RxCe - The Benefits and Challenges of Telepharmacy Materials

THE BENEFITS AND CHALLENGES OF TELEPHARMACY

GERALD GIANUTSOS, PhD, JD

Gerald Gianutsos, Ph.D., J.D., is an Emeritus Associate Professor of Pharmacology at the University of Connecticut School of Pharmacy.

Topic Overview

Telepharmacy, or the delivery of pharmacy care to patients via telecommunications, has been practiced in the United States for many decades. Originally conceived to serve remote, rural communities, telepharmacy expanded to address the need to reach other underserved areas. It was further spurred by the social and public health concerns and conditions created by the COVID-19 pandemic. Telepharmacy enables pharmacists or supervised remote-dispensing technicians to interact with patients remotely during pharmacy operations or patient-care services. There are clear benefits to telepharmacy, such as greater access to pharmacy services for patients. Telepharmacy also enables pharmacists to take a greater role in managed patient care. However, telepharmacy brings challenges since it impacts how the pharmacy and patient communicate and interact. In addition, with the end of the COVID-19 public health emergency, there are questions about what telepharmacy should look like.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is

Pharmacist 0669-0000-24-053-H03-P

Pharmacy Technician 0669-0000-24-054-H03-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $6.99

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Course Test and course evaluation

Release Date: May 5, 2024 Expiration Date: May 5, 2027

Target Audience: This educational activity is for pharmacists and pharmacy technicians

How to Earn Credit: From May 5, 2024, through May 5, 2027, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Define telepharmacy and describe its uses in the pharmacy setting

Describe the benefits and challenges of telepharmacy

Discuss federal regulation of telepharmacy and provide a few examples of how states regulate it

Identify ways to overcome the challenges of telepharmacy

Disclosures

The following individuals were involved in developing this activity: Gerald Gianutsos, PhD, JD, and Pamela Sardo, PharmD, BS. Pamela Sardo and Gerald Gianutsos have no conflicts of interest or financial relationships regarding the subject matter discussed. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

Educational Activity

The Benefits and Challenges of Telepharmacy Introduction

Telepharmacy, or the delivery of pharmacy care to patients via telecommunications, has been practiced in the United States for almost a century. Its use has expanded to serve remote, rural communities and other underserved patient groups in recent decades. More recently, telepharmacy was spurred by the social and public health concerns created by the COVID- 19 pandemic when face-to-face contact was discouraged. Telepharmacy can improve patient care and outcomes but also comes with challenges. This technology profoundly changes how people communicate and interact, which can lead to outcomes that may not be beneficial. Also, a new question has arisen now that the COVID-19 public health emergency has ended. It asks, “What should telepharmacy look like now that there is no public health emergency?” Pharmacists and pharmacy staff aware of these challenges and issues can mitigate them and help address them through proper education and practice.

The History and Definition of Telemedicine

Telemedicine is probably more than one hundred years old; however, it reached prominence in 1967.1-3 In that year, Dr. Thomas Bird and his colleagues used an audiovisual microwave circuit that enabled them to see and diagnose patients at Boston’s Logan Airport from their distant location at the Emergency Ward of Boston’s Massachusetts General Hospital.1,2 The patients were kept at the airport Medical Station, which was staffed by nurses. Miles away, physicians at Massachusetts General Hospital evaluated the patients by consulting with them using television sets.1 Likewise, the patients at the airport could see and interact with the physician on a television screen. Dr. Bird and his colleagues evaluated and consulted with over a thousand sick patients who were airport employees or travelers using a television receiver.1 They referred to this process as telediagnosis.1 This experiment aimed to

reproduce a normal clinical setting where the patient and physician are in the same room as closely as possible.1

Following his experiment with telediagnosis, Dr. Bird coined the term “telemedicine” sometime in the 1970s.3 The word telemedicine comes from a combination of the Greek word telos, which means “at a distance,” from which we derive “tele,” and the Latin word meden, meaning “to heal,” from which we get the English word “medicine.”4 Together, these words mean to heal from a distance. Thus, telemedicine has come to describe “the use of electronic information and telecommunication technologies to support long- distance clinical health care, patient and professional health-related education, health administration, and public health.”5,6

The term telemedicine is used interchangeably with telehealth and telecare.7 However, it may be more appropriate to distinguish these terms. Telemedicine usually refers to the patient-doctor relationship. Telehealth may be a broader term encompassing various remote healthcare services, such as services provided by nurses, pharmacists, or social workers.7 Finally, telecare refers to technology that consumers use, such as fitness apps, exercise tracking tools, or digital medication reminder systems, to name a few.7

The Definition of Telepharmacy

Telepharmacy is a more specific form of telemedicine. It is defined as the use of telecommunications technology in pharmacy practice in which pharmacists conduct or oversee pharmacy staff in the different aspects of pharmacy operations or patient-care services from a long distance.5,9 The National Association of Boards of Pharmacy (NABP), Model Act of August 2023, defines telepharmacy as follows: “‘Practice of telepharmacy’ means the practice of pharmacy by registered pharmacists located within US jurisdictions through the use of telepharmacy technologies between a licensee and patients or their agents at distances that are located within US jurisdictions.”10,11

