Studienlage · Detail
Unklar
103 Zitate
StichprobePositionspapier
EndpunktZulassungs- und…
Verblindungn.a.
DesignSurvey + Positionspapier-Synthese
THC:CBD1:1
Applikationoromukosal
Kernaussage
Survey dokumentiert erhebliche Unterschiede zwischen europäischen Ländern in der Verfügbarkeit und Zulassung von cannabisbasierten Arzneimitteln; Empfehlungen von Fachgesellschaften sind gemischt (teilweise empfehlend, teilweise ablehnend).
Zusammenfassung
Survey der European Pain Federation (EFIC) zu Zulassungsstatus von Cannabis-basierten Medikamenten in 31 europäischen Ländern; THC/CBD-Oromukosalspray in 21 Ländern für MS-Spastik zugelassen; deutsche und israelische Fachgesellschaften empfehlen Cannabis als Drittlinientherapie für chronischen Schmerz, während deutsche Ärztekammer und finnische Expertengruppe Verschreibung wegen fehlender Hochqualitäts-Evidenz nicht empfehlen.
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PopulationNationale Repräsentanten der European Pain Federation (EFIC) aus 37 Mitgliedsländern, n=31 Antwortende
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InterventionErhebung zum Zulassungs- und Verfügbarkeitsstatus cannabisbasierter Arzneimittel (THC/CBD-Spray, Dronabinol, Nabilon, medizinisches Cannabis) in Europa
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Outcome21 EFIC-Kapitel haben THC/CBD-Oromukosal-Spray für MS-Spastik zugelassen; 4 Kapitel Dronabinol für palliative Indikationen; 4 Kapitel Nabilon für Chemotherapie-Übelkeit; erhebliche Unterschiede zwischen Ländern hinsichtlich Zulassung und Kostenübernahme
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Abstract
Background: There is considerable public and political interest in the use of cannabis products for medical purposes.
Methods: The task force of the European Pain Federation (EFIC) conducted a survey with its national chapters representatives on the status of approval of all types of cannabis-based medicines, the covering of costs and the availability of a position paper of a national medical association on the use of medical cannabis for chronic pain and for symptom control in palliative/supportive care.
Results: Thirty-one out of 37 contacted councillors responded. Plant-derived tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray is approved for spasticity in multiple sclerosis refractory to conventional treatment in 21 EFIC chapters. Plant-derived THC (dronabinol) is approved for some palliative care conditions in four EFIC chapters. Synthetic THC analogue (nabilone) is approved for chemotherapy-associated nausea and vomiting refractory to conventional treatment in four EFIC chapters'. Eight EFIC chapters' countries have an exceptional and six chapters an expanded access programme for medical cannabis. German and Israeli pain societies recommend the use of cannabis-based medicines as third-line drug therapies for chronic pain within a multicomponent approach. Conversely, the German medical association and a team of finish experts and officials do not recommend the prescription of medical cannabis due to the lack of high-quality evidence of efficacy and the potential harms.
Conclusions: There are marked differences between the countries represented in EFIC in the approval and availability of cannabis-based products for medical use. EFIC countries are encouraged to collaborate with the European Medicines Agency to publish a common document on cannabis-based medicines.
Significance: There are striking differences between European countries in the availability of plant-derived and synthetic cannabinoids and of medical cannabis for pain management and for symptom control in palliative care and in the covering of costs by health insurance companies or state social security systems.
„Was dem Handeln im Weg steht, wird zum Weg.“