Implications of cannabis international regulation and its impact on medicinal use Dra. Leticia Cuñetti June 2018

June 2018 I declare that I have no conflicts of interest to make this presentation. Dra. Leticia Cuñetti Delmonte

Chronic pain is a major therapeutic problem in patients with kidney transplant due to the nephrotoxicity of NSAIDs In 2013, Law 19.172 approves the use of cannabis for medicinal purposes in Uruguay There is a benefit in the modulation of eCS in the treatment of chronic pain https://parlamento.gub.uy/documentosyleyes/leyes/ley/19172 JAMA.2015;313(24):2456-2473.doi:10.1001/jama.2015.6358

We had good results in pain control and in the limitation perception The adverse effects were mostly mild.

Studies that evaluate cannabis toxicity as an abuse substance can not be extrapolated to evaluate safety of Cannabis-based medicines % Effect They allow to set follow-up strategies to evaluate possible adverse effects Lo q dice

Common adverse effects reported in cannabinoid treatments Safety profile in therapeutics is already known and well documented JAMA.2015;313(24):2456-2473.doi:10.1001/jama.2015.6358

In Uruguay, cannabis recreational use is not a main public health problem Currently the biggest problem is access to quality controlled cannabinoids´ products for the relief of neurological diseases, cancer related disorders or chronic pain The high cost of regulated products with adequate quality controls has determined a black market of supposed medicinal products without quality control or medical follow-up http://monitorcannabis.uy/investigaciones/

Great variability of effect according to the preparation, route of administration, amount and proportion of different cannabinoids It is imperative the accessibility to quality controlled products in order to make a rational prescription http://w3.icf.uab.es/ficf/es/bin/view/Cannabis/FarmacologiaBasica

Presentations available in Uruguay Cannabis Sativa L extract solutions Epidiolex ® 2% CBD solution 2 gr CBD / 100 ml 10 ml 20 mg CBD / ml Charlotte’s Web ® CBD: THC (30:1) solution 6 gr CBD / 100 ml 100 ml 60 mg CBD / ml : 2 mg THC / ml Medropharm M 1337 ® CBD 5,35% :0,2%THC solution 5,35 gr CBD / 100 ml 30 ml y 100 ml 53,5 mg CBD / ml: 0,2 mg THC / ml Medropharm M 1661 ® CBD 5,25% (0,2%THC) solution 5,25 gr CBD / 100 ml 30 y 100 ml 52,5 mg CBD / ml :0,2 mg THC / ml Medropharm M 1771 ® CBD 7,5% - 0,9% THC solution 7,5 gr CBD / 100 ml 30 ml 75 mg CBD / ml :9 mg THC / ml The main problem to regulated preparations accessibility is high cost

Our main objective as doctors is to achieve universal access to these medicines that alleviate chronic pain and neurological and cancer-related conditions for a significant number of patients. This will only be achieved if these medicines of proven efficacy and safety are included in the national therapeutic formulary (FTN). The main limitation of the medicinal use of cannabinoids even in Uruguay is the current classification of cannabis in the international drug conventions. This classification determines great difficulties in prescribing, investigating its medicinal uses and also makes it very difficult to include it within any FTN making its use only available for the rich ones or in the black market without medical follow-up .

GREAT RESPONSIBILITY: as regulators as doctors as researchers as members of our society