(A) A pharmacist licensed under Chapter
4729. of the Revised Code may administer, by injection, any of the following
dangerous drugs if the dangerous drug that is to be administered has been
prescribed by a physician and the individual to whom the dangerous drug was
prescribed has an ongoing relationship with the physician, an advanced practice
registered nurse who has entered into a standard care arrangement with the
physician, or a physician assistant who has entered into a supervision
agreement with the physician:
(1) An opioid antagonist
used for treatment of drug addiction and administered in a long-acting or
extended-release form. An opioid antagonist may also be administered for the
treatment of alcohol dependence in accordance with approved labeling by the
United States food and drug administration.
(2) An antipsychotic drug
administered in a long-acting or extended-release form.
(3) Hydroxyprogesterone
caproate for pregnant women.
(4) Medroxyprogesterone
acetate for non-pregnant women.
(5) Cobalamin, to
include: cyanocobalamin, hydroxocobalamin or any other vitamin B12 injection
approved by the United States food and drug administration.
(6) Any other dangerous
drugs authorized for pharmacist administration pursuant to section 4729.45 of
the Revised Code.
(B) To be authorized to administer drugs
pursuant to this rule, a pharmacist shall comply with all the
following:
(1) Successfully complete
a course in the administration of drugs that satisfies the requirements
pursuant to paragraph (L) of this rule.
(2) Receive and maintain
certification to perform basic life-support procedures by successfully
completing a basic life-support training course certified by the American red
cross, American heart association or other training course approved by the
board. Certification shall be obtained and maintained through courses that are
conducted in-person or, at a minimum, offer an in-person training
component.
(3) Practice in
accordance with a protocol that meets the requirements of paragraphs (F) and
(G) of this rule.
(C) Each time a pharmacist administers a
drug pursuant to this rule, the pharmacist shall comply with all the
following:
(1) For each drug
administered by a pharmacist to an individual who is eighteen years of age or
older, the pharmacist shall obtain written permission from the
individual.
(2) For each drug
administered by a pharmacist to an individual who is under eighteen years of
age, the pharmacist shall obtain written permission from the individual's
parent or other person having care or charge of the individual.
(3) For each drug
administered by a pharmacist to an individual who lacks the capacity to make
informed health care decisions, the pharmacist shall obtain written permission
from the person authorized to make such decisions on the individual's
behalf.
(4) Permission obtained
in accordance with this paragraph shall also include notification of the
patient's right to request a private area in accordance with paragraph (J)
of this rule.
(5) In the case of an
opioid antagonist, obtain, in accordance with paragraph (D) of this rule, test
results indicating that it is appropriate to administer the drug to the
individual if either of the following is to be administered:
(a) The initial dose of the drug;
(b) Any subsequent dose, if the administration occurs more
than thirty days after the previous dose of the drug was
administered.
(6) Observe the
individual to whom the drug is administered to determine whether the individual
has an adverse reaction to the drug.
(7) Notify the physician
who prescribed the drug within seven days that the drug has been administered
to the individual. Notification of the physician shall be conducted using one
of the following methods that is capable of confirming delivery of the required
notification:
(a) Electronic mail;
(b) Interoperable electronic medical records
system;
(c) Facsimile;
(d) Electronic prescribing system;
(e) Electronic pharmacy record system;
(f) Documented verbal communication; or
(g) Any other method of notification that might reasonably
be expected to allow for the confirmed transmission of the required
notification.
(D) A pharmacist may obtain the test
results described in paragraph (C)(5) of this rule:
(1) From the prescribing
physician or the physician's agent; or
(2) By ordering blood and
urine tests for the individual to whom the opioid antagonist is to be
administered.
(E) If a pharmacist orders blood and
urine tests pursuant to paragraph (D) of this rule, the pharmacist shall
evaluate the results of the tests to determine whether they indicate that it is
appropriate to administer the opioid antagonist. A pharmacist's authority
to evaluate test results pursuant to this rule does not authorize the
pharmacist to make a diagnosis.
(F) A physician-established protocol for
the administration of dangerous drugs in accordance with section 4729.45 of the
Revised Code shall include the following:
(1) For the dangerous
drugs listed in paragraph (A) of this rule:
(a) Name and strength;
(b) Precautions and contraindications;
(c) Intended audience or patient population;
(d) Dosage;
(e) Administration schedules;
(f) Routes of administration;
(g) Injection sites; and
(h) The type of tests that may be ordered in accordance
with paragraph (E) of this rule.
(2) The length of time
the pharmacist must observe an individual for adverse effects, which shall be
based on standards of care established by the physician. The location of the
observation shall be in the general vicinity of the administering pharmacist to
allow for on-going evaluation.
(3) A method to address
emergency situations including, but not limited to, adverse reactions,
anaphylactic reactions, and accidental needle sticks.
(4) The locations that a
pharmacist shall engage in the administration of dangerous drugs in accordance
with paragraph (J) of this rule.
(5) Specify procedures to
be followed by a pharmacist when administering epinephrine, diphenhydramine, or
both, to an individual who has an adverse reaction to a drug administered by
the pharmacist.