The Evolution of Telepharmacy

The birth of telepharmacy can be said to have occurred when pharmacists first used the telephone to dispense prescriptions.11 While the telephone is commonplace and not ordinarily considered telemedicine, based on the above definitions, it could fall within this practice.11

Since the advent of the telephone, telecommunication technologies have expanded.4 Information is transferred instantaneously over the internet. People have adopted these technologies and made them part of their everyday lives.4 Telepharmacy was developed within these technologies to provide healthcare services to underserved populations remotely, i.e., from long distances.4

Technologies associated with telepharmacy have enabled pharmacists and pharmacy staff to provide pharmacy services to patients without seeing them face-to-face. In a typical telepharmacy environment, a licensed pharmacist may remotely supervise one or more pharmacy technicians through video conferencing technology at distant sites.9 Although specific features vary from state to state, the remote pharmacist generally reviews prescriptions, verifies dispensing by technicians, and aids patients in correct medication use.9,12 Other more specific pharmacy activities may also be done using telepharmacy. They include taking a patient’s medical history, patient assessment, medication therapy management, drug review, drug monitoring, patient counseling and consultation, verifying sterile and nonsterile compounding, reviewing patient outcomes, treatment planning, and disseminating drug information.8

The above paragraph describes activities that may be included in telepharmacy; however, a pharmacist or pharmacy technician must consult the laws in their licensing jurisdictions. For example, North Dakota allows using “a central pharmacy with one or more remote sites in which all sites are connected via computer link, videolink, and audiolink.”13 Arizona law allows telepharmacy through a “remote dispensing site pharmacy.”14 These remote-

access pharmacies may operate but only within the limitations discussed below.

With the development of these technologies, telepharmacy was primed to grow, but it needed something to drive it. Two events arose that would provide the impetus for telepharmacy to expand. The events were (1) a need to address the decline in access to pharmacy services in rural areas and

(2) the COVID-19 pandemic.

Telepharmacy and Access to Pharmacy Service

A profound growth in telepharmacy was driven by the need to provide access to pharmacy services to underserved regions and groups. This growth originated with a pilot program in North Dakota in 2001.9 The program aimed to improve access to pharmacy services in rural, sparsely populated, and underserved regions.13,15 A State Board of Pharmacy report found that 26 of the state's pharmacies in rural communities had closed, and pharmacies in 12 additional communities were at risk.15 Communities were at risk because poor access to pharmacy services leads to decreased medication adherence, poor outcomes, and increased healthcare costs.16

The decline in pharmacies in rural North Dakota was driven by economics: pharmacists were drawn to urban areas with higher pay and greater amenities. The Board responded to this gap in the availability of pharmacist care by establishing pilot rules for telepharmacy in 2001, hoping that virtual access would help restore pharmacy services to underserved remote rural communities. A federal grant funded this pilot program, implemented statewide, and tested at the North Dakota State University College of Pharmacy.9

A decline in access to pharmacy services was not peculiar to North Dakota.17-19 Moreover, a lack of access is not limited to rural areas.11,15,20,21 Patients in urban areas can experience poor access to pharmacy services due to race, ethnicity, and economic status.16 Elderly patients and shut-ins in urban areas are also at risk of poor access to pharmacy services.20,21

These obstacles to pharmacy services are referred to as “pharmacy deserts.”16 This term was borrowed from the US Department of Agriculture, which calls low access to healthy food a “food desert.”16 Similarly, a pharmacy desert describes a geographic area where patients have difficulty accessing pharmacy services and obtaining their medications.16

States Embrace and Regulate Telepharmacy

When the North Dakota pilot project proved successful, the state’s board of pharmacy established permanent rules and allowed telepharmacy to be practiced on a broader scale in the state.9 After 2001, laws and regulations specifically authorizing telepharmacy were established in several states. Today, over half of the states (28) have implemented regulations permitting some telepharmacy in various forms.11,12 Other states have pilot programs or waivers or are otherwise supportive of telepharmacies, while a few states are silent.11,12,22,23 Regulations among the states vary, with some being more restrictive than others. Some conditions where states differ are the number of remote dispensing sites a pharmacist may supervise, proximity restrictions, facility restrictions, personnel restrictions, staffing ratios, and intrastate restrictions.11,22,23 For example, Idaho will not approve a remote dispensing site if the proposed site is located within the same community as a retail pharmacy.13 Most states require that the pharmacy and pharmacist be licensed within the state; however, Idaho, Illinois, and Oregon allow out-of- state pharmacies to engage in telepharmacy if they meet the state’s requirements.23 North Dakota allows pharmacies in contiguous states to practice telepharmacy in North Dakota.23 In addition, videoconferencing has also been implemented by the Indian Health Service to provide pharmacist services to remote areas of Alaska and by the U.S. Navy.24

The introduction of telepharmacy into the various states has not been seamless. This is partly due to the fact that pharmacy laws and regulations were developed for onsite pharmacies, and they do not always fit into a telepharmacy practice.4 Issues such as the physical location of the pharmacist, the minimum amount of time that pharmacists must be on site, the

technologies used, and the role of technicians are examples of conflicting laws.4,5

Reviewing the laws of all 50 states is beyond the scope of this course. North Dakota and Arizona statutes are discussed here as examples of how states regulate telepharmacy. These examples illustrate how states may address access issues and dispense controlled substances remotely. Pharmacists and pharmacy technicians must consult legal counsel to interpret state laws and stay current on possible changes.

