ARC 6416C

ARC 6416C

PHARMACY BOARD[657]

Adopted and Filed

Rule making related to remote supervision of pharmacy technicians

The Board of Pharmacy hereby amends Chapter 3, "Pharmacy Technicians," and Chapter 6, "General Pharmacy Practice," 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 sections 147.76 and 155A.6A.

Purpose and Summary

These amendments provide for pharmacist delegation of technical functions relating to prescription processing activities (e.g., data entry) under specific conditions to an Iowa-registered certified pharmacy technician who is performing the delegated functions at a location other than where the supervising pharmacist is physically located. The authorized delegation will allow pharmacies to continue such remote activities initiated under the pandemic-related public health emergency under conditions that require:

●Adequate security and supervision to be maintained at all times to prevent unauthorized access to, and unauthorized storage/transfer of, confidential patient information or patient records;

●The supervising pharmacist to have real-time access to the prescription processing system that the technician is using or the patient records that the technician is processing;

●The technician to have access to the supervising pharmacist via a real-time communication mechanism; and

●The prescription processing system to be capable of documenting the functions performed by the technician.

These amendments also authorize a pharmacist to provide patient counseling via real-time interactive communication when the pharmacist is at a location other than the licensed pharmacy.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on April 6, 2022, as ARC 6279C. A public hearing was held on April 27, 2022, at 10 a.m.in the Health Professions Board Room, 400 S.W. 8th Street, Suite H, Des Moines, Iowa, and via Zoom.

Eleven individuals attended the hearing with one participant asking a question but providing no comment on the proposed amendments.

One written comment requested clarification if the Board's expectation is that the technician is located in the state while engaging in delegated supervised functions. Two written comments suggested removal of the phrase "insurance processing" from the list of examples of functions that may be completed remotely by a technician because of concern that it would imply that the function may only be performed by a technician.

While the Board determined no clarification was needed to require that a technician be physically located in the state provided that the technician is Iowa-registered and supervised in accordance with the rule, the Board did acknowledge the potential confusion that could result from the phrase "insurance processing" and, in response, removed the phrase from subrule 3.21(2).

Adoption of Rule Making

This rule making was adopted by the Board on June 28, 2022.

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 has been found.

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 August 31, 2022.

The following rule-making actions are adopted:

Item 1. Amend rule 657—3.5(155A), introductory paragraph, as follows:

657—3.5(155A) Certification of pharmacy technicians. Except as provided in subrule 3.5(1), all pharmacy technicians shall be required to be nationally certified as provided by this rule. National certification acquired through successful completion of any NCCA-accredited pharmacy technician certification program and examination fulfills the requirement for national certification. National certification does not replace the need for licensed pharmacist control over the performance of delegated functions, nor does national certification exempt the pharmacy technician from registration pursuant to these rules. A certified pharmacy technician shall maintain the technician's national certification, in addition to the technician's Iowa registration, during any period of employment in or for an Iowa pharmacy as a certified pharmacy technician.

Item 2. Amend rule 657—3.21(155A) as follows:

657—3.21(155A) Delegation of functions.

3.21(1) Policies and procedures. Pursuant to established policies and procedures and the supervising pharmacist's professional judgment, a an Iowa-licensed supervising pharmacist may delegate any technical or nontechnical functions in the operation of the pharmacy, except those which are prohibited pursuant to rule 657—3.23(155A), to an appropriately trained and registered Iowa-registered pharmacy technician, but only if the pharmacist is on site and available to supervise the pharmacy technician when delegated functions are performed, except as provided in rule 657—6.7(124,155A) or 657—7.6(155A), as appropriate, or as provided for telepharmacy in 657—Chapter 13.

3.21(2) Remote supervision. A supervising pharmacist may delegate technical functions relating to prescription processing (e.g., data entry) to a certified pharmacy technician who is performing the delegated functions at a location that is not a licensed pharmacy only if the following conditions are met:

a. Adequate security and supervision are maintained at all times to prevent unauthorized access to, and unauthorized storage/transfer of, confidential patient information or patient records;

b. The supervising pharmacist has real-time access to the prescription processing system which the certified pharmacy technician is using or the patient record which the certified pharmacy technician is processing;

c. The supervising pharmacist is available to respond to certified pharmacy technician questions via a real-time communication mechanism at all times when delegated functions are being performed; and

d. The pharmacy's prescription processing system is capable of documenting the functions performed by the certified pharmacy technician.

3.21(3) Pharmacist final verification required. Except as provided for an approved technician product verification program pursuant to 657—Chapter 40, the pharmacist shall provide and document the final verification for the accuracy, validity, completeness, and appropriateness of the patient's prescription or medication order prior to the delivery of the medication to the patient or the patient's representative.

3.21(4) Further delegation prohibited. A pharmacy technician shall not delegate technical functions to a pharmacy support person.

Item 3. Renumber subrules 6.14(4) to 6.14(6) as 6.14(5) to 6.14(7).

Item 4. Adopt the following new subrule 6.14(4):

6.14(4) Remote counseling. Patient counseling that is provided by the pharmacy via a pharmacist who is at a location other than the licensed pharmacy shall be provided via a real-time interactive communication mechanism.

[Filed 6/30/22, effective 8/31/22]

[Published 7/27/22]

Editor's Note: For replacement pages for IAC, see IAC Supplement 7/27/22.