American Society of Consultant Pharmacists (ASCP) 2013 Spring Conference

May 14-17, 2013; Orlando, FL
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EDUCATION SESSION

Consultant Pharmacists Can Play a Key Role in Facilitating the New CMR Rule

On January 1, 2013, the Centers for Medicare & Medicaid Services (CMS) issued a rule requiring all Medicare Part D plans to offer annual comprehensive medication reviews (CMR) to all eligible beneficiaries, including persons living in long-term care (LTC) settings. As part of this rule, Part D plans will be expected to display the percentage of CMRs completed in 2013, and CMRs will become a plan rating measure starting in 2014. Although this new Plan D requirement poses many challenges for LTC facilities throughout the United States, an education session at the ASCP spring conference also showed that consultant pharmacists can play an integral role in overcoming these challenges and facilitating medication safety in LTC facilities. 

During the session, Barbara Zarowitz, PharmD, chief clinical officer and vice president of clinical services, Omnicare, Inc, provided an overview of CMR. She noted that CMR is a systematic process that consists of the following tasks: collecting patient-specific information; assessing medication therapies to identify potential medication-related problems; developing a prioritized list of these problems; and creating a plan to resolve them with the patient, caregiver, and/or prescriber. The objective is to improve a patient’s and/or his or her caregiver’s knowledge of the prescription and over-the-counter medications, herbal therapies, and dietary supplements that the patient is taking, enabling them to better understand and manage the patient’s medication regimen.

Zarowitz noted the following guidelines that must be followed to meet the new Plan D CMR requirement:

1.    For cognitively impaired beneficiaries who cannot make medical decisions, the pharmacist or qualified provider should invite the beneficiary’s prescriber, caregiver, or other authorized individual (eg, resident’s healthcare proxy or legal guardian) to take part in the beneficiary’s CMR.

2.    The CMR must be conducted in real-time, whether face-to-face or via telehealth consultations.

3.    CMR beneficiaries must receive a written summary of the CMR in CMS’ standard format for medication therapy management (MTM), which includes a cover letter, a medication action plan that outlines drug therapy recommendations, and a personal medication list.

Nicole Brandt, PharmD, associate professor, University of Maryland School of Pharmacy, Baltimore, proceeded to discuss CMS’ efforts to increase beneficiary awareness of CMR through a multifaceted education approach. This approach consists of expanded information about MTM in the 2013 Medicare & You handbook and improved access to plan-specific MTM information within the Medicare Plan Finder. CMS also encouraged Part D plan outreach to promote beneficiary participation in MTM services, and Brandt recommended that attendees share the CMS resources with eligible beneficiaries.

Ken Tuell, RPh, CGP, director, Health Services Outcomes Research, Emerging Healthcare Sectors, Bristol-Myers Squibb, continued the session by discussing the insurance issues surrounding CMR. For the most part, payers lack knowledge regarding LTC, including who the relevant players are and what the LTC population’s needs are, he said. At the same time, payers want their specific corporate goals met, including CMS compliance, consumer acceptance, and member retention. Subsequently, consultant pharmacists have an opportunity to play an essential role in helping insurance providers with CMR implementation in the LTC setting, he said.

Consultant pharmacists have geriatric expertise that exceeds what payers have available in their typical MTM networks. In addition to understanding the intricacies of the institutional setting, they have expertise with regard to multiple comorbidities, age-related decline (eg, in renal and hepatic function), and other aspects of geriatric care. They also have a high percentage of recommendations being accepted. Based on all of these factors, consultant pharmacists are ideal candidates for optimizing CMR and meeting CMS’ objectives, noted Tuell.—Christina T. Loguidice
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PRODUCT THEATERS

Treating Exocrine Pancreatic Insufficiency With Pancrelipase

Chronic pancreatitis (CP) is a persistent inflammation of the pancreas characterized by repeated attacks of abdominal pain, steatorrhea, and maldigestion. Because of its propensity to inflict progressive and irreversible damage, CP eventually leads to impairment of exocrine and endocrine function, resulting in exocrine pancreatic insufficiency (EPI), which has an increased prevalence in diabetic patients. Some risk factors for CP include genetic predisposition, autoimmune triggers, recurrent acute pancreatitis, pancreatic obstruction, and the presence of certain diseases (eg, Crohn’s disease, primary biliary cirrhosis). The complex etiology of CP leads to underdiagnosis, placing patients at increased risk of developing EPI, said gastroenterologist Cynthia Rudert, MD, medical advisor, Celiac Disease Foundation and Gluten Intolerance Group of North America, and medical director, Atlanta Gluten Intolerance Group, during a product theater at the ASCP spring conference.