North Dakota

In North Dakota, a pharmacist at a “central pharmacy” must approve any prescription at the remote site before it leaves the site and confirm that the prescription dispensed and the prescription’s label are accurate.13,14 The pharmacist must also remotely counsel the patient (or patient's agent) on all new prescriptions and refills. Also, some exceptions allow dispensing when the technician is not present.13,14

The remote site may dispense controlled substances. Controlled substances shall be kept at the remote site in accordance with North Dakota Century Code chapter 19-03.1, the Uniform Controlled Substances Act (CSA), and federal laws.14 Records related to dispensing controlled substances must be kept at the central pharmacy.14

Arizona

In 2018, Arizona passed A.R.S. 32-1961.01, governing the use of telepharmacy. Arizona includes remote dispensing site pharmacies in the state.14 Section 32-1961.01 requires, among other things, that the pharmacy be located within the state or under contract with an Arizona-based pharmacy.14 A pharmacist licensed and located in the State of Arizona must be designated to supervise the remote dispensing of medications. The designated pharmacist is responsible for overseeing the remote dispensing site pharmacy.14 If a pharmacist is supervising and dispensing in a licensed

pharmacy, the pharmacist may supervise one remote dispensing site pharmacy. A pharmacist may supervise up to two remote dispensing site pharmacies if the pharmacist is not simultaneously supervising and dispensing at another licensed pharmacy.14

In Arizona, a remote dispensing site pharmacy may dispense controlled substances such as opioids. States require safeguards to protect against drug diversion or other unauthorized access. For example, Arizona law permits remote dispensing site pharmacies to store, hold, and dispense all prescription medications, including controlled substances, but there are requirements.14 Opioids that are Schedule II controlled substances must be stored separately from other prescription medications and locked so unauthorized personnel cannot access them. Before dispensing a Schedule II controlled substance, the pharmacist must use the state’s controlled substances prescription monitoring program.14 The pharmacy must also follow dispensing limits associated with prescribing opioids that are Schedule II controlled substances. The pharmacy department must be kept under continuous video surveillance, and the recordings must be maintained for at least sixty days.14

A sign must be prominently displayed to the public stating that the facility is a remote dispensing site pharmacy, it is under continuous video surveillance, and the video is recorded and retained.14 The pharmacy must maintain an electronic recordkeeping system between the supervising pharmacy and the remote dispensing site pharmacy or allow the supervising pharmacy to access all the remote dispensing site pharmacy's dispensing system records.14

A remote dispensing site pharmacy must have a policy and procedures manual. The manual must explain how the remote dispensing site pharmacy will comply with federal and state laws, rules, and regulations.14 The manual must also describe how the pharmacy will be supervised and provide monthly inspections by the supervising pharmacist.7 Inspections include keeping a running count and inventory of controlled substances. Inspection records must be preserved.14

The pharmacist at a remote dispensing site pharmacy in Arizona must counsel patients or their caregivers using audio and visual technology that complies with HIPAA.14 A remote dispensing site pharmacy must also describe how it will improve patient access to a pharmacist and pharmacy services.14

Federal Law and Telepharmacy

Telepharmacies that dispense controlled substances must comply with the Controlled Substances Act and are subject to the Drug Enforcement Administration’s (DEA) regulations.24 The DEA considers telepharmacies to be online pharmacies since they use the internet to dispense controlled substances and are subject to the Ryan Haight Online Pharmacy Consumer Protection Act (RHA).24,25 The RHA was enacted because of the recognition that the use of prescription controlled substances for non-medical purposes was increasing, especially among adolescents, and this was being exploited by drug trafficking on the internet.26 The act intended to target rogue internet pharmacies and the prescribing of controlled substances online.27 Two areas of the act with particular relevance are that practitioners conduct an in-person medical evaluation before prescribing controlled substances using the internet and that online pharmacies obtain a modified registration from the DEA before dispensing controlled substances.24,28 As discussed below, some of these requirements were suspended during COVID-19, and the suspension continues today.

The RHA has been a barrier to telehealth because of its requirement that controlled substances cannot be prescribed without a face-to-face office visit.29 The DEA is considering promulgating revised regulations specifically dealing with telepharmacies since they are not defined in the CSA or the DEA.25 Some advocates argue that telepharmacies resemble traditional pharmacies more closely than online pharmacies based on pharmacist oversight and management level and that they should be regulated accordingly.24

Take-home message:

Healthcare providers should receive legal counsel from persons competent to advise on state and federal regulation of telehealth and telepharmacy.

