Use of Research Evidence Varied in Efforts to Expand Pharmacist Prescriptive Authority: Recommendations to Increase Research Utilization

Background: An expanding body of literature shows that pharmacists’ interventions improve health outcomes and are cost-saving. However, diverse state regulations of pharmacists’ scope of practice create a discrepancy between what pharmacists are trained to do and what they legally can do. This study hopes to investigate stakeholder utilization of research evidence to expand scope of practice in their respective states. Methods: Using autonomous pharmacist prescriptive authority as a surrogate for general pharmacist scope of practice, a general policy document analysis was performed to understand the scope of practice landscape for pharmacists across the United States. Next, a systemized review and semi-structured interviews were conducted to explore how the identied states in the policy document analysis utilized evidence during the policy make process. Investigators analyzed ndings from the systemize review and transcribed interviews through application of the SPIRIT Action Framework. Resulting codes were summarized across themes, and recommendations to researchers about increasing utilization of research evidence were crafted. Results: Sixteen states with 27 autonomous pharmacist prescriptive authority policies were identied. The systemized review yielded no relevant peer-review literature regarding evidence utilization, so gray literature and interviews were analyzed. Public health need and safety considerations motivated evidence engagement, while key considerations dictating utilization of research included perceptions of research, access to resources and experts, and the successful implementation of similar policy. Research evidence helped to advocate for and set terms for pharmacist prescribing. Barriers to research utilization include stakeholder opposition to pharmacist prescribing, inability to interpret research, and a lack of relevant evidence. Recommendations for researchers include investigating specic metrics to evaluate scope of practice policy, developing relationships between policymakers and researchers, and leveraging pharmacy practice stakeholders. Conclusions: Overall, alignment of researcher goals and legislative priorities, coupled with timely communication, may help to increase research evidence engagement in pharmacist scope of practice policy. By addressing these factors regarding research engagement identied in this study, researchers can increase evidence-based scope of practice, which can help to improve patient outcomes, contain costs, and provide pharmacists with the legal infrastructure to practice at the top of their license.

healthcare access and outcomes varies based on state scope of practice policy. Studies at both the single-site clinic and state level demonstrate broader expansion of scope of practice in these areas, such as pharmacist prescribing and disease management, experience greater access in healthcare and improvements in clinical outcomes (34,35).
Despite the ample evidence supporting the effectiveness and safety of pharmacists, inconsistent state-tostate restrictions on pharmacy practice demonstrate a gap between research and effective policy. Not only do these discrepancies between states hinder pharmacists from performing at the top of their training to improve patient care, but it has the potential to create impactful discrepancies in health care access (36). One potential way to reconcile these discrepancies is by improving the dissemination of research and engagement of research by stakeholders in pharmacy policy (37). Leveraging this research supporting advanced pharmacy services can create an opportunity to broaden scope of practice and create evidence-based health policy.
This study aims to characterize these approaches by investigating the utilization of evidence in formulating scope of practice policy. Speci cally, this research explores how policymakers, including legislators and other members of government entities, and pharmacist advocates interact with evidence when developing and implementing autonomous pharmacist prescriptive authority policies. Autonomous prescriptive authority describes the lawful ability for pharmacists to prescribe certain medications based on their own licensing and training requirements, rather than under the license of another prescriber (28,38). Allowing pharmacists to prescribe independent of physicians provides a benchmark for other elements of pharmacist scope of practice. Within this realm, the National Alliance of State Pharmacy Associations (NASPA), which advocates for broadening prescriptive authority, identi ed three areas of existing expanded pharmacist prescriptive authority: (1) contraception access, (2) tobacco cessation, and (3) naloxone access (39-41). These three category-speci c examples are the focus of this study. Understanding how research was utilized in and in uenced these existing policies can illuminate effective methods for disseminating evidence for the creation of new evidence-based scope of practice policies.

Methods
This study sought to examine the connection between successful policymaking that enhances pharmacy practice and improves public health outcomes through the application of the SPIRIT Action Framework (42). Data collection and analysis was conducted from January 2019 to March 2020. The rst aim of this study was to rst characterize states with pharmacists' autonomous contraception, tobacco cessation, or naloxone prescriptive authority policies passed during the time frame of 2000 to the fall of 2019. The second aim was to evaluate the use of research evidence in these policies through the application of the SPIRIT Action Framework (42) to a systematize literature review and semi-structured interviews of policymakers and pharmacist advocates. Finally, the third aim was to determine recommendations surrounding conducting research and disseminating evidence in the context of pharmacist scope of practice.

Analytical Framework and De nitions
The SPIRIT Action Framework was developed to assesses research engagement and in uence on health policy and takes into account the role research evidence plays in the context of other factors in policymaking (42,43). Operating on the hypothesis that research-informed policies can lead to improved health outcomes the framework outlines four pillars: catalyst, capacity, research engagement, and research use. A catalyst is needed for the use of research, and the response to the catalyst is determined by the capacity of the organization and the individual staff. Where there is su cient capacity, research engagement activities must occur that facilitate the use of this research. In this study, the SPIRIT Action Framework was used to analyze research evidence utilization in the realm of three categories of autonomous prescriptive authority for pharmacists.
To determine research evidence engagement and use during the development and implementation of prescriptive authority policy, this study considers the perspectives of stakeholders' policymakers and pharmacist advocates involved in the policymaking process. Policymakers were de ned as state legislators who were sponsors of bills, legislation proponents, or agency administrators such as Board of Pharmacy members. Pharmacists advocates included members of pharmacy professional associations, such as state chapters of the American Pharmacists Association or the American Society of Health-System Pharmacists.
To fully encompass and assess the use of different types of research, research evidence was de ned as the analyses of data or concepts found in peer reviewed papers, technical monographs or books, population trends, gray literature such as internal studies and evaluations, and reports published on government and association websites.

