European Journal of Cardiovascular Medicine

Introduction: Adverse drug reactions (ADR) are an important aspect of drug therapy and can be a major setback in clinical practice. An ADR is defined by the World Health Organization (WHO) as ‘a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man. The safety of drugs used in patients of an adult age group cannot be extrapolated to a pediatric age group. The pharmacokinetics and pharmacodynamics of many commonly used drugs vary significantly between these two age groups of patients2.  Adverse drug reactions (ADRs) in children can have a relatively more severe effect when compared to adults. Thus, the ADRs can lead to significant morbidity among children.3 An increase in the number of drugs and self-medication with various medications have enhanced the occurrence of adverse drug reactions in recent times, especially in pediatric population. Material & Methods: This was a prospective, observation based, non-interventional study was Conducted in Dept. of Pediatrics, SCB Medical college and SVPPGIP, Cuttack which are two institutions under one department. This Department is a tertiary care center for pediatric patients in our state. Our institution is an approved ADR Monitoring Center (AMC) under Pharmacovigilance programme of India (Pvpi). ADRs were confirmed by the clinicians based on temporal relationship between start of drug and reaction, withdrawal of drug leading to decrease severity or abolition of reaction (dechallenge), exclusion of other causes etc. Sensitization of doctors in various seminar were done for spontaneous ADR reporting in Suspected Adverse Drug Reaction Reporting Forms by health care professionals. Results: Out of total 350 cases, dermatological system was most commonly involved i.e. 207 cases (59. 14%).This is followed by involvement of central nervous system 46 number of cases (13.14%). The GI system was involved in 34 cases i.e. (9.71%). Most of the ADRs were due to Antibiotics, these drugs are involved in 198 (56.57%) cases. Commonest antibiotics causing ADRs were Ofloxacin involving 26 cases (13.13%) of antibiotics followed by Ceftriaxone and cefixime comprising 22 cases (11.11%) and 14 cases (7.07%) respectively of total antibiotics used. A single drug as a possible causative agent of ADR,177 such cases were reported which constituted 50.57% of the total ADRs. Sometimes these agents were used with other drugs but Dechallenge test ruled out the probability of other drugs involvement. Out of 177, 110 drugs caused ADRs when used alone i.e. 31.4 % drug reactions were caused by monotherapy. Conclusion: Our study showed varied range of ADRs with higher reports in male children compared to females and maximum reports of ADRs obtained in age group 5-10 Years. Dermatological ADRs have highest incidence out of all the ADRs and FDE is most frequent among dermatological ADRs. Antibiotics were the commonest suspected agent in the reported ADRs. This study also exposed high occurrence of over-the-counter prescription to the pediatric age group causing ADRs (20.87%) of total ADRs and 12% of total serious ADRs. Incidence of serious ADRSs were more where multiple drugs were the suspected causative agents of ADRs. Various atypical ADRs were also observed due to active monitoring. Hence this study further emphasizes the need of proactive Pharmacovigilance, restriction of over-the-counter medications and increasing awareness among health care professionals, patients and public, for rational use of antibiotics, avoiding multidrug therapy and FDCs to reduce the incidence of ADRs especially in pediatric age groups.