Epilepsy Interim Expert Advice for Prescribing Cannabis Medicines

Abstract

There is international interest for consensus advice for prescribers working in the field of drug resistant epilepsy intending to trial potential therapies which are non-registered or off-label. Cannabinoids are one such therapy. In Australia in 2017, the New South Wales State Government set up a cannabinoid prescribing guidance service for a wide variety of indications, based on known pharmacology together with the relevant new literature as it became available. Increasing interest in cannabis medicines outside NSW over the following last five years together with a paucity of registration-standard clinical trials and lack of information around dosing issues, drug interactions and biological plausibility means there remains a large unmet need for such advice. To address the unmet need, and until medicines were registered or regulator quality data was available, it was agreed to bring together a working group comprising paediatric and adult epilepsy specialists, clinical pharmacists. pharmacologists and cannabis researchers from across Australia, to develop interim ‘Consensus Advice’ for prescribers. Although interim, this consensus advice addresses much of the current practice gap by providing an informed overview of the different cannabis medicines currently available for use in the treatment of epilepsy in paediatric and adult settings, with information on dose, drug interactions, toxicity and type and frequency of symptom and seizure relief. As such it supplements the limited evidence currently available from clinical trials with experience from front-line practice. It is expected that this consensus advice will be updated as new evidence emerges and will provide guidance for a subsequent Guideline.

Complementary and alternative therapies in the palliative setting

“…8 The cannabinoid cannabidiol (CBD) has been touted for a wide variety of symptoms, but the strongest scientific evidence is for its effectiveness in treating drug-resistant childhood epilepsy syndromes, such as Dravet and Lennox-Gastaut syndromes, where randomised controlled trials (RCTs) were undertaken. 9 It is noted that placebo response rates are high, and even in the cannabinoid group, it is unclear whether the response is always caused by CBD or by the fact that CBD inhibits the enzyme that breaks down benzodiazepines, which are commonly coprescribed. 10 Based on this evidence, Epidyolex, in which CBD is the active ingredient, is the first CBD product to be TGA listed.…”

“…A scan of Therapeutic Goods Administration (TGA) data shows that the highest use is in people with chronic noncancer pain, cancer symptoms and other symptoms such as insomnia, anxiety and posttraumatic stress disorder 8 . The cannabinoid cannabidiol (CBD) has been touted for a wide variety of symptoms, but the strongest scientific evidence is for its effectiveness in treating drug‐resistant childhood epilepsy syndromes, such as Dravet and Lennox–Gastaut syndromes, where randomised controlled trials (RCTs) were undertaken 9 . It is noted that placebo response rates are high, and even in the cannabinoid group, it is unclear whether the response is always caused by CBD or by the fact that CBD inhibits the enzyme that breaks down benzodiazepines, which are commonly coprescribed 10 …”