Adverse drug reactions in pediatric asthma patients attending a tertiary care teaching hospital

Sukhmeen Kaur Kohli; Dr. B.M. Sattigeri

Volume : VIII, Issue : VII, July - 2019

Adverse drug reactions in pediatric asthma patients attending a tertiary care teaching hospital

Sukhmeen Kaur Kohli, Dr. B. M. Sattigeri

Abstract :

Background of the study: Adverse drug reactions (ADR) are an unfortunate burden on the society, both financially as well as in terms of human suffering. As compared to adults, ADRs in children can have a relatively more severe effect. As such, study of ADRs in pediatric patients of onchial asthma can play a significant role in systemized ADR monitoring and protect the patients from preventable harm. Materials and Methods: An observational, non–interventional and cross–sectional study was conducted in pediatric patients of onchial asthma at a tertiary care teaching hospital for a period of 16 months. All the adverse drug reactions (ADRs) occurring during the therapy (either spontaneously reported or identified by the investigator) among the outpatient as well as inpatient departments were examined for relevant data like type of ADR, drug suspected to cause ADR, body system affected by the ADR. Adverse drug reactions were then assessed for causality by WHO–UMC scale and Naranjo�s scale & their severity were also assessed by modified Hartwig and Siegel�s scale Results: During the study period, a total of 35 ADRs were reported among 330 patients. The incidence rate of ADRs was found to be 10.6%. The percentage of ADRs was the highest (37.14 %) in patients aged between 5 to 8 years. The most commonly reported ADRs were palpitations (11.42%), dryness of mouth (11.42%), Tachycardia (8.57%), headache (8.57%), sore throat (8.57%) and diarrhea (8.57%). There were no severe reactions, 29 (82.85 %) accounted for mild reactions and 6 (17.14 %) were moderate reactions in the severity scale. Causality analysis revealed that about 42.5 % of ADRs were probable, 54.28 % were possible and 2.85 % were certain. None of the reported ADRs were found to be fatal, life threatening or needed hospital admission for management. Conclusion: Adverse drug reactions associated with anti–asthmatic drugs are quite common. Increased awareness regarding these ADRs, among children, their parents and physicians may result in early detection of ADRs, their early reporting and minimize risk of ADR related harms. This demands necessity of rigid ADR monitoring in pediatric population.