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Access to Medicinal Cannabis in Australia for Patients

Access to Medicinal Cannabis in Australia for Patients: Regulations Around Prescribing

Medicinal cannabis has been legal to prescribe in Australia since 2016. Recreational use of cannabis is still illegal in Australia. Medicinal cannabis products are considered ‘unapproved medicines’ by the Therapeutic Goods Administration (TGA), the government body that regulates medicines and complementary medicines. Thus, whilst it is legal to have medicinal cannabis prescribed, it’s not simply a matter of going into your local general practitioner and asking for a prescription. This article will discuss the regulations around prescribing of medicinal cannabis in Australia and how patients are able to access medicinal cannabis legally.

Regulations around access to medicinal cannabis for patients

Access to medicinal cannabis has been legal in Australia since 2016. This means that it is legal for particular medicinal cannabis products, imported or manufactured by companies with appropriate licenses to do so, to be prescribed by a medical practitioner. It is not legal for you to grow your own plants for personal use in your backyard. It is not legal to buy cannabis from anyone, regardless of whether it’s for medicinal reasons, unless it is prescribed by a medical practitioner through one of the Therapeutic Goods Administration’s Schemes. Here is where it gets complicated.

Medicinal cannabis is treated as a pharmaceutical rather than a herbal medicine by the TGA, and products are also considered ‘unapproved medicines’. As a result, there is a complex prescribing process that must be followed (discussed later). Two of the main constituents of the plant Cannabis Sativa (cannabis) are tetrahydrocannabinol (THC) and cannabidiol (CBD). These are both types of ‘phytocannabinoids’ (‘phyto’ meaning ‘plant’), phytocannabinoids being one of the main categories of active constituents in the plant. THC has potentially intoxicating effects that are dose dependent. CBD does not have such intoxicating effects. THC is contained in Schedule 8 (Controlled Drugs) and CBD is contained in Schedule 4 (Prescription Only medicines) of the national Standard for the Uniform Scheduling of Drugs and Poisons (SUSMP). The SUSMP is the national drugs and poisons code, and the schedules are categories with specific criteria around access- the higher the number, the more restrictions are placed on access, in order to protect public health. The entries of the SUSMP are generally adopted into state and territory drugs and poisons codes and lists because access to drugs and poisons is controlled by state and territory legislation. By including THC and CBD, the main constituents of medicinal cannabis products, in the SUSMP, this automatically restricts access to consumers by requiring them to go to a medical practitioner. You cannot buy CBD products over the counter, unlike in Europe, Canada and some states in the US.

Doctors must first gain approval to prescribe medicinal cannabis for patients

Because medicinal cannabis is considered an ‘unapproved medicine’ by the TGA, the doctor must gain approval from the TGA to prescribe it. There are two main TGA schemes by which a doctor may gain approval to prescribe medicinal cannabis products to a patient: the Special Access Scheme-B (SAS-B) and the Authorised Prescriber (AP) Scheme (there is also an SAS-A scheme for end of life prescribing when death is imminent). Under the SAS-B, the doctor applies to prescribe a specific medicinal cannabis product for that particular patient, typically via an online form on the TGA website. If they want to prescribe a Schedule 8 medicinal cannabis product (which is any product containing THC or a CBD product where CBD constitutes less than 98% of the total cannabinoids), they must also apply to their state/territory health department for permission (since drugs and poisons legislation is state-based in Australia). Thankfully, the TGA online application form now goes to both the TGA and the state/territory health department (except for Tasmania), cutting down on paperwork for doctors.

Under the Authorised Prescriber Scheme, the doctor applies for permission to prescribe specific medicinal cannabis products for particular medical condition(s). This means that once approved to prescribe for a particular condition, they don’t have to apply to the TGA for each new patient with that particular condition. However, if they are going to prescribe a Schedule 8 product, then they still must apply to their state and territory health department for approval for that particular patient. The AP process is very time consuming for doctors- they must be first be approved by an ethics committee or specialist college, then once approved there, apply to the TGA for final approval.

