657—22.9 (155A) Home health agency/hospice emergency drugs. Recognizing the emergency and unanticipated need for drugs to be available to qualified individuals authorized to administer drugs and employed by a home health agency or hospice, an Iowa-licensed pharmacy may provide an emergency drug supply pursuant to this rule. Such qualified individuals may carry the emergency drug supply. An inpatient hospice facility may have an emergency drug supply provided by an Iowa-licensed pharmacy pursuant to rule 657—22.7(124,155A), which supply may be maintained within the facility.
	   22.9(1) Contract. A written contract shall exist between the home health agency or hospice and the pharmacist in charge of the Iowa-licensed pharmacy. This contract shall be available for review by the board or its authorized agent upon request.
	   22.9(2) Ownership retained. The drugs included in this emergency supply shall remain the property of and under the responsibility of the Iowa-licensed provider pharmacy.
	      a.    	 The pharmacist shall ensure that each portable container of emergency drugs is sealed in such a manner that a tamperproof seal must be broken to gain access to the drugs.
	      b.    	 Each portable container of emergency drugs shall be labeled on the outside of the container with a list of the contents and the earliest expiration date.
	   22.9(3) Removal of drugs. All drugs shall be administered only on prior prescribers’ order or by protocol approved by the agency’s medical director or appropriate committee. Drugs administered from the emergency supply shall be replaced by submitting a prescription or medication order for the used item to the provider pharmacy within a reasonable time of administration.
	   22.9(4) Records. All records of drugs administered from the emergency supply shall be maintained as required by law. If a container of an injectable product is opened and partially used, any unused portion shall be immediately discarded and appropriately documented.
	   22.9(5) Drugs included. The provider pharmacist and the director of the home health agency or hospice, or their respective designees, shall jointly determine a list of drugs necessary for prompt use in the care of patients served by the home health agency or hospice and that will be available in the emergency drug supply. Drugs shall be listed by identity and quantity and shall be periodically reviewed in accordance with policy.
	   22.9(6) Policies and procedures. The pharmacy, pursuant to rule 657—8.3(155A) and in coordination with the home health agency or hospice, shall have policies and procedures to address storage conditions and security for drugs and kit maintenance. Outdated, expired drugs shall be properly disposed of by the pharmacy.
	   22.9(7) Responsibility for compliance. The pharmacist in charge and staff pharmacists shall share responsibility for compliance with this rule, and any abuse or misuse of the intent of this rule shall be immediately reported to the board.
This rule is intended to implement Iowa Code sections 155A.4, 155A.13, and 155A.15.
[ARC 1961C, IAB 4/15/15, effective 5/20/15]