Impact of pharmacy services on initial clinical outcomes and medication adherence among veterans with uncontrolled diabetes

While much of the focus of the Affordable Care Act (ACA) has been on its improving access to care for millions of Americans, this legislation also had a profound effect on how pharmacists could be leveraged as members of primary care teams. Specifically, provisions of the ACA facilitated pharmacist incorporation with patient primary care through integrated and collaborative models of care and expanded opportunities to provide medication therapy management (MTM) services in conjunction with changes to Medicare Part D and within the scope of Accountable Care Organizations (ACO) [1]. Consequently, and in concert with the growth in patient-centered medical home (PCMH) models across the United States, pharmacists are now more intimately involved with direct patient care than ever before [2].

Providing support for such opportunities, a growing body of evidence has demonstrated the impact that clinical pharmacist involvement can have on outcomes in primary care settings, particularly among diabetes patients. Within this population, the vast majority of investigations demonstrated significant hemoglobin A1C reduction among patients having visited or received services from a clinical pharmacist [3‐32]. Moreover, significantly more patients achieved recommended American Diabetes Association (ADA) treatment goals and, while less consistent, those having seen a clinical pharmacist often realized significant, positive changes in other clinical measures, such as systolic or diastolic blood pressure, low-density lipoprotein (LDL) levels, and body mass index (BMI) [4, 7‐10, 12‐14, 18, 19, 21, 32‐37]. Importantly, positive results have been observed in diverse patient populations from all corners of the United States and included Latinos, those from underserved areas, high-risk patients, rural residents, those nonadherent to medications, and members of health maintenance organizations as well as current and former members of the armed forces [3, 4, 8, 9, 12‐14, 34, 37]. Studies also reported that adding pharmacists to primary care teams is a cost-effective risk reduction strategy that can lead to significant cost avoidance among patients utilizing these services [7, 20‐22, 38‐40].

While results generally demonstrated that clinical pharmacy services have a positive impact on outcomes in patients with diabetes, these analyses tended to be limited by their sample size, length of follow-up, lack of control group, the inclusion of only 1 or a few sites, and variability in the point in time at which patients were intervened following either their diabetes diagnosis or treatment initiation [3‐7, 9, 12, 13, 17, 20‐22, 25‐32, 34‐36]. Recognizing these shortcomings, this study sought to evaluate the impact of clinical pharmacist services as implemented across a nationwide health system using a more robust and longitudinal data source: the Veterans Affairs (VA) electronic health record (EHR) system. Such a system is unique in its combined closed nature, nationwide data capture, and ability to identify each patient’s initial diagnosis as well as his or her treatment trajectory through the VA system. Moreover, since the VA has been particularly proactive in its adoption of clinical pharmacy services as part of their primary care teams their EHR includes codes specifically used to identify visits with clinical pharmacists. Consequently, in contrast to previously published work on pharmacist visits, the current study provides a broader examination of the pharmacist’s role as a resource to patients throughout a nationwide health system. Specifically, this research examines the initial impact of clinical pharmacy services among veterans with newly diagnosed, uncontrolled diabetes during their first year of oral antidiabetic (OAD) therapy.

Our results provide valuable insight on the extent to which visits with a clinical pharmacist can effectively contribute to managing the complex needs of veterans with diabetes in the first year of antidiabetic therapy. Compared to veterans with diabetes who had not seen a clinical pharmacist, those who had experienced significantly larger reductions in hemoglobin A1C over the first year of OAD therapy. Pharmacist visits were also associated with higher rates of OAD, antihypertensive, and lipid-lowering drug adherence, which is likely reflective of the benefit pharmacists provide in counseling patients on the importance of proper medication use. Although the observed differences in medication possession may not provide markedly higher clinical benefit, the achieving of higher rates of adherent patients (PDC ≥ 80%) may be clinically relevant as reaching this threshold has been associated with better health outcomes [49‐51]. In addition to differences in medication use, veterans under the care of a clinical pharmacist had greater reductions in hemoglobin A1Cand LDL, both measures of critical importance in managing diabetes. Taken together, these results lend support to pharmacists effectively intervening patients with diabetes, and other related needs, in order to contribute to providing guideline-recommended care and achieving objectives set forth by the ADA. However, as the statistical significance of the results were driven by the sample size, real-world implications of the findings should consider the extent to which the observed changes in clinical measures indicate meaningful improvements in disease management.

