The specialized role of nursing in the care and education of people with diabetes has been in existence for more than 30 years. Diabetes education carried out by nurses has moved beyond the hospital bedside into a variety of health care settings. Among the disciplines involved in diabetes education, nursing has played a pivotal role in the diabetes team management concept. This was well illustrated in the Diabetes Control and Complications Trial (DCCT) by the effectiveness of nurse managers in coordinating and delivering diabetes self-management education. These nurse managers not only performed administrative tasks crucial to the outcomes of the DCCT, but also participated directly in patient care.1
The emergence and subsequent growth of advanced practice in nursing during the past 20 years has expanded the direct care component, incorporating aspects of both nursing and medical care while maintaining the teaching and counseling roles. Both the clinical nurse specialist (CNS) and nurse practitioner (NP) models, when applied to chronic disease management, create enhanced patient-provider relationships in which self-care education and counseling is provided within the context of disease state management. Clement2 commented in a review of diabetes self-management education issues that unless ongoing management is part of an education program, knowledge may increase but most clinical outcomes only minimally improve. Advanced practice nurses by the very nature of their scope of practice effectively combine both education and management into their delivery of care.
Operating beyond the role of educator, advanced practice nurses holistically assess patients’ needs with the understanding of patients’ primary role in the improvement and maintenance of their own health and wellness. In conducting assessments, advanced practice nurses carefully explore patients’ medical history and perform focused physical exams. At the completion of assessments, advanced practice nurses, in conjunction with patients, identify management goals and determine appropriate plans of care. A review of patients’ self-care management skills and application/adaptation to lifestyle is incorporated in initial histories, physical exams, and plans of care.
Many advanced practice nurses (NPs, CNSs, nurse midwives, and nurse anesthetists) may prescribe and adjust medication through prescriptive authority granted to them by their state nursing regulatory body. Currently, all 50 states have some form of prescriptive authority for advanced practice nurses.3 The ability to prescribe and adjust medication is a valuable asset in caring for individuals with diabetes. It is a crucial component in the care of people with type 1 diabetes, and it becomes increasingly important in the care of patients with type 2 diabetes who have a constellation of comorbidities, all of which must be managed for successful disease outcomes.
Many studies have documented the effectiveness of advanced practice nurses in managing common primary care issues.4 NP care has been associated with a high level of satisfaction among health services consumers. In diabetes, the role of advanced practice nurses has significantly contributed to improved outcomes in the management of type 2 diabetes,5 in specialized diabetes foot care programs,6 in the management of diabetes in pregnancy,7 and in the care of pediatric type 1 diabetic patients and their parents.8,9 Furthermore, NPs have also been effective providers of diabetes care among disadvantaged urban African-American patients.10 Primary management of these patients by NPs led to improved metabolic control regardless of whether weight loss was achieved.
The following case study illustrates the clinical role of advanced practice nurses in the management of a patient with type 2 diabetes.
A.B. is a retired 69-year-old man with a 5-year history of type 2 diabetes. Although he was diagnosed in 1997, he had symptoms indicating hyperglycemia for 2 years before diagnosis. He had fasting blood glucose records indicating values of 118–127 mg/dl, which were described to him as indicative of “borderline diabetes.” He also remembered past episodes of nocturia associated with large pasta meals and Italian pastries. At the time of initial diagnosis, he was advised to lose weight (“at least 10 lb.”), but no further action was taken.
Referred by his family physician to the diabetes specialty clinic, A.B. presents with recent weight gain, suboptimal diabetes control, and foot pain. He has been trying to lose weight and increase his exercise for the past 6 months without success. He had been started on glyburide (Diabeta), 2.5 mg every morning, but had stopped taking it because of dizziness, often accompanied by sweating and a feeling of mild agitation, in the late afternoon.
A.B. also takes atorvastatin (Lipitor), 10 mg daily, for hypercholesterolemia (elevated LDL cholesterol, low HDL cholesterol, and elevated triglycerides). He has tolerated this medication and adheres to the daily schedule. During the past 6 months, he has also taken chromium picolinate, gymnema sylvestre, and a “pancreas elixir” in an attempt to improve his diabetes control. He stopped these supplements when he did not see any positive results.