Telepharmacy and COVID-19

The COVID-19 pandemic led to significant growth in the use of telemedicine worldwide as patients and providers sought to limit direct contact.30 Telepharmacy also grew dramatically during this time.9 In the United States, this growth in telemedicine and telepharmacy began with the January 31, 2020, declaration of the COVID-19 Nationwide Public Health Emergency.31 The COVID-19 public health emergency declaration allowed federal and state governments to take emergency steps, allowing easier access to remote care.32,33

The Department of Health and Human Services (HHS) took emergency steps and provided guidance through its “Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency,” which took effect on April 7, 2020.34 There was a temporary relaxation of the Health Insurance Portability and Accountability Act (HIPAA) requirements.35 This facilitated pharmacist use of popular teleconferencing platforms, which previously were noncompliant with privacy standards.9 The in-person medical evaluation before prescribing controlled substances required by RHA was suspended during COVID-19.29 The federal emergency declaration lifted or relaxed these restrictions (HIPAA and RHA).29,36

These changes in the delivery of medical and pharmacy services were needed to limit person-to-person contact, promote social distancing, and allow services to patients in quarantine during the declared public health emergency.37 The adoption of new methods of communication and delivery of services between healthcare practitioners and patients was essential to limiting the spread of COVID-19.38

Although the HIPAA rules were relaxed during the pandemic, healthcare providers were guided in their utilization of telehealth.39 The HHS stated that covered healthcare providers should not use Facebook Live, Twitch, TikTok, and similar video communication applications because they are “public- facing,” i.e., they are not sufficiently confidential or private.39 Skype for Business, Microsoft Teams, Updox, VSee, Zoom for Healthcare, Doxy.me, Google G Suite Hangouts Meet, Cisco Webex Meetings, Webex Teams, Amazon Chime, GoToMeeting, and Spruce Health Care Messenger are video communication products that can be HIPAA-compliant.39 To promote HIPAA compliance, providers are encouraged to enter into a business associate agreement with companies providing these video communication products.39

The HHS Office for Civil Rights (OCR) enforces compliance with HIPAA rules. However, during the COVID-19 public health emergency, a healthcare provider that used telehealth would not face penalties from the OCR for noncompliance with HIPAA rules if a communication product was used in good faith.34,35 Moreover, the OCR would not impose penalties against covered healthcare providers who failed to enter into a business associate agreement with a video communication vendor that protected patient health data.34,35 The purpose was to encourage healthcare providers acting in good faith to use telehealth services during the COVID-19 public health emergency.34,35

In addition to federal actions, nearly all the states declared a state of emergency and loosened restrictions on telepharmacy, either by executive order or board regulations and guidelines.26 Relaxed regulations on remote pharmacy access and requirements for the physical presence of a pharmacist encouraged social isolation while maintaining pharmacy operations.26 For example, Missouri amended its regulations to allow pharmacists to use technology to verify a product remotely to “prevent illness and staffing shortages […] if needed to provide disaster or emergency relief.”40

The HHS Notification that took effect on April 7, 2020, expired on May 11, 2023, ending the public health emergency.41 The changes implemented during the emergency were intended as short-term responses to the pandemic; therefore, HHS terminated some of its HIPPA enforcement

discretion following the expiration of the public health emergency, and covered entities were expected to comply by August 9, 2023. What will the end of the public health emergency mean for telepharmacy?42

Telepharmacy Post-COVID-19

Telepharmacy is a powerful tool for pharmacists, especially those in underserved areas. Former CMS administrator Seema Verma has said, “People recognize the value of this [telehealth], so it seems like it would not be a good thing to force our beneficiaries to go back to in-person visits."43 Pharmacy organizations, such as the American Society of Health-System Pharmacists (ASHP), advocate for telepharmacy utilization as a means to “improve patient outcomes, expand access to healthcare, enhance patient safety, achieve effective cost-of-care, and interact with other healthcare team members.”29 These opinions, coupled with the benefits described herein, make it likely telepharmacy will become a permanent fixture in the field of pharmacy.

Because of the public health emergency, healthcare use of many new digital technologies was ushered in quickly and without full review. This is understandable since governments and the healthcare industry had to act quickly to face the public health emergency. Consequently, some scholars argued that concerns and safeguards were not adequately reviewed and studied before the emergency responses were implemented.44 These concerns were confirmed by some patients and clinicians who reported lacking confidence in virtual consultations and the associated technologies. They also reported poorer clinical decision-making and outcomes.44

Although technologies may have been introduced quickly during COVID- 19, they will likely remain in some form in the post-COVID-19 era. Scientists will continue to study their impact on healthcare services and outcomes during COVID-19. These studies could lead to changes in telehealth and telepharmacy in the post-COVID-19 era.

