Ohio Admin. Code 4729:5-5-20 - Remote outpatient prescription processing
(A)
As used in this
rule:
(1)
"Remote prescription processing" means the processing of a
prescription for an outpatient pharmacy licensed as a terminal distributor of
dangerous drugs by a remote pharmacist. Remote prescription processing does not
include the dispensing of a drug, but may include receiving, interpreting,
evaluating, clarifying and approval of prescriptions. Additionally, remote
prescription order processing may include order entry, other data entry,
performing prospective drug utilization review, interpreting clinical data,
performing therapeutic interventions, and providing drug information services.
The requirements of this rule shall be limited to the processing of outpatient
prescriptions 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 outpatient pharmacies in this
state.
(3)
"Remote pharmacist" means any of the following:
(a)
If performing
remote prescription processing in this state: an Ohio licensed pharmacist,
either employed or a contract employee of an outpatient pharmacy or remote
pharmacy, who either processes prescriptions from a remote site, which may
include the pharmacist's residence or other location where the pharmacist 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 processing outside of
this state: a pharmacist licensed or registered in the state where the remote
prescription processing is occurring, 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 processes prescriptions from a remote site, which may include the
pharmacist's residence or other location where the pharmacist 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.
A pharmacist shall only be permitted to conduct remote prescription 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 outpatient pharmacy may outsource prescription
processing 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
processing shall ensure that all remote pharmacists providing such services
have been trained on the outpatient pharmacy's policies and procedures relating
to prescription 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, substitution, and
prospective drug utilization review requirements in accordance with rule
4729:5-5-08 of the
Administrative Code. The outpatient pharmacy and the remote pharmacy shall
jointly develop a procedure to communicate changes in policies and procedures
related to prescription processing.
(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 pharmacists
shall maintain or have access to a record of the name and address 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 prescription processing
services.
(F)
The outpatient pharmacy shall ensure that any remote
pharmacist shall have secure electronic access to the outpatient 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 prescription to
discuss any concerns identified during the pharmacist's review of patient
information and the order. A procedure must be in place to communicate any
problems identified with the prescriber and the outpatient
pharmacy.
(H)
Each remote entry record must comply with all
recordkeeping requirements for outpatient pharmacies, including capturing the
positive identification of the remote pharmacist involved in the review and
verification of the prescription.
(I)
An outpatient
pharmacy utilizing remote prescription processing is responsible for
maintaining records of all prescriptions 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 outpatient
pharmacy utilizing remote prescription 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 outpatient 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 prescription 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 outpatient pharmacy's patient information
system;
(c)
Maintaining appropriate records of each pharmacist
involved in prescription processing;
(d)
Complying with
federal and state statutes 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 prescription processing services.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.26, 3719.28
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