He does not test his blood glucose levels at home and expresses doubt that this procedure would help him improve his diabetes control. “What would knowing the numbers do for me?,” he asks. “The doctor already knows the sugars are high.”
A.B. states that he has “never been sick a day in my life.” He recently sold his business and has become very active in a variety of volunteer organizations. He lives with his wife of 48 years and has two married children. Although both his mother and father had type 2 diabetes, A.B. has limited knowledge regarding diabetes self-care management and states that he does not understand why he has diabetes since he never eats sugar. In the past, his wife has encouraged him to treat his diabetes with herbal remedies and weight-loss supplements, and she frequently scans the Internet for the latest diabetes remedies.
During the past year, A.B. has gained 22 lb. Since retiring, he has been more physically active, playing golf once a week and gardening, but he has been unable to lose more than 2–3 lb. He has never seen a dietitian and has not been instructed in self-monitoring of blood glucose (SMBG).
A.B.’s diet history reveals excessive carbohydrate intake in the form of bread and pasta. His normal dinners consist of 2 cups of cooked pasta with homemade sauce and three to four slices of Italian bread. During the day, he often has “a slice or two” of bread with butter or olive oil. He also eats eight to ten pieces of fresh fruit per day at meals and as snacks. He prefers chicken and fish, but it is usually served with a tomato or cream sauce accompanied by pasta. His wife has offered to make him plain grilled meats, but he finds them “tasteless.” He drinks 8 oz. of red wine with dinner each evening. He stopped smoking more than 10 years ago, he reports, “when the cost of cigarettes topped a buck-fifty.”
The medical documents that A.B. brings to this appointment indicate that his hemoglobin A1c (A1C) has never been <8%. His blood pressure has been measured at 150/70, 148/92, and 166/88 mmHg on separate occasions during the past year at the local senior center screening clinic. Although he was told that his blood pressure was “up a little,” he was not aware of the need to keep his blood pressure ≤130/80 mmHg for both cardiovascular and renal health.11
A.B. has never had a foot exam as part of his primary care exams, nor has he been instructed in preventive foot care. However, his medical records also indicate that he has had no surgeries or hospitalizations, his immunizations are up to date, and, in general, he has been remarkably healthy for many years.
A physical examination reveals the following:
Weight: 178 lb; height: 5′2″; body mass index (BMI): 32.6 kg/m2
Fasting capillary glucose: 166 mg/dl
Blood pressure: lying, right arm 154/96 mmHg; sitting, right arm 140/90 mmHg
Pulse: 88 bpm; respirations 20 per minute
Eyes: corrective lenses, pupils equal and reactive to light and accommodation, Fundi-clear, no arteriolovenous nicking, no retinopathy
Lungs: clear to auscultation
Heart: Rate and rhythm regular, no murmurs or gallops
Vascular assessment: no carotid bruits; femoral, popliteal, and dorsalis pedis pulses 2+ bilaterally
Neurological assessment: diminished vibratory sense to the forefoot, absent ankle reflexes, monofilament (5.07 Semmes-Weinstein) felt only above the ankle
Results of laboratory tests (drawn 5 days before the office visit) are as follows:
Glucose (fasting): 178 mg/dl (normal range: 65–109 mg/dl)
Creatinine: 1.0 mg/dl (normal range: 0.5–1.4 mg/dl)
Blood urea nitrogen: 18 mg/dl (normal range: 7–30 mg/dl)
Sodium: 141 mg/dl (normal range: 135–146 mg/dl)
Potassium: 4.3 mg/dl (normal range: 3.5–5.3 mg/dl)
• Total cholesterol: 162 mg/dl (normal: <200 mg/dl)
• HDL cholesterol: 43 mg/dl (normal: ≥40 mg/dl)
• LDL cholesterol (calculated): 84 mg/dl (normal: <100 mg/dl)
• Triglycerides: 177 mg/dl (normal: <150 mg/dl)
• Cholesterol-to-HDL ratio: 3.8 (normal: <5.0)
AST: 14 IU/l (normal: 0–40 IU/l)
ALT: 19 IU/l (normal: 5–40 IU/l)
Alkaline phosphotase: 56 IU/l (normal: 35–125 IU/l)
A1C: 8.1% (normal: 4–6%)
Urine microalbumin: 45 mg (normal: <30 mg)
Based on A.B.’s medical history, records, physical exam, and lab results, he is assessed as follows:
Uncontrolled type 2 diabetes (A1C >7%)
Obesity (BMI 32.4 kg/m2)
Hyperlipidemia (controlled with atorvastatin)
Peripheral neuropathy (distal and symmetrical by exam)
Hypertension (by previous chart data and exam)
Elevated urine microalbumin level
Self-care management/lifestyle deficits
• Limited exercise
• High carbohydrate intake
• No SMBG program
Poor understanding of diabetes
A.B. presented with uncontrolled type 2 diabetes and a complex set of comorbidities, all of which needed treatment. The first task of the NP who provided his care was to select the most pressing health care issues and prioritize his medical care to address them. Although A.B. stated that his need to lose weight was his chief reason for seeking diabetes specialty care, his elevated glucose levels and his hypertension also needed to be addressed at the initial visit.
