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Community and Clinical Pharmacy Services: A Step-by-Step Approach

Chapter 11. Diabetes

Ashley W. Ellis; Courtney Davis; Meagan Brown; Justin J. Sherman

Learning Objectives
A er reading this chapter, the pharmacy student, community practice resident, or pharmacist should be able to:

1. Recognize the role of pharmacists in diabetes management services.

2. Define diabetes.

3. Review the goals of diabetes management.

4. Identify key concepts in diabetes management.

5. Discuss ways to prepare for clinic initiation.

6. Identify aspects to consider when developing a business plan.

7. Discuss clinic design.

Introduction

Diabetes is a devastating disease a ecting nearly 25.8 million people, which corresponds to roughly 8.3% of the U.S. population.1 Of the 25.8 million a ected, it is
estimated that nearly 7 million are undiagnosed.1 In 2007, diabetes was labeled the 7th leading cause of death based on death certificates, which was likely
underreported as a primary cause of death.1 Overall, the risk of death is doubled for patients with diabetes compared with those without.1 Complications resulting
from diabetes may include heart disease, stroke, blindness, kidney disease, amputations, dental disease, and pregnancy complications.1 Notably, diabetes is the
leading cause of new cases of blindness in adults 20–74 years of age, accounts for 44% of all new cases of kidney failure, and is the cause of >60% of nontraumatic
lower-extremity amputations.1 According to a national survey in 2007–2009, Puerto Ricans, Mexican Americans, non-Hispanic blacks, and Hispanic/Latinos age 20
years or older comprised the highest percentage of the population with diabetes (13.8%, 13.3%, 12.6%, and 11.8%, respectively).1 Non-Hispanic whites made up
7.1%, while Cuban Americans and Central and South Americans each made up 7.6% of the population of patients over 20 years of age with diabetes.1 The increased
prevalence in minority populations may be due to genetic factors, lower income status, or lack of access to health-care. Community pharmacist-delivered
pharmaceutical care is one way to help address this disparity and increase access to care for some of these patients.

The total cost of diabetes was estimated in 2007 to be at least $174 billion, with $27 billion used to treat diabetes directly, $58 billion to treat chronic complications
related to diabetes, $31 billion in excess medical costs, and $58 billion accounting for reduced national productivity.2 On average about $1 in $5 health-care dollars
was spent caring for someone with diabetes, while $1 in $10 health-care dollars was attributed directly to diabetes.2 The average annual expenditures attributed to
the disease were estimated at $6649 in 2007.2

When diabetes is uncontrolled there is a greater likelihood of a rise in complications, which in turn can lead to increases in costs. The United Kingdom Prospective
Diabetes Study (UKPDS 35), which was reported in 2000, found a reduced incidence of microvascular complications (including neuropathy, nephropathy, and
retinopathy) in patients with type 2 diabetes that achieved intensive glycemic control.3 For every 1% decrease in mean hemoglobin A1C (A1C), there was an
associated 37% reduction in risk of microvascular complications, 14% reduction in risk of myocardial infarction, and 21% reduction in risk of any end point related to
diabetes.3 Additionally, the Diabetes Control and Complications Trial (DCCT) concluded that intensive diabetes therapy successfully slows the progression and onset
of diabetic retinopathy, nephropathy, and neuropathy in patients with type 1 diabetes.4 In 1997, Gilmer and colleagues looked at medical care charges for 3017
adults with diabetes over 4 years and found that charges increased for every 1% increase above A1C of 7%.5 As the A1C increased, the increase in charges also
escalated.5 It is evident from these findings that glycemic control helps reduce both complications and costs associated with diabetes.

With the steady rise in diabetes over the past decade, it is projected that by 2050 the prevalence of diabetes will increase from 14% to between 21% and 33% of the
adult population.6 This rise is expected to be at least partially due to the increasing size of high-risk minority populations and the aging of the population.6 The
burden of diabetes is rapidly growing and placing a significant impact on the health-care system as well as the quality of life for these individuals.

Pharmacists in a variety of practice settings can be an integral part of managing patients with diabetes or identifying those patients at a high risk of developing
diabetes. Pharmacists are exposed to rigorous curriculums that prepare them not only to be medication experts but also to e ectively manage patients with chronic
disease states, such as diabetes. With the increasing number of patients a ected by diabetes and amount of education and attention needed to properly manage
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these patients, combined with shortage of primary care providers, patients may not be receiving adequate diabetes education or management. Pharmacists are well
positioned and qualified to help fill this gap in care experienced by many patients. Having a pharmacist as part of the diabetes care team allows the practitioner to
see more patients with acute problems while still having the large number of patients with chronic conditions managed. The Asheville Project is a prime example of
how community pharmacists have positively impacted the health of employees with diabetes. In this study, pharmacists provided community-based pharmaceutical
care services for self-insured employees of the City of Asheville, NC.7 Average A1C decreased overall in these patients and total direct medical costs decreased by
$1200 to $1872 per patient per year when compared with baseline.7 The City of Asheville also noted an increase in productivity valued at $18,000.7 Another study
showing positive results from pharmacist interventions in patients with diabetes compared 87 men with diabetes who were managed by physician-supervised
pharmacists to 85 similar patients who did not receive pharmacist care, but were managed in the same health-care system between October 1997 and June 2000.8
The relative risk of achieving an A1C of ≤7% was significantly higher in the pharmacist-managed group versus the control group (RR 5.19, 95% confidence interval
[CI] 2.62–10.26).8 The average frequency of unscheduled diabetes-related visits/patient/year was also significantly higher in the nonpharmacist managed group
when compared with the pharmacist-managed cohort (1.33+/−3.74, 0.11+/−0.46, p+0.003).8 The evidence clearly demonstrates the positive impact of pharmacists'
contributions to diabetes management. Many opportunities exist for pharmacists to provide innovative diabetes management services.

Therapeutic Management of Diabetes

Categories and Goals of Diabetes Mellitus and Concomitant Disease States

The American Diabetes Association (ADA) classifies diabetes mellitus into four separate categories, including (1) type 1 diabetes, resulting from β cell destruction; (2)
type 2 diabetes, resulting from progressive insulin resistance and reduced insulin secretion; (3) diabetes due to other causes, such as genetic defects in β cell function
or insulin action; or (4) gestational diabetes, diagnosed during pregnancy. Because approximately 90% of all patients with diabetes in the United States have type 2,
this chapter will focus on the care and management of patients in this category. However, the goal and management of patients with type 1 diabetes is the same as
those with type 2. Both are chronic illnesses that require continuous medication therapy management (MTM) and medical care, along with intensive counseling and
patient self-management to decrease the risk of long-term complications.9

Diagnosis

Although pharmacists are not diagnosticians, pharmacists should be aware of the diagnostic criteria for diabetes. Test results of one of the following would be
diagnostic for diabetes, a er a repeat test is completed for verification: (1) A1C ≥6.5%; (2) fasting plasma glucose ≥126 mg/dL; (3) oral glucose tolerance test ≥200
mg/dL; or (4) a random plasma glucose ≥200 mg/dL (in a patient with classic symptoms of hyperglycemia). Point-of-care (POC) A1C assays are widely available, but
the ADA cautions that these assays are not su iciently accurate for diagnosing diabetes. However, POC can be used for diabetes screenings or to determine
treatment changes.9

Overall Goals

The major goal for most patients with diabetes is to decrease A1C to <7%. This has been shown consistently in many studies to decrease microvascular
complications, including retinopathy, nephropathy, and neuropathy.9 If achieved soon a er diagnosis, this goal has been associated with long-term reduction in
macrovascular complications as well. Macrovascular complications include cardiovascular disease (CVD), stroke, and peripheral vascular disease. However, a more
stringent goal of <6.5% is reasonable for selected patients, usually younger with a short duration of diabetes, long life expectancy, and no significant CVD.
Hypoglycemia has been associated with an increased risk of death; thus, clinicians should be cognizant of hypoglycemia in certain populations. These are generally
older patients with long-standing diabetes and/or a history of severe hypoglycemia, limited life expectancy, comorbidities, and advanced micro- or macrovascular
complications. For these latter patients, a less stringent goal of A1C <8% would be reasonable. Patient attitude and expected treatment outcomes are also important
determining factors for the approach to hyperglycemia management. Those who are highly motivated, adherent, with excellent ability to perform self-care
management and a good support system should be able to achieve more stringent goals.10

Concomitant Disease State Goals

CVD associated with macrovascular complications is a major cause of morbidity and mortality for patients with type 2 diabetes. However, controlling the
concomitant disease states of hypertension and hyperlipidemia is as important as achieving the goal A1C. Both are independent risk factors for CVD in the patient
with diabetes, each with their own separate goals. In particular, the American Association of Clinical Endocrinologists (AACE) suggests that by preventing the micro-
and macrovascular complications associated with diabetes, control of hypertension has the most significant impact on morbidity and mortality.11