Data Collection Policy Document Analysis
To identify states that utilize autonomous prescriptive authority, a policy document analysis (44) was conducted to select states which had legislation allowing for autonomous prescribing of either contraception, tobacco cessation aids, or naloxone. A combination of resources were utilized, including publications, search engines, and advocacy resources through pharmacy associations, NASPA and the Association of State and Territorial Health O cials (ASTHO) (8,19,(25)(26)(27)(28)(29)(30)(31)(32)(33)(34). From the states identi ed in these texts, the prescriptive authority policies were obtained from state legislature websites. To be included, state policies must have been rati ed as a law or approved as a rule by 2019 and authorize pharmacist independent prescribing of contraception, naloxone, or tobacco cessation. Policy mechanisms included were policies that stated "prescribe", "furnish", or "initiate" in their language. Collaborative practice agreements, standing orders, and laws and protocols that only allow pharmacists to "dispense" were excluded. States that satis ed all the inclusion criteria were selected and were utilized for analysis.

Systematized Review
A systematized review (52) was conducted to nd existing publications regarding the use of research evidence in developing autonomous pharmacist prescriptive authority for each state identi ed in the policy document analysis. Peer-reviewed and gray literature were found by searching academic databases in PubMed, Embase, and America's News, a news article database, using subject headings and keywords for the concepts of pharmacists and prescribing authority policy on contraception, tobacco cessation, and naloxone products. Peer-reviewed and gray literature was collected to capture all writings that documented the policy-making process, collection of data, or use of research and evidence for the purposes of conception, development, and passage of these prescriptive authority policies.
For peer reviewed papers, the general search strategy included searching for articles related to pharmacists and prescriptive authority policy. Then, searches were further narrowed by utilizing MeSH terms pertaining to each of the prescribing categories and speci c states; these terms were optimized with the help of a clinical librarian. Full search terms for each database are shown in Additional File 1. Articles found through these search strategies were screened rst based on title and abstract relevance.
Articles that were not excluded during this rst read-through were then screened through full-text review using the same exclusion parameters. Inclusion criteria for articles were: 1) publications from 1990 to 2019 in the United States, and 2) articles described evidence from states identi ed in the Policy Document Analysis phase. Importantly, articles that referred to evidence collected or utilized after the passage or implementation of the states' policies were excluded from analysis, since the focus of this project was on the role of research evidence in the policy-making process. Exclusion and inclusion of articles was separately con rmed by one other researcher.
For America's News database, search phrases like those used in PubMed searches were utilized to search news outlets and journalistic media of speci c states identi ed in the Landscape Policy Analysis. Full search terms for the America's News database are also re ected in Additional File 1. Full review screening of articles found through searches was conducted using similar criteria to peer-reviewed searches.

Semi-Structured Interviews: Sample Recruitment and Interview Process
Based on the states and policy mechanisms identi ed through the landscape analysis, investigators sought to interview policy makers and pharmacy advocates involved in the conception, development, and passage of statewide autonomous pharmacy prescriptive authority in either contraception, tobacco cessation, or naloxone. Through purposive sampling, individuals were recruited through email and phone calls to legislative o ces. Interview subjects were selected to create an equal distribution of representation across stakeholder types, prescriptive authority case types, political a liation, and geographic location. Subjects included policymakers and pharmacist advocates. A semi-structured interview guide (Additional File 2) was developed to explore the use of research used during the rule making process or passage. Speci c questions were adapted from items in tools developed from the SPIRIT Action Framework, called the Seeking, Engaging with and Evaluating Research (SEER) and Staff Assessment of enGagement with Evidence (SAGE) tools (53,54). After consent was obtained, interviews were conducted and recorded over Zoom Video Communications software, and transcribed verbatim (55). Individuals were recruited and interviewed until saturation of responses and perspectives was achieved among various stakeholder groups (56).

Coding and Data Analysis
Using a directed content analysis format, the codebook for analysis of articles and interviews was developed through a theory-derived format based on the elements of the SPIRIT Action Framework (42,57,58). Codes were developed before analysis, based on concepts from the prior the SEER and SAGE tools and agreed upon by the research team. Additionally, codes were made to assess recommendations that subjects made for researchers who seek to in uence evidence, as well as the types of research and importance of research in relation to the policy discussed. After initial codes were developed, two reviewers analyzed the rst interview together to reach agreement and common understanding of the codes. Then, a single reviewer analyzed the interview transcripts by conducting a rst read through, then a more thorough review and coding. Calibration of the codebook and revision of codes also occurred after continued analysis of the context of the information from the interviews (59). After all the interviews were analyzed by the rst reviewer, checks performed on 20% of the interviews by the third author. The kappa value was based on the two coders coding the presence or absence of 19 codes in each of the transcripts included in the 20% check (i.e., 3 interviews). The unit of analysis was the transcript; consequently, the kappa value was computed based on the total number of opportunities to agree on presence or absence of a particular code (58,60). Any disagreements that arose after coding independently were discussed and resolved. Articles identi ed from systemized review were analyzed similarly regarding the catalyst, capacity, research engagement actions, and research use. Coding was con rmed jointly by two researchers on the team.