The patient and his wife agreed that a referral to a dietitian was their first priority. A.B. acknowledged that he had little dietary information to help him achieve weight loss and that his current weight was unhealthy and “embarrassing.” He recognized that his glucose control was affected by large portions of bread and pasta and agreed to start improving dietary control by reducing his portion size by one-third during the week before his dietary consultation. Weight loss would also be an important first step in reducing his blood pressure.
The NP contacted the registered dietitian (RD) by telephone and referred the patient for a medical nutrition therapy assessment with a focus on weight loss and improved diabetes control. A.B.’s appointment was scheduled for the following week. The RD requested that during the intervening week, the patient keep a food journal recording his food intake at meals and snacks. She asked that the patient also try to estimate portion sizes.
Although his physical activity had increased since his retirement, it was fairly sporadic and weather-dependent. After further discussion, he realized that a week or more would often pass without any significant form of exercise and that most of his exercise was seasonal. Whatever weight he had lost during the summer was regained in the winter, when he was again quite sedentary.
A.B.’s wife suggested that the two of them could walk each morning after breakfast. She also felt that a treadmill at home would be the best solution for getting sufficient exercise in inclement weather. After a short discussion about the positive effect exercise can have on glucose control, the patient and his wife agreed to walk 15–20 minutes each day between 9:00 and 10:00 a.m.
A first-line medication for this patient had to be targeted to improving glucose control without contributing to weight gain. Thiazolidinediones (i.e., rosiglitizone [Avandia] or pioglitizone [Actos]) effectively address insulin resistance but have been associated with weight gain.12 A sulfonylurea or meglitinide (i.e., repaglinide [Prandin]) can reduce postprandial elevations caused by increased carbohydrate intake, but they are also associated with some weight gain.12 When glyburide was previously prescribed, the patient exhibited signs and symptoms of hypoglycemia (unconfirmed by SMBG). α-Glucosidase inhibitors (i.e., acarbose [Precose]) can help with postprandial hyperglycemia rise by blunting the effect of the entry of carbohydrate-related glucose into the system. However, acarbose requires slow titration, has multiple gastrointestinal (GI) side effects, and reduces A1C by only 0.5–0.9%.13 Acarbose may be considered as a second-line therapy for A.B. but would not fully address his elevated A1C results. Metformin (Glucophage), which reduces hepatic glucose production and improves insulin resistance, is not associated with hypoglycemia and can lower A1C results by 1%. Although GI side effects can occur, they are usually self-limiting and can be further reduced by slow titration to dose efficacy.14
After reviewing these options and discussing the need for improved glycemic control, the NP prescribed metformin, 500 mg twice a day. Possible GI side effects and the need to avoid alcohol were of concern to A.B., but he agreed that medication was necessary and that metformin was his best option. The NP advised him to take the medication with food to reduce GI side effects.
The NP also discussed with the patient a titration schedule that increased the dosage to 1,000 mg twice a day over a 4-week period. She wrote out this plan, including a date and time for telephone contact and medication evaluation, and gave it to the patient.
