Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule:
(1)
"Remote medication order processing" means the processing of
a medication order for an institutional pharmacy licensed as a terminal
distributor of dangerous drugs by a remote pharmacist. Remote medication order
processing does not include the dispensing of a drug, but may include
receiving, interpreting, evaluating, clarifying, and approval of medication
orders. Additionally, remote medication order processing may include order
entry, other data entry, performing prospective drug utilization review,
interpreting clinical data, performing therapeutic interventions, providing
drug information services, and authorizing release of the medication for
administration. The requirements of this rule shall be limited to the
processing of medication orders dispensed in or into this
state.
(2)
"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 that 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.
(3)
"Remote
pharmacist" means any of the following:
(a)
If performing
remote medication order processing in this state: an Ohio licensed pharmacist,
either employed or a contract employee of an institutional pharmacy or remote
pharmacy, who either processes orders from a remote site, which may include the
pharmacist's residence or other location where the pharmacist and the
institutional 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 medication order processing outside of this state: a pharmacist licensed
or registered in the state where the remote medication order processing is
occurring, 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 processes prescriptions
from a remote site, which may include the pharmacist's residence or other
location where the pharmacist and the institutional or remote pharmacy can
ensure the confidentiality and integrity of patient information, or on the
premises of a remote pharmacy or institution a pharmacy.
A pharmacist shall only be permitted to
conduct remote medication order processing 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 medication order processing 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 law, rules, and regulations.
(C)
The institutional
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 institutional
pharmacy utilizing remote medication order processing shall ensure that all
remote pharmacists providing such services have been trained on the
institutional pharmacy's policies and procedures relating to medication order
processing. The training of each pharmacist shall be documented.
(1)
Such training
shall include, but is not limited to, policies on drug and food allergy
documentation, abbreviations, administration times, automatic stop orders,
substitution, and formulary compliance. The institutional pharmacy and the
remote pharmacy shall jointly develop a procedure to communicate changes in
policies and procedures related to medication order processing.
(2)
A terminal
distributor of dangerous drugs may utilize one training program for all
institutional pharmacies under the terminal distributor's common ownership and
control.
(E)
An institutional pharmacy utilizing remote pharmacists
shall maintain or have access to a record of the name and license number of
each pharmacist, evidence of current pharmacist licensure in the state where
the pharmacist is performing remote order processing, and the address of each
location where the pharmacist will be providing remote medication order
processing services.
(F)
An institutional pharmacy shall ensure that any remote
pharmacist shall have secure electronic access to the institutional pharmacy's
patient information system and to other electronic systems that the on-site
pharmacist has access to when the pharmacy is open.
(G)
The remote
pharmacist must be able to contact the prescriber issuing a medication order to
discuss any concerns identified during the pharmacist's review of patient
information and the medication order. A procedure must be in place to
communicate any problems identified with the prescriber and the nursing staff
providing direct patient care.
(H)
Each remote entry
record must comply with all record keeping requirements for institutional
pharmacies, including capturing the positive identification of the remote
pharmacist involved in the review and verification of the medication
order.
(I)
An institutional pharmacy utilizing remote medication
order processing is responsible for maintaining records of all medication
orders entered into their information system, including orders entered by a
remote pharmacist. The system shall have the ability to audit the activities of
the remote pharmacists.
(J)
An institutional pharmacy utilizing remote medication
order processing 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)
Outline the
responsibilities of the institutional pharmacy and the remote
pharmacy;
(2)
Include a list of the names, addresses, telephone
numbers, and all license numbers of the pharmacies/pharmacists involved in
remote medication order processing; and
(3)
Include 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 institutional pharmacy's patient information
system;
(c)
Maintaining appropriate records of each pharmacist
involved in order processing;
(d)
Complying with
federal and state law, rules, and regulations;
(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; and
(f)
Annually reviewing the competencies of pharmacists
providing remote order entry processing services.
