Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule:
(1)
"Dishonesty" means any action by a licensee, registrant or
applicant to include, but is not limited to, making any statement that
deceives, misrepresents or misleads, or be a party to or an accessory to any
fraudulent or deceitful practice or transaction in the practice of pharmacy or
in the operation or conduct of a pharmacy.
(2)
"Dispensing
error" or "error in dispensing" has the same meaning as rule 4729:5-3-22 of the
Administrative Code.
(3)
"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.
(4)
"Unprofessional conduct" means conduct that is
detrimental to the best interests of the public, including conduct that
endangers the health, safety or welfare of a patient or client. Such conduct
shall include, but not be limited to, the following acts: coercion,
intimidation, harassment, sexual harassment, improper use of private health
information, threats, degradation of character, indecent or obscene conduct,
and theft.
(B)
A pharmacy licensed as a terminal distributor of
dangerous drugs shall be required to report, from direct observation or
objective evidence, the following to the board in accordance with paragraph (C)
of this rule:
(1)
Any error in dispensing when the error is the result of
reckless behavior.
(2)
Any error in dispensing where the error results in any
of the following per the "National Coordinating Council for Medication Error
Reporting and Prevention Medication Error Index (Revised 2/20/2001)":
(a)
Category G: an
error occurred that resulted in permanent patient harm.
(b)
Category H: an
error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac
arrest).
(c)
Category I: an error occurred that resulted in patient
death.
(3)
The termination or resignation of employment of any
individual licensed or registered by the board that was based, in whole or in
part, on an error or errors in dispensing.
(4)
The termination
or resignation of employment of any individual licensed or registered by the
board that was based, in whole or in part, on engaging in unprofessional
conduct, dishonesty, or reckless behavior.
(5)
The termination
or resignation of employment of any individual licensed or registered by the
board that was based, in whole or in part, on conduct indicating an individual
licensed or registered by the board is practicing pharmacy while physically or
mentally impaired by 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.
(C)
Reporting
required in accordance with this rule shall be made by mail, using the board's
online complaint form (available on the board's website:
www.pharmacy.ohio.gov), or telephone and shall include the following
information:
(1)
The name of the employer and the employer's terminal
distributor license number;
(2)
The full name and
license or registration number of the licensee or registrant for which a report
is being made;
(3)
If applicable, an explanation of the error in
dispensing that occurred, including details regarding any patient
harm;
(4)
If applicable, an explanation of the circumstances that
resulted in the individual's termination or resignation from employment;
and
(5)
The date(s) of and place(s) of occurrence(s), if
known.
(D)
All reports submitted in accordance with this rule
shall protect the confidentiality of patients. The Board may request additional
information, including patient information, as part of an investigation
conducted in accordance with Chapter 4729 of the Revised Code.
(E)
All required
reporting shall be submitted to the board no later than:
(1)
For an error in
dispensing pursuant to paragraphs (B)(1) to (B)(3) of this rule, ten days from
the date the quality assurance program review in accordance with rule
4729:5-3-22 of the Administrative Code was completed; and
(2)
For the
termination or resignation of an employee pursuant to paragraphs (B)(4) and
(B)(5) of this rule, ten days from the date the individual is terminated or
resigns from employment.
(F)
Notwithstanding
any provision of agency 4729 of the Administrative Code, a pharmacist, pharmacy
intern, certified pharmacy technician, registered pharmacy technician, or
pharmacy technician trainee shall not be required to make a report to the board
pursuant to the applicable duty to report rules in divisions 4729:1, 4729:2,
and 4729:3 of the Administrative Code if the licensee or registrant is employed
by or under contract with a pharmacy licensed as a terminal distributor of
dangerous drugs and the terminal distributor submits a report in accordance
with this rule.
(G)
In accordance with section
4729.23 of the Revised Code,
information submitted to the board in accordance with this rule shall be deemed
confidential, is not a public record, and is not subject to discovery in any
civil action.
