Current through all regulations passed and filed through September 16, 2024
In the absence of an available on-site
pharmacy, drugs prescribed for patient treatment in an institutional facility
may be obtained in the following manner:
(A)
Contingency
drugs, as defined in rule
4729:5-9-01 of the
Administrative Code, may be made available to licensed health care
professionals authorized pursuant to the Revised Code to administer drugs
during the professional's practice.
(B)
An institutional
facility maintaining contingency drugs shall hold a license, which may include
a campus license, as a terminal distributor of dangerous drugs.
(C)
An institutional
pharmacy may serve as the license holder for an institutional facility, if all
the following apply:
(1)
The institutional pharmacy maintains a terminal
distributor of dangerous drugs license on behalf of the institutional
facility.
(2)
The institutional pharmacy and institutional facility
maintain an executed contract or agreement outlining the services to be
provided and the responsibilities of each party in fulfilling the terms of the
contract or agreement in compliance with federal and state law, rules, and
regulations. The executed contract or agreement shall be maintained in a
readily retrievable manner.
(D)
An institutional
facility with an on-site pharmacy, including institutional facilities under a
campus license, shall develop and implement a policy whereby a licensed
pharmacist shall be made available for emergencies when the institutional
pharmacy is closed. The pharmacist may be made available via telephone or other
form of electronic communication.
(E)
Contingency drugs
shall be stored in accordance with the security requirements of rule
4729:5-9-03.2 of the
Administrative Code.
(F)
The entity holding the terminal distributor of
dangerous drugs license for an institutional facility's contingency stock
shall:
(1)
Designate personnel who are authorized to access to the
contingency drug supply;
(2)
Determine, in conjunction with the appropriate
interdisciplinary committees, the drugs that are to be included in the
contingency drug supply;
(3)
Ensure that such drugs are properly labeled and
packaged in amounts sufficient for the immediate treatment of
patients;
(4)
Ensure the security and control of the contingency
drugs in accordance with the requirements set forth in paragraph (E) of this
rule;
(5)
Institute record keeping procedures to comply with the
requirements set forth in rule
4729:5-9-03.3 of the
Administrative Code;
(6)
Develop and implement procedures for the inspection of
the contingency drug inventory to ensure proper utilization and replacement of
the drug supply; and
(7)
Comply with all applicable requirements for dangerous
drugs in accordance Chapter 4729:5-9 of the Administrative Code and all other
requirements for holding a terminal distributor of dangerous drugs license in
accordance with agency 4729 of the Administrative Code.
(G)
An
institutional facility may maintain an emergency kit (e-kit) containing
controlled substances provided by a licensed pharmacy to withdraw medication to
treat the immediate needs of a patient until patient-specific controlled
substance medication is physically delivered to the facility by the pharmacy.
If a multi-dose medication is removed from the emergency kit, it shall be
labeled to include the patient's name.
(1)
The pharmacy
providing the emergency kit must receive a valid outpatient prescription issued
in accordance with rule
4729:5-5-15 of the
Administrative Code prior to the administration of medication removed from the
kit.
(2)
The pharmacy providing the emergency kit shall be
responsible for generating and maintaining a record of the dispensing of the
medication obtained from the kit in compliance with the record keeping
requirements set forth in rule
4729:5-9-02.3 of the
Administrative Code.
(3)
The institutional facility and institutional pharmacy
shall comply with all other state and federal requirements for controlled
substances maintained in emergency kits (e-kit).
(H)
If a dangerous
drug is not available from the contingency drug stock and such drug is required
to treat the immediate needs of a patient whose health would otherwise be
jeopardized, the drug may be obtained from an on-site institutional pharmacy
pursuant to written policies and procedures adopted by the terminal distributor
of dangerous drugs. The policies and procedures shall:
(1)
Identify the
personnel authorized to access the pharmacy and the conditions under which
access may be gained to the pharmacy.
(2)
Ensure a minimum
of two employees of the institutional facility, one of whom shall be a
prescriber or nurse licensed pursuant to Chapter 4723. of the Revised Code, to
accompany and witness the activity of each other when accessing the
pharmacy.
(3)
Provide a written or electronic record documenting
emergency access to the pharmacy. Such record shall include the names, titles,
and positive identification of all institutional personnel accessing the
pharmacy, date and time of access, the name and quantity of drugs obtained, the
name of the patient, and the name of the ordering prescriber. Such records
shall be maintained for three years and made readily
retrievable.
(4)
The written or electronic record of each access to the
institutional pharmacy made in accordance with paragraph (H)(3) of this rule
shall be filed no later than the next business day with the institutional
facility's responsible person or the responsible person's designee and
maintained by the institutional pharmacy for three years.
(I)
An
institutional pharmacy may be accessed in the event of a fire, flood, natural
disaster, or other exigent circumstance pursuant to written policies and
procedures adopted by the terminal distributor of dangerous drugs. The policies
and procedures shall:
(1)
Identify the personnel authorized to access the
pharmacy and the conditions under which access may be gained to the
pharmacy.
(2)
Ensure a minimum of two employees of the institutional
facility, one of whom shall be a prescriber or nurse licensed pursuant to
Chapter 4723. of the Revised Code, to accompany and witness the activity of
each other when accessing the pharmacy.
(3)
Provide a written
or electronic record documenting emergency access to the pharmacy. Such record
shall include the names, titles, and positive identification of all
institutional personnel accessing the pharmacy, and the date and time of
access. If dangerous drugs are removed from the pharmacy, the name and quantity
of drugs removed, the name of the patient (if applicable), and the name of the
ordering prescriber (if applicable). Such records shall be maintained for three
years and made readily retrievable.
(4)
The written or
electronic record of each access to the institutional pharmacy made in
accordance with paragraph (I)(3) of this rule shall be filed no later than the
next business day with the institutional facility's responsible person or the
responsible person's designee and maintained by the institutional pharmacy for
three years.
