Cannabis Oils and Cannabidiol Oils What are they
Cannabis Oils and Cannabidiol Oils What are they and what are the differences? Colin Acknowledgement The authors would like to thank the RPS National Pharmacy Boards and the RPS Science and Research Board for their support and input. 1 Cable , Aileen 1 Bryson , Alex 1 Mac. Kinnon , Gino 2 Martini 1. Royal Pharmaceutical Society – Edinburgh, Scotland, UK 2. Royal Pharmaceutical Society – London, England, UK Corresponding author: Dr Colin Cable, Colin. Cable@rpharms. com Background Method Cannabis is the most widely used illegal drug in the UK 1. Cannabis generally makes users feel relaxed although some users experience confusion and feel anxious; dependence and tolerance to Cannabis can develop. Cannabis contains more than 400 chemical constituents, including cannabinoids, terpenoids and phenolic compounds, around 70 of which have potential for medicinal use. The most common of the cannabinoids are the psychoactive compound tetrahydrocannabinol (THC) and the non-psychoactive compound cannabidiol (CBD). Recently, ‘Cannabidiol oil’ (also known as ‘CBD oil’) has become available from health stores and some pharmacies in the UK as well as over the internet. Aim We aimed to develop practical guidance about ‘Cannabidiol oil’/‘CBD oil’ and how it differs from ‘Cannabis oil’ to address the confusion that exists about these products. Literature Search Evidence search using Medline and International Pharmaceutical Abstracts. Draft Dissemination/ Consultation Evidence base developed using references from the literature search, together with resources available from the NHS, Home Office and MHRA. A review of the relevant legislation was also carried out. Publication Draft document disseminated to the RPS National Pharmacy Boards, the RPS Science and Research Board and selected external stakeholders for comment. Results - The Guide Cannabidiol (CBD) Evidence for Medicinal Uses of Cannabidiol CBD in its pure form is a solid. CBD is not controlled under the Misuse of Drugs Act 1971 or the Misuse of Drugs Regulations 2001 because it is not psychoactive. Products containing CBD which are intended for a medical purpose would fall within the definition of a medicinal product. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued detailed guidance in respect of the classification of CBD products 2. CBD is claimed to have benefit in a wide variety of health conditions, but currently only a few published studies provide meaningful clinical evidence of the use of CBD for medicinal purposes. The terms ‘Cannabis Oil’ and ‘Cannabidiol Oil’/‘CBD oil’ are used widely but have no legal definitions and may cause confusion. Cannabidiol Oil (CBD Oil) The terms ‘Cannabidiol oil’ and ‘CBD oil’ are typically used to describe preparations prepared from extracts of Cannabis strains with a very low THC content and high CBD content. Similar to the ‘Cannabis oils’ the extracts are dissolved in a fixed (fatty) oil such as sesame or peanut oil. There a number of CBD products on the market as food supplements. As food supplements, it is not necessary for ‘Cannabidiol oils’/‘CBD oils’ to demonstrate quality, safety and efficacy as required for medicinal products, and there is no guarantee of the precise content of these products or their quality. Any CBD product that contains controlled cannabinoids (e. g. THC), unintentionally or otherwise is highly likely to fall within the scope of legislation on the misuse of drugs making supply or possession of such products unlawful in the UK. The Home Office has issued guidance in this regard 4. Figure 1: Cannabis sativa. THC tetrahydrocannabinol CBD cannabidiol Cannabis Oil The term ‘Cannabis oil’ is typically used to describe preparations consisting of an extract obtained from Cannabis dissolved in a fixed (fatty) oil such as sesame or peanut oil. In the case of ‘Cannabis oil’ the extract used will usually include cannabinoid compounds including THC, CBD and many others together with non-cannabinoid constituents, such as terpenoids. Different brands of ‘Cannabis oil’ can have different concentrations of THC and CBD. Furthermore, as ‘Cannabis oil’ is derived from a plant, it is possible that a specific product will have batch-to-batch variations in the concentration of individual compounds. In the UK, ‘Cannabis oils’ are regulated as controlled drugs and such products are not freely available to the public but may be prescribed under the