Abstract
Hispanic patients are more likely to have pronounced diabetes-related complications compared to patients from other ethnicities. Studies have shown that pharmacist interventions demonstrate statistically significant improvements in diabetes outcomes. However, limited data are available describing clinical pharmacist interventions in Hispanic patients with Type 2 diabetes. The purpose of this study was to evaluate the impact of pharmacist care on diabetes management and patient outcomes in a primarily Hispanic patient population compared to primary care providers in a federally qualified health center.
This retrospective cohort study focused on underserved Hispanic patients treated from October 2019 to April 2021 who were 18 years or older and diagnosed with type two diabetes.
Among the 495 patients enrolled in the study, the average drop in HbA1c was reported as 2.107%. Within the first month of comprehensive medication management services received by a clinical pharmacist, 5% reached the HbA1c of less than 8% and were discharged. By month six, 40% of patients reached HbA1c of less than 8%. A total of 45% of patients were seen by pharmacists and prescribed a GLP-1 receptor agonist compared to 12% of patients who received primary care provider only management. Similarly, 23% of patients were prescribed a SGLT-2 inhibitor by pharmacists compared to 9% of patients who received primary care provider only management.
Pharmacist interventions can significantly improve diabetes control with greater utilization of GLP-1 receptor agonists and SGLT-2 inhibitors in medically underserved primarily Hispanic patients with uncontrolled diabetes.
Background
According to the Centers for Disease Control and Prevention (CDC), an estimated 34.2 million people in the United States had diabetes in 2020.1 Adults of ethnic minority groups, specifically the Hispanic population, are more likely to have been diagnosed with diabetes than non-Hispanic whites and was shown to have the highest percentage of diagnosis in the U.S.1,2 Diabetes complications such as diabetic kidney disease, neuropathy and retinopathy are also more prevalent in this patient population.1
The American Diabetes Association (ADA) Standards of Care in Diabetes recommends engaging in collaborative goal settings to improve care and reduce A1c, blood pressure and LDL cholesterol.3 The standards of care are developed to include the most up-to-date recommendations to improve diabetes care and guide treatments based on evidence-based guidelines.4 Strategies shown to improve patient outcomes include incorporating pharmacists’ expertise into the patient care team.3
Diabetes With Cardiovascular Disease
According to the American Heart Association, diabetes is considered one of the seven major controllable risk factors of cardiovascular disease (CVD) and patients with Type 2 diabetes are twice as likely to be diagnosed and die from cardiovascular disease.2,5 Currently, the ADA guidelines for diabetes management of 2022 recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT-2) inhibitors with or without metformin based on glycemic needs as appropriate initial therapy for individuals with Type 2 diabetes with or at high risk for atherosclerotic cardiovascular disease, heart failure and/or chronic kidney disease.
Studies have shown that the use of SGLT-2 inhibitors or GLP-1 receptor agonists reduce chronic kidney disease (CKD) and has CVD benefit in Type 2 diabetes patients with CKD and albuminuria.6 For patients with Type 2 diabetes and CKD (eGFR < 60 ml/min/1.73m2), there is an increased risk of CVD events in which the use of a GLP-1 receptor agonist or SGLT-2 inhibitor has shown to provide CVD benefits.6 Cardiovascular outcome trials have shown that the use of GLP-1 receptor agonists or SGLT-2 inhibitors provides cardiovascular benefits, specifically liraglutide, dulaglutide, semaglutide, dapagliflozin and canagliflozin.6
Comprehensive Medication Management
Comprehensive medication management (CMM) is a tool pharmacists may use to help optimize patients’ medication to improve health outcomes by reviewing medications, promoting adherence and reducing errors.7 Pharmacists collaborate with the patient and health care providers to individually create a medication care plan that meets the standard of care to ensure optimal medication usage.7 Goals of therapy are developed after proper review of relevant information such as patient demographics, laboratory values, diagnostic tests and medication history.7 The pharmacist implements an evidence based care plan and focuses on patient understanding of goals of therapy. Ongoing follow-up and monitoring are provided to optimize and improve care.7 According to Alfayez et al., a statistically significant improvement in HbA1c was observed in patients following pharmacist intervention. Results have been shown to reduce mean HbA1c levels from 8.77% to 7.59% after involving pharmacists in direct