(G) All physician-established protocols
pursuant to this rule and section 4729.45 of the Revised Code shall comply with
the following:
(1) The protocol shall be
signed and dated by the physician prior to implementation and shall be readily
available to the administering pharmacist. The protocol shall be renewed by the
physician on a biennial basis.
(2) A physician may sign
one protocol for multiple locations licensed as terminal distributors of
dangerous drugs.
(3) Each location
licensed as a terminal distributor of dangerous drugs shall maintain a copy of
the protocol on-site for inspection by an agent, inspector or employee of the
state board of pharmacy.
(4) The protocol must be
established by a physician who has a scope of practice that includes treatment
of the condition for which the individual has been prescribed the drug to be
administered.
(H) Upon the request of the state board
of pharmacy, a pharmacist or terminal distributor of dangerous drugs shall
immediately provide the protocols for administration of drugs in accordance
with this rule. The state board of pharmacy, after review, may approve the
protocol or return it to the pharmacist or terminal distributor for revision
without approval. If a protocol has been returned for revision without
approval, it may not be implemented until the board has granted approval.
(I) A pharmacist may administer
epinephrine or diphenhydramine, or both, to an individual in an emergency
situation resulting from an adverse reaction to a drug administered by the
pharmacist.
(J) Dangerous drugs administered in
accordance with this rule shall be administered in a location that ensures the
privacy and dignity of the patient and is consistent with state and federal
privacy laws and regulations. When necessary to protect patient privacy, or if
requested by the patient, this shall include a private area located outside of
the pharmacy.
(K) Administration records shall be
maintained in accordance with rule 4729:5-5-04 of the Administrative
Code.
(L) A course in the administration of
dangerous drugs developed pursuant to section 4729.45 of the Revised Code shall
meet the following requirements:
(1) The course shall be
conducted by an accreditation council for pharmacy education (ACPE) accredited
provider.
(2) The course must
include the following components:
(a) A minimum of an hour and a half (0.15 C.E.U.s) of live
or home study coursework for each category of dangerous drug listed in
paragraph (A) of this rule that is covered by the course and shall
include:
(i) A review of the
conditions treated or prevented;
(ii) Mechanisms of
action;
(iii) Routes of
administration;
(iv) Injection sites and
ensuring patient privacy;
(v) Dosages and
administration schedules;
(vi) Monitoring and
treatment of the patient for adverse reactions, including the use of
diphenhydramine and epinephrine;
(vii) Patient
populations;
(viii) Precautions and
contraindications; and
(ix) Proper storage
requirements.
(b) A minimum of thirty minutes (0.05 C.E.U.s) of live or
home study coursework that includes:
(i) A review of sterile
technique in injectable dosage preparation and administration;
(ii) A review of the
proper disposal procedures for contaminated needles and dangerous drugs;
and
(iii) A review of the
proper procedures for accidental needle sticks.
(c) A minimum of one hour (0.1 C.E.U.s) of live and
supervised physical participation in administration techniques for the
categories of drugs covered by the course.
(d) If the course includes instruction on administration of
an opioid antagonist, a minimum of one hour (0.1 C.E.U.s) of live or home study
coursework that includes a review of the tests necessary to comply with
paragraph (C)(5) of this rule and the evaluation of such tests.
(3) A pharmacist is not
required to meet the training requirements of paragraph (L)(2)(b) of this rule
if the pharmacist has met the training requirements in paragraphs (A)(4)(c),
(A)(4)(e) and (A)(4)(f) of rule 4729:1-3-02 of the Administrative
Code;
(4) A pharmacist is not
required to meet the training requirements of paragraph (L)(2)(c) of this rule
if all of the following apply:
(a) The pharmacist has met the training requirements in
paragraph (A)(4)(d) of rule 4729:1-3-02 of the Administrative Code;
and
(b) The instruction on administration techniques provided
in accordance with rule 4729:1-3-02 of the Administrative Code includes the
same techniques necessary to administer each category of dangerous drug covered
by the training.
(5) The course must
provide a method to evaluate the successful comprehension of the
content.
(6) The course must
provide a method to demonstrate the pharmacist has successfully completed the
course.
(7) All live coursework
shall be taught by an instructor that is a licensed health care professional
who has the appropriate education and experience to teach a course in the
administration of the dangerous drugs included in the categories listed in
paragraph (A) of this rule.
(M) Courses may be reviewed by the state
board of pharmacy. A training course that fails to comply with the requirements
set forth in this rule shall be considered in violation of this
rule.
(N) A pharmacist who has not successfully
completed a course in drug administration that meets the requirements set forth
in this rule must complete a course that meets the requirements specified in
this rule prior to the administration of a dangerous drug listed in paragraph
(A) of this rule.
(O) A pharmacist shall maintain the
following records on file at the location(s) where the pharmacist administers
dangerous drugs in accordance with this rule:
(1) Proof of successful
completion of a training course specified in paragraph (L) of this rule;
and
(2) Proof of maintenance
of certification to perform basic life-support procedures in accordance with
paragraph (B)(2) of this rule.
