Abstract
Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% - 1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.
Highlights
A crucial issue in drug therapy is the risk of adverse drug reactions (ADRs)
The aim of this study was to assess: 1) the incidence and common types of Adverse drug reactions (ADRs); 2) the drug classes most frequently involved in ADRs among patients aged 0 - 18 years old hospitalized in five general hospitals of the Campania Region, Italy, using a common and simple approach in the general daily clinical practice, and checking for previous or during hospitalization drug exposure related to ADR
This paper showed the data of a six-month prospective observational study conducted in the general paediatric wards of five hospitals of the Campania Region
Summary
ADRs are an important clinical problem and contribute significantly to mortality and morbidity [1,2]. They can result in diminished quality of life, a greater need for physician visits and hospitalizations, and even death in adults and children [3,4,5]. Before a new drug is marketed, clinical trials are generally conducted in adult patients and, only in a few instances, in children, the situation is improving [6,7]. Pre-marketing trials are unable to detect the full range of ADRs that can occur both in adults and in the paediatric population. Some ADRs are specific to the paediatric population because of the growth and development that children undergo
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
