ABSTRACT
BACKGROUND AND OBJECTIVES:
The individualization of treatment has been recognized as essential in medical practice, especially due to the demand for different therapeutic approaches for similar situations. However, the complex and variable nature of the phytocannabinoids present in the cannabis plant presents challenges for the application of traditional models for testing the efficacy and safety of new drugs. The objective of the present study was to highlight the particularities of cannabis, including genetic variety, cultivation and production, which make it difficult to comply with traditional drug registration protocols, and the importance of individualizing treatment in the use of cannabis for the control of pain.
CONTENTS:
Traditional models for testing the efficacy and safety of new drugs are based on a rigid methodology, divided into development and post-market phases. However, the complexity of the cannabis plant, with hundreds of actives that can vary according to the genetic variety, cultivation and production process, makes the application of these models difficult. In addition, international rules do not allow the registration of patents on cannabis products, due to the consideration that they are natural products and the extraction methods are already used in the industry for other plant actives. The individualization of treatment is fundamental in the use of cannabis for pain control, given the complexity of the plant and the limitations of traditional models of testing and drug registration.
CONCLUSION:
The particularities of cannabis, such as genetic variability and the impossibility of registering patents, make compliance with current protocols difficult. However, the individualization of treatment allows adapting therapies to the needs of each patient, considering effectiveness and tolerance of side effects. Therefore, there is a need to rethink research and registry models to allow for a more flexible and personalized approach in the field of cannabis medicines.
Keywords:
Cannabinoids receptors; Cannabis; Evidence-based pharmaceutical practice; History; Medical marijuana; Pain
HIGHLIGHTS
Biological imposition of individualization of pain management according to pharmacogenetics characteristics.
Legal and regulatory restrictions on the development of studies with Cannabis sativa.
Infinite possibilities of concentrations and ratios of actives in each cannabis product according to plant variety, cultivation method and extraction method.
Lack of robust clinical trials due to impossibility of financial return through patent exploitation of natural products.