Legislative, Regulatory Changes Are Occurring Rapidly

Prior to the COVID-19 pandemic, the legislative and regulatory landscape for pharmacy technician–administered vaccines was in the beginning phase of a push toward change. Since the release of vaccines to help prevent the disease, major legislative and regulatory movement has occurred.

A study in 2019 by Eid et al examined laws in all 50 states and the District of Columbia to categorize findings of the legal landscape at the time.¹ Idaho was the first state, and a pioneer, to enact changes in 2016-2017; almost a year later, Rhode Island followed suit with updates to its administrative code.² Rhode Island created a tiered categorization of technicians within rule 216-40-15-1.12.³ Updates were made to allow “Pharmacy Technicians II” to perform vaccinations with proper training and other prerequisites. Utah reworked its statewide immunization protocol in 2019 to include delegation to technicians, then in 2020 the state promulgated rule changes.^4,5

The Washington State Pharmacy Quality Assurance Commission discussed issuing waivers through an auxiliary utilization plan in December 2019 and later approved allowances for technician-administered vaccines.⁶ In late December 2019, Illinois ran SB 2104, amending the state’s Pharmacy Practice Act to allow for the delegation to technicians of “any task within the practice of pharmacy if specifically trained for that task.”⁷ The bill passed unopposed and shifted to the state agency for consideration of the adoption of regulations as needed.

During the early stages of the pandemic, movement within legislative and regulatory vectors continued. In late March 2020, Indiana passed HB 1207 unopposed, which included the following within its language: “A pharmacy technician may administer an influenza immunization to an individual under a drug order or prescription...[under] direct supervision of the pharmacy technician by a pharmacist, a physician, a physician assistant, or an advanced practice registered nurse.”⁸ The bill also mentioned that the state pharmacy board would be adopting rules to establish requirements. This language would later prove to be a misstep and a common error made by lawmakers. The inclusion of 1 specific list of allowances for a product or vaccine later creates barriers and limits when expansion is needed. Had Indiana lawmakers included in the bill all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) or approved by the FDA, they would not have needed to add in the COVID-19 vaccine in a time of crisis. The Indiana Board of Pharmacy adopted emergency rules and may work on permanent allowances.⁹

In early March 2020 during a Michigan Board of Pharmacy meeting, board members indicated in a specific discussion that no rules or statutes existed to prohibit the administration of vaccines by technicians.¹⁰ In early fall 2020, prior to the fourth amendment to the Department of Health and Human Services (HHS) Public Readiness and Emergency Preparedness (PREP) Act, stakeholders in Michigan began training technicians to administer vaccines. In accordance with the act, they used statute MCL 333.9204, allowing for “a health professional other than a physician” to administer vaccines “under the direction of a physician,” which in turn allowed for physician delegation.¹¹

Since the multiple amendments that have been made to the PREP Act and the release of a guidance document from October 2020, a multitude of other states have made changes to regulations and statutes or enacted emergency rules with plans to make allowances for technician-administered vaccines permanent after the pandemic ends.¹² The changes mentioned are likely the result of COVID-19 and an increased need to immunize the public, but in addition it is hoped they will have a lasting impact on practice even after the pandemic is over. Colorado worked on a rule change effective March 2021 that added in delegation by pharmacists to a trained technician.¹³ Nevada made permanent changes to its rules proposed in August 2020 and approved later that fall.¹⁴ Missouri and New Mexico enact- ed emergency guidance and rules,^15,16 and Missouri has moved to make those rules permanent.¹⁷ Kentucky developed a pharmacy technician committee to discuss technician roles and has enacted emergency rules on the topic.¹⁸ Other states with more recent changes to their rules or statutes include Alabama (rules), Arkansas (statute), New Hampshire (statute), North Carolina (emergency statute), North Dakota (statute/rules), and Wisconsin (statute).^19-25 A few states are working on proposed rule changes, such as Arizona, Iowa, and Louisiana.^26-28

