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Medicinal Cannabis. A Patient Approach.

 

Medicinal cannabis can only be prescribed by a
registered medical practitioner.


Before prescribing medicinal cannabis, the doctor will
assess each patient to decide if the treatment is
appropriate for their condition and individual
circumstances. The doctor will take a medical history
and a family health history. The doctor will also consider
the patient's current medications and any problems with
drug dependence and substance abuse.

 

1.

INDICATIONS & CLINICAL JUSTIFICATION

Strong consumer demand has led to medicinal cannabis being used more
widely in the treatment of a number of medical conditions, or for patients
presenting with poor symptom control.

An application to prescribe medicinal cannabis can be submitted for:

 

1. Any Chronic condition that:

Has lasted for 3 months or longer, and

Has not responded to conventional
medical treatment, or had side effects

 

 

 

2. “Fast Track” Conditions*

- Chronic Pain
- Palliative Care
- Epilepsy
- Chemotherapy Induced Nausea
- Multiple Sclerosis

*These are conditions for which the TGA has provided guidance.

 

The TGA has approved special access scheme
(SAS) applications including, but not limited to,
the following indications:

  • Chemotherapy-induced nausea and vomiting,
  • Refractory paediatric epilepsy,
  • Palliative care indications,
  • Cancer pain,
  • Neuropathic pain,
  • Spasticity from neurological conditions,
  • Anorexia and wasting associated with chronic
  • illness (such as cancer).

 

CONTRAINDICATIONS

Products containing THC are generally not appropriate for patients who:

  • Have a history of hypersensitivity to any cannabinoid or products used in
    manufacture (e.g. sesame oil).
  • Have severe and unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease and arrhythmias) or risk factors for cardiovascular disease—THC acts through the CB1 receptors to decrease blood pressure, increase cardiac demand and causes vasodilation (In patients with unstable ischaemic heart disease who smoke cannabis, there is a four-fold increased risk of myocardial infarction in the hour following smoking).
  • Have a previous psychotic or concurrent active mood disorder or anxiety disorder.
  • Are pregnant/breastfeeding—there are some reports of pre-term labour and low birth weight. Cannabinoids appear in breast milk.

RELATIVE CONTRAINDICATIONS

While not preventing prescribing, the following should also be considered by a
medical practitioner:

  • Care should be taken in prescribing medicinal cannabis products containing THC to patients under 25 due to potential adverse effects on the developing brain. A risk analysis should be undertaken prior to prescribing these products.
  • Severe liver or renal disease
  • Drug dependence, including nicotine and heavy users of alcohol
  • Other medications especially other sedatives such as opioids and benzodiazepine
  • Paediatric and elderly patients—little is known about how these patient groups react to cannabis. As metabolism in the elderly is slower it is likely they will be more sensitive to the pharmacological effects of cannabis. Treatment should, therefore, be commenced at very low doses and adjusted very slowly.

 

2.

CLINICAL ASSESSMENT

Before a medical practitioner applies to access medicinal cannabis for a patient,
they should complete a comprehensive clinical assessment identifying risk
factors that will want to be addressed.


An accurate and thorough history taken by the medical practitioner should include:

 

Presenting symptoms and underlying diagnosis

The symptoms and/or disease for which the medicinal cannabis product is being considered.
 

Past medical history

In particular, cardiovascular disease, liver disease and renal disease.
 

Medication review

Treatments that have been tried and have failed; as well as the length of time the treatments were trialled and the reasons for ceasing.
 

Mental health history

History of mental illness, particularly schizophrenia.
 

Family health history

Including mental health, particularly a family history of schizophrenia.
 

“At risk” behaviours

Focusing on those associated with drug dependence and substance abuse disorder. While previous cannabis use may not be a contraindication, care should be taken to manage the risk of dependence. Attention should be paid to histories of nicotine dependence (may contribute to patient smoking product), alcohol dependence abuse, and previous illicit drug use
 

Social history

Social and family support for the use of a medicinal cannabis product. Consideration should be given to family responsibilities such as caring for young children, child safety, employment (especially where it involves driving or operating machinery), “at risk” living conditions and the risk of falls in older patients;
 

Physical investigations as appropriates

These are left to the medical professional’s discretion.

 

3.

INITIAL TREATMENT PLAN

We suggest an initial treatment plan indicate a 4-12-week trial period in which the
effectiveness of the medicinal cannabis product for the patient’s
condition/symptoms can be determined.

The plan should clearly indicate:

 

Treatment goals for medical cannabis use

These need to be clearly documented and discussed with the patient, related to the symptoms for which the patient is prescribed medicinal cannabis and if possible, should be measurable. For example, weight gain in patients with anorexia and, cessation or minimisation of nausea and vomiting and improved function in patients with chronic non-cancer pain.
 

