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MEDICINAL CANNABIS 33 Mr Sclavos added: “PTSD \\\\\\\\\\\\\\\[post traumatic stress disorder\\\\\\\\\\\\\\\] ... will be a growing area. \\\\\\\\\\\\\\\[There is a\\\\\\\\\\\\\\\] large cohort that use \\\\\\\\\\\\\\\[medicinal cannabis for PTSD\\\\\\\\\\\\\\\] in Israel.” The safety profile of medicinal cannabis Dr Jansen says that because CBD is not psychoactive, “the rates of side effects are very low”. “The side effects that you get from CBD are usually in the first week and they go away,” he said. “And it’s usually dry mouth or upset stomach – loose bowels, but that usually goes away. “From the THC side of things, the side effects are usually minor, so they don’t cause harm. Somewhere between one per cent and 10 per cent of patients will have a side effect \\\\\\\\\\\\\\\[which will cause them to\\\\\\\\\\\\\\\] then stop taking their medication. That would be sedation, forgetfulness, fatigue ... some patients feel anxious with the THC.” Referring to contraindications for THC use, Dr Jansen says these include schizophrenia, pregnancy and breastfeeding, and severe heart disease. “Contraindications for THC are a past history of schizophrenia or a risk, so, direct family members,” he said. “THC doesn’t cause new schizophrenia ... but it can unmask it in those who were already at risk.” Mr Sinclair says that while most of the studies conducted into CBD “suggest it has a favourable safety profile” with “tolerable side effects and low toxicity”, “knowledge gaps still exist”. He adds that a recent World Health Organization report on CBD suggests it doesn’t seem to be associated with abuse potential. “That being said, CBD has a complex pharmacokinetic and pharmacodynamic profile with potential for drug interactions particularly through the Cytochrome P450 system ... As such, investigating the potential for drug interactions is an increasingly important area for researchers, and pharmacists and doctors need to be aware that, particularly at higher doses of CBD, such interactions need to be monitored for,” Mr Sinclair said. The role of a pharmacist assistant While dispensing of medicinal cannabis is largely the domain of an approved prescriber and doctors who have received approval through the SAS, given the potential change in low dose CBD scheduling, all pharmacists will soon play a role within this arena, and will need to know how to dispense medicinal cannabis appropriately, and according to health conditions. This means that pharmacy assistants will need to upskill in this area also, in order to assist the pharmacists they work with. “\\\\\\\\\\\\\\\[At present\\\\\\\\\\\\\\\] CBD is a Schedule 4; THC is a Schedule 8 – any product that has more than two per cent of any other cannabinoid apart from CBD is considered a Schedule 8 as well,” Dr Jansen said. “The government is looking to change the scheduling of smaller bottles of CBD to across-the-counter pharmacy only (Schedule 3) ... so \\\\\\\\\\\\\\\[if this goes ahead\\\\\\\\\\\\\\\] pharmacists would have more of a role in dispensing CBD \\\\\\\\\\\\\\\[and\\\\\\\\\\\\\\\] ... would need to give accurate advice.” Dr Jansen points out that pharmacy assistants also need to upskill in this area. To help pharmacists and assistants upskill, courses and platforms such as those of CanView are becoming available. Dr Jansen adds that through CanView, an educational platform is about to be released that pharmacists can access for further training around medicinal cannabis. “It will be free for pharmacists and doctors to go on and learn about medicinal cannabis – when it’s appropriate and what is the dosing that you should do,” he said. “That course is open to retail pharmacy assistants as well. I guess really ... the duty of care falls under the pharmacist to make sure their staff is trained appropriately.” In addition to the option of the CanView platform, on 1 July 2020 NPS MedicineWise released a new portal to “help health professionals and consumers navigate evidence-based information about medicinal cannabis”. “Medicinal cannabis is a medicine that Australians want to know more about,” said NPS MedicineWise CEO Adjunct Associate Professor Steve Morris. “Accessing clear, accurate and up-to-date information about medicinal cannabis can be challenging ... because there are many groups with an interest in this area, and a complex regulatory environment.” Referring to the potential role of pharmacy assistants in the medicinal cannabis space, Dr Sean Hall, CEO and Managing Director of Medlab Clinical, said: “People walk into a pharmacy, they look down the back and the pharmacist appears busy. Chances are the pharmacy assistant is going to get hit up with the questions.” Dr Hall says he is unsure about what, “ethically”, the extent of pharmacy assistant’s knowledge about medicinal cannabis should be “on what, at the end of the day, is \\\\\\\\\\\\\\\[a Schedule 4 or Schedule 8 medicine, or potentially Schedule 3 for low dose CBD\\\\\\\\\\\\\\\]. “But we know a couple of really good pharmacists, Kos \\\\\\\\\\\\\\\[Sclavos\\\\\\\\\\\\\\\] included, who will probably help us to understand what that looks like. Then we’ll tailor \\\\\\\\\\\\\\\[educational material\\\\\\\\\\\\\\\] and meet that \\\\\\\\\\\\\\\[need\\\\\\\\\\\\\\\] appropriately.” In summary Delving into the medicinal cannabis arena, it’s fair to say that this a complex topic – one that pharmacists and assistants cannot shy away from, particularly given the fact that, if it passes, low dose CBD may soon be downgraded to a Schedule 3 medicine. “Currently a delegate-initiated proposal is before the Joint Advisory Committee on Medicines and Chemicals Scheduling to downschedule CBD to Schedule 3 in the Standard for the Uniform Scheduling of Medicines and Poisons, with a ruling expected later this year,” Mr Sinclair said. References: 1. Guidance for the use of medicinal cannabis in Australia: Patient information, tga.gov.au/ publications/guidance-use-medicinal-cannabis- australia-patient-information \\\\\\\\\\\\\\\[Accessed 1.7.2020\\\\\\\\\\\\\\\]. 2. Australian Government Department Health TGA, ‘Safety of low dose cannabidiol’, Version 1.0, April 2020. 3. Australian Government Department Health TGA, ‘Safety of low dose cannabidiol’, Version 1.0, April 2020. 4. Australian Government Department Health TGA, ‘Safety of low dose cannabidiol’, Version 1.0, April 2020. 5. Review on the safety of low dose cannabidiol, tga.gov.au/alert/review-safety-low-dose-cannabidiol \\\\\\\\\\\\\\\[Accessed 2/7/20\\\\\\\\\\\\\\\]. 6. Guidance for the use of medicinal cannabis in Australia: Patient information, tga.gov.au/ publications/guidance-use-medicinal-cannabis- australia-patient-information \\\\\\\\\\\\\\\[Accessed 1/7/20\\\\\\\\\\\\\\\]. Platforms to access further information about medicinal cannabis CanView: canview.com.au/ NSP MedicineWise: nps.org.au/ professionals/medicinal-cannabis- what-you-need-to-know RETAIL PHARMACY ASSISTANTS • AUG 2020