Current through all regulations passed and filed through March 18, 2024
(A) As used in this rule:
(1) "Error in dispensing" or "prescription
error" means an act or omission of clinical significance relating to the
dispensing of a drug. An error in dispensing may be considered a violation of
division (A)(2) of section
3715.52 and
section
3715.64
of the Revised Code.
(2) "Harm"
means impairment of the physical, emotional, or psychological function or
structure of the body and/or pain resulting therefrom.
(3) "Intervention" means a change in therapy
or active medical/surgical treatment.
(4) "Intervention necessary to sustain life"
means cardiovascular and respiratory support (e.g., CPR, defibrillation,
intubation, etc.).
(5) "Reckless
behavior" means a person who acts recklessly or who is reckless. A person acts
recklessly when, with heedless indifference to the consequences, the person
disregards a substantial and unjustifiable risk that the person's conduct is
likely to cause a certain result or is likely to be of a certain nature. A
person is reckless with respect to circumstances when, with heedless
indifference to the consequences, the person disregards a substantial and
unjustifiable risk that such circumstances are likely to exist.
(6) "Unprofessional conduct" has the same
meaning as defined in paragraph (A) of rule
4729:1-4-01
of the Administrative Code.
(B) Pursuant to section
4729.10 of the Revised
Code, a pharmacist who has knowledge, from direct observation or objective
evidence, of violations described in paragraph (C) of this rule shall report
such conduct to the state board of pharmacy.
(C) The following shall be reported to the
board:
(1) Except as provided in paragraph
(C)(1)(a) of this rule, conduct indicating an individual licensed or registered
by the board is addicted to or is suspected to be abusing alcohol, drugs or
other chemical substances or impaired physically or mentally to such a degree
as to render the individual unfit to carry out their professional duties.
(a) A pharmacist shall not be required to
report in accordance with this rule if the pharmacist becomes aware of any
condition described in paragraph (C)(1) of this rule as a result of either:
(i) The pharmacist's treatment of the
individual for the condition; or
(ii) The pharmacist having access to the
individual's protected health information.
(2) Except as provided in paragraph (H) of
this rule, violations, attempts to violate, or aiding and abetting in the
violation of any of the provisions of Chapters 4729., 4752., 3715., 3719.,
3796., 2925., and 2913. of the Revised Code, or any rule adopted by the board
under those provisions, by an individual or entity licensed or registered by
the board.
(3) Conduct by a
pharmacy technician trainee, registered pharmacy technician, certified pharmacy
technician, pharmacy intern or pharmacist that constitutes unprofessional
conduct or dishonesty as defined in rule
4729:1-4-01
of the Administrative Code.
(D)
(1)
Pursuant to section
4729.23
of the Revised Code, the identity of the pharmacist making a report in
accordance with this rule shall remain confidential.
(2) Notwithstanding the confidentiality
provided in accordance with paragraph (D)(1) of this rule, a pharmacist may be
required to testify in a disciplinary proceeding as to the conduct or
violations listed in paragraph (C) of this rule without disclosing the
pharmacist was the reporting individual.
(E) Reporting required in accordance with
this rule shall be made in writing, either by mail, using the board's online
complaint form (available on the board's web site:
www.pharmacy.ohio.gov), or by
telephone and shall include the following information:
(1) The name of the licensee, registrant or
other individual who may have committed a violation listed in paragraph (C) of
this rule;
(2) The violation which
is believed to have occurred; and
(3) The date(s) of and place(s) of
occurrence(s), if known.
(F) A licensed pharmacist shall notify the
board of any of the following:
(1)
Any criminal conviction for, judicial finding of guilt
of, or plea of guilty to a disqualifying offense within ten days after the date
of conviction.
(2)
The pharmacist is convicted of, plead guilty to, is subject to a judicial
finding of eligibility for intervention in lieu of conviction in this state
under section
2951.041
of the Revised Code or the equivalent thereof in another jurisdiction within
ten days after the individual is deemed eligible.
(3) The pharmacist is granted entry into a
diversion program, deferred prosecution program, or the equivalent thereof
within ten days after the individual is granted entry into a program.
(4) Any arrest for a felony within ten days
after the arrest.
(G) A
pharmacist shall notify the board of any disciplinary licensing or registration
action taken by another state against the licensee within ten days of the
notice action. This includes, but is not limited to, a disciplinary action that
is stayed pending appeal.
(H) An
error in dispensing shall not be required to be reported pursuant to paragraph
(C) of this rule except when the error is the result of reckless behavior or
unprofessional conduct and meets any of the following per the national
coordinating council for "Medication Error Reporting and Prevention's Index for
Categorizing Medication Errors" (2/20/2001):
(1) An error occurred that may have
contributed to or resulted in temporary harm to the patient and required
intervention;
(2) An error occurred
that may have contributed to or resulted in temporary harm to the patient and
required initial or prolonged hospitalization;
(3) An error occurred that may have
contributed to or resulted in permanent patient harm;
(4) An error occurred that required
intervention necessary to sustain life; or
(5) An error occurred that may have
contributed to or resulted in the patient's death.
(I) Pursuant to section
4729.10 of the Revised
Code, in the absence of fraud or bad faith, a person who reports in accordance
with this rule or testifies in any adjudication conducted under Chapter 119. of
the Revised Code is not liable to any person for damages in a civil action as a
result of the report or testimony.