New regulatory approach to Schedule 8 cannabis medicines

Sammi: Good evening everybody and welcome to this evenings new regulatory approach to Schedule 8 cannabis medicines webinar. My name is Samantha and I will be your host for this evening. Before we start, I would like to make an Acknowledgement of Country. We recognise the traditional custodians of the land and sea on which we live and work and we pay our respects to Elders past and present.

So before we jump in I would just like to introduce our facilitator and presenters for this evening. So, our facilitator this evening is Dr Harry Nespolon. So, as I am sure most of you are aware Harry is the current President of the RACGP. He has also been a Quality Assurance Examiner for the OSCE component of the Fellowship Exams for over 10 years. And our presenters, Dr Jan Fizzell and presenter Judith Mackson. So Jan is a Public Health Physician working as a Medical Advisor in the Office of the Chief Health Officer at the New South Wales Ministry of Health. She has been working on facilitating the New South Wales Clinical Trials Program for medicinal cannabis and cannabis-derived products and assisting in cannabis therapeutic policy development in New South Wales. Jan also has a keen interest in health technology assessment and population-based screening programs. Thanks for joining us, Jan. And then onto Judith. So, as New South Wales Chief Pharmacist, Judith manages regulation of medicines and poisons with the administration of the Poisons and Therapeutic Goods Administration, and provides technical and policy advice to the health system. Judith’s professional interests encompass evidence-based health policy and medicines regulation, quality use of medicines, drug utilisation and health outcomes research, and clinical guideline implementation. So, thank you Harry, Jan and Judith for joining us this evening. I will now hand over to Harry to take us through our learning outcomes for this evening.

Harry: Good evening everyone. I hope this will be a very interesting new look at cannabis in New South Wales, especially with the recent changes. So by the end of this QI and CPD activity you should be able to identify the new requirements for authority to prescribe Schedule 8 cannabis medicines in New South Wales. List the group of patients for which approval from New South Wales Health must be sought to prescribe Schedule 8 cannabis medicines, discuss ethical and legal responsibilities and liabilities that apply to prescribers when using unregistered medicines with patients who are drug dependent or who are under 16 years of age, and as important is to source clinical support and advice when considering prescribing a cannabis medicine. I will now hand over to Jan.

Jan: Thanks. So, we have had some recent developments in regulation around cannabis medicines in New South Wales, so we would like to take you back through how you can access cannabis medicines. We will talk you through how we have changed the regulations. We will help you understand how you can apply for an authority to prescribe. We will also talk you through some prescribing considerations for patient groups. Also, some things that you need to know about prescriptions and dispensing and also where to get that clinical advice and information.

So all medical practitioners have the ability to legally prescribe a cannabis medicine for a patient if they believe it is an appropriate treatment option. And GPs are definitely people who are key to this. We really want to emphasise the fact that the patient’s current treating medical practitioner is the most appropriate person to prescribe for this patient. There is no pre-determined list of conditions. It is really between you and your patient and the evidence to work out whether this is something that is appropriate for this patient. And there are legal access pathways to unregistered medicines under the Therapeutic Goods Act. These are not exclusive to cannabis. They are for all unregistered medicines and they can be accessed through a clinical trial, through an Authorised Prescriber Scheme, through the Special Access Scheme which is the most common way for people accessing cannabis medicines and I would like to emphasise that the TGA does not charge to make an application to them for the Special Access Scheme, nor does New South Wales Health.

So we have a number of different cannabis medicines available for doctors to prescribe. There is one registered cannabis medicine in Australia and that is Sativex (nabiximols). It is the only one on the ARTG and it is registered for spasticity and multiple sclerosis. All the other cannabis medicines you can access are unregistered medicines so their use can be considered experimental. We do not have the same sorts of product information available that has been approved by a regulator that has looked at the safety and efficacy and different conditions or what side effects different people could get, or even good drug monographs telling us about the drug interactions. So it is really important that you get good advice about what you are prescribing to particular patients. They are not subsidised on the pharmaceutical benefits scheme, because one of the absolute prerequisites for getting onto the PBS is that it needs to be a registered medicine. We have found in the last 12 months that there are many different products coming to market and even for very similar products, the prices can vary significantly and also the amount that a pharmacy is going to charge a patient to handle that medicine can change significantly. So, these are things that we have very little influence over, but as doctors you can become informed by the Cannabis Medicines Advisory Service.