To make matters a bit more difficult, the type of doctor who can prescribe medicinal cannabis varies from state to state in Australia. In Tasmania, for example, only specialists may prescribe it. In other states and territories, general practitioners may prescribe it, though in some, they may need a specialist to support the application.

Are many doctors prescribing medicinal cannabis?

As of the end of April 2019, the TGA has approved more than 6300 SAS-B applications for medicinal cannabis. This figure does not mean 6300 patients though, as each time a new prescription for the same patient is written, it requires another SAS-B form to be completed. It is not known how many patients this figure actually represents. As of the end of April 2019, there were 57 authorised prescribers approved by the TGA.

Why aren’t there more doctors prescribing medicinal cannabis?

There are not many doctors prescribing medicinal cannabis at this point in time (however the good news is that the number of SAS-B applications is increasing). This is likely to simply be due to lack of knowledge about medicinal cannabis, its evidence-base (that is, scientific evidence that it is effective), how to prescribe it, and the fact that it’s only been legal to prescribe since 2016.

Medicinal cannabis products are also different to standard pharmaceuticals, and this might be a factor. Most medicinal cannabis products available legally in Australia are in the form of oils in bottles and prescribing must be individualised to the patient (a concept familiar to herbalists). Most are whole plant extracts or extracts of CBD and/or THC, often blended together in various ratios. In my opinion, these are clearly herbal medicines. There are synthetic cannabis products on the market also- synthetic copies of single molecules of the main phytocannabinoids. These have the advantage of a high degree of reproducibility, though whether they are more or less efficacious than a whole plant medicine remains to be seen. These are clearly pharmaceuticals. There are over 500 chemical constituents in the cannabis plant, and THC and CBD are only two of phytocannabinoids isolated from the plant. There are also at least 140 terpenes, which give the oil its characteristic smell and these also have therapeutic properties. It is believed that these constituents of the plant work in synergy to create a therapeutic effect beyond the effect created by just one constituent.

The TGA does not consider medicinal cannabis products as a first-line therapy and states this clearly on its website. This means there is an expectation that other approved medicines will have been tried first. Incidentally, this is not something this author agrees with- it is the right of the consumer to be able to choose how they want to address their health issues, ideally in consultation with their healthcare practitioner.

Education and dispelling myths

There are many myths around about cannabis, and that is unfortunate as many are simply not true. There is quite a lot of scientific evidence about how cannabis works, its effects in the body and its effectiveness in a range of conditions. In other conditions, more evidence is needed. Education about medicinal cannabis is crucial in dispelling some of these inaccurate ideas, and empowering both doctors and patients. The not-for-profit organization Global Health Initiative, of which the author is CEO, is presenting its first conference on medicinal cannabis and mental health for practitioners in July 2019. It will also be developing online courses for healthcare practitioners as well as the public in the near future, and it has begun a Medicinal Cannabis Practitioner Register so that patients will be able to find a practitioner quickly.

How can I get access to medicinal cannabis products as a patient with endometriosis?

If you, as a patient, are considering if medicinal cannabis could be helpful for your endometriosis symptoms, you need to find a practitioner who is knowledgeable in medicinal cannabis and is happy to prescribe it. Black market sources are definitely not recommended – you have no real knowledge of what you could be getting and there is no quality control. That’s what the TGA does very well in Australia- quality control of medicines and complementary medicines in order to protect the public.

Your doctor will discuss whether medicinal cannabis might be suitable for you or not. The TGA make it very clear that medicinal cannabis is not a ‘first-line therapy’ meaning that other treatment options should have been tried first. If you and your doctor decide that medicinal cannabis is appropriate for you to try, then she/he will either apply to prescribe it via the SAS-B Scheme (which has a turnaround time of within 48 hours) or if they are an authorised prescriber already, they will write a prescription. However, if it is a Schedule 8 product, they need to apply to their state/territory health department for permission to prescribe it. Once you get the prescription, you take it to the pharmacist who then contacts the supplier of the medicinal cannabis product and it will be couriered to the pharmacy. You are then able to collect it. Pharmacies do not keep stock of medicinal cannabis products (in general).