According to ADA recommendations, blood pressure for patients with diabetes should be measured at each visit. A goal blood pressure of <140/80 mm Hg is
appropriate for most patients with diabetes and concomitant hypertension. Lower goal targets (<130/80 mm Hg) may be appropriate for some, such as younger
patients, if this can be achieved without significant adverse events. Lifestyle changes should be suggested if the blood pressure is > 120/80 mm Hg. If patients have a
blood pressure ≥140/80 mm Hg, prompt initiation of medication along with lifestyle therapy should occur. Multiple agents may be needed to achieve significant
blood pressure reduction. Angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) may be used as first-line agents for controlling
hypertension due to the high CVD risk associated in patients with diabetes. Also, many patients with hypertension require multiple-drug therapy to reach treatment
goals. A variety of antihypertensive agents are valuable in reducing cardiovascular e ects, including ACE inhibitors, ARBs, diuretics, β-blockers, and calcium channel
blockers. Selection could be based on other comorbidities (e.g., CVD, heart failure, and post-myocardial infarctions), presence of albuminuria, potential metabolic
adverse e ects, pill burden, adherence, and cost.9

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Fasting lipid profiles should be measured at least annually with the following goals for patients with diabetes: low-density lipoprotein (LDL) <100 mg/dL, high-density
lipoprotein (HDL) >40 mg/dL in men and >50 mg/dL in women, and triglycerides (TG) <150 mg/dL.9 To improve the lipid profile, lifestyle modifications should be
recommended as the cornerstone of therapy. In addition, for individuals under 40 years of age and without overt CVD, therapy with a statin should be started if the
LDL is >100 mg/dL. A statin should be started, regardless of baseline lipid levels, for any patient with diabetes who has overt CVD.12

If the individual without overt CVD is under 40 years of age (i.e., lower risk patients), LDL cholesterol >100 mg/dL could require implementation of a statin in addition
to lifestyle therapy. In patients with overt CVD, attempting to attain a more stringent LDL goal of <70 mg/dL is an option. While it is reasonable to strive for the goals
of all fasting lipid profile components, LDL-targeted therapy using a statin is preferred. If target goals of therapy are not achieved with maximum statin therapy (or
maximum doses cannot be tolerated), a 30 to 40% reduction in baseline LDL goal is reasonable. Combination therapy with a statin has not been shown to provide
additional cardiovascular benefit in comparison to a statin alone, and is not recommended.9

Other recommendations for patients with diabetes include the use of antiplatelet agents and smoking cessation. Daily therapy with an 81 mg strength aspirin is
recommended as secondary prevention for all patients with diabetes and a history of CVD. For those without CVD, primary prevention is not as clear-cut. If patients
with type 1 or 2 diabetes are at increased cardiovascular risk (i.e., 10-year risk is >10%), daily aspirin therapy is recommended. These patients would include men 50
years of age or older and women 60 years of age or older with at least one other major risk factor including: hypertension, family history of CVD, smoking,
dyslipidemia, or albuminuria. For younger patients without additional risk factors, the risk of bleeding will outweigh the benefits of daily aspirin therapy. For those
with an allergy to aspirin, clopidogrel may be used as an alternative.9

Smoking cessation is encouraged for all patients with diabetes. Tobacco users with diabetes have an increased risk of CVD and mortality rates, and a quicker
propensity to develop microvascular complications. Neuropathy, in particular, is problematic in smokers with diabetes. Smoking also may be correlated to
development of type 2 diabetes. Of interest, blood glucose levels can increase in the short-term post-cessation, while reductions in A1C and mortality are benefits in
the long-term.9 Smoking cessation may be particularly di icult, as patients with diabetes may view tobacco use as part of a weight-control tool. However, these
patients must be assured that the long-term benefits of A1C and mortality reduction strongly favor cessation. Smoking also increases insulin metabolism, possibly
increasing insulin doses required for control. Smokers with diabetes should be o ered cessation medications along with support counseling, as both together are
more e ective than either alone. Also, combination cessation therapy may be needed in this special population. Using cessation medications that do not cause
weight gain, such as bupropion SR, may also be considered.9

Primary Counseling Concepts

Hypoglycemia and Hyperglycemia

Patients with diabetes should know the signs and symptoms of hypoglycemia and hyperglycemia, and the resultant action to take, as either condition can be life-
threatening.

Hypoglycemia can be a significant barrier in achieving A1C goals. When titrating insulin, sulfonylureas, or meglitinides, or when patients do not manage meals or
exercise regimens properly, hypoglycemia can result. These symptoms can be especially unnerving during a first-time experience. Hypoglycemia should be
discussed during an initial visit because medications will be titrated to achieve the A1C goal. Hypoglycemia is an acute circumstance that must be addressed
immediately. The symptoms of hypoglycemia include shakiness, nervousness, hunger, sweating, dizziness, confusion, anxiety, or weakness. For many patients,
hypoglycemia may be experienced when blood glucose levels drop <70 mg/dL, with symptoms if blood glucose is <60 mg/dL.9,10

When symptoms occur, patients should promptly check the blood glucose. The preferred form of treatment is 15 g of glucose, usually three or four tablets,
depending on the brand. Other options for treatment include four ounces of juice or sugar-sweetened soda or eight ounces of low-fat milk. If the blood glucose has
not increased to an acceptable level a er 15 minutes, the treatment regimen should be repeated. Once blood glucose has normalized, the patient can then eat a
small meal or snack containing protein and carbohydrate to prevent any recurrence. For the patient at risk for severe hypoglycemia, a glucagon kit should be
prescribed and administration instructions taught to family members and caregivers. Glucagon should be administered when patients are unable to swallow or are
unconscious due to hypoglycemia. Also, the pharmacist should monitor for medications that could cause hypoglycemia unawareness, such as β-blockers. This class
of antihypertensives is not contraindicated for patients with diabetes, but sweating may be the only indication of hypoglycemia when a β-blocker is used. The
pharmacist should ensure that such patients maintain awareness when the blood glucose runs low. If the patient has hypoglycemia unawareness, short-term
allowance of higher glycemic targets is in order. A er several weeks of higher blood glucose levels, counterregulation and awareness of hypoglycemic symptoms may
be improved.9

Hypoglycemia may be experienced at relatively higher blood glucose levels when A1C is greatly elevated at baseline. These patients may “just feel better” when their
blood glucose levels are elevated and may be more reluctant to titrating medications. Titration may be “uncomfortable” for these patients at first, but they should be
counseled to treat for hypoglycemia only when blood glucose levels are less than 70 mg/dL. They should be reassured that they will become more accustomed to
this lower “set point” for hypoglycemia, and that hyperglycemic complications could occur if the medications are not titrated. Until the patients become accustomed
to lower blood glucose levels, half of a usual treatment dose for hypoglycemia (e.g., two ounces of orange juice rather than four ounces) could be recommended.9,10

Another common mistake concerning hypoglycemia is when a patient withholds insulin inappropriately. Patients are o en uncomfortable giving insulin injections
when the blood glucose is below a certain level. This results in withholding long-acting insulin, with later glucose levels in the day being greatly elevated. Patients
should be counseled to administer long-acting insulin to prevent elevated blood glucose levels later in the day—unless blood glucose levels are low (e.g., less than 50
or 60 mg/dL) and the patient is having di iculty increasing the blood glucose levels. Short-acting insulin doses should be withheld if hypoglycemia is occurring, and

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the hypoglycemia should be treated. Then, as the hypoglycemia is resolved, a normal schedule of insulin injections can be implemented along with a normalized
meal schedule.

A patient experiencing hyperglycemia should be counseled to contact the provider. Hyperglycemia is not necessarily an acute event, unless associated with
hyperosmolar hyperglycemic nonketotic syndrome (HHNS) or ketoacidosis. The classic symptoms of hyperglycemia are polyuria (excessive urination), polyphagia
(excessive hunger/eating), and polydipsia (excessive thirst/drinking). Other symptoms may include blurred vision, weight loss, fatigue, dry mouth, pruritus, frequent
urinary tract infections, and poor wound healing. The patient should have a plan in place with their medical provider if they begin to experience these symptoms
along with elevated blood glucose levels.9,10

Lifestyle Modifications—Medical Nutrition Therapy (MNT) and Exercise

Lifestyle modifications are the cornerstone of management for all patients with diabetes. This is o en the most di icult aspect of MTM for patients with diabetes
because most are overweight and will need significant behavioral modification. Achieving weight loss is an important goal; even a modest weight loss of 5–10% is
associated with improved glycemic control and reduced insulin resistance. Many patients believe that this goal should be much higher and may become discouraged
when the weight does not immediately respond to initial e orts. A sustained 1% weight loss per week is the most achievable goal in the long term. However, to
achieve and maintain weight loss goals, patients should implement both components of lifestyle modification—MNT and exercise.9,10

For MNT, diets low in carbohydrates and fats, restricted in calories, or Mediterranean diets may be e icacious in the short term. Although a “fad” diet may be
tempting, the long-term e ectiveness is poor. Moreover, the long-term health e ect of very-low-carbohydrate diets is unclear. Instead, dietary improvements should
become a way of life. The best mix of the macronutrients carbohydrate, protein, and fat will vary according to the individual. An individualized meal plan based on
population-wide dietary recommendations and the patient's culture and preferences should be recommended. High-fiber foods (vegetables, some fruits, whole
grains, and legumes) and lean meats should be a large part of the diet. Conversely, foods high in saturated fats and sugar-sweetened drinks, desserts, and snacks
should be greatly minimized. Attention should be given to total carbohydrate intake, whether by counting carbohydrates, calculating carbohydrate choices, or
another method. Clinical studies have documented that e ective MNT programs can reduce the A1C from 0.25% to 2.9% in even short periods of time.9,10

