| (F) Remote pharmacy service--The provision of pharmacy
services, including the dispensing and delivery of prescription drugs,
in remote delivery sites.
(3) General requirements for a provider pharmacy to
provide remote pharmacy services using an automated dispensing and
delivery system to dispense and deliver a prescription that is verified
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
dispensing and delivery system located at the remote delivery site
including supervision of the automated dispensing 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
dispensing 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 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 dispensing and distribution
system shall be stored at proper temperatures, as defined in the USP/NF
and §291.15 of this title.
(G) A provider pharmacy may only provide remote pharmacy
services using an automated dispensing 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 dispensing and delivery system at the remote delivery site
must be tested by the provider pharmacy and found to dispense and
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 and this section.
(4) Operational standards.
(A) Application to provide remote pharmacy services
using an automated dispensing 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 dispensing 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
dispensing 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.
(C) Environment/Security.
(i) A provider pharmacy shall only store prescription
drugs at a remote delivery site within an automated dispensing 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 dispensing 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 dispensing and delivery
system.
(iii) Drugs shall be stored in compliance with the
provisions of §291.15 of this title and §291.33(c)(8) of
this title, including the requirements for temperature and the return
of undelivered medication to stock.
(iv) the automated dispensing 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 dispensing and delivery system.
Stocking of prescription drugs in an automated dispensing 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 dispensing and delivery system
at a remote delivery site shall operate according to a written program
for quality assurance of the automated dispensing and delivery system
which:
(i) requires continuous supervision of the automated
dispensing and delivery system; and
(ii) establishes mechanisms and procedures to routinely
test the accuracy of the automated dispensing 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 dispensing 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:
(I) a current list of the names and addresses of the
pharmacist-in-charge and all personnel designated by the pharmacist-in-charge
to have access to the prescription drugs stored in the automated dispensing
and delivery system;
(II) duties which may only be performed by a pharmacist;
(III) a copy of the portion of the written contract
or lease agreement between the pharmacy and the remote delivery site
location which outlines the services to be provided and the responsibilities
and accountabilities of each party relating to the operation of the
automated dispensing and delivery system in fulfilling the terms of
the contract in compliance with federal and state laws and regulations;
(IV) date of last review/revision of the policy and
procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the automated dispensing and delivery
system;
(-c-) preventative maintenance of the automated dispensing
and delivery system;
(-d-) sanitation;
(-e-) storage of prescription drugs;
(-f-) supervision;
(-g-) delivery of prescription drugs; and
(-h-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through
an automated dispensing 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 dispensing and delivery system shall maintain a
written plan for recovery from an event which interrupts the ability
of the automated dispensing and delivery system to dispense and deliver
prescription drugs. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated dispensing and delivery system is experiencing
downtime;
(II) procedures for response when an automated dispensing
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:
Cont'd... |