During the visit, A.B. and his wife learned to use a glucose meter that features a simple two-step procedure. The patient agreed to use the meter twice a day, at breakfast and dinner, while the metformin dose was being titrated. He understood the need for glucose readings to guide the choice of medication and to evaluate the effects of his dietary changes, but he felt that it would not be “a forever thing.”
The NP reviewed glycemic goals with the patient and his wife and assisted them in deciding on initial short-term goals for weight loss, exercise, and medication. Glucose monitoring would serve as a guide and assist the patient in modifying his lifestyle.
A.B. drew the line at starting an antihypertensive medication—the angiotensin-converting enzyme (ACE) inhibitor enalapril (Vasotec), 5 mg daily. He stated that one new medication at a time was enough and that “too many medications would make a sick man out of me.” His perception of the state of his health as being represented by the number of medications prescribed for him gave the advanced practice nurse an important insight into the patient’s health belief system. The patient’s wife also believed that a “natural solution” was better than medication for treating blood pressure.
Although the use of an ACE inhibitor was indicated both by the level of hypertension and by the presence of microalbuminuria, the decision to wait until the next office visit to further evaluate the need for antihypertensive medication afforded the patient and his wife time to consider the importance of adding this pharmacotherapy. They were quite willing to read any materials that addressed the prevention of diabetes complications. However, both the patient and his wife voiced a strong desire to focus their energies on changes in food and physical activity. The NP expressed support for their decision. Because A.B. was obese, weight loss would be beneficial for many of his health issues.
Because he has a sedentary lifestyle, is >35 years old, has hypertension and peripheral neuropathy, and is being treated for hypercholestrolemia, the NP performed an electrocardiogram in the office and referred the patient for an exercise tolerance test.11 In doing this, the NP acknowledged and respected the mutually set goals, but also provided appropriate pre-exercise screening for the patient’s protection and safety.
In her role as diabetes educator, the NP taught A.B. and his wife the importance of foot care, demonstrating to the patient his inability to feel the light touch of the monofilament. She explained that the loss of protective sensation from peripheral neuropathy means that he will need to be more vigilant in checking his feet for any skin lesions caused by poorly fitting footwear worn during exercise.
At the conclusion of the visit, the NP assured A.B. that she would share the plan of care they had developed with his primary care physician, collaborating with him and discussing the findings of any diagnostic tests and procedures. She would also work in partnership with the RD to reinforce medical nutrition therapies and improve his glucose control. In this way, the NP would facilitate the continuity of care and keep vital pathways of communication open.
Advanced practice nurses are ideally suited to play an integral role in the education and medical management of people with diabetes.15 The combination of clinical skills and expertise in teaching and counseling enhances the delivery of care in a manner that is both cost-reducing and effective. Inherent in the role of advanced practice nurses is the understanding of shared responsibility for health care outcomes. This partnering of nurse with patient not only improves care but strengthens the patient’s role as self-manager.
Geralyn Spollett, MSN, C-ANP, CDE, is associate director and an adult nurse practitioner at the Yale Diabetes Center, Department of Endocrinology and Metabolism, at Yale University in New Haven, Conn. She is an associate editor of Diabetes Spectrum.
Note of disclosure: Ms. Spollett has received honoraria for speaking engagements from Novo Nordisk Pharmaceuticals, Inc., and Aventis and has been a paid consultant for Aventis. Both companies produce products and devices for the treatment of diabetes.
- American Diabetes Association
Advanced practice pharmacists in the field of diabetes work collaboratively with patients’ medical providers, often in primary care settings or in close proximity to the providers’ practices. They help to integrate the pharmaceutical, medical, education/ counseling, and direct patient care activities necessary to meet patients’ individual self-management and diabetes care needs.
Patient education and self-management behavioral change are underpinnings of pharmaceutical care, and not only as they directly relate to the use of medications. Pharmacists, especially those who are certified diabetes educators (CDEs), frequently provide diabetes patients with education not only on medications, but also on the overall disease state, nutrition, physical activity, decision-making skills, psychosocial adaptation, complication prevention, goal setting, barrier resolution, and cost issues.