Research Team and Re exivity
The research team consisted of a faculty member and pharmacist with signi cant experience in dissemination and implementation science research and pharmacy policy systems; a health policy fellow and pharmacist with experience in rulemaking and public health policy; and a pharmacy student interested in pharmacy advocacy and advancement without prior experience in qualitative analysis. The study was conducted as a part of the pharmacy student's honors thesis. To ensure an objective and intentional approach, researchers corresponded regularly during data collection and analysis to re ne methodology, discuss the application of the action framework, and review and align deduction of salient themes. Researchers also consulted others who were experienced in qualitative thematic analysis to validate methods and utilized the Standards for Reporting Qualitative Research (61) to promote transparency. To standardize technique in the semi-structured interview, the pharmacy student, who conducted all interviews, was rst supervised and guided by the faculty member, then used the interview guide to explore various themes based on respondents' answers to framework-based questions. These efforts ensured rigor within qualitative analysis and helped to enhance researchers' re exivity (62).
To further encourage the balanced in uence of researcher and outsider perspectives, codes were also summarized across interviews into an executive summary document and shared with interviewees to validate results as part of a systemized member checking process (63). The participants were given two weeks to review the summary, respond to several questions to ensure that their experiences were accurately re ected, and to supplement any additional re ections. Participants' feedback was crossreferenced with existing codes and were incorporated into deduced themes. Areas where participants disagreed were recognized and reported.

Policy Document Analysis of Prescriptive Authority Policies
The analysis found 27 instances of autonomous prescriptive authority in either contraception, naloxone, or tobacco cessation spanning 16 different states across the US (Fig. 1). The mechanism for expansion of scope of practice varied from state to state. Twenty-six of the policies involved authorization via statute, which either referred to the creation of a new law or the amendment of the act authorizing the practice of pharmacy of that respective state. Additionally, 17 of those statutes were implemented via a Board of Pharmacy rule or statewide protocol; only one state exclusively used a rule to authorize prescribing instead of a statue.

Characteristics of Systematized Review of Literature
In the peer-reviewed literature analysis, out of 24 papers identi ed through the PubMed and Embase search strategies, no articles were found to t the inclusion criteria. The most common reasons for exclusion included the failure of mention of evidence use during the policy-developing process. In most cases, research was conducted after the passage or authorization of the prescriptive authority policy or was not relevant to the policy of interest.
In the gray literature analysis, out of 2,772 news articles found across the 16 states that had passed prescriptive authority, only 7 news articles published from 4 states (ME, HI, OR, NM) were found to describe the direct use of research evidence by policymakers or advocates of pharmacist prescriptive authority.

Characteristics of Participants of Semi-Structured Interviews
In total, 14 individuals participated in semi-structured interviews regarding the use of research evidence in pharmacist prescriptive authority. The distribution of subjects by interviewee and prescriptive authority type, as well as the characteristics of state cases, is outlined in Table 1.

Analysis of Articles and Interviews Through Applying the SPIRIT Action Framework
Overall, the articles and interviews provided insight into how legislators, association members, and agency members engaged with research evidence to develop and advocate for prescriptive authority policy. Types of evidence that was used for policymaking included statistical data and population trends, published peer-reviewed articles and meta-analyses from prominent pharmacy journals, and clinical data and guidelines. The following sections present the ndings framed through the various pillars of the SPIRIT Action Framework. Analysis of interview responses and interrater reliability was veri ed with a calculated kappa coe cient of 0.78.

Catalyst: Public Health Need and Safety Concerns Motivates Utilizing Research
The SPIRIT Action Framework (42) de nes the rst component for evidence utilization, "catalyst", as a prompt that occurs to initiate the process of engaging with or using the research to in uence the prescriptive authority policy. The major themes in this category from participant interviews is summarized in Table 2. Overwhelmingly, both the interviews and articles showed that public health need was the primary factor in driving research utilization. Interviewees cited data regarding access to care and public health concerns (e.g., high rates of unintended pregnancies, smoking rates, and opioid related deaths in their states).
Interviewees also cited research establishing the safety of having pharmacist providing prescriptive services for these medications as another catalyst. Designating prescribing to professionals other than physicians often requires extensive advocacy and discussion regarding the capability and expertise of these professions. As one legislator said regarding contraceptive prescriptive authority: …whenever you make a major change like this, especially when it's something around reproductive health…you have to really have your ducks in a row. So without the right, the solid evidence to support it, we knew we weren't going to get anywhere. So we had to be able to marshal our facts and have all the information available and be able to convince people that the data were overwhelmingly clear that this was a safe thing to do.
To this end, policymakers often looked to other states' data regarding evidence of successful prescriptive authority policy development to inform new policies in their state.

Capacity: Components That Supported Research Evidence Use
The SPIRIT Action Framework (42) identi es the existing resources, tools, and knowledge that an organization or individual has to utilize research evidence as the "capacity" for research engagement. Table 3 presents the themes for capacity: individual and organizational value of research, skills and knowledge for acquiring and applying research, the availability of resources to access research, and the staff and manpower to utilize research.
Many individuals interviewed cited a strong regard for research from both their personal perspective as well as on behalf of their policymaking organization. Despite the recognized importance of research in policymaking, interviewees acknowledged research sometimes did not play a role in the policy making process, which was not aligned with their own value of research. Others discussed how research evidence is important for progressing pharmacy practice and developing other prescriptive authority policies for their state.
In addition to value, interviewees cited that having a health care background or training helped to increase the capacity to use research. Health care professionals, such as those in professional associations, or legislators with experience in health care enhanced research evidence use because of their ability to analyze and apply data.
Participants also cited how different resources helped to increase evidence use capacity. When describing evidence that was available to them, publicly available research (e.g., news articles, professional organizations materials, and open access journals), were identi ed more than restricted access sources (e.g., internal evidence from a governmental department, standard subscription journals). Additionally, capacity to use these resources were closely tied to the availability staff members and their ability to engage and apply research evidence. Speci cally, a few participants discussed having other staffers and/or fourth year pharmacy students as key to their capacity to utilize research.

