ARC 4388C

ARC 4388C

PHARMACY BOARD[657]

Notice of Intended Action

Proposing rule making related to statewide protocols

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 Iowa Code sections 147.76 and 155A.46.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code section 155A.46.

Purpose and Summary

Following adoption of rule making relating to a pharmacist's participation in statewide protocols (ARC 4270C, IAB 1/30/19), concern was raised relating to the term "prescribe" used in the applicable rules for the statewide protocols. To address the concern, amendments that replace "prescribe" with "order" consistent with language used in the Iowa Code were adopted and filed emergency and are published herein (ARC 4387C, IAB 4/10/19). Those amendments are included in this Notice to allow for public comment. Additional amendments are proposed in this Notice to clarify that, for the purpose of these rules, the order shall constitute a prescription to ensure that medications dispensed pursuant to a statewide protocol by a pharmacist's order can be eligible for third-party reimbursement.

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 April 30, 2019. Comments should be directed to:

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)"b," an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

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 actions are proposed:

Item 1. Amend rule 657—39.6(155A) as follows:

657—39.6(155A) Statewide protocols. A pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of public health and available on the board's website at pharmacy.iowa.gov, prescribe order and dispense medications pursuant to rules 657—39.8(155A), 657—39.9(155A), and 657—39.11(155A). For the purpose of this rule, the order shall constitute a prescription.

Item 2. Amend rule 657—39.8(155A) as follows:

657—39.8(155A) Statewide protocol—naloxone. An authorized pharmacist may prescribe order and dispense naloxone to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of naloxone to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist. For the purpose of this rule, the order shall constitute a prescription.

39.8(1) to 39.8(6) No change.

39.8(7) Records. An authorized pharmacist shall maintain records of naloxone prescribed ordered and dispensed pursuant to the statewide protocol.

Item 3. Amend rule 657—39.9(155A) as follows:

657—39.9(155A) Statewide protocol—nicotine replacement tobacco cessation products. An authorized pharmacist may prescribe order and dispense nicotine replacement tobacco cessation products to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of a nicotine replacement tobacco cessation product to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist. For the purpose of this rule, the order shall constitute a prescription.

39.9(1) to 39.9(6) No change.

39.9(7) Records. An authorized pharmacist shall maintain records of nicotine replacement tobacco cessation products prescribed ordered and dispensed pursuant to the statewide protocol.

Item 4. Amend rule 657—39.11(155A) as follows:

657—39.11(155A) Vaccine administration by pharmacists—statewide protocol. An authorized pharmacist may prescribe order and administer vaccines and immunizations pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the prescribing ordering and administration of a vaccine to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist. For the purpose of this rule, the order shall constitute a prescription.

39.11(1) No change.

39.11(2) Vaccines authorized by statewide protocol. The vaccines authorized to be prescribed ordered and administered pursuant to the statewide protocol shall include:

a. to c. No change.

39.11(3) and 39.11(4) No change.

39.11(5) Verification and reporting. Prior to the prescribing ordering and administration of an immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and review the statewide immunization registry or health information network. As soon as reasonably possible following administration of a vaccine, the pharmacist shall report such administration to the patient's primary health care provider, primary physician, and a statewide immunization registry or health information network. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the vaccine administered to the patient and shall advise the patient to consult a physician.