The Department of Justice (DOJ) and the DEA recently rescheduled marijuana, moving FDA-approved and state-regulated medical marijuana products to Schedule III of the Controlled Substances Act.
For years, there has been much discussion regarding the rescheduling of marijuana. As a Schedule I controlled substance, marijuana faced various restrictions surrounding clinical research, drug development, medical utilization and reimbursement, and more. This monumental change now makes it important for stakeholders to assess policy, utilization and operational impacts.
It is worth noting that this change effectively reschedules only medical marijuana and not recreational marijuana. At the federal level, marijuana is still illegal and subject to strict controls, though regulatory wheels are moving to evaluate a potential broader rescheduling.
Understanding Drug Scheduling
Drug scheduling directly determines how medications are prescribed, monitored, reimbursed, and operationalized within pharmacy and claim systems.
According to the DEA, certain drugs are classified into five distinct schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. Schedule I has no accepted medical use and the highest abuse or dependency potential, while Schedule V has the most acceptable medical use and the lowest abuse or dependency potential.
Schedule III drugs can be dispensed by a pharmacist, pursuant to a prescription authorized by a healthcare practitioner, or administered or dispensed directly by a medical practitioner in the course of their professional practice, though various prescription limits still exist.
At this time, raw marijuana and a majority of currently available medical marijuana products are not FDA-approved drugs. These items could not be prescribed or dispensed at a pharmacy. However, marijuana-derived drugs could be prescribed and dispensed by pharmacists if they are approved by the FDA. This is particularly noteworthy as the rescheduling of marijuana now allows for greater clinical research, which could lead to such FDA-approved products.
Two Distinct Paths That Could Influence Utilization
Rescheduling marijuana may influence marijuana utilization patterns via two different pathways – each carrying very different implications for clinical consistency, reimbursement, and utilization management.
First, the reduction of restrictions for clinical research is anticipated to accelerate drug development and support evidence-based FDA oversight of marijuana-derived products. Such drugs could then be prescribed and dispensed like any other medication, backed by efficacy and safety data that prescribers could reference in clinical decision-making.
Second, because the rescheduling of marijuana acknowledges its potential for medical use, there may be an increase in provider willingness to recommend currently-available, non-FDA-approved medical marijuana products that are obtainable via state programs.
Continue reading the article in full at RxInformer magazine online.
