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 order entry" means the entry of medication
orders for an inpatient pharmacy licensed as a terminal distributor of
dangerous drugs by a remote technician under the direct supervision or remote
supervision of a pharmacist. Remote order entry does not include dispensing,
interpreting, evaluating, or approval of medication orders or any other
activities not permitted by state or federal laws, rules, and regulations.
Remote order entry may include clarifying orders and other data entry,
including the processing of insurance coverage. The requirements of this rule
shall be limited to the entry of orders 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
institutional 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 order 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 inpatient pharmacy or remote
pharmacy, who either conducts order 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 institutional
pharmacy; or
(b)
If performing remote order entry outside of this state:
a pharmacy technician who meets the following criteria:
(i)
The pharmacy
technician licensed or registered in the state where the remote order 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 institutional pharmacy or remote pharmacy who holds a
nonresident pharmacy license in accordance with Chapter 4729:5-8 of the
Administrative Code, who either conducts order 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
institutional 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 order entry.
(d)
A remote technician shall only be permitted to conduct
remote order 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
institutional pharmacy may outsource order entry to a remote pharmacy provided
the pharmacies are under common ownership or control or the institutional
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 inpatient
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 inpatient
pharmacy utilizing remote order entry shall ensure that all remote technicians
providing such services have been trained on the inpatient pharmacy's policies
and procedures relating to order entry.
(1)
The training of
each remote technician shall be documented. The inpatient pharmacy and the
remote pharmacy shall jointly develop a procedure to communicate changes in
policies and procedures related to order entry.
(2)
A terminal
distributor of dangerous drugs may utilize one training program for all
inpatient pharmacies under the terminal distributor's common ownership and
control.
(E)
An inpatient 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 order entry
services.
(F)
The inpatient pharmacy shall ensure that any remote
technician shall have secure electronic access to the inpatient 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 inpatient
pharmacies, including capturing the positive identification of the remote
technician involved in the entry of the medication order.
(H)
An inpatient
pharmacy utilizing remote order entry is responsible for maintaining records of
all orders entered into their information system, including orders entered by a
remote technician.
(I)
An inpatient pharmacy utilizing remote order 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 inpatient
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 order 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 inpatient pharmacy's patient information
system;
(c)
Maintaining appropriate records of each technician
involved in order 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 order entry pursuant to the requirements of this
rule.
