| (F) Remote pharmacy service--The provision of pharmacy
services, including the storage and delivery of prescription drugs,
in remote delivery sites.
(3) General requirements for a provider pharmacy to
provide remote pharmacy services using an automated storage and delivery
system to deliver a previously verified prescription that is dispensed
by the provider pharmacy to a patient or patient's agent.
(A) The pharmacist-in-charge of the provider pharmacy
is responsible for all pharmacy operations involving the automated
storage and delivery system located at the remote delivery site including
supervision of the automated storage and delivery system and compliance
with this section.
(B) The patient or patient's agent shall receive counseling
via a direct link to audio or video communication by a Texas licensed
pharmacist who has access to the complete patient medication record
(patient profile) maintained by the provider pharmacy prior to the
release of any new prescription released from the system.
(C) A pharmacist shall be accessible at all times to
respond to patients' or other health professionals' questions and
needs pertaining to drugs delivered through the use of the automated
storage and delivery system. Such access may be through a 24 hour
pager service or telephone which is answered 24 hours a day.
(D) The patient or patient's agent shall be given the
option whether to use the system.
(E) An electronic notice shall be provided to the patient
or patient's agent at the remote delivery site with the following
information:
(i) the name and address of the pharmacy that verified
the previously dispensed prescription; and
(ii) a statement that a pharmacist is available 24
hours a day, 7 days a week through the use of telephonic communication.
(F) Drugs stored in the automated storage and distribution
system shall be stored at proper temperatures, as defined in the USP/NF
and §291.15 of this title (relating to Storage of Drugs).
(G) A provider pharmacy may only provide remote pharmacy
services using an automated storage and delivery system to patients
at a board-approved remote delivery site.
(H) A provider pharmacy may provide remote pharmacy
services at more than one remote delivery site.
(I) Before providing remote pharmacy services, the
automated storage and delivery system at the remote delivery site
must be tested by the provider pharmacy and found to deliver accurately.
The provider pharmacy shall make the results of such testing available
to the board upon request.
(J) A provider pharmacy which is licensed as an institutional
(Class C) pharmacy is required to comply with the provisions of §§291.31
- 291.34 of this title (relating to Definitions, Personnel, Operational
Standards, and Records for Class A (Community) Pharmacies) and this
section.
(4) Operational standards.
(A) Application to provide remote pharmacy services
using an automated storage and delivery system.
(i) A community (Class A) or institutional (Class C)
pharmacy shall file a completed application containing all information
required by the board to provide remote pharmacy services using an
automated storage and delivery system.
(ii) Such application shall be resubmitted every two
years in conjunction with the application for renewal of the provider
pharmacy's license.
(iii) Upon approval of the application, the provider
pharmacy will be sent a certificate which must be displayed at the
provider pharmacy.
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing
within ten days of a discontinuance of service.
(ii) A provider pharmacy shall comply with appropriate
controlled substance registrations for each remote delivery site if
dispensed controlled substances are maintained within an automated
storage and delivery system at the facility.
(iii) A provider pharmacy shall file an application
for change of location and/or name of a remote delivery site as specified
in §291.3 of this title (relating to Notifications).
(C) Environment/Security.
(i) A provider pharmacy shall only store dispensed
drugs at a remote delivery site within an automated storage and delivery
system which is locked by key, combination or other mechanical or
electronic means so as to prohibit access by unauthorized personnel.
(ii) Access to the automated storage and delivery system
shall be limited to pharmacists, and pharmacy technicians or pharmacy
technician trainees under the direct supervision of a pharmacist who:
(I) are designated in writing by the pharmacist-in-charge;
and
(II) have completed documented training concerning
their duties associated with the automated storage and delivery system.
(iii) Drugs shall be stored in compliance with the
provisions of §291.15 (relating to Storage of Drugs) and §291.33(c)(8)
(relating to Returning Undelivered Medication to Stock) of this title,
including the requirements for temperature and the return of undelivered
medication to stock.
(iv) the automated storage and delivery system must
have an adequate security system, including security camera(s), to
prevent unauthorized access and to maintain patient confidentiality.
(D) Stocking an automated storage and delivery system.
Stocking of dispensed prescriptions in an automated storage and delivery
system shall be completed under the supervision of a pharmacist.
(E) Quality assurance program. A pharmacy that provides
pharmacy services through an automated storage and delivery system
at a remote delivery site shall operate according to a written program
for quality assurance of the automated storage and delivery system
which:
(i) requires continuous supervision of the automated
storage and delivery system; and
(ii) establishes mechanisms and procedures to routinely
test the accuracy of the automated storage and delivery system at
a minimum of every six months and whenever any upgrade or change is
made to the system and documents each such activity.
(F) Policies and procedures of operation.
(i) A pharmacy that provides pharmacy services through
an automated storage and delivery system at a remote delivery site
shall operate according to written policies and procedures. The policy
and procedure manual shall include, but not be limited to, the following:
(ii) A pharmacy that provides pharmacy services through
an automated storage and delivery system at a remote delivery site
shall, at least annually, review its written policies and procedures,
revise them if necessary, and document the review.
(iii) A pharmacy providing remote pharmacy services
using an automated storage and delivery system shall maintain a written
plan for recovery from an event which interrupts the ability of the
automated storage and delivery system to deliver dispense prescription
drugs. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated storage and delivery system is experiencing
downtime;
(II) procedures for response when an automated storage
and delivery system is experiencing downtime; and
(III) procedures for the maintenance and testing of
the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available,
for at least two years for inspecting and copying by the board or
its representative and to other authorized local, state, or federal
law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Pharmacy.
If the pharmacy maintains the records in an electronic format, the
requested records must be provided in an electronic format if specifically
requested by the board or its representative. Failure to provide the
records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records
in violation of the Act.
(ii) The provider pharmacy shall have a workable (electronic)
data retention system which can produce a separate audit trail of
drug delivery and retrieval transactions at each remote delivery site
for the preceding two years.
(B) Transaction information.
(i) The automated storage and delivery system shall
electronically record all transactions involving drugs stored in,
removed, or delivered from the system.
(ii) Records of delivery from an automated storage
and delivery system for a patient shall be maintained by the provider
pharmacy and include the:
Cont'd... |
