State Regulation of Telepharmacy

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

Operational Issues in Telepharmacy Practice

The 3 most typical operational requirements come in the form of limitations on the setting in which telepharmacy can be provided, staffing requirements for remote telepharmacy sites, and recordkeeping requirements for telepharmacy sites.

Settings for Providing Telepharmacy Services

Through their pharmacy practice acts and pharmacy regulations, states generally permit pharmacists to practice telepharmacy in one or both of 2 settings via:

• Automated dispensing devices or “kiosks”
• Remote dispensing at a staffed location, within either a remote pharmacy or clinic or an institutional facility such as a hospital, correctional facility, or long-term care facility.

States that authorize dispensing through kiosks generally define them as mechanical systems that (1) perform operations or activities, other than compounding or administration, relative to storage, packaging, and dispensing, or distribution of medications; and (2) collect, control, and maintain all transaction information. States that include requirements for kiosks include Arkansas, Delaware, Illinois, Iowa, Kentucky, and Oklahoma.

Staffing Requirements for Telepharmacy Settings and Dispensing Methods

States in which telepharmacy occurs through a remote dispensing site generally require increased pharmacist supervision of pharmacy technicians at the remote site. This increased supervision can occur through an electronic link between the pharmacist at the central pharmacy and the pharmacy technicians at the remote site.

In Colorado, an unlicensed pharmacy technician may provide services at a remote telepharmacy site without the direct, in-person supervision of a licensed pharmacist, but only if a licensed pharmacist is connected to the remote site via telecommunication equipment and is readily available to consult with and assist the pharmacy technician in performing the tasks associated with telepharmacy dispensing.¹²

Recordkeeping Requirements

States may impose separate recordkeeping requirements for pharmacies that engage in telepharmacy practice. When the pharmacist is in one location but the dispensing occurs at a remote location, state law will dictate where the records should be physically located. Because the practice of pharmacy occurs at both sites, recordkeeping may be required at both sites and those records must be available if requested by the state’s board of pharmacy. If the practice is occurring via kiosk, the kiosk itself is typically required to store transaction data—in lieu of physical pharmacy records—electronically.

Other Requirements

In addition, unless a state specifically provides an exception, the practice of telepharmacy will be governed by the definition of the “practice of pharmacy” under a state’s pharmacy practice act. Any restrictions on a pharmacist’s, or other provider’s, scope of practice under the act will typically apply to the pharmacist’s authority to practice telepharmacy in the state.

States impose various additional licensing and operational requirements on telepharmacy practice. For example, states differ with regard to whether stocking, and subsequent dispensing, of controlled substances via telepharmacy is permitted. States that allow this generally require that the pharmacy operating the kiosk or supervising the remote site obtain state and federal controlled substance registrations and/or licenses.

Future of Telepharmacy Regulation

In the health care climate going forward, the pharmacy industry’s use of telepharmacy will continue to grow. This area of pharmacy law will continue to develop as pharmacies continue to incorporate technology into their delivery of services.

On one hand, telepharmacy can increase access to pharmacy services in rural communities that are experiencing a shortage of pharmacists, as highlighted by the North Dakota Telepharmacy Project. Pharmacies can also use telepharmacy services to supplement the medical community’s use of telemedicine to combat perceived future primary care provider shortages in rural America. On the other hand, technology continues to develop at breakneck speed. In this device-filled world, pharmacists and patients are becoming more comfortable with mobile health delivery.

However, the law does not generally keep up with such fast-paced changes in technology. With time, pharmacy regulators will adapt to the ever-changing world of telepharmacy. Areas that will need to be addressed include:

• Updating the definition of the “practice of pharmacy” under state laws to include the provision of telepharmacy services
• Modernizing requirements relating to operation of pharmacies to facilitate the provision of telepharmacy services, including facilitating remote dispensing, online patient counseling, institutional telepharmacy services, etc
• Developing the framework of security requirements relating to the delivery of telepharmacy services via mobile devices
• Addressing the interstate practice of telepharmacy to allow pharmacists to provide telepharmacy services to patients located in other states

^aThe National Association of Boards of Pharmacy (NABP) is an association of which all 50 states’ and the District of Columbia’s boards of pharmacy are members. The NABP assists the boards in developing and implementing pharmacy laws, in part through its Model Pharmacy Practice Act and Regulations.

This article should not be construed as legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult your own lawyer on any specific legal questions you may have concerning your situation. This article is published in collaboration with the Directions in Pharmacy CE Conference program.

Anne B. Compton-Brown is an associate in the Chicago office of Barnes & Thornburg LLP. As a member of the Healthcare Department, Ms. Compton-Brown focuses her practice on transactional and regulatory matters for a variety of providers in the health care industry, including hospitals, pharmacies, home health care providers, wholesale drug distributors, dialysis centers, and physician practices. She can be reached by e-mail at Anne.Compton-Brown@btlaw.com.

Serj Mooradian is an associate in the firm’s Healthcare and Corporate departments and a member of the Food, Drug and Device Law Practice Group. His practice includes counseling health care clients, including retail and hospital pharmacies and wholesale drug distributors, on federal and state regulatory matters. He can be reached by e-mail at Serj.Mooradian@btlaw.com.

References

• Operations. NDAC 61-02-08-03. WestlawNext through Supplement 282. December 1, 2002.
• History and progress of HRSA/OAT telepharmacy funding. North Dakota State University website. ndsu.edu/telepharmacy/history. Accessed March 9, 2016.
• Clifton GD1, Byer H, Heaton K, Haberman DJ, Gill H. Provision of pharmacy services to underserved populations via remote dispensing and two-way videoconferencing. Am J Health Syst Pharm. 2003;60(24):2577-2582.
• Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. National Association of Boards of Pharmacy website. nabp.net/publications/assets/ModelAct.doc. Published August 2012. Accessed March 9, 2016.
• APhA policy: telemedicine/telehealth/telepharmacy. American Pharmacists Association website. pharmacist.com/policy/telemedicinetelehealthtelepharmacy-16. Accessed March 9, 2016.
• Draft ASHP statement on telepharmacy. American Society of Health-System Pharmacists website. ashp.org/doclibrary/bestpractices/draftdocs/draftstatementtelepharmacy.aspx. Accessed March 9, 2016.
• Use of electronic technology or telepharmacy by hospital. Quality assurance evaluations. C.S.G.A. 20-609a.
• Licensure. Ga Comp R & Regs. 480-37.02.
• Authority to use automated medication system. 856 IAC 5-1-5.
• Telepharmacy Operations. Mont. Admin. R. 24.174.1302.
• General Requirements for Telepharmacy. Iowa Admin Code 657-9.5(2)(c).
• Definitions. C.R.S.A. § 12-42.5-102.