Two common problems that many people have upon first starting lifestyle modifications are that they consume sugar-sweetened beverages and eat fewer, but
larger, meals throughout the day. Many mistakenly believe that “healthy” beverages include fruit juices and sports-type drinks. Removing these completely can
achieve better glycemic control. Consuming these drinks usually results from inability to read a nutrition label, so it is helpful to discuss how to read and determine
the following: serving size, total carbohydrates, total number of calories, amount of sugar, and alternative forms of sugar. Helping the patient switch solely to drinks
with artificial sweeteners—and optimally, water—o en produces quick results. Also, patients should consume smaller, more frequent meals at specific times
throughout the day. An optimal number of meals would be four to six small meals, eliminating snacks altogether. The patient should also check postprandial blood
glucose levels before and a er changing to a four to six small meal per day regimen to learn the e ect of certain foods on glycemic control.9,10

Simple carbohydrate counting may also be e ective. The patient could be counseled that women need 45–60 g of carbohydrate (or 3 to 4 choices, as 1 carbohydrate
choice = 15 g carbohydrate) at each of three meals and 15 g (1 choice) for snacks. Men need 60–75 g (4 to 5 choices) at each of three meals and 15–30 g (1 to 2 choices)
for snacks. Patients should calculate the total carbohydrate per serving size and divide that total number by 15. The resulting number is the number of carbohydrate
choices in that particular serving size of the food item. However, these carbohydrate choice recommendations are for the average patient. If the patient is consuming
many more daily carbohydrate choices at baseline, the pharmacist should recommend “small steps” to achieve the goals, as recommended above.9,10

Other helpful information for MNT includes having the patient keep up with all meals and portion sizes for a week. Then, the pharmacist can discuss how to make
better food choices throughout the day. Using a sample meal plan and providing a food list for that meal plan is also e ective. Other discussions could include the
plate method of planning meals and estimating portion sizes based on the palm, fist, thumb, and thumb tip. The plate method involves limiting a quarter of the plate
to each of the following: fruit, nonstarchy vegetables, lean meat, and starches.13 Portion sizes can be estimated according to the following: the palm equals three
ounces of cooked meat, the fist equals 1 cup (30 g) of carbohydrates, the thumb equals one tablespoon or serving of salad dressing or reduced-fat mayonnaise, and
the thumb tip is about one teaspoon or serving of margarine. The ADA Web site (www.diabetes.org) provides other useful tips regarding MNT.14

If time allows, the MNT discussion should be coupled with tips on increasing physical activities and exercise. Patients with diabetes should spend at least 150
minutes per week engaging in aerobic exercise of moderate intensity, designed to increase the heart rate to 50–75% of the maximum. If patients spent 30 minutes
per day for 5 days a week, they would be able to adhere to this recommendation. Ideally, no more than two consecutive days should pass without increased activity
in this manner. This standard recommendation, in practice, must be highly individualized to implement. The most important thing to remember is for the patient to
start implementing small increments of exercise into a daily routine to work toward this goal. Many patients become frustrated with this recommendation. They feel
that they are “active,” but upon further questioning the pharmacist may discover that the activity is not aerobic. Instead, patients consider “puttering in the garden”
as being active. It should be emphasized that the 30 minutes (alternatively, exercise can be two separate 15-minute activities) should be a continuous activity with
the goal of increasing the resting heart rate to at least half of its maximum rate. Also, many patients (e.g., patients with arthritis) have limitations for weight-bearing
exercise. These patients should be encouraged to participate in activities such as swimming or swim aerobics. Even walking in place for 30 minutes can be helpful for
some patients. Patients should be encouraged at each visit to increase their level of activity in order to realistically achieve their weight loss goal.9,10

Other Counseling Points for Initial Visits

In addition to the other topics of discussion, the pharmacist should be prepared to discuss the following:

Proper education on medications

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Insulin injection technique and proper storage (if applicable)
Diabetes self-management education (DSME)
Sick day management
Foot care
Importance of adherence

Medication Therapy and Principles of Management

The overall aims for MTM of diabetes are to achieve individualized A1C goals and to prevent microvascular complications of diabetes while avoiding hypoglycemia,
blood glucose instability, and significant quality-of-life reduction. As tools to accomplish these aims, several new classes of medications have received approval by
the Food and Drug Administration (FDA) for treatment of diabetes over the past decade. Treatment guidelines and principles of medication management have
changed in response to new studies and medication approvals. Although guidelines by several organizations recently have been published, all agree that treatment
for patients with diabetes must be individualized.15–21

General Principles of Using Oral Agents

As stated earlier, reduction in A1C to <7% has been associated with significant reductions in microvascular complications and, if achieved early in the course of type 2
diabetes, possibly macrovascular complications as well. Thus, a main principle to consider prior to starting therapy is the baseline A1C. Patients with a high baseline
A1C are not likely to achieve su icient A1C reduction with oral therapy—even with dual or triple combination therapy.9 A recent position statement from the ADA and
the European Association for the Study of Diabetes (EASD) suggests that insulin therapy should be started if the baseline A1C is ≥10%. If baseline A1C is below this
level, it may be reasonable to begin oral therapy according to this position statement.22 Alternatively, the most recent guideline from the AACE suggests that if the
patient is symptomatic for hyperglycemia and the A1C is >9%, insulin could be started.

Most guidelines suggest that metformin, a biguanide, should be initiated for treatment of type 2 diabetes along with lifestyle interventions at the time of diagnosis.
Metformin should be initiated unless (1) contraindications exist, (2) the A1C level indicates the need for insulin (at which time both insulin and metformin could be
started), or (3) the A1C level is very close to goal (within 0.5% of goal) at the time of diagnosis and the patient is motivated to make appropriate lifestyle
interventions. Metformin reduces hepatic glucose production, is weight neutral, and does not increase the risk of hypoglycemia when used as monotherapy. It is a
cost-e ective agent for glycemic control and has been shown in the UKPDS to reduce mortality in obese patients. However, it is associated with dose limiting
gastrointestinal side e ects and should be avoided in any patient at risk of lactic acidosis (serum creatinine ≥1.4 ng/dL for females and ≥1.5 ng/dL for male, or heart
failure exacerbation), patients receiving contrast dyes, or those with significant hepatic dysfunction. Most patients can tolerate the gastrointestinal side e ects if they
take metformin with meals, and the dose is started at 500 mg once or twice daily. A er a few weeks, it should be titrated up to the maximum e ective dose, which is
1000 mg twice daily, for the maximum benefit of lowering A1C.9,10,11

Advancing to Dual Therapy

If monotherapy with the maximized dose of metformin fails to achieve the desired A1C goal within about 3 months, the following actions can be taken: (1) add a
second oral agent, (2) add a glucagon-like peptide 1 (GLP-1) receptor agonist (injection), or (3) add basal insulin. However, the choice of next oral agent to add with
metformin is unclear. The choice should be individualized according to e icacy in A1C lowering, unique benefits, dosing frequency, side e ect profiles, and cost. In
general, the A1C lowering capacity is greatest for metformin and sulfonylureas (average 1–2%), next greatest for GLP-1 agonists and thiazolidinediones (average 1–
1.5%), and least for meglitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, alpha-glucosidase inhibitors (AGIs), and colesevelam (average 0.5–1%). The mechanisms
of action, A1C lowering, and advantages and disadvantages of each diabetes medication can be found in Table 11-1.9,10,11

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Table 11-1. Medications for Treatment of Diabetes

Primary Physiologic Action/A1C

Class/Medications Lowering Capacity Advantages/Disadvantages

Biguanides ↓ hepatic glucose production/ No weight gain or hypoglycemia

Metformin ↓ A1C 1–2% ↓ CVD events in overweight patients (per
UKPDS study)
Side e ects include gastrointestinal and lactic
acidosis risk

DPP-4 Inhibitors ↑ And ↓ glucose-dependent insulin and glucagon secretion, respectively/↓ A1C 0.8% No hypoglycemia; weight neutral
Linagliptin Well-tolerated oral formulation
Saxagliptin Modest A1C lowering
Sitagliptin

GLP-1 Receptor ↑ And ↓ glucose-dependent insulin and glucagon secretion, respectively; slows gastric emptying; ↑ No hypoglycemia; weight reduction
Agonists satiety/↓ A1C 0.8–1.5% Gastrointestinal side e ects (less with
Exenatide Bydureon)
Liraglutide Possible acute pancreatitis
Bydureon Medullary thyroid tumors (animals)
Injection-only; expensive

α-Glucosidase Slows intestinal carbohydrate absorption/↓ A1C 0.5–1 % Specific for ↓ postprandial glucose
Inhibitors Significant gastrointestinal side e ects
Frequent dosing schedule
Modest A1C lowering