But given that putting an application in to get these medicines prescribed does mean that you are transmitting personal information for your patient, it is probably a good time to talk about potential costs with your patients before you share information on products. At the moment, there are typical medicines that could cost around $3 to $5 a day if treating someone on a standard dose for pain. But if you were using a medicine that has got a very high cannabidiol content such as we have used for kids with epilepsy, that can be as high as $130 to $150 a day. So it is a huge spectrum depending on what drug you are prescribing and then there are those on costs as I discussed. The other thing to be aware of, the number of cannabis companies that are supplying software to assist people in prescribing cannabis medicines. So again if you are transmitting your patient’s personal information, please be careful to ensure that your patient has given consent for their information to be shared that way.

And I will just give you an overview of the regulation amendment. So on the 30^th September this year there was an amendment to the Poisons and Therapeutic Goods Regulation. It means now that only a Therapeutic Goods Administration issues approval is required in most cases. So for most patients, the protections that are needed for you know, what are classed as high risk medicines in these categories is adequate through the TGA’s oversight. The new regulation in summary is that New South Wales Health authority is only needed when prescribing or supplying a Schedule 8 cannabis medicine that is to a drug dependent person for a clinical trial where it is an unregistered cannabis medicine, or to a child aged under 16 years, and in this case the 16 years is the legal definition.

So the Regulation Amendment in New South Wales alone does not affect the requirement for doctors to still need an approval from the Therapeutic Goods Administration to prescribe an unregistered cannabis medicine as opposed to a registered medicine. The TGA considers issues such the prescriber’s expertise, suitability of the medicine to treat the condition and the quality of the medicine. And hence they ask questions about those issues.

The application process itself has not changed itself as a result of the New South Wales Regulation Amendment. And we encourage that the TGA’s online system is used for Special Access Scheme applications as it offers a streamlined process. The TGA’s website is used to access that portal.

So again, the criteria, the particularly relevant criteria are prescribing or supplying for a drug dependent person requires an authority, and prescribing or supplying for a child aged under 16 years is particularly important. Authorities that were issued before the 30^th September remain valid. We have contacted doctors who had authorities in progress and should have dealt with them individually with you. And it is important to note that New South Wales Health authority is not needed to prescribe a Schedule 4 cannabis medicine which is essentially a cannabidiol only product.

So one of the things that people are often curious about is, well what is the definition of a drug dependent person? And we would point out in New South Wales, this is not just about cannabis medicines, it is actually about other Schedule 8 medicines. So this is not a rule for cannabis medicines that is different. This is about coordinating care to a vulnerable group of patients who are drug dependent. And so it is a legal definition. It is a person who has acquired an overpowering desire for the continued administration of a drug of addiction, or a prohibited drug as a result of repeated administration of that drug. So when people then say, so how do we define that? It is about that craving or strong desire to use the drug. It is that prioritising the drug use over other things that you would normally do in your life. There is a loss of control over the drug use such as using escalating doses of the drugs so that they can get the same effect. And it is that continued use despite harm or negative consequences.

One of the key groups that you can more readily identify are those people who are on the Opioid Treatment Program and they are considered to be drug dependent just because part of that qualification to be on that treatment program. And again, I would emphasise that this is not unique to cannabis. People who are using oxycodone, fentanyl or morphine, these are all drugs for which you need an authority to prescribe to a drug dependent person. And it is really important that we do not fragment people’s care, particularly people who are drug dependent because we do know that there are some people who are reading the literature about maybe this is going to help me wean my opiate use or maybe this is going to change things for me. And so it is really important that we do not send people off to get different care from somebody else and that all the prescribers are on the same page.

