Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.13 - Telepharmacy › Rule 24.174.1302 - TELEPHARMACY OPERATIONS

Current through Register Vol. 13, July 5, 2024
(1) A remote
				telepharmacy site shall be connected to its parent pharmacy via computer,
				video, and audio link.
(2) A site
				cannot be licensed as a remote telepharmacy site if it is located within a
				twenty-mile radius of an existing pharmacy.
(3) A remote telepharmacy site manned by a
				registered pharmacy technician shall access and use the parent pharmacy's
				central processing unit or common database.
(4) A remote telepharmacy site shall comply
				will all the requirements of pharmacy rules and statutes of Montana. The remote
				telepharmacy site is considered to be under the personal charge of the
				pharmacist at the parent pharmacy.
(a) The
				remote telepharmacy site must have a registered pharmacy technician present and
				a working computer, video, and audio link to a pharmacist at the parent
				pharmacy to have the prescription area open.
(b) The technician at the remote telepharmacy
				site must:
(i) be currently registered with
				the board;
(ii) be currently
				certified with the Pharmacy Technician Certification Board (PTCB), or Exam for
				the Certification of Pharmacy Technicians (ExCPT), or other board-approved
				certifying entity; and
(iii) have
				at least 500 hours experience as a pharmacy technician, technician-in-training,
				or experience deemed as equivalent by the board.
(c) The technician may unlock the
				prescription and storage areas. While the technician is on duty, the
				prescription area may remain open. Security standards for pharmacies shall be
				maintained at all times pursuant to ARM
				24.174.814.
(d) The technician will be subject to all
				rules of ARM
				24.174.701 through
				24.174.714.
(e) All prescription records and consecutive
				prescription numbers must be maintained at the parent pharmacy or remote site.
				The remote telepharmacy site must transmit copies of new prescriptions via
				secure electronic means to the parent pharmacy, keeping the original
				prescription blank at the remote telepharmacy site.
(f) Prescriptions filled at the remote
				telepharmacy site must be distinguishable in some manner from those filled at
				the parent pharmacy.
(g) Daily
				reports for both the parent pharmacy and remote telepharmacy site must be
				maintained at the parent pharmacy or telepharmacy site.
(h) The remote telepharmacy site may have a
				prescription inventory. Prescription medications including controlled
				substances shall be securely maintained at the remote telepharmacy site in
				accordance with current Montana pharmacy statutes and rules.
(i) If controlled substances are dispensed or
				handled, both the remote telepharmacy site and the parent pharmacy must be
				registered with the DEA and must obtain individual DEA numbers.
(j) All records must be stored at the parent
				pharmacy or telepharmacy site, except those required by DEA to be at a DEA
				registered site.
(k) The software
				system utilized must be able to generate labels from the parent pharmacy or at
				the remote telepharmacy site.
(l)
				The input of drug information may be done by a pharmacist at the parent
				pharmacy or a technician at either location if verified by a
				pharmacist.
(m) New prescriptions
				may be received at the parent pharmacy and entered there with a label printing
				at the remote telepharmacy site.
(n) New prescriptions received at the remote
				telepharmacy site may be entered into the computer system at the remote
				telepharmacy site. The pharmacist at the parent pharmacy remains responsible
				for all verification, interaction checking, and profile review.
(o) All filled prescriptions must have a
				label meeting the requirements of ARM
				24.174.511 attached to the final
				drug container before the pharmacist verifies the dispensing process.
(p) Unless the remote telepharmacy site is a
				remote telepharmacy dispensing machine site, a pharmacist shall compare via
				video link the stock bottle, drug dispensed, and strength. The entire label
				must be checked for accuracy on the video link.
(q) The computer, video, and audio link must
				be operational at all times. In the event of connectivity loss to the parent
				location, no new prescriptions may be processed, filled, or dispensed from the
				telepharmacy site until connectivity is reestablished. Refill prescriptions
				that have a final check by the pharmacist may be dispensed.
(r) A code containing both the pharmacist's
				and technician's initials must appear on the fill screen, patient profile, and
				prescription label.
(s) No
				prescription medication may be released to a patient until approved by a
				pharmacist in person or via the computer, video, and audio link.
(t) The pharmacist shall offer to counsel the
				patient or the patient's agent via video and/or audio link on all new
				prescriptions.
(u) When the
				technician is not present, dispensing and counseling via video and audio link
				may be done using a secure alternate delivery system with prior approval of the
				board.
(v) The license holder,
				agent of the parent pharmacy, or the pharmacist-in-charge of the parent
				pharmacy, or the pharmacist-in-charge of the remote site, if different from the
				parent pharmacist-in-charge, shall apply for a license for the remote
				telepharmacy site.
(w) As
				dispensing is considered to be done by the pharmacist, the pharmacist shall be
				responsible for and held accountable for dispensing at the remote telepharmacy
				site.
(x) Policies and procedures
				must be in place to ensure the safe and effective distribution of
				pharmaceutical products and delivery of required pharmaceutical care.
(y) The pharmacist at the parent pharmacy
				shall perform an ongoing analysis of incident reports and outcomes, with
				appropriate corrective action taken when necessary, to ensure patient
				safety.
(z) The pharmacist at the
				parent pharmacy or that person's designee shall conduct and complete monthly
				inspections of the remote telepharmacy site. Inspection criteria must be
				included in the policies and procedures for the site. The inspection report
				must be available for review at the next board inspection.