A technician s guide to injectable diabetes medications

Transcription

1 By Andrea Wooley, Pharm D, BCACP clinical assistant professor, and Nancy Lyons BS Pharm MBA CDE, consultant, NLCM and director CE and clinical content at Drug Store News Author Disclosures: Andrea Wooley, Nancy Lyons and the DSN editorial and continuing education staff do not have any actual or potential conflicts of interest in relation to this lesson. Universal program number: H01-T CE Broker Tracking # Activity type: Knowledge-based Initial release date: Aug. 5, 2016 Planned expiration date: Sept. 8, 2018 This program is worth one contact hour (0.1 CEUs). Target Audience: Technicians in community-based practice. Program Goal: The goal of this lesson is to review available injectable diabetes therapies, providing the pharmacy technician with practical information to advocate for patient care. Learning Objectives Upon completion of this program, the technician should be able to: 1. Identify patients who are in need of education on proper injection technique for injectable diabetes therapies. 2. Facilitate patient education sessions with the pharmacist. 3. Describe the treatment indications for the use of injectable diabetes medications. 4. Detect possible symptoms of adverse reactions in patients using injectable diabetes medications. To obtain credit: Complete the learning assessment and evaluation questions online at DrugStoreNewsCE.com. A minimum test score of 70% is needed to obtain a statement of credit. Your statement of credit will be available at CPE Monitor (NABP.net). Your correct e-pid number must be included in your DSN CE profile to ensure transmission of credit to CPE Monitor. Questions: Contact the DSN customer service team at (800) Cost: There is no cost to participate in this program. This program is sponsored by BD. Drug Store News is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This lesson is sponsored by BD A technician s guide to injectable diabetes medications INTRODUCTION Diabetes is a common health epidemic in the United States. Recent statistics report that 29.1 million people (9.3% of the United States population) currently have diabetes with nearly 95% of those with the disease having Type 2 diabetes, the type of diabetes that usually is diagnosed in adults, although some children have Type 2 diabetes. 1 Diabetes will become a bigger issue in the coming years as the Centers for Disease Control and Prevention estimates that 86 million adults in the United States have prediabetes, a condition that, if left untreated, could change the incidence of diabetes to 1-in-3 in the coming decades. 2 In addition to the harmful health effects, caring for people with diabetes and the multiple complications that uncontrolled diabetes has is expensive. Diabetes costs, as calculated in 2012, were $245 billion.1 Researchers also estimate that average medical expenditures for a person with diabetes are 2.3 times higher than a person who does not have the disease. 1,2 THE HISTORY OF DIABETES THERAPY Prior to 1921 and the discovery of insulin, people with Type 1 diabetes, the type of diabetes that is caused by the body s inability to make the hormone, did not have long lives. That discovery resulted in the miraculous 1922 recovery of Leonard Thompson the first human patient to receive injected insulin.3 Around the same time, researchers also were working on a drug that was similar to metformin, a drug that is now recommended as a first-line treatment for most people with Type 2 diabetes. In 1937, scientists were working on a drug that was similar to the early sulfonylurea drugs. Examples of common sulfonylurea drugs today are glyburide, glipizide and glimepiride. Since those early days of discovery, multiple medications for diabetes have been developed and marketed in the United States with multiple new classes and new formulations of older medications. 3 In addition to the availability of new drugs, experts in the care of diabetes regularly publish guidelines to recommend the best ways to use all of the available therapies for patients based upon continuing research. These guidelines can be used by all healthcare professionals who care for people with diabetes. Key groups that regularly publish clinical guidance documents include the American Diabetes Association or the ADA, the American Association of Clinical Endocrinologists or the AACE, the American College of Endocrinology or the ACE and the European Association for the Study of Diabetes or EASD. In January 2016, the ADA published the annual update to the Standards of Medical Care, a commonly referenced resource. At the same time AACE/ACE also published an update to the Comprehensive Type 2 Diabetes Management Algorithm. While these two key guidelines differ slightly in the specific recommendations for the management and clinical treatment goals of diabetes, both groups stressed the need for a personalized approach when developing treatment plans. As patients arrive in the pharmacy to fill medications, the pharmacist can reference these guidelines to review recommendations and help ensure patients are receiving the best care. In the past, diabetes treatment guidelines for patients with Type 2 diabetes often recommended that patients first try to change their diet 1 SEPTEMBER

