Rule 24.174.1302 - TELEPHARMACY OPERATIONS(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.Mont. Admin. r. 24.174.1302
NEW, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2010 MAR p. 2968, Eff. 12/24/10; AMD, 2012 MAR p. 896, Eff. 4/27/12.37-7-201, MCA; IMP, 37-7-101, 37-7-201, 37-7-321, MCA;