| (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:
(I) identity of the system accessed;
(II) identification of the individual accessing the
system;
(III) date of transaction;
(IV) prescription number, drug name, strength, dosage
form;
(V) number of prescriptions retrieved;
(VI) name of the patient for whom the prescription
was retrieved;
(VII) name of prescribing practitioner; and
(VIII) name of pharmacist responsible for consultation
with the patient, if required, and documentation that the consultation
was performed.
(iii) Records of stocking or removal from an automated
storage and delivery system shall be maintained by the pharmacy and
include the:
(I) date;
(II) prescription number;
(III) name of the patient;
(IV) drug name;
(V) number of dispensed prescription packages stocked
or removed;
(VI) name, initials, or identification code of the
person stocking or removing dispensed prescription packages from the
system; and
(VII) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled;
(C) the pharmacy shall make the automated storage and
delivery system and any records of the system, including testing records,
available for inspection by the board; and
(D) the automated storage and delivery system records
a digital image of the individual accessing the system to pick-up
a prescription and such record is maintained by the pharmacy for two
years.
|
| Source Note: The provisions of this §291.121 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective September 14, 2010, 35 TexReg 8358; amended to be effective December 7, 2014, 39 TexReg 9358; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective June 7, 2018, 43 TexReg 3591; amended to be effective March 12, 2019, 44 TexReg 1334 |
