Part 1 of a 2-Part Series. For Part 2, click here.
With the prevalence of diagnosed and undiagnosed diabetes mellitus pegged at 8.3% in 2010 by the Centers for Disease Control and Prevention (CDC) (Figure), and evidence suggesting that medical therapy is suboptimal in a majority of patients, efforts to ensure that patients know how to best manage their disease are more critical than ever. And although educational programs to achieve this end are available, according to one assessment, only 55% of patients with diabetes have accessed these resources (http://apps.nccd.cdc.gov/DDTSTRS/default.aspx).
The magnitude of the public health challenge posed by diabetes is even greater in Alabama, where in 2010, Kristi Kelley, PharmD, helped to launch a pharmacist-run education program for patients with type 2 diabetes at Baptist Health Inc., in Birmingham. An estimated 11.7% of Alabama’s citizens reportedly carried a diagnosis of diabetes in 2011 (http://apps.nccd.cdc.gov/DDTSTRS/default.aspx), she said.
When Dr. Kelley’s team created a collaborative, individualized education program at two of Baptist Health’s internal medicine resident clinics—the initial point of care for many of the health system’s patients with diabetes—they wanted to ensure patients had access to the program (poster 85). “At least one-third of the patients in our internal medicine clinics are uninsured and from an underserved population, which had made it challenging to refer to the hospital’s existing diabetes education programs, since they require payment,” explained Dr. Kelley, a clinical pharmacist in the hospital’s Continuity of Care Clinic and an associate clinical professor in the Department of Pharmacy Practice at Auburn University Harrison School of Pharmacy, in Auburn. Given the patient population, Dr. Kelley’s team offered one-on-one sessions with a clinical or student pharmacist free of charge. A scarcity of resources meant the program had to be targeted for maximum efficacy, so she and her team asked clinic staff to refer only those patients who would most likely benefit from additional education.
During sessions, patients received printed literature, counseling and a demonstration insulin injection to ensure their technique was correct. Educational content was tailored to each patient’s specific needs, with the most common topics being nutritional management and lifestyle modification, medication safety, ways of maximizing drug treatment efficacy, the role of blood glucose monitoring and the importance of preventing, detecting and treating acute disease complications. Some participants received more than one session if the pharmacist deemed it necessary or if the patient requested it.
According to Dr. Kelley, 27% (47 of 172) of the internal medicine clinics’ patients with diabetes participated in at least one session during the 18-month study period following the program’s implementation. Among the 25 participants with available pre- and postintervention laboratory data, average hemoglobin A1c (HbA1c) levels dropped from 9.4% prior to the intervention to 8.2% afterward.
Noting that a 1% reduction in HbA1c is associated with an approximately 40% reduction in the incidence of microvascular complications, Dr. Kelley emphasized that the results are clinically meaningful (Diabetes 1995;44:968-983).
She said the multidisciplinary aspect of the program was critical to its success. Access to patient medical records allowed the pharmacist to contact the treating physician and recommend dose adjustments. For individuals who could not afford prescribed medications, the pharmacist worked with a social worker or resident to help obtain medications that were within their budget.
Although the initiative was linked to improved patient outcomes, Dr. Kelley suggested that staff have limited time to devote to work that is not reimbursed. “In a different setting such as a private physician’s office or a group practice, it potentially could be easier to bill,” she said.
In Burlington, N.C., Rachel Selinger, PharmD, a clinical pharmacy specialist at the University of North Carolina at Chapel Hill’s Campus Health Services, and her colleagues ran a diabetes patient education program in a community health clinic setting (poster 37).
The initiative, which was implemented at the Charles Drew Community Health Center, where Dr. Selinger was the pharmacy manager at the time of the intervention, was part of the Patient Safety and Clinical Pharmacy Services Collaborative, a government-funded program aimed at improving outcomes and reducing adverse drug events (http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html). Like the Alabama program, it also targeted higher-risk patients—specifically, those with little clinic contact and HbA1c levels above 9%. About 95% of the patients seen had type 2 diabetes, Dr. Selinger noted.
Between September 2010 and August 2011, a case manager contacted 30 of these patients by phone and explained that their disease was not under control and that they were at risk for developing related complications. Those patients who were interested in better managing their disease subsequently met with a clinical pharmacist who reviewed optimal medication management strategies, provided medication adherence counseling and overall disease education, and worked with the patient’s physician or nurse practitioner to make dose adjustments if necessary.
