ASHP Statement on Telepharmacy

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22 Automation and Information Technology–Statements ASHP Statement on Telepharmacy

Position dards.”5 It further recommends that telepharmacy technology should be available for use in pharmacy departments ASHP believes appropriately trained and equipped pharma- “to enable remote supervision” and to “allow pharmacists to 5 cists can use telepharmacy to remotely oversee pharmacy interact with patients from a remote location.” operations and provide distributive, clinical, analytical, and managerial services. ASHP advocates that telepharmacy be Telepharmacy Applications applied to suitable functions of pharmacy operations and patient care to improve patient outcomes, expand access to Telepharmacy has demonstrated value in medication selec- healthcare, and enhance patient safety. ASHP further advo- tion, order review, and dispensing; i.v. admixture verifica- cates that boards of pharmacy adopt compatible regulations tion; patient counseling and monitoring; and the provision that enable the use of U.S.-based telepharmacy services of clinical services.6 Telepharmacy may be especially useful within and across state lines for appropriate practice settings in supporting settings that perform medication-use activities and that further research be conducted to establish best prac- when a pharmacist is not physically present or when phar- tices for telepharmacy. macy resources may be limited, such as in geographically isolated ambulatory care clinics and healthcare facilities.7 Background Telepharmacy also provides a solution for order review and verification in tertiary medical centers when staffing, par- Telemedicine. The Centers for Medicare and Medicaid ticularly in specialty areas such as oncology and pediatrics, Services (CMS) describes telemedicine as a means for im- is limited (e.g., due to attrition or staff turnover), creating proving a patient’s health by permitting two-way, real-time, a mechanism for health systems to provide enterprise-level interactive communication between a patient and a health- pharmacy services throughout the system even when not all care provider who are geographically separated.1 This com- pharmacies operate 24 hours per day. munication is conducted via interactive telecommunications equipment that includes, at a minimum, audio and video Medication Selection, Order Review, and Dispensing. A equipment to meet standards for telehealth set by the U.S. 2012 national survey of hospitals revealed that 34% of in- Department of Health and Human Services.2 It is impor- patient pharmacies operating in the United States did not 8 tant to recognize, however, that telemedicine is a rapidly offer 24-hour pharmacy coverage. Telepharmacy services evolving field and that new methods of telecommunica- can extend pharmacy coverage in hospitals that do not offer tions, such as texting and mobile applications, are already round-the-clock pharmacy services. Telepharmacy has suc- in use. Standards for interactive telecommunications equip- cessfully enabled pharmacists to become directly involved ment that include text and binary data must address interac- in the medication selection process for patients at geographi- tions with and without audio and video. The Food and Drug cally remote hospitals, review new medication orders trans- Administration (FDA) has established definitions, stan- mitted by fax or electronically, to remotely enter new orders dards, and methodologies for mobile medical applications.3 into a patient’s electronic medication profile, remotely re- lease the ordered medication from an automated medication Definitions of Telepharmacy. The Model State Pharmacy dispensing cabinet, and electronically supervise technicians 9-16 Act and Model Rules of the National Association of Boards in the performance of full-service pharmacy operations. of Pharmacy (Model Act) defines the practice of tele- In one case, critical access hospitals and rural referral hos- pharmacy as “the provision of pharmacist care by registered pitals developed a common workflow and technologies to pharmacies and pharmacists located within U.S. jurisdictions create a common electronic health record and monitor medi- through the use of telecommunications or other technologies cation dispensing and administration, improving patient care 17 to patients or their agents at distances that are located within and medication process quality and safety. Pharmacies are U.S. jurisdictions” and provides definitions of related terms now using mobile applications and the Internet to receive (i.e., coordinating pharmacy, remote pharmacy, and remote requests for refill orders from patients and to transfer pre- 18 dispensing site).4 For the purposes of this document, ASHP scriptions. defines telepharmacy