In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a variety of ways. Many state boards of pharmacy are proactively issuing guidance for pharmacies on emergency prescription refills, pharmacy closings, garb shortages, waiver requests, sterile compounding, and remote work order entry.
State pronouncements and positions are changing constantly. To assist pharmacies in understanding the current landscape, we have compiled a list of state specific pronouncements affecting pharmacy operations available here and a list of state regulations related to emergency refills available here. In the absence of state guidance, many pharmacies are reaching out to boards of pharmacy for feedback on work from home plans and other emergency matters. In light of the current climate, reaching boards is proving more difficult than usual.
In addition to state-specific announcements related to COVID-19, pharmacies may also look to state statutes and regulations to determine whether it is permissible to let staff work from home, and if so, under what conditions. We have found that few states expressly address work from home permissions. When the state regulations do not expressly prohibit working from home, we recommend reviewing how the state defines the practice of pharmacy and whether regulations expressly link those defined activities to the physical pharmacy location. Also, reviewing pharmacist supervision requirements can clarify whether pharmacy technicians may work in a separate location from the pharmacist.
Examples of Boards of Pharmacy Announcements and Regulations Include
In California, the state Board of Pharmacy has issued several pharmacy law waivers for 30 days. For example, facilitating “work from home” Business and Professions Code § 4071.1(a) has been waived to permit pharmacists to remotely conduct order entry, other data entry, prospective drug utilization review, interpretation of clinical data, insurance processing, interpreting clinical data, and therapeutic intervention. However, this wavier does not permit the dispensing of a drug or final product verification by remote processing. The waiver also permits remote processing by pharmacy technicians and pharmacy interns for nondiscretionary tasks, including prescription or order entry and insurance processing of prescriptions for which a pharmacist is available for remote supervision. On March 19, 2020, the board authorized a waiver of staffing ratio provisions, permitting the ratio of pharmacists to pharmacy technicians to allow for one additional technician for each supervising pharmacist if certain conditions are satisfied.
The board has also waived signature requirements for a pharmacist accepting delivery of prescription drugs, and waived the requirement for a consulting pharmacist to perform quarterly visits to a clinic during the emergency if a desk audit is performed in lieu of an in-person visit and a report is generated. Board guidance has also addressed personal protective equipment shortages during compounding. Pharmacies may submit a waiver request in accordance with instructions found here.
On March 16, 2020, the Florida Department of Health issued an Emergency Order that suspended the provisions of Florida Statutes Chapter 465, related to pharmacy operations, which could limit distribution, dispensing, or administration of prescription drugs that could prevent mitigation of “any health-related condition.” Such provisions have been suspended for 30 days, but this does not relate to controlled substances. Arguably, this waiver can be relied upon to permit pharmacists to work from home, but the state board has not issued specific guidance on the topic.
Remote supervision of pharmacy technicians by pharmacists is permitted under Florida law. For tasks delegable to technicians in Florida, the technician must be “directly supervised” by a pharmacist who is aware of the tasks being delegated and is directly available. Fla. Admin. Code 64B16-27.4001(2). Direct supervision means supervision by a pharmacist who is “readily and immediately available” at all times the delegated tasks are being performed; who is aware of delegated tasks being performed; and who provides personal assistance, direction and approval throughout the time the tasks are being performed. “Readily and immediately available” means the pharmacist and technician(s) are on the same physical premises, or if not, technology is used to enable real time, two-way communications between the pharmacist and technician(s). Fla. Admin. Code 64B16-27.4001(2).
A pharmacist may employ technological means to communicate with or observe the pharmacy technician in complying with direct supervision requirements. If technology is being used to provide direct supervision of pharmacy technician(s), it should be sufficient to provide the personal assistance, direction and approval required to meet the standard of practice for the delegated tasks and the parties should comply with all applicable laws, including state and federal privacy and security laws. Fla. Admin. Code 64B16-27.4001(2). A pharmacist may not delegate engaging in prospective drug review, transferring a prescription, engaging in patient counseling, or receiving any new non-written prescription or making changes to medication or strength of an existing prescription. Fla. Admin. Code 64B16-27.420(2).
The Louisiana Board of Pharmacy issued a waiver allowing pharmacists to work from home and to access the pharmacy’s dispensing system to process prescription orders. The following requirements must be met:
- The pharmacy must establish controls to maintain the confidentiality of records.
- The pharmacist does not engage in receiving (or maintaining) written prescription or medical orders.
- No part of the pharmacy’s dispensing information system will be duplicated, downloaded, or removed from the pharmacy’s dispensing information system. In a separate guidance document, the board clarified that the waiver extends to “pharmacy personnel” including pharmacy interns, pharmacy technicians, and pharmacy technician candidates.