Research Engagement Actions: Using Resources and Experts to Access and Apply Research
Highlighted by the Action Framework to be a bridge between "Capacity" and the outcome of research application, the actual collection of evidence and interaction with research is de ned by the "Research Engagement Actions." As shown in Table 4, four components were considered based on the Action Framework:

Access Research
Convenient, familiar sources were used by association members and policy makers. Most referenced sources were ones that could be accessed through search engines and that respondents recognized through their professional experiences and connections. Databases referenced included PubMed, Google Scholar, and the Cochrane Library. Academic and specialized resources also were used for policymaking, such as the Surgeon General's guidelines for tobacco cessation interventions or the American College of Obstetrics and Gynecology's (ACOG) contraception guidelines. In addition, some individuals also reported having access to public health data from their state's Department of Health or non-published data from other states that had implemented pharmacist prescriptive authority.

Appraise Research
The relevance and signi cance of the research was important to its use in policymaking. Some respondents reported carefully evaluating research and public health data from other states and countries to ensure applicability and impact to their own state's policy. Additionally, if the research advocated for an actionable direction, or if interviewees found the ndings "compelling", as some interviewees said, it helped to motivate policy development in that direction. These concepts of relevance, the potential to see similar impact in their own states, and clear recommendations illuminated by the research dictated engagement with the evidence.

Interact with Researchers
The SPIRIT Action Framework emphasized "interactions with researchers" as a component of its Research Engagement Actions; however, participants in this study reported engaging with researchknowledgeable experts and stakeholders who helped to present and summarize the available research for policy makers. These brokers of evidence knowledge were found in special interest organizations, such as Planned Parenthood or Harm Reduction Coalitions, or with professional organizations, such as physician or pharmacist groups.
Practitioner testimony was also utilized for their key insights into research and their ability to connect the research to actionable policy making for legislators. Two states, Maine and Hawaii, also created explicit Task Forces to analyze available evidence and policy goals to create recommendations for policy regarding the opioid crisis; these were made up of individual practitioners and organizational representatives who accessed and presented research for broadening access to naloxone through pharmacists.

Generate New Research
Generation of new research for the purposes of policy making is another component of the "Research Engagement Actions" pillar. Only one state, Colorado, had conducted research for the purpose of in uencing their prescriptive authority policy out of those interviewed.
Research Use: Advocate for Safety and In uence Key Components of Policy Finally, the SPIRIT Action Framework "Research Use" pillar describes how the research informed the policy. This pillar was composed of two main component -how research was used (i.e., s conceptual, instrumental, tactical, or imposed fashions) and when it was used (i.e., time in the policy making process). The themes are summarized in Table 5.
How was research used in prescriptive authority?
Broadly, research evidence and public health data was used to understand the considerations necessary for allowing pharmacists to prescribe these products. Speci cally, participants described using research evidence to conceptualize the safety and e cacy of pharmacist prescribing, barriers to implementation from prior prescriptive authority policies, and the public health issue at hand.
Research evidence and data from successful prior prescriptive authority policies helped to also dictate the speci c components included in the participants' states' policies. Pharmacy advocates and legislators alike discussed how successful pharmacist immunization policies helped to dictate the formatting of subsequent prescriptive authority policies. Studies also support the use of other aspects of the policies, such as incorporating reimbursement methods and certain training requirements. Finally, participants used research evidence to identify speci c products pharmacists could prescribe and other requirements to provide complete care. In one state, studies highlighting the effectiveness of the Quitline, the national telephone-based tobacco cessation service, supported its incorporation into prescribing authority policy, where pharmacists had to also refer patients to this service.
Another use for research was advocacy for participants' policies allowing pharmacists to prescribe. Interviewees and news articles re ected the use of evidence when defending the legislation against opposing stakeholders, In one case, a pharmacy advocate even employed research evidence engagement as a tool to argue for the safety of pharmacists compared to the risks associated with these public health concerns: We basically focused on is the risk of smoking higher than the risk of having a pharmacist prescribed smoking cessation products…we challenged them to … show us something in the in the literature that shows us that having a pharmacist assist with tobacco cessation went horribly wrong and, and then we will put our data up…against your data and that that kind of helped us defend our position.
Clinical data and research evidence were also used to advocate for the feasibility of autonomous pharmacist prescribing. For example, legislators used a study called the Direct Access study, to support the ease of selecting contraception based on patient factors (40). This, along with clinical guidance from ACOG helped support having pharmacists prescribe contraception rather than doctors. Similarly, California and Colorado turned to research-driven tobacco cessation pilot programs to demonstrate pharmacists successfully implementing tobacco cessation interventions and product selection on a smaller scale (41). According to interviewees, these forms of evidence engagement helped to successfully advocate for prescriptive authority.
A few respondents speci cally discussed how research evidence engagement was required due to a state mandate or a funding requirement. However, this was not common, and research was primarily used for the substance it provided to policy making.
When was research used in prescriptive authority?
Evidence and research were used throughout the policy making process. Research evidence helped to prioritize policy and set the legislative agenda by comparing the need for the prescriptive authority policy versus its feasibility of implementation. Additionally, research evidence was used throughout the policy development process, from helping to direct the details and wording of the policies to dictating the processes for how pharmacists prescribed and documented their services. Finally, respondents described collecting evidence and analyzing metrics of uptake of pharmacist prescribing and medication access after policies were passed, demonstrating the use of research evidence to monitor the implementation and impact of prescriptive authority policies.