as a method used in pharmacy practice in which a pharmacist utilizes telecommunications technol- I.V. Admixture Verification. Although technology systems ogy to oversee aspects of pharmacy operations or provide for remote checking of i.v. admixture preparation were origi- patient care services. Telepharmacy operations and services nally designed to reduce contamination risk by decreasing may include, but are not limited to, drug review and moni- the need for pharmacists to physically enter sterile com- toring, dispensing, sterile and nonsterile compounding veri- pounding areas to review and verify finished preparations, fication, medication therapy management (MTM), patient these and similar technologies can be used for verification assessment, patient counseling, clinical consultation, out- of admixtures at different stages of preparation, across mul- comes assessment, decision support, and drug information. tiple sites, and over long distances.19 The technologies also reduce exposure risk by reducing the number of pharmacy Practice Advancement Initiative. The ASHP Practice personnel and other providers required to handle hazard- Advancement Initiative states that “sufficient pharmacy ous medications such as chemotherapy. Documentation can resources must be available to safely develop, implement, also be enhanced with these systems, as images capture lot and maintain technology-related medication-use safety stan- numbers and expiration dates in addition to the step-by-step Automation and Information Technology–Statements 23 processes of preparation. Some of these systems perform healthcare, whether online, mobile, or inhouse.38 Pharmacists in-process verification steps (e.g., barcode verification of communicating with a patient via a mobile application should correct product selection, gravimetric verification of addi- ensure that the application is compliant with FDA standards.3 tive quantities), which provide additional assurance to the See the appendix for a list of federal resources. remote pharmacist that the preparation is correct. State Regulation. The Model Act, while not a federal stan- Patient Counseling and Monitoring. Pharmacists have dard, provides boards of pharmacy with model language been using telecommunications technology to counsel pa- for developing state laws or board rules.4 The Model Act tients about the proper use of their medications for as long defines telepharmacy-related terms and provides require- as telephone service lines have been available. Early exam- ments for remote pharmacy services. Many states now have ples of pharmacists employing videoconferencing technol- specific regulations for telepharmacy.39 These state laws ogy to counsel geographically remote patients include the and regulations, however, demonstrate wide variation in outreach program by a federally qualified health center in the application and control of telepharmacy systems.40,41 eastern Washington State20 and another program in North States have various descriptions of telepharmacy, includ- Dakota.21,22 The Indian Health Service has also imple- ing remote order management with or without dispensing mented videoconferencing technology to provide pharma- using automated dispensing cabinets, remote supervision of cist services to remote areas of Alaska,23 and the U.S. Navy medication order filling with or without automated medi- has deployed the use of this technology worldwide.24 Other cation order dispensing, and inpatient dispensing activities examples include the use of videoconferencing to provide (including i.v. preparation). State laws and regulations vary 25 26 MTM, pharmacist-managed anticoagulation, and mental based on the definition of telepharmacy, licensing require- 27 health services. Implementation of intensive care unit tele- ments, education and training for participating pharmacists medicine services, including telepharmacy, led to decreased and technicians, practice setting restrictions, and geographic durations of hospitalization, an increase in institutional best- limitations for the remotely practicing pharmacist. State practice adherence, and lower rates of preventable compli- laws and regulations also vary widely regarding the tech- 28 cations. Pharmacists are being encouraged to use mobile nology required to implement telepharmacy. Although most applications to communicate with patients to help them stipulate a camera and some audio exchange between the 29,30 manage their diseases and medications. pharmacy and the remote pharmacist, the specification of the types of technology (video versus still, telephone versus Expanding Pharmacy Services. Telepharmacy can be uti- voice over Internet protocol) and the types and amounts of lized to allow onsite pharmacy activities to be fulfilled even transactional information captured vary