Diabetes in the Long Term Care Setting: Advantages of Basal Insulin Therapy and Insulin Pen Devices

Diabetes in the Long Term Care Setting: Advantages of Basal Insulin Therapy and Insulin Pen Devices By: Wendy A. Stearns, RPh and William R. (Rob) Godwin, RPh, CGP Contact Information: 866-577-3784 PharMerica PharMerica Corporation Corporation 2011 2011 1

Table of Contents Diabetes Type 1 and Type 2 1 Basal Insulin Provides Steady Absorption Rate 1 Bolus Insulin Provides Quick Absorption 1 Effect of Single Insulin Dosage 2 Basal-Bolus Combination Regimen Effect 2 Insulin Delivery 2 Dosing Accuracy 4 Cost Considerations 4 Achieving Better Glucose Control 5 2011 by PharMerica Corporation All rights reserved. Printed in the United States of America. No part of this document may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embodied in critical articles and reviews. PharMerica Corporation 2011 2

Data released in January 2011 according to the 2011 National Diabetes Fact Sheet states that 18.8 million people in the United States are diagnosed with diabetes. In 2010, there were 1.9 million new cases diagnosed in people over 20 years of age and total costs of diagnosed diabetes in the United States in 2007 was $174 billion 1. As it relates to the long-term care industry, approximately 23% of Americans over 60 suffer from diabetes, including 25% of long term health care facility residents 2. In fact, residents with diabetes have an average of 6.4 major diagnoses compared to only 2.4 for those without the disease 3. These patients represent a complex, high-risk group and often require an individualized approach to diabetes care. Diabetes: Type 1 and Type 2 Diabetes is a disease characterized by elevated blood glucose levels. The body s blood glucose level is regulated by several hormones, including insulin, which is naturally produced by the pancreas. Insulin allows glucose to move from the blood into the body s cells so that it can be converted into energy. Most people continuously produce insulin to manage bodily glucose functions throughout the day. However, individuals with Type 1 diabetes stop producing the insulin needed to maintain a normal blood glucose level. Alternatively, those with Type 2 diabetes have the ability to produce insulin, but the body becomes resistant and is less efficient at, or unable to move sugar out of the bloodstream and into the cells for energy conversion. Over time, the beta cells stop producing insulin altogether. When glucose builds up in the bloodstream instead of moving into the body s cells, it can lead to serious diabetes complications. Approximately 90% of diabetes cases are diagnosed as Type 2. 4 More than half of all people with Type 2 diabetes require insulin to control their blood sugar levels at some point during their illness. Diet, weight loss, and oral medications are first line treatment options. While there is currently no cure for diabetes, the disease can be managed by maintaining glucose control. In addition to achieving and maintaining normal glycemic control, general treatment goals should include maintaining adequate nutritional status, reducing the risk of extremity complications, controlling pain, participating in physical activities and initiating medications, if needed. Basal Insulin Provides Steady Absorption Rate Insulin therapy seeks to mimic the physiologic pattern of insulin secretions. There are several types of insulins available that differ by rate of action. Basal insulin is a long-acting insulin which provides a steady baseline amount of insulin to assist the movement of glucose into cells. It provides a slow and consistent rate of absorption into the bloodstream. Bolus Insulin Provides Quick Absorption To achieve adequate levels of insulin throughout the day for glucose control, additional doses of bolus insulin may need to be administered at meal times. Bolus insulin is a rapid-acting insulin which provides quick absorption into the bloodstream. It is administered whenever food is eaten or when blood sugars are too high and need to be corrected. Because insulin is dosed to equal a calculation ratio of carbohydrates to insulin, carbohydrate counting becomes a key component of diet management and insulin coverage. The most effective treatment plan includes one dose of basal insulin daily plus three doses of bolus insulin at meal times. However, many patients can reach their treatment goal by using basal insulin once daily in addition to one injection of rapid-acting insulin to cover the largest meal of the day where the most carbohydrates are consumed. PharMerica Corporation 2011 1

Effect of Single Insulin Dosage Adapted from Edelman SV, Morello CM. South Med J. 2005;98:363-371 Patients who are administered multiple daily doses of Regular and NPH insulins may experience significant fluctuations in blood sugar, which can cause regular discomfort and diminish their overall quality of life. With basal-bolus regimens, patients experience less blood sugar fluctuation and better overall health outcomes. The charts on this page demonstrate the effects of different insulin regimens on a patient s plasma insulin level. Basal-Bolus Combination Regimen Effect Polonsky. N Engl J Med. 1996;334:777-783. Insulin Delivery While there are several options for administering insulin such as vials and syringes, insulin pen device delivery has shown to reduce dosing and needle stick errors. Switching from vials and syringes to pen devices has also shown to reduce healthcare costs when adherence, hypoglycemic events, and diabetes-attributed costs are taken into consideration. Insulin pen usage also offers less waste for short-stay residents and patients with low volume insulin usage. PharMerica Corporation 2011 2