Barriers to Utilizing Research Evidence in Prescriptive Authority Policy
Though participants spoke to most of the components of the SPIRIT Action Framework and discuss their engagement with research evidence, it was evident that research evidence did not always play a role in policymaking. When participants were asked to rate the importance of research in their prescriptive authority policy on a scale of zero (low importance) to ve (high importance), the average rating was 3.2 (standard deviation of 1.5). Participants were asked to identify barriers to engaging with research evidence. These barriers were categorized into three groups, described in Table 6.

Individual Barriers
Individual barriers describe the innate obstacles a policymaker or advocate may have to utilize and translate evidence into actionable policy. A lack of knowledge or skills to apply research evidence to policy prevented some participants from using research evidence to advocate for legislative change and expanding pharmacist practice. Additionally, one participant argued that for some policies it is hard for legislators to allocate enough time to nd and interpret research evidence for policy.

Contextual Barriers
Lack of High-Quality, Applicable Research One barrier that prevented research engagement outside of individual skills includes the lack of research.
Many participants discussed how prescriptive authority for pharmacists was a novel concept, and before policies like this were passed, there was no research testing or proving some of those concepts. Several commented that their states were one of the rst to allow for pharmacist prescribing, limiting the amount of data that they had available to use.
Even when evidence was present, the lack of relevant data prevented use of research evidence in prescriptive authority. Small sample sizes for studies, limited double-blinded trials, and research that did not discuss the policy at hand (e.g., utilizing evidence of successful contraceptive prescriptive authority for tobacco cessation policy) were cited as reasons for inapplicable data.
Other In uences on Scope of Practice Policy Had a More Impactful Role For some participants, the ultimate barrier to utilizing research was that it was a secondary goal compared to other in uences on prescriptive authority policy. The political opposition of scope of practice policy, for example, prevented the optimal use of research evidence in prescriptive authority policy. Subjects often cited that while they themselves knew of the evidence supporting pharmacist prescriptive authority, opposing stakeholders were against broadening pharmacist scope of practice. This caused policymakers to compromise on policy even when it did not re ect the supporting evidence of what pharmacists could do. Examples of this included limiting pharmacists to prescribe only over the counter medications instead of effective prescription medications or limiting the age of patients that could be prescribed contraception.
Like political opposition, research evidence was sometimes not as valued by other stakeholders and thus not always an effective advocacy tool. Some legislators commented that anecdotal stories (i.e., personal testimonies from patients or clinicians) played a bigger role in in uencing policy, since legislators could better empathize and relate to it. Some interviewees attributed this to lawmakers' backgrounds being primarily in elds other than science, preventing them from evaluating the signi cance of the data over nancial considerations or anecdotes from their constituents.

Research May Have Just Been Unnecessary for this Public Health Policy
At its core, pharmacist prescriptive authority in the areas of contraception, tobacco cessation, and naloxone were often viewed as solutions to a public health need, with the added bene t of advancing pharmacist practice. Due to this, some interviewees identi ed that in these situations, policy development could not wait for available research; the urgency of the public health need to mitigate the problem took precedence over research evidence. For some individuals, especially Association and Board of Pharmacy administrators, pharmacists "just make sense" when it came to solving a public health concern; they used the pharmacists' expertise and accessibility to justify the policy logically. Regardless, limited time and urgent need for developing a policy solution was a barrier for research utilization across all prescriptive authority categories.

Recommendations from Participants To Increase Research Evidence Engagement
Based on their experience, interviewees' recommended ways to increase research evidence engagement (Table 7).

Research Evidence Should Be Clearly Relevant to Policymakers' Goals
Lawmakers, association, and agency members commented extensively on the need to measure speci c outcomes and sustainable payment mechanisms to produce research evidence that is relevant for policy makers. Many interviewees considered real life scenarios and barriers that patients may face, prescribing rates, and the practical implications surrounding pharmacist prescribing practice. Some even suggested creating pilot programs with constituents to test a potential policy and its impact prior to passage.
Quotes about some of the key metrics that participants were interested in are outlined in Table 8.
Additionally, interviewees found monitoring the practical implications of these policies important for future policy development. Numerous interviewees discussed how monitoring and evaluating policy impact post-implementation, for their own or other states' prescriptive authority policies, was critical. One participant emphasized the importance of demonstrating the e cacy of these policies for future broadening of scope: I think research is critical in the reality of moving beyond naloxone, you know, I think you'll probably talking to other states where you know they've expanded their prescriptive authority beyond naloxone and I think that's really where You know, pharmacists have a lot of opportunity…providing that research behind in some of those states where it has been effective and have been implemented, then that could really build the build the ladder for other states to take that on as well.

Maintain Connections Before and After Researchers In uence Policy
Multiple interviewees also recommended that researchers should maintain strong relationships with policymakers and advocates throughout the research pipeline -from conceptualization to dissemination.
Increasing awareness of legislators for potentially policy relevant studies can overcome legislative time restrictions and support evidence use in prescriptive authority policy. Other pharmacy advocates also recommended that researchers seek opportunities to converse with policymakers and pharmacy policy in uencers outside of legislative sessions and other policymaking meetings. Overall, interviewees cited that because of barriers to actively accessing and being aware of evidence, researchers should maintain connections and engage policymakers in research development and new ndings as they come, not simply when lawmakers are in session.