widely. Some state if the pharmacist is not physically located at the point of boards of pharmacy have identified specific training, certifi- pharmacy operation or patient care. As of 2016, most ar- cation, or experience that pharmacy technicians engaged in eas of the country were not experiencing severe pharmacist telepharmacy must possess.42 31 shortages. However, work force issues continue to plague As the use of telepharmacy expands, state board of 32 rural areas. Many small rural hospitals rely on contracts pharmacy regulations and state laws regarding the use of with local retail pharmacists to provide pharmacy services telepharmacy will increase. ASHP advocates that state gov- at the hospital. Telepharmacy can allow those pharmacists ernments adopt laws and regulations that standardize tele- to devote their limited onsite time to the oversight of drug pharmacy practices across state lines and facilitate the use of therapy management, inventory, controlled substances, and U.S.-based telepharmacy services. ASHP further advocates policy and procedure development rather than real-time or- that boards of pharmacy and state agencies that regulate der review and verification. In addition, telepharmacy ef- pharmacy practice address the following in regulations for fectively allows for the work of 1 pharmacist to be spread telepharmacy services: (1) education and training of partici- across several small-volume hospitals, permitting them to pating pharmacists, (2) education, training, and certification share the expense of such services and creating an opportu- by the Pharmacy Technician Certification Board and licen- nity to provide 24-hour pharmacy services. ASHP supports sure of participating pharmacy technicians, (3) communica- the implementation of telepharmacy services in rural areas tion and information systems requirements, (4) remote order to increase the availability and scope of clinical pharmacy entry, prospective order review, verification of the com- 33 services. Other facilities may utilize telepharmacy services pleted medication order before dispensing, and dispensing, for supplemental workload balancing, which includes net- (5) direct patient care services, including MTM services and 34 work workload balancing and on-call assistance. patient counseling and education, (6) licensure (including reciprocity) of participating pharmacies and pharmacists, Federal and State Regulation (7) service arrangements that cross state borders, (8) service arrangements within the same corporate entity or between Federal Regulation. Federal regulation of telepharmacy different corporate entities, (9) service arrangements for has evolved over the years. CMS has established stan- workload relief in the point-of-care pharmacy during peak dards for telehealth.2 The Health Insurance Portability and periods, (10) pharmacist access to all applicable patient in- Accountability Act35 (HIPAA) and subtitle D of the Health formation, and (11) development and monitoring of patient Information Technology for Economic and Clinical Health safety, quality, and outcomes measures.43 (HITECH) Act,36 which was enacted as part of the American In addition, some state legislatures have passed laws Recovery and Reinvestment Act of 2009,37 address privacy ensuring that insurance reimbursement for telemedicine and security concerns associated with the electronic trans- is the same as that for nontelemedicine services. Whether mission of health information. FDA has jurisdiction over these statutes can or will be applied to telepharmacy ser- medical software and equipment that may be involved in vices in those states remains unanswered. 24 Automation and Information Technology–Statements

Because telepharmacy is continuously evolving, the the electronic medical record, and workstation session per laws and regulations that address it will need to evolve as AH5 after periods of inactivity. well. Before the implementation of any telepharmacy services, it is important to review the laws and regulations in Conclusion the jurisdictions in which the provider and receiver of care are located. The laws and regulations should be reviewed Telepharmacy is a method in which a pharmacist uti- on a regular basis after implementation to ensure continued lizes telecommunications technology to oversee aspects compliance and to assess the appropriate use of telephar- of pharmacy operations or provide patient-care services. macy and its potential overuse. Telepharmacy allows expanded coverage, improved patient safety, and improved communication among patients, Telepharmacy Infrastructure healthcare providers, and pharmacists and is supported by ASHP. Variability in laws among states and evolving reg- The technology infrastructure required for the implementa- ulations must be closely monitored when