Improving Drug Safety in Pediatric and Young Adult Patients with Hemato-Oncological Diseases: A Prospective Study of Active Pharmacovigilance

Abstract

The acquisition of relevant pediatric clinical safety data is essential to ensure tolerable drug therapies. Comparing the real number of Adverse Drug Reaction (ADR) reports in clinical practice with the literature, the idea of ADR underreporting emerges. An active pharmacovigilance observational prospective study was conducted to assess the safety of oncology pharmacological prescriptions in patients aged 0–24 years at Institute for Maternal and Child Health IRCCS Burlo Garofolo in Trieste and IRCCS CRO National Cancer Institute in Aviano (Italy) between January 2021 and October 2023. Prescriptions and ADRs were evaluated by a multidisciplinary team. A total of 1218 prescriptions for 38 patients were analyzed, and 190 ADRs of grade 3–5 were collected. As compared to historical data, we registered a significant increase (p < 0.001) in the number of ADRs. The risk of ADR was 3.4 times higher in the case of off-label prescriptions compared to on-label ones (OR 3.4; [1.47; 7.89]; p-value = 0.004). The risks of error and near-miss were reported for 6.3% and 18.2% of total prescriptions, respectively. Of the total of 133 interactions, 47 (35.3%) resulted in ADRs. This study shows the importance of pro-active pharmacovigilance to efficiently highlight ADRs, and the fundamental role of multidisciplinary teams (oncologist, pharmacist, pharmacologist, pediatrician, nurse) in improving patients’ safety during therapy.

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study

“…The challenges in recognizing ADRs in oncology settings are often due to polypharmacy and under-reporting [ 18 , 20 ]. Nonetheless, it is crucial to acknowledge that ADR reporting in oncology settings has shown an upward trend over the years [ 10 , 21 ]. A recent study on PV for oncological prescriptions in patients aged 0–24 showed a significant increase in ADR reports, with off-label prescriptions being 3.4 times more likely to result in ADRs than on-label ones [ 21 ].…”

“…Nonetheless, it is crucial to acknowledge that ADR reporting in oncology settings has shown an upward trend over the years [ 10 , 21 ]. A recent study on PV for oncological prescriptions in patients aged 0–24 showed a significant increase in ADR reports, with off-label prescriptions being 3.4 times more likely to result in ADRs than on-label ones [ 21 ]. It was also found that 6.3% of prescriptions had errors and 18.2% near-misses, with 35.3% of 133 drug interactions causing ADRs [ 21 ].…”

“…A recent study on PV for oncological prescriptions in patients aged 0–24 showed a significant increase in ADR reports, with off-label prescriptions being 3.4 times more likely to result in ADRs than on-label ones [ 21 ]. It was also found that 6.3% of prescriptions had errors and 18.2% near-misses, with 35.3% of 133 drug interactions causing ADRs [ 21 ]. This underscores the importance of active PV and a multidisciplinary team approach in enhancing safety, especially with off-label prescriptions.…”

“…Employing PV practices facilitates the early identification of potential ADRs [ 18 , 21 ]. A notable study delved into the ADRs, specifically leukopenia and thrombocytopenia, associated with CDK4/6 inhibitors in the treatment of breast cancer, by analyzing data from the European Spontaneous Adverse Event Reporting System [ 22 ].…”