Tailor Research Dissemination Towards Audience
When disseminating evidence, multiple interviewees commented that researchers needed to be cognizant of their audience. Interviewees discussed how to better formulate evidence to reach legislators who are either pressed for time or who do not have the same capacity to interpret and apply literature as other researchers. One association member discussed utilizing graphs and charts for portraying key takeaways to make the data more accessible to policymakers. Interviewees cited that even when studies have a robust design and supports policy goals, researchers should also convey these ndings in non-peer reviewed resources that can be easily accessed and interpreted by those who are not research-oriented.

Leverage Stakeholders to Conduct and Disseminate Research Evidence
Participants also discussed the value of collaboration when advocating for evidence-based expansion of scope of practice. Utilizing national organizations and policy advocate groups to relay research to lawmakers was strongly encouraged by stakeholders. Organizations, such as the National Conference of State Legislatures, provide resources to legislators at the state level, creating an identi able channel for making research evidence more accessible. Additionally, interviewees also discussed the use of pharmacists in academia and practice to help conduct research and expand the available data on pharmacists' impact in scope of practice. Schools of pharmacy were cited by some as a potential resource for creating evidence and monitoring the impact of new policies. Lastly, one participant described using community pharmacists and residents to monitor implementation of scope of practice, as they can document the uptake of prescribing and barriers to providing services.

Building the Evidence Base on Prescriptive Authority and Expanded Pharmacist Practice
Regardless of the ndings of a study, some participants identi ed that all data regarding development of scope of practice policy was valuable. Thus, interviewees recommended that researchers should pursue amassing as much research evidence on broadening scope of practice, as it could help future decisions regarding pharmacists' scope of practice. One participant even stated that researchers should work to make all evidence, regardless of the rigor or formal design of the study, available to legislators and advocates to inform decision making.

Discussion
This study investigated factors that in uence research evidence utilization among policymakers and pharmacist advocates during the creation and passage of pharmacist prescriptive authority policies.
Laws were found to be the primary mechanism for policymaking surrounding pharmacist prescriptive authority, re ecting that legislative policymakers are key arbiters of pharmacist scope of practice. Key motivating factors for research evidence engagement included addressing a public health need, evaluating the safety and e cacy of expanding pharmacist practice, and examining the successes and challenges of similar policy. Additionally, the capacity to utilize research was in uenced by value of research, familiarity with analyzing and applying evidence, and access to resources and staff. Respondents discussed how the actual act of engaging with research involved easily accessible sources and interactions with research-knowledgeable individuals. Research evidence was appraised for policy use by assessing its relevance and signi cance. While research evidence was used throughout the policymaking process, from agenda setting to post-passage policy monitoring, respondents also utilized research evidence to comprehend the issue at hand, to dictate policy wording, and to advocate for the policy to others. Respondents re ected on a lack of time and skillset that limited their capacity to utilize research, while also addressing situational obstacles such as available research, value of evidence, and the urgent need of a policy. Nevertheless, respondents were able to contribute several recommendations to researchers who seek to utilize their work to in uence policy, encouraging its importance and use in evidence-based scope of practice.
To our knowledge, this is the rst study that assesses the in uence of research evidence on pharmacist scope of practice policy. Despite this lack of literature on pharmacist practice policy, literature surrounding nurse scope of practice and advocacy has been a key legislative issue for nurses for many years. Nursing organizations have used research ndings supporting expanding scope of practice by creating key advocacy materials to help promote their profession (64,65) and garnering support from other medical institutions such as the Institute of Medicine (66). While this is not yet true for pharmacists, this study identi es key factors that can foster engagement with research evidence in encouraging broader scope of practice. Like nurses' scope of practice, advocacy methods that capitalize upon the research evidence can potentially help move not only pharmacist practice and patient care forward, but also the implementation of evidence-based health policy and practice.
This study has some limitations that must be considered when examining the implications of its ndings.
While our study had a small sample of interviewees, there was equal representation across different stakeholder types, political parties, and prescriptive authority types, increasing the study's generalizability.
Additionally, another potential limitation is the subjectivity inherent in the qualitative analysis study design and ndings. To mitigate the biases of the authors, synthesized member-checking was conducted and a re ection on the re exivity of the study design was addressed. Statistical veri cation of interrater reliability through determining the kappa coe cient, in addition to member checking, helped to establish not only the trustworthiness, but also the external validity and transferability of this thematic analysis.
Overall, despite the presence of limitations, this study optimized a purposeful representation of policymakers and pharmacy advocates to create a generalizable characterization of research engagement use in prescriptive authority policymaking.
This study highlights that there is room to improve the dissemination and implementation of research to expand scope of practice for pharmacists. As identi ed by respondents, a multitude of other factors, from constituent anecdotes to political opposition, compete with the consideration of evidence in policymaking. To better increase the signi cance of their work, researchers investigating the impact of advanced pharmacy practice can use a multitude of initiatives to enhance engagement by policy makers with their studies. First, researchers may need to better understand the policymaking process and the considerations of expanding scope of practice to nd ways where they can contextualize their studies with other policy in uences. Not only, as respondents recommended, do researchers need to form relationships with policymakers early in policymaking, but these relationships also need to be wellestablished and reciprocal. A potential model for the policymaker-researcher relationship is depicted in Researchers seeking to in uence scope of practice policy also must consider the method of dissemination. As outlined by respondents, policymakers without a medical or science background have di culty accessing, interpreting, and prioritizing research evidence in policymaking. It has been shown previously that social media has enhanced the dissemination of knowledge and has continued to be explored as a tool for disseminating research (70)(71)(72). Researchers can take advantage of social media, traditional media, and other easily accessible sources that legislators may be more likely to engage. Additionally, researchers can consider portraying their results in novel ways to enhance readership and understanding of the implications of their work. Creating reviews of the literature in a policy paper format, for example, helps to potentially frame research in a format that lawmakers are more familiar with, comparing the advantages and pitfalls of certain models of practice. Blog posts, visual abstracts, and other resources that help to frame the relevance of quality research and results within policy context can help to engage policymakers and make their implications for policy change evident and easily translatable.
Future directions and areas for further study include investigating the in uences of research evidence in other areas of pharmacist scope of practice, such as in provider status. This work and insights into research evidence engagement can also be compared to pharmacist scope of practice expansion legislation that was introduced but did not become law in other states, to compare the role that it played throughout the scope of practice legislative process.

