New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.9 - OPERATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. A remote
				tele-pharmacy shall comply with all standards of
				16.19.6.8
				NMAC governing the procedure for obtaining a license to operate a pharmacy in
				New Mexico.
(1) The license holder of the hub
				pharmacy must apply for a license to operate a remote tele-pharmacy. A remote
				tele-pharmacy license is established for the purpose of conducting a remote
				tele-pharmacy. The license is issued to a remote tele-pharmacy connected to a
				hub pharmacy via an electronic link. The initial licensure fee and subsequent
				license renewal fee are the same as those for retail pharmacies, as required by
				Subsection E of
				16.19.12.13
				NMAC.
(2) A remote tele-pharmacy
				that operates under different ownership than the hub pharmacy to which it is
				attached; shall have a written contractual agreement outlining the
				responsibilities of each pharmacy. This written agreement shall be submitted
				with the initial licensure application for a remote tele-pharmacy. Any
				subsequent changes to that contractual agreement shall be submitted to the
				board's executive director for approval. The applicant must provide sufficient
				evidence that the addition of a tele-pharmacy will augment or expand the
				availability of pharmacy services and pharmacy access within the proposed area
				of location.
(3) A remote
				tele-pharmacy shall comply with all the applicable requirements for a pharmacy
				as contained in 16.19.6 NMAC, including the requirement that all medications
				are stored under proper conditions.
(4) A remote tele-pharmacy shall be connected
				to a hub pharmacy via HIPAA-compliant electronic link. All links must be fully
				operational during all hours of operation of the remote tele-pharmacy. If the
				link malfunctions, the remote tele-pharmacy must be closed to the public unless
				a pharmacist is physically present at the remote tele-pharmacy site.
(a) Video equipment must be capable of
				providing not less than four simultaneous camera views of the pharmacy
				operation at the remote tele-pharmacy.
(b) The video equipment at the remote
				tele-pharmacy site must be capable of resolution sufficient to allow for
				pharmacist identification of medication dosage forms and the reading of bottle
				labels via video camera.
(c) The
				video equipment at the remote tele-pharmacy site must be capable of recording
				and maintaining at least 90 days of video surveillance of the remote
				tele-pharmacy site and operations for future review.
(d) Only a remote tele-pharmacy technician
				designated for that site or a pharmacist who is physically present at the
				remote tele-pharmacy may access a remote tele-pharmacy site, linked to a hub
				pharmacy via an electronic link.
(e) The remote tele-pharmacy may only remain
				open to the public as long as the designated pharmacy technician is present in
				the remote tele-pharmacy and the hub pharmacist is providing indirect
				supervision from the hub pharmacy or the hub pharmacist is physically present
				at the remote site.
(f) The name of
				each certified pharmacy technician that works at a remote tele-pharmacy shall
				be recorded with the board.
(5) The remote tele-pharmacy shall utilize
				bar coding or similar technology that effectively recognizes the drug or device
				selected to fill the prescription is the same as indicated on the prescription
				label.
(6) The hub pharmacy and hub
				pharmacist are responsible for ensuring fulfillment of all pharmacist
				responsibilities in accordance with
				16.19.4.16
				NMAC.
(7) Written policies and
				procedures must be submitted to the board prior to the issuance of any license.
				The pharmacist-in-charge is responsible for the development, implementation,
				maintenance, and review of written policies and procedures for the safe and
				effective operation of the remote tele-pharmacy and the oversight by the hub
				pharmacy. These policies and procedures shall comport with board regulations
				and laws and shall be available for board inspection in both the remote
				tele-pharmacy and the hub pharmacy. The policy and procedure manual shall be
				reviewed by the pharmacist-in-charge at least annually and revised if necessary
				to promote improvements in safety and service at the remote tele-pharmacy. The
				annual review and any changes to the manual shall be documented. The policy and
				procedure manual must address each of the following, at a minimum:
(a) standards and practices necessary to
				ensure safety, accuracy, security, and patient confidentiality;
(b) standards and practices necessary to
				ensure drugs and devices are procured, handled, stored, and dispensed or
				otherwise dispositioned in accordance with state and federal laws and
				regulations;
(c) identification of
				pharmacy personnel authorized to access drug storage and dispensing areas at
				the remote tele-pharmacy and to receive drugs delivered to the remote
				tele-pharmacy;
(d) standards and
				practices necessary to ensure all records are maintained in compliance with
				board laws and regulations;
(e)
				processes to assure the integrity, legitimacy and authenticity of
				prescriptions;
(f) criteria for
				monthly inspections conducted during pharmacist site visits and appropriate
				site visit documentations;
(g)
				medication error prevention;
(h)
				training standards and practices to ensure facility personnel are properly
				trained and comply with all applicable policies and procedures. Training shall
				be required for the remote tele-pharmacy technicians and pharmacists to ensure
				the competence and ability of each person that operates the electronic
				verification system, electronic record keeping, and communication systems.
