| (i) A remote site shall be under the continuous supervision
of a provider pharmacy pharmacist at all times the site is open to
provide pharmacy services. To qualify as continuous supervision, the
pharmacist is not required to be physically present at the remote
site and shall supervise electronically through the use of the following
types of technology:
(I) audio and video;
(II) still image capture; and
(III) store and forward.
(ii) Drugs shall be stored in compliance with the provisions
of §291.15 and §291.33(f)(2) of this title including the
requirements for temperature and handling of outdated drugs.
(iii) Drugs for use in the telepharmacy system at a
remote healthcare site shall be stored in an area that is:
(I) separate from any other drugs used by the healthcare
facility; and
(II) locked by key, combination or other mechanical
or electronic means, so as to prohibit access by unauthorized personnel.
(iv) Drugs for use in the telepharmacy system at a
remote dispensing site shall be stored in an area that is locked by
key, combination, or other mechanical or electronic means, so as to
prohibit access by unauthorized personnel.
(v) Access to the area where drugs are stored at the
remote site and operation of the telepharmacy system shall be limited
to:
(I) pharmacists employed by the provider pharmacy;
(II) licensed healthcare providers, if the remote site
is a remote healthcare site; and
(III) pharmacy technicians;
(vi) Individuals authorized to access the remote site
and operate the telepharmacy system shall:
(I) be designated in writing by the pharmacist-in-charge;
and
(II) have completed documented training concerning
their duties associated with the telepharmacy pharmacy system.
(vii) Remote sites shall have adequate security and
procedures to:
(I) comply with federal and state laws and regulations;
and
(II) maintain patient confidentiality.
(D) Prescription dispensing and delivery.
(i) A pharmacist at the provider pharmacy shall conduct
a drug regimen review as specified in §291.33(c) of this title
prior to delivery of the dispensed prescription to the patient or
patient's agent.
(ii) The dispensed prescription shall be labeled at
the remote site with the information specified in §291.33(c)
of this title.
(iii) A pharmacist at the provider pharmacy shall perform
the final check of the dispensed prescription before delivery to the
patient to ensure that the prescription has been dispensed accurately
as prescribed. This final check shall be accomplished through a visual
check using electronic methods.
(iv) A pharmacist at the provider pharmacy shall counsel
the patient or patient's agent as specified in §291.33(c) of
this title. This counseling may be performed using electronic methods.
Non-pharmacist personnel may not ask questions of a patient or patient's
agent which are intended to screen and/or limit interaction with the
pharmacist.
(v) If the remote site has direct access to the provider
pharmacy's data processing system, only a pharmacist or pharmacy technician
may enter prescription information into the data processing system.
(vi) Drugs which require reconstitution through the
addition of a specified amount of water may be dispensed by the remote
site only if a pharmacy technician, pharmacy technician trainee, or
licensed healthcare provider reconstitutes the product.
(vii) A telepharmacy system located at a remote dispensing
site may not dispense a schedule II controlled substance.
(viii) Drugs dispensed at the remote site through a
telepharmacy system shall only be delivered to the patient or patient's
agent at the remote site.
(E) Quality assurance program. A pharmacy that provides
remote pharmacy services through a telepharmacy system at a remote
site shall operate according to a written program for quality assurance
of the telepharmacy system which:
(i) requires continuous supervision of the telepharmacy
system at all times the site is open to provide remote pharmacy services;
and
(ii) establishes mechanisms and procedures to routinely
test the operation of the telepharmacy 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.