Insulin ↑ Glucose uptake into cells Best e icacy for A1C lowering
Human NPH ↓ A1C variable Hypoglycemia; weight gain
Human Regular Injection-only
Lispro Expense can be variable
Aspart OTC and prescription only
Glulisine Can have “stigma” for patients
Glargine
Detemir
Premixed

Meglitinides ↑ Insulin secretion/↓ A1C 0.4–0.6 % ↓ Postprandial glucose

Repaglinide Hypoglycemia; weight gain
Nateglinide Modest A1C lowering

Sulfonylureas ↑ Insulin secretion/↓ A1C 1–2 % Extensive experience

Glyburide Very e ective
Glipizide Inexpensive
Glimepiride Hypoglycemia; weight gain

Thiazolidinediones ↑ Insulin sensitivity/ No hypoglycemia

Pioglitazone ↓ A1C 1–1.5 % Weight gain; edema

However, in context of adding on any of the above oral agents to metformin, the e icacy of lowering the A1C further is only about 1%. If the patient is a
“nonresponder” to an adequate trial of the additional agent (no clinically meaningful reduction in A1C), that agent should be discontinued and an alternative agent
added to metformin. Achieving optimal glycemic control should be the focus to alleviate the risk of complications, and therapy should be advanced methodically to
achieve this goal.9,10,11

Advancing to Triple Therapy

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Some studies have demonstrated e icacy of achieving glycemic control when a third oral agent is added to two-medication therapy. The most likely patient would
be one who needs a 1% or less reduction in A1C to meet glycemic goals and does not wish to start insulin. Patients should be counseled thoroughly regarding
possible side e ects and likelihood of achieving target goals. As discussed with dual therapy, patients should not be allowed to linger with an extended trial of triple
combination therapy if e icacy is not achieved within a reasonable time frame. When considering the progression from dual oral therapy, most patients should be
transitioned to insulin therapy if the degree of hyperglycemia remains elevated with a two-drug regimen (e.g., A1C ≥8.5%, for those with a goal of <7%).9,10,11

Transitioning to Insulin

Although many patients are reluctant to start insulin therapy, thorough counseling, encouragement, support, and even use of motivational interviewing tools can
assist in the transition. A basal insulin is usually begun at a low dose, such as 0.1–0.2 units per kg per day. For example, glargine (10 units) is typically started for many
patients. Larger amounts of basal insulin (0.3–0.4 units per kg per day) are reasonable starting doses for patients who have very poor glycemic control.

At this time, oral regimens should be evaluated for continuation with insulin initiation. Continuing metformin is usually reasonable and e ective for most patients.
However, oral agents that enhance insulin secretion (i.e., sulfonylureas and meglitinides) are usually stopped, or the dose decreased, to eliminate increased risk of
hypoglycemia. If postprandial blood glucose levels are elevated, bolus insulin (or a GLP-1 agonist as an alternative) could be started prior to meals. The class of TZDs
could increase weight gain in combination with insulin and are usually avoided when starting injections as well.

The most common way to titrate insulin is to increase 10–20% of the total daily dose. Thus, basal insulin could be titrated 1–3 units with the intent of achieving a
significant reduction in blood glucose levels. Titration should be individualized based on how sensitive or resistant the patient is to insulin. For example, insulin-
resistant patients with poor glycemic control may need 5 units or more increase in insulin. Patients also could be given (and instructed on the use of) bolus insulin,
with corrective insulin given based on each blood glucose reading. The average of corrective insulin needed for a particular meal over time could be added to the
basal dose of insulin.9,10,11

As basal insulin is titrated, it is essential that patients perform e ective self-monitoring of their blood glucose. The ADA recommends that self-monitoring should
occur three or more times daily if patients are using multiple insulin injections. Self-monitoring is still a useful tool when less frequent daily injections are used. Thus,
a typical self-monitoring program would consist of patients checking blood glucose levels before breakfast, before lunch, before their evening meal, and before
bedtime. Also, patients could be encouraged to check blood glucose 2 hours a er meals rather than before lunch and at bedtime.

An alternate method may be e ective when used for short periods of time in patients who refuse to check frequently. For approximately a month, patients could
check their blood glucose on the first day before breakfast and before their evening meals. On alternate days, they could check before lunch and before bedtime.
This method will give the clinician adequate fasting blood glucose averages, as well as postprandial and bedtime averages. These averages can then be used to
adjust basal and bolus insulin appropriately.

Use of bolus insulin before meals will become likely as the daily dose of basal insulin exceeds 0.5 units per kg per day. It can also be added to the regimen when the
fasting blood glucose levels are within goal, but the A1C is still above goal a er a 3–6 months trial of basal insulin alone. Bolus insulin given before meals is very
e ective at decreasing the postprandial blood glucose levels. For many patients, the blood glucose levels remain elevated for several hours a er each meal—
especially if the patient is eating heavier meals throughout the day. Also, use of daily peakless basal insulin and then bolus insulin before each meal most closely
resembles normal physiology of insulin release. The pharmacist managing such patients through MTM services can be most helpful in dose adjustment of these
insulin regimens. An example of this can be found in Table 11-2.9,10,11

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Table 11-2. Soap Note for Sample Insulin Adjustment Based on Average Blood Glucose Readings

S/O: JN is a 58-year-old man with type 2 diabetes for the past 15 years, with care transferred to medication therapy management (MTM) services for insulin initiation. Patient
also has hypertension, heart failure, and hyperlipidemia. He has been taking metformin 1000 mg twice daily and glyburide 10 mg twice daily for the past 6 months. He also
takes lisinopril 20 mg daily, carvedilol 25 mg twice daily, furosemide 20 mg daily, and atorvastatin 40 mg once daily. The physician sending the patient for MTM services notes
that the patient has been instructed to start glargine 10 units once daily in the mornings. He also was instructed to bring in blood glucose levels that have been monitored
four times daily, before meals, for the past 10 days. JN was instructed to stop glyburide and start insulin aspart according to the following sliding scale: for blood glucose
levels <150 mg/dL, no insulin aspart; between 150 and 200 mg/dL, give 2 units; between 201 and 250 mg/dL, give 4 units; between 251 and 300 mg/dL, give 6 units; between
301 and 350 mg/dL, give 8 units; >350 units, give 10 units. The patient states that he has “felt low” twice over the past 10 days. During those times, he drank a “few” glasses of
orange juice until the blood glucose increased and did not give any insulin until bedtime each of those days. His A1C 10 days ago was 9.4%. Today, he brings in the following
record of blood glucose measurements.

Date BF BG/SSI Lunch BG/SSI Dinner BG/SSI Bedtime BG/SSI Notes

7/1 212/4 units 234/missed 260/6 units 188/2 units Skipped bedtime snack

7/2 138/– 198/2 units 280/6 units 200/2 units Skipped snack again

7/3 102a/– 260/missed 290/missed 324/8 units BF-felt jittery; drank OJ

7/4 238/4 units 164/2 units 178/2 units 134/– “Light” dinner

7/5 156/2 units 178/2 units 202/4 units 160/2 units

7/6 122/– 194/2 units 216/4 units 224/4 units Skipped bedtime snack

7/7 118/– 168/2 units 184/2 units 160/2 units “Light” dinner; no snack

7/8 96a/– 290/missed 320/missed 394/10 units BF-felt jittery; drank OJ

7/9 202/4 units 198/2 units 355/10 units 224/4 units Ate ice cream at lunch

7/10 180/2 units 208/4 units 168/2 units 182/2 units

aPatient felt “symptoms” of low blood sugar and took action by drinking a “few” glasses of orange juice.

Avg 156.4 mg/dL 209.2 mg/dL 245.3 mg/dL 219 mg/dL

Avg 1.6 units 1.6 units 3.6 units 3.6 units

Insulin

A/P: JN's diabetes is not at goal with the most recent A1C 10 days ago at 9.4% (goal per ADA guidelines would be <7% for this patient). Although JN's blood glucose has begun
to respond with the introduction of glargine, this needs to be titrated. Would suggest increasing glargine to 15 units QHS, instead of in the morning, and patient was
instructed to continue taking the long-acting insulin regardless of “low blood sugar” because withholding glargine has resulted in escalation of blood glucose levels
throughout the day. Patient instructed that if blood glucose levels are <70 mg/dL, it would be appropriate to administer three glucose tablets or half glass of orange juice (not
“a few” glasses), recheck the blood glucose levels, and begin back with insulin when the hypoglycemia is resolved. Also, the number of units of the sliding scale are not able
to reduce the next blood glucose measurement appropriately, so will “tighten” the sliding scale to the following: <150 mg/dL no insulin aspart; 151–180 mg/dL, 2 units; 181–
210 mg/dL, 4 units; 211–240 mg/dL, 6 units; 241–280 mg/dL, 8 units; 281–310 mg/dL, 9 units; 310–350 mg/dL, 10 units; >350 mg/dL, 12 units.

Patient counseled to continue to check blood glucose levels as instructed before and try not to “miss” taking his bolus insulin. Also, discussed dietary and exercise goals and
only eating ice cream and other desserts with artificial sweeteners. Discussed not drinking “real” colas and substituting with those flavored with artificial sweeteners.
Discussed with patient about initiating an exercise plan as well, starting with 10–15 minutes every other day walking because he is usually very sedentary. Patient stated that
he would like to try to lose a pound per week, and would like to set this as his goal.