In addition to these substantial education responsibilities, advanced practice pharmacists who are Board Certified–Advanced Diabetes Managers (BC-ADMs) play an expanded role that encompasses disease state management. This includes performing clinical assessments and limited physical examinations; recognizing the need for additional care; making referrals as needed; ordering and interpreting specific laboratory tests; integrating their pharmacy patient care plans into patients’ total medical care plans; and entering notes on patient charts or carrying out other forms of written communication with patients’ medical care providers. Depending on state regulations and physician-based protocols, some advanced practice pharmacists can prescribe and adjust medications independently or after consultation with prescribing clinicians.
The clinical activities of BC-ADM pharmacists are not carried out independent of referring, collaborative practitioners. Rather, they are complementary to and serve to enhance the diagnostic, complex physical assessment, and management skills of medical providers.
The following case study illustrates the pharmacotherapeutic challenges of diabetes with other comorbidities, which can lead to potential drug-drug and drug-disease interactions. Although it does not offer detailed solutions to such problems, this case does describe the process of patient care and problem resolution as approached by advanced practice pharmacists.
B.L. is a 58-year-old white woman who has been referred to the pharmacist clinician for pharmacotherapy assessment and diabetes management. Her multiple medical conditions include type 2 diabetes diagnosed in 1995, hypertension, hyperlipidemia, asthma, coronary artery disease, persistent peripheral edema, and longstanding musculoskeletal pain secondary to a motor vehicle accident. Her medical history includes atrial fibrillation with cardioversion, anemia, knee replacement, and multiple emergency room (ER) admissions for asthma.
B.L.’s diabetes is currently being treated with a premixed preparation of 75% insulin lispro protamine suspension with 25% insulin lispro preparation (Humalog 75/25), 33 units before breakfast and 23 units before supper. She says she occasionally “takes a little more” insulin when she notes high blood glucose readings, but she has not been instructed on the use of an insulin adjustment algorithm.
Her other routine medications include the fluticasone metered dose inhaler (Flovent MDI), two puffs twice a day; salmeterol MDI (Serevent MDI), two puffs twice a day; naproxen (Naprosyn), 375 mg twice a day; enteric-coated aspirin, 325 mg daily; rosiglitazone (Avandia), 4 mg daily; furosemide (Lasix), 80 mg every morning; diltiazem (Cardizem CD), 180 mg daily (per cardiologist consult); lanoxin (Digoxin), 0.25 mg daily (per cardiologist consult); potassium chloride, 20 mEq daily; and fluvastatin (Lescol), 20 mg at bedtime. Medications she has been prescribed to take “as needed” include sublingual nitroglycerin for chest pain (has not been needed in the past month); furosemide, additional 40 mg later in the day if needed for swelling (on most days the additional dose is needed); and albuterol MDI (Proventil, Ventolin), two to four puffs every 4–6 hours for shortness of breath. She denies use of nicotine, alcohol, or recreational drugs; has no known drug allergies; and is up to date on her immunizations.
B.L.’s chief complaint now is increasing exacerbations of asthma and the need for prednisone tapers. She reports that during her last round of prednisone therapy, her blood glucose readings increased to the range of 300–400 mg/dl despite large decreases in her carbohydrate intake. She reports that she increases the frequency of her fluticasone MDI, salmeterol MDI, and albuterol MDI to four to five times/day when she has a flare-up. However, her husband has been out of work for more than a year, and their only source of income is her Social Security check. Therefore, she has been unable to purchase the fluticasone or salmeterol and so has only been taking prednisone and albuterol for recent acute asthma exacerbations.
B.L. reports eating three meals a day with a snack between supper and bedtime. Her largest meal is supper. She states that she counts her carbohydrate servings at each meal and is “watching what she eats.” She has not been able to exercise routinely for several weeks because of bad weather and her asthma.
The memory printout from her blood glucose meter for the past 30 days shows a total of 53 tests with a mean blood glucose of 241 mg/dl (SD 74). With a premeal glucose target set at 70–140 mg/dl, there were no readings below target, 8% within target, and 91% above target. By comparison, her results from the same month 1 year ago averaged 112 mg/dl, with a high of 146 mg/dl and a low of 78 mg/dl.