(i) A pharmacy that provides pharmacy services through
a telepharmacy 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:
(-a-) have access to the area where drugs are stored
at the remote site; and
(-b-) operate the telepharmacy system;
(II) duties which may only be performed by a pharmacist;
(III) if the remote site is located at a remote healthcare
site, a copy of the written contact or agreement between the provider
pharmacy and the healthcare facility which outlines the services to
be provided and the responsibilities and accountabilities of each
party in fulfilling the terms of the contract or agreement in compliance
with federal and state laws and regulations;
(IV) date of last review/revision of policy and procedure
manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the telepharmacy system;
(-c-) sanitation;
(-d-) storage of drugs;
(-e-) dispensing;
(-f-) supervision;
(-g-) drug and/or device procurement;
(-h-) receiving of drugs and/or devices;
(-i-) delivery of drugs and/or devices; and
(-j-) recordkeeping
(ii) A pharmacy that provides remote pharmacy services
through a telepharmacy 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
through a telepharmacy system shall maintain a written plan for recovery
from an event which interrupts the ability of a pharmacist to electronically
supervise the telepharmacy system and the dispensing of prescription
drugs at the remote site. The written plan for recovery shall include:
(I) a statement that prescription drugs shall not be
dispensed at the remote site, if a pharmacist is not able to electronically
supervise the telepharmacy system and the dispensing of prescription
drugs;
(II) procedures for response when a telepharmacy system
is experiencing downtime; and
(III) procedures for the maintenance and testing of
the written plan for recovery.
(6) Additional operational standards for remote dispensing
sites.
(A) A pharmacist employed by a provider pharmacy shall
make at least monthly on-site visits to a remote site. The remote
site shall maintain documentation of the visit.
(B) A pharmacist employed by a provider pharmacy shall
be physically present at a remote dispensing site when the pharmacist
is providing services requiring the physical presence of the pharmacist,
including immunizations.
(C) A remote dispensing site shall be staffed by an
on-site pharmacy technician who is under the continuous supervision
of a pharmacist employed by the provider pharmacy.
(D) All pharmacy technicians at a remote dispensing
site shall be counted for the purpose of establishing the pharmacist-pharmacy
technician ratio of the provider pharmacy which, notwithstanding Section
568.006 of the Act, may not exceed three pharmacy technicians for
each pharmacist providing supervision.
(E) A pharmacy technician working at a remote dispensing
site must:
(i) have worked at least one year at a retail pharmacy
during the three years preceding the date the pharmacy technician
begins working at the remote dispensing site; and
(ii) have completed a training program on the proper
use of a telepharmacy system.
(F) A pharmacy technician at a remote dispensing site
may not perform sterile or nonsterile compounding. However, a pharmacy
technician may prepare commercially available medications for dispensing,
including the reconstitution of orally administered powder antibiotics.
(7) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) accessible 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 remote site shall maintain original prescription
drug orders for medications dispensed from a remote site using a telepharmacy
system in the manner required by §291.34(b) of this title and
the provider pharmacy shall have electronic access to all prescription
records.
(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 by 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) Patient medication records. Patient medication
records shall be created and maintained at the remote site or provider
pharmacy in the manner required by §291.34(c) of this title.
If such records are maintained at the remote site, the provider pharmacy
shall have electronic access to those records.
(D) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs ordered and dispensed
by a remote site separate from the records of the provider pharmacy
and from any other remote site's records;
(II) keep a perpetual inventory of all controlled substances
that are received and dispensed or distributed from each remote site.
The perpetual inventory shall be reconciled, by a pharmacist employed
by the provider pharmacy, at least monthly.
(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 at the provider pharmacy.
(III) A copy of the inventory of the remote site shall
be maintained at the remote site.
(d) Remote pharmacy services using automated storage
and delivery 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 facility that is not at the same location as the Class
A or Class C pharmacy through an automated storage and delivery system.
(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.
(A) Automated storage and delivery system--A mechanical
system that delivers dispensed prescription drugs to patients at a
remote delivery site and maintains related transaction information.
(B) Deliver or delivery--The actual, constructive,
or attempted transfer of a prescription drug or device or controlled
substance from one person to another, whether or not for a consideration.
(C) Dispense--Preparing, packaging, compounding, or
labeling for delivery a prescription drug or device in the course
of professional practice to an ultimate user or his agent by or pursuant
to the lawful order of a practitioner.
(D) Provider pharmacy--The community pharmacy (Class
A) or the institutional pharmacy (Class C) providing remote pharmacy
services.
(E) Remote delivery site--A location at which remote
pharmacy services are provided using an automated storage and delivery
system.
Cont'd... |
