Ocena ustreznosti zdravil za zdravljenje otrok z epilepsijo na ketogeni dieti z vidika vsebnosti ogljikovih hidratov

Groznik, Klara (author), Kerec Kos, Mojca (mentor), Laptoš, Tomi (comentor)

Epilepsija je ena najpogostejših nevroloških motenj pri otrocih. Najpogosteje se zdravi s protiepileptičnimi zdravili. V primeru neobvladljive epilepsije se lahko za zdravljenje uporabi ketogeno dieto, tj. prehranski način z visokim vnosom maščob, nizkim vnosom ogljikovih hidratov in organizmu potrebnem vnosu beljakovin. Ketogena dieta je zahtevna za izvedbo, saj je potrebno spremljanje vsebnosti ogljikovih hidratov tako v hrani kot v zdravilih, ki jih bolniki prejemajo, ko so na ketogeni dieti. Pri teh bolnikih se zato uporabljajo zdravila, ki ne vsebujejo ogljikovih hidratov ali jih vsebujejo čim manj. V raziskavi smo analizirali kakovostno in količinsko sestavo zdravil z vidika ogljikovih hidratov, ocenili njihovo ustreznost za uporabo pri otrocih na ketogeni dieti in za neustrezna zdravila poiskali alternative. Glavni viri podatkov o sestavi zdravil so bili Povzetki glavnih značilnosti zdravil, Navodila za uporabo zdravil, recepture in sestave vehiklov. Pregledali smo zdravila, ki so bila otrokom z neobvladljivo epilepsijo predpisana v Univerzitetnem kliničnem centru Ljubljana (UKCL) v obdobju med 03. 01. 2020 in 09. 12. 2021, ter vsa magistralna tekoča peroralna zdravila, ki se pripravljajo v UKCL. Podatke o predpisanih zdravilih smo pridobili preko modula eRecept znotraj sistema eZdravje, podatke o magistralnih zdravilih pa v Lekarni UKCL. V dvoletnem obdobju analize je bilo 335 bolnikom v UKCL skupno predpisanih 2679 receptov za 332 različnih zdravil. Največ predpisanih zdravil je bilo iz ATC skupine N – Zdravila z delovanjem na živčevje (128/332; 38,6 %). Med predpisanimi zdravili jih 233/332 (70,2 %) ni bilo primernih za uporabo pri bolnikih na ketogeni dieti. Poiskali smo tudi alternative za najpogostejša neprimerna industrijsko proizvedena zdravila tako med drugimi industrijsko proizvedenimi zdravili kot med magistralnimi zdravili, vendar jih pri 11/32 (34,4 %) nismo našli. Magistralna tekoča peroralna zdravila, ki se pripravljajo v UKCL, so najpogosteje sodila v ATC skupino C – Zdravila za bolezni srca in ožilja (35/166; 21,1 %). 135/166 (81,3 %) magistralnih zdravil ni bilo ustreznih za uporabo pri bolnikih na ketogeni dieti. Najpogostejši neprimerni ogljikovi hidrati v zdravilih so bili saharoza, glicerol, sorbitol, etanol, različne oblike laktoze in škroba. Najpogostejša alternativa je bila zamenjava neprimernih vehiklov (ORA Sweet®, ORA-Blend®, ORA-Sweet® SF, SickKids®, sirup simplex) z ORA Plus®. Podatki o ustreznosti zdravil za uporabo pri bolnikih na ketogeni dieti bodo vneseni v šifrant zdravil kliničnega informacijskega sistema, ki se uporablja v UKCL. Naš pregled bo tako olajšal predpisovanje zdravil otrokom na ketogeni dieti.

• Language: Slovenian
• Keywords: epilepsija, otroci, ketogena dieta, ogljikovi hidrati, industrijsko proizvedena zdravila, magistralna zdravila
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-143442
• Publication date in RUL: 21.12.2022

Secondary language

• Language: English
• Title: Assessment of the suitability of medicines for the treatment of children with epilepsy on a ketogenic diet in relation to carbohydrate content

Abstract

Epilepsy is one of the most common neurological disorders in children. It is commonly treated with antiepileptic drugs. In cases of intractable epilepsy, a ketogenic diet can be used for treatment. The ketogenic diet is a dietary method with a high fat, low carbohydrate and the necessary protein intake. The implementation of the ketogenic diet is challenging because the carbohydrate content must be monitored both in the food and the medications that patients receive during the ketogenic diet. Therefore, these patients use medicines that contain no or as little carbohydrates as possible. The aim of our study was to analyse the qualitative and quantitative composition of medicines in relation to carbohydrates, to evaluate their suitability for use in children on the ketogenic diet, and to find alternatives for unsuitable medicines. The main sources of data on the medicines’ composition were the Summaries of Product Characteristics, the Patient Information Leaflets, formulations and solvent compositions. We reviewed the medicines prescribed to children with intractable epilepsy at the University Medical Centre Ljubljana (UMCL) in the period from 03. 01. 2020 to 09. 12. 2021, as well as all extemporaneously compounded liquid oral medicines prepared at the UMCL. We obtained the data on prescribed medicines through the eRecept module of the eZdravje system, and the data on extemporaneously compounded medicines at the UMCL pharmacy. During the two-year analysis period, a total of 2679 prescriptions for 332 different medicines were prescribed to 335 patients at the UMCL. Most of the prescribed drugs belonged to the ATC group N – Nervous system (128/332; 38.6 %). Of the medicines prescribed, 233/332 (70.2 %) were not suitable for the ketogenic diet. We also searched for alternatives for the most common unsuitable industrially produced medicines, both among other industrially produced medicines and extemporaneously compounded medicines, but we did not find them for 11/32 (34.4 %). Extemporaneously compounded medicines belonged most frequently to the ATC group C - Cardiovascular system (35/166; 21.1 %). Of them, 135/166 (81.3 %) were not suitable for the ketogenic diet. The most common unsuitable carbohydrates were sucrose, glycerol, sorbitol, ethanol, various forms of lactose and starch. The most common alternative was to replace unsuitable solvents (ORA-Sweet®, ORA Blend®, ORA-Sweet® SF, SickKids®, syrup simplex) with ORA-Plus®. Data on medicines’ suitability for use on the ketogenic diet will be entered into the UMCL clinical information system. Our review will thus facilitate the prescription of medicines for children on the ketogenic diet.

• Keywords: epilepsy, children, ketogenic diet, carbohydrates, industrially produced medicines, extemporaneously compounded medicines