Patient verbalized understanding to all instructions. Plan for follow-up visit in 2 weeks and will proceed with plan to adjust insulin as needed at that time. Physician is also
being notified of this note and instructions to the patient as well.

Note that all of the information provided in this section is considered “general principles” of managing medication therapy. The specifics of the individualized
situation, patient, and provider interactions will dictate what the pharmacist can and should do. Also, keep in mind that general principles for medication
adjustment will change with the advancement of medication classes and research in diabetes management. The references in this chapter can also serve as a more

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thorough guide for those needing more nuances of medication adjustment in this area. Specific references that will be helpful include two position statements: one
from the ADA and EASD for management of hyperglycemia in type 2 diabetes, and one from the AACE regarding an algorithm for glycemic control.11,22

Clinic Initiation
Preparing Yourself for Clinic

Ensuring that pharmacists involved in diabetes care services are adequately prepared for expanding pharmaceutical care services is vital to pharmacist confidence,
practitioner buy-in, and patient adherence to program goals and appointments. Several credentialing options are available for pharmacists interested in initiating
pharmacist services. The American Pharmacists Association o ers a certificate training program entitled “The Pharmacist and Patient-Centered Diabetes Care” that
provides comprehensive training on medication therapy, lifestyle modifications, and hands-on training for devices and physical assessments.23 This program o ers
continuing education and a certificate for display and can help communicate additional training by the pharmacist to others.

Becoming a Certified Diabetes Educator (CDE) is perhaps the most recognized credential for health-care professionals participating in DSME. The National
Certification Board for Diabetes Educators grants certification to health-care professionals, providing diabetes education through a written examination o ered once
yearly in December. Licensed clinical psychologists, registered nurses, occupational therapists, optometrists, pharmacists, physical therapists, physicians (MD or DO),
and podiatrists are all eligible to sit for the CDE exam. Registered dieticians or health-care professionals with a master's degree or higher degree in social work are
also eligible. Before applying for the CDE exam, pharmacists or other health-care professionals must have completed a minimum of exactly 2 years of professional
practice experience and a minimum of 1000 hours of direct DSME experience (minimum of 40% of those hours accrued within the past 4 years. It is important to note
that performing diabetes-related duties as part of one's job are not considered DSME for the purposes of the CDE exam. For example, a pharmacist could not include
patient counseling for diabetes products, performed as part of normal dispensing duties, and as part of the DSME. A er passing the CDE exam, pharmacists would be
expected to document diabetes-related continuing education. Becoming a CDE would help with marketing of the services to other health-care practitioners because
it is highly recognized and the requirements are well known that helps to communicate to others the level of training, knowledge, and experience. As will be
discussed later, it can also be helpful in attaining site credentialing that can be instrumental in attaining payment for services.24

Board Certified-Advanced Diabetes Management Certification (BC-ADM) is another credentialing opportunity for registered nurses, registered dietitians, pharmacists,
physician assistants, and physicians who communicate an advanced level of practice within the actual management of people with diabetes, as opposed to the
education element of focus with the CDE credential. BC-ADM can be attained by written examination that is o ered twice yearly. In order to qualify for the exam,
pharmacists or other health-care professionals must meet licensing requirements mentioned above and must have completed at least 500 clinical practice hours
managing diabetes within the 48 months prior to the exam but a er receipt of degree or license. BC-ADM also helps to communicate your level of expertise and
experience managing the condition of diabetes to external stakeholders and patients. It is also helpful in attaining site certification.25

In addition to opportunities for credentialing, diabetes-related continuing education is vital for any pharmacist interested in diabetes pharmacy services.
Breakthrough research in diabetes is dynamic and it is essential to read the literature available in major medical journals, as well as in mass media. It is not
uncommon for patients to present to clinic with questions about a new FDA advisory or a new study seen on the morning news and pharmacists must be prepared to
answer questions within the context of the research to make informed, individualized recommendations, and decisions. When trusting relationships with referring
practitioners are built, physicians, nurse practitioners, or physician assistants may ask for the opinion of the pharmacist, especially when it is concerning new
medication information.

Specific journals that pharmacists may want to frequent could include those published by the ADA such as Diabetes, Diabetes Care and Clinical Diabetes.26 The
journal specifically targeted for diabetes educators, entitled The Diabetes Educator, is a source for innovation and research regarding DSME.27

Preparing Your Clinic for Diabetes Services

When preparing for new pharmacy diabetes services, the level of service will determine the amount of preparation needed and the up front investment required. For
example, if diabetes is to be included in existing MTM services, new brochures, handouts, models, and demonstration devices will be needed. If a collaborative
practice agreement is to be pursued with area practitioners, the pharmacist will most likely need to perform some POC testing in order to make informed
recommendations and decisions. For instance, if diabetes medications are to be initiated or dosing changes made, it will be important to be able to test A1C levels. If
pharmacists intend to initiate statins for lipid lowering and cardiac benefits, the pharmacist should be able to assess lipid panels. It is extremely important that a
plan for laboratory testing be made in order for adequate follow-up and therapeutic decisions to be made. This also helps improve continuity of care and
collaboration among the diabetes management team.

If POC testing is considered, several safety concerns must be considered. Simple low risk tests that can be performed without regulatory oversight in clinic o ices or
other settings are defined by the Clinical Laboratory Improvement Amendment of 1988 (CLIA) by level of complexity as waived, moderate complexity or high
complexity. The devices used in most pharmacies for lipid testing, blood glucose testing, and A1C testing are considered waived.28 When a pharmacy decides to
include CLIA-waived testing, an application must be made to the appropriate State Agency o ice of the Centers for Medicare and Medicaid Services (CMS). The CLIA
application form, CMS-116, is available from the CMS Web site and includes instructions and required fees for the certificate allowing the use of CLIA-waived
devices.29

The Occupational Safety and Health Administration (OSHA) and other individual state requirements for work environments incorporating CLIA-waived devices
should be consulted. The OSHA blood-borne pathogens standard applies to sites where employees may become exposed to blood or blood-borne illnesses.
Requirements include having a written plan for control of exposure, the use of universal precautions with any human blood or body fluid, the use of safety needles,
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the use of gloves and protective equipment, the provision of hepatitis B immunization at no cost to the employee, and safety training on handling blood and disposal
of biohazards.28 Therefore, some initial start-up costs will be encountered if these have not already been addressed when initiating another service such as
immunizations.

A er safety concerns have been addressed, attention can be turned to selection of devices for the purpose of the new service. At a minimum, the clinic should be
equipped with a blood pressure monitor (including several cu sizes) and scale. As mentioned, monitoring A1C and lipid levels are most likely required for
implementation of diabetes management via protocol. Pharmacists should consider the cost of the device itself, technical support, and the anticipated cost of each
test. These devices may be a costly initial investment but can produce a return on investment with appropriate practitioner and patient buy-in because the cost per
test is generally less than outside laboratory testing, usually o ers results within minutes and allows the patient to have one stop for testing, management, and
education.

Pharmaceutical sales representatives can be particularly helpful when stocking the patient care area because they can o en provide demonstration devices, blood
glucose meters, and injection cushions. O ice supplies, some charting system (electronic or paper), a table, and chairs will be minimally expected to begin diabetes
services.

Accreditation of diabetes education programs or sites can facilitate payment for services from third-party payers and Medicare. This may be a longer term goal for
start-up programs because accreditation standards include evidence of the program's success and patient charts. It would be prudent to review application
instructions and requirements to help initially structure the program if accreditation is an important goal. Becoming aware of the costs of accreditation applications
and maintenance of accreditation once attained will help pharmacists to develop a long-term budget with appointment and reimbursement goals. Currently, CMS
recognizes two national accrediting organizations and states that accreditation must be obtained in order to receive Medicare reimbursement for diabetes self-
management training (DSMT). The DSMT benefit for Medicare beneficiaries has been historically underutilized.30 The Diabetes Education Accreditation Program
(DEAP) is o ered through the American Association of Diabetes Educators31 and the ADA also o ers education recognition programs.32

Developing a Business Plan

Upon attainment of a su icient level of knowledge regarding diabetes care plus seeking credentialing, if needed, the pharmacist should critically observe his/her
resources, stakeholders, and potential for obtaining payment in order to build the optimal level of services provided for patients. The first aspect of developing the
plan is to view the overall community and assess the need for a diabetes service.