2 and activity and wait to see if the changes helped. Over time, researchers have concluded that waiting to see how lifestyle interventions might work was not the best plan. As prescribers began adding diabetes medications for patients with Type 2 diabetes in the past, many would try oral therapies, and if the patient did not reach his or her goal, prescribers would increase the dose of the oral therapies and add more oral therapy classes. Insulin, the first successful drug for the treatment of diabetes, was avoided by many prescribers and patients with Type 2 diabetes. Many considered insulin the last resort. Today s updated guidelines recommend different approaches. Insulin is now considered a first-line therapy option with Type 2 diabetes patients who are newly diagnosed and have marked symptoms (polyuria, polydipsia, polyphagia) and/or elevated blood glucose or A1c results. If patients using other diabetes medications are at the maximum-tolerated doses and are not reaching their personalized A1c target for a period of three months, the new guidelines recommend adding one of the injectable diabetes medications that include insulin (usually beginning with a long-acting insulin) or a newer class called glucagon-like peptide 1 receptor agonists. This recommendation is important if the patient s A1c is elevated significantly due to the limits of A1c reduction in the oral medications. GLP- 1 RA agents may be considered to be added after basal insulin instead of the addition of a prandial insulin.4,5 GLP-1 RA agents are recommended over short-acting, meal-time insulin because GLP-1 RA agents have the ability to lower blood glucose with less risk of hypoglycemia and have a potential to cause weight loss rather than weight gain that is more common with insulin. 4,5 These agents also may be used as double therapy with metformin, or triple therapy with metformin plus thiazolidinediones, sulfonylureas or insulin. 4,5 BARRIERS TO USE OF INJECTABLE THERAPIES Even though the clinical guidelines for the treatment of Type 2 diabetes are clear, many patients and prescribers still avoid using insulin and GLP-1 RA agents. The Diabetes Attitudes Wishes and Needs or DAWN study was a large study of 5,000 people with diabetes and 3,000 healthcare professionals in 13 countries in DAWN was conducted to explore many psychosocial thoughts that patients and prescribers have about diabetes and its treatment. One of the components of the study concentrated on the barriers or reasons why more than half of patients living with diabetes are not at clinical goals, even though medications and evidence-based guidelines are available. 6 In 2005, researchers published results of specific findings related to provider and patient resistance to insulin therapy. Patients expressed feelings of self-blame in not properly self-managing diabetes as key reasons for avoiding insulin, associating the use of insulin as a personal failure rather than the normal progression of the disease. Researchers also examined providers attitudes and beliefs that lead to the reasons that 50% to 55% of nurses and general practitioners delayed adding insulin, calling it a last resort even when patients weren t at clinical goals. These providers delayed insulin when they felt that patients were non-adherent to medication regimens or appointments. 6 Other provider reservations included their perceptions of their patients family support, abilities to complete needed training and overall cognitive abilities to understand instruction. 6 Other studies offered similar reasons for patient and prescriber reluctance to use injectable insulin therapies. Additional patient reasons included fear of the actual self-injection process and concerns about available support resources, including financial costs/ insurance coverage and family member/ caregiver support. Primary care providers noted lack of available knowledgeable resources for patient training, complicated dosing and monitoring needs and concerns about patient safety as key reasons for delaying injectable insulin. 7,8,9,10,11 OPPORTUNITIES FOR COMMUNITY PHARMACY Each of the reasons patients and prescribers raised for their delay in using insulin and other injectable diabetes medications is an opportunity for community pharmacy to set up diabetes patient care programs and processes designed to fill the needs. Pharmacists across the country already have set up successful medication therapy management programs, with some being able to use protocols to care directly for patients. Pharmacists also participate in programs with providers, employer groups and patients to serve as diabetes coaches for patients that result in significant healthcare savings, while overcoming many of the patient- and prescriber-identified obstacles to diabetes care. 12,13 Each of these examples offers models that can be adapted to benefit local patients, providers and payers. By working collaboratively and involving all members of the patient s support resources, pharmacy can make a difference with key barriers. Programs to provide knowledgeable resources to allow