Those who administer insulin by various pen devices should be aware of the need to use a safety needle device attached to the insulin cartridge. Safety needles provide a shield for the needle that retracts during administration and then locks into place afterwards for additional protection from inadvertent needle sticks. These safety needles come in various brands such as BD Auto shield, Novo Fine, etc., and provide for administration. Additional training should be sought by those who self-administer or caregivers who administer insulin by pen devices to insure accuracy and safety. Pharmacists, nurses, or other trained health care professionals should be able to advise on proper administration and storage of insulin and insulin pen devices. General instructions for use of an insulin pen are listed in Table 1. Once in use, different types of insulin in vials and pen devices have different expiration periods. For example, once a NovoLog Mix 70/30 FlexPen is punctured, it should be kept at temperatures below 30 C (86 F) for up to 14 days, but should not be exposed to excessive or indirect heat or sunlight. Additionally, a NovoLog Mix 70/30 FlexPen in use must not be stored in a refrigerator. An unpunctured NovoLog Mix 70/30 FlexPen can be used until the expiration date printed on the label if it is stored in a refrigerator. Alternatively, the Novolog FlexPen has an expiration period of 28 days once in use and should be stored outside the refrigerator during the in use period at a temperature less than 86 degrees fahrenheit. Table 1. General Instructions for Use of an Insulin Pen 1. Select a site for your injection. 2. Clean your injection site with an alcohol pad and allow the site to air dry. 3. Remove the cap from your insulin pen. 4. If the type of insulin you are using is a cloudy insulin, gently roll the pen with your hands to mix the insulin. 5. Use an alcohol swab to clean the end of your pen where the pen needle twists on, and allow the alcohol to air dry. Do not use an alcohol swab on the pen itself, as this may damage the device. 6. Peel back the cover on your pen needle and screw (or snap) the needle onto the pen snugly. 7. Remove the cap from the needle and clean any air out of your pen by turning the dial to 2 units, holding the pen so the needle is pointing straight into the air, and pushing the plunger on the pen to release the insulin. If you do not see a drop of insulin on the end of the needle repeat this process to be sure all of the air has been released from the insulin pen. 8. Set your dose of insulin by turning the dial until you see the number of units you require. 9. Lightly pinch and hold your skin with one hand at your injection site. 10. Insert the needle straight into the skin with a fast motion such that the needle is all the way into your skin. 11. Push the trigger down slowly and wait approximately 10 seconds until all of the insulin is injected. 12. Let go of the pinched skin and pull the needle straight out. 13. Carefully remove the needle from the insulin pen and dispose of it into an appropriate sharps container. 14. Place the cover back on your insulin pen. Specific instructions will vary depending on the insulin pen used. Always consult and refer patients to the Users Guide for specific details and instructions for use PharMerica Corporation 2011 3

Dosing Accuracy Insulin pens are specifically designed to improve and simplify dosing accuracy. The sound and feel associated with dosing dials on insulin pens can provide important sensory feedback for patients with impaired vision or dexterity and help to facilitate accuracy. Participants in one study reported that a prefilled pen had a more accurate dosing mechanism compared to a traditional syringe. 7 A study examining dosing accuracy for several insulin devices reported the superior accuracy of doses prepared with the Humalog KwikPen and FlexPen as compared with those of a vial and syringe. 8 Another study comparing the handling, safety, and accuracy of the FlexPen with that of the vial and syringe, as administered by health care practitioners, reported that therapy-naïve practitioners found the FlexPen to be easier to handle and preferable over the vial and syringe. All health care practitioners in the study were able to deliver more accurate doses of insulin with the FlexPen as compared with the vial and syringe (P <.001). The insulin pens currently available provide a host of different features that maximize the ability of patients to accurately deliver an insulin dose. Caregivers and patients should always be instructed to prime their insulin pen prior to each use to remove any air bubbles that may be present within the insulin cartridge or prefilled insulin pen. Air bubbles can result in the administration of less insulin than intended and, subsequently trigger unintended consequences such as hyperglycemia. In fact, in another study focused on determining the accuracy of insulin pens, investigators found many cases of underdosing during initial injections with a newly changed OptiClik cartridge. 10 Additionally, pen orientation must be considered at time of use. The dose display must be held properly, not upside down or backwards, to read the numbers correctly. 14 Cost Considerations While many medication administration devices demonstrate improvements in clinical care, (i.e. inhaler spacers, dose counters, etc.) use is often determined by the financial limitations of the patient or the patient s insurance plan. Studies have shown that initiating insulin therapy with a pen device is associated with improved medication adherence and significant reductions in health care resource utilization and associated costs compared with insulin administration with a vial and syringe. A study conducted by Pawaskar with Medicaid patients found that total annualized health care costs were significantly lower for patients using an insulin pen when compared to those using a vial and syringe. 13 Cost reductions were reflected in hospital costs, diabetes-related costs, and outpatient costs. Another study demonstrated similar findings, with annual health care costs decreasing significantly after switching to or initiating therapy with an insulin pen. 12 The overall annually adjusted mean all-cause health care costs decreased per patient from $16,359 to $14,769 after initiating a switch from a vial and syringe to a pen device. Cobden and colleagues likewise showed a total mean reduction in annual treatment costs of $1,748 per patient for those converted from a vial and syringe to an insulin pen device. 11 Annual costs associated with hypoglycemia were reduced by $908 per patient, with a reduction in annual diabetes-attributable costs of $643 per patient. Insurance coverage varies for insulin pens, insulin cartridges, and other insulin supplies depending upon insurance providers and prior authorizations may be required by some plans. PharMerica Corporation 2011 4

