Some medicines do not have marketing authorisation in the Republic of Slovenia, but they can still be used in exceptional cases based on the approval of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. The aim of this retrospective research is to review prescription and dispensing of oral anticancer medicines without marketing authorisation in the Republic of Slovenia at the Institute of Oncology Ljubljana. The research focuses on two drugs, procarbazine and lomustine. We reviewed cases in which they were prescribed to patients and evaluated crucial information that should be included in patient counselling when dispensing medicines as their product packaging does not include patient information leaflet in the Slovene language.
In the period from October 2017 to September 2018, procarbazine and lomustine were dispensed to 109 patients, 106 of which (97%) were included in the analysis. The studied drugs were prescribed to patients with CNS tumours (37 %), Hodgkin's lymphoma (31 %), non-Hodgkin's lymphoma (30 %) and mixed cell lymphoma (2 %). Most of the patients (57 %) were treated in hospitals and 35 % of them in outpatient clinics. Reviewing dosing records, we determined that 90–100 % relative dose intensity was reached in 53 of 87 patients (61 %). Relative dose intensity was reduced also due to delayed therapy that occurred in 56 of 330 therapy cycles (17 %), which were most frequently (13 %) delayed by 1 to 2 weeks. Analysing complete blood count of patients, we determined that 50 of 553 laboratory results (9 %) did not allow further treatment. This required delayed therapy, which was considered in 66 % of cases. Patients with CNS tumours (PCV treatment) were prescribed a uniform dose of procarbazine and/or lomustine that did not deviate from required dose for more than 10 % in 66 % and 90 % of patients in the case of procarbazine and lomustine, respectively. The median value of concomitantly prescribed medicines per patient was 12 (without considering drug from the anticancer therapy scheme). According to the ATC classification, the patients were most frequently prescribed drugs from groups A (23 %), J (19 %) and N (20 %). Reviewing interactions in the Lexicomp® database, we detected potential interactions of X and D categories in 36 % of patients, while the IBM Micromedex® database revealed potential contraindicated and major interactions in 72 % of patients.
Based on the results, we identified crucial elements in treatment with procarbazine and lomustine and prepared two documents that will help in patient counselling when dispensing these two drugs. Uniform consultation can contribute to a more effective and safe treatment.
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