (DDA). Lack of adequate human resources for managing the pharmacovigilance program in Nepal has been a limitation for the growth of pharmacovigilance activities. Currently, there is neither any involvement of community pharmacists in Adverse Drug Reaction (ADR) reporting process nor any involvement of consumers for the same. This paper reviews the current status of pharmacovigilance and mentions possible benefits of involving consumers or patients in the existing pharmacovigilance program. A systematic review were conducted by searching different databases like PubMed, Google scholar, EMBASE, NepJOL, and Scopus. This study also describes the role of healthcare professionals in ADR reporting, possible reasons for underreporting of ADRs, regulatory perspectives and benefits of involving consumers in pharmacovigilance. DOI: http://dx.doi.org/10.3126/ajms.v6i4.11659Asian Journal of Medical Sciences Vol.6(4) 2015 9-13

scholarly journals Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Ronald Kiguba ◽  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Associated Factors ◽  
Sub Saharan Africa ◽  
Pharmacovigilance Centre ◽  
Public And Private ◽  
Logistic Regression Models ◽  
The Past ◽  
National Pharmacovigilance Centre ◽  
Nationally Representative ◽  
Sub Saharan

Abstract Background Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness. Methods Survey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness. Results One in five (20%, 137/685; 95% CI 17–23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI 1.41–4.21), HCPs aged under 25 years (OR = 2.2, 95% CI 1.29–3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI 1.29–3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI 1.62–5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI 0.28–0.93) and western (vs central; OR = 0.4, 95% CI 0.17–0.77) parts of Uganda. Conclusion One in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

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