Available evidence currently indicates that insulin pen delivery provides some benefits to patients. See Table 2 below for potential advantages and disadvantages of insulin pen delivery compared to vial and syringe delivery. Table 2. Potential Advantages and Disadvantages of Insulin Pens Compared With Vial and Syringe Potential Advantages Ease of use Improved dosing accuracy Improved adherence to therapy Decreased burden on health care providers for patient training More discreet insulin delivery with less perceived social stigma Improved patient acceptance and satisfaction Reduced overall health care costs Potential Disadvantages Potential for device malfunction Increased initial expense to the patient, if not covered by insurance Limited dosing capacity at high doses Achieving Better Glucose Control 12 Appropriate diabetes management can improve glucose control, which can positively affect a patient s quality of life and decrease the risk of complications. Intensive diabetes management may not be advised for frail patients, but relatively healthy patients may benefit from the following treatment goals: Lowering A1c to <7%; Achieving a fasting glucose of 70-130 mg/dl and; Maintaining a peak plasma glucose of <180mg/dl. As a premier pharmacy services provider, PharMerica Corporation provides quality resident care and innovative, cost-effective pharmacy solutions to customers in long-term care and alternate care settings. For additional information, please call 866. 577.3784 or email info@pharmerica.com PharMerica Corporation 2011 5

About the Authors Wendy A. Stearns, RPh, is a registered pharmacist and licensed consultant pharmacist in the state of Florida. She has worked for PharMerica for over 20 years and currently serves as the clinical program development director with oversight of all educational programs and resource tools for PharMerica s consultant pharmacists and customer nursing staff. William R. (Rob) Godwin, BS, RPh, CGP, currently serves as vice president of clinical program development for PharMerica. Rob serves as Co-chair for the PharMerica Pharmacy & Therapeutics Committee. He is also a Council Member on the Council for Nutrition and Clinical Strategies in LTC. He has been actively engaged in long term care (LTC) pharmacy since 1985, holding positions in both the operational and clinical functional areas. References for this article include: 1. American Diabetes Association Web site. Diabetes Statistics. www.diabetes.org/diabetes-basics/diabetes-statistics. Accessed 03/14/2011 2. Feldman SM, Rosen R, DeStasio J. Status of diabetes management in the nursing home setting in 2008: a retrospective chart review and epidemiology study of diabetic nursing home residents and nursing home initiatives in diabetes management. J Am Med Dir Assoc. 2009;10(5):354-360. 3. Resnick B. Ann Long Term Care. 2005;13:26-32. 4. EndocrineWeb, Type 1 Diabetes. http://www.endocrineweb.com/conditions/type-1-diabetes/type-1-diabetes 5. ADA Standards of Medical Care 2010. Diabetes Care. 2010; 33:S23. 6. American Medical Directors Association. Diabetes Management in the Long-Term Care Setting Clinical Practice Guideline. Columbia, MD: AMDA 2008 7. Graff MR, McClanahan MA. Assessment by patients with diabetes mellitus of two insulin pen delivery systems versus a vial and syringe. Clin Ther. 1998;20(3):486-496. 8. Ignaut DA, Schwartz SL, Sarwat S, Murphy HL. Comparative device assessments: Humalog KwikPen compared with vial and syringe and FlexPen. Diabetes Educ.2009;35(5):789-798. 9. Asakura T, Seino H, Nakano R, et al. A comparison of the handling and accuracy of syringe and vial versus prefilled insulin pen (FlexPen). Diabetes Technol Ther.2009;11(10):657-661. 10. Hänel H, Weise A, Sun W, et al. Differences in the dose accuracy of insulin pens. J Diabetes Sci Technol. 2008;2(3):478-481. 11. Pawaskar MD, Camacho FT, Anderson RT, et al. Heath care costs and medication adherence associated with initiation of insulin pen therapy in Medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis. Clin Ther.2007;29:1294-1305. 12. Lee WC, Balu S, Cobden D, et al. Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third-party managed care claims data. Clin Ther. 2006;28:1712-1725. 13. Cobden D, Lee WC, Balu S, et al. Health outcomes and economic impact of therapy conversion to a biphasic insulin analog pen among privately insured patients with type 2 diabetes mellitus. Pharmacotherapy. 2007;27(7):948-962. 14. http://www.ismp.org/newsletters/acutecare/articles/20080508.asp PharMerica Corporation 2011 6