Policy document analysis of prescriptive authority policies
The analysis revealed 27 instances of autonomous prescriptive authority in contraception, naloxone, or tobacco cessation spanning 16 different states across the United States (Fig. 2). The mechanism for expansion of scope of practice varied from state to state. Twenty-six of the policies involved authorization via statute, which referred to either the creation of a new law or amendment of an existing act authorizing pharmacy practice in the respective state. Additionally, 17 of those statutes were implemented via a pharmacy board rule or statewide protocol; only one state exclusively used a rule instead of a statute to authorize prescribing.
Characteristics of participants in semi-structured interviews
In total, 14 individuals participated in semi-structured interviews regarding the use of research evidence in pharmacist prescriptive authority. Interviews lasted between 30 and 60 minutes on average. 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 interviews through application of the SPIRIT Action Framework
Overall, the 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 were used for policy-making 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 findings framed within the various pillars of the SPIRIT Action Framework. Analysis of interview responses and inter-rater reliability was verified with a calculated kappa coefficient of 0.78.
Catalyst: public health need and safety concerns motivate utilization of research
The SPIRIT Action Framework  defined the first component for evidence utilization, “catalyst,” as a prompt that occurs to initiate the process of engaging with or using the research to influence the prescriptive authority policy. The major themes in this category from participant interviews are summarized in Table 2. Overwhelmingly, most respondents commented 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 pharmacists providing prescriptive services for these medications as another catalyst. Designating prescribing to professionals other than physicians often required extensive advocacy and discussion regarding the capability and expertise of these professions. As one legislator said regarding contraceptive prescriptive authority:
[W]henever 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, policy-makers 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  identified 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 person power to utilize research.
Many individuals interviewed cited a strong regard for research from both their personal perspective as well as on behalf of their policy-making organization. Despite the recognized importance of research in policy-making, interviewees acknowledged that 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 advancing pharmacy practice and developing other prescriptive authority policies for their state.
In addition to value, interviewees cited that having a healthcare background or training helped to increase the capacity to use research. Healthcare professionals, such as those in professional associations, or legislators with experience in healthcare enhanced research evidence use because of their ability to analyse 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 organization materials, and open-access journals) was identified more frequently than restricted-access sources (e.g., internal evidence from a governmental department, standard subscription journals). Additionally, capacity to use these resources was closely tied to the availability of staff members and their ability to engage and apply research evidence. Specifically, 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 SPIRIT Action Framework as a bridge between “capacity” and the outcome of research application, the actual collection of evidence and interaction with research was defined by the “research engagement actions”. As shown in Table 4, four components were considered based on the action framework.
Convenient, familiar sources were used by association members and policy-makers. The most commonly 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 policy-making, 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 unpublished data from other states that had implemented pharmacist prescriptive authority.
The relevance and significance of the research was important to its use in policy-making. 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 findings “compelling”, as some interviewees noted, 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 research-knowledgeable 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. Individual practitioner testimony was also utilized for their key insights into research and their ability to connect the research to actionable policy-making for legislators.
Generate new research
Generation of new research for the purposes of policy-making is another component of the “research engagement actions” pillar. When interviewees were asked specifically about this, only those from one state described conducting research for the purpose of influencing their prescriptive authority policy.
Research use: advocate for safety and influence key components of policy
Finally, the SPIRIT Action Framework “research use” pillar described how the research informed the policy. This pillar was composed of two main components—how research was used (i.e., 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 were used to understand the considerations necessary for allowing pharmacists to prescribe these products. Specifically, participants described using research evidence to conceptualize the safety and efficacy 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 also helped to dictate the specific 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 supported the use of other aspects of the policies, such as incorporating reimbursement methods and certain training requirements. Finally, participants used research evidence to identify specific 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 also had to refer patients to this service.
Another use for research was advocacy for participants’ policies allowing pharmacists to prescribe. Interviewees and news articles reflected 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 prescribe smoking cessation products…we challenged them to … show us something…in the literature that shows us that having a pharmacist assist with tobacco cessation went horribly wrong…and then we will put our data up…against your data, and 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 . 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 programmes to demonstrate the successful implementation of tobacco cessation interventions and product selection by pharmacists on a smaller scale . According to interviewees, these forms of evidence engagement helped to successfully advocate for prescriptive authority.
A few respondents specifically 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 whereby pharmacists prescribed and documented their services. Finally, respondents described collecting evidence and analysing 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 discussed their engagement with research evidence, it was evident that research evidence did not always play a role in policy-making. When participants were asked to rate the importance of research in their prescriptive authority policy on a scale of 0 (low importance) to 5 (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 two groups, described in Table 6.
Individual barriers describe the innate obstacles a policy-maker or advocate may have faced in utilizing and translating 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 find and interpret research evidence for policy.
Lack of high-quality, applicable research
One barrier that prevented research engagement outside of individual skills was 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 proof of concept study. Several commented that their states were among the first 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 the 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 influences 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 influences 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 noted that while they themselves knew of the evidence supporting pharmacist prescriptive authority, opposing stakeholders were against broadening pharmacist scope of practice. This caused policy-makers to compromise on policy even when it did not reflect 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 testimonials from patients or clinicians) played a larger role in influencing policy, since legislators could better empathize and relate to it. Some interviewees attributed this to lawmakers’ backgrounds being primarily in fields other than science, preventing them from evaluating the significance of the data over financial 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 benefit of advancing pharmacist practice. For this reason, some interviewees noted 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 pharmacy board administrators, pharmacists “just make sense” when it came to solving a public health concern; they used the pharmacists’ expertise and accessibility to logically justify the policy. 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 policy-makers’ goals
Lawmakers and association and agency members commented extensively on the need to measure specific 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 programmes with constituents to test a potential policy and its impact prior to passage. Quotes regarding 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 efficacy 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 talk 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 ladder for other states to take that on as well.
Maintain connections before and after researchers influence policy
Multiple interviewees also recommended that researchers maintain strong relationships with policy-makers and advocates throughout the research pipeline—from conceptualization to dissemination. Increasing awareness among 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 policy-makers and pharmacy policy influencers outside of legislative sessions and other policy-making meetings. Overall, interviewees noted that because of the barriers to actively accessing and being aware of evidence, researchers should maintain connections and engage policy-makers in research development and new findings as they appear, not simply when lawmakers are in session.
Tailor research dissemination towards audience
Multiple interviewees commented that, when disseminating evidence, 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 policy-makers. Interviewees noted that even when studies have a robust design and support policy goals, researchers should also convey these findings 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 NCSL provided resources to legislators at the state level, creating an identifiable 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 findings of a study, some participants identified that all data regarding development of scope of practice policy was valuable. Thus, interviewees recommended that researchers amass as much research evidence as possible 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 rigour or formal design of the study, available to legislators and advocates to inform decision-making.
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