| (ii) within 10 miles of the remote site, if the remote
site is not located in an MSA.
(C) A provider pharmacy may not provide remote pharmacy
services at a remote dispensing site if a Class A pharmacy is located
within 22 miles by road of the remote dispensing site.
(D) If a Class A or Class C pharmacy is established
in a community in which a remote healthcare site has been located,
the remote healthcare site may continue to operate.
(E) If a Class A pharmacy is established within 22
miles by road of a remote dispensing site that is currently operating,
the remote dispensing site may continue to operate at that location.
(F) Before providing remote pharmacy services, the
telepharmacy system at the remote site 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.
(G) A provider pharmacy which is licensed as a Class
C pharmacy is required to comply with the provisions of §§291.31
- 291.34 of this title and this section.
(H) A provider pharmacy can only provide pharmacy services
at no more than two remote dispensing sites.
(4) Personnel.
(A) 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.
(B) The provider pharmacy shall have sufficient pharmacists
on duty such that each pharmacist may supervise no more than two remote
sites that are simultaneously open to provide services.
(C) The following duties shall be performed only by
a pharmacist at the provider pharmacy:
(i) receiving an oral prescription drug order for a
controlled substance;
(ii) interpreting the prescription drug order;
(iii) verifying the accuracy of prescription data entry;
(iv) selecting the drug product to be stored and dispensed
at the remote site;
(v) interpreting the patient's medication record and
conducting a drug regimen review;
(vi) authorizing the telepharmacy system to print a
prescription label at the remote site;
(vii) performing the final check of the dispensed prescription
to ensure that the prescription drug order has been dispensed accurately
as prescribed; and
(viii) counseling the patient.
(D) A pharmacy technician at the remote site may receive
an oral prescription drug order for a dangerous drug.
(5) Operational standards.
(A) Application to provide remote pharmacy services
using a telepharmacy system.
(i) A Class A or Class C pharmacy shall file a completed
application containing all information required by the board to provide
remote pharmacy services using a telepharmacy system.
(ii) Such application shall be resubmitted every two
years in conjunction with the renewal of the provider pharmacy's license.
(iii) On approval of the application, the provider
pharmacy will be sent a license for the remote site, which must be
displayed at the remote site.
(iv) If the average number of prescriptions dispensed
each day at a remote dispensing site is open for business is more
than 125 prescriptions, as calculated each calendar year, the remote
dispensing site shall apply for a Class A pharmacy license as specified
in §291.1 of this title (relating to Pharmacy License Application).
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing
within ten days of a discontinuance of service, or closure of a remote
site where a telepharmacy system is operated by the pharmacy.
(ii) A provider pharmacy shall comply with appropriate
federal and state controlled substance registrations for each remote
site, if controlled substances are maintained.
(iii) A provider pharmacy shall file a change of location
and/or name of a remote site as specified in §291.3 of this title.
(C) Environment/Security.
(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.
Cont'd... |
