Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 22 - Unit Dose, Alternative Packaging, and Emergency Boxes › Rule 657-22.7 - Emergency/first Dose Drug Supply

Current through Register Vol. 47, No. 3, July 24, 2024
In any facility registered with the board under Iowa Code
				chapter 124 that does not have an institutional pharmacy, drugs may be supplied
				in one or more emergency/first dose drug supply containers located at the
				facility, provided that the emergency/first dose drug supply meets the
				requirements of this rule. The use of drugs from the emergency/first dose drug
				supply shall be limited to authorized personnel. The pharmacy supplying the
				emergency/first dose drug supply is responsible for verifying the
				qualifications of the facility.
(1)
Emergency/first dose drug supplies.
Contents of the
			 emergency/first dose drug supply shall be provided by a primary provider
			 pharmacy designated by the facility, and the drug supply shall be available to
			 meet the needs of all patients of the facility, without penalty or
			 discrimination. If the primary provider pharmacy does not supply or is unable
			 to supply all drugs and products needed for the emergency care of facility
			 patients, a second provider pharmacy may provide an emergency/first dose drug
			 supply consisting only of drugs and products not stocked or available from the
			 primary provider pharmacy including, but not limited to, parenteral or
			 compounded drug products. The provider pharmacies shall be properly registered
			 with the federal Drug Enforcement Administration (DEA) and the board and shall
			 be currently licensed by the board. The provider pharmacist or pharmacists, the
			 consultant pharmacist, the director of nursing of the facility, and the medical
			 director of the facility, or their respective designees, shall jointly
			 determine and prepare a list of drugs necessary for prompt use in patient care
			 that will be available in each emergency/first dose drug supply. Drugs shall be
			 listed by identity and quantity, shall be limited to drugs necessary to meet
			 the emergency needs of the patients served, and shall be periodically reviewed
			 pursuant to policy. Careful patient planning should be a cooperative effort
			 between the pharmacies and the facility to make drugs available, and
			 emergency/first dose drug supplies shall only be used for emergency or
			 unanticipated needs. The intent of the emergency/first dose drug supply is not
			 to relieve a pharmacy of the responsibility for timely provision of a patient's
			 routine drug needs and is not intended to relieve any provider pharmacy from
			 the provider pharmacy's responsibility to provide 24-hour services to facility
			 patients; the intent is to ensure that a supply of drugs is available to each
			 patient in case of urgent need. The drugs in emergency/first dose drug supplies
			 are the responsibility of the respective provider pharmacy and, therefore,
			 shall not be used or altered in any way except as provided in this
			 rule.
(2)
Storage.
The emergency/first dose drug supply shall be stored in an area suitable to
			 prevent unauthorized access and to ensure a proper environment for preservation
			 of drugs contained therein as required in official compendia. The provider
			 pharmacist is responsible for establishing procedures to maintain the security
			 of the emergency/first dose drug supply.
(3)
Labeling
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exterior.
The exterior of an emergency/first dose drug supply
			 shall be labeled clearly and shall unmistakably indicate that it is an
			 emergency/first dose drug supply. Such label shall also contain a listing of
			 the name, strength, and quantity of each drug contained therein and an
			 expiration date of the supply based upon the earliest expiration date of any
			 drug contained in the supply.
(4)
Labeling
-
interior.
All drugs contained in
			 the emergency/first dose drug supply shall be labeled in accordance with
			 subrule 22.3(2) or 22.1(3), as appropriate.
(5)
Removal of drugs.
A drug
			 shall be removed from the emergency/first dose drug supply only pursuant to a
			 valid prescription order and by authorized personnel or by the provider
			 pharmacist. The patient's dispensing pharmacy shall be notified, prior to the
			 administration of a second dose, that a drug was administered to a specific
			 patient. Upon notification, the dispensing pharmacist shall perform drug use
			 review to assess the appropriateness of the drug therapy for the patient. If
			 the emergency/first dose drug supply contains a multidose package of a drug
			 product that is removed from the supply for administration of one or more doses
			 of the product to a patient and if following that administration the package
			 contains one or more additional doses of the drug product and if the prescriber
			 authorizes continuation of the drug product for that patient, the provider
			 pharmacy shall complete either of the following processes.
a. Prepare and affix to the multidose package
			 a label in compliance with rule
			 657-23.11
			 (124,155A). The label shall be prepared and affixed to the package within 24
			 hours of administration of the emergency dose or doses.
b. Dispense, pursuant to a valid prescription
			 order and in compliance with rule
			 657-23.11
			 (124,155A), an appropriately labeled supply of the drug for the patient. The
			 new prescription shall be delivered to the facility within 24 hours of
			 administration of the emergency dose or doses.