Taking the right path


At a crossroads: medicinal cannabis or opioids?

As new laws regarding the prescribing, dispensing and cultivation of medicinal cannabis come into play, pharmacists have an essential role in ensuring patients receive the right advice

Since legislative changes were introduced in 2016, there has been a steady interest and growing awareness of the potential benefits of medicinal cannabis to treat an array of medical conditions.

Despina Lord, Bod Australia head of Market Access, tells the AJP, “Chronic pain makes up about 50% of the total prescriptions of our pharmaceutical grade medicinal cannabis, MediCabilis, with seizure management being the next most common prescription.

“The prescriptions for this product have steadily increased each month, growing at about 117% on average.”

Lord says that the Therapeutic Goods Administration’s (TGA’s) online Special Access Scheme approval portal is making it much easier for doctors to apply for approval to prescribe unapproved medicinal cannabis.

“Doctors are reporting that the TGA is reviewing applications and responding quickly, sometimes within hours. Some state health authorities have also made it easier by removing the need for the doctor to get TGA and state health authority approvals. However, most states still require state health authority approval for paediatric prescriptions, and in some cases for S8 medicines.”

Challenges in the supply chain

Community pharmacist Sami Isaac says that it’s not the prescribing process that’s the issue with medicinal cannabis; it’s the actual supply process that is the problem.

“The laws are in place to ensure that if a doctor can verify that a patient needs medicinal cannabis the special access can be applied for and approved by the TGA (so long as the patient meets the criteria).

“The issue is the supply process. If we had started cultivating cannabis for medicinal purposes in Australia prior to the legislation being put in place, that might have put us in a better place with regards to the supply chain.

“Essentially, how it works is that the patient seeks the advice of a trained specialist, the doctor then applies for a TGA approval. Once TGA approval is received, the doctor is provided with a letter, which they can hand to the patient and that grants them access to a valid prescription.

“The patient takes the script to the pharmacy and requests the medication in the same way they would with any S8 medication. However, the pharmacy then has to hold the TGA approval and apply through the manufacturer (in some cases the doctor will specify a certain brand) to have the product imported.

“It’s a very lengthy process. The other issue that myself and my colleagues notice in practice is that it’s still a private prescription that cannot be covered through the PBS, which leaves patients out of pocket.

“Additionally, the issue of the sponsorship and going through the Special Access Scheme is quite difficult and the pharmacy doesn’t get reimbursed very much.

“What’s more, there are instances where the doctor has advised the patient how much the product will cost, but they don’t take into account the processes and the administration fees the pharmacist has to pay in order to be a sponsor.

“This is where remuneration needs to come into play and the cultivation we’re currently seeing in Australia needs to be fast tracked. We need to be able to cultivate and provide adequate supply at a PBS cost,” says Isaac.

While the Medicinal Cannabis Medicines Portal has helped to streamline the process and support healthcare practitioners who have registered to prescribe or dispense medicinal cannabis, issues seem to lie with the structure of the supply chain.

Isaac explains, “Let’s just say the doctor prescribes a different cannabis product. To access it you have to contact the supplier itself. The supplier could be in Canada, the US or Europe, which can make it difficult. If it’s not the same consistent companies that we’re contacting it becomes quite difficult and certainly time consuming to add them to the system in the first instance. As a result, the efficiency is lost.

“While if it was through the PBS, if it was an Australian-based TGA-approved product or if we were only dealing with one product, I feel it would streamline things; not only for the patient, but for the doctor and pharmacist too. There would be fewer issues with regards to trying to obtain access and sponsorship.”

He adds, “In cases where you have a patient who needs the medicine for a terminal illness or to help with MS-associated muscle spasticity, not being able to tell your patient honestly when the supply will come in is difficult.

“The human connection is lost and you don’t want to lose rapport with people you’ve been serving for years. This is where I feel it’s a very complex problem.

“Certainly, the study I did back in 2016 showed that pharmacists are open to partaking in medicinal cannabis, just as long as all the measures are in place to make sure it is streamlined and standardised.”

Cannabis uses and side effects

“There are a number of knowledge gaps among Australian healthcare professionals, including pharmacists, which is understandable given it is a new medicine with emerging evidence,” says Lord.

“There is also variance in quality, cannabinoid potency, stability and so on. Medicinal cannabis is a broad term that covers many different medicine presentations. Each medicinal cannabis medicine needs to be individually assessed to determine its suitability.

“Medicinal cannabis is recognised as a suitable medicine for Multiple Sclerosis, with a medicine currently available (Nabiximols) as a Registered Medicine with the TGA. The TGA has also approved the use of medicinal cannabis for a range of treatment resistant conditions including palliative care, neuropathic pain, anxiety, autism and PTSD.

