**1. Introduction**

Vaccines remain one of the most cost-e ffective preventative health measures available and have been estimated to reduce direct financial burden on healthcare by \$9.9 billion [1]. Additionally, pharmacies represent the second most common location for an adult to receive an influenza vaccination [2]. With an estimated 42,000 adult and 300 child deaths per year on average attributable to influenza alone, opportunity exists to improve access to this crucial preventative health intervention through expansion of patient access to vaccinations [1]. The World Health Organization (WHO) estimated that vaccinations prevent between two and three million deaths each year [3]. Kamal et al. identified various factors that may contribute to low rates of vaccination such as apathy, misconceptions, cost, distance to clinics, wait times, and inconvenient hours [4]. When it comes to barriers to receiving immunizations, less talked about or mentioned are the statutes and regulations surrounding them or who may be authorized to provide them. Given that pharmacies are one of the most accessible health destinations for the general public, they have served as a gateway to increase vaccination rates and improve access to care. According to data reported by the American Pharmacist Association (APhA) and National Alliance of State Pharmacy Associations (NASPA), pharmacists are authorized legally to administer vaccines in all 50 states and D.C. [5]. Pending a couple of states that have worked on recent law changes (New Jersey, New York), student pharmacists (interns) will soon be able to administer vaccines in all states as well [5–7].

As pharmacist roles continue to evolve over time, so will those of pharmacy technicians. Pharmacists' professional delegation has become a key shift towards ensuring workload allocations and safe practices can remain intact. Working together with pharmacists and student pharmacists, pharmacy technicians play a critical role in impacting public health. Technicians represent a key opportunity to add a team member to help attribute to the public health initiative of increasing access to vaccinations. More recently, a technical but seemingly innovative role for pharmacy technicians, administration of vaccines, has emerged. With recent outbreaks of vaccine preventable diseases, and patient safety at the forefront of missions of boards of pharmacy, the public may benefit from adding another pharmacy team member to help increase access to vaccinations.

In 2016–17, Idaho actively underwent a rule rewrite which included adding language that directly permitted pharmacy technicians to administer immunizations [8]. With this, they became the first state within the U.S. to do so and also became the first state to actively involve pharmacy technicians in a training program and administration at local pharmacies. More recently in 2018, Idaho broadened language to allow for delegation utilizing professional judgement and therefore laws became "silent" on the topic. Seeing that statutes and regulations are silent, this could be interpreted as technically not an illegal task to delegate and perform, or in legal terminology; permissive. This also raises an interesting concept of silence within law and how state agencies or others may interpret these findings. Rhode Island became the second in late 2018 to promulgate rules and Utah made changes to their statewide vaccine protocol shortly after [9,10].

To date, three states have made changes within scope of practice to include pharmacy technician administration of vaccinations, including Idaho, Rhode Island, and Utah with others pending [8–11]. What may not be as apparent are the statutes and regulations surrounding allowance, prohibition, or silence in all 50 states and D.C. The purpose of this survey was to review and compile data surrounding the statutes and regulations pertaining to pharmacy technician administration of immunizations. With the data analyzed, the goal of the project was to provide a national overview of state specific language, citations, and examples of law variations. This report may serve as an informative reference for discussion or changes that could be made to either statutes or regulations per respective states.

#### **2. Materials and Methods**

Data collection consisted of a two-pronged approach in which a state-specific board of pharmacy survey and a peer-reviewed classification process were conducted. This project was found to be exempt from Institution Review Board (IRB) approval by the Ferris State University IRB (IRB-FY18-19-58).

In October 2018, a nine-question survey constructed in QuestionPro was emailed to 50 state boards of pharmacy, including the District of Columbia. Contact information for each board of pharmacy had been identified using a publicly available complied contact list collected via the website www.stateside.com. Any failure to deliver notices or kickback messages required direct communication with that specific board for updated contact information. Instructions for completion of the survey along with consent were included in an introduction with a given time estimate of 5–15 minutes. Those contacted were informed that participation in the survey was voluntary, and that all responses, including non-response, would be recorded and published. No personal or demographic information was collected, and all respondents remained anonymous. Representatives were asked to indicate the state agency their response represented. See Table A1 in Appendix A, for a comprehensive list of survey questions.

The survey was disseminated 24th October 2018, with a two-week timeline of 6th November 2018. Reminders to complete the survey were sent 29th October 2018, one week before the deadline via email to the same contact address used initially. Data was assimilated from QuestionPro into a shared data collection program for evaluation. The classification process contained two-steps: 1) manual review of state-specific statutes and regulations, and, 2) group peer review of manual review results. The peer-review classification process began in November 2018 and concluded in May 2019.

While the manual survey categorization methods could be considered somewhat unique, a review of methodology from Tzanetakos et al. and Stewart et al. helped build the foundation [12,13]. The manual review of state-specific statute began with the division of 50 states (and the District of Columbia) alphabetically (Alabama through Missouri; Montana through Washington D.C.) into two sets consisting of 25 and 26 states. One author was then selected to review each of these divisions, with selection of author review of these groups arbitrarily chosen. The protocol in Figure 1 was used as a standardized approach to research, identify, and document state-specific results: State-specific statutes (Public Health Code, Revised Code, and "State Code") were reviewed through the use of the following key words: "Practice of pharmacy", "Pharmacy Technician", "Immunizations [or] Vaccines", "Delegate [or] Delegation", "Professional Judgement", and "Administration". If language was found in state-specific statute after the search using these keywords, it was documented into one of four categories discussed in the Results section (Section 3). If no language was found in state-specific statute, that same search protocol was directed at the matching state's Board of Health and Board of Medicine. At this step, regardless of if language had been identified or not, it would be categorized per protocol and documented into the shared data collection program into one of the following categories: Not Expressly Prohibited, Prohibited Directly, Prohibited Indirectly, and Permissive. This process was then repeated for that identical state's regulations (Board of Pharmacy Rules or Administration Code) with categorization and documentation occurring in an equal fashion. After both statutes and regulations had been documented for a state, this entire procedure was repeated until all states had been categorized. Upon completion of data collection, the author assigned to one set subsequently peer reviewed the opposite set via the same protocol, ensuring that every data point had received equal analysis. A color-coded system (red, yellow, green) was used to compare agreemen<sup>t</sup> in findings (complete disagreement, agreemen<sup>t</sup> with discourse, and complete agreement) to facilitate the group peer-review process.

The group peer-review process began shortly after the conclusion of the manual review. A final step of the peer review process involved having the primary investigator review all entries to confirm categorization or settle di fferences identified. All authors met and discussed results of data collection using citations documented in the shared data collection program. Discussion occurred until every data point had been finalized to facilitate bias mitigation and settle any discrepancies. This peer review methodology known as triangulation was adopted from Farmer et al. [14]. The primary investigator also reconciled survey data as another comparator. Final data categorization was then recorded.

Definitions of Permissive, Prohibited Directly, Prohibited Indirectly, and Not Expressly Prohibited are encapsulated in Table A2 in Appendix A.