Environmental Scan

The first place to begin, of course, would be to assess the needs of patients in the pharmacy. The pharmacist should determine what percentage of patients obtains
refills for oral medications or insulin for diabetes. Which patients obtain equipment for self-monitoring of blood glucose levels, such as monitors and strips, and
which patients obtain insulin and needles—both through insurance and self-pay? Are many of the questions from the pharmacy's patrons regarding diabetes or
ancillary aspects of this disease state? Of the top 10 diseases targeted by MTM programs in 2010 and the percentage of programs that targeted each disease, diabetes
was the number one targeted disease state. Almost 97% of all MTM programs in 2010 targeted diabetes. If other pharmacies have not yet begun MTM services for
diabetes in the community, the need for this service is potentially very high. Even if local services specifically for diabetes exist in the community, due to the high
patient population with this disease state and the propensity of disease progression to lead to microvascular complications, there still may be great potential to
market such a service to outside stakeholders and to clients already obtaining services from the pharmacy.17 To evaluate the need further, other questions regarding
those already using the pharmacy's services could be:

What is the average number of medications for diabetes each person receives?
Over time, have the doses and/or need for multiple medications increased?
Over time, have patients added insulin therapy to their diabetes regimens?
Are people frequently not obtaining their filled prescriptions or delaying purchase due to cost?
Are the majority of prescriptions filled generally low-cost medications, or high-cost ones?
Do most of the patients receiving medications for diabetes have adequate insurance coverage?
Are diabetes supplies purchased in high volume at the pharmacy? If so, which ones?
What percentage of patients with diabetes receives four or more prescriptions? Six or more prescriptions?
What percentage of patients with diabetes is enrolled in Medicare programs?
What percentage of patients with diabetes has other concomitant disease states that would meet the eligibility criteria for MTM programs (i.e., hypertension, heart
failure, dyslipidemia, respiratory diseases such as asthma or chronic obstructive pulmonary disease, arthritis, or mental disorders such as depression, schizophrenia,
or bipolar disorder)?
Who are the prescribers for all of the patients with diabetes? Do certain prescribers tend to write higher priced prescriptions that the patients cannot purchase due to
price?
What percentage of patients with prescriptions for diabetes-related supplies and medications also obtain prescriptions for hypertension and dyslipidemia? What
percentage of these patients receives six or more prescriptions?
What percentage of patients with prescriptions for diabetes-related supplies and/or medications also smokes? Take aspirin?
What percentage of these patients has presented discharge prescriptions from a local hospital within the past year?

These and other questions cover barriers that patients with diabetes have in filling their medications. They will give the pharmacist insight as to which direction
he/she should go in enlisting outside stakeholders in the diabetes service, and what actual services should be provided.17,33

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Support from External Stakeholders

The successful pharmacist in the community already knows the importance of building and keeping good relationships with patients, physicians, and other health-
care providers within the community. Long-standing patients with the pharmacy should already be supportive of MTM services that could be provided. They may
have a need (either an actual need or perceived need) for various levels of services. The ones needing in-depth services are more likely the ones with whom the
pharmacist has already spent much time answering questions. Alternatively, answering the questions above could also reveal the clients most likely to need these
services.

Relationships already built with physicians and other health-care providers would be a reasonable starting point for marketing MTM services for patients with
diabetes. If the pharmacy already has a collaborative practice agreement with physicians in some other aspect, such as with giving immunizations, this would be an
optimal situation. If not, MTM services for patients with diabetes still are highly marketable for pharmacists. In the past, physicians may have been skeptical of
pharmacist-based services due to the potential for competition. However, the prudent pharmacist will market his/her services by making it clear that a true
collaboration is being sought with the physician. The aspect of being able to provide continuity of care could be lucrative to some physicians, especially if the
physician expresses concern that not enough time is available to provide all the counseling and education that the patients need.17,20

A face-to-face discussion with the physician, preferably away from the clinic during a lunch or dinner, would be the most optimal way to pitch the potential MTM
services. Concentrate the discussion on the services that could be provided and how the therapeutic goals for diabetes could be achieved (i.e., A1C to goal by
concentrating on ADA recommendations, and decreasing the likelihood of patients developing microvascular complications). Many physicians are frustrated by their
patient load and the fact that they usually do not have the amount of time to spend with each patient that they would like.20 In addition to discussing potential
medication management aspects, the pharmacist should discuss the counseling and education that they could o er to assist with behavioral modification e orts.
The physician should be able to appreciate the amount of time that is needed with patients to assist them with proper education and behavioral modification for
diabetes. Having a sample of patient-education handouts, computer monitoring programs, and how communication would take place with the physician (i.e.,
documentation system) about the patients would be helpful during the conversation. Be prepared to discuss recent and landmark studies (if the physician brings
this up), ADA recommendations, and an example of MTM scenario. However, do not inundate the physician with vast, unnecessary information. Rather, keep the
discussion focused and always make sure that he/she knows that you simply want to collaborate for the overall good of the patients' health. Also, keep in mind that
physicians may be sensitive that medication changes will not be made just from a “cost” standpoint. Some may already feel that they have to field too many requests
from pharmacists and third-party providers to change prescriptions to a lower cost alternative. They may feel that the alternatives are not as good of a therapeutic
choice as the original prescription written. Finally, do not forget clinic support sta . Nurses could readily identify potential patients that need more intense
instruction about diabetes, and could be a valuable resource as MTM services are being built.20

Some pharmacists new to providing MTM services have the impression that they must have all physicians in the community “on board” before services can be
adequately provided. This is not true. O en, pharmacists find that if one physician will “buy-in” to the MTM concept and begin sending patients, early successes can
lead to burgeoning MTM services. Remember the advertising adage that “word of mouth” is the best advertisement. This is true with providing valuable MTM
services, because that physician will become a “champion” for the pharmacist. This will lead to enrolling more of that physician's patients, and other patients as well
when word spreads to other providers in the community.

Levels of Services

The pharmacist should consider which level of service that will be o ered upon the thorough needs analysis regarding the patient population of the clinic. Aspects
that should be considered include the overall needs of current patients in the community and pharmacy, referral services through physicians and other health-care
providers, ability to provide MTM services, and other considerations. Of course, multiple levels of services could be o ered dependent on varying needs of potential
patients. Services could take the form of intensive counseling sessions (individualized or group), sales of durable medical equipment (diabetes self-monitoring
equipment) and related training, and MTM with or without collaborative practice agreements.

Pricing Diabetes Services

As mentioned in other chapters, correct pricing of services helps ensure successful implementation of any pharmacy service. As mentioned in Chapter 5, direct cost
of services o ered can be calculated with the following formula (Table 11-3):

Cost = SAL + MAT = NDC + OHC34

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Table 11-3. Cost = SAL + MAT + NDC + OHCRupp

Legend Table 11-3

SAL: Salary of all personnel

MAT: Materials, supplies, equipment and variable costs

NDC: Non-salary direct fixed costs

OHC: Rent and non-rent overhead costs

The most important di erence in calculating the cost of providing diabetes services as opposed to asthma services is the cost of equipment that would be
considered direct fixed costs. Examples of this include a Cholestech LDX cassette for assessing lipid panels, meter test strips, and A1C testing supplies. Because this
testing is not required at every visit, pharmacists can consider marketing it as a separate fee from the diabetes management service. For example, if a patient is
recently diagnosed or is discovered to have an elevated A1C at an o ice visit, it is important to communicate to referring practitioners and include the most recent
lab results with the referral. This will prevent unnecessary retesting costs for the patient and can help the pharmacist have more informed ideas about medication
recommendations or initiations before the patient arrives for the first appointment.

As with any business plan, it is important to recognize the price of diabetes services o ered in other clinics, pharmacies, or surrounding institutions when deciding
appropriate pricing strategies. It is not always necessary to undercut a competitor's price, but it is always necessary to di erentiate a new service from what
consumers already have available.

Marketing

Marketing of external stakeholders like local family medicine clinics or practitioners with established pharmacy relationships is the best first step when marketing a
new service. Sometimes practitioners can be concerned that pharmacies o ering POC testing can decrease patient visits to the practitioner or decrease lab revenue.
It is crucial to correctly communicate through marketing and practitioner calls that pharmacist-provided services are collaborative and will not interfere with the
practitioner–patient relationship. Be very clear about which POC testing will be o ered, the benefits of it, and which laboratory testing will require a follow-up visit to
the practitioner or lab. If collaborative practice agreements are developed, this needs to be clearly defined. Practitioners who are interested in a more traditional
MTM relationship in which recommendations are o ered and reviewed by the practitioner a er each patient visit should also be targeted for marketing. If MTM is a
newer concept, this marketing should occur as early in the process as possible to help ensure acceptance of recommendations and continued referrals.

Many times marketing of new pharmacy services can begin by scanning our own environment. Most pharmacies have return patients and it is important to make
them feel important every time they walk through the pharmacy door. Patients who have had a specific question, needed help with a co-pay coupon, or just were not
sure about a new medication until the pharmacist took the time to discuss it with them are prime targets for marketing of new services. Social media is becoming
ever more important for all business. Encourage patients to “like” your business Facebook page or follow your Twitter account. Use this opportunity to advertise to
your own patients about new diabetes services. More traditional marketing tools such as recorded messages that are played when a call is on hold, posters, and bag
stu ers can be e ective tools for marketing of a pharmacy's own patient base.

Having a “kick o ” day or “grand opening” event for a new diabetes clinic is an excellent way to attract attention. Plan your event on a day mid-week when the
pharmacy or clinic is adequately sta ed to handle the normal workload. Sales representatives for blood glucose testing devices will o en provide signage and bring
meters for patients to trade in older models. Partnering with a school of pharmacy for student pharmacists to provide glucose and blood pressure screenings can
help ensure that the event is accessible to a crowd. O en, student pharmacist organizations need service projects like these type of events or American Pharmacist
Month projects and are willing to help local pharmacies while gaining patient care experience.

