Missouri Regulations
Department of Commerce and Insurance/Board of Registration for the Healing Arts
Code of State Regulations 2021-06-30
PUBLICATION DATE: 06/30/2021
ACTION DATE: 06/01/2021
EFFECTIVE DATE: 07/30/2021
PUBLICATION TYPE: Centralized Repository
REGISTER SOURCE: Vol. 46, No. 11, Missouri Register 2021-06-01 p.967
PUBLICATION DATE: 06/01/2021
ACTION DATE: 06/01/2021
EFFECTIVE DATE: 07/30/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 46, No. 3, Missouri Register 2021-02-01 pp.182-183
PUBLICATION DATE: 02/01/2021
ACTION DATE: 01/04/2021
EFFECTIVE DATE: 01/19/2021
EXPIRATION DATE: 07/17/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 46, No. 3, Missouri Register 2021-02-01 p.262
PUBLICATION DATE: 02/01/2021
ACTION DATE: 01/04/2021
COMMENT DEADLINE: 03/03/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Office of the Secretary of State 2021-01-19
PUBLICATION DATE: 01/19/2021
ACTION DATE: 01/04/2021
EFFECTIVE DATE: 01/19/2021
EXPIRATION DATE: 07/17/2021
PUBLICATION TYPE: Agency

Title 20-DEPARTMENT OF COMMERCE AND INSURANCE

Division 2150-State Board of Registration for the Healing Arts

Chapter 5-General Rules

ORDER OF RULEMAKING

By the authority vested in the Missouri State Board of Registration for the Healing Arts under section 334.125, RSMo 2016, the board amends a rule as follows:

20 CSR 2150-5.025 is amended.

A notice of proposed rulemaking containing the text of the proposed amendment was published in the Missouri Register on February 1, 2021 (46 MoReg 262). Those sections with changes are reprinted here. This proposed amendment becomes effective thirty (30) days after publication in the Code of State Regulations.

SUMMARY OF COMMENTS: Pursuant to sections 334.125 and 338.010, RSMo, the Missouri State Board of Registration for the Healing Arts and the Missouri Board of Pharmacy jointly promulgat-ed the rule regulating the administration of vaccines per protocol; specifically, rule 20 CSR 2150-5.025 for the Missouri State Board of Registration for the Healing Arts, and rule 20 CSR 2220-6.050 for the Missouri Board of Pharmacy. Both boards proposed amendments and published the same for comments on or about February 1, 2021. Subsequently, four (4) comments were received on the proposed amendments from CVS Health and the Chief Inspector of the Board of Pharmacy, Tom Glenski. The Board of Pharmacy prepared a sum-mary of comments, responses and proposed further amendments in response to the comments for the Missouri State Board of Registration for the Healing Arts to review during the open session of its March 28, 2021 meeting. Following that review, the Missouri State Board of Registration for the Healing Arts has decided to adopt amendments proposed by the Board of Pharmacy.

COMMENT #1: CVS Health supported expansion of pharmacist technician activities. However, CVS Health recommended adding a "grandfathering clause" that would allow pharmacy technicians who have administered immunizations during the COVID-19 pandemic to continue immunizing under the proposed amendment without being required to have a pharmacy technician certification.

RESPONSE: The Board of Pharmacy believes both pharmacy technicians' work experience and pharmacy technicians' certification are necessary to protect the public and to ensure pharmacy technicians are properly trained in vaccine administration. The Missouri State Board of Registration for the Healing Arts agrees with the Board of Pharmacy regarding jointly promulgated rule 20 CSR 2150-5.025. No changes have been made in response to the comment.

COMMENT #2: Tom Glenski, the Chief Inspector of the Board of Pharmacy, recommended further amending section (1) of this rule so it is consistent with proposed changes made to section (1) of jointly promulgated rule 20 CSR 2220-6.050. Specifically, Mr. Glenski recommended amending section (1) to provide that vaccines may be administered at any Missouri licensed pharmacy "as allowed" in the governing protocol.

RESPONSE AND EXPLANATION OF CHANGE: The Board of Healing Arts agrees that the proposed change the Board of Pharmacy made to jointly promulgated rule 20 CSR 2220-6.050 should also be made to 20 CSR 2150-5.025. The rule has been amended as request-ed.

COMMENT #3: Tom Glenski also recommended amending section (3) of this rule so as to remove the requirement that pharmacists complete a vaccine administration program that includes training/instruction in current CDC vaccine guidelines and recommendations, basic immunology, and vaccine protection. Mr. Glenski noted these training elements are not required by the federal government for pharmacists administering vaccines pursuant to the emergency COVID-19 Declaration issued by the U.S. Department of Health and Human Services under the federal Public Readiness and Emergency Preparedness Act (PREP Act).

RESPONSE: The Board of Pharmacy believes the proposed rule 20 CSR 2220-6.050 would ensure pharmacists are appropriately trained to administer all vaccines authorized by Chapter 338, RSMo. Significantly, education providers have discretion to determine the scope and level of training needed. The Missouri State Board of Registration for the Healing Arts agrees with the Board of Pharmacy regarding jointly promulgated rule 20 CSR 2150-5.025. Accordingly, no changes have been made in response to the comment.

COMMENT #4: Tom Glenski also recommended further amending subsection (1)(E) of this rule so it is consistent with proposed changes the Board of Pharmacy made to jointly promulgated rule 20 CSR 2220-6.050. Mr. Glenski noted revised 20 CSR 2220-6.040 will allow a pharmacist to delegate medication administration to a pharmacy technician, if the pharmacy technician has one (1) year of work experience in Missouri or another U.S. state or territory. Mr. Glenski suggested the Board of Pharmacy amend 20 CSR 2220-6.050 to match the allowance in 20 CSR 2220-6.040.

RESPONSE AND EXPLANATION OF CHANGE: The Missouri State Board of Registration for the Healing Arts agrees with the comment and has amended the rule 20 CSR 2150-5.025 accordingly so it is consistent with the changes made by the Board of Pharmacy to jointly promulgated 20 CSR 2220-6.050.

20 CSR 2150-5.025 Administration of Vaccines Per Protocol

(1) A pharmacist may administer vaccines authorized by Chapter 338, RSMo, pursuant to a written protocol with a Missouri licensed physician who is actively engaged in the practice of medicine. Unless otherwise restricted by the governing protocol, vaccines may be administered at any Missouri licensed pharmacy or at any non-phar-macy location as allowed in the governing protocol.

(A) Vaccines must be administered in accordance with current treatment guidelines established by the Centers for Disease Control (CDC) and the manufacturer's guidelines, provided CDC guidelines shall control in the event of a conflict. Vaccines may not be administered to persons under seven (7) years of age unless otherwise authorized by law.

(E) For purposes of this rule, a "qualified pharmacy technician" is defined as a currently registered Missouri pharmacy technician who

1. Holds an active pharmacy technician certification issued by a certification entity accredited by the National Commission for Certifying Agencies;

2. Has an initial and, if applicable, annual documented assessment of competency in vaccine administration; and

3. Has assisted in the practice of pharmacy as a registered/licensed pharmacy technician in the state of Missouri or another U.S. state or territory for a minimum of one (1) year.