scholarly journals Pharmacovigilance: Characterization and Methods of Causality Assessment

2018 ◽  
Vol 5 (4) ◽  
Author(s):  
Osama H Mohamed Ibrahim
Keyword(s):  
Causality Assessment

scholarly journals Circulatory Inflammatory Mediators in the Prediction of Anti-Tuberculous Drug-Induced Liver Injury Using RUCAM for Causality Assessment

Biomedicines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 891
Author(s):  
Cheng-Maw Ho ◽  
Chi-Ling Chen ◽  
Chia-Hao Chang ◽  
Meng-Rui Lee ◽  
Jann-Yuan Wang ◽  
...  
Keyword(s):  
Liver Injury ◽  
Inflammatory Mediators ◽  
Cox Regression ◽  
Causality Assessment ◽  
Area Under The Curve ◽  
Assessment Method ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Tb Treatment ◽  
Pre Treatment

Background: Anti-tuberculous (TB) medications are common causes of drug-induced liver injury (DILI). Limited data are available on systemic inflammatory mediators as biomarkers for predicting DILI before treatment. We aimed to select predictive markers among potential candidates and to formulate a predictive model of DILI for TB patients. Methods: Adult active TB patients from a prospective cohort were enrolled, and all participants received standard anti-tuberculous treatment. Development of DILI, defined as ≥5× ULN for alanine transaminase or ≥2.6× ULN of total bilirubin with causality assessment (RUCAM, Roussel Uclaf causality assessment method), was regularly monitored. Pre-treatment plasma was assayed for 15 candidates, and a set of risk prediction scores was established using Cox regression and receiver-operating characteristic analyses. Results: A total of 19 (7.9%) in 240 patients developed DILI (including six carriers of hepatitis B virus) following anti-TB treatment. Interleukin (IL)-22 binding protein (BP), interferon gamma-induced protein 1 (IP-10), soluble CD163 (sCD163), IL-6, and CD206 were significant univariable factors associated with DILI development, and the former three were backward selected as multivariable factors, with adjusted hazards of 0.20 (0.07–0.58), 3.71 (1.35–10.21), and 3.28 (1.07–10.06), respectively. A score set composed of IL-22BP, IP-10, and sCD163 had an improved area under the curve of 0.744 (p < 0.001). Conclusions: Pre-treatment IL-22BP was a protective biomarker against DILI development under anti-TB treatment, and a score set by additional risk factors of IP-10 and sCD163 employed an adequate DILI prediction.

Methods for Causality Assessment of Adverse Drug Reactions

Drug Safety ◽  
2008 ◽  
Vol 31 (1) ◽  
pp. 21-37 ◽  
Author(s):  
Taofikat B Agbabiaka ◽  
Jelena Savović ◽  
Edzard Ernst
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Drug Reactions

scholarly journals Causality assessment in drug-induced liver injury using a structured expert opinion process: Comparison to the Roussel-Uclaf causality assessment method

Hepatology ◽  
2010 ◽  
Vol 51 (6) ◽  
pp. 2117-2126 ◽  
Author(s):  
Don C. Rockey ◽  
Leonard B. Seeff ◽  
James Rochon ◽  
James Freston ◽  
Naga Chalasani ◽  
...  
Keyword(s):  
Liver Injury ◽  
Expert Opinion ◽  
Causality Assessment ◽  
Assessment Method ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Process Comparison

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.

Suspected black cohosh hepatotoxicity—Challenges and pitfalls of causality assessment

Maturitas ◽  
2009 ◽  
Vol 63 (4) ◽  
pp. 302-314 ◽  
Author(s):  
Rolf Teschke ◽  
Ruediger Bahre ◽  
Alexander Genthner ◽  
Johannes Fuchs ◽  
Wolfgang Schmidt-Taenzer ◽  
...  
Keyword(s):  
Causality Assessment ◽  
Black Cohosh

scholarly journals ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

2018 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Organ Systems ◽  
A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

scholarly journals Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

2018 ◽  
Vol 7 (7) ◽  
pp. 1345
Author(s):  
Kabilan K. ◽  
Sathyanarayanan V. ◽  
R. Jammuna Rani
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Type A ◽  
Drug Reactions ◽  
Male Predominance ◽  
Organ Systems ◽  
A Prospective Study

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

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