ARC 6071C

ARC 6071C

PHARMACY BOARD[657]

Adopted and Filed

Rule making related to pharmacy technician administration of vaccines

The Board of Pharmacy hereby amends Chapter 3, "Pharmacy Technicians," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 155A.6A.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code section 155A.6A.

Purpose and Summary

This rule making provides the minimum training requirements for pharmacy technicians to engage in the administration of vaccinations. Currently, under the national public health emergency declaration and Public Readiness and Emergency Preparedness (PREP) Act in response to the global coronavirus pandemic, pharmacy technicians are authorized, pursuant to training and continuing education requirements, to administer pediatric vaccinations to any patient aged 3 to 18 years old and COVID-19 vaccinations to patients of any age for which the vaccination is authorized or approved. This rule making identifies properly trained pharmacy technicians so that the technicians may engage in pharmacist-delegated vaccine administration for immunizations and not be limited to pediatric or COVID-19 vaccinations.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on August 11, 2021, as ARC 5831C. This rule making was also adopted and filed emergency and published in the Iowa Administrative Bulletin as ARC 5820C on the same date.

A public hearing was held on September 2, 2021, at 10:30 a.m.in the Health Professions Board Room, 400 S.W. 8th Street, Suite H, Des Moines, Iowa, as well as by Zoom.

Nine individuals attended the public hearing with one individual providing oral comments on behalf of the Iowa Pharmacy Association in support of the rule making and stating that its membership has provided overwhelmingly positive feedback. The Board received two written comments, which were both supportive of the rule making.

No changes from the Notice have been made.

Adoption of Rule Making

This rule making was adopted by the Board on November 10, 2021.

Fiscal Impact

This rule making has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rule making, no impact on jobs can be determined.

Waivers

Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

Effective Date

This rule making will become effective on January 19, 2022, at which time the Adopted and Filed Emergency rule making is hereby rescinded.

The following rule-making action is adopted:

Amend rule 657—3.17(155A) as follows:

657—3.17(155A) Training and utilization of pharmacy technicians.

3.17(1) Policies and procedures. All licensed pharmacies located in Iowa that utilize pharmacy technicians shall develop, implement, and periodically review written policies and procedures for the training and utilization of pharmacy technicians appropriate to the practice of pharmacy. Pharmacy policies shall specify the frequency of review.

3.17(2) Documented training. Pharmacy technician training shall be documented and maintained by the pharmacy for the duration of employment. Policies and procedures and documentation of pharmacy technician training shall be available for inspection and copying by the board or an agent of the board.

3.17(3) Vaccine administration training and continuing education. A pharmacy technician who administers a vaccine or immunization under the supervision of a pharmacist shall document successful completion of the requirements in paragraph 3.17(3)"a" or "b" and shall maintain competency by completing and maintaining documentation of the continuing education requirements in paragraph 3.17(3)"c."

a. Initial qualification. Except as provided in paragraph 3.17(3)"b," a technician shall have successfully completed an Accreditation Council for Pharmacy Education (ACPE)-accredited program on vaccine administration that is an evidence-based program 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 (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)Immunization record management; and

(9)Identification of adverse events.

b. Previous qualification. A technician who is currently licensed as a registered nurse shall be deemed to have met the training requirement.

c. Continuing education. During any technician registration renewal period, a technician 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 "T" or "P."

d. Certification maintained. During any period within which a technician may engage in the administration of vaccines, the technician shall maintain current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.

[Filed 11/15/21, effective 1/19/22]

[Published 12/15/21]

Editor's Note: For replacement pages for IAC, see IAC Supplement 12/15/21.