				Technician training documentation shall be maintained in accordance with
				16.19.22 NMAC.
(8) The
				pharmacist-in-charge is responsible for an ongoing review of incident reports
				and outcomes, with appropriate corrective action taken and
				documented.
(9) The
				pharmacist-in-charge must ensure each remote tele-pharmacy location records,
				for each prescription dispensed, the identification of each pharmacist who
				performed:
(a) order interpretation;
(b) order entry verification;
(c) prospective drug utilization
				review;
(d) final order
				verification;
(e) any intervention
				required; and
(f) patient
				counseling, when there are no other means of definitively determining the
				identity of the pharmacist who provided counseling.
(10) A hub pharmacist shall not provide
				direct or indirect supervision for more than four pharmacies.
(11) The hub pharmacist must conduct
				pharmacist site visits and complete inspections of the remote tele-pharmacy at
				least once monthly. The pharmacist shall increase frequency of the monthly site
				visits if issues are identified, and additional pharmacist intervention shall
				be taken and documented until the issue is resolved. A list of inspection
				criteria shall be included in the policy and procedure manual for the remote
				tele-pharmacy. The pharmacist's inspection shall include a determination of the
				average number of prescriptions filled per day. A copy of the inspection report
				shall be reviewed and signed by the pharmacist-in-charge of the hub pharmacy
				and a copy of the inspection report shall be maintained at both the remote
				tele-pharmacy and at the hub pharmacy for the board of pharmacy
				inspection.
(12) The number of
				pharmacy technicians that a hub pharmacist shall oversee shall be limited
				according to
				16.19.22.10
				NMAC. Any pharmacy technician on duty at the hub pharmacy site shall be taken
				into account along with any remote tele-pharmacy technicians working at a
				remote tele-pharmacy site, when computing the ratio of pharmacists to pharmacy
				technicians.
(13) A remote
				tele-pharmacy may have a dangerous drug inventory. Any controlled substances
				shall be kept at the remote site in accordance with 16.19.20 NMAC.
(a) If controlled substances are kept, the
				remote tele-pharmacy shall be registered with the drug enforcement
				administration and obtain a DEA number.
(b) If controlled substances are kept, the
				remote tele-pharmacy shall have a valid New Mexico controlled substance
				registration as required in 16.19.20 NMAC.
(c) All controlled substances kept in
				inventory by the remote tele-pharmacy shall be listed on a perpetual inventory
				log, which shall be updated upon the dispensing of each controlled substance
				prescription or other disposition.
(d) The pharmacist shall perform monthly
				inventory of all controlled substances during pharmacist site visits to the
				remote tele-pharmacy. If a perpetual reconciliation is not achieved through the
				use of technology, the pharmacist shall perform and document a complete monthly
				reconciliation.
(14)
				Prescriptions may be received, entered and filled or re-filled by the hub
				pharmacy and sent to the remote tele-pharmacy for distribution to the patient
				during hours when the technician is present in the remote tele-pharmacy. A
				pharmacist at the hub pharmacy must complete a final check of each prescription
				before it leaves the remote tele-pharmacy site, in accordance with Subsection B
				of
				16.19.4.16
				NMAC.
(a) The pharmacist's initials and the
				technician's initials shall be recorded.
(b) The pharmacist shall compare the stock
				bottle, drug dispensed and drug strength. The entire prescription label must be
				checked for accuracy. All prescriptions distributed by the remote-
				tele-pharmacy must have the label affixed to the prescription container prior
				to being inspected by the pharmacist via electronic link.
(15) Patient counseling shall be done by a
				hub pharmacist via patient-pharmacist audio-visual link in accordance with
				Subsection F of
				16.19.4.16
				NMAC.
(16) A remote tele-pharmacy
				is limited to filling no more than 200 prescriptions per day. If filling more
				than 200 prescriptions per day, the remote tele-pharmacy shall be converted to
				a retail pharmacy and is subject to all applicable requirements of 16.19.6
				NMAC.
(17) No drug compounding
				shall occur at any remote tele-pharmacy.
(18) All records required by this part shall
				be kept on-site at the tele-pharmacy for a period of at least three years and
				shall be readily retrievable for inspection by the board or the board's
				agent.