Changes to Pharmacy Rules Governing Automated Storage and Delivery Systems Due to COVID-19
Health & Life Sciences Alert 04/02/20 Edward D. Rickert
In the wake of the COVID-19 pandemic, some state boards of pharmacy are suspending or modifying certain pharmacy rules to allow for the expanded use of patient-accessible remote automated pharmacy systems as a means of expanding access to pharmacy services, including the dispensing and delivery of prescription drugs.
Patient-accessible remote automated pharmacy systems are dispensing and delivery systems operated by a pharmacy to facilitate patient access to prescription medications from locations outside the licensed pharmacy. This technology has been approved in several states for deployment in a variety of settings, including hospitals, clinics, employer work-sites, and other locations where pharmacy services are not generally available. There are two types of patient accessible remote pharmacy systems in use. The first are storage and delivery systems that serve as prescription pick-up kiosks that store patient-specific medications that have already been filled by a pharmacy, and placed in the kiosk for retrieval by the patient. The second type of system is an automated dispensing system that stores non-patient-specific prescription drug inventory in unit of use packaging. A pharmacist operates the system remotely, and through the use of bar code enabled robotics, the system is able to select, label, and deliver a patient's medication from the kiosk. Both types of systems are also typically equipped with technology to allow the patient to interact with the pharmacist via a real-time audio and video interface to facilitate patient counseling.
Many state boards of pharmacy already allow prescription pick-up kiosks and automated dispensing systems. In response to the COVID-19 pandemic, many other states are recognizing the patient care benefits of leveraging technology to expand access to pharmacy services. Prescription pick-up kiosks and automated storage, dispensing, and delivery systems are patient-accessible and allow patients to obtain their medications at locations that are remote from a pharmacy.
Presently, two states—Texas and South Carolina—have relaxed their pharmacy rules to allow for the use of prescription pick-up kiosks and automated storage, dispensing, and delivery systems during the COVID-19 pandemic. In Texas, pharmacy regulations already allow for the use of prescription pick up kiosks. In order to expand access to pharmacy services, the Office of the Governor has temporarily suspended the requirements of the state's remote pharmacy services rules to allow for remote automated dispensing through automated dispensing systems. A copy of the Governor's Executive Order can be found here.
South Carolina's Board of Pharmacy has in the past allowed for the use of prescription kiosks through a waiver from existing regulations. However, the Board has temporarily lifted its rule that requires permittees to obtain approval from the Board and the Board's Practice and Technology Committee prior to deployment of that technology. A copy of the South Carolina Order can be found here. This will allow permittees to temporarily deploy prescription kiosks without appearing before the State's Practice and Technology Committee. That said, only previously approved models of pharmacy pickup kiosks can be deployed without prior approval pursuant to this order. Permittees choosing to deploy preapproved prescription kiosks must notify the Board Administrator and comply with all applicable provisions of South Carolina's Pharmacy Practice Act, including:
- Controlled substances requirements imposed by the Department of Health and Environmental Control; and
- Requirements to document any errors resulting from the use of pickup kiosks and appear before.
As a result of the COVID-19 pandemic, state boards of pharmacy are determining that strict compliance with certain dispensing laws could prevent, hinder, or delay the delivery of pharmaceutical services. With respect to automated storage and delivery systems, boards are recognizing the utility of these systems to expand access to pharmacy services, while reducing face-to-face contact between the public and pharmacy personnel and promoting social distancing.
We are continuously monitoring the COVID-19 situation and are here to help. For more information, contact your Quarles & Brady attorney or:
- Edward D. Rickert: (312) 715-5139 / [email protected]