B.L. is well-appearing but obese and is in no acute distress. A limited physical exam reveals:
Weight: 302 lb; height 5′1″
Blood pressure: 130/78 mmHg using a large adult cuff
Pulse 88 bpm; respirations 22 per minute
Lungs: clear to auscultation bilaterally without wheezing, rales, or rhonchi
Lower extremities +1 pitting edema bilaterally; pulses good
B.L. reports that on the days her feet swell the most, she is active and in an upright position throughout the day. Swelling worsens throughout the day, but by the next morning they are “skinny again.” She states that she makes the decision to take an extra furosemide tablet if her swelling is excessive and painful around lunch time; taking the diuretic later in the day prevents her from sleeping because of nocturnal urination.
For the sake of brevity, only abnormal or relevant labs within the past year are listed below.
Hemoglobin A1c (A1C) measured 6 months ago: 7.0% (normal range: <5.9%; target: <7%)
Creatinine: 0.7 mg/dl (normal range: 0.7–1.4 mg/dl)
Blood urea nitrogen: 16 mg/dl (normal range: 7–21 mg/dl)
Sodium: 140 mEq/l (normal range: 135–145 mEq/l)
Potassium: 3.4 mg/dl (normal range: 3.5–5.3 mg/dl)
Calcium: 8.2 mg/dl (normal range: 8.3–10.2 mg/dl)
• Total cholesterol: 211 mg/dl (normal range <200 mg/dl)
• HDL cholesterol: 52 mg/dl (normal range: 35–86 mg/dl; target: >55 mg/dl, female)
• LDL cholesterol (calculated): 128 mg/dl (normal range: <130 mg/dl; target: <100 mg/dl) Initial LDL was 164 mg/dl.
• Triglycerides: 154 mg/dl (normal range: <150 mg/dl; target: <150 mg/dl)
Liver function panel: within normal limits
Urinary albumin: <30 μg/mg (normal range: <30 μg/mg)
Poorly controlled, severe, persistent asthma
Diabetes; control recently worsened by asthma exacerbations and treatment
Dyslipidemia, elevated LDL cholesterol despite statin therapy
Persistent lower-extremity edema despite diuretic therapy
Hypokalemia, most likely drug-induced
Hypertension JNC-VI Risk Group C, blood pressure within target and stable
Coronary artery disease, stable
Chronic pain secondary to previous injury, stable
Status post–atrial fibrillation with cardioversion
Status post–knee replacement
Financial constraints affecting medication behaviors
Insufficient patient education regarding purposes and role of specific medications
Wellness, preventive, and routine monitoring issues: calcium/vitamin D supplement, magnesium supplement, depression screening, osteoporosis screening, dosage for daily aspirin
Strand et al.1 proposed a systematic method for evaluation of and intervention for a patient’s pharmacotherapy, using a process called the Pharmacist’s Work-Up of Drug Therapy (PWDT). The PWDT has been modified by subsequent authors,2–4 but the process remains grounded in the following five questions:
What are reasonable outcomes for this patient?
Based on current guidelines and literature, pharmacology, and pathophysiology, what therapeutic endpoints would be needed to achieve these outcomes?
Are there potential medication-related problems that prevent these endpoints from being achieved?
What patient self-care behaviors and medication changes are needed to address the medication-related problems? What patient education interventions are needed to enhance achievement of these changes?
What monitoring parameters are needed to verify achievement of goals and detect side effects and toxicity, and how often should these parameters be monitored?
Outcomes and Endpoints
Clinical outcomes are distinctly different from therapeutic or interventional endpoints. The former refers to the impact of treatment on patients’ overall medical status and quality of life and should emphasize patient-oriented evidence that matters (POEMs) rather than disease-oriented evidence (DOEs).
Therapeutic endpoints include the anticipated and desired clinical effects from drug therapy that are expected, ultimately, to achieve the desired outcome(s). As such, therapeutic endpoints are used as surrogate markers for achievement of outcomes. Commonly, more than one endpoint will be needed to achieve an outcome. For example, near-normal glycemic control and normalization of blood pressure (endpoints) would be necessary to significantly reduce the risk of end-stage renal disease (outcome).
Therapeutic endpoints should be specific, measurable, and achievable within a short period of time. Achievement of clinical outcomes usually cannot be determined except by long-term observation or retrospective analysis.
