State Regulation of Telepharmacy

MARCH 23, 2016
Anne Compton-Brown, JD, and Serj Mooradian, JD
State regulation of telepharmacy varies depending on the market-driven needs within each particular state. This article synthesizes the patchwork of telepharmacy laws to provide an overview of the regulation of telepharmacy in the United States.
 
The first state to regulate telepharmacy was North Dakota. In 2001, the state’s Board of Pharmacy promulgated rules for a telepharmacy pilot program in an effort to combat the closure of pharmacies in rural areas. Under the program, pharmacies could operate remote sites without the physical presence of a pharmacist, so long as the pharmacy maintained a central site staffed by a pharmacist to whom the remote site was connected through “computer link, audio link, or video link telecommunication.”1 The next year, the North Dakota Telepharmacy Project used 4 central pharmacies to serve 6 remote pharmacy sites, and the success of that program led to the permanent implementation of telepharmacy rules by the Board of Pharmacy in 2003.2
 
Other states permit telepharmacy practice without explicit regulations. For example, in the same year that North Dakota established its telepharmacy pilot program, a federally qualified community health center in Spokane, Washington, made federal 340B Program drugs available using remote dispensing and counseling via a 2-way interactive videoconferencing system.3 However, to this day, Washington state has not issued specific telepharmacy-related regulations.
 
Since these telepharmacy programs began in 2001, various states have passed legislation and promulgated regulations permitting different forms of telepharmacy practice. In addition, the National Association of Boards of Pharmacy,a through its Model Pharmacy Practice Act (Model Act), has developed a definition of the “practice of telepharmacy.”4 Various pharmacy associations also support the development of telepharmacy practice.5,6 Despite these efforts, however, regulation of telepharmacy remains inconsistent among the states.
 
What Is Telepharmacy?
Practically speaking, telepharmacy can be defined as the provision of pharmacy services through telecommunication. However, state laws usually define telepharmacy more narrowly, based on pharmacy practice in the states.

The Model Act provides a broad framework for understanding the pharmacy services that can be provided using telepharmacy. The Model Act defines the “practice of telepharmacy” as “the provision of pharmacist care by registered pharmacies and pharmacists located within US jurisdictions through the use of telecommunications or other technologies to patients or their agents at distances that are located within US jurisdictions.” “Pharmacist care” is “the provision by a pharmacist of patient care activities … with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process.”
 
The Model Act also defines “coordinating pharmacy,” “remote pharmacy,” and “remote dispensing site.” Remote pharmacies are staffed by a pharmacist, intern, or pharmacy technician. Remote dispensing sites are automated dispensing kiosks located within various institutional facilities or clinics. Remote pharmacies and remote dispensing sites are all linked to coordinating pharmacies “via a computer system and/or a video/auditory communication system.”4
 
However, as the scope of pharmacy practice and telecommunication technology continues to evolve, the breadth of telepharmacy services makes them difficult to regulate uniformly. Therefore, when states craft their telepharmacy laws, they often impose varying requirements. For example, the Connecticut legislature recognized that in practice, telepharmacy can be broader than pharmacy services provided to patients via remote or automated pharmacy locations, thus permitting telepharmacy to be used by hospital pharmacists to review and verify intravenous sterile compounding by remote pharmacy technicians.7 This is just one example of the flexibility states have to regulate telepharmacy in a manner that aligns with current state telepharmacy and pharmacy practice. State differences in the regulation of telepharmacy also occur with respect to licensing and operational requirements.
 
Licensing Requirements for Telepharmacy Practice
States may impose additional telepharmacy licensing requirements on central and remote pharmacy sites and pharmacists, above and beyond the requirement that those entities and individuals obtain the required state licensure to operate as a pharmacy or practice pharmacy within that state. For example, pharmacies that operate kiosks in Georgia must be licensed as a pharmacy in Georgia, obtain a separate license to install and operate the kiosks from the Georgia Board of Pharmacy, and pay the associated licensing fee.8 Moreover, such pharmacies may only install and operate kiosks in a Georgia-licensed skilled nursing facility or hospice that does not have an onsite licensed pharmacy.8 As in Georgia, other states also require such facilities to obtain state board of pharmacy approval for kiosks or remote dispensing sites prior to installing the kiosk or beginning operations.9
 
In addition, some states (eg, Montana) place restrictions on telepharmacy facility licensing by requiring that the offsite pharmacy location obtain a separate license to operate as a remote telepharmacy, in addition to the license requirements imposed on the managing or supervising pharmacy.10 However, such a site may not be licensed as a remote telepharmacy site if it is within a 20-mile radius of an existing pharmacy.10
 
The practice of telepharmacy lends itself to the provision of services across state lines. This interstate practice exposes the pharmacists and pharmacies involved to licensing requirements for the state in which the pharmacist and pharmacy are located and for the state in which the patient is located. For example, Louisiana law requires out-of-state pharmacies to be appropriately permitted or licensed by the state in which the pharmacy is located and to obtain an out-of-state pharmacy permit from the Louisiana Board of Pharmacy before the pharmacy may operate a kiosk in Louisiana.11
 


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