So the prescriptions for a registered or an unregistered Schedule 8 medicine does not need to bear a New South Wales Authority number. However if it is a compounded medicine, so that is something that the TGA has not actually always had a hand in. Judith, I am just looking at my colleague, Judith. They still require an authority and we see things like ketamine lozenges in the community and other things like that. They actually, if it is happening in the community, it requires an authority for that to occur. The Authority number is still required for some Schedule 8 medicines so that is things like psychostimulants used in the treatment of ADHD, so the requirement has not gone completely again, we are not treating cannabis very differently. Some Schedule 8 medicines do need it, some Schedule 8’s do not and if you are ever concerned it is easy to contact us to find out. And the prescribers need to specify all the usual requirements on a prescription for a Schedule 8 prescription. So that is the directions for use, the quantity in words and figures, the repeat intervals and only one item on a particular prescription. And that is to try and limit the opportunities for fraudulent behaviour. The really important thing is we are now starting to see computer generated prescriptions that can put out a prescription but it does not actually meet those requirements and some of them would be actually quite easy to alter from how it is generated. So you really must be careful to think about how your computer software is formatting your prescriptions. And again, as for anything that we do for our patients, we need to make a record of what we have prescribed, how we have prescribed it and what we expect to have happen.

So this is our service that the New South Wales has funded to help doctors. It is free, it is focussed on giving you information for your particular patient and it is evidence-based clinical advice. It is available to any practitioner in New South Wales, or anyone caring for a New South Wales patient. So if you are in the border areas you can certainly call them about people who are resident in New South Wales. It is available Monday to Friday 9 to 5. It has got an email address and a phone number. There is also a number of documents that you can access that can give you additional information. There is the TGA guidance documents which were written on the base of a significant evidence review. And then also, New South Wales Health has sponsored the NHMRC seat for the Australian Centre for Cannabinoid Clinical and Research Excellence and giving you some prescribing guidance which tends to combine the steps that you might have taken before you get to a cannabis medicine along with information about what is the evidence for the different cannabis medicines available for a particular health condition.

So some people are starting to ask about the opiate treatment program process, and so when somebody meets the definition of drug dependent we will check our records and we will find who the OTP prescriber is. If the OTP prescriber and a cannabis medicine prescriber are the same person, we assume they know what they are doing. However if there is more than one person starting to prescribe drugs of addiction for a particular patient, we will try and get the two different prescribers to come together to develop a treatment plan for that patient so that there is not a conflict in aims and goals of the two different prescribers. And the prescriber can always ring us to ask about patients who may be on the OTP if they are not sure.

Harry: And that is available quite readily. So if I ring up New South Wales Health Pharmaceutical Regulatory Unit with a patient in front of me, you can tell me whether they are on the OTP list or not.

Jan: Yes. So that is the easiest way to check, apart from having a patient who discloses. But you do not have to ring us about every patient by any stretch of the imagination, it is only the ones for whom you may have some concerns. So we basically, as I say, we wind up with a treatment plan for that patient and the authority will be issued.

So this is one of the types of scenarios that we have had here. So Doug who is 57 goes to his regular GP for his OTP requirements. He has been stable on methadone for a number of years but he has still got some very bad back pain from a work injury and he has been self-medicating with THC which he feels is helping his pain. He seeks advice from a GP who advertises as being willing to prescribe cannabis of part of a clinic, who has put in a request to prescribe for Doug. Now, because Doug meets the legal definition of a drug dependent person, the GP prescriber will need the authority to prescribe to Doug. And it is really important here that Doug’s usual treating team also knows that Doug is seeking this cannabis prescription because if we have not had that conversation between the different care givers, the person who is running this clinic may or may not know if that THC use has been of concern to the GP or has been part of a de-escalation process of opiates. So generally if an alternate prescriber wants to prescribe the cannabis medicine to Doug we will make sure that the OTP knows about it. If Doug’s OTP says, yes I know about it, I sent him over to that clinic, they have been good to him, no problems, your authority is likely to be granted. If his OTP prescriber is concerned however, we will keep having a chat to the doctor who wants to prescribe to Doug and sometimes that new prescriber if they are trained and ready to do OTP, they will take over Doug’s care and manage both issues. However, Doug’s OTP prescriber has worked with Doug regarding his pain and he has taken the responsibility for introducing the THC medicine with regular monitoring of progress and dosage. He has a care plan with his treatment target all across both programs. So we have got Doug being looked after by his usual carers and that is probably the best outcome for somebody like Doug.

