[Submitted electronically to www.regulations.gov]
Administrator Anne Milgram
Drug Enforcement Administration
Attn:Liaison and Policy Section
8701 Morrissette Drive
Springfield, VA 22152
RE: Comments on RIN 1117-AB74/Docket No. DEA-759. The Drug Enforcement Administration (DEA) is issuing this advanced notice of proposed rulemaking to obtain further information regarding the practice of telepharmacy. Telepharmacy is not specifically defined by the Controlled Substances Act (CSA) or DEA regulations; however, to the extent telepharmacies dispense controlled substances, they are under the purview of the CSA and DEA.
Dear Administrator Milgram:
ASHP (American Society of Health-System Pharmacists) is pleased to submit comments to the Drug Enforcement Administration (DEA) regarding the request for information on telepharmacy and further implementation of electronic prescribing of controlled substances (EPCS). ASHP is the collective voice of pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings spanning the full spectrum of medication use. The organization’s more than 60,000 members include pharmacists, student pharmacists, and pharmacy technicians. For 80 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
ASHP thanks DEA for the opportunity to comment on the request for information. We hope that our feedback will assist DEA in refining the telepharmacy and electronic prescribing of controlled substances to meet our shared patient care and quality goals.
Request for Information on Telepharmacy
Formalizing a Definition of Telepharmacy:
ASHP recommends that DEA create a formalized definition of telepharmacy under the telehealth umbrella of patient care. Telepharmacy should be defined as a method used in pharmacy practice in which a pharmacist utilizes telecommunication technology to oversee aspects of pharmacy operations or provide patient care services. Telepharmacy operations and services may include, but are not limited to, drug review and monitoring, dispensing, sterile and nonsterile compounding verification, comprehensive medication management (CMM), patient assessment, patient counseling, clinical consultation, outcomes assessment, decision support, and drug information. A formal definition of pharmacist care within telepharmacy should not restrict practices related to prescribing and monitoring of controlled substances within their scope of practice.
Additionally, a distinction should be made between telepharmacy dispensing and distribution and telepharmacy drug use review and drug therapy monitoring.
- Telepharmacy dispensing and distribution: This should define the ability for a patient to fill a prescription via an automated kiosk after a remote pharmacist reviews and authorized the dispensing of a prescription. Pharmacists are available for consultation 24/7 with the alternative option for a pharmacist to work remotely, while technicians and staff are filling prescriptions under remote pharmacist oversight.
- Telepharmacy drug use review and drug therapy monitoring: This facet of telepharmacy should fall under clinical telepharmacy services and should include patient counseling and direct patient care such as a clinical pharmacist doing telehealth medication management as part of a coordinated care team of providers.
Telepharmacy Remote sites and Automated Machine Ownership:
Comments from ASHP members reveal that the typical situation for ownership is that pharmacies and remote sites and automated machines have the same owner. Remote sites and automated machines are operated in most cases are operated by the closest pharmacy in proximity. ASHP is in favor of a hub pharmacy solution because it would keep ownership and record keeping clear. The automated dispensing machines should be owned and under the same pharmacy license as the pharmacy it is located so consultations, dispenses and refilling the machine can be tracked with the utmost transparency.
Location of Remote Sites and Automated Machines:
Comments from ASHP members showed that the location of remote sites and automated dispensing machines varies; however, a number of variables help to dictate the location. These variables include distance to closest pharmacy, lack of services in a particular area, sociodemographics, and state legislature allowances. The information considered in the sociodemographics variable includes food-desert status, crime statistics for the area, and concentrated numbers of patients needing pharmacy services.
Telepharmacy Pharmacists and Telepharmacy Support Staff Training:
ASHP supports the ability of appropriately trained and equipped pharmacists to use telepharmacy to remotely oversee pharmacy operations and provide distributive, clinical, analytical, and managerial services. Telepharmacy should be leveraged to suitable functions of pharmacy operations and patient care to improve patient outcomes, expand access to healthcare, and enhance patient safety. ASHP further advocates that boards of pharmacy adopt compatible regulations that enable the use of U.S.-based telepharmacy services within and across state lines for appropriate practice settings and that further research be conducted to establish best practices for telepharmacy.
ASHP advocates for states to regulate training and education for pharmacists and support staff engaging in telepharmacy to allow for a safe environment for telepharmacy to be readily used. ASHP members have commented that training for telepharmacy has been offered through their facilities and practice sites.
Additionally, ASHP and other organizations offer accreditation and certificate programs for practice sites and individual practitioners of telepharmacy and telehealth services. These programs educate pharmacy professionals about best practices for telepharmacy a guides the user through all of the processes and situations a practice site could experience. The accreditation program is divided into three learning categories: practice management, patient care services, and quality improvements.
The training and education requirements need to be standardized in order to guarantee the same quality of care across telepharmacy. Allowing different training to apply to different localities create a disparity that is not conducive to consistency. ASHP members have commented urging DEA to provide consistency across telepharmacy regulation.
