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Regime di dispensazione dei preparati contenenti Cannabis

Sollecitati da alcuni farmacisti che hanno chiesto delucidazioni in merito al regime di dispensazione di un preparato a base di infiorescenze di Cannabis, anche alla luce della registrazione del medicinale di origine industriale Sativex®, riportiamo quanto segue.
I medicinali di origine vegetale a base di Cannabis sono iscritti nella Tabella II, sezione B, di cui al DPR 309/90 (DM 23/01/2013, pubblicato sulla GU n. 33 del 08/02/2013 e in vigore dal 23 febbraio u.s.), pertanto per la loro dispensazione è richiesta almeno una ricetta non ripetibile.

All’atto della spedizione il farmacista deve apporre sulla ricetta data, prezzo e timbro, e deve consegnare il medicinale a persona maggiore di anni 18 e non inferma di mente; inoltre il farmacista è tenuto a registrare e conservare l’originale della ricetta per 2 anni insieme al Registro entrata-uscita degli stupefacenti a far data dall’ultima trascrizione.
In base alla categoria terapeutica e/o all’indicazione d’uso si possono ipotizzare tre casi in cui sono prescritte le infiorescenze di Cannabis:
 
1. per il trattamento del dolore neuropatico nella sclerosi multipla, in analogia al medicinale di origine industriale Sativex®, approvato con Determinazione AIFA pubblicata sulla GU n. 100 del 30/04/2013, e in accordo con la Nota in calce alla Tabella N. 4 della FU XII edizione “i preparati magistrali a base di principi attivi contenuti in medicinali di origine industriale e soggetti a ricetta limitativa secondo gli artt. 92, 93 e 94 del DLvo n. 219/06 possono essere allestiti solo alle condizioni previste in sede di AIC per i medicinali industriali corrispondenti”, la ricetta deve essere esclusivamente redatta da centro ospedaliero o dallo specialista neurologo;
 
2. come antiemetico in terapia antiblastica o come stimolante dell’appetito in terapia anti HIV, la ricetta non è limitativa e di conseguenza può essere prescritta da qualunque medico;
 
3. nella terapia del dolore o altro, laddove vi sia letteratura scientifica a supporto, ma non esista un medicinale di origine industriale registrato in Europa, la ricetta deve essere redatta conformemente all’art. 5 della L. 94/98, cioè il medico è tenuto ad acquisire dal paziente il consenso informato al trattamento riportando sulla ricetta il codice alfa-numerico, anziché il nome e cognome dello stesso, e le motivazioni particolari per cui ricorre alla prescrizione; in questa eventualità il farmacista deve entro la fine del mese inviare copia della ricetta alla ASL di appartenenza.
 
Si ricorda che alla presentazione della ricetta il farmacista non è tenuto a conoscere quale sia l’indicazione terapeutica -ove il medico non la espliciti- e che si affiderà alle modalità prescrittive adottate dal medico per ricondurre la ricetta ad uno dei tre casi sopra riportati

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