“[Chronic pancreatitis] is very chameleon-like in its presentation,” she said, making it difficult for clinicians to diagnose and properly treat. There are no established guidelines to guide diagnosis and management of CP, and no single sign or symptom is pathogenic for pancreatic disease. Therefore, diagnosis requires a high index of suspicion and complementary diagnostic techniques. “Chronic pancreatitis should be considered in all patients with un-explained abdominal pain,” noted Rudert.

Until there is a definitive diagnostic test for CP, abdominal imaging and enzyme measures for assessing CP should be used, said Rudert. Once CP is identified, pancreatic enzyme replacement therapy (PERT) is the standard of care to prevent maldigestion, malnutrition, and excessive weight loss in patients who are also found to have EPI. Although CP is the most common cause of EPI, it can also result from pancreatectomy, cystic fibrosis, and other conditions.

Rudert described the use of Creon (pancrelipase), a PERT option, for patients with EPI. She explained that this medicine is administered in capsules with food; the capsules may not be crushed or chewed. The capsules dissolve in the stomach, releasing enteric-coated spheres sized between
0.7 mm and 1.6 mm in diameter, which enables the medication to travel beyond the low pH of the stomach through the pylorus and into the small intestine, where the enteric-coated spheres dissolve in the high pH environment and help break down fats, proteins, and carbohydrates.

Rudert noted that Creon is not interchangeable with other pancrelipase products, and that treatment should be initiated at the lowest recommended dose and gradually increased. The dose should also be individualized based on a patient’s clinical symptoms and weight, degree of steatorrhea, and amount of dietary fat consumed. Caution is warranted in patients with cystic fibrosis who are taking high-dose PERT (>2500 lipase units per kg of body weight per meal or >10,000 lipase units per kg of body weight per day) and in patients who are known to be allergic to pork products, as Creon is a combination of porcine-derived lipases, proteases, and amylases. Clinical studies did not include sufficient numbers of patients aged 65 years and older to determine whether this population responds differently than younger adults, but reported clinical experiences have not identified any age-related differences.—Christina T. Loguidice

This product theater was sponsored by AbbVie, Inc.
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PRODUCT THEATERS

Treating Moderate to Severe Alzheimer’s Disease With Memantine

The Alzheimer’s Association predicts that by 2025 the number of people aged 65 and older with Alzheimer’s disease (AD) will reach 7.1 million, a 40% increase from the 5 million in this age group currently affected. AD is associated with neuronal death, which results in reduced production of acetylcholine, explained Dana Saffel, PharmD, president and chief executive officer, PharmaCare Strategies, Inc, during a product theater at the ASCP spring conference. Saffel said recognizing the signs and symptoms of moderate AD is an important component in the diagnosis and treatment of the disease.

Pharmacological treatment for AD includes acetylcholinesterase inhibitors (AChEI) and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine. For AD patients in long-term care (LTC) settings, clinicians may consider memantine hydrochloride (HCI) extended-release (XR) capsules as a treatment option. The medication, which is due to launch this month (June 2013), is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Memantine is thought to exert its therapeutic effect by acting as a low to moderate affinity uncompetitive (open-channel) NMDA receptor antagonist, binding preferentially to the NMDA receptor-operated cation channels, which are broadly involved in brain function. According to its prescribing information, however, there is no evidence that memantine prevents or slows neurodegeneration in patients with AD.

Saffel reviewed the results of a double-blind, placebo-controlled trial that assessed the safety and efficacy of memantine HCI XR. In the trial, 677 patients receiving an AChEI (either donepezil, galantamine, or rivastigmine) were randomly assigned to receive memantine HCI XR
28 mg daily or a placebo. The efficacy of memantine HCI XR was evaluated using the parameters of the Severe Impairment Battery (SIB) to assess cognitive function in patients with moderate to severe dementia, and the Clinician’s Interview-Based Impression of Change (CIBIC-Plus) to assess the medication’s overall clinical effect. The SIB is scored from 0 to 100, with low scores indicating greater cognitive impairment. The CIBIC-Plus is scored as a 7-point categorical rating, ranging from a score of 1, indicating “marked improvement,” to a score of 7, indicating “marked worsening.”

At week 24 of treatment, the mean difference in the SIB change scores for the memantine HCI XR/AChEI group compared with the placebo/AChEI group was 2.6 units, and the mean difference in the CIBIC-Plus scores between these groups was 0.3 units. When using last observation carried forward analysis, memantine HCI XR/AChEI treatment was found to be statistically significantly superior to placebo/AChEI in both study outcome measures. In the trial, the most commonly observed adverse reactions in patients taking memantine HCI XR were headache, diarrhea, and dizziness.

The recommended starting dosage and target dosage of memantine HCI XR are 7 mg once daily and 28 mg once daily, respectively. The starting dose should be increased in 7-mg increments to achieve the target dosage, provided the previous dose is well tolerated. Saffel said that prescribers should allow an interval of at least 1 week between dose increases. Memantine HCI XR can be taken with or without food, and it can be taken intact or may be opened and sprinkled on applesauce, making it a good option for patients with swallowing difficulties; however, unless specifically sprinkled on applesauce, the capsule must be taken whole and should not be divided, chewed, or crushed.