Conclusion
By analyzing the utilization of research evidence by policymakers and pharmacy advocates and the barriers researchers face when conceptualizing and advocating for evidence-based scope of practice authority, researchers seeking to in uence pharmacist scope of practice and health policy can better understand how to disseminate and implement their work. Utilizing pharmacist prescriptive authority as a proxy for scope of practice policy, this study's ndings emphasize the need to address motivation for research use, capacity for use, engagement, and purpose of research evidence in policymaking. By identifying and creating lasting partnerships with stakeholder groups that can in uence policy, as well as addressing common barriers to utilizing research evidence, researchers can adopt dissemination strategies to effectively interact with policy in uencers. The recommendations for engaging policymakers and improving the dissemination of research can not only be applied to broadening pharmacist prescriptive authority, but also to broadening scope of practice as the pharmacist's role transforms from traditional dispensing to evolved patient care.  19-1867). Study participants were consented to participate in the semi-structured interviews.

Consent for publication
Not applicable.

Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no competing interests.

Funding
The authors have no funding sources to declare for this research.
Authors' contributions AK collected data during both the systematized review and semi-structured interviews, analyzed data, and was a major contributor in writing the manuscript. CB conceptualized the study design, analyzed data, and a major editor for the manuscript. AB conceptualized the direction and study design and contributed to editing for this manuscript. All authors read and approved the nal manuscript. Association Members Administrators of pharmacist professional associations such as state chapters of the American Pharmacist Association or American Society of Health-System Pharmacists.

Agency Members
Administrators of government organizations, such as the Department of Health, or the Board of Pharmacy.  Safety and e cacy of pharmacists prescribing "So we had to be able to marshal our facts and have all the information available and be able to convince people that the data were overwhelmingly clear that this was a safe thing to do." "It was de nitely part of, kind of, again, that foundational research body... in terms of looking at it basically was the basis for a while, he said there is advocacy, you know, it is a promising practice to use pharmacist to conduct this work" Establish a need for a policy Public health need "the need for naloxone was quite evident in information and resources that we use and found where [our state] was second from highest for opioid overdose death rates... it was clearly a public health concerns and an area where pharmacist should be involved" Physician shortage "…the data that was used was just pointing to the primary care shortages and being able to point to that as a need for expanded care." In uence the text of a policy Former successful precedents were followed "There were others who actually reviewed that data of other similar programs and brought information from anecdotal information from other states to that failed and that helped to inform us in making this program as successful as it has been" "[Our state] had a long history of allowing pharmacists to do, to give immunizations, for example, we've been doing that for a really long time for people 10 and above, and then… we pass legislation that saying in the event of a public health emergency they could give them the kids as young as three. So we feel pretty strongly that pharmacists… in general has pretty wide scope of practice laws"  [and] that's pretty clear for us at that whole board. One of the things we wanted to do was to make sure that every decision that we made was as evidence based as it could be"

Skills and Knowledge
Health care providers' familiarity with interpreting research enhanced capacity.
""Having two physicians one in the house and one in the Senate to, you know, help write the policy and then also you are the primary advocates for it in the legislature was very helpful because it brought subject matter expertise…As scientists and physicians, we are trained to solve the problem using data, research and trial and error."

Resources to Access Research
Emphasis on recognizing publicly accessible research resources as opposed to private sources for research evidence.
"[H]e starts his PubMed searches and things like that to nd out who's got published data on any given topic… he's on the editorial board for APPH as journal."

Staff and Manpower
Staff and students enhance potential for using research.
"[A]s far as actually doing the research or getting the research, A lot of that was done by board staff and if we had P4 pharmacy students on rotation at the time…the board itself relied heavily on board staff to do a lot of that research and present the ndings" "most of them are peer reviewed journal some of them are not but they still published whatever somebody else found out some place else or you know the American pharmacists Association has research and papers presented at their annual meetings " "I think with every policy we scan the nation to see who was doing what and... I would say That we did look out to see who else was prescribing naloxone" "the demographics of [our state], the dept. of health publishes the demographics on the overdose death rate, what the products are, and that sort of thing, so we used their research" "…there was also just there were some articles, I don't know that I read the study, but they're articles about how…there were more people using contraception [in another state] after their Legislation had been enacted and implemented" Appraise Research Evaluated relevance and signi cance of research evidence "we were very deliberate in talking through… primary differences between the California model and New Mexico's model and our model… California only allows prescriptive authority for the nicotine replacement therapy products. They've got all ve, they include the over the counter products as well as the to prescription inhaler nasal spray. But there was quite a bit of back and forth, especially with the physicians on the group. Are there are their concerns and even though black box warnings, the black box warning that removed....And that was something where we have these very Engaged discussions and it kind of came out that you know these products when use is recommended are FDA approved and they're generally safe. And so we wanted to include all seven. "

