Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule:
(1)
"Direct supervision" and "personal supervision" have the
same meaning as in rule
4729:3-1-01 of the
Administrative Code.
(2)
"Remote prescription entry" means the entry of
prescriptions for an outpatient pharmacy licensed as a terminal distributor of
dangerous drugs by a remote technician under the direct supervision or remote
supervision of a pharmacist. Remote prescription entry does not include
dispensing, interpreting, evaluating, or approval of prescriptions or any other
activities not permitted by state or federal laws, rules, and regulations.
Remote prescription entry may include clarifying prescriptions and other data
entry, including the processing of insurance coverage. The requirements of this
rule shall be limited to the entry of prescriptions dispensed in or into this
state.
(3)
"Remote pharmacy" means either:
(a)
A pharmacy
licensed as a terminal distributor of dangerous drugs that dispenses dangerous
drugs; or
(b)
A pharmacy licensed as a limited category II terminal
distributor of dangerous drugs which does not stock, own, or dispense any
dangerous drugs, and whose sole business consists of entry, review, and/or
verification of prescriber orders and consulting services under contract for
outpatient pharmacies in this state.
(4)
"Remote
supervision" means that a pharmacist directs and controls the actions of remote
technicians through the use of technology that ensures a supervising pharmacist
can meet the requirements listed in this paragraph. A pharmacist providing
remote supervision shall:
(a)
Be readily available to answer questions of a remote
technician; and
(b)
Be fully responsible for the practice and accuracy of
the remote technician.
(5)
"Remote
technician" means any of the following:
(a)
If performing
remote prescription entry in this state: an Ohio registered certified pharmacy
technician, registered pharmacy technician, or pharmacy technician trainee,
either employed or a contract employee of an outpatient pharmacy or remote
pharmacy, who either conducts prescription entry from a remote site, which may
include the technician's residence or other location where the technician and
the outpatient or remote pharmacy can ensure the confidentiality and integrity
of patient information, or on the premises of a remote pharmacy or outpatient
pharmacy; or
(b)
If performing remote prescription entry outside of this
state: a pharmacy technician who meets the following criteria:
(i)
The pharmacy
technician is licensed or registered in the state where the remote prescription
entry is occurring, or if working in a state that has not yet implemented a
technician registration process, has received training and is working as a
pharmacy technician in accordance with of the laws and regulations of their
state of practice; and
(ii)
The pharmacy technician is either employed or a
contract employee of an outpatient pharmacy or remote pharmacy who holds a
nonresident pharmacy license in accordance with Chapter 4729:5-8 of the
Administrative Code, who either conducts prescription entry from a remote site,
which may include the technician's residence or other location where the
technician and the outpatient or remote pharmacy can ensure the confidentiality
and integrity of patient information, or on the premises of a remote pharmacy
or outpatient pharmacy.
(c)
A nonresident
pharmacy shall be responsible for ensuring all actions performed by an
unregistered technician comply with the applicable requirements for conducting
remote prescription entry.
(d)
A remote
technician shall only be permitted to conduct remote prescription entry within
the United States, to include the District of Columbia, the Commonwealth of
Puerto Rico or a territory or insular possession subject to the jurisdiction of
the United States.
(B)
An outpatient
pharmacy may outsource prescription entry to a remote pharmacy provided the
pharmacies are under common ownership or control or the outpatient pharmacy has
entered into a written contract or agreement with a pharmacy that outlines the
services to be provided and the responsibilities and accountabilities of each
party to the contract or agreement in compliance with federal and state
statutes and regulations.
(C)
The outpatient pharmacy and remote pharmacy must
maintain a copy of the contract or agreement in a readily retrievable manner
for inspection and review by an agent, inspector, or employee of the
board.
(D)
An outpatient pharmacy utilizing remote prescription
entry shall ensure that all remote technicians providing such services have
been trained on the outpatient pharmacy's policies and procedures relating to
prescription entry.
(1)
The training of each remote technician shall be
documented. The outpatient pharmacy and the remote pharmacy shall jointly
develop a procedure to communicate changes in policies and procedures related
to prescription entry.
(2)
A terminal distributor of dangerous drugs may utilize
one training program for all outpatient pharmacies under the terminal
distributor's common ownership and control.
(E)
An outpatient
pharmacy utilizing remote technicians shall maintain or have access to a record
of the name and address of each technician, evidence of current licensure or
registration, and the address of each location where the technician will be
providing remote prescription entry services.
(F)
The outpatient
pharmacy shall ensure that any remote technician shall have secure electronic
access to the outpatient pharmacy's patient information system and to other
electronic systems that an on-site technician has access to when the pharmacy
is open.
(G)
Each remote entry record must comply with all
recordkeeping requirements for outpatient pharmacies, including capturing the
positive identification of the remote technician involved in the entry of the
prescription.
(H)
An outpatient pharmacy utilizing remote prescription
entry is responsible for maintaining records of all prescriptions entered into
their information system, including prescriptions entered by a remote
technician.
(I)
An outpatient pharmacy utilizing remote prescription
entry services shall develop and implement a policy and procedure manual. A
remote pharmacy shall maintain a copy of those portions of the policy and
procedure manual that relate to the remote pharmacy's operations. Each manual
shall include all the following:
(1)
An overview of the responsibilities of the outpatient
pharmacy and the remote pharmacy;
(2)
A list of the
names, addresses, telephone numbers, and all license numbers of the pharmacies
and remote technicians involved in remote prescription entry;
and
(3)
Policies and procedures for:
(a)
Protecting the
confidentiality and integrity of patient information;
(b)
Ensuring that no
patient information is duplicated, downloaded, or removed from the outpatient
pharmacy's patient information system;
(c)
Maintaining
appropriate records of each technician involved in prescription
entry;
(d)
Complying with federal and state statutes and
regulations; and
(e)
Reviewing written policies and procedures at least
every three years or upon the implementation of a significant change of written
policies and procedures and documentation of the review.
(J)
A pharmacy intern that is licensed in this or any other
state may engage in remote prescription entry pursuant to the requirements of
this rule.