Pharmacist Oversight of Telepharmacy Technicians and Staff:
Pharmacists within ASHP’s membership are able to supervise technicians and staff remotely through virtual check-ins by utilizing a secure, real-time audio-and-video link and digital imaging cameras between pharmacist-staffed sites and remote pharmacies. Through the link, a pharmacist can view the original prescription and critical dispensing steps, speak with the pharmacy technician, and counsel patients when they pick up medications. The remote pharmacist observes through video link but must only engage and communicate with one pharmacy technician at a time. These check-ins allow for the pharmacist to account for all prescriptions and controlled substances. Additionally, pharmacists participate in weekly site visits to account for perpetually maintained controlled substances. Lastly, state laws and regulations may vary with respect to telepharmacy requirements (e.g., certain mile radius from pharmacy, support of a defined rural area, hospital bed size, closure of critical gaps in patient access, approve on a case-by-case basis).
Over the last several years there have been a number of instances where telepharmacy has been implemented prior to the COVID-19 pandemic in an effort to expand patient access, ease pharmacist shortages, and improve patient outcomes. Within the reference section of these comments are several examples of this implementation.
Pharmacist Remote Verification of Filled Prescriptions:
The final verification of prescriptions that are filled remotely are done through product image capture and in the cases of controlled substances images of counted groups of 5 and 10s. These images are logged into the system so it can be tracked and recorded. In most cases final verification are treated similarly to in-person verification with entering those images into the system after those prescriptions have been filled. Processes utilize a blend of technology checks (e.g., barcode scanning) and human verification checks via video-conferencing. After completing the normal dispensing practices, pharmacy technicians enter information into the electronic medical record. The supervising pharmacist reviews the label information, original prescription, and product. Once approved, the technician dispenses the medication to the patient while the pharmacist simultaneously renders medication counseling and education with the patient. The technology and systems today are more accurate than manual recordkeeping and there should be little difference to a virtual final verification than an in-person final verification. Images are saved for up to 5 years.
Additional Areas of Concern Regarding Telepharmacy:
ASHP requests that the DEA’s current definition of telepharmacy be expanded to align with a broader definition that the National Association of Boards of Pharmacy (NABP) endorses and be transparent about the elements of telepharmacy practice that DEA has regulatory authority to affect. DEA should not be more restrictive than it needs to be regarding telepharmacy due to the fact that it could impact pharmacy services in locations that would not have pharmacy services without telepharmacy.
ASHP members feel that pharmacists registered with DEA should be allowed to manage care with regards to controlled substances in a similar manner allowed by their state scope of practice as is any other recognized provider.
Finally, to address enhanced record keeping, DEA requires images of controlled substances within telepharmacy. Monthly auditing of filling and dispensing as well as signature capturing. These checks and balances will help curb diversion.
Electronic Prescriptions of Controlled Substances (EPCS) Regulation
Effect of EPCS Regulation Change:
Regulation to explicitly state that a DEA-registered retail pharmacy may transfer electronic prescriptions for schedule II-V controlled substances to another DEA-registered retail pharmacy for initial dispensing on a one-time basis would be helpful for our pharmacies. This change would allow for patients to be able to receive their medication in a timely manner by allowing a different pharmacy to fill the prescription should the original pharmacy not have the medication needed or if the prescription was sent to the wrong pharmacy. This would also allow for a reduction in duplicate prescriptions in the event of either of these scenarios.
Additionally, DEA should make special consideration of the possibility of a receiving care facility not having EPCS access. In this event, a paper version of the prescriptions, including those for controlled substances, would be necessary. The originating pharmacy would need there to be a place in regulation that would allow for the prescription to be printed in order to transfer the documentation on that prescription to the new pharmacy and the electronic version to be closed in the system.
In summary, ASHP appreciates the opportunity to offer our input and suggestions the request of information on telepharmacy and electronic prescribing of controlled substances. Please do not hesitate to contact Jillanne Schulte Wall at 301-664-8698 or [email protected] if ASHP can provide any further information or assist the agency in any way.
Vice President, Government Relations
American Society of Health-System Pharmacists(ASHP)
The instances of telepharmacy implementation as referenced in the pharmacist oversight of telepharmacy technicians and staff section can be viewed below:
Navy takes telepharmacy worldwide: https://doi.org/10.2146/news100051
Telepharmacy project aids North Dakota’s rural communities: https://doi.org/10.2146/news060013
Provision of pharmacy services to underserved populations via remote dispensing and two-way videoconferencing: https://doi.org/10.1093/ajhp/60.24.2577
Remote technician supervision up and running in Kansas: https://doi.org/10.2146/news120014
Wisconsin creates remote-dispensing law to ease pharmacist shortage: https://doi.org/10.2146/news080047
AZ Statute 32-1961.01. Remote dispensing site pharmacies: https://www.azleg.gov/ars/32/01961-01.htm
Current practices in state regulations regarding telepharmacy in rural hospitals: https://doi.org/10.2146/ajhp090531