Now, Maisie is a different kettle of fish. She is a 40-year-old lady who has been diagnosed with rheumatoid arthritis. She has just seen a rheumatologist, been commenced on methotrexate. Her rheumatologist has prescribed a non-steroidal anti-inflammatory to help with pain and morning stiffness. But she has come to you as her GP asking for a prescription for a cannabis medicine as she hopes that by using a more natural medicine, and this is something that is really important to a lot of people who are interested in cannabis medicines, they feel it is natural so it will not have side effects and it will not have problems. But what we have found it when the GP talks to Maisie, what is actually really worrying her, is actually that she has seen that the methotrexate is a chemotherapy agent and she is really scared about that and somebody else told her, did you not see that non-steroidal anti-inflammatory drugs can give you a heart attack? And so she is basically really worried about what is going on. So like all good GPs they looked after Maisie. They talked to her about methotrexate and that is a much lower dose for rheumatoid arthritis. They will keep looking at her for the side effects and they will try and wean her from the anti-inflammatory medicines as soon as it is appropriate. Maisie’s GP also looks at the literature which shows that cannabinoids may have a place in therapy for rheumatoid arthritis patients, but the evidence is weak.

Now Maisie is really at the beginning of her treatment journey, so this is probably not the time to add in any experimental treatment, and she has actually got quite a few lines of treatment to go before you want to be reaching for experimental treatment. And unlike some of the more modern therapies, biological agents we do not yet have good evidence that cannabinoids will actually modify disease activity in any way. And so her GP looks after her, talks through her current treatment and says that when the time comes we will talk about the cannabis medicine then. So it is not taken off the table it is just a reassurance that it is expensive, it is experimental and we have got other things for you first.

So, this is something that most GPs will not come into contact with, with the clinical trials although we are seeing some primary care clinical trials using cannabis medicines. So if it is a proper clinical trial with clinical trial notification to the TGA, you also need to get a clinical trial notification and an authority from us to prescribe. And there is a form that you can use directly from the New South Wales Health website, but also if your patients are asking you about clinical trials, we have seen some very loose terminology I think it is fair to say around cannabis medicine and what is a clinical trial and is it a clinical trial if I use the Special Access Scheme to treat one patient and record the outcomes? So if you wanted to know what are the clinical trials that have gone through an ethics committee and been registered through the normal process, you can always look at the Australian and New Zealand Clinical trials registry and also that is a place where if you have got a patient who is interested in what else can I do for my condition, it could help.

So again, this is not unique to cannabis medicines. Outside of health legislation there is also protections for children so that we do not have some of the things that may have happened in past years where children were exposed long term to benzodiazepines or other S8 medications without having a very good treatment plan and appropriate care. So we are working really hard to make sure that children who are being prescribed a cannabis medicine, that it is being done in a thoughtful manner and our colleagues over at the Department of Communities and Justice who were previously Families and Community Services, are responsible for having this legislation that protects children. So generally, when your application to treat a child comes through the TGA they will forward it to New South Wales Health if the date of birth indicates that the person is under the age of 16. We then write to the Secretary of FACS and say can you please approve this. It can take up to 21 days for that approval to come through, but it has been coming through much more rapidly, usually two weeks. So it is really important though that it is understood that is a necessary process because we know that there are a lot of people who are interested in the S4 and the S8 medicines for the intractable childhood epilepsies, managing behavioural symptoms of autism spectrum disorder, the behavioural symptoms of ADHD and Tourette’s syndrome. Now, we would say however that the evidence for use in many of these areas apart from childhood epilepsy is really very limited. It tends to be case series type evidence, very few randomised control trials have been reported.

