657—39.10(155A) Vaccine administration by pharmacists—physician-approved protocol. Through June 30, 2019, an authorized pharmacist may administer vaccines pursuant to protocols established by the CDC in compliance with the requirements of this rule. An authorized pharmacist may only delegate the administration of a vaccine to an authorized pharmacist-intern under the direct supervision of the authorized pharmacist.
	39.10(1) Definitions. For the purposes of this rule, the following definitions shall apply:
“ACIP” means the CDC Advisory Committee on Immunization Practices.
“ACPE” means the Accreditation Council for Pharmacy Education.
“Authorized pharmacist” means an Iowa-licensed pharmacist who has met the requirements identified in subrule 39.10(2).
“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has met the requirements for an authorized pharmacist identified in paragraphs 39.10(2)“a” and “c.”
“CDC” means the United States Centers for Disease Control and Prevention.
“Immunization” shall have the same meaning as, and shall be interchangeable with, the term “vaccine.”
“Protocol” means a standing order for a vaccine to be administered by an authorized pharmacist.
“Vaccine” means a specially prepared antigen administered to a person for the purpose of providing immunity.
	39.10(2) Authorized pharmacist training and continuing education. An authorized pharmacist shall document successful completion of the requirements in paragraph 39.10(2)“a” and shall maintain competency by completing and maintaining documentation of the continuing education requirements in paragraph 39.10(2)“b.”
	a. 	Initial qualification. An authorized pharmacist shall have successfully completed an organized course of study in a college or school of pharmacy or an ACPE-accredited continuing education program on vaccine administration that:
	(1)	Requires documentation by the pharmacist of current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.
	(2)	Is an evidence-based course that includes study material and hands-on training and techniques for administering vaccines, requires testing with a passing score, complies with current CDC guidelines, and provides instruction and experiential training in the following content areas:
	1.	Standards for immunization practices;
	2.	Basic immunology and vaccine protection;
	3.	Vaccine-preventable diseases;
	4.	Recommended immunization schedules;
	5.	Vaccine storage and management;
	6.	Informed consent;
	7.	Physiology and techniques for vaccine administration;
	8.	Pre- and post-vaccine assessment, counseling, and identification of contraindications to the vaccine;
	9.	Immunization record management; and
	10.	Management of adverse events, including identification, appropriate response, documentation, and reporting.
	b. 	Continuing education. During any pharmacist license renewal period, an authorized pharmacist who engages in the administration of vaccines shall complete and document at least one hour of ACPE-approved continuing education with the ACPE topic designator “06” followed by the letter “P.”
	c. 	Certification maintained. During any period within which the pharmacist may engage in the administration of vaccines, the pharmacist shall maintain current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.
	39.10(3) Protocol requirements. A pharmacist may administer vaccines pursuant to a protocol based on CDC recommendations. A protocol shall be unique to a pharmacy. The pharmacy shall comply with the parameters of the protocol. The prescriber who signs a protocol shall identify within the protocol, by name or category, those pharmacists or other qualified health professionals that the prescriber is authorizing to administer vaccines pursuant to the protocol. A protocol:
	a. 	Shall be signed by an Iowa-licensed prescriber practicing in Iowa.
	b. 	Shall expire no later than one year from the effective date of the signed protocol.
	c. 	Shall be effective for patients who wish to receive a vaccine administered by an authorized pharmacist, who meet the CDC recommended criteria, and who have no contraindications as published by the CDC.
	d. 	Shall require the authorized pharmacist to notify the prescriber who signed the protocol within 24 hours of a serious complication, and the pharmacist shall submit a Vaccine Advisory Event Reporting System (VAERS) report.
	e. 	Shall specifically indicate whether the authorizing prescriber agrees that the administration of vaccines may be delegated by the authorized pharmacist to an authorized pharmacist-intern under the direct supervision of the authorized pharmacist.
	39.10(4) Influenza and other emergency vaccines. An authorized pharmacist shall only administer via protocol, to patients six years of age and older, influenza vaccines and other emergency vaccines in response to a public health emergency.
	39.10(5) Other adult vaccines. An authorized pharmacist shall only administer via protocol, to patients 18 years of age and older, the following vaccines:
	a. 	A vaccine on the ACIP-approved adult vaccination schedule.
	b. 	A vaccine recommended by the CDC for international travel.
	39.10(6) Vaccines administered via prescription. An authorized pharmacist may administer any vaccine pursuant to a prescription or medication order for an individual patient. In case of a serious complication, the authorized pharmacist shall notify the prescriber who authorized the prescription within 24 hours and shall submit a VAERS report.
	39.10(7) Verification and reporting. The requirements of this subrule do not apply to influenza and other emergency vaccines administered via protocol pursuant to subrule 39.10(4). An authorized pharmacist shall:
	a. 	Prior to administering a vaccine identified in subrule 39.10(5) or 39.10(6), consult the statewide immunization registry or health information network.
	b. 	As soon as reasonably possible following administration of a vaccine identified in subrule 39.10(5) or 39.10(6), report the vaccine administration to the statewide immunization registry or health information network and to the patient’s primary health care provider, if known.
[ARC 3858C, IAB 6/20/18, effective 7/25/18; ARC 4270C, IAB 1/30/19, effective 3/6/19; see Delay note at end of chapter]