Linking detailed medical marijuana dispensing data with claims and vital statistics records enables longitudinal tracking of clinical outcomes of medical marijuana use to conduct safety and effectiveness studies. The healthcare database MEMORY – Medical Marijuana Clinical Outcomes Research Data Repository has been built by the Consortium for Medical Marijuana Clinical Outcomes Research (Consortium), established per Florida statute to conduct and disseminate research on clinical outcomes of medical marijuana (MMJ) use.
The growing use of MMJ in Florida offers a unique opportunity for real-world evaluations of MMJ clinical outcomes that can help overcome the lack of randomized clinical trials and accelerate the availability of evidence on clinical outcomes. MEMORY has been conceived to establish the infrastructure for real-world evidence generation similar to that employed by the U.S. Food and Drug Administration (FDA) to evaluate and monitor the benefit-risk of approved medications.
To facilitate longitudinal follow-up on clinical conditions, the Consortium has linked the Office of Medical Marijuana Use (OMMU) Medical Marijuana Use Registry (MMUR) with Florida Medicaid and Medicare claims data, and Florida birth, death and fetal death records. Using MEMORY, the Consortium will address the following research questions to evaluate the safety and effectiveness of MMJ use:
1. To describe socio-demographic and clinical characteristics of MMJ users in Florida, across time (throughout the growth of the Florida Medical Marijuana Program), space, and across specific subpopulations (e.g., children, elderly)
2. To evaluate the safety and effectiveness, and other health outcomes of MMJ in subpopulations with specific indications, considering comorbidities and concomitant medication use, including for example:
- Prescription opioid and other controlled or psychotropic drug utilization rates and related outcomes in users and non-users of MMJ with similar clinical characteristics
- Pregnancy complications and adverse pregnancy outcomes in women who use or don’t use MMJ during pregnancy for similar indications and with similar clinical history
- Risk for injuries (e.g., car accidents, falls) in users and non-users of MMJ with similar indications and disease history
- Changes in hospitalizations for seizures (in patients with epilepsy), severe anxiety (in patients with post-traumatic stress disorder) and other potential benefit of MMJ in defined subpopulations (especially pediatric populations)
- Risk for severe psychosis, cognitive problems and other potential side effects in MMJ users and matched control groups with similar clinical history overall, and in vulnerable populations such as children and elderly or patients with a variety of comorbidities and/or concomitant therapy
- Use and effects of MMJ in pain management and management of other symptoms such as among patients with cancer
- Drug-drug interactions that may affect the safety and effectiveness of MMJ or of the concomitantly used medication