Outcomes and endpoints for any given patient should be determined collaboratively between patient and provider before selecting or initiating pharmacotherapy or nonpharmacological interventions. Taking the time to identify these components up front (and periodically revise them later on) helps ensure that subsequent medications or strategies are appropriately directed. It further ensures a common vision and commitment for ongoing patient care and self-management among the care team (including the patient), thus maximizing the potential for optimal disease control and patient satisfaction.
The outcomes and endpoints for a patient such as B.L. are numerous and obviously would not be addressed or attained in a single session. Therefore, after desired outcomes and endpoints are determined, they should be prioritized according to medical urgency and patient preference. Implementation and goal setting related to these priorities can then be undertaken, thus establishing a treatment plan for the eventual attainment of the full list.
During ongoing and follow-up visits, this care plan should be reviewed and modified as indicated by changes in patient status, preferences, and medical findings. Examples of desired outcomes and endpoints for B.L. are given in Tables 1 and 2. For the sake of brevity, these tables are not intended to be inclusive.
Medication-Related Problems and Proposed Interventions
With agreement between patient and clinician concerning desired outcomes and endpoints, the next logical step is to evaluate whether the current treatment plan is likely to achieve those goals, or, if treatment is to be initiated, which therapies or interventions should be selected.
According to Strand et al.,1 a medication-related problem is any aspect of a patient’s drug therapy that is interfering with a desired, positive patient (therapeutic) outcome or endpoint. The PWDT proposes a systematic and comprehensive method to identify, resolve, or prevent medication-related problems based on the following major categories:
No indication for a current drug
Indication for a drug (or device or intervention) but none prescribed
Wrong drug regimen (or device or intervention) prescribed/more efficacious choice possible
Too much of the correct drug
Too little of the correct drug
Adverse drug reaction/drug allergy
Drug-drug, drug-disease, drug-food interactions
Patient not receiving a prescribed drug
Routine monitoring (labs, screenings, exams) missing
Other problems, such as potential for overlap of adverse effects
Once problems are identified, resolutions must be developed, prioritized, and implemented. Patient or caregiver input is especially helpful at this stage because the individual can describe subjective as well as objective data, expectations or concerns that may be affecting drug therapy, and deficits in drug knowledge, understanding, or administration.
Resolutions may result from numerous strategies, including dose alteration, addition or discontinuation of medication, adjunct medications, regimen adjustment, complementary therapies, instruction on medication administration or devices, disease or medication education, development of “cues” as compliance reminders (e.g., pill boxes), and identification of ways to avoid, detect, or manage side effects or toxicities. Needless to say, the involvement of patients and family or caregivers is critical for successful implementation of most resolution strategies and for optimal disease management.
Because of the extent of B.L.’s medication-related problems and potential interventions (Tables 3 and 4), it was agreed to tackle first her asthma exacerbations and high blood glucose levels. To this end, B.L. was counseled about the role of maintenance asthma medications versus rescue drugs. The root of her confusion between these agents was easy to understand—because the prednisone and fluticasone were both called steroids, it seemed likely that the tablets were a cheaper and easier way to take the medicine. Likewise, since albuterol and salmeterol were both called bronchodilators, it seemed that the albuterol was the cheaper way to take the medicine.
Having grasped the concept of asthma prevention, she was willing to convert to a product combining fluticasone and salmeterol (Advair Diskus) for maintenance/prevention and to reserve the albuterol for quick relief of acute symptoms. Free samples of the new product were dispensed, and B.L. was enrolled in the manufacturer’s indigent drug program for subsequent supplies.
She was further instructed on the use of a peak flow meter and advised to monitor her readings and symptoms. At the next visit, these data will be used to determine her maximal expiratory effort (“personal best”) and to construct an asthma action plan.
B.L.’s insulin was changed to a basal-based regimen utilizing bedtime glargine (Lantus) insulin and premeal lispro (Humalog) insulin. Education was provided on this dosing concept. She and the pharmacist discussed how this regimen can give greater flexibility in dosing, especially for responding to changes in diet, exercise, and disease exacerbations or medications. She was also given an initial supplementary adjustment algorithm (sliding scale) to correct for any temporary elevation of blood glucose. She agreed to test four times daily and to record her blood glucose results, carbohydrate intake, and insulin doses. At the next visit, these data will be used to modify the adjustment algorithm and to construct a prospective algorithm for matching premeal bolus insulin to the anticipated carbohydrate intake (insulin-to-carbohydrate ratio).