patient care.8 A review article included 25 studies indicating the significant improvement of diabetes outcomes when pharmacists are involved in direct patient care.9 Included studies reported the measurement of HbA1c values pre- and post-intervention by pharmacists revealing the positive impact on the outcome of diabetes. Muhammad et al. reported that a review of 19 clinical studies have shown pharmacist-led interventions reduced HbA1c levels with a mean of 0.75% with a study duration of one year.9 Pharmacists were involved in providing diabetes education on the disease state, complications, medication adherence and lifestyle education. Furthermore, in a retrospective analysis, Ip et al. reported that in a 12-month study period the mean HbA1c value was decreased from 9.5% to 6.9% in the enhanced care group including a pharmacist, and from 9.3% to 8.4% in the control group seen by primary care.10 Pharmacists identified medication-related problems, such as lack of medication education and nonadherence, associated with uncontrolled diabetes in underserved Hispanic patients. The impact of pharmacist-provided CMM on HbA1c in underserved, primarily Hispanic patients as discussed in the studies mentioned were significantly positive, yielding HbA1c reductions.9-11
Federally Qualified Health Centers
Federally qualified health centers (FQHC) are community-based health care providers that receive funds from the United States Health Resources and Services Administration Health Center to provide primary care services in underserved areas. They must meet a stringent set of requirements, including providing care on a sliding fee scale based on ability to pay and operating under a governing board that includes patients.12 This FQHC has 16 different sites and about 70,000 patients receive care at one of the centers every year.13 The clinic is one of the nation’s largest community health centers. The clinic’s mission statement is “to provide quality, safe and comprehensive primary health care to medically underserved residents of Los Angeles County, particularly in the San Fernando and Santa Clarita Valleys, in a manner that is sensitive to the economic, social, cultural and linguistic needs of the community.”13 Seventy-six percent of the patient population at the clinic are Hispanic. About 62% of patients at the clinic fall below the 100% federal poverty level. Patients seen at the clinic either have no health insurance or are primarily covered by Medicare, Medi-Cal or Medi-Cal Managed Care. Each of these insurance companies have different formularies and may require prior authorizations for many medications. The pharmacists and other health care providers at the clinic have a collaborative practice agreement (CPA) in which a licensed provider makes a diagnosis, supervises patient care and refers patients to a pharmacist under a protocol that allows the pharmacist to perform specific patient care functions, such as modifying or initiating medication therapy based on patient-specific laboratory values and goals. Pharmacists at the clinic provide diabetes care management under a CPA. Under this protocol, the clinical pharmacist can modify diabetes, hypertension and dyslipidemia medications based on the patient’s specific laboratory values, parameters and goals of therapy. From October 2019 to April 2021, three clinical pharmacists were part of the clinic’s patient care team focusing on disease management, including uncontrolled diabetes, defined as HbA1c greater than 8%. During each visit, patients have 25-45 minutes with clinical pharmacists to review current and past diabetes medications, medication adherence, allergies, family and social history, diet, exercise, goals of therapy and diabetes-related education. Over 90% of patients were Hispanic and monolingual in Spanish. Pharmacists are not native Spanish speakers, therefore over 90% of appointments utilized interpreters with non-English speaking patients. Patients are managed either face to face or with telephone appointments. Telephone appointments were the primary mode of care during the COVID-19 pandemic. Patients who are managed by a pharmacist and have a reduction in HbA1c below 8% are discharged from the pharmacy service. The patients are then managed by primary care alone. Patients can be re-enrolled in pharmacy services if their HbA1c raises to above 8% or if they have been clinically lost-to-follow-up.
Objectives
The primary objective of this study was to evaluate the impact of pharmacists' provided care on diabetes management and HbA1c reduction below 8% in a primarily Hispanic patient population in FQHC. The secondary objective was to assess the utilization of GLP-1 receptor agonists and SGLT-2 inhibitors in CMM with clinical pharmacists compared to the primary care provider only management. Primary care provider only management was defined as the care patients receive by primary care providers as part of their routine visits.