Compared to previous studies of patients on oral diabetic therapy in the VA system, our results provide a more system-wide interpretation of clinical pharmacy services with at least comparable findings. Whereas prior studies observed mixed impact of pharmacists on clinical management and/or medication use in veterans with diabetes, the current analysis demonstrated more positive improvements in hemoglobin A1C and LDL cholesterol and higher rates of adherence [25, 30, 34, 37, 52‐54]. However, it is important to note that several of these earlier studies were conducted prior to full implementation of PCMH models by the VA, potentially limiting pharmacist impact. As our analysis includes multiple years of data following widespread PCMH adoption, the current assessment may be a better representation of what clinical pharmacist incorporation may contribute to patient outcomes. Moreover, a major strength of this assessment is the sample size used as many studies examining clinical pharmacist impact are hindered by small cohorts. By using a large, nationwide records system we add insight from all portions of the country and do so among a larger collection of those receiving clinical pharmacy services.

This study was limited in several ways. First, the analysis was limited to patients within the VA system, which facilitates access to care for veterans across the country; therefore, results may not be generalizable beyond veterans with diabetes or to populations where access to care remains problematic. Secondly, the actual services provided by pharmacists could not be gleaned from electronic records, which limits our ability to interpret what methods may have been more or less effective across VA facility. Our analysis was also restricted to using data collected within VA facilities; consequently, patient medication use and other clinical data captured from non-VA facilities were missing. Moreover, data collected on patient clinical measures came straight from EHR sources and are subject to misclassification. Additionally, the sample included only those that had lab tests both at baseline and 1 year later; therefore, results include those who may be more inclined to be engaged with the healthcare system and their care, which may have led to better than average results. Finally, while PDC is a widely used and accepted measure of adherence, it is still an indirect method of describing medication use and may not be indicative of actual medication consumption.

In spite of these limitations, this study has important implications for management of patients with diabetes in primary care settings. By demonstrating that visits with clinical pharmacists can positively contribute to disease management, the results suggest a potential role for these practitioners to play. A recent report prepared for the Association of American Medical Colleges highlighted a looming crisis in the United States: in the next decade, a significant shortfall in practicing physicians is expected across the country, ranging from 61,700 to 94,700 [55]. Within primary care, this shortfall may exceed 30,000 by 2025, which would significantly affect Americans’ ability to access a wide range of necessary services [55]. As demand for primary care services continues to escalate, in part due to implications of the ACA, the US healthcare system needs to adapt innovative solutions to ensure that demand for services is being met. As primary care practices become increasingly challenged by demand, pharmacists may be able to step in and manage patients with diabetes once the focus of treatment involves oral or injectable therapies. Consequently, primary care physician time can then be freed to better accommodate an increasing patient base or address those with cases that are more complex.

Considering the extent to which the VA has implemented clinical pharmacy services across its facilities, this system remains an important source of evidence for the impact of pharmacist intervention. Future studies using VA data sources should examine the precise mechanisms by which pharmacists influence medication use and disease management, both in diabetes and other conditions, as well as the role that these practitioners may play in assisting with patients that have multiple chronic conditions and, therefore, more complex treatment regimens. Moreover, evaluations beyond those involving patients with uncomplicated diabetes can shed light on how pharmacists can affect health outcomes among those with more advanced disease or when multiple comorbid conditions are involved. Results may then provide timely guidance to non-VA systems as pharmacist provider status continues to grow and expanded collaborative practice agreements spread across the country. Finally, an additional consideration tied to involving clinical pharmacists are the costs of their services. A future analysis should involve determining the cost-benefit ratio of incorporating clinical pharmacists into the care of patients with diabetes and other chronic conditions to examine long-term economic impact, results of which will add to a growing body of analyses suggesting that pharmacist involvement is a cost-effective means to improve diabetes management [7, 21, 38, 39].

The involvement of clinical pharmacists in the care of veterans with diabetes was associated with gains in hemoglobin A1C reduction and slightly better OAD use in the first year of therapy, rivaling the outcomes of patients receiving only physician-directed care. Health systems across the United States beyond the VA should further consider how clinical pharmacists could contribute to the management of patients with diabetes, particularly among those with potentially complex medication management needs.