Methods of Payment

Diabetes costs Medicare a significant amount of money that makes it a targeted disease state for MTM. Some Medicare patients are eligible for MTM services through
their Medicare Part D prescription drug plans. There are specific eligibility criteria including, but not limited to an amount spent on medications per year, number of
medications, and number of disease states. Because there are many di erent Part D plans, eligibility also varies.35 Each year Medicare sets standards for drug plan
providers to adhere to in order to try and limit the variability between plans and allow for more patients to benefit from these services. Pharmacies can easily
identify eligible patients by contracting with an MTM provider who refers patients to them based on location. Depending on the state, Medicaid and some third
parties will pay for MTM services. Before setting up the appointment, discuss and review with the patient the possible price of service and hold them responsible for
payment regardless if insurance will pay for services. An example of a form used to hold patients responsible for payment can be viewed in Fig. 11-1. The pharmacy
or the patient should call the insurance company to find out their eligibility criteria and guidelines for reimbursement.

Figure 11-1.

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Noncovered services waiver.

In some cases, state-specific Medicare Part B provides coverage for DSME. Requirements for coverage can vary but, in general, cover sessions provided by CDEs.
These visits are billed in 30-minute increments and require referral by a provider specifying a patient's need for this type of service.36 Medicare also covers di-abetes-
related supplies such as blood glucose meters strips, lancets, needles, pen needles, and diabetic shoes.

Pharmacists can also use a fee-for-service or sliding scale for payment. Using one of these methods allows the pharmacist or pharmacy to set fees and obtain
payment without administration of insurance claims. Challenges with this method may include the patient's inability or resistance to pay out-of-pocket. Thoroughly
explaining the benefit of this service and getting patient buy-in prior to the visit may be ways to overcome these issues. Pharmacists should thoroughly research
what is available in the area and patient perception of the appropriate value of the service being provided.

Advocacy by pharmacy organizations and national health-care entities to increase recognition of pharmacists as a provider according to CMS is ongoing and
improving.37 In December 2011, the U.S. Public Service released a report called “Improving Patient and Health System Outcomes through Advanced Pharmacy
Practice.” This report provided evidence and examples of advanced pharmacy practice models that further promote the importance of pharmacists to be recognized
as providers. It also discusses compensation and health-care reform that is necessary to continue advancing pharmacy. It is important for pharmacists to continue to
demonstrate evidence of the value we bring to patient care and demonstrate the unique addition of a pharmacist's training especially in the care of patients with
diabetes.38,33

Clinical Service Design and Collaborative Practice Agreements

Evaluation of the clinical service design should be developed synergistically with the collaborative practice agreement. Elements provided with the clinical service
should be as cohesive as possible with the prescribers who will refer patients to the MTM service. The pharmacist should consider all aspects of an agreement for
patient referral, how and for whom MTM services will be provided at the pharmacy, and the method of discharging patients from the MTM service. Even if a
collaborative practice agreement is not implemented with a particular physician, the pharmacist can still make written and faxed recommendations regarding the
discussion of lifestyle interventions with the patient and possible medication therapy adjustments. Ultimately, though, pursuing a collaborative practice agreement
with physicians is advisable. Such an agreement formalizes the pharmacist–physician relationship and the fact that they are both part of the health-care team. It can
serve as the foundation for a great clinical relationship with the physician. It also allows MTM to be performed within a certain scope of practice with which both

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pharmacist and physician are comfortable, and defines those activities within the MTM concept. An example of a collaborative practice agreement can be found in
Figure 11-2.

Figure 11-2.

Example of a collaborative practice agreement for medication therapy management services in diabetes.

Design of the service will depend on the level of service being provided and whether education will take place in an individual or group format. For example, sessions
for single patients may take place at regularly scheduled visits and cover highly individualized counseling and medication management sessions to achieve

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therapeutic goals. In contrast, group diabetes counseling sessions could be conducted for a specifically identified group of patients, such as those newly diagnosed
with diabetes or those needing escalation to insulin therapy. Alternatively, physicians could be encouraged to refer patients who continue to have poor glycemic
control (e.g., >9 or 10%) for a year or more a er starting treatment.

The group sessions could be mainly educational in nature with certain subjects discussed at each session. Group sessions are beneficial especially for those newly
diagnosed with diabetes because initial education can be very similar. Also, patients have common questions and can learn from one another. Another advantage of
group sessions is that patients develop a rapport with each other and provide support and accountability as they make behavioral changes in their diet and exercise
regimen. An example of topics for di erent sessions of a continuous group program for patients newly diagnosed with diabetes could include an overview of
diabetes, setting attainable short-term and long-term goals, the need for A1C measurements, blood glucose self-monitoring, diet and nutrition, starting an exercise
regimen, how to take medications appropriately, and the need for follow-up with a diabetes care team.

A specific procedure should be developed for referral and provision of MTM services. When collaborating with a physician, there should be an understanding in
writing (usually a protocol within a collaborative practice agreement) regarding how the patient will be referred for the MTM services and who will be the most likely
candidates (e.g., patients with A1C >9%, newly diagnosed diabetes). An understanding between collaborators should be established regarding specific goals for the
series of MTM visits, preferably with written goals at the time of the referral. The physician should also provide a thorough but pertinent history for the patient,
including the present list of medications. A baseline A1C and most recent blood glucose levels as determined in clinic should be included in the referral, along with
documentation of a diabetes diagnosis. The pharmacist should then take a thorough history, including the past medical history, family history, social history,
medication use history, current disease presentation, and review of systems. The pharmacist should take basic physical assessment measurements, including vital
signs and foot examination with monofilament testing. Laboratory monitoring should be conducted either through the patient's provider with appropriate
communication to the pharmacist, or through POC testing. POC testing could be used to determine fasting blood glucose levels and A1C at the time of the MTM visit.

The pharmacist could be authorized to modify diabetes medications, depending on specific state laws and the scope of the collaborative practice agreement. The
pharmacist should either contact the physician with specific recommendations or modify medications during the MTM visit. Communication is key regardless of the
method of performing MTM, with proper documentation and consent by both the physician and the patient. If the pharmacist is allowed to alter medications, the
physician entering into the collaborative practice agreement may be comfortable with allowing this to occur according to national guideline standards, or a certain
protocol may be required.

The collaborative practice agreement should specify how documentation should be used. If the pharmacist is allowed authority to change doses of medications, this
should be documented and sent to the physician in a timely manner. This is also true if the pharmacist is only allowed to make recommendations, of course.
However, a clear understanding as described through the agreement should stress expediency with which this should occur—especially how recommendations
should be implemented with the patient.

Finally, if the MTM services are individualized and not performed as a group education class only, the collaborative practice agreement should include the system of
patient referral back to the provider. Remember that continuity of care is paramount. Ultimately, the provider does not want MTM services to replace his/her service,
but rather they should be in addition to physician visits. Thus, the agreement should specify at what point the patient will be formally referred back to the physician
for all services, and when the MTM services will be complete. Optimally, this referral will take place when the goals for A1C and other cardiovascular risk parameters
(e.g., goal blood pressure and cholesterol panel) have been achieved through MTM services.

Putting It All Together: Patient Case

LU is a 47-year-old Caucasian man with type 2 diabetes who presents to clinic for initial diabetes management at the diabetes clinic. Patient was first diagnosed in
2004 a er having blurry vision, increased thirst, and a random blood glucose of 400 mg/dL. LU has noticed increased fatigue and thirst over past 4–5 days. He has not
been checking blood glucose very o en in past 2–3 months. LU is currently taking metformin 500 mg twice daily, glimepiride 4 mg twice daily a er meals, and HCTZ
25 mg daily. He reports tolerating all medications. LU is walking about twice per week for 30 minutes at a time. LU is aware his A1C is very high and asks if he will have
to start insulin. He said that he wants his diabetes to be better controlled and is willing to do whatever it takes.

24-hour dietary recall:

Breakfast—1 cup of cheerios with milk, 1 large banana, 8 ounces of orange juice, 1 piece of toast with a teaspoon of jelly, co ee with sugar substitute
Lunch—1 turkey sandwich with cheese and mustard, small bag of baked lays, water
Snack—peanut butter crackers (2–3 crackers)
Supper—baked chicken breast, 2/3 cups of macaroni and cheese, small piece of cornbread, 1/2 cup peas, 8 ounces of sugar-sweetened soda

Lab data:

BP: 134/78 mm Hg
BMI: 34.7 (Wt: 256 lbs., Ht: 72 inches)
A1C: 10.7%
Fasting blood glucose: 220 mg/dL
Fasting lipid panel: TC 131, LDL 130, HDL 30, TG 178
SCr: 1.1 mg/dL
UACR: 200 mg/g
AST/ALT: WNL

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What is this LU's goal A1C?

<7% (per ADA guidelines) or <6.5% (per ACE/AACE guidelines)

What changes would you recommend today?