patients to select the best products, receive training, guidance and structured services to improve adherence to injectable therapies, assist in titration of doses, educate patients in needed self-care skills and perform thorough monitoring are examples of pharmacy services that could benefit the patients of busy primary care practices. As options to enhance services are explored, the pharmacy technician has a role in assisting patients with appropriate product selections, identifying opportunities for enhanced education and training sessions with the pharmacist and advocating for patients to seek the care needed. As pharmacy-delivered diabetes services are developed, a place to begin collaboration is with primary care practices that may not have in-office access to education and support resources. In these offices where educational resources are limited, insulin initiation can present challenges with the multiple patient education, monitoring and follow-up responsibilities that are needed to safely start patients on therapies. By building pharmacy services that fill in the gaps and offer solutions to patients and prescribers, recommended treatment options become easier to carry out for all. Some pharmacies offer options for prescribers to refer patients to the pharmacy, using a prearranged protocol for a standard basal insulin initiation. In the process, the pharmacy would first work with the prescriber, patient and insurance to ensure that the patient receives all medications and supplies that are recommended. Once the patient is set with needed supplies, services also can include self-management skills training, general education about self-care and other resources, as well as monitoring and titration of therapy with documented follow-up communication provided to the prescriber. The needs of patients and prescribers, and the laws that govern pharmacy, vary across the country. By working within the local community to assess needs and customize services available to meet those needs, patients will benefit. Community pharmacies equipped with knowledgeable staff can offer the skills, abilities and processes that can impact medication adherence, patient knowledge, self-care skills and overall medication safety. A LOOK AT INJECTABLE DIABETES THERAPIES Each of the injectable diabetes therapies that are available has specific education and counseling points that must be covered by the pharmacist. An awareness of key aspects of injectable diabetes medications will allow the pharmacy technician to better support the needs of the patient and the pharmacy staff. Many of the therapies available for injection are marketed in prefilled devices that allow patients to prepare doses for administration more easily. Insulin, the most common injectable diabetes therapy, is available in both a vial that requires a separate syringe and in a pen SEPTEMBER

3 device that requires the attachment of a pen needle prior to administration. One of the first considerations that will be made for patients selecting injectable therapies is what kind of administration device will be used. That will guide the product selection as prescriptions are processed. Syringes Patients using multidose vials of insulin will need insulin syringes or, in at least one case, tuberculin syringes in order to administer their medication. The need for tuberculin syringes will be discussed later. Insulin syringes are available in a variety of barrel sizes, needle lengths and gauges. To assist a patient in selecting the appropriate syringe, consider the following points: Concentration of insulin Until recently, the majority of insulin products used by patients in the United States were of U-100 concentration, or 100 units per ml. U-40 and U-500 products were available to meet specific patient needs, but were not as common. With the increased incidence of insulin resistance, or the body s need for larger doses of insulin to get the cells to respond, a number of concentrated insulin products now are available in addition to the U-500 regular insulin that has been around for decades. Dosing considerations for concentrated insulins will be discussed later. In general, patients using U-100 insulins should choose U-100 insulin syringes to accurately measure the dose. Units to be administered The next step in selecting the appropriate syringe is to match the maximum number of units that the patient expects to inject to the capacity of the insulin syringe. Insulin syringes are available in 3/10 cc, ½ cc and 1 cc. 3/10 cc syringes measure 30 units or less markings are in ½-unit increments ½ cc syringes measure 50 units or less markings are in one-unit increments 1 cc syringes measure 100 units or less markings are in two-unit increments General considerations when selecting the barrel size of the syringe are to use the syringe that is closest to the maximum dose to be administered during the various times of the day. For example, a 20-unit dose of insulin would be easiest to see and measure with a 3/10 cc syringe. There are a few additional considerations needed when a patient is just beginning insulin therapy. In many cases, prescribers will start the patient on a low dose and