Pattern of Adverse Drug Reactions (ADRs) in Medical Wards of a Tertiary Care Hospital through Spontaneous Reporting System.

Drug Safety ◽  
2006 ◽  
Vol 29 (10) ◽  
pp. 911-1010
Author(s):  
D. Potikuri ◽  
V.R. Srinivasan ◽  
J.C.U. Shobha ◽  
A.C. Upadhyaya
Author(s):  
Priyanka S. Survase ◽  
Amit P. Date ◽  
Archana S. Borkar ◽  
Rupesh T. Badwaik ◽  
Riaz A. Siddiqui ◽  
...  

Background: Adverse drug reactions are one of the major medicine related problem related to pharmacotherapy which may lead to increased morbidity and mortality causing increased hospital stay and financial burden on the society. Spontaneous voluntary reporting of adverse drug reaction can play a vital role in generating safety signals in which nurses can play important role, hence this study was undertaken to evaluate the knowledge attitude and practice of ADR reporting along with factors affecting reporting among nurses.Methods: The present study was a cross sectional questionnaire based study, which included nurses of a tertiary care hospital in central India. We tried to find out the possible ways to perk up spontaneous reporting of ADR and factors responsible for scarce reporting of ADRs.Results: After analyzing the data, we observed few of responders were aware of the ADR reporting system and the most encouraging finding was that majority of the responders were of the view that this reporting system is necessary. However, response to practice related questions was below average. Main factors which discouraged ADR reporting by nurses was thinking that reporting would lead to extra work and non availability of forms.Conclusions: The deficiencies in ADR reporting require awareness so as to perquisite spontaneous reporting and improve safety of patients. Training to nurses will lead to improvement in reporting of ADR.


Author(s):  
Swati V. Patil ◽  
Sudhir R. Pawar

Background: To evaluate the adverse effect profile of spontaneously reported cases of adverse drug reactions due to antiretroviral (ART) drugs in a tertiary care teaching hospital.Methods: A descriptive retrospective study of pattern of ART induced adverse drug reactions (ADRs) spontaneously reported to the Pharmacology department at a tertiary care hospital from January 2011 to December 2016. The details of suspected ADRs including drugs involved, treatment given for ADRs, and the outcome were also documented. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale), seriousness (ICH E 2A guidelines), preventability (Schumock and Thornton scale) and type based on Edwards and Aronson classification system.Results: Of the 75 cases of ART induced ADRs, reactions were slightly more common in males (52%) and had median age and duration of ART as 36 years and 109 days respectively. Drug induced anemia was the most common presentation followed by cutaneous ADR and zidovudine being the commonest offender. Severity was moderate in 85.3% and causality was probable in 16% and possible in 84% cases. The type reaction was augmented type in 41.3% and not preventable in 76%.Conclusions: Zidovudine is the commonest drug implicated in causing anemia amongst the antiretrovirals. Spontaneous reporting method for antiretroviral pharmacovigilance is insufficient. Targeted spontaneous reporting or cohort event monitoring need to be studied for antiretroviral pharmacovigilance.


2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra

Author(s):  
Maria Antonietta Barbieri ◽  
Paola Maria Cutroneo ◽  
Chiara Baratelli ◽  
Giuseppe Cicala ◽  
Alessandro Battaglia ◽  
...  

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

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


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