Abstracts

Rationale:
Medical cannabis (MC) use differs in the United States by state and the content of product and doses being used in patients are variable. Due to the allowances for distributing MC in some states, epilepsy patients have access to both main ingredients, cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC), in various forms and from many manufacturers. Our objective was to describe doses being distributed to epilepsy patients in MN, a state with a more highly regulated state MC program centered on health practitioner certification, pharmacist-led dispensation, third-party testing, required pharmacovigilance, and standardized products.
Method:
This was a retrospective analysis of data from one of two manufacturers in MN collected over 4 years (2005 - 2019) reflecting approximately 50% of the individuals both certified and dispensed MC in the state of Minnesota. Data included age, type and dose of product dispensed, formulation, and route of administration. This study explored the prescribed daily dose (DD) (mg/day) of THC and CBD for individuals diagnosed with epilepsy without any other co-occurring disorder after 6 weeks of starting treatment, for capsules and oral solutions separately. Data was stratified by age (≤ 18 years, and > 18 years). For each formulation, THC and CBD DDs were expressed as median (range). THC and CBD DD between formulations was compared using a two-sample t-test (p< 0.05). Analysis was performed using R Software (v.3.5.2).
Results:
A total of 14,316 individuals were included. From 473 individuals with a diagnosis of epilepsy (3.3%), 344 (72.7%) did not have any other co-occurring disorder. These 344 individuals had a median (range) of age of 27.5 (1.1 – 88.7) years. From those, 46 and 98 individuals were dispensed only capsules and oral solutions, respectively. Individuals were mainly dispensed products containing both THC and CBD (56.6% for capsules, and 54.1% for oral solutions). 30.4% (capsules) and 32.6% (oral solutions) of the individuals were prescribed products that only contained CBD. A total of 118 individuals were dispensed MC for more than 6 weeks. THC DD was lower than CBD DD for both capsules (median of 7.5 vs 142.5 mg/day) and oral solutions (median of 5.2 vs 100.0 mg/day). DD for capsules was significantly higher than oral solutions for CBD (p = 0.0007) but not for THC (p =0.352). Both formulations were equally used in individuals > 18 years, and those < 18 years mainly used oral solutions. THC and CBD DD were not significantly different for capsules and oral solutions when stratified by age.
Conclusion:
MC programs differ by state allowing exposure of epilepsy patients to both CBD and THC. This study describes the use of MC in individuals with epilepsy as part of a more highly regulated state program. These data show that epilepsy patients may be exposed to lower than suggested doses of CBD for epilepsy and to THC. Limitations of this study include the possible exclusion of co-morbidities within a patient which could further explain why THC is utilized in patients with epilepsy.
Funding:
:NA