The final interventions for this visit were to increase the dose of potassium chloride and change the fluvastatin to atorvastatin (Lipitor) to further reduce B.L.’s LDL cholesterol. Medication education for atorvastatin was provided, and patient questions were answered.
Other medication-related problems and interventions identified for B.L. are listed and briefly discussed in Tables 3 and 4. For the sake of brevity, these lists are not inclusive nor are all pharmacotherapy issues discussed.
Monitoring for Effectiveness, Side Effects, and Toxicity
The last step in the PWDT process is to develop a plan to evaluate the patient’s progress in attaining desired outcomes, therapeutic endpoints, and behavior changes; to assess effectiveness of pharmacotherapy; and to identify side effects, drug interactions, or toxicity issues that need to be addressed.
The monitoring/follow-up component is the most tedious aspect of the PWDT. For each medication or intervention, key parameters must be identified as markers for effectiveness, for side effects, for drug interactions, and for toxicity. In addition, the time frame and process for assessing those parameters must be determined. Finally, the desired range for the parameter must be listed or a “decision point” must be identified to signal that additional action will be required.
It should be noted that only a limited number of parameters are selected for a given patient. For example, it is not necessary to list and monitor for every possible side effect with equal intensity and frequency. Selection of the monitoring parameters is based on the positive effects (efficacy) that are most important to the care of that patient, as well as the adverse effects (side effects, toxicity, or drug interactions) that are most important to avoid for the safety of that patient or to which that patient is most prone.
Because the monitoring component is usually extensive, examples listed for B.L. in Table 5 have been limited to three of the medication or regimen changes that were made at the first pharmacist visit: switching from fluvastatin to atorvastatin; switching from two shots of premixed 75/25 lispro to bedtime glargine with premeal lispro; and substituting the combination inhaler product for her fluticasone and salmeterol MDI prescriptions. Because atorvastatin and fluvastatin differ chemically, the monitoring parameters for this change are similar to those for initiation of a new medication. Monitoring for the new insulin regimen (basal insulin with premeal bolus) focuses primarily on glycemic control patterns and hypoglycemic episodes. Because B.L. has previously used the two ingredients of her new inhaler product (fluticasone and salmeterol) without adverse effect, monitoring of her new asthma therapy is focused on effectiveness, tolerance of inhalation of its dry powder formula, and use of the administration device.
Diabetes patients with multiple co-morbidities have concerns about all of their problems, not just the diabetes; therefore, BC-ADM pharmacists must comprehensively explore all the ramifications of comorbidities as well as patients’ feelings, expectations, and concerns for total health. B.L. is a good example of this; even though her referral was for “diabetes management,” her greatest concern at this visit was her asthma exacerbations.
As can be seen in this case, each coexisting disease or coprescribed drug has a domino effect, affecting other diseases or drugs and ultimately affecting quality of life. With input from B.L., the pharmacist clinician was able to develop a PWDT that addresses her diabetes as well as her other health care needs.
B.L. was able to leave the health center with a few achievable self-care goals and medication changes that address her acute concerns and with the knowledge and confidence that, at each subsequent visit, additional progress will be made toward her personalized health status goals.
Examples of B.L.’s Desired Outcomes
Examples of B.L.’s Therapeutic Endpoints
Examples of B.L.’s Medication-Related Problems
Examples of B.L.’s Interventions (Prioritized and to be Implemented Accordingly)
Examples of B.L.’s Monitoring Plans
Peggy Yarborough, PharmD, MS, BC-ADM, CDE, FAPP, FASHP, NAP, is a professor at Campbell University School of Pharmacy in Buies Creek, N.C., and a pharmacist clinician at Wilson Community Health Center in Wilson, N.C.
For information concerning POEMs and DOEs: a multitude of literature on this topic is available through Internet sources. Search for “patient oriented evidence that matters” using a medical topic browser.
- American Diabetes Association