MONITORING OF ADVERSE DRUG REACTIONS IN PAEDIATRIC ASTHMA PATIENTS ATTENDING A PRIVATE HOSPITAL

Sukhmeen Kaur; Bhagya. M. Sattigeri; Deepali Jaybhaye; Sumeet Patni

Volume : IX, Issue : II, February - 2020

MONITORING OF ADVERSE DRUG REACTIONS IN PAEDIATRIC ASTHMA PATIENTS ATTENDING A PRIVATE HOSPITAL

Sukhmeen Kaur, Bhagya. M. Sattigeri, Deepali Jaybhaye, Sumeet Patni

Abstract :

Background of the study: Adverse drug reactions (ADR) constitute a significant health problem in children. Pharmacotherapy of asthma includes prolonged multidrug therapy, which results in its association with different ADRs. Studies involving ADR monitoring in paediatric patients of asthma are limited. Therefore, this study was planned to observe the occurrence of the adverse drug reactions associated with pharmacotherapy of asthma in children. Materials and Methods: After the institutional ethical approval, an observational, non–interventional and cross–sectional study was conducted in pediatric patients of onchial asthma in outpatient as well as inpatient setting of a private hospital in Aurangabad from November 2017 to March 2019. All Asthmatic children presenting with adverse drug reactions were studied. All relevant data like patient�s demographic details, type of ADR, drug suspected to cause ADR, body system affected by the ADR were extracted. The causality of ADRs was then assessed by WHO–UMC scale and Naranjo�s scale. Also, modified Hartwig and Siegel�s scale was utilized to assess the severity of recorded ADRs. Results: Out of total 330 asthmatic children that attended the hospital during the study period, 41 children presented with ADRs. The incidence rate of ADRs was found to be 12.42%. The percentage of ADRs was the highest (43.9%) in patients aged between 5 to 8 years and majority of them were males. The most commonly occurring ADRs were headache (14.63%), sore throat (14.63%), tachycardia (12.19%), dryness of mouth (9.75%), cough (9.75%), drowsiness (7.31%) and oral candidiasis (7.31%). There were no severe reactions, 85.36% ADRs were mild and only 14.63% were moderate in their level of severity. Causality analysis revealed that about 41.46% ADRs were probable and 58.53% were possible. None of the reported ADR was found to be fatal, life threatening or needed hospital admission for management. Conclusion: This study highlights the need of rigid ADR monitoring in paediatric asthma patients to ensure safe pharmacotherapy. Adherence to pharmacovigilance guidelines and practices will not only reduce the incidence of ADRs but also reduce cost. Keeping this in mind, various pharmacovigilance awareness programs should be implemented to sensitize health care professionals about spontaneous reporting of ADRs.