Start Lantus 20 units qhs due to extremely high A1C. In order to determine a starting dose of insulin, one method is to use weight-based dosing and estimate 0.2
units/kg for a patient with type 2 diabetes. When adding insulin you may reduce the dose of sulfonylurea in order to decrease chance for hypoglycemia. In this case,
one may decrease glimepiride to 2 mg bid AC when adding Lantus.
Increase metformin to 1000 mg bid.
Add lisinopril 5 mg daily. May add an ACE inhibitor or ARB for renal protection due to (+) microalbuminuria and for blood pressure control (goal <140/80 mm Hg).
Start atorvastatin 10 mg daily, since patient has diabetes, his LDL goal would be at least <100 mg/dL. For some patients, atorvastatin may not be covered well on
insurance or the patient may not have prescription coverage. If this is the case, then pravastatin 40 mg qhs would be a great option for the patient.

What education would you give to LU today?

Counsel him on taking glimepiride right before or with the first bite of food at breakfast and supper to decrease risk of hypoglycemia.
Discuss dietary changes, such as eliminating sugary drinks (soda, orange juice) and switch to water, diet drinks, or other drinks with sugar substitute; also LU is
eating too many carbohydrates at breakfast and supper (>100 g of carbohydrates at breakfast, and >90 at supper). As a general guide to counting carbohydrates, men
should aim for 4–5 servings of carbohydrates per meal while women should aim for 3–4 servings. One serving of carbohydrates equals 15 g of carbohydrate, so LU
should aim for 60–75 g per meal; however, his goal may be 45–60 g per meal if he is trying to achieve weight loss.
Encourage patient to increase activity gradually to 5 days per week as tolerated.

Summary Points
Nearly 25.8 million people (8.3% of the U.S. population) have diabetes, of which nearly 7 million remain undiagnosed. Billions are spent yearly on health-care costs
directly and indirectly attributable to diabetes and its complications, but studies such as the Ashville Project have reduced costs and optimized outcomes. Thus,
pharmacists providing MTM services have considerable potential to attenuate the impact of diabetes on the patient population.
Although the overall goal of diabetes management for most patients is to decrease the A1C to <7%, the pharmacist should try to achieve specific goals for
concomitant disease states such as hypertension, dyslipidemia, and other cardiovascular diseases.
Essential counseling points include action to take when experiencing hypoglycemia and hyperglycemia, medical nutrition therapy, exercise, medication use and
adherence, self-management with checking blood glucose readings, sick day management, proper foot care, and insulin injection technique and storage (if
applicable).
Oral agents, starting with metformin, can be e ective in reducing the A1C in most patients and can be advanced to dual or triple therapy if needed—except for those
with a high baseline A1C who are not likely to achieve goal through oral medication therapy. In these cases, insulin therapy should be started and titrated to achieve
A1C goals.
For pharmacists wanting to start MTM services in diabetes, becoming credentialed as a CDE® or BC-ADM is helpful (especially for obtaining reimbursement for
services), but not essential.
When starting MTM services for patients with diabetes, factors that should be considered include developing a business plan, obtaining stakeholder support,
deciding what level of services would be provided, how payment for services will be obtained, design of the service itself, and how collaborative practice agreements
need to be implemented.

Expert Interview—Diabetes Management Services

ELISA Greene, PharmD

Clinical Pharmacist

Assistant Professor, Pharmacy Practice

Belmont University College of Pharmacy

Nashville, TN

Siloam Family Health Centeris a faith-based, nonprofit clinic focused on providing a ordable, whole person care to those in need. We serve uninsured patients in
Middle Tennessee, over 80% of whom are immigrants or refugees. Siloam Family Health Center uses a multidisciplinary approach involving social work, behavioral
health, pastoral care, and clinical pharmacy working along with physicians, nurses, and nurse practitioners to provide patients with quality care.

What unique qualities do you believe pharmacists bring to a diabetes management team?

Pharmacists have extensive training in pharmacology, interpreting literature, and in managing patients with complex medication regimens. We are in a profession
that generally enjoys collaboration and naturally seeks the patient's best interests. Additionally, we are conscious of the many barriers to patient adherence, and
recognize that the best therapeutic option is one that the patient agrees to use. Because of these characteristics, diabetes management and pharmacy fit naturally
together. A pharmacist in this position can o en spend more time on patient education, and learning their needs, fears and beliefs, than would be possible in a
typical o ice visit.
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How is the clinic constructed in order to make recommendations?

We have worked out a system that suits the provider's preferences. It involves any recommendation being made in writing through the “task” function in the
electronic medical record. This links the recommendation to a specific provider and patient, shows up in the providers “to do” list, but is not part of the permanent
record. It also allows the providers to communicate back and forth, electronically, with any follow-up suggestions or questions. Per the request of the other health-
care providers on my team, I always follow up a written recommendation with a face-to-face notification. This part may be brief or more in-depth, depending on the
circumstances. Additionally, there are more formal consults that can be initiated by me or by another provider and involve documentation in the EMR, either in
preset templates or free-text fields.

How is the clinic compensated for the pharmacist's time?

The clinic has a contract with Belmont University COP, which is my o icial employer and pays my salary. Since this site serves uninsured patients, funding comes
largely from donors and grants, in addition to some governmental programs. There is no direct reimbursement or billing by the clinic for my services for these two
reasons.

What barriers did you encounter in implementing diabetes services? How did you overcome them?

When I began at my clinic, very few, if any, of the other members of the health-care team had personal experience working with a clinical pharmacist. This in itself
was a barrier, as I had to educate them on my background and training, what I hoped to implement, di erent models of providing interdisciplinary care,
collaborative practice agreements, and how I, as a pharmacist, could help them provide quality patient care. Building relationships, accepting slow progress and
small advances, and being willing to help wherever needed in the beginning went a long way in establishing myself as a valuable contributor. Another barrier was the
limitation of physical space. Initially, a closet area was cleared out and renovated to provide workspace and a consultation area. However, it continues to be a high-
tra ic multipurpose area. We are working around this limitation by being flexible and accommodating in meeting with patients in exam rooms or the consultation
area as needed. Other providers are also respectful of the shared space and recognize that on occasions when the door is closed, the situation calls for privacy. A
third barrier involves working within an organizational structure; anytime there are changes, implementation is slow, and there are di erent perceptions of the best
direction to take when working out the details. I have taken the approach that we are all working for the same goal—implementing focused diabetes services to
better care for our patients—and have been willing to compromise on some of the details of my exact role and the timing when patient care will not be compromised.

What were your personal struggles when you first started diabetes management services?

I struggled with accepting that every practice is di erent, and what works at one clinic may not be the best model in another. I had to find a balance between what I
had previously seen and been a part of versus acknowledging that there were many di erent ways we could reach the goal of improving patient care. Also, it was a
di icult at first, as the “new kid on the block,” to know when to push and when to compromise when barriers arose. Another struggle somewhat unique to my (or
similar) sites was the language barrier present with non-English-speaking patients. I had to adjust my style to accommodate low levels of health literacy and
interpreter services, which can really change the flow of an interaction.

What barriers did you experience while building relationships with providers?

I was blessed to come into a situation where the providers unanimously welcomed me. Some of the challenges came with educating them about what I was able to
contribute, how they could best use my services, and incorporating me into the flow of the clinic. With everyone being stretched by their patient load and other
responsibilities, there was not a copious amount of time for us to get to know each other initially. Over time, through many shorter conversations between meetings
or patients, occasional shared lunches, identifying common interests or goals, and even beginning to socialize outside of clinic hours, our relationships have been
strengthened. Being available and willing to help, taking the initiative to meet a need, and seeking feedback from them were also ways that I was able to win their
trust.

How is quality assessed in your clinic?

For diabetes, quality is assessed by the percentage of patients meeting the standards of care for diabetes (A1C <7%, LDL <100 mg/dL, ASA if indicated, BP <130/80
mm Hg, annual retinopathy screen, on an ACE-i/ARB, if no contraindication). A previous assessment revealed that our clinic was in line with national averages for
similar settings, which resulted in our push for improvement and implementation of more specific diabetes services (some of which are still in progress).

Were there any unexpected outcomes a er initiating diabetes services?

Once providers realized how much time I could save them by providing diabetes services, especially with initial diagnosis, glucometer education, and insulin
initiation, they began to seek me out more for these services. Additionally, they began to be creative with thinking of other ways to use my services in other areas as
well. One component of my services is beginning to assess and document health literacy in our patients with diabetes. An unexpected outcome with this is that
patients who have performed well on the health literacy assessment have o en reported learning from weight watchers. This has prompted us to look into how we
may be able to partner with them in using some of their materials in providing nutrition information to our patients.

What intangible benefits have you or your sta enjoyed from starting this service?

There is an enhanced sense of camaraderie and teamwork. Whether curbside or formal, consults are more frequent and well received. Having the vision of improving
care in this specific area has helped unite us.

What tips can you give for someone who is planning to start diabetes management services?

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Start with a plan and clear goals, know your population and your providers, be willing to compromise on unessential details, be open-minded, don't be discouraged
if the going is slow, especially at first, be persistent with identifying particular patients who may be candidates for your services and volunteering, even in a small
way, to contribute to their care.

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