Cannabinoids in Australia – Medicinal Products and Workplace Drug Testing
Australia’s Therapeutic Drugs Administration announced on 15 December 2020 a down-scheduling of some low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist only medicine). This will become an over-the-counter pharmacy medicine available without prescription.
CBD is a component of cannabis and cannabis extracts that is free of the euphoria-inducing effects of cannabis (the ‘high’ associated with THC). The TGA review found that the adverse effects of CBD at low doses were not serious. It is expected that approved products containing CBD will be indicated for use for some patients experiencing chronic severe pain, including in cancer treatment, palliative care, and some neurological conditions. Products will represent a daily maximum dose of 150mg, and over the counter products will be limited to those approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG).
The first thing to note is that there will not be a flood of products on the Australian market. There are currently no CBD-containing products on the ARTG that meet the Schedule 3 criteria. No manufacturers have yet applied to register a product on the ARTG, and it is expected that supply will not commence for 6 to 12 months.
The second thing to note is that efficacy studies have shown that cannabidiol is not a wonder drug for all patients, nor all indicated conditions. Pharmacists and medical practitioners will provide advice and assistance to those wishing to use CBD.
The third matter is the amount of THC (the euphoria-inducing component of cannabis) permitted in the products for over-the-counter sale. Cannabinoids other than CBD are not to exceed 2% of the total cannabinoid content of the product, and THC cannot exceed 1% of the total. This means a daily CBD dose of 150mg/day will contain no more than 1.5mg of THC. This is comparatively low since a ‘typical’ cannabis cigarette will deliver 5-25mg THC. CBD products sourced overseas may contain substantially more THC and will not satisfy the TGA conditions for Schedule 3 use. It remains illegal to access these products without a prescription unless they are obtained through the Special Access Scheme or Authorised Prescriber scheme for medicinal cannabis products.
Frequently asked questions
Will my use of an ARTG registered low dose CBD product be detected in a workplace drug test?
CBD does not give a reaction to the THC-specific indicator panels on either oral fluid or urine drug test devices used by AusHealth. The low level of THC permitted in ARTG registered products will not yield a non-negative test result for THC. A non-negative on-site screening test result for THC or its metabolite will suggest exposure to THC-containing products and will require a laboratory confirmation test.
Will my use of an ARTG registered low dose CBD product be confirmed by a laboratory test?
Although determination of CBD is not included in the standard panel of drug identities analysed in laboratory confirmation, additional testing of oral fluid and urine samples may be undertaken, and the likely dose of CBD consumed may be estimated. THC is unlikely to be detected if it represents no more than 1% of cannabinoids in any ARTG registered product, unless the dose of CBD consumed grossly exceeds the recommended daily dose.
Now that TGA has approved the supply of low dose CBD products over the counter, will I be able to access similar products on the internet from overseas?
Only low dose CBD products that are on the ARTG may be obtained without a prescription. Some overseas CBD products may contain significant amounts of THC and other psychoactive cannabinoids that do not meet the criteria for prescription-free supply in Australia. Importation of these products without a valid Australian prescription remains illegal. The higher concentrations of THC in these products would also mean that it is likely to return a non-negative onsite test, and a confirmed positive laboratory test for THC.
My workplace conducts hair sampling and analysis to test for drugs. Will hair testing reveal CBD or THC?
CBD and THC may very likely be detected in hair specimens. However, the cut-off concentrations that may be applied can consider use of ARTG-registered low dose CBD products. A special request must be made for CBD analysis.
One of my employees has tested non-negative in a drug test for THC. He claims to be using an ARTG-registered CBD product. What should I do?
Any on-site non-negative drug test result for THC in oral fluid or THC metabolite in urine must be confirmed by a NATA accredited laboratory. Advice about the interpretation of confirmation test results can be obtained from the AusHealth Toxicology team. Additional laboratory testing for CBD may be requested.
A confirmation drug test certificate from the laboratory shows that my employee has THC present but no CBD. He says he is taking an ARTG-registered CBD product. What does this result suggest?
If laboratory analysis for CBD is requested, then the proportions of THC and CBD can be determined. Presence of THC in the absence of CBD may suggest THC (cannabis) use. Advice about the interpretation of confirmation test results can be obtained from the AusHealth Toxicology team.
My employee has advised me she is taking an ARTG-registered CBD product. Will she be fit for duty?
As with all medicines, it is recommended that employees declaring medications that may impair performance should provide a letter from their medical practitioner or pharmacist confirming that they will be fit for duty whilst using their medication.
AusHealth provides support that will help your supervisors understand issues surrounding CBD and THC use. Consider a review of your policy and procedures relating to drug testing to ensure that your policy and procedures are robust and provide sufficient direction in the event of declared or detected cannabinoid use. Toxicology and policy advice is available on request from our Senior Toxicologist – Dr John Edwards, who can be contacted via Customer Service on 1800 633 838 or email@example.com.
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