A last thing to remember- in Australia, if you have any amount of THC in your body, and you are pulled over for a drug-driving test and test positive for THC, regardless of whether or not you are impaired by it, you have committed an offence under our driving laws. It doesn’t matter if you have a prescription for the medicinal cannabis product or not- you will be prosecuted under our laws. In Canada where recreational use of cannabis has been legalized in 2018, it is only an offence to drive with THC in your system if you are impaired by it. It is my opinion that our laws need to be changed.

By Professor Kylie O’Brien PhD,

Adjunct Professor at Torrens University. She is CEO of the Global Health Initiative, a not-for-profit organisation focused on medicinal cannabis education and research. She also conducts consultancy work with medicinal cannabis companies. 

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Australia’s first glimpse into the prevalence of self-reported endometriosis diagnosis

Australia’s first glimpse into the prevalence of self-reported endometriosis diagnosis

Recently, Australian researchers from Endeavour College of Natural Health and the Australian Centre for Complementary and Integrative Medicine, at the University of Technology Sydney, published a research study on the prevalence rates of self-reported diagnosed endometriosis in the Australian population. This study is the first glimpse into the self-reported prevalence rates of endometriosis in the Australian community and highlights a significant need for more research in this area, particularly with reference to the challengers associated with diagnosis. As many women experience, receiving a diagnosis can require various difficulties including “doctor shopping”, limited access for referrals to gynaecologiststreatment and surgical costs, waiting periods of laparoscopic diagnosis, and inadequate educational resources for women and medical professionals in context of understanding the characteristics of normal and abnormal presentations of menstruation. Without addressing these factors, among others, the prevalence rate of endometriosis in Australia will continue to be hindered.  

Previous studies have identified an estimated prevalence rate of approximately 560,000 of Australian women are diagnosed with endometriosis, which aligns with another study that reported a 3.7% prevalence rate. This study identified a rate of 3.4% of women of reproductive age in Australia are diagnosed with endometriosis. These reports align with the estimated global prevalence of 4.8% that was reported in 2015. Additionally, as reported in the 2015 study, as prevalence rates rise, as does the cost to women’s out of pocket expenses and cost to the health care system, as recently highlighted in a news article stating that as much as 20% could be increased to standard medical treatments for endometriosis.  

Receiving an accurate prevalence rate of endometriosis is not without its own difficulties. Firstly, to receive diagnosis women are required to undergo a costly surgical procedure – laparoscopic surgery, being the gold standard for diagnosis. However, there are barriers that are causing women to not be able to receive a correct diagnosis such as cost, waiting periods etc. Additionally, due to these factors, some women may receive a verbal confirmation of diagnosis from their medical professionals, purely based on presentation of their symptoms. This however, leads to over diagnosis and not an accurate presentation of the disease in Australia.  

It is hoped, that with continued research focus on the prevalence rates of endometriosis, policy makers will have a greater understanding of this disease and the burden it can have on women’s lives, the health care system, and the economy. Within the Australian context a movement has begun with the launch of Australian Coalition for Endometriosis (ACE) and the development of the National Action Plan for Endometriosis. While this movement is in its infancy, the more research and government attention this disease can draw upon, the more accurate rates of prevalence, alternative routes for diagnosis, and supportive treatment regimens can be developed to assist women living with this disease. 

By Rebecca Reid 

Associate Director Research, Office of Research, Endeavour College of Natural Health
PhD (candidate), University of Technology Sydney
Fellow, International Naturopathy Research Leadership Program, ARCCIM, University of Technology Sydney

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Five ways to take control, endometriosis the disease that has no cure

Five ways to take control, endometriosis the disease that has no cure

Support For Endo

Tip #1:
Don’t take no for an answer, you know your body more than anyone else. If a doctor tells you nothing is showing up on the ultrasound but you know in your gut something is wrong push for a diagnosis.

Tip #2:
You are not broken, having a disease shared with many women means that you also have a voice and can help others out.

Tip #3:
Period underwear, if you haven’t tried them yet they are amazing. Go completely Zero Waste and couple it with a Diva Cup or something similar.

