(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 dangerous 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, the prescriber
shall affix a label to the sample container or provide written documentation
accompanying the sample that includes the following:
(1) 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
in any thirty day period quantities personally furnished to all patients shall
not exceed two thousand five hundred dosage units 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 CFR 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) 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, a pharmacist, or a nurse in accordance
with paragraph (F) of this rule.
(2) The personal
supervision requirement listed in paragraph (E)(1) of this rule does not apply
if a licensed health care professional acting within the scope of the
professional's practice is preparing and packaging either of the
following:
(a) Methadone for the purpose of treating drug dependence or
addiction; or
(b) Buprenorphine for the purpose of treating drug dependence or
addiction.
(3) 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 (F) 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.
(F) Only a prescriber shall personally
furnish a drug. The act of personally furnishing shall be documented using
positive identification.
A prescriber may delegate the act of personally
furnishing pursuant to the following:
(1) A prescriber may
delegate the act of personally furnishing to a licensed pharmacist. The
delegated pharmacist shall document the act of personally furnishing using
positive identification.
(2) A prescriber may
delegate the act of personally furnishing methadone for the purpose of treating
drug dependence or addiction to a nurse practicing in accordance with Chapter
4723. of the Revised Code pursuant to the following:
(a) The opioid treatment program utilizes an automated methadone
dispensing system that is routinely calibrated to ensure the accuracy of the
methadone personally furnished.
(b) The nurse shall document the act of personally furnishing
using positive identification.
(3) A prescriber may delegate the act of personally
furnishing buprenorphine for the purpose of treating drug dependence or
addiction to a nurse practicing in accordance with Chapter 4723. of the Revised
Code. The nurse shall document the act of personally furnishing using positive
identification.
(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 a licensed healthcare professional acting within the scope of the
professional's practice 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 under any of the following
circumstances:
(a) The drug is provided to the patient by a licensed health care
professional, acting within the scope of the professional's practice, and
the drug provided is either:
(i) Methadone for the
purpose of treating drug dependence or addiction and a prescriber or licensed
pharmacist is available for counseling by means of electronic communication
during normal hours of operation; or
(ii) Buprenorphine for
the purpose of treating drug dependence or addiction as part of an opioid
treatment program and a prescriber or licensed pharmacist is available for
counseling by means of electronic communication during normal hours of
operation.
(b) The drug is being provided to a patient by a licensed
pharmacist.
(c) A non-controlled 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 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 label the naloxone in accordance with
the requirements of this rule.
(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.