“As more research emerges we are able to understand the pharmacology more and look for relevant clinical applications, for example a research review published in 2019 showed medicinal cannabis may have a role in managing neuro-inflammation.”

Indeed, in October last year the Australian Government announced it will be investing $3 million towards examining the wider benefits of medicinal cannabis.

While the outcome of such studies will assist healthcare professionals, particularly prescribers, more information is needed on the doses required and adverse effects.

According to the TGA, the side effects of medicinal cannabis may include:

  • fatigue and sedation;
  • vertigo;
  • nausea and vomiting;
  • fever;
  • appetite increase or decrease;
  • dry mouth;
  • diarrhoea;
  • convulsions;
  • feelings of euphoria (intense happiness) or depression;
  • confusion;
  • hallucinations or paranoid delusions; and
  • psychosis or cognitive distortion (having untrue thoughts)

Lord explains, “Medicinal cannabis works on a system within the body called ‘the endocannabinoid system’ found throughout the body. The hypothesis is that medicinal cannabis helps support equilibrium with other body systems, helping to regulate dysfunction. However, more research will help demonstrate and explain how medicinal cannabis works.”

She adds, “Dr Google’ isn’t a reputable source of factual information, and cannabinoids have been touted as a ‘cure-all’, which is not true. A patient may see this information and gain false hope, and may even turn to ‘recreational’ cannabis or buy offshore in the hope they get the cure they are looking for. It is important patients understand the potential dangers in these actions.”

Isaac says, “It’s frightening that it’s often easier to access cannabis using illegal routes. However, it’s not a product that has been verified to ensure it contains the components the person needs.

“Cannabis has multiple different cannabinoids in it and to try and extract the one that works is very hard, particularly in a black market.”

Counselling role

Certainly, the current lack of information — combined with the increased public interest — means that pharmacists have an important role as the main conduit between the doctor, the supplier and the patient.

There’s no doubt that pharmacists play a vital role with regards to dosage instructions, as individual titrating is often needed to find the optimal dose of medicinal cannabis.

Back in 2018, clinical pharmacist and past national president of the Pharmacy Guild of Australia, Kos Sclavos, told the AJP, “Whether it’s for cancer pain, non-cancer pain or epilepsy, this is a long-term therapy. The pharmacist will need to counsel the patient, but probably the most important factor is the pharmacist’s role in titrating doses.

“Dosing always starts low and changes slow; the pharmacist plays a key role in ongoing dose review and most doctors are happy to have the pharmacist in that role because they’re the ones dealing with the patient on a regular basis.”

Lord says, “Pharmacists are in a unique position in the community as they are likely to see the patient more often than the doctor and see how often the patient is consuming the prescribed medicines. The pharmacist may see abuse of medicine or over-consumptions of medicine that they can alert the doctor to. With growing interest in medicinal cannabis the pharmacist can help provide evidence-based information to support patients with their decision-making.”

Isaac adds, “The pharmacy profession is at the forefront of seeing all patients from birth until their passing. When it comes to something such as a chronic disease or terminal illness, and even in cases of epilepsy in children, where medicinal cannabis can be utilised, we play a huge role in ensuring and explaining not only what the medicine is about, its profile, side effects and how to take it—but providing support and reassurance.

“Patients don’t have to wait to go see a doctor; they can come into the pharmacy and speak to us as medicine experts. Within our pharmacy training we learn communication skills that are invaluable to the pharmacy profession.

“From my own experience when handing out a prescription for medicinal cannabis, it’s essential to ask the patient how everything is going for them. Whether it’s the carer or an individual patient, it’s important they are able to unload their stresses over what they’ve experienced or endured. I feel that this is missed in a doctor’s practice. It’s very much an in and out process and, unfortunately, in many instances patient’s are dealt with as a condition first and a person second.

“There should be greater communication about how accessible pharmacists are for those very intricate, and often difficult, conversations that we have for safety reasons.

“Just look at the patients we work with as part of the opioid substitution program. We know these people are at greater risk of using other drugs, including recreational cannabis. However, we provide general counselling on this without judgment or persecution to help make sure they are protected and able to make safe decisions. This is what the pharmacy profession is good at and we should utilise this skill more.

“In my practice I have had several patients asking about medicinal cannabis. I discuss the facts and what we know in terms of where the evidence is. These conversations were happening well before the new legislation was put in place.

“Medicinal cannabis is a hot topic that we all have to keep our eye on to see where it goes. I think in 10 years time it’ll be streamlined and hopefully more accessible for people that need it. Likewise, I’m sure we’ll also have more data and more evidence to show its potential benefits and pitfalls. Watch this space!”.

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