Regulation for Prescribing and Dispensing System of Cannabis: the Italian Case

Background: The medicinal properties of cannabis are now recognized. Indeed, in many countries, lawmakers have introduced specific laws and programmes to allow patients to use cannabis preparations in various forms; nevertheless, controversial situations can still be found. In Europe, medicinal- grade cannabis is mainly available as standardized dried flower tops of the cannabis plant used in magistral formulas. These are pharmaceutical preparations compounded in a pharmacy – following Good Compounding Practices - in accordance with a physician’s prescription for an individual patient. Aim of this work is to discuss the available Cannabis based preparations and regulation for prescription and distribution, with reference to Italy. Methods: We undertook a structured search of Italian laws, ministerial decree and circulars related to therapeutic use of Cannabis, interpreted in light of Italian Society of Compounding Pharmacists’ (SIFAP) position. Results: Seven documents were analysed. Cannabis can be orally administered to patients - as a dried drug dosed in filter or capsules for infusion or as an extract in olive oil prepared in a pharmacy - or inhaled with a specific vaporizer. Considering the costs and limited availability of Dutch medicinal-grade cannabis, the Italian Government, with the latest Decree of November 9th, 2015, has authorized the production of cannabis in the Military Pharmaceutical Chemical Institute on Florence, describing also the therapeutic use of cannabis and the requirements to be adhered to by physicians and pharmacists. Conclusion: A well-established national regulation guarantees the proper therapeutic use of Cannabis. Description of preparation method in monograph Pharmacopoeia will be the way to assure quality and therefore the efficacy of these products.