Millions of Americans have limited access to health care and are ethnically diverse and medically underserved. Many of these patients are seen in community health centers (CHCs). These centers are federally supported clinics that provide primary care services for > 11 million underserved patients.1 CHCs were established in 1965 under the Public Health Services Act, through a federal grant program. CHCs serve patients who are uninsured, underinsured, or have a very low income. Many of these patients are at great risk for safety because of cultural or language barriers.
Starting in 2000, the Health Resources and Services Administration (HRSA)of the Department of Health and Human Services awarded clinical pharmacy demonstration grants to 18 CHC networks. The purpose of these grants was to demonstrate that access to medications and comprehensive pharmacy services results in an improvement in the health status of patients by either starting pharmacies to provide affordable medications through 340B Drug Pricing Programs2 or expanding medication assistance programs (MAPs) by pharmaceutical manufacturers. Another goal was to determine the impact of pharmacists on diabetes and its comorbidities in these settings. In many cases, CHC patients were provided access to pharmacist care for the first time. These networks were composed of HRSA-funded health centers, a college of pharmacy, and sometimes other organizations.
Mathematica Policy Research, provided the overall evaluation of these grants and prepared a report to the HRSA.3 Mathematica highlighted five of the clinical pharmacy demonstration projects (CPDPs) in their report. Each CHC project was unique, but all provided certain components of disease management, expanded patient access to medications, medication formulary activities, and training of pharmacy students or residents. The highlighted projects had at least three characteristics in common: positive diabetes disease management clinical data, a large number of patients given pharmacist-provided care, and good retention rates (majority of patients retained for at least 12 months).
The five CPDP networks highlighted in the report included the El Rio Santa Cruz Neighborhood Health Center Network in Tucson, Ariz.; the Siouxland Community Health Center Network in Sioux City, Iowa; the Community Health Center Network in Salt Lake City, Utah; Bond Community Health Services Network in Tallahassee, Leon County, and Gadsen County, Fla.; and the Trenton Medical Center Network in Gainesville, Fla.
El Rio Project
The El Rio Santa Cruz Neighborhood Health Center provided service primarily to Spanish-speaking and Native-American people. The El Rio Project was particularly successful and was a recipient of the American Society of Health System Pharmacists Best Practices Award at its annual Midyear Meeting in December 2005. The program's clinical pharmacist was bilingual, speaking both English and Spanish, and was a certified diabetes educator (CDE).
This project was unique because of a change in Arizona law. Arizona Revised Statute 32-1970 allowed qualified pharmacists working in specified health care settings such as CHCs to independently initiate and modify medications in accordance with written protocols approved by physicians. This practice model is known as collaborative drug therapy management and is used in health care programs administered by such entities as the U.S. Public Health Service, the armed services, and the Veterans Health Administration.4
The program pharmacist assessed diabetes control, medication adherence,nutrition, exercise, and testing regimens. She also ordered necessary laboratory tests and conducted required exams, such as blood pressure checks and foot exams. She modified the overall treatment plan, provided diabetes education, and had full diagnostic and therapeutic responsibility for patients' diabetes and related comorbidities.
Major clinical outcomes at El Rio are summarized in Table 1. The El Rio Project demonstrated that a pharmacist-run diabetes management program for underserved people with diabetes is a viable option for providing care to the burgeoning diabetes population. The results of this project have been published in part elsewhere.5
Siouxland Project
The Siouxland CHC served primarily white underserved patients, although one-third were Hispanic. The majority of patients had incomes below the federal poverty level. People with diabetes were randomized into a treatment group with disease management by a clinical pharmacist or a control group managed by a nurse. After 9 months, the control group crossed over into the treatment group to receive clinical pharmacy services.
The clinical pharmacist provided intensive education and saw patients every 2 weeks for 9 months, providing education and adjusting medications as necessary under a collaborative agreement with physicians. The pharmacist telephoned patients to remind them of appointments to diminish the rate of missed appointments. This project was strongly endorsed by physicians because it reduced the extra time they had to spend with patients to provide diabetes information and thus allowed them time to see more patients.
Several incentives were provided to retain patients in the program. These included free glucose meters and up to 9 months of free glucose meter strips,free memberships to an exercise program at the local YMCA, and gift certificates to a local grocery store for each return visit.
Major clinical outcomes at Siouxland are summarized in Table 2.
Salt Lake City Project
This project involved an ethnically diverse population consisting of Hispanic, Native-American, and white patients with an 88% uninsured rate. The pharmacist was a faculty member at the University of Utah College of Pharmacy as well as a CDE who was board certified in advanced diabetes management. The pharmacist provided diabetes care in a collaborative practice with prescribers in the CHC system.
