653—13.3 (147) Supervision of pharmacists who administer adult immunizations. A physician may prescribe adult immunizations via written protocol for influenza and pneumococcal vaccines for administration by an authorized pharmacist if the physician meets these requirements for supervising the pharmacist.
	 13.3(1) Definitions.
	  a.   	 “Authorized pharmacist” means an Iowa-licensed pharmacist who has documented that the pharmacist has successfully completed an Accreditation Council for Pharmacy Education (ACPE)-approved continuing pharmaceutical education program on vaccine administration that:
	 (1) 	 Requires documentation by the pharmacist of current certification in the American Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health care providers;
	 (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 Centers for Disease Control and Prevention 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 and counseling;
	  9. 	 Immunization record management; and
	  10. 	 Management of adverse events, including identification, appropriate response, documentation, and reporting.
	  b.   	 “Vaccine” means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.
	  c.   	 “Written protocol” means a physician’s order for one or more patients that contains, at a minimum, the following:
	 (1) 	 A statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of administration of adult immunizations for influenza and pneumococcus;
	 (2) 	 A statement identifying the individual authorized pharmacist;
	 (3) 	 A statement that forbids an authorized pharmacist from delegating the administration of adult immunizations to anyone other than another authorized pharmacist, a registered pharmacist-intern under the direct personal supervision of the authorized pharmacist, or a registered nurse;
	 (4) 	 A statement identifying the vaccines that may be administered by an authorized pharmacist, the dosages, and the route of administration;
	 (5) 	 A statement identifying the activities an authorized pharmacist shall follow in the course of administering adult immunizations, including:
	  1. 	 Procedures for determining if a patient is eligible to receive the vaccine;
	  2. 	 Procedures for determining the appropriate scheduling and frequency of drug administration in accordance with applicable guidelines;
	  3. 	 Procedures for record keeping and long-term record storage including batch or identification numbers;
	  4. 	 Procedures to follow in case of life-threatening reactions; and
	  5. 	 Procedures for the pharmacist and patient to follow in case of reactions following administration;
	 (6) 	 A statement that describes how the authorized pharmacist shall report the administration of adult immunizations, within 30 days, to the physician issuing the written protocols and to the patient’s primary care physician, if one has been designated by the patient. In case of serious complications, the authorized pharmacist shall notify the physicians within 24 hours and submit a VAERS report to the bureau of immunizations, Iowa department of public health. (VAERS is the Vaccine Advisory Event Reporting System.) A serious complication is one that requires further medical or therapeutic intervention to effectively protect the patient from further risk, morbidity, or mortality.
	 13.3(2) Supervision. A physician who prescribes adult immunizations to an authorized pharmacist for administration shall adequately supervise that pharmacist. Physician supervision shall be considered adequate if the delegating physician:
	  a.   	 Ensures that the authorized pharmacist is prepared as described in subrule 13.3(1), paragraph “a”;
	  b.   	 Provides a written protocol that is updated at least annually;
	  c.   	 Is available through direct telecommunication for consultation, assistance, and direction, or provides physician backup to provide these services when the physician supervisor is not available;
	  d.   	 Is an Iowa-licensed physician who has a working relationship with an authorized pharmacist within the physician’s local provider service area.
	 13.3(3) Administration of other adult immunizations by pharmacists. A physician may prescribe, for an individual patient by prescription or medication order, other adult immunizations to be administered by an authorized pharmacist.
This rule is intended to implement Iowa Code sections 147.76 and 272C.3.