Agreement between a regional pharmacovigilance centre and an adjudication committee regarding drug adverse reactions on a cohort of hospitalised children

Therapies ◽  
2021 ◽  
Author(s):  
Nicolas Pages ◽  
Anissa Bounabi ◽  
Inesse Boussaha ◽  
Maritou Ndiaye ◽  
Aurélie Portefaix ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Pharmacovigilance Centre ◽  
Adjudication Committee ◽  
Drug Adverse Reactions

scholarly journals Pharmacogenomics Study to Avoid Serious Drug Adverse Reactions

2011 ◽  
Vol 131 (2) ◽  
pp. 237-238
Author(s):  
Ryuichi HASEGAWA ◽  
Masaru IWASAKI
Keyword(s):  
Adverse Reactions ◽  
Drug Adverse Reactions

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 The Fas Signaling Pathway Is a Common Genetic Risk Factor for Severe Cutaneous Drug Adverse Reactions Across Diverse Drugs

2018 ◽  
Vol 10 (5) ◽  
pp. 555 ◽  
Author(s):  
Heung-Woo Park ◽  
Sang-Heon Kim ◽  
Yoon-Seok Chang ◽  
Sang-Hoon Kim ◽  
Young-Koo Jee ◽  
...  
Keyword(s):  
Risk Factor ◽  
Signaling Pathway ◽  
Genetic Risk ◽  
Adverse Reactions ◽  
Genetic Risk Factor ◽  
Fas Signaling ◽  
Drug Adverse Reactions

scholarly journals Accuracy of an automated knowledge base for identifying drug adverse reactions

2017 ◽  
Vol 66 ◽  
pp. 72-81 ◽  
Author(s):  
E.A. Voss ◽  
R.D. Boyce ◽  
P.B. Ryan ◽  
J. van der Lei ◽  
P.R. Rijnbeek ◽  
...  
Keyword(s):  
Knowledge Base ◽  
Adverse Reactions ◽  
Automated Knowledge ◽  
Drug Adverse Reactions

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 Allergic diseases, drug adverse reactions and total immunoglobulin E levels in lupus erythematosus patients

2003 ◽  
Vol 12 (2) ◽  
pp. 95-99 ◽  
Author(s):  
Anna Wozniacka ◽  
Anna Sysa-Jedrzejowska ◽  
Ewa Robak ◽  
Zbigniew Samochocki ◽  
Malgorzata Zak-Prelich
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Adverse Reactions ◽  
Immunoglobulin E ◽  
Allergic Diseases ◽  
Enzyme Linked Immunosorbent Assay ◽  
Systemic Lupus ◽  
Total Ige ◽  
Drug Adverse Reactions ◽  
Total Immunoglobulin

Background:The association of allergic diseases, drug adverse reactions and elevated total immunoglobulin E (IgE) concentration in systemic lupus erythematosus patients remains controversial. The aim of the study was to investigate the prevalence of those features in active and inactive systemic lupus erythematosus patients, and in the control group as well.Methods:Total IgE concentration was evaluated by enzyme-linked immunosorbent assayResults and conclusions:The results of our study revealed that concomitant allergic diseases were not more frequent in systemic lupus erythematosus patients than in the general population. Total IgE concentration was significantly higher during the active stage of the disease. Drug reactions were very frequent but not connected with IgE elevation. Our results indicate that IgE may play a role in lupus pathogenesis, especially in the active phase of the disease.

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.

Drug Recording and Classification by the WHO Research Centre for International Monitoring of Adverse Reactions to Drugs

1974 ◽  
Vol 13 (03) ◽  
pp. 169-178 ◽  
Author(s):  
Margaretha Helling ◽  
J. Venulet
Keyword(s):  
Adverse Reactions ◽  
Research Centre ◽  
Suspected Drug ◽  
System A ◽  
International Monitoring ◽  
Drug Names ◽  
Different Types ◽  
Trade Names ◽  
Cross Reference ◽  
Drug Adverse Reactions

Recording and classifying drugs reported in relation to suspected drug adverse reactions by fifteen countries has required the development of a special system. A comprehensive cross reference system between different types of drug names (INN, other nonproprietary names, trade names, etc.) and their occurrence in single and multiple ingredient products has been developed. Separate pharmacologic and therapeutic classifications designed for the needs of drug monitoring provide for farther special grouping.On the basis of accumulated data, some analysis is given of reporting patterns and drug profiles in different countries.

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