For example, pharmacies that continue to utilize telepharmacy post- COVID-19 should obtain and use a secure platform designed to protect patient privacy and comply with state and federal regulations.39 Another safeguard that should be used is patients should be informed of the technology's privacy and security limitations regarding their personal health information when virtual consultations and associated technologies are used.45 After disclosure of the risks, clinicians should obtain the patient's consent to the use of virtual consultations and associated technologies.45

In the post-COVID-19 period, covered healthcare providers must be HIPAA-compliant since there may no longer be safe harbors for “good faith” use of technologies. For Medicare patients, the use of telehealth services during the pandemic may continue to be used through December 31, 2024, as provided for by the Consolidated Appropriations Act, 2023.46 Practitioners who had established a telemedicine relationship with their patients on or before November 11, 2023, may continue prescribing controlled substances to them using telemedicine without the in-person medical evaluation required by RHA through November 11, 2024.47 Healthcare providers should receive legal counsel from persons competent to provide advice on state and federal regulation of telehealth and telepharmacy.

Technologies Used in Telepharmacy

The internet has led to greater innovation in the digital world. The creation of computer or phone applications and remote access devices such as kiosks drives the most profound changes. Telemedicine and telepharmacies have incorporated many of the popular innovations developed.

Technologies and Applications

The most commonly used technologies involve telephones, videoconferencing, and the internet.5 They may also use applications such as Skype, FaceTime, Zoom, Google, and others, such as ChatGPT.9,48 Devices such as smartphones are also important links to telepharmacy access.5 According to the Pew Research Center, nine in ten Americans own a

smartphone.49 Approximately 15% use their smartphone for all their internet uses.50 Studies state that 83% of internet users search for healthcare or health-related information, with 45% of the searches being related to over- the-counter or prescription drugs.51

Like other technologies, smartphones help facilitate more equitable and accessible healthcare for many, especially those residing in communities lacking adequate healthcare facilities.5 The smartphone has also changed the perception of the patient, who is now a “more informed” consumer who demands more from his or her pharmacist or healthcare provider.5

Kiosks

Self-service, automated vending machines, also known as kiosks that directly connect patients to remote pharmacists through real-time video and audio communication are another form of telepharmacy.24 These machines store medications, including controlled substances, and can label and dispense prescriptions.24 The patient loads the prescription into the machine, and the on-call pharmacist, connected via an audio-visual link, can review the prescription, provide counseling, and authorize the machine to dispense the medication.51 Pharmacy kiosks have been available since 2014, when they were installed for student use at Arizona State University, but only a handful of states currently permit pharmacy kiosks.51,52 Kiosks can be found in many states where they are allowed, such as Arizona, while recently, Florida expanded the number of sites where kiosks will be permitted.52

Services Provided Through Telepharmacy

Digital technologies used in telepharmacy are typically used to provide the following pharmacy services:5,9,53

Inpatient telepharmacy: A pharmacist at a remote location reviews and verifies prescriptions and consults with the hospital staff before medication is dispensed to the patient.5,53

Remote site dispensing: A pharmacist supervises a pharmacy assistant or technician located at a remote site where the assistant or technician dispenses medications. The pharmacist and pharmacy assistant or technician interact from a distance using audio and video computer links. The pharmacist may supervise more than one remote location.5,14

Remote review of IV admixtures and compounding: A pharmacist reviews intravenous medication prescriptions, compounding, and mixing of medications and can participate in assessing intravenous infusion usage.54

Remote patient counseling: A pharmacist at a central location provides counseling to patients using audio and video computer links.5 However, pharmacists should know that counseling errors were considerably higher in remote pharmacy services than prescription errors in remote settings.55

Take-home message:

When counseling patients, pharmacists must pay special attention to counseling errors, which can occur more often in the remote pharmacy setting.

Benefits of Telepharmacy

There are clear benefits to telepharmacy. Some of the more important benefits will be discussed here. They include the following: telepharmacy services can provide pharmacy access to rural and underserved communities; it can reduce medication errors and improve patient outcomes; it can reduce healthcare costs; it can provide pharmacists with more opportunities to deliver clinical services; and it can help reduce social contact during healthcare emergencies.

As mentioned above, some patients and clinicians reported lacking confidence in virtual consultations and the associated technologies. However, overall, patients see the benefits of telepharmacy, and its potential use in promoting beneficial lifestyle changes in patients has been recognized.5,9

Pharmacy Access for Rural and Underserved Communities

Telepharmacy increases patient access and provides better care for a wide variety of pharmacy activities.56 This is especially true in rural and other underserved areas where a shortage of trained healthcare professionals is an obstacle to adequate healthcare.5 Thus, telepharmacy provides patients access to pharmacists in areas where a pharmacist is not physically available.4,13,56 Moreover, studies show that telepharmacies can expand medication access without negatively affecting the quality of medication use.57

