By the authority vested in the Missouri Board of Pharmacy under sections 338.010, 338.140, and 338.220, RSMo Supp. 2020, the board amends a rule as follows:
20 CSR 2220-6.050 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 262-263). 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: The board received five (5) comments on the proposed amendment from CVS Health, Board of Pharmacy Chief Inspector Tom Glenski, and staff.
COMMENT #1: CVS Health supported the board's expansion of pharmacist technician activities. However, CVS Health recommended the board add 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 believes both pharmacy technician work experience and pharmacy technician certification are necessary to protect the public and to ensure pharmacy technicians are properly trained in vaccine administration. No changes have been made in response to the comment.
COMMENT #2: Tom Glenski, Board Chief Inspector, recommended the board amend subsection (1)(E) of this rule to be consistent with proposed changes to paragraph (4)(A)10. 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 agrees and the rule has been amended as requested. The Board of Healing Arts agrees to make the proposed change to jointly promulgated rule 20 CSR 2150-5.025.
COMMENT #3: Tom Glenski recommended the board amend section (1) to remove the requirement that pharmacy technicians 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 pharmacy technicians 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 believes the proposed amendment would ensure pharmacy technicians 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. Accordingly, no changes have been made in response to the comment.
COMMENT #4: Tom Glenski recommended the board amend sub-section (1)(E) of this rule to be consistent with proposed changes to rule 20 CSR 2220-6.040 which has also been filed for public comment. 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 amend 20 CSR 2220-6.050 to match the allowance in 20 CSR 2220-6.040.
RESPONSE AND EXPLANATION OF CHANGE: The board agrees with the comment and has amended the rule accordingly.
COMMENT #5: Staff members suggested the board amend subsec-tion (1)(A) to require that vaccines must be administered in accordance with "current" treatment guidelines established by the Centers for Disease Control (CDC) and the manufacturer's guidelines.
RESPONSE AND EXPLANATION OF CHANGE: The board agrees and has amended the rule to include the recommendation.