We do need to make sure that there is care around the delta-9 THC in the kids because the THC containing medicines are the S8 medicines. I would say that there are a number of preparations out there which are S8 medicines because they have got the 1 mg of THS and 20 mg of cannabidiol. What can happen really rapidly though, is children can get exposed to quite a high dose of THC if they are being given the therapeutic dose of cannabidiol, so for epilepsy where we have got 20 mg a kilogram of cannabidiol you can very easily get up to that 30 mg of THC which is what we would expect an adult to have as a maximum each day. We also know that there has been concerns from free clinical and observational studies about THC development on the brain and we can see the day coming when there is going to be community concern similar to the dexamphetamine and ADHD type concerns. So we really need to make sure that as this drug which may be promising and may be helpful, does not become so restricted because people are concerned. So we want to make sure that the controls are similar to those for stimulants in the management of ADHD, however non-paediatricians have been able to prescribe the cannabis medicines at this time and our experience is that if there is an inadequate reason given on the application to the TGA about why a medicine might be used at this point, that there will be further questions asked by the Department of Communities and Justice.

So this is just to give you a couple of examples of how cannabis medicines may be used in children. So, Sally who is four years old has one of these terrible refractory epilepsy conditions and her parents would like to try cannabis medicine for her. She has been on many anti-epileptic drugs, a ketogenic diet. They have given her some control but she is still having regular drop seizures. So her paediatrician talking to her paediatric neurologist says okay to the parents, a cannabidiol medicine could be trialled. Her parents provide financial and informed consent and she is started on an escalating dose of cannabidiol. Now the really important part of the GP is to be part of this treatment triad between the paediatrician and neurologist and the GP where the GP can particularly monitor Sally’s liver function tests and discuss any issues around drug-drug interactions. So if the GP becomes concerned that she is much, much more drowsy than at any other encounter they have had previously, it is a good time to signal that there might be something going on. Now, because these are Schedule 4 medicines, we do not need a New South Wales authority or exemption but Sally’s GP cannot take over the prescribing without doing the same process through the Special Access Scheme through the TGA to become her primary prescriber. And if you would like some information around the clinical evidence for epilepsy, it is one of the best studies areas and the review is in the TGA guidance.

Lachlan is based on another case were we see often, where parents are coming to the end of their rope I guess trying to look after and care for a child with severe behavioural disorders connected to their autism spectrum disorder and his mum, despite all her best efforts of following all the advice, she is really worried for her personal safety and for Lachlan’s safety. They are living in a rural area. Some services you just cannot get to. And of course Grandma, because she loves Lachlan is saying look there are miracle changes being reported in the news. What can we do to help Lachlan? And so they have come to you as the GP seeking help and you as their rural GP has been the person who is looking after this family. You know this family well. So after talking to Lachlan’s paediatrician, getting advice from the Cannabis Medicines Advisory Service, the GP in this case was willing to prescribe and unregistered cannabis medicine that contained THC, because even though there are concerns about brain developments, it was also where the best evidence was that it would impact his behaviour. So the GP gave written and informed consent from Lachlan’s mother having explained risks, benefits, possible costs and written informed consent in this case because we are transmitting information and it is an experimental treatment that you have got for your child. The GP applied through the SAS portal of the TGA. That automatically gets sent through to New South Wales Health for us to process due to the S8 medicine and Lachlan’s age. And then we send it over to the Department of Communities and Justice.

So Communities and Justice make sure that Lachlan is not actually in care or a child of concern, and they can see that he has been well looked after by his GP, paediatrician, the justification for treating him with this medicine is clear, and so they issue the exemption. We send that on to the GP. TGA approval is provided by the TGA and the GP initiated the therapy along the dosing regimen described in an Israeli study. And so again that was a case series but I know that when we have very little in the way of evidence, a case series might be the best thing we have to hang our hat on at the moment. And also they talked about what the family could expect to see as far as behavioural change. What was acceptable?

So, one of the things that is coming up now that we are seeing, often cannabis medicine companies sponsor cannabis clinics setting up. Now the GPs within those clinics are making their own decisions about what they prescribe but it should be you know, said that there are vested interests sometimes behind the provision of these clinics. And it is really important to know that we really are encouraging people to think very carefully about where we are referring people and if you as a GP do not want to prescribe a medicine, being really clear about what that reason is, because we are also hearing reasons that we are hoping to address tonight, like it costs too much money to apply to the TGA. It costs nothing as far as monetarily goes, but of course it costs time and effort and energy to apply to the TGA. People are concerned that if they prescribe a cannabis medicine for one patient they will then be the cannabis doctor for everybody. So there are lots of really appropriate reasons sometimes, or sometimes you could really say to somebody, the evidence is just not good. The clinical guidance is that this is not the right next step for you. But it is really important to be quite honest in why that is happening. So, if you are looking after a patient in a hospital, you do not need a new authority to keep prescribing to that patient in hospital. If however that patient leaves the hospital and you are going to take over and write a prescription you will need a new authority from the TGA.