The pharmacist was bilingual and was able to provide patient education to the > 50% of the patient population who spoke only Spanish. The pharmacist also provided recommendations for initiating or changing drug therapy,obtaining laboratory assessments, and monitoring medications obtained through pharmaceutical patient assistance programs. The pharmacist provided continuing chart review for patients and continued recommendations for disease state management and followed patients for 1–3 years.
The pharmacist also screened for potential problems with drugs sent through MAPs. These problems included wrong doses or wrong drugs sent; correct drugs inappropriately ordered; no appropriate indication for ordered drugs; drugs discontinued because of side effects; drugs contraindicated because of problems with renal, hepatic, electrolyte, or other abnormalities; doses no longer appropriate (too low or too high); drugs that were a therapeutic duplication of another drug the patient was taking; or appropriate baseline laboratory tests not performed.
It was estimated that 21% of medications received through these programs required interventions such as withholding or discontinuing the drug, waiting for appropriate laboratory evaluations, or adjusting the dose. The pharmacist monitored for problems, consulted with the medical providers, and then determined whether the drug could not be given out because of these problems.
Another component of this project was to provide intensive inservice programs and education to primary care providers in the CHC system to educate them about new guidelines and medications used to treat diabetes. Pharmacotherapy consultations were also provided when requested by providers.
Bond Project
Two HRSA-funded CHCs and two universities participated in this project. Pharmacists tailored the disease management services to provide culturally appropriate education for a predominantly African-American patient population. The clinical pharmacist spent several weeks working with nutritionists at Florida State University to develop a culturally sensitive educational plan.
The clinical pharmacist provided 1-hour individual counseling sessions for patients with diabetes. She also initiated diabetes management counseling groups. She held four diabetes groups per month, and each group of patients was asked to attend four sessions. During the first two sessions, diabetes education was provided, patients were taught to use glucose meters, and exercise was discussed. Nutritionists provided education about healthy eating habits during the next two sessions.
The pharmacist secured a grant to purchase a year's supply of diabetes testing strips and secured donated glucose meters from a meter company. Grocery store coupons were also obtained for the first 3 months and used as incentives for patient attendance at classes. Additionally, this center increased use of MAPs.
Major clinical outcomes at the Bond Project are summarized in Table 4.
Trenton Project
This center served primarily non-Hispanic white populations. This network had a dispensing pharmacy and trained its dispensing pharmacists to provide diabetes education. The pharmacists received 50 hours of certification training at the University of Florida and then received follow-up assistance from an experienced clinical pharmacist to discuss patient issues.
One problem encountered was that dispensing duties conflicted with individual diabetes counseling sessions. This was addressed by hiring temporary staff to fill in for pharmacists while they provided diabetes education. Group education consisted of two 2-hour classes followed by assessment of patient knowledge, using a 14-item questionnaire.
This project was unique in that a clinical pharmacist at the site was also a physician assistant, which allowed the clinic to bill third-party payers for some of her time spent providing patient care. Major clinical outcomes at Trenton project are summarized in Table 5.
Case Study
The following case provides an example of the patients served and activities provided in one of the CPDPs.
M.C. is a 45-year-old Hispanic woman who was diagnosed with type 2 diabetes 7 years ago. She has been referred for diabetes education and care to a pharmacist because her diabetes is in poor control. Her hemoglobin A1c (A1C) is 11.4%, and although she is on maximum doses of oral diabetes medications, she does not want to start insulin. She is on the following medications obtained through MAPs:
metformin ER, 1 g twice daily
glipizide ER, 10 mg twice daily
rosiglitazone, 4 mg twice daily
lisinopril, 20 mg daily
On examination, her blood pressure is 120/72 mmHg, and her weight is 150 lb(BMI 27 kg/m2). Her fasting laboratory tests results are:
Blood glucose: 379 mg/dl (normal 90–105)
Blood urea nitrogen: 18 mg/dl (normal 6–20)
Creatinine: 0.9 mg/dl (normal 0.8–1.5)
Potassium 4 mEq/l (normal 3.3–5.1)
Liver function tests: normal
LDL cholesterol: 145 mg/dl (normal < 100)
Diabetes assessment
M.C. lives with her daughter and granddaughter and reports eating two meals a day. The nutrition assessment reveals that she eats 8–12 tortillas per day, has 1 cup of pinto beans with breakfast and lunch, and usually has sopa con carne y verduras como calabaza (rice with meat and vegetables, such as squash) for lunch. She states she does not eat supper. After further questioning, she reports that she does not eat a meal for supper, but that she usually has a banana, an apple, a piece of pan dulce (Mexican pastry), and a glass of milk. Sometimes she only eats a large bowl of cereal with fruit.
M.C. states that she does not eat sugar but does use honey in her coffee because “that is healthier.” She states that although she likes green salads and certain vegetables such as broccoli and cauliflower, she does not think to buy these items at the grocery store.
She reports walking for 15 minutes four times a day, five days a week, when she walks her granddaughter to kindergarten each day. She states that on Saturdays and Sundays she walks briskly for 1 mile around a park close to her home.