implementing tion and maintenance of telepharmacy services may be scal- telepharmacy services. ASHP advocates more research be able and adjusted to fit the care setting. Two intrasystem conducted to investigate best practices for implementing facilities may already share a network, a pharmacy informa- telepharmacy services. tion system, and possibly an order management system. In this scenario, perhaps the only additional equipment needed References is a digital communication system for the transmission of any orders not provided via computerized provider order 1. Centers for Medicare and Medicaid Services. entry. Telemedicine. www.medicaid.gov/Medicaid-CHIP- In contrast, the intersystem model provides telephar- Program-Information/By-Topics/Delivery-Systems/ macy services to a facility external to the health system. In Telemedicine.html (accessed 2017 Jan 25). extreme situations, a facility may not have a pharmacy in- 2. 42 CFR 410.78—telehealth services. www.gpo.gov/ formation system, necessitating the purchase of a pharmacy fdsys/pkg/CFR-2004-title42-vol2/pdf/CFR-2004- title42-vol2-sec410-78.pdf (accessed 2017 Jan 24). module to allow for the implementation of remote pharmacy 3. Food and Drug Administration. Mobile medical appli- services. cations. www.fda.gov/medicaldevices/digitalhealth/ Audiovisual equipment used to verify pharmaceutical mobilemedicalapplications/default.htm (accessed products at the remote facility must include high-resolution 2015 Nov 12). cameras. While most states do not require video rather than 4. National Association of Boards of Pharmacy. Model still imaging, one state recommends that equipment include State Pharmacy Act and Model Rules of the National a high-resolution video camera and a document camera for Association of Boards of Pharmacy. https://nabp. reading unit dose packages or verifying parenteral doses.39 pharmacy/publications-reports/resource-documents/ It is also suggested that equipment be mounted on a mobile model-pharmacy-act-rules/ (accessed 2017 Jan 24). cart to be used in the medication preparation area, at the 5. American Society of Health-System Pharmacists. The automated dispensing cabinet, or at the patient’s bedside. consensus of the Pharmacy Practice Model Summit. ASHP supports the utilization of properly implemented Am J Health-Syst Pharm. 2011; 68:1148-52. telepharmacy services and calibrated digital telemedicine 6. Calenda S, Levesque C, Groppi J, et al. 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Field MJ, ed. Telemedicine: a guide to assessing telecom- Organizations munications in health care. Washington, DC: National Organizations that can provide assistance for implement- Academy Press; 1996:36. ing telepharmacy technologies to ensure compliance with Food and Drug Administration. Guidance for industry, com- federal regulations and national standards include the fol- puterized systems used in clinical trials. www.gpo. lowing: gov/fdsys/pkg/FR-1999-05-10/pdf/99-11735.pdf (accessed 2017 Jan 24). • National Committee on Vital and Health Statistics Food and Drug Administration. General principles of soft- (NCVHS) ware validation; final guidance for industry and FDA • ANSI Accredited Standards Committee staff. www.fda.gov/downloads/MedicalDevices/ • Committee on Operating Rules for Information DeviceRegulationandGuidance/GuidanceDocuments/ Exchange (CORE), Council for Affordable Quality ucm085371.pdf (accessed 2017 Jan 24). Healthcare (CAQH) Garrelts J, Gagnon M. Improve coverage with remote phar- • NACHA—Electronic Payments Association (formerly macy services. Pharm Purch Prod. 2011; 8.10:20-3. National Automated Clearing House Association) Hash J, Bowen P, Johnson A, et al. An introductory re- • National Council for Prescription Drug Programs source guide for implementing the Health Insurance (NCPDP) Portability and Accountability Act (HIPAA) security • Workgroup for Electronic Data Interchange (WEDI) rule. NIST Special Publication 800-66. www.cypherix. • Medicare Electronic Data Interchange (EDI) com/docs/nist_security_rules.pdf. Moldenhauer ET. Remote checking of prescriptions in Various agencies have provided grant funding to off- Navy health facilities. Am J Health-Syst Pharm. 2005; set some of the equipment and installation costs. Granting 62:1866-7. agencies include the following: Thorne A, Williamson S, Jellison T, et al. Implementation of home-based medication order entry at a community • U.S. Department of Agriculture (USDA) hospital. Am J Health-Syst. Pharm. 