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Observational Study
. 2024 Apr;90(4):1050-1057.
doi: 10.1111/bcp.15995. Epub 2024 Jan 15.

PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study)

Marta Di Salvo  1 , Greta Santi Laurini  2 , Domenico Motola  2 , Giorgia Valpiani  3 , Ester Sapigni  4 , Adriana Pompilio  5 , Elena Arzenton  6 , Anna Marra  1
Affiliations
Free article
Observational Study

PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study)

Marta Di Salvo et al. Br J Clin Pharmacol. 2024 Apr.
Free article

Abstract

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.

Keywords: ADR; children; off‐label; pharmacovigilance; safety.

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Conflict of interest statement

All authors declare there are no conflicts of interest in this paper.

References

REFERENCES

    1. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) product‐ or population‐specific considerations IV: paediatric population. Accessed October 24 2022. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-go...
    1. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015;38(5):437‐453. doi:10.1007/s40264‐015‐0281‐0
    1. Smyth RM, Gargon E, Kirkham J, et al. Adverse drug reactions in children – a systematic review. PLoS ONE. 2012;7(3):e2406. doi:10.1371/journal.pone.0024061
    1. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out‐patients: a systematic review and meta‐analysis of prospective studies. Br J Clin Pharmacol. 2001;52(1):77‐83. doi:10.1046/j.0306‐5251.2001.01407.x
    1. Khan Z, Muhammad K, Karatas Y, Bilen C, Khan FU, Khan FU. Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: a mini systematic review. Gaz Egypt Paediatr Assoc. 2020;68(1):24. doi:10.1186/s43054‐020‐00038‐8

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