Overall, since the initiation of this movement for technician-administered vaccines in 2016 with Idaho taking the lead, momentum within the legislative and regulatory space has picked up. Prior to the COVID-19 pandemic, the administration of vaccines by technicians became a hot topic with associations such as the American Pharmacists Association and National Association of Boards of Pharmacy.^29,30 Slow but sure progress led to the first tide of permanent law or rule changes on the state level following Idaho’s lead. With the COVID-19 pandemic causing a need for pharmacies to step up, the HHS removed some legislative and regulatory barriers with the enactment of the PREP Act. The most recent expansion through amendments includes allowances for technicians administering COVID-19 therapeutics and influenza and other ACIP-recommended vaccines, and for lowering the age limits of those who can receive vaccines.¹² Using the PREP Act, technicians across all 50 states and the District of Columbia have stepped up and protected the public by showing compelling evidence that state laws and rules should not limit the administration of vaccines after the pandemic has subsided.

Deeb D. Eid, PharmD, RPh, serves as a regulatory affairs adviser in pharmacy for CVS Health.

REFERENCES

1. Eid D, Osborne J, Borowicz B. Moving the needle: a 50-state and District of Columbia landscape review of laws regarding pharmacy technician vaccine administration. Pharmacy (Basel). 2019;7(4):168. doi:10.3390/pharmacy7040168
2. Idaho IDAPA 27.01.01: Subchapter A Rule 100.
3. Pharmacists, pharmacies, and manufacturers, wholesalers, and distributors (216-RICR-40-15-1). Rhode Island Department of State. Accessed October 17, 2021. https://rules.sos.ri.gov/regulations/part/216-40-15-1
4. Vaccine Administration Protocol. State of Utah Department of Commerce. Updated September 24, 2020. Accessed October 17, 2021. https://dopl.utah.gov/pharm/vaccine_administration_protocol.pdf
5. Notice of proposed rule. State of Utah. September 20, 2019. Accessed October 17, 2021. https://dopl.utah.gov/laws/Prop_R156-17b_OAR_44108.pdf
6. Update: COVID-19 Governor Waivers & Pharmacy FAQs. Washington State Department of Health. April 28, 2020. Accessed October 17, 2021. https://content.govdelivery.com/accounts/WADOH/bulletins/288eef0
7. Illinois Senate Bill 2104. LegiScan. Accessed October 17, 2021. https://legiscan.com/IL/text/SB2104/2019
8. Indiana House Bill 1207. LegiScan. Accessed October 17, 2021. https://www.legiscan.com/IN/text/HB1207/2020
9. Title 856 Indiana Board of Pharmacy Emergency Rule LSA Document #21-256(E). Indiana Register. June 23, 2021. Accessed October 17, 2021. http://iac.iga.in.gov/iac//20210623-IR-856210256ERA.xml.pdf
10. Michigan Board of Pharmacy Public Workgroup public notice. State of Michigan Department of Licensing and Regulatory Affairs. March 6, 2021. Accessed October 17, 2021. https://www.michigan.gov/documents/lara/Pharmacy_Work_Group_Public_Notice_3-6-20_681170_7.pdf
11. Public health code statute (excerpt) MCL 333.9204. Michigan legislature. Accessed October 17, 2021. http://www.legislature.mi.gov/(S(kbji132fmipkr1rcbjckunzs))/mileg.aspx?page=GetObject&objectname=mcl-333-9204
12. Public Readiness and Emergency Preparedness Act. US Department of Health and Human Services. October 8, 2021. Accessed October 17, 2021https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx
13. Notice of permanent rulemaking hearing. Colorado Department of Regulatory Agencies. Accessed October 17, 2021. https://drive.google.com/file/d/13Q-WE2szXw0fX7SB1IrziP5tFdg--2T6/view
