| (III) the facility's healthcare environment.
(iii) A current list of the drugs stored in each remote
site's emergency medication kit shall be maintained by the provider
pharmacy and a copy kept with the emergency medication kit.
(iv) An automated pharmacy system may be used as an
emergency medication kit provided the system limits emergency access
to only those drugs approved for the emergency medication kit.
(v) Drugs for use in an emergency medication kit shall
be packaged in the original manufacturer's container or prepackaged
in the provider pharmacy and labeled in compliance with the board's
prepackaging requirements for the class of pharmacy.
(F) Stocking emergency medication kits.
(i) Stocking of drugs in an emergency medication kit
shall be completed at the provider pharmacy or remote site by a pharmacist,
pharmacy technician, or pharmacy technician trainee under the direct
supervision of a pharmacist, except as provided in clause (ii) of
this subparagraph.
(ii) If the emergency medication kit is an automated
pharmacy system which uses bar-coding, microchip, or other technologies
to ensure that the containers or unit dose drugs are accurately loaded,
the prepackaging of the containers or unit dose drugs shall occur
at the provider pharmacy unless provided by a FDA approved repackager.
The prepackaged containers or unit dose drugs may be sent to the remote
site to be loaded into the machine by personnel designated by the
pharmacist-in-charge provided:
(I) a pharmacist verifies the container or unit dose
drug has been properly filled and labeled;
(II) the individual containers or unit dose drugs 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 or
unit dose drugs are accurately loaded in the automated pharmacy system.
(iii) All drugs to be stocked in the emergency medication
kit shall be delivered to the remote site by the provider pharmacy.
(G) Policies and procedures of operation.
(i) A provider pharmacy that provides pharmacy services
through an emergency medication kit 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) duties which may only be performed by a pharmacist;
(II) a copy 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 in fulfilling
the terms of the contract in compliance with federal and state laws
and regulations;
(III) date of last review/revision of the policy and
procedure manual; and
(IV) policies and procedures for:
(-a-) security;
(-b-) operation of the emergency medication kit;
(-c-) preventative maintenance of the automated pharmacy
system if the emergency medication kit is an 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 emergency medication kit 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 emergency medication kit which is an automated pharmacy system
shall maintain a written plan for recovery from an event which interrupts
the ability of the automated pharmacy system to provide emergency
medications. 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 emergency medication
kit in compliance with §291.34(b) 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) A prescription drug order shall be maintained by
the provider pharmacy as the record of removal of a drug from an emergency
medication kit for administration to a patient.
(ii) The remote site shall notify the provider pharmacy
electronically or in writing of each entry into an emergency medication
kit. Such notification may be included on the prescription drug order
or a separate document and shall include the name, strength, and quantity
of the drug removed, the time of removal, and the name of the person
removing the drug.
(iii) A separate record of stocking, removal, or dispensing
for administration from an emergency medication kit shall be maintained
by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug
stocked, removed, or dispensed for administration;
(III) name, initials, or identification code of the
person stocking, removing, or dispensing for administration, drugs
from the system;
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled; and
(V) unique prescription number assigned to the prescription
drug order when the drug is administered to the patient.
(E) 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, 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.
(c) Remote pharmacy services using telepharmacy systems.
(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 healthcare facility that is not at the same location
as a Class A or Class C pharmacy through a telepharmacy system as
outlined in §562.110 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when
used in this section, 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) Prepackaging--The act of repackaging and relabeling
quantities of drug products from a manufacturer's original commercial
container into a prescription container for dispensing by a pharmacist
to the ultimate consumer.
(B) Provider pharmacy--The community pharmacy (Class
A) or the institutional pharmacy (Class C) providing remote pharmacy
services.
(C) Remote site--a facility not located at the same
location as a Class A or Class C pharmacy, at which remote pharmacy
services are provided using a telepharmacy dispensing system.
(D) Remote pharmacy service--The provision of pharmacy
services, including the storage and dispensing of prescription drugs,
drug regimen review, and patient counseling, at a remote site.
(E) Still image capture--A specific image captured
electronically from a video or other image capture device.
(F) Store and forward--A video or still image record
which is saved electronically for future review.
(G) Telepharmacy system--A system that monitors the
dispensing of prescription drugs and provides for related drug use
review and patient counseling services by an electronic method which
shall include the use of the following types of technology:
(i) audio and video;
(ii) still image capture; and
(iii) store and forward.
(H) Unit-of-use--A sufficient quantity of a drug for
one normal course of therapy as determined by the pharmacist-in-charge
and the prescribing practitioner(s) at the healthcare facility.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy
services using a telepharmacy system to:
(i) a rural health clinic regulated under 42 U.S.C.
Section 1395x(aa), as amended;
(ii) a health center as defined by 42 U.S.C. Section
254b, as amended; or
(iii) healthcare facility located in a medically underserved
area as defined by state or federal law.
(B) A provider pharmacy may not provide remote pharmacy
services if a Class A (Community) or Class C (Institutional) pharmacy
that dispenses prescription drug orders to out-patients is located
in the same community. For the purposes of this subsection a community
is defined as:
(i) the census tract in which the remote site is located,
if the remote site is located in a Metropolitan Statistical Area (MSA)
as defined by the United States Census Bureau in the most recent U.S.
Census; or
(ii) within 10 miles of the remote site, if the remote
site is not located in a MSA.
(C) The provider pharmacy shall have sufficient pharmacists
on duty such that each pharmacist may supervise no more than three
remote sites that are simultaneously open to provide services. An
exception to the supervision limit may be granted by the board in
situations where the provider has documented a need for a pharmacist
to supervise additional remote sites and has demonstrated that appropriate
safeguards are in place to assure proper supervision of each remote
site.
(D) Before providing remote pharmacy service, the telepharmacy
system at the off-site facility must be tested by the provider pharmacy
and found to operate properly. The provider pharmacy shall make the
results of such testing available to the board upon request.
(E) 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.
(F) The pharmacist-in-charge of the provider pharmacy
is responsible for all operations at the remote site including supervision
of the telepharmacy system and compliance with this section.
(4) Operational standards.
(A) Application to provide pharmacy services using
a telepharmacy system.
(i) A Class A or class C Pharmacy shall make application
to the board to provide remote pharmacy services using a telepharmacy
system. The application shall contain an affidavit with the notarized
signatures of pharmacist-in-charge, and the medical director or the
person responsible for the on-site operation of the facility (e.g.,
administrator, owner, chief executive officer, chief operating officer),
and include the following:
(I) the name, address, and license number of the provider
pharmacy;
(II) name and address of the healthcare facility where
the remote pharmacy services will be provided;
Cont'd... |