C.M. states that she believes that she developed diabetes because of susto (fright) after learning that her mother in Mexico had suffered a stroke. Her mother also had diabetes and eventually died 2 years after her stroke. She says she does not want to start insulin because her uncle became blind after starting insulin and her mother had a stroke after starting insulin. She claims that she can intensify her diabetes treatment by eating more nopales (prickly pear cactus) and making a liquado(shake) using sábila (aloe vera).
Interventions and diabetes care plan
Nutrition. C.M. is given nutritional counseling about the carbohydrate content of tortillas, beans, and rice. The pharmacist also explains that even though she does not consider what she is eating at supper a meal, she is still consuming carbohydrates at that time.
She agrees to cut back to four tortillas per day, reduce her portion sizes of rice and beans, start eating a green salad daily using lemon juice instead of salad dressing, and start incorporating other vegetables into her daily eating. She also agrees to try a sugar substitute instead of honey in her coffee. She agrees to limit Mexican pastry to two or three times a week.
The pharmacist advises that M.C. can add prickly pear to her diet because it is a good source of fiber, but she cautions against use of aloe vera because the raw product may contain anthraquinones and may result in diarrhea and electrolyte disturbances.7
Physical activity. M.C. states that she will try to walk more briskly on her daily trips to and from her granddaughter's school. She will also take a route that requires an extra 10 minutes of walking.
Monitoring. M.C. has been checking her fasting blood glucose daily and states that most of the values are in the low- to mid-200 mg/dl range. She agrees to continue testing her blood glucose daily, both fasting and 2 hours after her largest meal of the day.
Medications. The pharmacist provides education regarding the need for starting insulin. The pharmacist is respectful of the health care beliefs that many Hispanics have regarding the etiology of diabetes and insulin use. People who provide care for Hispanic patients must understand and acknowledge these beliefs.8
The pharmacist tries to show respect for the patient's health care beliefs by agreeing that she could try prickly pear, but also asks her to try insulin to help lower her blood glucose levels and A1C results. The pharmacist arranges for M.C. to talk to other Hispanic people with diabetes who are using insulin. They provide affirmation and support and explain that although they were also afraid initially, the insulin has helped them control their blood glucose, and they feel much better.
The pharmacist explains that she will help with the first dose of insulin and will follow up by telephone every day to assess M.C.'s blood glucose values. The pharmacist self-injects with 10 units of normal saline to demonstrate the process.
The patient will continue her diabetes medications. Additionally, the following medications are added:
atorvastatin, 10 mg daily
aspirin, 81 mg daily
glargine, 10 units daily
Follow-up
The pharmacist calls M.C. daily for 1 week to follow up and review insulin self-administration technique. Together, the pharmacist and patient evaluate how the patient is doing. Additional questions or concerns are clarified, such as M.C.'s worries about becoming “addicted to insulin.”
The dose of glargine will be increased weekly, if needed, by evaluation of fasting blood glucose values. M.C. will continue to monitor blood glucose and will return weekly or contact the pharmacist by phone until there are no further concerns. In 6 weeks, fasting lipids will be reassessed to determine the impact of atorvastatin on LDL cholesterol, and A1C will be reassessed to determine the impact of glargine on glycemic control.
After 3 months, the patient's dose of glargine is 25 units daily. When reevaluated, her fasting LDL cholesterol is 72 mg/dl, and her A1C is 7.1%. The dose of glargine is eventually increased to 35 units, and in 3 more months,her A1C is 6.7%. Because the pharmacist has provided ongoing education and care, M.C. has benefited from the services provided.
Conclusions
The HRSA projects allowed for the provision of pharmacist involvement with underserved patients in CHCs. Through innovative practices and collaborative drug therapy management services, the projects demonstrated positive outcomes. Collectively, data from the projects demonstrated that mean A1C declined from 9.1 to 7.7% (P <0.05).9 The proportion of patients achieving the A1C goal of < 7% doubled from 18% at baseline to 37% at the final measure (P < 0.01). Mean systolic and diastolic blood pressure declined from 132.2 and 78.9 mmHg, respectively, at baseline to 128.2 and 76.4 mmHg, respectively, at final measure (P< 0.01 for systolic and diastolic pressures). LDL cholesterol declined from 117 mg/dl at baseline to 102 mg/dl (P < 0.01).
These programs demonstrate that primary care providers can gain time to see more patients while pharmacists provide chronic care education and follow-up. It is hoped that there will be more opportunities for pharmacists to become involved with provision of direct patient care and education to other underserved patients with diabetes.
Laura Shane-McWhorter, PharmD, BCPS, FASCP, BC-ADM, CDE, is a professor(clinical) at the University of Utah College of Pharmacy, Department of Pharmacotherapy, in Salt Lake City.