14. Proposed regulation of the State Board of Pharmacy. Nevada. August 20, 2020. Accessed October17, 2021.https://www.leg.state.nv.us/Register/2020Register/R142-20P.pdf
15. Qualified pharmacy technician childhood and COVID-19 vaccine administration and COVID-19 testing. New Mexico Board of Pharmacy. October 30, 2020. Accessed October 17, 2021.https://www.rld.state.nm.us/uploads/FileLinks/ad6770c244f74bdaaeaa53842023b4c7/Pharmacy_Technician_Vaccine_and_COVID_19_Test_Administration.pdf
16. Mo. Code Regs. tit. 20 § 2220-6.040. Casetext. October 1, 2021. Accessed October 17, 2021. https://casetext.com/regulation/missouri-administrative-code.title-20-department-of-commerce-and-insurance.division-2220-state-board-of-pharmacy.chapter-6-pharmaceutical-care-standards.section-20-csr-2220-6040-administration-by-medical-prescription-order
17. Orders of rulemaking. Missouri Register. 2021;46(11). Accessed October 17, 2021. https://www.sos.mo.gov/CMSImages/AdRules/moreg/2021/v46n11June1/v46n11b.pdf
18. Special called board meeting agenda pursuant to KRS 61.823. Kentucky Board of Pharmacy. February 8, 2021. Accessed October 17, 2021.https://pharmacy.ky.gov/BoardInformation/2021%20Board%20Meetings/February%208,%202021%20Special%20Called.pdf
19. 2021 Wisconsin Act 3. Wisconsin State Legislature. February 20, 2021. Accessed October 17, 2021. https://docs.legis.wisconsin.gov/2021/related/acts/3
20. House Bill 1135. State of Arkansas. March 8, 2021. Accessed October 17, 2021. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FBills%2F2021R%2FPublic%2FHB1135.pdf
21. Transmittal sheet for notice of intended action. Alabama State Board of Pharmacy. June 16, 2021. Accessed October 17, 2021. https://albop.com/oodoardu/2021/09/June-PHARM-680-X-2-.46-Proposed-new.pdf
22. Senate bill No. 2279. Sixty-Seventh Legislative Assembly of North Dakota. January 5, 2021. Accessed October 17, 2021. https://www.legis.nd.gov/assembly/67-2021/documents/21-0893-03000.pdf
23. 61-04-11 administration of medications and immunizations. North Dakota Board of Pharmacy. June 2021. Accessed October 17, 2021. https://www.nodakpharmacy.com/pdfs/61-04-11_Immunizations.pdf
24. House Bill 572. State of New Hampshire. August 10, 2021. Accessed October 17, 2021. http://gencourt.state.nh.us/bill_Status/billText.aspx?sy=2021&id=690&txtFormat=html
25. House bill 96. General Assembly of North Carolina. August 20, 2021. Accessed October 17, 2021. https://www.ncleg.gov/Sessions/2021/Bills/House/PDF/H96v6.pdf
26. Arizona proposed rule R21-97. Arizona Secretary of State. August 13, 2021. Accessed October 17, 2021. https://apps.azsos.gov/public_services/register/2021/33/contents.pdf
27. Iowa proposed rule ARC 5831C. Legislative Services Agency. September 14, 2021. Accessed October 17, 2021. https://www.legis.iowa.gov/docs/publications/AA/1230362.pdf
28. Proposed rule 2021-F. Louisiana Administrative Code. Accessed October 17, 2021. http://www.pharmacy.la.gov/assets/docs/Cmtes/RegRev/RegProp2021-F_MedAdmin_Draft2.pdf
29. Member boards, NABP continue to explore expansion of pharmacy technician roles. Innovations. 2019;48(7)6-8, 10. Accessed October 17, 2021. https://nabp.pharmacy/wp-content/uploads/2020/09/August-2019-Innovations.pdf
30. Pharmacy-based immunization administration by pharmacy technicians. American Pharmacists Association. January 20, 2020. Accessed October 17, 2021. https://www.pharmacist.com/Education/Certificate-Training-Programs/Technician-Immunizations