Tip #4:
Treat your health like you would bad service at a restaurant, keep going higher up till you get the answers you need. If the GP and lab techs don’t know what they are dealing with see a specialist in the field.

Tip #5:
Use Endo as a motivator to improve your overall health. Eat a balanced diet, find ways to exercise and relax that you enjoy.

Stay in Touch

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Is Endometriosis A Chronic Disease?

Is endometriosis a chronic disease?

For someone who has been diagnosed with the condition, who continues to experience ongoing symptoms, the answer might seem rather obvious given the physical, social and psychosocial effects of this disease. Endometriosis is a condition where tissue similar to the lining of the uterus is found in places outside of the uterus, which can result in pain and adhesions. Symptoms of endometriosis may include: pain with periods, pain with intercourse, bladder and bowel symptoms, chronic pelvic pain, infertility or subfertility and fatigue. The gold standard for diagnosis is laparoscopy and at present, there is no cure. 

The study published in the Australian Health Review examined the definition of chronic disease within Australian policy documents. The core definitional elements of chronic disease included onset, causation, duration, treatment, disease course and impact (individual and societal).

When these elements were examined within the endometriosis context using peer-reviewed research and clinical practice guidelines it was found that endometriosis met five out of the six criteria. There was insufficient information regarding whether endometriosis was consistent with the ‘onset’ element of chronic disease.  

Whilst there are many theories about the cause of endometriosis none of these have been entirely proven although it is considered to be multifactorial, which is consistent with definitions of chronic disease. Additionally, chronic diseases are defined as long-term and persistent requiring ongoing management, which satisfies the duration and treatment elements of chronic disease definitions. There is currently no cure for endometriosis so people experiencing ongoing symptoms often seek long-term treatment to manage the symptoms of endometriosis (e.g. surgery, pain medications, hormonal treatments or complementary and alternative treatments). The condition may have significant impacts on the individual’s work, family and social life due to the varying symptoms that they may experience.  

As part of this study, the researchers from Monash University examined the four clinical practice guidelines that were available for use in Australia. Only one of these guidelines labelled endometriosis as a chronic disease. However, given that endometriosis meets most of the elements of chronic disease, the researchers argue that it would be useful to reframe endometriosis as a chronic disease in clinical practice guidelines, policy documents and information sources about the disease. 

Why does it matter what we call it? 

Language is important in how individuals and others identify with a concept. If someone mentions they have diabetes most people have heard of the condition and identify it is a long-term, chronic condition. When presenting to a health care provider diabetes is acknowledged as a chronic condition and the GP may prepare a chronic disease management plan or team care arrangement to assist with the management of this condition. These plans are mechanisms within the Australian medical system which provide for care coordination for this person with chronic disease. Additionally, a team care arrangement provides access to subsidised multidisciplinary care e.g. allied health services such as physiotherapy, diabetes education, podiatry, exercise physiologists.  

Reframing endometriosis as a chronic condition may assist practitioners to work with the patient to manage any ongoing symptoms. Any condition that lasts longer or is expected to last longer than six months that the GP feels would benefit from a multidisciplinary approach is eligible for a chronic disease management plan and team care arrangement. This may be useful for individuals who have endometriosis that are experiencing ongoing symptoms to access additional support services (e.g pelvic physiotherapy, psychology).  

As there is no cure for endometriosis and it can remain symptomatic despite medical intervention, it is important that it is recognised as a chronic disease. Awareness is slowly improving and the conversation is becoming more mainstream thanks to the efforts of advocacy groups and associations in Australia (e.g Australian Coalition of Endometriosis – ACE), researchers, media, personalities and individuals speaking about the disease. The launch of the National Action Plan for Endometriosis acknowledges the chronic nature of endometriosis. Minister Greg Hunt in a speech at the launch of the plan highlighted that individuals ‘should feel free to talk about this in the way that anybody might talk about a knee injury’. Therefore, reframing endometriosis as a chronic disease may assist with raising awareness, management in the health care system and provide further acknowledgement to individuals with the disease.

By Beck O’Hara
Endometriosis researcher | Health research and evaluation