2009; 66:1939-42. • Office of the National Coordinator for Health Information Technology (ONC) Web Resources • U.S. Department of Health and Human Services, American Society of Health-System Pharmacists. ASHP Health Resources and Services Administration statement on bar-code-enabled medication admin- (HRSA) istration technology. www.ashp.org/DocLibrary/ • Office for the Advancement of Telehealth (OAT) BestPractices/AutoITStBCMA.aspx (accessed 2017 • Telehealth Resource Center (TRC) Jan 25). • Office of Rural Health Policy American Telemedicine Association. Telemedicine, • Federal Communications Commission (FCC) telehealth, and health information technology: an • Universal Service Administrative Company—Rural ATA issue paper (May 2006). https://higherlog- Health Care Division (USAC-RHCD) icdownload.s3.amazonaws.com/AMERICAN • USDA Distance Learning and Telemedicine Loan and TELEMED/3c09839a-fffd-46f7-916c-692c11d78933/ Grant Program (USDA–DLT) UploadedImages/Policy/telemedicine-telehealth-and- • Centers for Medicare and Medicaid Services (CMS) health-information-technology.pdf (accessed 2017 Jan • Agency for Healthcare Research and Quality (AHRQ) 25). • Private foundations Czech A. USDA Recovery Act grant helps establish a telepharmacy to help seniors, town residents, in Minnesota. http://blogs.usda.gov/2010/09/17/usda-recovery-act- grant-helps-establish-a-telepharmacy-to-help-seniors- Developed through the ASHP Section of Pharmacy Informatics and town-residents-in-minnesota/ (accessed 2017 Jan 25). Technology and approved by the ASHP Board of Directors on June Federal Communications Commission. Rural telemedicine 8, 2016, and by the ASHP House of Delegates on November 18, program funds 16 more broadband telehealth net- 2016. works. http://hraunfoss.fcc.gov/edocs_public/attach- match/DOC-296348A1.doc (accessed 2017 Jan 25). ASHP gratefully acknowledges the following organizations and Health Resources and Services Administration. Telehealth individuals for reviewing this statement (review does not imply programs. www.hrsa.gov/ruralhealth/telehealth/ (ac- endorsement): Association of Medical Directors of Information cessed 2017 Jan 25). Systems; Great Plains Telehealth Resource and Assistance Center; Health Resources and Services Administration. North Dakota Pharmacists Association; North Dakota State Board Telepharmacy rescues drug stores, improves health of Pharmacy; Parata Systems; Leslie Addison, M.P.H.; John A. care and creates jobs in North Dakota towns. https:// Armitstead, M.S., FASHP; Sarah Bledsoe, Pharm.D.; Adam D. dcp.psc.gov/osg/pharmacy/documents/pac0509g.pdf Boon, BCPS; John Bowman, B.S.Pharm., M.S.; Jeff Brittain, (accessed 2017 Jan 25). Pharm.D., BCPS; Michelle Casey, M.S.; Thomas Cerbone, Minnesota Board of Pharmacy. Remotely engaging in dis- B.S.Pharm.; Philip Chan, Pharm.D.; Christine Ciolko, B.S.Pharm.; pensing activities (January 2012). https://nabp.phar- Jennifer Cui, B.S.; Kenneth Dandurand, M.S.; Doina Dumitru, macy/wp-content/uploads/2016/06/MN012012.pdf Pharm.D., M.B.A.; Stacy Elder, Pharm.D., BCPS; Abimbola (accessed 2017 Jan 25). Farinde, Pharm.D., M.S.; Michelle DeLuca Fraley, Pharm.D.; North Dakota State University. Telepharmacy. www.ndsu. Barbara Giacomelli, Pharm.D., M.B.A., FASHP; Kerry Goldrosen, edu/telepharmacy (accessed 2017 Jan 25). Pharm.D.; Erkan Hassan, Pharm.D., FCCM; Philip E. Johnson, Automation and Information Technology–Statements 27

M.S.; Nishaminy Kasbekar, Pharm.D., FASHP; Patricia Andrea Darr, Pharm.D., BCPS, Avera eCARE, Sioux Falls, SD. Kienle, M.P.A., FASHP; Jim Lile, Pharm.D., FASHP; Kevin Matthew T. Jenkins, Pharm.D., M.S., University of Virginia Health Marvin, M.S., FASHP, FHIMSS; Patrick McDonnell, Pharm.D.; System, Charlottesville, VA. Candis M. Morello, Pharm.D., CDE, FCSHP, FASHP; Linda A. Nelson, Pharm.D.; Eric C. Nemec, Pharm.D., BCPS; Brandon Robert D. Long, B.S.Pharm., Banner Churchill Community Ordway, Pharm.D., M.S.; Fred J. Pane, B.S.Pharm., FASHP; James Hospital, Fallon, NV. Ponto, M.S., BCNP, FASHP; Curt W. Quap, M.S., FASHP; Traci Colleen J. Shipman, Pharm.D., M.P.H., BCPS, Department of Synderman, B.S.Pharm.; Shelly Spiro, B.S.Pharm.; John P. Swenson, Pharmacy, Oregon Health and Science University, Portland, OR. B.S.Pharm., M.S., FASHP; Jenny Szparkowski, Pharm.D., FASHP; James A. Trovato, Pharm.D., M.B.A., BCOP, FASHP; Laura Timothy P. Stratton, Ph.D., BCPS, FAPhA, Department of Pharmacy Tyndall, Pharm.D.; Ray Vrabel, Pharm.D.; Jody Jacobsen Wedret, Practice and Pharmaceutical Sciences, University of Minnesota B.S.Pharm., FASHP, FCSHP; Stewart R. Wirebaugh, Pharm.D., College of Pharmacy, Duluth, MN. FASHP; and William Yee, Pharm.D., FCSHP, FASHP. Copyright © 2017, American Society of Health-System Pharmacists, The authors have declared no potential conflicts of interest. Inc. All rights reserved.

Emily Alexander, Pharm.D., BCPS, Envision Telepharmacy LLC, The bibliographic citation for this document is as follows: American Alpine, TX. Society of Health-System Pharmacists. ASHP statement on tele- C. David Butler, Pharm.D., M.B.A., Teradata, Richmond, VA. pharmacy Am J Health-Syst Pharm. 2017; 74:e236-41.