new regulations which allow access to cannabis-based products for medicinal use 3. Figure 2: Chemical structure of THC and CBD. The strongest evidence is for its effectiveness as an add-on treatment for some childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically do not respond sufficiently to other medications 5, 6, 7. CBD has been reported to reduce the number of seizures in a proportion of these patients. Recently, in the United States, the FDA approved a new CBD medicine (Epidiolex) to treat rare childhood epilepsies (Dravet syndrome and Lennox-Gastaut syndrome in patients two years of age or older); Epidiolex is currently under assessment within the EU. Other conditions for which CBD has been suggested as being effective include: multiple sclerosis 8, 9 Alzheimer's disease 9, 10; Parkinson's disease 9, 11, 12; schizophrenia 13, 14; anxiety 15. However, much more high-quality evidence from human studies on the use of CBD in these conditions is required before any benefit can be concluded. Drug Interactions with Cannabidiol CBD is metabolized by the cytochrome p 450 enzymes CYP 3 A 4 and CYP 2 C 19. Administration of a moderate or strong inhibitor of these enzymes, such as ketoconazole, will increase CBD plasma concentrations, which may result in a greater risk of adverse reactions. Conversely, administration of a drug that induces these enzymes, such as rifampicin, will produce lower plasma concentrations of CBD can also have an impact on the metabolism of other drugs due to its potential to interact with a range of other liver enzymes. Drugs which interact with CBD can be found on the NHS Specialist Pharmacy Services website 16 while more detailed information about drug interactions can be found in the product information on Epidiolex 17. Figure 3: Cannabidiol Oil (CBD Oil). Conclusion While CBD itself is not a controlled substance, any CBD products that contain controlled cannabinoids, such as THC, will fall within legislation on the misuse of drugs. There is limited evidence on the clinical uses of CBD and much more data from high-quality human studies is required. CDB is known to interact with other drugs mainly due to its actions on liver enzymes. REFERENCES 1. Drug misuse: Findings from the 2017/2018 crime survey for England Wales. Home Office (2018). 2. A guide to what is a medicinal product: MHRA guidance note 8. Medicines and Healthcare products Regulatory Agency (2016). 3. Medical cannabis (and cannabis oils). NHS (2018). 4. Drug licensing factsheet – Cannabis, CBD and other cannabinoids Home Office. (2019). 5. Devinsky, O. et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. The Lancet Neurology (2016) 15 270 -278. 6. Perucca, E. Cannabinoids in the treatment of epilepsy: hard evidence at last? J Epilepsy Res. (2017) 7 61– 76. 7. Stockings, E. et al. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. J Neurol Neurosurg Psychiatry (2018) 89 741– 753. 8. Nielsen, S. et al. The use of cannabis and cannabinoids in treating symptoms of multiple sclerosis: a systematic review of reviews. Curr Neurol Neurosci Rep (2018) 18. 9. Mannucci, C. et al. Neurological aspects of medical use of cannabidiol. CNS & Neurological Disorders - Drug Targets (2017) 16 541 -553. 10. Watt, G. and Front, K. T. In vivo evidence for therapeutic properties of cannabidiol (CBD) for Alzheimer's disease. Front Pharmacol, (2017). 11. Crippa, J. A. S. et al. Is cannabidiol the ideal drug to treat non-motor Parkinson’s disease symptoms? Eur Arch Psychiatry Clin Neurosci (2019). 12. Chagas, M. H. N et al. Effects of cannabidiol in the treatment of patients with Parkinson's disease: An exploratory double-blind trial. Journal of Psychopharmacology (2014). 13. Rohleder, C. et al. Cannabidiol as a potential new type of an antipsychotic. A critical review of the evidence. Front Pharmacol (2016). 14. Zuardi, A. W. et al. A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational investigation. Curr Pharm Des (2012) 18 5131 -40. 15. Blessing, E. M. et al. Cannabidiol as a potential treatment for anxiety disorders. Neurotherapeutics (2015) 12 825– 836. 16. Cannabidiol oil – potential adverse effects and drug interactions. NHS Specialist Pharmacy Services (2018). 17. Epidiolex. Highlights of prescribing information. Greenwich Biosciences Inc, USA (2018). © 2019 The Royal Pharmaceutical Society www. rpharms. com support@rpharms. com 0207 572 27370
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