Methods
This was an IRB-approved retrospective cohort analysis of patients 18 years or older diagnosed with Type 2 diabetes treated at the clinic. Subjects were selected utilizing an EHR through disease-state diagnosis, specific disease state markers such as HbA1c and diagnosis codes. Data was collected via e-database and quantitatively analyzed utilizing Microsoft Excel. The primary outcome was assessed at baseline, three months and six months after re-enrollment in CMM services. The baseline characteristics used to analyze groups were age, gender, body mass index (BMI), hypertension, hyperlipidemia and HbA1c. Secondary outcomes were evaluated throughout the study. Data analyzed in this study were collected from October 2019 to April 2021. Change in HbA1c was analyzed using GraphPad Prism 8 for Mac (San Diego). The difference in HbA1c value was compared with a two-sided paired t-test and a p-value of < 0.05 was considered statistically significant. Medication use evaluation was performed by comparing pharmacists and primary care providers prescribing habits of GLP-1 receptor agonists and SGLT-2 inhibitors.
Results
During the study period of October 2019 through April 2021, 495 patients with diabetes were enrolled and managed in pharmacists-led interventions and 6,612 patients with diabetes received primary care provider only management; the baseline characteristics analyzed between groups were age, gender, BMI, hypertension, hyperlipidemia and HbA1c. Among the patients managed by pharmacists and primary care standard of care, more patients were female (Table 1). The average age among the patients managed by pharmacists was 55 compared to the average age of 53 managed by primary care. Furthermore, the initial HbA1c at diagnosis and final HbA1c was reduced significantly in patients managed by pharmacists. The total number of patients enrolled included 495 patients and the total number of recorded pre- and post-entries included 546 due to the number of patients discharged and re-enrolled. Sixty percent of diabetes patients managed in CMM by clinical pharmacists had hyperlipidemia and 70% had hypertension before their visits (Table 1). Comparatively, 43% of patients with diabetes who received primary care had hyperlipidemia, and 58% had hypertension before their visits (Table 1). The baseline BMI between both groups was similar (Table 1). Patients seen by pharmacists had an initial HbA1c of 10.75 % which was reduced to 8.64 %. On the other hand, patients seen by a primary care provider had an initial HbA1c of 9.91 which was reduced to 9.32 %. (Figure 1) The results of this study demonstrated a significant HbA1c lowering of 2.11 % (standard deviation + 2.134) (Figure 2). The initial average HbA1c in the patients seen by the pharmacists was 10.75%. The time to achieve an HbA1c reduction of 2.107% was five months. Five percent of patients achieved HbA1c of less than 8% within the first month of pharmacists’ led interventions (Figure 3A). By month six, 40% of patients reached HbA1c of less than 8% (Figure 3A). A total of 518 patients were adherent after data analysis was completed. Medication adherence can be measured by several methods during a patient interview process. The following methods were used in this FQHC: questionnaires, therapeutic drug monitoring, pill counts, etc. Data show 8% of patients who were adherent reached the HbA1c of less than 8% within the first month of CMM services received by a clinical pharmacist. By month six, 43% of adherent patients reached an HbA1c of less than 8% (Figure 3B). When comparing the initial HbA1c with the final HbA1c, the percentage of patients with an HbA1c of less than 8% increased (Figure 3A and 3B). Patients who reached HbA1c of less than 8% were discharged to allow proper allocation of resources to patients with higher HbA1c levels. However, a total of 28 patients were re-enrolled after discharge due to HbA1c no longer being under control.
The utilization of GLP-1 receptor agonists and SGLT-2 inhibitors in both the primary care and CMM was analyzed as the secondary outcome. The results showed greater utilization of these medications by CMM with clinical pharmacists. A total of 45% of patients were seen by pharmacists and prescribed a GLP-1 receptor agonist demonstrating a threefold increase compared to 12% of patients who received primary care. Similarly, SGLT-2 inhibitors were utilized more frequently by CMM with clinical pharmacists demonstrating a 2-fold increase. The percentage of utilization of liraglutide, semaglutide and dulaglutide among clinical pharmacists were 17%, 15%, and 14% respectively, versus primary care by 5%, 3%, and 4% respectively. The percentage of utilization of empagliflozin, ertugliflozin, canagliflozin and dapagliflozin among clinical pharmacists were 13%, 8%, 1% and less than 1% respectively, versus primary care by 3%, 4%, 1% and less than 1% respectively.