Molly Howard, a PharmD candidate at Creighton University’s School of Pharmacy and Health Professions, in Omaha, Neb., and an intern at the Charles Drew Community Health Center when the program took place, presented the initiative’s outcomes at the ACCP Symposium. She said that after an average of three to four sessions, each lasting 15 to 30 minutes, HbA1c levels fell below 9% in roughly 40% of the participants.
However, like the Auburn program, the N.C. initiative also came up against logistical and financial hurdles. “The time and resources required for programs like ours are difficult to sustain, with employees taking on additional tasks and with no organizational profit to warrant additional staffing,” Dr. Howard explained. “That being said, when the resources are available, these initiatives ultimately decrease the workload for physicians, improve outcomes and lower the overall cost to our health care system.”
Indeed, the CDC has reported the benefits of various preventive care strategies in diabetes (Table).
Strength in Numbers
A group-based approach outlined by Brittany Cogdill, PharmD, a clinical pharmacy specialist in ambulatory care at the Medical University of South Carolina’s College of Pharmacy, in Charleston, may be less time-intensive than individual education (abstract 8). Furthermore, it offers other unique advantages.
“Group members benefit from receiving advice from others with diabetes, particularly when it comes to diet, instead of listening to health care professionals tell them what they should do,” Dr. Cogdill said in an interview, noting that 85% of participants in a group program she and her colleagues implemented preferred this format over an individual approach.
The program was offered free of charge to patients referred from the university’s affiliated hospital outpatient family medicine clinic. Individuals were initially contacted by phone by a pharmacist and invited to attend four 2.5-hour educational sessions—a total of 10 hours over a one-year period, she noted.
Dr. Cogdill structured the group discussions on the American Diabetes Association’s Diabetes Conversation Maps (http://www.healthyinteractions.com/conversation-map-programs/conversation-map-experience/current-programs/usdiabetes), which provide talking points around nutritional management, insulin treatment and blood glucose monitoring as well as information on the natural course of the disease, potential complications and gestational diabetes.
Thirty-two patients with type 2 diabetes attended a single class and nine returned for more than one session over a one-year period. The intervention proved effective as evidenced by decreases in HbA1c. Among those with available laboratory data, average HbA1c dropped from 9.4% to 8.3% after group participation. Furthermore, systolic and diastolic blood pressure as well as low-density lipoprotein levels also decreased. Although the changes were not statistically significant, “the numbers “trended toward improved patient outcomes,” Dr. Cogdill said.
The program did not involve a drug management component, but some patients may have had medication adjustments under their physicians’ care—a factor that Dr. Cogdill’s team did not account for when analyzing their outcomes.
Kudos on Effort, But Study Design Criticized
Pharmacist-run programs will only be reimbursed if studies like these continue to be conducted, according to Brian Irons, PharmD, the division head of ambulatory care and an associate professor in the Department of Pharmacy Practice at the Texas Tech University Health Sciences Center’s School of Pharmacy, in Lubbock.
“We know we can provide high-quality patient education and drug therapy management, and we need more demonstration projects like these to show other providers what we can bring to the table,” said Dr. Irons, who has previously developed and studied pharmacist-led educational programs but was not involved in the studies.
Although the studies are encouraging, the conclusions are hampered by several significant design weaknesses, he said, and stronger studies on the topic need to be conducted. “The number of patients in each of the abstracts is small, there were no control groups, and there are many possible confounding variables that are difficult to account for,” he said. “Therefore, it’s not clear precisely to what extent the interventions and the pharmacist’s involvement actually contributed to improved outcomes and HbA1c reductions.”
Drs. Irons, Cogdill and Kelley and Ms. Howard reported no relevant financial conflicts of interest.
More than one-third of diabetes patients do not take their insulin as prescribed1 and one-fifth intentionally skip doses.2 Pharmacists can help address the issue of poor insulin adherence in two ways:
Recommending shorter needles also might improve injection site rotation, which about half of diabetes patients report not doing frequently enough,3 and which can cause lipohypertrophy and significantly affect insulin absorption.4 Longer needles require that patients pinch up skin and use two hands, whereas shorter needles can be injected with one hand and injection sites can be accessed more easily. Longer needles also may enter into the muscle, where insulin injection can lead to hypoglycemia.
Many pharmacists would say they do not have the time to schedule appointments and provide one-on-one education, but tasks like checking blood glucose, running a lipid panel or weighing the patient before they meet with the pharmacist, can be delegated to a technician in many cases, leaving the pharmacist with more time to review training and results.
Taking the few extra minutes to check a patient’s treatment routine and ensure appropriate protocols are being followed can improve outcomes and position the pharmacy as a recognized center for diabetes care.