This expanded access through telepharmacy is critical since nearly 20% of the United States population lives in rural areas. Moreover, the number of independently owned pharmacies serving these areas has been consistently declining, resulting in the erosion of pharmacy services available to the inhabitants.13 This may occur because a small, rural community loses the only pharmacist in the area. The loss of a rural community’s only pharmacy can severely limit the community members' access to medication and may leave the community without a clinical healthcare provider.5 The presence of a telepharmacy facility, which allows the pharmacist to communicate with patients, ensures a high level of accessibility to all members of the public regardless of demographics or a patient's ability to visit a neighborhood pharmacy.38

Telepharmacy Can Reduce Medication Errors

Telepharmacy can help reduce medication errors when dispensing inpatient and outpatient medications.51 Importantly, the involvement of pharmacists in telepharmacy in tracking prescriptions can lower medication error rates.5,50 As stated above, telepharmacies can expand medication access without negatively affecting the quality of medication use.57

Telepharmacy and Patient Outcomes

Research suggests a general level of patient satisfaction with telepharmacy services and that implementation can improve medication- related patient safety and clinical outcomes.5,9,57 Studies have also described how technology can be successfully applied in encouraging smoking cessation, weight loss, and reducing alcohol consumption.29,38 Implementation of telepharmacy in the intensive care unit has been shown to reduce hospital length of stay and lower rates of preventable complications.29

Patients with multiple comorbidities or immunosuppression may prefer telehealth to avoid environmental exposure to possible infections or due to difficulty ambulating or patients who are shut-ins. This can help improve outcomes.33

Telepharmacy Can Reduce Healthcare Costs

Evidence is limited, but it supports the position that telepharmacy services can be cost-effective.58 This can also apply to a patient’s travel or productivity costs.58 These savings can be seen in telephone consultations or remote monitoring. Providers should consider that healthcare cost savings can be offset by initial capital outlays for the technologies.53 The cost-effectiveness evidence should apply across the spectrum of managing chronic health conditions.58

Expanded Role for Pharmacists

In addition to providing replacement services when a brick-and-mortar pharmacy closes, telepharmacy may provide pharmacists with more opportunities to participate in managed care and deliver clinical services.55 A broad spectrum of pharmacy practice and patient care services and operations can be provided through telepharmacy.29

A pharmacist may use telepharmacy to analyze a patient’s healthcare data and for clinical consultation.29 A patient’s medication may be selected, and other medications reconciled when an order is reviewed and dispensed. Patient assessments, evaluations, counseling, and the detection and monitoring of adverse drug events may be completed through telepharmacy. Drug information may be provided to a patient, and patient outcomes may be evaluated. Also, pharmacists have recently expanded their role in patient medication management therapy. Telepharmacy may be used for comprehensive medication management and chronic disease state management. Finally, this technology can help with compounding verification, supervision of personnel, oversight of pharmacy operations, on-call assistance, and interactions with other healthcare practitioners.29

Expanded Role for Pharmacy Technicians

When patients visit a local pharmacy, the pharmacy technician usually meets them and then processes and delivers their prescriptions.59 The difference between telepharmacy and brick-and-mortar pharmacy is that the technician may be the only individual to assist the patient. In this context, a patient’s experience with the pharmacy is based on their experience with the technician. Good communication skills and an ability to handle peak periods when the pharmacy may be busy are essential.59

Technicians working in the telepharmacy setting will have greater autonomy and responsibility. They must have the skills to manage all pharmacy operations. This could include “auditing and procuring inventory, establishing and managing pharmacy/prescriber relationships, fulfilling custom patient needs, and resolving billing and insurance disputes.”59 Telepharmacy allows technicians to have an elevated role in the pharmacy and provide patients with pharmacy services in cases where access to services would otherwise be unavailable.59 If state law permits, patient-facing telehealth may allow a trained pharmacy technician to obtain a medication history and discuss auxiliary labels. In pharmacist-remote technician settings, technicians have uninterrupted time with the pharmacist to ask questions

about drug stability, incompatibilities, interactions, return procedures, or event reporting procedures.

With telepharmacy, the technician does not replace the pharmacist.59 The pharmacist must still supervise the pharmacy services from a remote, central location. The telepharmacy cannot dispense medications or operate without a supervising pharmacist.59 If the supervising pharmacist is unavailable, the remote pharmacy site should close.59 Also, a technician should never provide medication advice or counseling to patients. If a patient has a question, the technician should reach out to the pharmacist through an applicable technology, e.g., by video or telephone, and let the pharmacist answer the patient's questions.59

Take-home message: Pharmacy technicians in a remote dispensing site pharmacy should close the remote site when the supervising pharmacist at the central pharmacy is unavailable.

