Analiza predpisovanja peroralnih protitumornih zdravil brez dovoljenja za promet v Republiki Sloveniji na Onkološkem inštitutu Ljubljana

Verbič, Drago (author), Kerec Kos, Mojca (mentor), Eberl, Andreja (comentor)

Nekatera zdravila nimajo dovoljenja za promet v Republiki Sloveniji, vendar se lahko na podlagi odobritve Javne agencije Republike Slovenije za zdravila in medicinske pripomočke v izjemnih primerih vseeno uporabljajo. Namen retrospektivne raziskave je bil pregled predpisovanja in izdaje peroralnih protitumornih zdravil brez dovoljenja za promet v Republiki Sloveniji na Onkološkem inštitutu Ljubljana. Dejansko gre le za dve zdravilni učinkovini, prokarbazin in lomustin. Pregledali smo njuno predpisovanje bolnikom in ovrednotili kritične točke, ki bi jih bilo treba vključiti v svetovanje ob izdaji, saj ta zdravila nimajo priloženih Navodil za uporabo v slovenskem jeziku. V obdobju od 1. 10. 2017 do 30. 9. 2018 sta bila prokarbazin in lomustin izdana 109 bolnikom, od katerih je bilo v analizo vključenih 106 (97 %) bolnikov. Zdravilni učinkovini sta se predpisovali bolnikom, ki so se zdravili zaradi tumorja CŽS (37 %), Hodgkinovega limfoma (31 %), ne-Hodgkinovega limfoma (30 %) in mešanega limfoma (2 %). Večina (57 %) bolnikov je prejemala terapijo bolnišnično, 35 % pa ambulantno. Pri pregledu odmerjanja smo ugotovili, da je bila relativna intenzivnost zdravljenja 90–100 % dosežena pri 53/87 (61 %) bolnikov. Na znižanje intenzivnosti zdravljenja vpliva tudi zakasnitev terapije, ki se je pojavila pri 56/330 (17 %) ciklov, pri čemer se je cikel največkrat (13 %) zakasnil za 1–2 tedna. Pri pregledu krvne slike bolnikov smo ugotovili, da 50/553 (9 %) laboratorijskih izvidov ni dopuščalo nadaljevanja zdravljenja in bi bila potrebna zakasnitev terapije, kar je bilo upoštevano v 66 % primerov. Bolniki s tumorji CŽS (PCV shema) so imeli poenoteno predpisovanje odmerka prokarbazina in/ali lomustina, ki pa ni odstopal od predpisanega za več kot 10 % v primeru prokarbazina pri 66 % bolnikov in v primeru lomustina pri 90 % bolnikov. Mediana sočasno predpisanih zdravil na bolnika je bila 12 (brez upoštevanja zdravilnih učinkovin iz sheme protitumorne terapije). Bolniki so imeli najpogosteje predpisana zdravila iz skupin A (23 %), J (19 %) in N (20 %) po klasifikaciji ATC. Pri pregledu interakcij smo v bazi Lexicomp® zaznali potencialne interakcije kategorije X in D pri 36 % bolnikov in v bazi IBM Micromedex® potencialne kontraindicirane in pomembne interakcije pri 72 % bolnikov. Na podlagi rezultatov smo identificirali kritične točke pri zdravljenju s prokarbazinom in lomustinom ter pripravili obrazca, ki bosta v pomoč pri svetovanju ob izdaji teh zdravilnih učinkovin. Poenoteno svetovanje lahko pripomore k boljši učinkovitosti in varnosti zdravljenja.

• Language: Slovenian
• Keywords: peroralna kemoterapija, zdravila brez dovoljenja za promet, prokarbazin, lomustin, izdaja, svetovanje bolnikom
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2020
• PID: 20.500.12556/RUL-118613
• Publication date in RUL: 28.08.2020

VERBIČ, Drago, 2020, Analiza predpisovanja peroralnih protitumornih zdravil brez dovoljenja za promet v Republiki Sloveniji na Onkološkem inštitutu Ljubljana [online]. Master’s thesis. [Accessed 31 March 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=118613

Secondary language

• Language: English
• Title: Prescribing analysis of oral anticancer medicines without marketing authorisation in the Republic of Slovenia at the Institute of Oncology Ljubljana

Abstract

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.

• Keywords: oral chemotherapy, medicines without marketing authorisation, procarbazine, lomustine, dispensing, patient counselling