Moving Away from Pharmacist Efficacy and Toward Pharmacist Effectiveness: Refocusing Research that Generates Knowledge about Pharmacist-Provided Services

FEBRUARY 15, 2016
Mary Roth McClurg, PharmD, MHS
Research is critical to generating evidence and advancing knowledge. In medicine, research has led to significant discoveries regarding new drugs, disease pathways, and devices; new strategies for improving care delivery; and meaningful insights into patient behavior and engagement in their care.1 Research has contributed to our knowledge and understanding of the benefits and risks of medications, gaps in quality care attributed to poor medication use and management, and the integral role pharmacists can play in optimizing medication use and improving care.
 
Despite a significant body of evidence supporting pharmacist-provided services, gaps remaining in the evidence base need to be addressed to accelerate the adoption of pharmacy services into evolving health care delivery models. Understanding these gaps is important in targeting research efforts. In addition, careful consideration of the approach to conducting research is essential to ensure that research findings are answering the questions of most relevance to advancing patient care and care delivery.
 
The Efficacy–Effectiveness Gap
In research, there is a fundamental difference between efficacy and effectiveness, even though the words are often used interchangeably.2 Efficacy describes how a medication or an intervention (eg, a new service or program) performs in a controlled or ideal setting. Effectiveness describes how a medication is used or a new service or program is implemented in a real-world setting where patients, populations, and the day-to-day operations and busyness of health care vary considerably and cannot be controlled.2
 
There is an assumption that effectiveness research flows naturally from successful efficacy-based research, but this has not happened. Each area of research has evolved on its own, leaving a gap in the translation of efficacy into real-world effectiveness. A lot has been written about the gap between efficacy and effectiveness, especially as it relates to the volume of research generated and the lack of translation of this evidence into health care practice. Researchers have estimated that it takes an average of 17 years for 14% of original research to be integrated into clinical practice.3 Many factors contribute to this phenomenon, but perhaps the most important is that current research designs “fail to maximize the clinical utility for practicing clinicians and other decision makers.”3 In other words, efficacy-based research often fails to consider implementation of the intervention in a real-world context.
 
Another way of thinking about efficacy- and effectiveness-based research is to consider that even when one has strong evidence that “something” works, taking that “something” and implementing it in a real-world environment requires ensuring that the environment (the real-world setting) is equipped and ripe for adoption of the intervention. Although good science may be conducted and important findings generated, if the research does not consider mitigating factors (eg, human, workflow, environmental) that are key to facilitating successful implementation and uptake into a real-world setting (eg, a pharmacy, hospital, or medical clinic), then the evidence and its impact, no matter how strong it is, will never be fully realized.
 
In addition, to effectively implement an evidence-based service or program into real-world clinical care requires that the organization or practice (eg, physician clinics, pharmacies, hospitals) place high value on research as a means of informing change and invest the time needed to implement the change. This requires commitment to a process for engaging in change, along with the realization that implementing science into practice is not a quick fix. If organizations place little value on the adoption of evidence-based findings into real-world care, this, too, will limit meaningful change in care. So how can researchers, health care administrators, and health care practitioners begin to close this gap between efficacy and effectiveness? And, importantly, what does this mean for pharmacy?
 
Implementing Evidence into Real-World Care
The answer may lie in implementation science: the study of methods to promote the integration of research findings and evidence into health care policy and practice.4 This field of science is growing in popularity and importance.4 It seeks to understand the behavior of health care professionals and other stakeholders (ie, the real-world environment) as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions.
 
Several studies have suggested that blending the effectiveness and implementation stages of research design could improve the speed at which knowledge is created and increase the clinical usefulness of the findings. Specifically, Curran and colleagues suggest that blending the effectiveness and implementation stages of research design is needed to accelerate the adoption and translation of research into clinical practice.5 Implementation, in this case, is defined as an effort specifically designed to get promising and best-practice findings and related products into routine and sustained use through appropriate change, uptake, and adoption of interventions.
 
