Remote Pharmacy Legislation
In an attempt to improve access to pharmacy services in rural areas, the Michigan legislature recently enacted Public Act 4 of 2020 (“PA 4”), permitting licensure of “remote pharmacies” in Michigan. Effective April 26, 2020, a “parent pharmacy” licensed and located in Michigan may obtain a license for a “remote pharmacy,” provided there is no licensed pharmacy within a 10 mile radius of the remote pharmacy location. The 10-mile rule does not apply if the remote pharmacy is located at a licensed hospital or mental health facility. The Board of Pharmacy may waive the mileage requirement upon application if the parent pharmacy demonstrates that the proposed remote pharmacy location is in an area where access to pharmacy services is limited, and there are compelling circumstances that justify the waiver. The parent pharmacy and the remote pharmacy must both be located in Michigan, and be under common ownership.
Surveillance and Telepharmacy System Requirements
Under PA 4, a remote pharmacy is not required to be under the “personal charge” of a licensed pharmacist, where personal charge is defined to require the pharmacist’s physical presence. Instead, “qualified pharmacy technicians” may provide pharmacy services at a remote pharmacy, provided they are overseen by a licensed pharmacist located at the parent pharmacy through the use of a “surveillance system” and a “telepharmacy system.” A “surveillance system” means a real-time, continuous audio and visual camera system that connects a pharmacist at the parent pharmacy to the remote pharmacy. “Telepharmacy system” means an interoperable computer system that: (a) shares real-time data and uses a real-time audio and video link to connect the pharmacist at the parent pharmacy to the remote pharmacy; and (b) uses a camera of sufficient resolution and quality to permit the pharmacist at the parent pharmacy to identify markings on tablets and capsules at the remote pharmacy. A licensed pharmacist may not simultaneously oversee the activities of more than 2 remote pharmacies.
Dispensing at a Remote Pharmacy
The parent pharmacy pharmacist overseeing the remote pharmacy must receive, review and verify an exact digital image of all prescriptions received at the remote pharmacy before a prescription may be dispensed. A prescription dispensed at a remote pharmacy is considered dispensed by the licensed pharmacist who oversees the remote pharmacy, but from the remote pharmacy location. Both the pharmacist and the qualified pharmacy technician involved in dispensing a drug shall sign or otherwise be identified on the prescription record, and all tasks performed by each of them during the dispensing process must be recorded in the pharmacy management system. A remote pharmacy may not dispense more than an average of 150 prescriptions per day during a 90-day period.
In the event the surveillance system or telepharmacy system stops working, or there is no licensed pharmacist physically on site at the parent pharmacy to oversee the remote pharmacy, the remote must immediately close to the public.
Staffing at a Remote Pharmacy
Qualified Pharmacy Technician. While nothing in PA 4 prohibits a remote pharmacy from being staffed with a licensed pharmacist all or part of the time, the purpose of the legislation is to permit operation without the physical presence of a licensed pharmacist. Therefore, PA 4 requires that if no licensed pharmacist is present, the remote pharmacy must be staffed by a “qualified pharmacy technician.” A qualified pharmacy technician is defined as an individual with a pharmacy technician license (other than a temporary or limited license) who has accumulated at least 1,000 hours of pharmacy work experience after obtaining his/her license, and who holds national certification as pharmacy technician from a Board-approved organization.
Pharmacist-in-Charge (“PIC”). PA 4 eliminates the current limitation that a pharmacist may serve as PIC only at one pharmacy, and requires the PIC at the parent pharmacy to serve as the PIC at the remote pharmacy. After April 26, 2020, a pharmacist may serve as PIC for not more than 3 pharmacies at once, including remote pharmacies. Further, as to a remote pharmacy, a PIC is not required to meet the usual requirement that he/she be physically present at the remote pharmacy for an average of 8 hours per week, and may instead satisfy the hours requirement through the telepharmacy system.
Remote Pharmacy Policies and Procedures
The PIC at the parent pharmacy must establish and maintain a written policy and procedure manual pertaining to operation of the remote pharmacy that includes all of the following:
A description of how the remote pharmacy will comply with state and federal laws and regulations.
The procedure by which a licensed pharmacist at the parent pharmacy will oversee the qualified pharmacy technician at the remote pharmacy.
The procedure for reviewing drug inventory and prescriptions and other records at the remote pharmacy.
Policy and procedure for providing adequate security to protect the confidentiality and integrity of patients’ protected health information at the remote pharmacy.
The procedure for recovering from an event that interrupts the pharmacist from overseeing the remote pharmacy through the surveillance and telepharmacy system, including a requirement that the remote pharmacy is closed to the public during such interruptions.
The remote pharmacy’s procedure for complying with the Michigan Automated Prescription System (MAPS) before dispensing a controlled substance.
A description of the specific tasks, acts and functions that a qualified pharmacy technician may perform at a remote pharmacy, which may not include consultation regarding medications or information in a patient record, or sterile/non-sterile compounding (except reconstitution per manufacturer’s directions).
A requirement that the PIC complete a monthly, in-person inspection of the remote pharmacy, which includes, at minimum, inventory reconciliation of controlled substances, and review surveillance video as needed.
A requirement that all video and audio recordings from the surveillance system be maintained for at least 45 days.
A requirement that the PIC post at the remote pharmacy in a conspicuous place visible to the public, a notice stating: (a) that pharmacy services are being provided at a remote pharmacy; (b) that if patient counseling is provided it may be provided by a pharmacist using audio and video communication; and (c) the address of the parent pharmacy.