ARC 6012C

ARC 6012C

PHARMACY BOARD[657]

Notice of Intended Action

Proposing rule making related to collaborative pharmacy practice

and providing an opportunity for public comment

The Board of Pharmacy hereby proposes to amend Chapter 39, "Expanded Practice Standards," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in 2021 Iowa Acts, Senate File 296.

State or Federal Law Implemented

This rule making implements, in whole or in part, 2021 Iowa Acts, Senate File 296.

Purpose and Summary

The proposed amendment updates a Board rule relating to collaborative pharmacy practice agreements between pharmacists and Iowa-licensed prescribers who have independent prescribing authority. The rule making identifies the minimum required elements of such agreements.

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.

Public Comment

Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m.on November 23, 2021. Comments should be directed to:

Public Hearing

A public hearing at which persons may present their views orally or in writing will be held as follows:

Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.

Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs.

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).

The following rule-making action is proposed:

Rescind rule 657—39.13(155A) and adopt the following new rule in lieu thereof:

657—39.13(155A) Collaborative pharmacy practice.

39.13(1) Definitions. For the purpose of this rule, the following definitions shall apply:

"Collaborative pharmacy practice" means a practice of pharmacy whereby one or more pharmacists provides patient care and drug therapy management services not otherwise permitted to be performed by a pharmacist to patients under a collaborative pharmacy practice agreement with one or more practitioners which defines the nature, scope, conditions, and limitations of the patient care and drug therapy management services to be provided by the pharmacist(s) in order to ensure that a patient achieves the desired outcomes.

"Practitioner" means a physician, dentist, podiatric physician, veterinarian, optometrist, or advanced registered nurse practitioner who holds an active license to practice in Iowa.

39.13(2) Collaborative practice agreement.

a. Pursuant to these rules, a pharmacist or pharmacy may engage in collaborative pharmacy practice under a collaborative pharmacy practice agreement with one or more practitioners to provide patient care and drug therapy management services to one or more patients.

b. A collaborative pharmacy practice agreement shall include:

(1)The identification of the parties to the agreement, including the name(s) or category of the pharmacist(s), including registered pharmacist-intern(s) under the supervision of a pharmacist, who are authorized to perform delegated activities under the agreement and the name(s) or category of the practitioner(s) who are delegating activities under the agreement;

(2)The establishment of the delegating practitioner's scope of practice authorized in the agreement and a description of the permitted activities and decisions to be performed by the pharmacist(s);

(3)The protocol, formulary, or clinical guidelines that describe or limit the pharmacist's authority to perform the patient care or drug therapy management services and, as applicable, the drug name, class or category provided under drug therapy management;

(4)A description of the process to monitor compliance with the agreement and clinical outcomes of patients;

(5)The effective date;

(6)A provision addressing termination of the agreement; and

(7)The signatures of the parties to the agreement and dates of signing.

c. Parties to the collaborative pharmacy practice agreement shall review and revise such agreement as appropriate, but no less than every two years.

d. Any collaborative pharmacy practice agreement shall be maintained by the pharmacist(s) or pharmacy and be available upon request or inspection.

e. Prior to engaging in patient care or drug therapy management services under a collaborative pharmacy practice agreement, including when the agreement is updated, each pharmacist practicing under the agreement shall attest that the pharmacist has read and understand the agreement. Documentation of pharmacist attestation shall be maintained by the pharmacy for at least two years from the attestation date and be available upon request or inspection.