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
Universal Citation: 16 NM Admin Code 16.19.33.9
Current through Register Vol. 35, No. 18, September 24, 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.
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