Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule, "dispensing error" or "error in dispensing" means one or more of the
following discovered after the dispensation (e.g., final verification) by a
pharmacist or verification in accordance with rule
4729:5-3-17 of the
Administrative Code, regardless of whether the patient received the drug:
(1)
Variation from
the prescriber's prescription or drug order, unless otherwise modified by the
pharmacist in accordance with agency 4729 of the Administrative Code,
including:
(b)
Incorrect drug
strength;
(c)
Incorrect dosage form;
(d)
Incorrect
patient; or
(e)
Inadequate or incorrect packaging, labeling, or
directions.
(2)
Failure to exercise professional judgment in
identifying and managing:
(a)
Known therapeutic duplication;
(b)
Known
drug-disease contraindications;
(c)
Known drug-drug
interactions;
(d)
Incorrect drug dosage or duration of drug
treatment;
(e)
Known drug-allergy interactions;
(f)
Any product
quality issue attributed to a compounded drug preparation;
(g)
A clinically
significant, avoidable delay in therapy; or
(h)
Any other
significant, actual, or potential problem with a patient's drug therapy related
to the practice of pharmacy.
(3)
Sale of a drug to
the incorrect patient.
(4)
Variation in bulk repackaging or filling of automated
devices, including:
(b)
Incorrect drug
strength;
(c)
Incorrect dosage form; or
(d)
Inadequate or
incorrect packaging or labeling.
(5)
A dispensing
error does not include the delivery of an incorrect drug to a patient by a
pharmacy delivery agent as defined in rule
4729:5-5-22 of the
Administrative Code.
(B)
A "dispensing
error" or "error in dispensing," as defined in paragraph (A) of this rule, may
be considered a violation of division (A)(2) of section
3715.52 and section
3715.64 of the Revised
Code.
(C)
Each pharmacy licensed as a terminal distributor of
dangerous drugs shall establish or participate in an established quality
assurance program that documents and assesses dispensing errors to determine
cause and an appropriate response to improve the quality of pharmacy service
and prevent errors.
(1)
Each quality assurance program shall be managed in
accordance with written policies and procedures maintained in the pharmacy to
be made readily retrievable upon request of an agent, inspector, or employee of
the board.
(2)
The quality assurance program shall include necessary
documentation, internal reporting, and assessment of dispensing errors to
determine the cause and an appropriate response to prevent future dispensing
errors.
(3)
All records of the quality assurance program for each
pharmacy shall be maintained for three years from the date of creation in a
readily retrievable manner.
(4)
Any record
reviewed in accordance with this paragraph shall be for investigation or
inspection purposes and shall be subject to confidentiality protections
pursuant to section 4729.23 of the Revised
Code.
(5)
If applicable, a quality assurance review may be
conducted by a quality assurance committee established in accordance with
section 2305.24 of the Revised
Code.
(D)
When a pharmacy determines or has been notified that a
dispensing error has occurred, a representative of the terminal distributor of
dangerous drugs shall as soon as possible:
(1)
Communicate to
the patient or the patient's caregiver the fact that an error in dispensing has
occurred, and the steps required to avoid harm or mitigate the
error.
(2)
Communicate to the prescriber the fact that an error in
dispensing has occurred only if the error could result in potential or actual
patient harm.
(3)
The communication requirement of this paragraph shall
only apply when a patient receives a drug that was the result of a dispensing
error and the error poses harm to the patient. Harm includes impairment of the
physical, emotional, or psychological function or structure of the body and/or
pain resulting therefrom.
(4)
The pharmacy shall maintain documentation that the
communications requirements of this rule were completed. Such documentation
shall be maintained for three years from the date of creation in a readily
retrievable manner.
(E)
If a pharmacy is
notified of a dispensing error by the patient, the patient's caregiver, or a
prescriber, a representative of the terminal distributor of dangerous drugs is
not required to communicate with that individual as required in paragraph (E)
of this rule.
(F)
The terminal distributor of dangerous drugs shall
inform pharmacy personnel of changes to pharmacy policy, procedure, systems, or
processes made as a result of recommendations generated by the quality
assurance program.
(G)
Nothing in this rule shall be construed to prevent a
pharmacy from contracting or otherwise arranging for the provision of personnel
or other resources by a third party or administrative offices with such skill
or expertise as the pharmacy believes to be necessary to satisfy the
requirements of this rule.
(H)
The pharmacy
shall comply with the reporting requirements for dispensing errors pursuant to
rule 4729:5-4-02 of the Administrative Code.