657—7.12(124,126,155A) Drugs in the emergency department. Drugs maintained in the emergency department are kept for use by or at the direction of prescribers in the emergency department. Drugs shall be administered or dispensed only to emergency department patients. For the purposes of this rule, “emergency department patient” means a patient who is examined and evaluated in the emergency department and includes the partner or partners of a patient treated pursuant to Iowa Code section 139A.41.
	7.12(1) Accountability. Established policies and procedures shall include a system of drug control and accountability in the emergency department. The system shall identify drugs of the nature and type to meet the emergency needs of patients. Drugs shall be administered or dispensed only in accordance with the system.
	7.12(2) Controlled substances. Controlled substances maintained in the emergency department are kept for use by or at the direction of prescribers in the emergency department.
	a. 	In order to receive a controlled substance, a patient shall be examined in the emergency department by a prescriber who shall determine the need for the drug. It is not permissible under state and federal regulations for a prescriber to see a patient outside the emergency department setting, or talk to the patient on the telephone, and then proceed to call the emergency department and order the administration of a stocked controlled substance upon the patient’s arrival at the emergency department except as provided in paragraph 7.12(2)“c” or “d.”
	b. 	A prescriber may authorize, without again examining the patient, the administration of additional doses of a previously authorized drug to a patient presenting to the emergency department within 24 hours of the patient’s examination and treatment in the emergency department.
	c. 	In an emergency situation when a health care practitioner authorized to prescribe controlled substances is not available on site, and regardless of the provisions of paragraph 7.12(2)“a,” the emergency department nurse may examine the patient in the emergency department and contact the on-call prescriber. The on-call prescriber may then authorize the nurse to administer a controlled substance to the patient pending the arrival of the prescriber at the emergency department. As soon as possible, the prescriber shall examine the patient in the emergency department and determine the patient’s further treatment needs.
	d. 	In an emergency situation when a health care practitioner authorized to prescribe controlled substances examines a patient in the prescriber’s office and determines a need for the administration of a controlled substance, and regardless of the provisions of paragraph 7.12(2)“a,” the prescriber may direct the patient to present to the emergency department for the administration of a controlled substance for which the prescriber has issued a prescription in compliance with federal regulation and board rules. As soon as possible, the prescriber shall examine the patient in the emergency department and determine the patient’s further treatment needs.
	7.12(3) Drug dispensing. Only a pharmacist or prescriber may dispense any drugs to an emergency department patient pursuant to the provisions of this rule.
	a. 	Responsibility. Pursuant to rule 657—8.3(155A), policies and procedures shall be established to ensure the accuracy and labeling of prepackaged drugs and accurate records of dispensing of drugs from the emergency department shall be maintained.
	(1)	Except as provided in subrule 7.12(4), drugs dispensed to an emergency department patient may be dispensed in quantities not to exceed a 72-hour supply or the minimum quantity in suitable containers, except that an authorized supply of a drug provided through the department of public health may be dispensed for the treatment of a victim of sexual assault. Prepackaged drugs shall be prepared pursuant to the requirements of rule 657—22.3(126).
	(2)	Drugs dispensed pursuant to this paragraph shall be appropriately labeled as required in paragraph 7.12(3)“b,” including necessary auxiliary labels.
	b. 	Prescriber responsibility. Except as provided in subrule 7.12(4), a prescriber who authorizes the dispensing of a prescription drug to an emergency department patient is responsible for the accuracy of the dispensed drug and for the accurate completion of label information pursuant to this paragraph, including when any portion of the dispensing process is delegated to a licensed nurse under the supervision of the prescriber.
	(1)	Except as provided in subrule 7.12(4), at the time of delivery of the drug the prescriber shall be responsible for ensuring that the dispensing container bears a label with at least the following information:
	1.	Name and address of the hospital;
	2.	Date dispensed;
	3.	Name of prescriber;
	4.	Name of patient, except when the drug is dispensed for one or more unnamed partners receiving expedited partner therapy pursuant to Iowa Code section 139A.41;
	5.	Directions for use; and
	6.	Name, quantity, and strength of drug.
	(2)	Except as provided in subrule 7.12(4), the prescriber, or a licensed nurse under the supervision of the prescriber, shall give the appropriately labeled, packaged drug to the patient or patient’s caregiver. The prescriber, or a licensed nurse under the supervision of the prescriber, shall explain the correct use of the drug and shall explain to the patient that the dispensing is for an emergency or starter supply of the drug. If additional quantities of the drug are required to complete the needed course of treatment, the prescriber shall issue a prescription for the additional quantities to be filled at a pharmacy of the patient’s choice.
	7.12(4) Use of an outpatient point-of-care automated dispensing system (OPCADS). A hospital located in an area of the state where 24-hour outpatient pharmacy services are not available within 15 miles of the hospital may utilize an outpatient point-of-care automated dispensing system (OPCADS) in the emergency department only as provided by this subrule. For the purpose of this rule, an OPCADS is a secure dispensing system which contains prepackaged medications verified by authorized pharmacy personnel for dispensing to a patient upon issuance of a valid prescription by a prescriber. The OPCADS shall be owned by the facility, shall be operated under the facility’s hospital pharmacy license, shall not be issued a separate general or limited use pharmacy license, and shall not provide any financial incentive for use to any prescriber employed or under contract with the emergency department.
	a. 	Persons with access to the OPCADS for the purposes of stocking, inventory, and monitoring shall be limited to pharmacists, pharmacy technicians, and pharmacist-interns.
	b. 	The OPCADS shall be used only in the emergency department for the benefit of patients examined or treated in the emergency department when the benefit to the patient outweighs the burden on the patient to obtain the medication elsewhere.
	c. 	The OPCADS shall be located in a secure and professionally appropriate environment.
	d. 	The stock of drugs maintained and dispensed utilizing the OPCADS shall be limited to acute care drugs provided in appropriate quantities for a 72-hour supply or the minimum commercially available package size, except that antimicrobials may be dispensed in a quantity to provide the full course of therapy.
	e. 	Drugs dispensed utilizing the OPCADS shall be appropriately labeled as provided in 657—paragraphs 6.10(1)“a” through “g.”
	f. 	Prior to authorizing the dispensing of a drug utilizing the OPCADS, the prescriber shall offer to issue the patient a prescription that may be filled at a pharmacy of the patient’s choice.
	g. 	During consultation with the patient or the patient’s caregiver, the prescriber or licensed nurse under the supervision of the prescriber shall clearly explain the appropriate use of the drug supplied. If additional quantities of the drug are required to complete the needed course of treatment, the prescriber shall issue a prescription for the additional quantity to be filled at a pharmacy of the patient’s choice.
	h. 	The pharmacy shall, in conjunction with the emergency department, implement policies and procedures to ensure that a patient utilizing the OPCADS has been positively identified.
[ARC 8909B, IAB 6/30/10, effective 8/4/10; ARC 1961C, IAB 4/15/15, effective 5/20/15; ARC 4267C, IAB 1/30/19, effective 3/6/19; ARC 4903C, IAB 2/12/20, effective 3/18/20]