Patient-specific supportive documentation

- for use of medicinal cannabis from a specialist in the field of medicine for which the symptom is being treated (e.g. palliative care) should be documented.
 

Risk management processes

- such as the frequency of dispensing. For example, weekly dispensing if there are concerns that a patient may self-escalate their dose.
 

Monitoring arrangements

- weekly/fortnightly/monthly reviews, blood tests, specialist reviews, other investigations (as needed) for the medical condition and/or symptoms being treated.
 

An exit strategy

- for situations where the medication is not helping manage the symptoms or the goals of treatment are not reached.
 

That informed consent has been obtained

- and the patient provided with information about the medicinal cannabis product, possible side effects and treatment goals, and that treatment will be discontinued if the benefit has not been demonstrated.
 

That the patient has been advised

- that they are not able to drive while on medicinal cannabis.

 

4.

INTENDED MONITORING

As medicinal cannabis is an unapproved medicine, it is important that patients are
reviewed regularly to ensure efficacy and to manage any adverse events. We suggest
that a monitoring program similar to opioids would be clinically useful.

Once established on a dose, a monthly review is recommended as a minimum.

At each review the medical practitioner should ensure the following areas are covered:
Symptom Control, Adverse Events, Aberrant Behaviour, Records (SAAR):

 

Symptom Control

is the product improving the patient’s symptoms? - For example, are they eating better, experiencing less nausea and vomiting, have improved pain management and spasticity or evidence of fewer seizures?
 

Adverse Events

are they reporting any side effects? For example, is there any signs of drug-drug interactions that may require adjustment of the product or the other medications?
 

Aberrant Behaviour

Are there concerns that the patient may be on-selling their product? For example, are they using more than prescribed at any one time?
 

Records

it is important to keep adequate records, especially as this is an unapproved medicine.

 

 

5.

DOSING MEDICINAL CANNABIS

dried cannabis flower  cannabis oil

Dosing of medicinal cannabis is highly individualised and relies on titration of the product, regardless of the cannabinoid content, using the premise "start low, go slow". Finding the right dose, where therapeutic the effect is maximised and adverse effects are minimised, requires patients and doctors to work together in determining the efficacy of the product for the patient and their medical condition.

Doses depend on the type of product used, individual variation, the development of tolerance, interaction with other drugs and previous exposure to cannabis either recreationally or medically. Lower doses are less likely to be associated with adverse effects.

When initiating therapy, patients should be advised to have someone with them should they experience any adverse effects. All first doses should be given in the evening to assist with the management of side effects. Doses of THC as low as 2.5–3mg (and even lower), may be associated with a therapeutic benefit and minimal psychoactivity.

BASIC TITRATION

Titration is the process of gradually increasing a doseis achieved. We advise all new patients to start low and go slow. Patients should not ingest additional cannabis until they have accurately gauged the effect of their prior dose. Taking too much cannabis can cause discomfort and should be avoided. Below are some key notes in finding your titration point.

  • Start dosing in the evening and separate doses by at least six (6) hours.
  • Maintain a consistent dosing schedule and increments.
  • Gradually increase the quantity (if needed) until you find the optimal dose.
  • Adjust dose timing accordingly based on the severity the of symptoms.
  • Some patients prefer to take smaller doses at greater intervals.

 

Below is an example of a titration schedule for an oil formulation containing 20mg/ml of active ingredient, taken BD. It should be noted that titration is response dependant:

Start dosing in the evening and separate doses by at least six (6) hours.

Gradually increase the quantity (if needed) until you find the optimal dose.

Maintain a consistent dosing schedule and increments.

Adjust dose timing accordingly based on severity of symptoms. Some patients prefer to take smaller doses at greater intervals.

Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Morning(ml) 0 0.25 0.25 0.5 0.5 0.75 0.75 1 1 1.25 1.25 1.5 1.5 1.75
Evening(ml) 0.25 0.25 0.5 0.5 0.75 0.75 1 1 1.25 1.25 1.5 1.5 1.75 1.75
Day Morning(ml) Evening(ml)
1 0 0.25
2 0.25 0.25
3 0.25 0.5
4 0.5 0.5
5 0.5 0.75
6 0.75 0.75
7 0.75 1
8 1 1
9 1 1.25
10 1.25 1.25
11 1.25 1.5
12 1.5 1.5
13 1.5 1.75
14 1.75 1.75

 

 

Please note, the table is a guide to dosing for your patient. The dose may also very dependent on the concentration of active ingredient (THC / CBD) in the formulation.