A prospective study of adverse drug reactions in hospitalized children

Abstract

Aims There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. Methods An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. Results A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR=1.66, 95% CI 1.03-2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. Conclusions Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.

Adverse drug reactions in neonates of neonatal intensive care unit in Barranquilla, Colombia

“…Con relación a los grupos de medicamentos implicados en las reacciones adversas, el 80,5 % de estas se asoció a los antibióticos sistémicos. En su estudio, Martínez, et al (26), reportaron que el 45,1 % de las reacciones adversas se asociaron con el uso de estos fármacos. Los fármacos más comúnmente prescritos en neonatos en cuidados intensivos en un estudio en España también correspondieron a estos medicamentos, a los del sistema nervioso y a los cardiovasculares (27).…”

“…Estos datos difieren ligeramente de lo evidenciado por Martínez, et al (26), en cuyo estudio los más afectados fueron el sistema digestivo, con 36,6 %, y el sistema nervioso, con 22,3 %. Debido al diseño del presente estudio, es decir, descriptivo, observacional y transversal de período, no era posible intervenir en el tratamiento del paciente y debe resaltarse que, debido a cuestiones éticas, los investigadores se limitaron a observar los tratamientos usados.…”

“…Sin embargo, dado que el período de observación fue de seis meses, el estudio permitió determinar la incidencia y el comportamiento de las reacciones adversas en los pacientes estudiados, y se encontraron datos similares a los reportados en otros estudios (22,24,26).…”

A survey on knowledge, attitude and practice of pharmacovigilance and adverse drug reaction reporting among healthcare professionals in a tertiary care hospital of Bihar, India

“…3,4 They affect both children and adults with varying magnitudes; causing morbidity and mortality. 5,6 Pharmacovigilance Programme of India (PvPI) has been established by the Ministry of Health and Family Welfare, Government of India in July 2010 to provide the safe and effective healthcare system in India promote rational use of medicines. The programme is being coordinated by the Indian Pharmacopoeia commission (IPC), Ghaziabad as a National Coordination Centre (NCC).…”

An analysis of the pharmacological management of respiratory tract infections in pediatric in-patients at a tertiary care teaching hospital

“…Steroids have been prescribed only in cases of acute laryngotracheobronchitis (reduces laryngeal edema) and lobar pneumonia (ineffective). [23] It should be mentioned that the ADRs seen in our study were caused by antibacterials, as was also seen in Spain, [24] Brazil, [25] and Italy, [26] thus substantiating the widely acknowledged fact that irrational use of antibacterials led to adverse drug reactions. A disturbing fact noted was that all ADRs were preventable in nature (two defi nitely WHO=World health organization, EML=Essential medicines list and one probably), as either the causal drugs were not indicated in the patients or preventive measures could have been taken.…”