Causality Assessment of Possible Adverse Drug Reactions in Clinical Trials: An Analysis of Factors Associated with Decision Making by Clinical Investigators in Japan

2015 ◽  
Vol 29 (5) ◽  
pp. 275-284 ◽  
Author(s):  
Shinichiro Takeuchi ◽  
Makiko Kusama ◽  
Shunsuke Ono
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Drug Reactions ◽  
Factors Associated

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 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.

scholarly journals Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

2012 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Durga Bista ◽  
Bal Ram Shrestha ◽  
Prakash Rai ◽  
Akhilesh Chandra Jauhari ◽  
Vishnu Kant Kulshrestha
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Causality Assessment ◽  
Age Group ◽  
Drug Reactions ◽  
Preliminary Stage ◽  
Medical College ◽  
Probable Relationship ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

scholarly journals AN OVERVIEW OF VARIOUS SCALES USED IN CAUSALITY ASSESSMENT OF ADVERSE DRUG REACTIONS

2020 ◽  
pp. 1-5
Author(s):  
ADUSUMILLI PRAMOD KUMAR ◽  
DHARINI BHOOPATHI ◽  
HARIPRIYA SUNKARA ◽  
SRI HARSHA CHALASANI
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Individual Variability ◽  
Drug Reactions ◽  
Root Cause ◽  
Advantages And Disadvantages ◽  
Single Scale ◽  
Relationship Of ◽  
High Possibility

Establishing a relationship of causality between the medications received and the events occurred utilizing causality assessment scale is much needed to reduce the occurrence of Adverse Drug Reactions (ADRs) and to prevent exposure of patients towards additional drug hazards. Causality assessment can be defined as the determination of chance, whether a selected intervention is the root cause of the adverse event observed. The causality assessment is the responsibility of either a single expert or an established committee. As it is a common phenomenon of variable perception of knowledge and experience by each expert, there is a high possibility of disagreement and inter-individual variability on assessment. Many of the causality assessment methods have their advantages and disadvantages. However, no single scale has been adopted as standardized and considered for uniform acceptance.

Risk factors associated with the severity of adverse drug reactions by Xiyanping injection: A propensity score-matched analysis

2020 ◽  
Vol 250 ◽  
pp. 112424 ◽  
Author(s):  
Rui Zheng ◽  
Liyuan Tao ◽  
Joey S.W. Kwong ◽  
Changming Zhong ◽  
Chengyu Li ◽  
...  
Keyword(s):  
Risk Factors ◽  
Propensity Score ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Factors Associated

A Bayesian Approach to Causality Assessment for Adverse Drug Reactions: Analysis of a Case of Exfoliative Dermatitis

1986 ◽  
Vol 20 (4) ◽  
pp. 523-533 ◽  
Author(s):  
Michael S. Kramer ◽  
Tom A. Hutchinson ◽  
David A. Lane ◽  
Judith K. Jones ◽  
Claudio A. Naranjo
Keyword(s):  
Adverse Drug Reactions ◽  
Bayesian Approach ◽  
Causality Assessment ◽  
Drug Reactions ◽  
Exfoliative Dermatitis
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