Nová vyhláška pro předepsání léčebného konopí
Ke dni 1. dubna 2025 vstoupila v platnost novela vyhlášky upravující podmínky pro předepisování a výdej léčebného konopí. Cílem novely je sjednocení evidence, zjednodušení preskripce a zavedení přesnějších pravidel pro zacházení s konopím určeným k léčebným účelům.
Přehledný souhrn změn se dočtete níže.
Hlášení o průběhu léčby
Ministerstvo zdravotnictví vyhovělo žádostem o prominutí povinnosti hlásit průběh léčby konopím pro léčebné použití podle vyhlášky č. 236/2015 Sb., o stanovení podmínek pro předepisování, přípravu, distribuci, výdej a používání individuálně připravovaných léčivých přípravků s obsahem konopí pro léčebné použití.
Hlášení o průběhu léčby konopím pro léčebné použití za rok 2024 tak není potřeba podávat, s čímž vyslovil souhlas i Státní ústav pro kontrolu léčiv.
Nové kódy léčebného konopí
Nově jsou zavedeny dva jednotné kódy:
9190000 – pro sušené léčebné konopí (veškerá sušina),
9390000 – pro extrakt z léčebného konopí (včetně extraktu suchého).
Tyto kódy nahrazují dosavadní specifické kódy a budou používány v systému eRecept. Ještě po dobu jednoho roku (do 1. 4. 2026) bude možné vydávat konopí na staré recepty s původními kódy.
Pokud tedy bude mít pacient od lékaře předepsaný nový kód a lékárník bude mít na skladové kartě a v evidenci pouze kód starý, lze konopí se starými kódy v lékárenském systému převést směrem ze starých kódů na nové. Tento proces lze provést i obráceně.
Sjednocení klasifikace odrůd
Nově se nerozlišují odrůdy SATIVA a INDICA. Tato změna vychází z nového článku Cannabis flos v Evropském lékopise, který se zaměřuje na standardizaci požadavků na kvalitu bez ohledu na botanickou klasifikaci.
Změny v oblasti evidence
Léčebné konopí nadále zůstává v příloze č. 1 nařízení vlády č. 463/2013 Sb. jako vysoce návyková látka. Evidence je tedy povinná – buď v písemné podobě (opiátová kniha), nebo elektronicky.
Česká lékárnická komora (ČLnK) doporučuje:
v případě písemné podoby vést dvě kolonky pro nové kódy (9190000 a 9390000),
během přechodného období (1 rok) je možné vést i kolonky pro původní kódy,
u elektronické evidenci lze provádět převody mezi starými a novými kódy v rámci skladových karet dle možností systému lékárny.
Předepisování receptů
Lékař musí na receptu či žádance uvést:
odpovídající nový kód (9190000 nebo 9390000),
požadované procentuální zastoupení THC a CBD (možno i v rozmezí),
u extraktů také typ (tekutý, hustý, suchý, tinktura) a celkové množství.
Téma možností předepisovaného obsahu je stále nevyjasněné – ČLnK však zastává názor, že nemusí jít o přesně vyjádřenou koncentraci, ale lékař může dle svého uvážení uvést i rozmezí, pokud tak uzná za vhodné.
Tento způsob předepisování je zejména vhodný u konopí s velice nízkým obsahem CBD nebo THC (pod 1 %). Lékárník je pak povinen při přípravě respektovat uvedené hodnoty s tolerancí ±10 %. Pokud dostupná odrůda neodpovídá požadovanému obsahu, je možné provést záměnu se souhlasem lékaře a pacienta.
Omezení a limity
Zavádějí se nové limity v předepisování:
Sušené konopí (9190000): max. 540 g za 3 měsíce (z toho 90 g na zdravotní pojišťovnu).
Extrakt (9390000): max. 180 g za 3 měsíce (z toho 30 g na zdravotní pojišťovnu).
Poměr přepočtu extraktu ze sušiny se mění ze 7:1 na 3:1, což umožňuje vydávat větší množství extraktu. Limity předepsaného konopí i nadále bude hlídat Registr pro léčivé přípravky s omezením (RLPO), ve kterém je přes systém eRecept možno limity ověřit.
Konopí je možno předepsat na 3 měsíce – limit je ohraničen množstvím gramů, ale zároveň i dávkováním uvedeným na receptu. Farmaceut nemá povinnost kontrolovat, jaké dávkování sušiny/extraktu bylo předepsáno na předchozím předpisu, tzn. 90denní limit preskripce s dávkováním kontroluje pouze u vydávaného receptu. Musí však vždy dodržet maximální množství předepsaného konopí v RLPO.
Předepisování dětem a nové odbornosti
Novela zavádí přísnější pravidla pro pacienty mladší 18 let. Konopí lze předepsat pouze ve výjimečných případech a na základě výjimky. Dále je možné předepsání na specializovaných pracovištích (bez ohledu na specializaci lékaře) s vlastním typem certifikátu, nebo lékařem s odborností v paliativní medicíně při poskytování paliativní péče (včetně radiační a klinické onkologie a hematologie). V obou případech není nutné uvádět diagnózu.
Léčebné konopí nově mohou předepsat i lékaři s odborností:
001 – všeobecné praktické lékařství,
002 – praktické lékařství pro děti a dorost (pediatrie), a to pouze pro diagnózu R521 – chronická neutišitelná bolest.
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