Rule 4729:5-9-03.1 | Contingency drugs in an institutional facility and emergency access to an institutional pharmacy.
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.
Last updated February 1, 2022 at 9:26 AM
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