657—39.11(155A) Vaccine administration by pharmacists—statewide protocol. An authorized pharmacist may prescribe and administer vaccines and immunizations pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the prescribing and administration of a vaccine to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.
	39.11(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 39.11(3).
“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has met the requirements for an authorized pharmacist identified in subrule 39.11(3).
“Board” means the Iowa board of pharmacy.
“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.”
“Vaccine” means a specially prepared antigen administered to a person for the purpose of providing immunity.
	39.11(2) Vaccines authorized by statewide protocol. The vaccines authorized to be prescribed and administered pursuant to the statewide protocol shall include:
	a. 	To patients ages 18 years and older:
	(1)	An immunization or vaccination recommended by ACIP in its approved vaccination schedule for adults.
	(2)	An immunization or vaccination recommended by CDC for international travel.
	(3)	A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application.
	(4)	Other emergency immunizations or vaccinations in response to a public health emergency.
	b. 	To patients ages six months and older:
	(1)	A vaccine or immunization for influenza.
	(2)	Other emergency immunizations or vaccines in response to a public health emergency.
	c. 	To patients ages 11 years and older:
	(1)	The final two doses in a course of vaccinations for human papillomavirus (HPV).
	(2)	Reserved.
	39.11(3) Authorized pharmacist training and continuing education. An authorized pharmacist shall document successful completion of the requirements in paragraph 39.11(3)“a” and shall maintain competency by completing and maintaining documentation of the continuing education requirements in paragraph 39.11(3)“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.
	39.11(4) Assessment. An authorized pharmacist shall assess a patient for appropriateness of receiving a vaccine pursuant to the statewide protocol.
	39.11(5) Verification and reporting. Prior to the prescribing and administration of an immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and review the statewide immunization registry or health information network. As soon as reasonably possible following administration of a vaccine, the pharmacist shall report such administration to the patient’s primary health care provider, primary physician, and a statewide immunization registry or health information network. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the vaccine administered to the patient and shall advise the patient to consult a physician.
[ARC 4270C, IAB 1/30/19, effective 3/6/19; see Delay note at end of chapter]