ARC 5820C

ARC 5820C

PHARMACY BOARD[657]

Adopted and Filed Emergency

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 of immunizations and not be limited to pediatric or COVID-19 vaccinations.

Reason for Adoption of Rule Making Without

Prior Notice and Opportunity for Public Participation

Pursuant to Iowa Code section 17A.4(3), the Board finds that notice and public participation are unnecessary or impractical because emergency adoption was approved by the Administrative Rules Review Committee. The normal rule-making process would extend well into or beyond the coming fall influenza and pneumonia vaccination season (typically initiated late August and primarily completed by the end of October). The requirements in this rule making essentially mirror the requirements under the federal PREP Act for pharmacy technicians to engage in vaccine administration. The Board will also complete the notice and public participation processes via a simultaneous rule making.

In compliance with Iowa Code section 17A.4(3)"a," the Administrative Rules Review Committee at its July 13, 2021, meeting reviewed the Board's determination and this rule making and approved the emergency adoption.

Reason for Waiver of Normal Effective Date

Pursuant to Iowa Code section 17A.5(2)"b"(1)(b) and (c), the Board also finds that the normal effective date of this rule making, 35 days after publication, should be waived and the rule making made effective on July 15, 2021, because allowing properly trained pharmacy technicians to assist pharmacists in vaccine administration during the upcoming influenza/pneumonia season (when there may also continue to be the compounding public health risk of continued COVID-19 infections or the public health protection of continued COVID-19 initial or booster vaccinations) will allow pharmacists to focus on the clinical aspects of the process and provide patients with increased access to vaccinations.

Adoption of Rule Making

This rule making was adopted by the Board on July 14, 2021.

Concurrent Publication of Notice of Intended Action

In addition to its adoption on an emergency basis, this rule making has been initiated through the normal rule-making process and is published herein under Notice of Intended Action as ARC 5831C to allow for public comment.

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 became effective on July 15, 2021.

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 Emergency 7/14/21, effective 7/15/21]

[Published 8/11/21]

Editor's Note: For replacement pages for IAC, see IAC Supplement 8/11/21.