When examining the efficacy–effectiveness research gap, it is clear that efforts to ensure more rapid translation of evidence into real-world health care practice are needed to accelerate the pace at which best practices are adopted and integrated into real-world clinical care. This same need holds true in pharmacy practice: we have reached a critical time in the evolution of pharmacy and pharmacist-provided services, in that we must carefully consider the research questions that are most relevant to advance pharmacy practice and the approaches that we must take to accelerate the rapid translation of evidence into real-world care.
 
Refocusing Research Efforts in Pharmacy
As health care transitions from episodic, fee-for-service care to whole person–oriented, value-based care, pharmacy finds itself well positioned to optimize medication use for patients and populations, thereby addressing a critical component of efforts to improve national health care. To that end, how do we ensure that we are designing and conducting research that facilitates the rapid translation and uptake of evidence around pharmacist-provided services into new and evolving health care delivery models?
 
Studies of pharmacist-provided services fall into classic efficacy-based research or effectiveness-based research. Efficacy studies are well designed and compare pharmacy-provided services in a given setting to usual care, and do so in a controlled environment. Some efficacy studies have demonstrated evidence supporting the positive impact of pharmacy services on the quality of patient care, clinical outcomes, and cost.6,7 Additional studies (some more observational in nature with no control group or randomization of groups) suggest that pharmacist-provided services may have a positive effect on reducing medication-related problems, improving adherence, improving health outcomes, reducing cost, and decreasing hospital admissions and emergency department visits.8,9
 
Translating this evidence into real-world practice is often met with limitations. Regardless of the study design used, limitations impeding successful implementation of evidence into practice include (1) lack of explicit protocols describing the core elements of the intervention or pharmacist-provided service and how it was carried out, making it difficult to understand what the actual intervention is and how to implement it; (2) limited insight into factors within the environment or setting that facilitate the successful uptake of the intervention; and (3) a lack of insight into work flow and the roles and responsibilities of each member of the integrated care team in improving medication use.
 
Further, the lack of a sustainable business case for pharmacy-provided services has been a significant barrier to widespread adoption of such services across health care. These are a few of the gaps that limit our ability as a profession to effectively translate evidence into real-world implementation to ensure replication, scalability, and sustainability. This raises the question, what “evidence” does the pharmacy profession need to generate in order to advance pharmacy-provided services as a means of improving patient care and health care delivery, and how do we do this in a way that facilitates rapid uptake and adoption into contemporary health care practice?
 

Sidebar 1: Fundamental Questions to Accelerate Uptake of Pharmacist-Provided Services in Clinical Practice: Less about Efficacy and More about Implementation and Effectiveness 
  • Which patients and populations benefit the most from pharmacist-provided services? Are individuals in greatest need, such as those frequently visiting emergency departments and those admitted to hospitals, receiving services that optimize medication use?
  • What is the process of care (the intervention) that pharmacists are providing? How is continuity of care established?
  • How are pharmacist-provided services integrated into workflow—whether in a pharmacy, a hospital, a primary care medical practice, or elsewhere—to optimize medication and the role of the health care team?
  • What is the impact on the patient experience when patients receive pharmacist-provided services?
  • What is the return on investment—to a health system, a primary care medical practice, an insurer, and others—by having access to pharmacy-provided services aimed at optimizing medication use? In other words, how do we financially sustain medication optimization efforts as a core component of delivering quality health care?
  • What do policymakers and payers feel are the fundamental questions that must be answered to advance and sustain pharmacist-provided services in the context of new value-based care delivery and payment models?
  • How do we more quickly replicate and scale best practices around implementation of effective pharmacy services to ensure sustained uptake into clinical care?