Discussion
The World Health Organization (WHO) estimated there is a shortage of 4.3 million primary care physicians, contributing to lower quality care, time limits on office visits and work overload.14 Thus, there is an increased demand for accessible health care professionals, such as pharmacists, who can help fill primary care roles.11 The patient population included in this study was greatly impacted by the COVID-19 pandemic which may have resulted in the loss of income and accessibility to appointments. Pharmacists’ accessibility and availability in the primary care setting improve health outcomes by offering targeted therapy modifications. For patients with uncontrolled Type 2 diabetes, the ADA Standards of Medical Care in Diabetes guidelines recommend the implementation of additional therapeutic approaches. The therapeutic regimen should be tailored to comorbidities, patient-centered treatment factors and management needs.15 First-line therapy generally includes metformin and comprehensive lifestyle modifications.15 Medications such as GLP-1 receptor agonists or SGLT-2 inhibitors, with or without metformin, are considered appropriate initial therapy for patients with Type 2 diabetes who are at high risk for atherosclerotic cardiovascular disease, heart failure and/or chronic kidney disease.15
Several studies have demonstrated the positive impact of clinical pharmacist intervention versus physician on outcomes in patients with Type 2 diabetes.11,16 Pharmacist interventions and the expanded role of pharmacists on the care team are associated with positive outcomes for patients with diabetes, including improved clinical measures, patient and provider satisfaction, adherence and reduced treatment cost.17 However, there is limited data on clinical pharmacist interventions in Hispanic patients with Type 2 diabetes. As mentioned previously, a retrospective observational study evaluated the impact of pharmacists-led interventions and found significant improvement in diabetes control.11 Additionally, this study focused on the impact of integrating pharmacists' expertise in primary care and results have shown to significantly improve outcomes for diabetes management in primarily Hispanic populations.
In this study, 28 patients enrolled in CMM were lost to clinical follow-up and re-enrolled. Among the patients enrolled in the CMM service, 68 had an increase in HbA1c of 1.1%. This may be due to the transition of care via telemedicine during the COVID-19 pandemic, limiting patient understanding, availability, poor adherence or coverage of care. When the utilization of SGLT-2 inhibitors and GLP-1 receptor agonists were compared between the primary care providers and pharmacists, pharmacists utilized these therapeutics more frequently. Specific GLP-1 and SGLT-2 agents were used based on both coverage and clinical decision-making. Once the GLP-1 or SGLT-2 agent was deemed appropriate, the choice was narrowed down based on coverage. One barrier that may contribute to the decrease of a GLP-1 receptor agonist or SGLT-2 inhibitor accessibility included insurance limitations and prior authorizations limiting the use by the standard of care providers due to time constraints. Pharmacists routinely reviewed insurance formularies when optimizing care and submitted prior authorization forms when initiating the medications to prevent further delays in blood sugar management.
Some health insurance companies have stricter regulations on the therapies used to treat diabetes. For example, MHLA requires a patient to try and fail metformin, sulfonylurea (SU) and thiazolidinediones (TZD) before being able to initiate a SGLT-2 inhibitor. Other MHLA requirements also include the presence of microalbuminuria or a history of CAD. If one of four different criteria is met, then the patient would qualify for the SGLT-2 inhibitor, empagliflozin. Furthermore, pharmacists typically spend up to 25-45 minutes reviewing patients’ health insurance, guidelines and initiation of medications, compared to approximately 15-20 minutes seen by the primary care providers.
Conclusion
The purpose of this study was to evaluate the impact of pharmacist care on diabetes management and patient outcomes in a primarily Hispanic patient population compared to the primary care providers in an FQHC. This study has shown that pharmacist care has a significant, positive impact on the Hispanic population by reducing HbA1c levels. Utilization of GLP-1 receptor agonists and SGLT-2 inhibitors in patients managed by pharmacists was higher compared to the primary care providers. Pharmacists’ accessibility and availability in the primary care setting improve health outcomes by offering target therapy modification. In collaboration of pharmacists’ care with the primary care team, patient outcomes in diabetes management have improved. Significant reductions in HbA1c and utilization of medication use were seen by optimizing treatment options, improving access to care and reducing the wait time for therapeutics.