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PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study)
Marta Di Salvo1, Greta Santi Laurini2, Domenico Motola2
1Hospital Pharmacy, Azienda Ospedaliero-Universitaria di Ferrara Arcispedale S. Anna, Cona, Ferrara, Italy.
Insights
Off-label drug use is extensive in Italian pediatric hospitals, with half of all prescriptions used improperly. Improved drug regulation and adverse drug reaction (ADR) reporting are crucial for child patient safety.
Area of Science:
- Pediatric Pharmacology
- Drug Safety Surveillance
- Hospital Pharmacy Practice
Background:
- Off-label drug use in pediatric patients is a significant concern.
- Adverse drug reactions (ADRs) in children require careful monitoring.
- Italian hospitals face challenges in adhering to drug licensing for pediatric care.
Purpose of the Study:
- To quantify the prevalence of off-label drug prescriptions in Italian pediatric and neonatal wards.
- To assess the incidence of suspected adverse drug reactions (ADRs) in pediatric patients.
- To evaluate the impact of a pharmacovigilance educational intervention on ADR reporting.
Main Methods:
- A 2-year prospective cohort study involving 22 Italian hospital wards.
- Data collection included retrieval of reported ADRs and evaluation of drug prescriptions for off-label use.
- An educational intervention on pharmacovigilance was implemented, followed by a repeat data collection phase.
Main Results:
- Fifty percent of all prescribed drugs were used off-label, primarily concerning dosage variations.
- Neonatal wards showed a slightly higher rate of off-label prescriptions, with antibacterials most frequently involved.
- ADR reporting increased significantly after the educational intervention, with 10 of 35 reports linked to off-label drug use.
Conclusions:
- Off-label drug administration is widespread in Italian pediatric healthcare settings.
- There is a need for regulatory actions to ensure drug use aligns with current evidence and improve pediatric ADR reporting.
- Further studies are required to establish appropriate pediatric indications and dosages for commonly used medications.
Aims:
To assess the extent of off-label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals.
Methods:
We conducted a 2-year prospective cohort study across 22 Italian hospital wards from September 2020 to September 2022. As part of the surveillance project, we performed a 6-month retrieval of all reported ADRs and evaluated all drug prescriptions for their possible off-label use. Following an educational project on pharmacovigilance addressed to healthcare professionals in participating wards, the same data collection was performed.
Results:
Among the 892 patients included in the study, 64% were admitted to paediatric wards and 36% to neonatal wards. Fifty per cent of all drugs prescribed were used off-label and mainly concerned the administration of a different dose from the one authorized. In neonatal wards, off-label prescriptions occurred slightly more often, with antibacterials being the most frequently used off-label drugs. A total of 35 reports of suspected ADRs were collected, five before the educational project and 30 afterwards. Based on product licence, 10 of the total 35 reports concerned at least one off-label drug use.
Conclusions:
The off-label use of drugs in treating paediatric patients was extensive in Italian hospitals. Regulatory interventions are needed to promote the use of drugs based on the latest available literature and improve ADR reporting on children. Paediatric indications and dosages of the drugs most commonly used in children should be supported by appropriate ad hoc studies.
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