An intensive monitoring of adverse drug reactions in pediatric hospitalized patients of a tertiary care hospital
Keywords:Intensive monitoring, Pediatric patients, Adverse drug reactions, Risk factors
Background: Children are at a higher risk of therapeutic failure due to major difference in pharmacokinetic, pharmacodynamics of drugs, off-label use and divergence of their illness from adult. The safety of drugs used in adult patients cannot be extrapolated to a pediatric age group. Hence, this study aimed to evaluate the incidence and overall pattern of adverse drug reactions in pediatric patients hospitalized in pediatric wards at a tertiary care hospital in India.
Methods: Pediatric patients up to 12 years hospitalized in two randomly selected pediatric units were enrolled and followed up daily till discharge. Detailed information of patients and ADRs (adverse drug reactions) if any were recorded from case records. ADRs were assessed for incidence, onset, duration, management, outcome, causality, severity, preventability, seriousness and risk factors. Appropriateness of drug treatment in patients with ADRs was analyzed using Phadke’s criteria. Data was analyzed using student’s t test, ANOVA and Chi square test.
Results: A total of 700 patients were enrolled (mean age 3.95±0.12 years). A total of 66 ADRs observed in 58 patients. Intravenous (70.4%) being most common route for ADRs. The incidence of ADRs was 8.28%. Majority of ADRs occurred within 1 day, commonly affected skin and appendages followed by (28.78%), GI (25.75%) ADRs were frequently associated with antimicrobials (69.38%) and vaccines and sera (12.24%). Majority of reactions were mild (56%%), non-serious (77.2%), not preventable (95.4%), recovered completely at discharge (83.33%) and had possible (77.2%) causal association with suspect drug. Age group 0-3 years and prescription of ≥5 drugs were risk factors for occurrence of ADRs. Semi rational drug therapy was observed in 65.5% patients.
Conclusions: Clinicians should be vigilant regarding occurrence of ADRs in pediatrics especially during the first week of hospitalization. Risk factors like 0-3 years of age and multiple drugs should be taken into consideration during treatment of these patients to help minimize adverse drug reactions.
Castro-Pastrana LI, Carleton BC. Improving pediatric drug safety: need for more efficient clinical translation of pharmacovigilance knowledge. J Populat Therap Clinic Pharmacol. 2011;18(1).
Klassen TP, Hartling L, Craig JC, Offringa M. Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med. 2008;5(8):172.
Napoleone E. Children and ADRs (adverse drug reactions). Italia J Pediatrics. 2010;36(1):4.
Leeder JS, Pearce RE, Gaedigk A, Modak A, Rosen DI. Evaluation of a [13C]‐dextromethorphan breath test to assess CYP2D6 phenotype. J Clinic Pharmacol. 2008;48(9):1041-51.
Doshi MS, Patel PP, Shah SP, Dikshit RK. Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital. J Pharmacol Pharmacotherap. 2012;3(4):308.
Eshetie T, Hailemeskel B, Mekonnen N, Paulos G, Mekonnen A, Girma T. Adverse drug events in hospitalized children at Ethiopian University Hospital: a prospective observational study. BMC Paediat. 2015:15:83.
Fattinger K, Roos M, Vergères P, Holenstein C, Kind B, Masche U, et al. Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000;49(2):158-67.
Shah RB, Gajjar BM, Desai SV. Evaluation of the appropriateness of prescribing in geriatric patients using Beers criteria and Phadke's criteria and comparison thereof. J Pharmacol Pharmacotherap. 2011;2(4):248.
WHO-Uppsala Monitoring Centre. Fact sheet: The Use of WHO-UMC system for standardised case causality assessment. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. Accessed on 20th March, 2021.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clinic Pharmacol Therapeut. 1981;30(2):239-45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hospital Pharm. 1992;49(9):2229-32.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hospital Pharm. 1992;27(6):538.
Berry MA, Shah PS, Brouillette RT, Hellmann J. Predictors of mortality and length of stay for neonates admitted to children's hospital neonatal intensive care units. J Perinatol. 2008;28(4):297.
Choonara I, Gill A, Nunn A. Drug toxicity and surveillance in children. Brit J Clinic Pharmacol. 1996;42(4):407.
Morales-Carpi C, Chover NJ, Lobatón RC, Estañ L, Rubio E, Lurbe E, et al. Medicamentos utilizados en pediatría extrahospitalaria:¿ disponemos de información suficiente? In Anales Pediatría. 2008;68(5):439-46.
Divyalasya TV, Vasundara K, Pundarikaksha HP. Impact of educational session on knowledge and attitude toward palliative care among undergraduate medical, nursing and physiotherapy students: a comparative study. Int J of Basic Clin Pharmacol. 2014 May;3(3):442.
Oehme AK, Rashed AN, Hefele B, Wong IC, Rascher W, Neubert A. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison. PloS One. 2012;7(9):44349.
dosSantos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Safety. 2006;15(9):635-40.
Khan LM, Al-Harthi SE, Saadah OI. Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian university hospital and impact of pharmacovigilance in reporting ADR. Saudi Pharmaceut J. 2013;21(3):261-6.
Oshikoya KA, Senbanjo IO, Njokanma OF. Parental reporting of suspected adverse drug reactions in children in Lagos, Nigeria. Arch Dis Child. 2009;94(6):469-73.
Sharma VK, Sethuraman G, Kumar B. Cutaneous adverse drug reactions: clinical pattern and causative agents-a 6 year series from Chandigarh, India. J Postgrad Med. 2001;47(2):95.
Rai N. A study of adverse drug reactions in paediatric age group with assessment of causality, severity and preventabilty in a tertiary Care Hospital. OSR Journal of Dental and Medical Sciences. 2014;13(5):42-8.
Rashed AN, Wong IC, Cranswick N, Tomlin S, Rascher W, Neubert A. Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study. Europe J Clinic Pharmacol. 2012;68(5):801-10.
Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC. Frequency and preventability of adverse drug reactions in paediatric patients. Drug Safety. 2004;27(11):819-29.