then gradually increase the recommended units based upon blood glucose results or other monitoring. In those cases, the patient may outgrow the capacity of the 3/10 cc syringe quickly and be left with unusable supplies. If patients are beginning therapy by adding a short-acting or rapid-acting mealtime bolus insulin, the number of units can vary greatly based upon the amount of carbohydrate consumed. If the typical meal s recommended dose is near the capacity of the selected syringe, it may be advisable to use the next size to allow for special occasions. Always check with the pharmacist if you suspect that a patient may need to start on a slightly larger capacity syringe. It also is important to consider the number of units that will be measured. The markings on a 1 cc syringe are spaced in two-unit increments, while the ½ cc syringe is in oneunit increments and the 3/10 cc syringes allow ½-unit measurement. Because patients with diabetes can have visual problems, having a syringe with easy-to-see markings is beneficial. Needle gauge The next step is to assist the patient in understanding the differences in the gauge PATIENT SCENARIO 1 of available syringes. Needle gauges of syringes can range from 28 to 31. The larger number translates into a thinner gauge, which is considered more comfortable. Needle length Syringes also are available in a number of lengths, ranging from 6 mm to 12.7 mm. It was originally thought that obese patients needed longer needle lengths to receive accurate doses, and the shorter lengths should be reserved for children and thin patients. This guidance was reversed by a study published in 2011 in Diabetes Technology and Therapeutics. In that study, researchers compared two needle lengths and found no significant differences in the A1c measured in the two groups. 14 Shorter needles effectively deliver insulin doses into the targeted subcutaneous tissue space and avoid injection into the muscle in thin and obese patients. While researchers did not find a statistically significant difference in study patients preferences for the two lengths, clinical recommendations have been updated to recommend starting patients on shorter needle lengths to ensure delivery into the appropriate subcutaneous space, to increase comfort and Part 1 Joe, a 49-year-old Asian-American male, is a regular patient at the pharmacy. He has a number of prescriptions on file, including metformin, repaglinide, hydrochlorothiazide and atorvastatin. Additionally, he has a prescription on file for diabetes test strips. He arrives at the pharmacy with a new prescription for exenatide, the twice-daily formulation. He confides in the technician that he is not thrilled about the new prescription, but his doctor told him it would help him with his blood sugar, and he may lose a few pounds. As the technician begins processing the prescription, he notices that the prescriber wrote a prescription for needles and supplies in addition to the exenatide prescription. How should the technician proceed? Discussion Joe will need to have a supply of pen needles and alcohol swabs in order to use the exenatide twicedaily prescription. Based upon the current recommendations concerning needle length, the technician selects a box of 4 mm-32 gauge pen needles and a supply of alcohol swabs to be used when cleaning the pen device prior to attaching the pen needle. The technician lets Joe know that it will take 10-to-15 minutes to finish processing the orders Part 2 Approximately 20 minutes later, Joe arrives at the pick-up window. The technician greets Joe and begins the check-out process. He advises Joe that the pharmacist will be right over to review some important information about the new prescriptions. Joe begins explaining that he doesn t have any questions and wants to just pick up the prescription and go. How should the technician respond? Discussion The technician is in a difficult position as the pharmacist is tied up with other responsibilities as a regular patient is forced to wait. The patient already has indicated that he has no questions and wants to take his prescription and leave. At this point, the technician should explain why he is hesitating. The new prescription that Joe is picking up has some important counseling points that he wants to be sure the pharmacist can share. It is important for the technician to stress that he is simply trying to make sure that the patient can safely use the new medication. 3 SEPTEMBER

