Patient-reported outcomes and medication errors during oral antitumour therapy in paediatrics: Results from the youngAMBORA care programme.

AIM: Increasing use of oral antitumour therapeutics (OAT) in paediatrics is associated with numerous advantages, but also with error-prone aspects. Based on the randomized AMBORA trial including adults treated with various OAT, we developed a tailored pharmacological/pharmaceutical care programme for children and their caregivers during OAT treatment (youngAMBORA). We now aimed to analyse the impact of the youngAMBORA care programme on medication safety by assessing (1) patient-reported outcomes (PROs) and (2) medication errors. METHODS: Depending on the intended OAT treatment duration, the youngAMBORA care programme included three or four consultation sessions starting at therapy initiation (Week 0) and using developed information material. Validated questionnaires were used to record PROs (e.g., knowledge [Satisfaction with Information about Medicines Scale, SIMS, primary outcome] and side effects [Ped-PRO-CTCAE®]). Advanced medication reviews were conducted in every consultation session, and medication errors were systematically categorized (e.g., PCNE V9.1). RESULTS: We counselled 54 patients treated with 61 OAT. The most frequently prescribed OAT was 6-mercaptopurine (14/61; 23%). Knowledge about the OAT improved significantly between Week 0 at OAT initiation and Week 1 (SIMS total score 8.1 ± 4.2 vs. 15.8 ± 1.6; p < .0001). On average, patients and caregivers reported 2.6 OAT-related side effects per patient, with gastrointestinal symptoms (i.e., 'nausea') being most frequent and severe. Fifty-six OAT-related medication errors were detected (mean 1.0 per patient), and of these, 84% (47/56) were completely resolved. CONCLUSION: The youngAMBORA care programme improved caregivers' knowledge about OAT, enabled structured monitoring of patient-reported side effects and facilitated the identification and resolution of medication errors during paediatric OAT treatment to optimize medication safety.