Telepharmacy and Mandatory Social Distancing

Telepharmacy is beneficial when human-to-human close contact needs to be limited or discouraged.4,13,55 The value of telepharmacy became most apparent during the COVID-19 pandemic when mandatory social distancing interfered with a patient’s ability to visit a pharmacy in person, thereby limiting patient-pharmacist interactions. The pandemic also created staffing shortages in pharmacies.9 Telepharmacy became a tool to overcome pandemic-related challenges. During the pandemic, the most common telepharmacy initiatives were virtual consultations, home delivery of medications, and patient education.9

Identifying and Minimizing the Challenges of Telepharmacy

While telepharmacy offers many benefits to patients and pharmacists, its use has disadvantages and barriers. These include the impact that telepharmacy may have on empathy and the pharmacist-patient relationship, telesecurity and HIPAA compliance within telepharmacy, computer or technological literacy, monopolization of telepharmacy by national pharmacies, prolonged and inappropriate use of videoconferencing tools, and the potential issues due to the different state and federal laws applicable to telepharmacy.

Telepharmacy and Digital Empathy

Empathy on the part of a healthcare provider is recognized as vital to patient care and the patient-provider relationship.60 Its presence positively affects a patient’s satisfaction, a practitioner’s ability to treat the patient, and the patient’s health outcome.60 On the other hand, the absence of empathy can negatively impact patient care. Empathy may be disrupted during digital telepharmacy consultations.60 Digital platforms allow people “to instantly share thoughts, feelings, and behaviors with the rest of society […] in mere seconds, often without the empathetic social filter that accompanies traditional communications.”60 Digital communications may not provide the parties engaged in conversation with the emotional signals and cues they experience when communicating face-to-face. This can cause the interaction to be more impersonal, leading to a “disinhibition effect,” an effect that can lead people in digital conversations to be unempathetic, hostile, or intimidating.60

In response to the disinhibition effect, Terry and Cain (2016) refer to “digital empathy,” which is defined as the “traditional empathic characteristics such as concern and caring for others expressed through computer-mediated communications.”60 They recommend that digital empathy should be taught and practiced. This can help pharmacists and pharmacy staff avoid the disinhibition effect digital communications may give rise to.60

Telesecurity and HIPAA Compliance within Telepharmacy

Another major barrier is concern about telesecurity and patient confidentiality.5,9 Healthcare providers must also comply with HIPAA requirements.5,9 Similarly, there is the challenge of finding adequate physical and private space where pharmacists or patients can conduct remote teleconferences.9,61

Computer or Technological Literacy

There are also considerable demographic challenges. People who would benefit most from telepharmacy, such as the elderly, patients of lower economic status, patients with mental health or addictive disorders, and the homeless, might be less likely to have a device capable of sharing videos and may be less proficient in the use of the necessary technology; they also may have poor or no internet capability.9,61-63 Similarly, patients with language barriers or certain disabilities may struggle with telepharmacy applications.61

Monopolization of Telepharmacy by National Pharmacies

One group of researchers published that another concern is that national pharmacy chains could exploit lenient telepharmacy regulations to establish large call centers staffed with pharmacists using video to counsel patients, placing local, rural pharmacies in jeopardy.56 Some states have rules that telepharmacies must be located in-state, but others have fewer restrictions and allow the central pharmacy to be located in another state and staffed by pharmacists not licensed by the patient’s home state.56

Telepharmacy Technology and Videoconferencing Fatigue

The level of a technology’s performance can create challenges. Interference with internet connections, poor screen resolution, and poor reception can impair the rapport, trust, and empathy needed for the patient- clinician relationship.32 Clinicians must make an effort to ensure their hardware and software are working properly.

Overusing videoconferencing tools can lead to “Zoom” or “videoconferencing fatigue.”58 This can lead to stress caused by a depletion of physiological and cognitive resources.54 Studies show that videoconferencing may require greater efforts to communicate than telephone or face-to-face interactions. This could be a result of the importance of vocalizations, gestures, and movements people use when they communicate and the instantaneous responses people receive to show they understand each other. These important nonverbal communication tools could be missing when people are not interacting face-to-face.64 This supports the conclusion that telemedicine should play an adjunct role in healthcare and not replace in- person care.32

Regulatory Issues Related to Telepharmacy

State regulation was discussed above under the section on telepharmacy’s evolution. State regulation can shape this technology for a state's specific needs, which is positive; however, state-by-state legislation can also be viewed as a barrier. Some scholars consider the different telepharmacy laws a major barrier that can create inconsistencies in the use of telepharmacy.4 Laws and regulations governing the practice of telepharmacy are evolving, with more states adopting the concept and federal and state laws being revised to facilitate its utilization.59 There is also the interaction of federal and state laws and agencies, and conflicts of law or preemption of federal law may occur.

Inconsistencies in state telepharmacy laws may be addressed through multistate licensing. The NABP has provided guidance on multistate licensing regulation and indicated that it “would like to establish a platform that enables consistent processes and procedures across all states.”65

The Future of Telepharmacy

The benefits from the utilization of telepharmacy and the generally positive reception patients have toward it make it likely that telepharmacy will become a permanent fixture in the pharmacy field. The prevailing view is that

telemedicine should play an adjunct role in healthcare and not replace in- person care.