Saffel said no dosage adjustment is recommended in patients with mild or moderate hepatic impairment or mild or moderate renal impairment, whereas a target dosage of 14 mg daily is recommended in patients with severe renal impairment. Memantine HCI XR should be administered with caution in patients with severe hepatic impairment. Saffel also advised that in LTC settings, patients initiated on memantine HCI XT should be placed on a fall prevention protocol, as is common when medications are changed in elderly persons.—Eileen Koutnik-Fotopoulos

This product theater was sponsored by Forest Pharmaceuticals, Inc.
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Linagliptin Improves Glycated Hemoglobin Levels Across a Broad Range of Patients

In the United States, the number of adults aged 65 years and older is expected to nearly double, rising to 72 million, by 2030. As a result, the number of older adults with diabetes is also projected to increase, and the Centers for Disease Control and Prevention estimate that 33% of adults could have diabetes by 2050. Type 2 diabetes mellitus, the form most prevalent in the long-term care setting (LTC), accounts for 90% to 95% of all cases. Although managing type 2 diabetes in the elderly population can be challenging, we now have numerous options to treat diabetes, said Ajay Chaudhuri, MD, Department of Medicine, School of Medicine and Biomedical Sciences, University at Buffalo, NY, during a product theater at the ASCP spring conference.

“These are exciting times in the field of diabetes, and they are also challenging times,” noted Chaudhuri. “The major innovation of these new options is how to treat hypoglycemia,” he added. “Even in the elderly, in whom you want to prevent acute hypoglycemia, your goals might be different, but you still want to control blood glucose,” he said. He recommended that physicians treating LTC patients use the American Medical Directors Association’s eight-step plan for diabetes management.

Chaudhuri proceeded to discuss linagliptin (Tradjenta), one option for managing type 2 diabetes in elderly LTC residents. Linagliptin is a single-strength dipeptidyl peptidase-4 inhibitor that is approved by the US Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. The efficacy of linagliptin has been studied as monotherapy and as a combination therapy with metformin, sulfonylureas, pioglitazone, or insulin. Linagliptin has also been studied in special populations, including patients with type 2 diabetes and severe renal impairment and in patients aged 70 years and older. Clinical trials demonstrated that linagliptin produced clinically significant improvements in hemoglobin A_1C levels, fasting plasma glucose levels, and 2-hour postprandial glucose levels.

Linagliptin improved hemoglobin A_1C levels across all age groups, said Chaudhuri. “When you have people older than 65, they may have diabetes for a long time. Many people in long-term care are on insulin, and linagliptin can be used.”

Chaudhuri discussed the results of a randomized, double-blinded, placebo-controlled trial that included patients whose type 2 diabetes was inadequately controlled on basal insulin alone or in combination with oral drugs. The mean total daily insulin dose at baseline was 42 units for the group that received linagliptin add-on therapy and 40 units for the placebo-treated group. The findings showed that linagliptin versus placebo in combination with insulin improved hemoglobin A_1C levels by 0.7% at 24 weeks.

He also noted that patients receiving linagliptin as add-on therapy to a stable dose of insulin at 52 weeks showed no significant difference in investigator-reported hypoglycemia compared with placebo (31.4% vs 32.9%, respectively). Severe hypoglycemic events were reported in 1.7% of patients in the linagliptin group and 1.1% of patients in the placebo-treated group.

In a separate double-blind study involving patients aged 70 years and older, linagliptin was administered for 24 weeks as add-on glucose therapy to elderly patients who had inadequate glycemic control despite background therapy with metformin and/or sulfonylureas and/or basal insulin. Chaudhuri said the results showed linagliptin was effective in the adjusted mean change in hemoglobin A_1C level from baseline over time. The difference versus placebo at 24 weeks was -0.6%. The incidence of hypoglycemia was 22.8% in the linagliptin group and 16.5% in the placebo group.

The safety of linagliptin has been demonstrated in more than 6000 patients in clinical trials. The overall incidence of adverse events with linagliptin was similar to placebo in placebo-controlled clinical studies of linagliptin as monotherapy or combination therapy. The most commonly reported adverse events with linagliptin, which occurred in at least 2% of patients treated with this agent, were nasopharyngitis, diarrhea, and cough.

The recommended dose of linagliptin is 5 mg once daily, and this agent can be taken with or without food. No dosage adjustment is required for elderly patients, persons with declining renal function, or individuals with hepatic impairment. When linagliptin is used in combination with an insulin secretagogue (eg, sulfonylureas) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia, said Chaudhuri.—Eileen Koutnik-Fotopoulos

This product theater was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.