So this is not an unusual situation in many places where somebody is providing palliative care for somebody with metastatic breast cancer and she is having her terminal care at a local health facility. The palliative care specialist has commenced and added a cannabis medicine to her medications to help with symptom control. She has found that it helps her sleep and manage her pain and talking to the local health district Drugs and Therapeutics Committee which is a government step with in a New South Wales health facility. Barbara’s GP VMO can continue to prescribe that medicine while she is an inpatient including the dose adjustment and the hospital will generally use Barbara’s own medication at this point. So the only time the GP would need to apply to the TGA is if they wanted to change the product, so say Barbara was on a low THC high cannabidiol product but they wanted to alter the amount of different things, that is when we would need to get a new application through to the TGA, through the Special Access Scheme. But also, if she is admitted to hospital and you feel very strongly that it may not be helping her, it might not be the right thing, it is really important to have that conversation with Barbara or her family if Barbara is not able to have that conversation, about why you do not want to keep prescribing the medicine. And again, it just needs that honest conversation. And if Barbara’s GP needs assistance in managing the cannabis medicine because they are feeling uncertain for themselves, that is what the Cannabis Medicines Advisory Service is there to help with. Or again, Barbara’s palliative care specialist who started the medicine in the first place.

One of the things that we get in correspondence quite a lot is patients being told that they need to be referred to a special cannabis clinic. That is not true. It is really important that their usual practitioners are looking after them. We would say that we know that these are not always staffed with experts. They are not always GPs, they are not always specialists in the diseases and some of them will only consult by Telehealth. So, again it comes back to that good medical practice obligation we have were we take reasonable steps to ensure that the people we delegate to or refer to or hand over, have the qualifications, experience, knowledge and skills to provide the care required. And it is a huge difference across the different clinics with how they are staffed, what their model of care is. So, if a patient comes to you with a piece of paper saying I want to be off to a cannabis clinic, please do remember that the TGA is actually relying on you as their GP to be providing that ongoing care and they will say that I am consulting with the GP about this patient’s care. So you need to be comfortable that the person you are consulting with is a person that you are willing to keep working with. The other thing is, that the cannabis clinics can also be a source of employment. So please, if you are going to go and work in a cannabis clinic, do make sure you know about the entire breadth of products available and make treatment and product recommendations based on your best clinical judgement. It is just common good medical practice but it is really important.

So, where to get help? So, if you are a medical practitioner and you would like to know about using a cannabis medicine to treat your patient, the New South Wales Cannabis Medicines Advisory Service is there to help you through those clinical steps, the different medicines and even some of the pricing information that they have been able to obtain from suppliers. If you want to know about the whole authority process, you have got a child you want to prescribe to, you have got a patient that you think is on the OTP, the Pharmaceutical Regulatory Unit is there to help. And there is a whole website where we have got most of this information available to you.

I think that is us back at the learning outcomes.

Harry: So we might just take a few questions now. If we go back to Maisie, if the GP or even the specialist applied for some medicinal cannabis, given that she had not gone through all the therapeutic steps, would she have gotten an authority?

Jan: Quite probably from the TGA. They would have said you and the specialist together have consulted, you have thought about what the next step on this patient’s treatment journey is. And so they are not going to second guess the clinical team who are looking after her, and so that is a reasonable thing.

Harry: One of the common questions is, can someone drive when they are taking medicinal cannabis?

