Therapeutic use of cannabidiol-based products in Brazil: a descriptive study, 2014–2017
DOI:
https://doi.org/10.22239/2317-269X.01338Keywords:
Brazilian Health Regulatory Agency, Cannabidiol, Cannabis, Epidemiology Descriptive, Pharmaceutical PreparationsAbstract
Introduction: Little is known about the characteristics and clinical conditions of patients on therapeutic use of cannabidiol-based products in combination with other cannabinoids, despite a growing number of countries that have authorized the use of these products. Objective: This study describes the characteristics and clinical conditions of patients who obtained exceptional authorization from Anvisa to import cannabidiol-based products in combination with other cannabinoids for therapeutic use in Brazil. Method: A descriptive and retrospective study based on records of patients who obtained authorization from Anvisa to import cannabidiol-based products in association with other cannabinoids, between December 2014 and May 2017. The characteristics of the patients studied were: i) demographic (sex and age); ii) geographical (region and Federation Unit); iii) medical diagnoses of patients by ICD-10 codes; iv) medical specialties that prescribed the products to patients; and v) products intended for import by patients or caregivers (main products and country of importation). Results: 1,713 patients were identified, of whom 61.7% were aged ≤ 19 years. Epilepsy (62.9%), chronic pain (3.8%) and Parkinson’s disease (3.6%) were the most frequent ICD-10 codes. Of the products requested for therapeutic use, 15 (57.7%) were not included in the Anvisa’s Resolution. Conclusions: Patients who have obtained authorization from Anvisa to import cannabidiol-based products in combination with other cannabinoids are mostly under the age of 20 and suffering from epilepsy. These findings are in accordance with the determinations provided for in Resolution No. 2,113 / 2014 of the Federal Council of Medicine.
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