The coronavirus disease 2019 pandemic prompted state and federal government to shift guidance and relax policies on a wide range of telehealth services, which resulted in a boom in remote offerings for patients. However, long before this rapid transformation in telehealth, telepharmacy, an increasingly popular form of remote pharmacy care, has operated under a patchwork of state laws with no clear federal regulations governing the practice. That soon may change.
In November 2021, Drug Enforcement Administration (DEA) announced that it is considering promulgating regulations on telepharmacies and issued an advanced notice of proposed rulemaking to gather information on existing telepharmacy practices.
Although not currently defined or regulated at the federal level, telepharmacy is generally considered to be telehealth services in which a remote pharmacist delivers care and services to a patient at a dispensing site through telecommunication or similar technologies. These services include dispensing prescriptions, such as controlled substances (CS); counseling on prescriptions; reviewing patient drug use; and performing drug therapy monitoring.
Since telepharmacies use the internet and can dispense CS, they may technically qualify as online pharmacies, which are internet-based pharmacies that sell and ship medications to patients and are regulated at the federal level. However, telepharmacy operations often differ from those of online pharmacies.
There are two common types of telepharmacies: brick-and-mortar remote sites and self-service, automated machines. Brick and mortar remote sites are traditional pharmacies where patients interact with non-pharmacist staff who are supervised by a pharmacist at a remote location through continuous and real-time computer, video, and audio links. Self-service, automated machines are kiosks that directly connect a patient to a remote pharmacist through real-time video and audio communication. These kiosks manage prescription refills, label and dispense prescriptions, and store medication, including CS.
Telepharmacies that dispense CS to patients are under the DEA’s purview, according to the Controlled Substances Act (CSA). The CSA authorizes DEA to manage and control the production, distribution, and dispensing of all CS. Under the CSA, entities that engage in these activities, as well as import, export, or prescribe CS, must register with DEA. The CSA also permits the DEA Administrator to register and regulate telepharmacies if the Administrator determines that registering these entities is in the public interest.
In addition to the CSA, the Ryan Haight Online Pharmacy Consumer Protection Act (RHA) regulates online pharmacies by requiring them to register with DEA and also requiring practitioners to first conduct an in-person medical evaluation before prescribing CS using the internet.
In remote and rural areas in which pharmacies often serve a much wider geographical footprint, telepharmacy services can significantly improve access to care. However, the current patchwork of state regulations on telepharmacy creates a regulatory environment vulnerable to security and safety concerns, especially when engaging in activities that involve CS without a consistent federal framework.
In the agency’s call for comments, DEA suggests that telepharmacies operate similarly to online pharmacies – since they both use the internet to dispense CS – and therefore could be required to obtain a modified registration under RHA or meet one of RHA’s exceptions that would exempt them from registration.
Some industry stakeholders assert that DEA’s broad interpretation of RHA will adversely affect patient access to medication and stifle innovations in the delivery of pharmacy care through telepharmacy. Other advocates point out that telepharmacies are more similar to traditional pharmacies than online pharmacies in the level of pharmacist oversight and management.
As DEA reviews hundreds of stakeholder comments in response to its notice, demand for telepharmacy continues to surge and is estimated to be an over $21,500 million industry by 2030. How DEA’s regulations impact this projection remains to be seen.