Interact with Researchers
Interacted with researchknowledgeable individuals "about 30 stakeholder groups, local health departments, health insurers, Pharmacists, pharmacies" "we did have the expert [from Dept of Health] with us, and she utilizes those statistics to, you know, kind of backup the evidence that we had cited" Individual and organizational opinion were valued equally "The Nurses Association, the pharmacist, you know, so we had a lot of positive testimony... their organization supported this and they support it because... they thought it was the right thing to do based on the scienti c evidence"

Generate New Research
Not often utilized to engage with research evidence "So we did a statewide survey that basically look at...if this legislation was passed, you know essentially what, what direction [will] we go into the protocols that were selected... through the statewide survey.... So we had physicians, physician assistants… respond to this... and then we did have non clinicians answer so you know essentially health plan or payer staff, public health staff, and that sort of thing and kind of get a broad cross section." "that our biggest concern, of course, is, you know, around safety… is this a practice that is going to be bene cial for women's health and not hurt people. And the data is pretty clear with regards to that experience" "…one of the things you know that research shows us was that there are one of the barriers for pharmacists actually being able to provide this service is the barrier of getting compensated for the service, reimbursement" Instrumental: To directly in uence the content or wording of a policy Used to inform components of the policy itself "Our adult immunization rates in [our state] were horrible; I'd say they're probably the best of the best in the nation now, because of the program...And so we would basically take that same protocol that we had for immunizations and we would go in and insert in and put in naloxone therapy" "We did kind of look at that model as far as how that may work as far as the education, the training that we want to get pharmacists involved in" "So the protocol for prescriptive authority was not deemed effective. It did not increase item movement. It did not decrease opioid death rates opioid overdose death rates in New Mexico. So it was not statistically are clinically signi cant..... We did see I don't want to say a statistically signi cant number in naloxone is given out at the pharmacy level, but an increase. " "It's still relatively new. So we were one of the rst you know handful of states to actually implement the policy…sometimes policy get ahead of where research is Yeah, and so You know that potential obstacle" "…sometimes there's not great data. You know the studies are small so they have their study limitations, all the same ones we always hear studies, small, you know, not enough numbers in power. You know, you know, it wasn't, it wasn't the double blinded double"

External Stakeholder Opposition
External opposition led to compromised practice "So turf battles with medicine is pretty popular opposition that we face for a lot of these ... So that's probably you know the sticks out my mind sort of the rst the rst And most prominent of the hurdles that we face because we face it every time we every time we try to do this"

Lack of Value
Research evidence was not as highly valued as other considerations "Some of them like research but most of them like anecdotal stories so if you can get somebody to come in and say "I overdosed on this and I wish someone gave me a naloxone and revived me" that's a good story. Works better than hard research sometimes" Catalyst Did Not Exist Pharmacists were the "logical" solution "It was looked at as a pretty common sense approach to allow pharmacists to prescribe you know what is, you know, pretty universally seen as a Safe medication... I don't know if there would really be able to point to much that I would say that this is what really drove at home or anything else. " The urgent need of the policy outweighed research use "there wasn't a lot to research at the time and the value of developing the policy importance is still...important that we do it. That's not fair, but it's what I feel." "…prescriptive authority for oral contraceptives or prescriptive authority for Smoking cessation products and that I mean you know we can we can make some… arguments for and against that...but when you look at naloxone speci cally, I mean, The goal here is to save people's lives, you know, in that respect, and take care of an epidemic that was you know we're right in the middle of so it just was not a controversial item" Research should be clearly relevant to policymakers' goals "I think that it's, Sort of keeping up with where different policy trends are or major issue areas are and then reaching out to people who, to legislators to make them aware of their research would be helpful" Maintain connections with policymakers "You can't just like show up when you need something, so to create a network and a relationship with Like in uencers prior to and even...creating that relationship. So that to me is the most important thing" Tailor research dissemination to audience "…about sending, you know, about press releases that talk about the practical implications of this research " "look at research and site numbers, especially if you have nice visual. Like graphs or tables that always helps make a stronger case…. remember that their audience Is probably is not going to be research oriented and not going to be an academic. So while of course you still want and really robust study design. It really comes out on the back end to think about How that evidence is portrayed for potential lay people" Leverage stakeholders "And I think that in every state there is a College of Pharmacy… you know, State College of Pharmacy is indeed a great resource for legislators who are interested in such things." Continue to build evidence base "Publish often, publish more… even if the research showed, hey, this didn't work.
That would be useful too because they're just really was, you know, there's not always a lot of data" " And what is the referral rate…physicians are very worried about fragmented care." …one of the common questions… is like, well, if that state did it, how did it turn out? And so we need more post data collection…because so many times, we're like, was it successful? How many did we prescribe? And how did it change things?
Cost and Payment "proving of… their ability to potentially save the healthcare system dollars is something that I think is instrumental you know" "I think for pharmacist uptake research around payment… " do not imply the expression of any opinion whatsoever on the part of Research Square concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. This map has been provided by the authors.