Ohio Admin. Code 4729:5-19-02 - Personally furnishing dangerous drugs
(A)
A prescriber who
personally furnishes a dangerous drug, other than a sample drug pursuant to
section 3719.81 of the Revised Code,
shall affix to the container a label showing:
(1)
The name and
address of the prescriber;
(2)
The name of the
patient for whom the drug is intended;
(3)
Name and strength
of the drug;
(4)
Directions for use;
(5)
Date furnished;
and
(6)
If a compounded drug, the statement "Compounded Drug"
or other similar statement shall also be displayed prominently on the
label.
(B)
A prescriber who personally furnishes a dangerous drug
labeled as a sample and where the directions for use are different from the
directions on or in the sample container shall affix a label to the sample
container or provide written documentation accompanying the sample that
includes the following:
(1)
The name of the prescriber;
(2)
The name of the
patient for whom the drug is intended; and
(3)
Directions for
use.
(C)
For controlled substances, quantities personally
furnished to a patient are limited to a seventy-two-hour supply and quantities
personally furnished to all patients shall not exceed two thousand five hundred
dosage units in any thirty day period pursuant to section
4729.291 of the Revised
Code.
(D)
None of the following shall be counted in determining
whether the amounts specified in paragraph (C) of this rule have been
exceeded:
(1)
Methadone personally furnished to patients for the purpose of treating drug
dependence or addiction, if the prescriber meets the conditions specified in
21 C.F.R.
1306.07 (6/23/2005);
(2)
Buprenorphine
personally furnished to patients for the purpose of treating drug dependence or
addiction as part of an opioid treatment program licensed under section
5119.37 of the Revised
Code.
(3)
Controlled substances personally furnished to research
subjects by a facility conducting clinical research in studies approved by a
hospital-based institutional review board or an institutional review board
accredited by the association for the accreditation of human research
protection programs.
(E)
(1)
Except as provided in paragraph (E)(2) of this rule,
only a prescriber shall personally furnish a drug. The act of personally
furnishing shall be documented using positive identification.
(2)
A prescriber may
delegate the act of personally furnishing to a licensed Ohio pharmacist
practicing at a free clinic, as defined in section
3701.071 of the Revised Code.
The act of personally furnishing shall be documented using positive
identification.
(F)
(1)
A prescriber may designate a licensed health care
professional acting within the scope of the professional's practice and, under
the personal supervision of a prescriber or pharmacist, to prepare and package
a dangerous drug that will be personally furnished by the prescriber or a
pharmacist in accordance with paragraph (E)(2) of this rule.
(2)
A prescriber may
designate an unlicensed person, under the personal supervision of a prescriber
or pharmacist, to prepare and package a dangerous drug that will be personally
furnished by the prescriber or a pharmacist in accordance with paragraph (E)(2)
of this rule. An unlicensed person shall not prepare and package any of the
following dangerous drugs:
(a)
Anesthesia;
(b)
Controlled
substances; or
(c)
Drugs administered intravenously.
(G)
Counseling.
(1)
A prescriber, pharmacist or a delegate in accordance
with paragraph (H)(1) of this rule shall personally offer to provide, or may
provide in writing, the service of counseling pursuant to paragraph (G)(2) of
this rule to a patient or caregiver whenever any dangerous drug is personally
furnished. A prescriber or pharmacist shall not be required to counsel a
patient or caregiver when the patient or caregiver refuses, either verbally or
in writing, the offer of counseling or does not respond to the written offer to
counsel.
(2)
Prescriber or pharmacist counseling may include, but is
not limited to, the following:
(a)
The name and description of the drug;
(b)
The dosage form,
dose, route of administration, and duration of drug therapy;
(c)
The intended use
of the drug and the expected action;
(d)
Special
directions and precautions for preparation, administration, and use by the
patient;
(e)
Common adverse effects or interactions and therapeutic
contraindications that may occur, including possible methods to avoid them, and
the action required if they occur;
(f)
Techniques for
self-monitoring drug therapy;
(g)
Proper storage
and disposal;
(h)
Action to be taken in the event of a missed dose;
and
(i)
The prescriber or pharmacist's comments relevant to the
patient's drug therapy, including other necessary information unique to the
specific patient or drug.
(H)
Provision of
dangerous drugs.
(1)
A prescriber may delegate an individual or individuals
to distribute dangerous drugs personally furnished by a prescriber or
pharmacist if all the following apply:
(a)
A prescriber or
pharmacist provides personal supervision;
(b)
Counseling is
offered in accordance with paragraph (G) of this rule; and
(c)
This task may be
delegated in accordance with applicable state laws and rules.
(2)
Paragraph (H)(1)(a) of this rule does not apply if a non-controlled substance
dangerous drug is provided to the patient by a licensed health care
professional, acting within the scope of the professional's practice, and a
prescriber or pharmacist is available for counseling by means of electronic
communication during normal hours of operation.
(I)
No prescriber or
pharmacist acting in accordance with paragraph (E)(2) of this rule may
personally furnish to a patient to whom there is no valid prescriber patient
relationship, pursuant to applicable state and federal laws, regulations, and
rules.
(J)
Personally furnishing naloxone.
(1)
Except as
provided in paragraph (J)(3) of this rule, an authorized individual personally
furnishing naloxone on behalf of a physician pursuant to a protocol established
in accordance with sections
4731.941 and
3707.561 of the Revised Code,
shall do all of the following:
(a)
Prepare, package and appropriately label the
naloxone.
(b)
Conduct the final association of the naloxone to the
patient.
(c)
Keep and maintain all records in accordance with this
chapter.
(d)
Conduct patient counseling, including training on the
use of naloxone, as specified in the physician protocol.
(2)
An
authorized individual personally furnishing naloxone on behalf of a physician
pursuant to a protocol established in accordance with sections
4731.941 and
3707.561 of the Revised Code may
personally furnish the drug to themselves in order to assist an individual who
there is reason to believe is experiencing an opioid-related overdose if all of
the following conditions are met:
(a)
The authorized individual complies with the protocol
established by the authorizing physician, including having completed the
training required by the protocol.
(b)
The authorized
individual has received training instructing them to summon emergency services
as soon as practicable either before or after administering
naloxone.
(c)
Such practice is authorized in the physician approved
protocol.
(3)
An authorized individual personally furnishing naloxone
pursuant to paragraph (J)(2) of this rule shall not be required to comply with
paragraphs (J)(1)(a), (J)(1)(b) and (J)(1)(d) of this rule.
(4)
A terminal
distributor of dangerous drugs may also administer naloxone in accordance with
section 4729.514 of the Revised
Code.
(K)
Any patient specific dangerous drug dispensed by a
pharmacy that is provided to a patient by a prescriber pursuant to rule
4729:5-5-14 of the
Administrative Code is the property of that patient and is not considered
personally furnishing. No prescriber that provides a patient with a drug
pursuant to rule
4729:5-5-14 of the
Administrative Code shall charge any additional fees or require any additional
monetary compensation for the dangerous drug.
(L)
Paragraph (K) of
this rule does not prohibit a prescriber from charging a patient for any of the
following:
(1)
The cost of an office visit or any expense related to the administration of a
dangerous drug; or
(2)
The cost of a dangerous drug dispensed by a pharmacy to
a patient if paid for by the prescriber.
(M)
A prescriber
personally furnishing dangerous drugs shall comply with all drug database
reporting requirements pursuant to Chapter 4729. of the Revised Code and
division 4729:8 of the Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.51, 3719.06, 3719.81
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