In Nevada, the Board of Pharmacy has issued a statement partially waiving existing regulations on remote site operations to permit pharmacy professionals (specifically including pharmacists, pharmacy interns, and technicians) to process prescriptions and medication orders from remote sites. See NAC 639.391-.399. Under the waiver, certain parameters exist such as requirements for appropriate policies, record keeping, and privacy. The remote processing permitted does not include dispensing, but may include receiving, interpreting, evaluating, clarifying, and approving prescriptions, as well as order entry, performing prospective drug utilization review, interpreting clinical data, insurance processing, performing therapeutic interventions, providing drug information services, and authorizing the release of medication for administration. The waiver expressly addresses pharmacy technicians permitting remote processing such as prescription or order entry, insurance processing, and clarifying prescriptions and medication orders. The board’s waiver clarified that a pharmacist may specifically provide direct or personal supervision of intern pharmacists and pharmaceutical technicians conducting remote processing via technological means.
Also in Nevada, upon request, the board is granting waiver requests of pharmacy regulations for up to 30 days to aid in the protection of public health or the provision of care after the state governor declared a state of emergency on March 12, 2020. Any licensee may submit a request for a waiver of pharmacy regulations via email to the state board for consideration and include a brief statement detailing the extent of the waiver sought, how the emergency caused the need for the wavier, and relevant law(s) for which the pharmacy is seeking a waiver.
The North Carolina Board of Pharmacy has issued guidance authorizing certain remote operations such as prescription order entry, prescription data verification, long-term care facility chart review, and dispensing PA/NP weekly review for pharmacists and pharmacy personnel to reduce person-to-person contact and preserve a pharmacist’s ability to ensure patient care. The board is encouraging efforts to adjust workflows to reduce person-to-person transmission. The board also created a pathway for the reactivation of certain pharmacist licenses in case of pharmacist shortages. The board has also issued a document on best practices for garb shortages and noted that it will exercise enforcement discretion during this time of limited supplies if a pharmacy can demonstrate it complied with best practices of documented supply limitations.
In Tennessee, Governor Lee issued Executive Order No. 15 on March 19, 2020, specifically suspending pharmacy laws to permit a pharmacist to dispense a 90-day supply of maintenance prescriptions without prior authorization to respond to and prevent the spread of COVID-19. The Executive Order also provides the state Commissioner of Health with discretion regarding pharmacist licensure requirements. The Executive Order also permits pharmacy technicians and pharmacists to complete computer-based processing of prescriptions at alternative locations, including residences, per the Health Insurance Privacy and Accountability Act of 1996. The Tennessee Board of Pharmacy has provided a link to guidance regarding the shortages of personal protective equipment, including masks and gowns, used in sterile compounding, but reminds pharmacists to ultimately “be safe” and use their professional judgment based on patient safety. The board has also provided a link to guidance on compounding alcohol-based hand sanitizer during the COVID-19 pandemic.
The Texas Board of Pharmacy has not yet issued any guidance directly on working remotely. Under Texas law, a pharmacist for a Class A community pharmacy may conduct a drug regimen review remotely by accessing the pharmacy’s electronic database from outside the pharmacy as long as the pharmacist is an individual Texas licensed and employee of the pharmacy. 22 Tex. Admin. Code § 291.33. Certain controls to protect the privacy of the patient and the security of confidential records are required. 22 Tex. Admin. Code § 291.33. Pharmacists are required to “directly supervise” technicians who are entering prescription data into the pharmacy’s data processing system by either being physically present or electronically. 22 Tex. Admin. Code § 291.32(D).
For electronic supervision, the pharmacist must comply with the following requirements:
- Can immediately communicate directly with the technician/trainee.
- Has immediate access to any original document containing prescription information or other information related to dispensing, including by imaging technology.
- Verifies the accuracy of the entered information before the release of the information to the system for storage and/or generation of the label.
It is not clear whether a pharmacist must be present on-site for a technician to perform any work in the pharmacy. Also, initialing and receiving refill authorization requests is an activity for which supervision is not clear.
A Class A pharmacy is required to be under the continuous on-site supervision of a pharmacist during the time it is open for pharmacy services (Tex. Occ. Code § 562.101); however, during an emergency, a Class A pharmacist-in-charge may be the pharmacist-in-charge of up to two Class A pharmacies simultaneously if such pharmacist works at least 10 hours per week in each pharmacy. 22 Tex. Occ. Code § 291.32. The Texas Board of Pharmacy rules define “emergency situation” as “an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacy services.” 22 Tex. Admin. Code § 291.127.
In Texas, the state board is encouraging email communication. The board has a link of COVID-19 resources, including guidance on emergency dispensing of prescription medications for up to a 30-day supply of a prescription drug, other than a Schedule II controlled substance, when specific conditions are met. It also provides guidance for sterile compounding pharmacies and notes that the board is aware of pharmacy challenges during this time and will take these into account during pharmacy inspections.
Overall, the states board of pharmacy responses to the COVID-19 pandemic have been varied throughout the country and are changing constantly. We recommend continuous monitoring of state board of pharmacy, Department of Health and other state websites as new guidance is being issued daily in response to new COVID-19 developments. If you have questions about interpreting the guidance, please contact one of the authors.