Jan: And this is one of the ages at the moment unfortunately. So one of the problems for people taking any drug that can cause impairment is that it is actually illegal to drive while you are impaired. So it does not matter whether you have taken morphine, amitriptyline, Phenergan over the counter from the chemist. If you drive while you are impaired by that drug it is actually unlawful, and you will have trouble with your insurance. The difference is, for cannabis people will actually test you at the roadside, and there is an assumption that at the level that you can have the cannabinoid detected in the saliva, it is likely that you will be impaired. So whilst it is a presence offence like any other test, you actually have to get over a particular threshold for the test to be positive. And the advice that we have had from experts and the advice may change, but at the moment the advice we have had from experts is, the therapeutic range in people’s blood when they are finding that a drug is helpful, and the level at which the swab test is being done overlap significantly. So it is really hard for us to make a good argument that it is safe for somebody on a cannabis medicine. We also have information that you are less likely to habituate to the effects of a cannabis medicine. So that is good because you are not escalating the dose constantly like you might do with an opioid, but at the same time you are not getting any better at driving. So this is one of the problems that we are still learning and still finding out about with cannabis medicines and we are constantly talking to experts in the field to give us advice so that we can move forward.

Harry: So the follow up question is, so if they are on a CBD only drug, if there is or a combination, does that get them past the THC test on the side of the road?

Jan: So the answer is, if you go on cannabidiol and you are impaired, you might not get picked up by the side of the road, but you have still got a problem, but you will not get picked up. Assuming you are taking a cannabidiol only Schedule 4 medicine. And when I say that, some people are importing questionably, cannabidiol products from overseas where you can go into a shop and buy them. Now the problem is, the ones overseas are not quality controlled. The FDA every year put out a whole lot of warnings about things that you have brought from the American States for example, some of which have high levels of THC, some of which have got very little CBD so you are just buying very expensive olive oil. So unless it is a product that has actually been batch tested by the TGA, a cannabidiol that is a Schedule 4 medicine, I would be really careful about what I did with any cannabinoid that I bought.

Harry: Now the other regular question is about do, well the question is, does illicit cannabinoids cause schizophrenia? Do we know anything about medicinal cannabinoids and schizophrenia because I actually was at a talk last week and the answer was, it is a bit of a catch 22. People who are likely to be along that journey of schizophrenia are more likely to be using cannabinoids from a variety of sources, so whether that actually brings out schizophrenia in that group or not is open to debate. But do we have any evidence one way or the other?

Jan: So if we look at the Nabiximols product information, we know that when we escalate to a certain dose more and more people have a psychosis. So they are not schizophrenic, they are having a temporary psychosis. But how often that happens, how often that happens when a dose has been carefully escalated I am not sure. But the other thing is, in mouse models of schizophrenia, we know that cannabidiol for example helps ameliorate some of the disturbing behaviour and we are starting to see early studies, so we have not got good evidence, but we are starting to hope that some of the cannabinoids may actually moderate some of those effects. But are we there to hand out cannabidiol in every psych ward in Australia? Absolutely not.

Judith: And the other challenge is because with the unregistered products, they have not been subjected to any trials in humans at all, and certainly long term studies. We do not actually know what happens in cohorts of patients who are using the unregistered medicines so it is also highly uncertain.

Harry: So one of the questions here is, can you just ring the TGA or do you have to apply online?

Jan: Sadly the TGA do not have a prescription express. They made a huge concession to the 21^st Century by going online and the online is available.

Harry: And just to be crystal clear, you just cannot write a “private script” for medicinal cannabinoids, you do need to still apply through the TGA to get an authority to supply the S8 drug.

Jan: Yes, here in Australia.

Harry: Alright. I think that covers most of the sort of general questions. Sam.

Sammi: We might give a couple of minutes for participants if they have got any more questions that we have not yet gotten to. There is one that has come through about jurisdiction restrictions, travelling interstate with cannabis, how that may?

Jan: So, crossing borders, not a problem with cannabis that has been lawfully prescribed in Australia. Travelling overseas is a whole different kettle of fish because unlike opiates which you would still be very careful about some of the countries that you travel with your prescribed opiates with your prescription with your doctor’s letter, because the status of cannabis medicines are different in different locations I would be enquiring with the embassy of the country to which you wish to travel before you left Australia with it. Similarly, being able to bring cannabis into Australia is a very tricky proposition. We are a bit restricted by international conventions around this, so if you got a whole lot of cannabis prescribed on Venice Beach and tried to bring it back, because it has actually not been lawfully prescribed and dispensed in the United States of America, it has just been lawfully authorised and sold to you as opposed to there you would not be able to bring it back. However, if you had had your cannabis medicine lawfully prescribed and dispensed in say Germany where they have a similar system to us, my understanding is, assuming you could fly straight from Germany, which I do not think Qantas has managed yet, so we have got the intermediary countries where it could be a problem, I understand you could have that. But that is only that supply for that very short period of time.