Although a traditional research approach may be desirable to generate more data to show that pharmacists improve chronic disease care and help to control health care costs, we must question whether these types of data alone will get us to where we need to be. Similarly, although it is easy to attribute a lag in translation of evidence into clinical practice to the lack of recognition of pharmacists as providers or the lack of payment for pharmacist-provided services, resolution of these factors alone is not likely to ensure that the value-added role of pharmacists in optimizing medication use and improving care will be effectively implemented and sustained. Instead, the following actions may get us closer to ensuring adoption of pharmacist-provided services into new value-based care delivery models: shifting our focus toward more closely examining what pharmacists are doing and how they are working as members of an integrated team; implementing and replicating best practices in medication optimization into real-world care; working with payers, policymakers, and other key stakeholders to identify and test alternative payment models for such services; and building the business case for integration of these services into health care. This type of real-world implementation research will require that we work more closely with patients, payers, policy makers, and health care providers, and increase efforts to disseminate best practices. It will also require that we address fundamental questions about pharmacist-provided services in the context of health care delivery (Sidebar 1) and refocus research efforts to facilitate and accelerate the uptake of best practices in pharmacist-provided services into routine clinical care (Sidebar 2).
 
Sidebar 2: Strategies for Refocusing Research Efforts in Pharmacy
  • Place greater emphasis on effectiveness-implementation research designs that focus on testing implementation strategies while observing and gathering information on the clinical intervention’s impact on relevant outcomes.
  • Engage patients, providers, payers, and policymakers in the design, evaluation, and dissemination of the research to ensure relevance of the research questions and alignment with needs.
  • Explicitly describe what the pharmacist and other members of the health care team are doing, and how they are doing it.
  • Outline strategies for how health care executives, pharmacy directors and managers, medical providers, and pharmacists can integrate and sustain effective pharmacist-provided services and strategies across multiple settings.
  • Encourage research teams to (1) assume more responsibility for extending their work beyond publishing and demonstrating that it works and (2) work toward implementing evidence into  clinical practice by working with payers, providers, pharmacists, health care executives, and medical directors to ensure adoption, uptake, and sustainability.
  • Encourage research teams to consider how to best generate data that can be shared in real time or as early and often as possible to ensure replication and rapid uptake into evolving health care settings.
  • Build a business case that ensures the sustainability and scale of effective services into clinical practice.

Conclusion
As health care transitions toward value-based care, it is important that we demonstrate the role of the pharmacist as an integral member of the health care team in optimizing medication use and improving patient care. We need to rethink our approach to research and shift some of our efforts to the translation and implementation of research findings into practice.  Efforts to demonstrate that pharmacist-provided services work and the degree to which they work should continue; however, we must place more emphasis on how to integrate best practices in pharmacy-provided services into value-based care delivery and payment models. Shifting the emphasis to implementation science and how to put best practices into routine and sustained use will go a long way toward accelerating effective adoption of value-based pharmacy services into health care. Being able to then simultaneously demonstrate effectiveness (Does it work when implemented?) will be powerful. Engaging patients, providers, payers, and policymakers on the front end is critical to ensuring relevance of the research to the questions most on the mind of these key stakeholders. The goal is to strike a balance between generating strong evidence and providing real-world, practical guidance on how to integrate value-added pharmacy services into the day-to-day operations of pharmacies, health systems, and other settings.
 
This article is published in collaboration with the Directions in Pharmacy CE Conference program.


Mary Roth McClurg is an associate professor at the University of North Carolina (UNC) Eshelman School of Pharmacy. For 12 years, Dr. Roth McClurg practiced as a clinical pharmacist in inpatient medicine in the VA Health System and then as a pharmacist embedded within a primary care clinic, providing direct patient care as part of a collaborative team. As a researcher, Dr. Roth McClurg has focused her efforts on advancing the role of the pharmacist in primary care as well as other settings, with the goal of optimizing medication use and improving care in patients with multiple chronic diseases. One of her primary areas of work has been the development of a consistent approach to providing comprehensive medication management in the delivery of team-based care. She is particularly interested in improving the safe and effective use of medications in health care, advancing the role of the pharmacist in new care delivery models, and working toward new payment models for pharmacy services. In addition to her research efforts, Dr. Roth McClurg is helping to lead the UNC Eshelman School of Pharmacy’s transformation of its Doctor of Pharmacy program. She completed her PharmD and residency training at the St. Louis College of Pharmacy and received her master of health sciences in clinical research from Duke University School of Medicine. 

References
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