| (II) the individual cartridges or containers are transported
to the remote site in a secure, tamper-evident container; and
(III) the automated pharmacy system uses bar-coding,
microchip, or other technologies to ensure that the containers are
accurately loaded in the automated pharmacy system.
(iii) All drugs to be stocked in the automated pharmacy
system shall be delivered to the remote site by the provider pharmacy.
(G) Quality assurance program. A pharmacy that provides
pharmacy services through an automated pharmacy system at a remote
site shall operate according to a written program for quality assurance
of the automated pharmacy system which:
(i) requires continuous supervision of the automated
pharmacy system; and
(ii) establishes mechanisms and procedures to routinely
test the accuracy of the automated pharmacy system at a minimum of
every six months and whenever any upgrade or change is made to the
system and documents each such activity.
(H) Policies and procedures of operation.
(i) A pharmacy that provides pharmacy services through
an automated pharmacy system at a remote 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 name and address of the pharmacist-in-charge
and personnel designated by the pharmacist-in-charge to have access
to the drugs stored in the automated pharmacy system;
(II) duties which may only be performed by a pharmacist;
(III) a copy of the portion of the written contract
or agreement between the pharmacy and the facility which outlines
the services to be provided and the responsibilities and accountabilities
of each party relating to the operation of the automated pharmacy
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 pharmacy system;
(-c-) preventative maintenance of the automated pharmacy
system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through
an automated pharmacy system at a remote 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 pharmacy system shall maintain a written plan for
recovery from an event which interrupts the ability of the automated
pharmacy system to dispense prescription drugs. The written plan for
recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated pharmacy system is experiencing downtime;
(II) procedures for response when an automated pharmacy
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 maintain original
prescription drug orders for drugs dispensed from an automated pharmacy
system in compliance with §291.34(b) of this title.
(iii) if prescription drug records are maintained in
a data processing system, the system shall have a workable (electronic)
data retention system which can produce a separate audit trail of
drug usage by the provider pharmacy and each remote site for the preceding
two years as specified in §291.34(e) of this title.
(B) Prescriptions. Prescription drug orders shall meet
the requirements of §291.34(b) of this title.
(C) Records of dispensing. Dispensing records for a
prescription drug order shall be maintained by the provider pharmacy
in the manner required by §291.34(d) or (e) of this title.
(D) Transaction information.
(i) The automated pharmacy system shall electronically
record all transactions involving drugs stored in, removed, or dispensed
from the system.
(ii) Records of dispensing from an automated pharmacy
system for a patient shall be maintained by the providing pharmacy
and include the:
(I) identity of the system accessed;
(II) identification of the individual accessing the
system;
(III) date of transaction;
(IV) name, strength, dosage form, and quantity of drug
accessed; and
(V) name of the patient for whom the drug was accessed.
(iii) Records of stocking or removal from an automated
pharmacy system shall be maintained by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug
stocked or removed;
(III) name, initials, or identification code of the
person stocking or removing drugs from the system; and
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled.
(E) Patient medication records. Patient medication
records shall be created and maintained by the provider pharmacy in
the manner required by §291.34(c) of this title.
(F) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned
from a remote site separate from the records of the provider pharmacy
and from any other remote site's records; and
(II) keep a perpetual inventory of controlled substances
and other drugs required to be inventoried under §291.17 of this
title (relating to Inventory Requirements) that are received and dispensed
or distributed from each remote site.
(ii) As specified in §291.17 of this title, a
provider pharmacy shall conduct an inventory at each remote site.
The following is applicable to this inventory.
(I) The inventory of each remote site and the provider
pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included
with, but listed separately from, the drugs of other remote sites
and separately from the drugs of the provider pharmacy.
(b) Remote pharmacy services using emergency medication
kits.
(1) Purpose. The purpose of this section is to provide
standards for the provision of pharmacy services by a Class A or Class
C pharmacy in a facility that is not at the same location as the Class
A or Class C pharmacy through an emergency medication kit as outlined
in §562.108 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when
used in this subsection, shall have the following meanings, unless
the context clearly indicates otherwise. All other words and terms
shall have the meanings defined in the Act or §291.31 of this
title.
(A) Automated pharmacy system--A mechanical system
that dispenses prescription drugs and maintains related transaction
information.
(B) Emergency medication kits--Controlled substances
and dangerous drugs maintained by a provider pharmacy to meet the
emergency medication needs of a resident:
(i) at an institution licensed under Chapter 242 or
252, Health and Safety Code; or
Cont'd... |
