Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital

2015 ◽  
Vol 27 (1) ◽  
pp. 45-53 ◽  
Author(s):  
Mohd Masnoon Saiyed ◽  
Tarachand Lalwani ◽  
Devang Rana
Keyword(s):  
Risk Factor ◽  
Prospective Study ◽  
Pediatric Patients ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Off Label Use ◽  
Drug Reactions ◽  
Off Label ◽  
A Prospective Study

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 Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Mohd Masnoon Saiyed ◽  
Tarachand Lalwani ◽  
Devang Rana
Keyword(s):  
Observational Study ◽  
Prospective Observational Study ◽  
Pediatric Patients ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Quality Data ◽  
Care Hospital ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary.Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression.Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI;P<0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI;P<0.001).Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.

scholarly journals Adverse drug reactions in the department of dermatology at a tertiary care hospital: a prospective study

2017 ◽  
Vol 7 (1) ◽  
pp. 162
Author(s):  
Sujatha Sowmyanarayan ◽  
Rajeshwari K. A. ◽  
Swati Banerjee
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Acne Vulgaris ◽  
Diclofenac Sodium ◽  
Tertiary Care ◽  
Topical Steroids ◽  
Care Hospital ◽  
Drug Reactions ◽  
A Prospective Study

Background: To study cutaneous adverse drug reactions with regard to their clinical pattern. etiology, causality and severity.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients with cutaneous ADRs presenting in Dermatology OPD were studied. Causality and severity of the adverse drug reactions were analysed and other parameters such as gender wise distribution of the ADRs and types of ADR were studied.Results: 35 cases of ADRs were enrolled for the study in the duration of Sept.2016 to May 2017. The majority of the patients were in the age group of 21-30 years (37.14%). The most common CADRs were Acne vulgaris (22.86%), followed by Fixed Drug eruption (11.43%) and Tinea cruris (8.57%). The most common class of drugs causing ADRs were topical steroids (64%), followed by non-steroidal anti-inflammatory drugs (14.29%).Conclusions: Female preponderance was seen. Topical steroids were the most offending drug followed by Diclofenac Sodium, the analgesic. Causality assessment showed a high score of Certain category. These variations may be explained by variations in drug usage patterns. The knowledge of the adverse drug reactions and the drugs causing them is essential for the clinician so that the choice of drug therapy can be made keeping these adverse drug reactions in mind.

scholarly journals A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital

2014 ◽  
Vol 22 (4) ◽  
pp. 303-308 ◽  
Author(s):  
M. Shamna ◽  
C. Dilip ◽  
M. Ajmal ◽  
P. Linu Mohan ◽  
C. Shinu ◽  
...  
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
A Prospective Study
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