Judith: And patients and their doctors can find some information on the Commonwealth Office of Drug Control website and also on the New South Wales Health Ministry of Health website, as far as we can give the advice. Although as Jan said, the problem is that it is the laws of another country.

Harry: Talking about another country. Let us talk about Victoria, is one of the questions. I gather that in Victoria you still need your State Department’s authority before you can prescribe a drug, so dual regulation, so the TGA and Victorian.

Jan: They have got the streamlined process as well in Victoria where you only apply to the TGA and then I am really sorry, not being a Victorian bureaucrat I cannot talk so much with their information. But they have a similar, they have got a medicinal cannabis unit in the Victorian Department of Health and if you seek information about what you need to know in Victoria from there, it is generally either in the Chief Pharmacist Unit or a Medicinal Cannabis Unit in most states and territories to assist you.

Harry: So I have learnt something tonight. I thought it was only in New South Wales being progressive when it came to cannabinoid prescribing. So we are getting a few questions about different states. I think it probably be better that people spoke to their local.

Jan: Absolutely. Most Department of Health websites in the different jurisdictions have got clear information for you about the processes. So I would really encourage you, just google cannabis medicine Queensland Department of Health, cannabis medicine Western Australia Department of Health, and hopefully you will get to the right people.

Harry: And we might make this the last question. It is about palliative care. The doctor asks if a patient has got severe pain in palliative care, do they still need to go through the TGA to prescribe?

Judith: Yes. If it is an unregistered medicine, yes. The other pathway is called the Special Access Scheme category A, but it is only available when you import the product, so it is an unhelpful pathway to give in palliative care because it is a more difficult process. So yes. And with the streamlined application process through the portal, it really is relatively straight forward. So it is a delay but it is not a particular delay and I know the TGA are very responsive that if there is a particular urgency, they have been very responsive is my understanding.

Harry: I have heard that they will give authority within hours usually.

Judith: Absolutely.

Harry: And I guess the last question is, do we know what the state of the industry is in Australia at the moment? I hear that there are a few companies that are producing Australian cannabinoids. Do we know about that?

Jan: So my understanding is there are Australian companies that are producing cannabinoids and are producing them in standard formats and they are drugs that people are accessing through Special Access Scheme category B. They have got the same processes and quality control as the overseas imported medicines. And I think, as I say, it is not like you can pick up a TGA regulator approved product information sheet. So it is about really understanding what you are prescribing and being ready to understand that because cannabinoids get absorbed differently from person to person, some people are more sensitive. It is like any other medicine. It is just that we do not have our nice product monograph to go back to, to help us when something has gone a little bit different and I was very sorry to people in our other states, in New South Wales you can ring the Cannabis Medicines Advisory Service if you have concerns.

Harry: Okay.

Sammi: There is actually one more question that just came through Jan regarding the TGA website and going between that and New South Wales Health. I do not know how familiar you are with sites and assuming you probably work with them quite often, whether you can offer any guidance about navigation.

Jan: So once you have registered with the TGA portal which I can understand any new registration process can be a struggle. But once you are registered, the difference is once you are in there and once you have prescribed once, it makes it much easier for you to prescribe again, particularly if you are prescribing for the same patient or if you prescribing for a different patient with a similar condition. So, my understanding from people who have used the portal, I have to say I am sorry I am a public health physician so I am the last person who should be prescribing cannabis medicines, but my understanding is from the palliative care specialists I have spoken to and some of the GPs who have worked with the system, is once you are in the system it is not hard to use. But getting in, and I take your point, we will try our best.

Sammi: Great. So that does wrap us up for this evening. I would like to thank Jan, Judith and Harry for joining us tonight. Thank you very much everybody for joining us and enjoy the rest of your evening.