Many questions remain to be studied regarding the use and effectiveness of telemedicine and telepharmacy and what these technologies should look like in healthcare.32 As discussed above, one question is whether a meaningful number of states will cooperate with a multistate licensing program.65 Other questions include: How will this technology impact the patient-clinician relationship and trust? Will this relationship suffer from the loss of nonverbal communication and therapeutic touch?

Will patient-focused mobile applications replace some appointments, as they are beginning to do with prescription digital therapeutics? Could an artificial intelligence format like ChatGPT help with patient counseling?48 For example, could an artificial intelligence application start an appointment, and a pharmacist or prescriber take over to complete the interaction? For pharmacist-technician remote telepharmacy, will the technician have more artificial intelligence tools that a pharmacist may review, resulting in less discussion time?

Summary

Telemedicine is probably more than one hundred years old. Originally conceived to serve remote, rural communities, telepharmacy has been expanding to reach other underserved areas. The COVID-19 pandemic further spurred the social and public health conditions. Telepharmacy is a more specific form of telemedicine. It is defined as the use of telecommunications technology in pharmacy practice in which pharmacists conduct or oversee pharmacy staff in the different aspects of pharmacy operations or patient-care services from a long distance. Pharmacy technicians in a remote dispensing site pharmacy should cease dispensing medications when the supervising pharmacist at the central pharmacy is unavailable.

There are clear benefits to telepharmacy. Telepharmacy services provide pharmacy access to rural communities that would be underserved without it. Telepharmacy also provides pharmacists with more opportunities to deliver clinical services. Patient response to telepharmacy has been positive, and its potential use in promoting beneficial lifestyle changes in patients has been recognized. Also, telepharmacy provides a vehicle for the delivery of pharmacy services when mandatory social distancing is instituted. However, pharmacists should know counseling errors may be higher in remote pharmacy services.

While telepharmacy offers many benefits to patients and pharmacists, its use has disadvantages and barriers. These include the impact that telepharmacy may have on empathy and trust in the pharmacist-patient relationship, telesecurity and HIPAA compliance within telepharmacy, computer or technological literacy, monopolization of telepharmacy by national pharmacies, and the issues due to the different state and federal laws applicable to telepharmacy. Telepharmacy is here to stay but should play an adjunct role in pharmacy practice and not replace in-person services.

Course Test

Telepharmacy was initially used in North Dakota to

provide pharmacy services to Native American homelands.

provide pharmacy services to remote rural regions that experienced pharmacy closures.

provide pharmacy services during COVID-19 lockdowns.

enhance communications among different healthcare professionals.

What percentage of the United States population resides in rural areas?

Less than 10%

About 20%

About 1 in 3

Roughly half

A “pharmacy desert” describes a geographic area where

the pharmacy technician is the primary person interacting with patients

telepharmacy is the primary source of pharmacy services.

telemedicine has replaced in-person healthcare.

patients have difficulty accessing pharmacy services and obtaining their medications.

Which of the following is correct regarding pharmacy Kiosks?

Kiosks are permitted in only one state

Kiosks first emerged in response to COVID

A pharmacist can authorize dispensing of medication from a kiosk remotely via an audio-visual link

Kiosks act as vending machines with no pharmacist oversight

In the remote pharmacy setting, pharmacists must pay special attention to

over-the-counter purchases by patients.

pandemic-related challenges.

counseling errors, which can occur at a higher rate when they are counseling patients remotely.

whether patients are visiting their local brick-and-mortar pharmacy.

True or False: Pharmacy technicians in a remote dispensing site pharmacy should close the remote site when the supervising pharmacist at the central pharmacy is unavailable.

True

False

Which of the following is CORRECT regarding state restrictions on remote pharmacies?

Pharmacy technicians do not need to be certified in any state to work at a remote dispensing site.

If a pharmacy or pharmacist is licensed in a state, other states must accept the license and cannot require the pharmacy or pharmacist to be licensed within their state.

Most states permit pharmacists to supervise any number of technicians remotely as long as the pharmacist can handle it.

Most states require that the pharmacy and pharmacist be licensed within the state.

In the post-COVID-19 period, pharmacies utilizing telepharmacy technologies

need to monitor state and federal laws and guidelines on telehealth.

do not need to comply with HIPAA rules.

can no longer dispense controlled substances remotely.

need to encourage their patients to use the brick-and-mortar pharmacies.

What is the Ryan Haight Online Pharmacy Consumer Protection Act intended to do?

Regulate mail-order pharmacies

Limit the number of supervised technicians in remote pharmacy sites

Place limitations on prescribing opioids during the COVID emergency

Limit prescribing of controlled substances over the internet

Which of the following describes the DEA’s position on telepharmacies?

The DEA considers telepharmacy operations to be online pharmacies

The DEA has a specific legal definition of telepharmacy

The DEA does not have any jurisdiction over telepharmacies

The DEA does not permit dispensing of controlled substances by remotely operated pharmacies.

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DISCLAIMER

The information provided in this course is general in nature, and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

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