4 to lessen needle phobia that some patients reported. Additional studies support the clinical recommendation to start patients on shorter needles. Pen Needles Many of the newer injectable diabetes therapies are packaged in delivery devices that remove some of the technical barriers that patients experience when needing to pull doses from a multidose vial. These newer devices simplify the injection considerations and remove the concentration and dose capacity decisions, leaving only needle gauge and length to be chosen. Pen needle gauge As with traditional insulin syringes, pen needles are available in a variety of gauges, ranging from 29 to 32. Thinner needles are associated with increased comfort for the patient. Pen needle length Pen needles range in length from 4 mm to 12.7 mm. Newer clinical recommendations support the use of shorter needles for all patients, including obese patients to ensure delivery into the subcutaneous space rather than allowing penetration of the muscle. This recommendation was supported by the 2011 needle length comparison study results published in Diabetes Technology and Therapeutics. 14 GENERAL INJECTION CONSIDERATIONS 16 Hygiene 16 With any injectable therapy, patients should be advised to practice good hygiene to avoid the risk of infection and contamination. Handwashing should be a part of the discussion, as well as maintaining a clean workspace when filling a syringe or attaching a pen needle. Most manufacturers also recommend using an alcohol swab to clean the stopper of open, multidose vials and pen devices prior to inserting the syringe or pen needle. For that reason, a patient who will be using insulin or another injectable diabetes medication will need alcohol swabs to be included on the supplies list. Many patients also ask about the need to swab the site they will be injecting because they have seen nurses, pharmacists and other healthcare professionals use an alcohol swab before administering injections. Patients who are not within an institution, such as a hospital or clinic, and who are able to practice good general hygiene (i.e., access to a shower) are not required to swab the skin of the injection site with alcohol prior to administering the dose as alcohol can dry the skin and increase the potential for damage. 15,16 If the patient is in a particularly dirty environment at the time of injection and soap and water are not available, using an alcohol swab is acceptable. Injection sites 16 Many patients will receive instruction from the prescriber or the person providing their injection training about the location in which to inject the prescribed medication. The most common injection site chosen is the abdomen in areas at least two inches away from the umbilicus, or belly button. Additional sites in which the patient may inject include the upper arms, the upper buttocks or hip area and the thigh. When patients are unsure about the injection site selection, it is important to arrange a discussion with the pharmacist as there are important considerations about avoiding areas with moles, scars or other disruptions, rotating the point of injection within the chosen site and providing information about inflammation, lipodystrophy and pitting that the pharmacist will want to cover with the patient. Selection of appropriate device 16 When the injectable diabetes medication is available in multiple packaging and delivery options, there are many considerations to select the best option. Cost often is an initial factor, and insurance coverage should be explored. The patient should then consider the physical manipulation needs of the vial/syringe versus the pen device, as well as dosage availability, storage requirements and portability needs. General injection method 16 Each device has specific injection instructions that must be covered during the counseling session with the pharmacist. When patients arrive to pick up new injectable diabetes therapies, it is very important to alert the pharmacist about the need to counsel the patient, even if the patient feels that he or she can figure the instructions out independently. With these therapies, there can be significant safety issues or areas in which a simple mistake can cause a loss of the dose. Be sure to be an advocate for the patient by filling in the gaps that there are important pieces of information that he or she will want before using the product, and politely ask the patient to wait for the pharmacist to share the needed information. General practical tips When working with patients to help in the selection of the best insulin syringe or pen needle for their medication delivery, it is important to reinforce that both syringes and needles are intended for single use only. Disposal of sharps When patients begin new injectable therapies, it also is important to review sharps disposal recommendations when assisting with needed supplies. Because sanitation requirements for the general public can vary by county and are different than the requirements placed on pharmacies and other institutions, it is important to investigate local laws and statutes to provide the most accurate information. In some cases, the general public may not be required to purchase a sharps container, if they take reasonable precautions to dispose of sharps in puncture-resistant containers. In general, the following recommendations can be shared: Patients must be made aware of the risks associated with syringes, pen needles and other sharps they may use including lancets. The instruction should include personal risks and risks to others, including family members, pets, friends and sanitation workers. Pharmacies should offer solutions that are applicable to any environment in which the patient may introduce a used sharp, including home, work, travel and social gatherings. Adverse effects and hypoglycemia With any medication, the pharmacist will discuss the potential of adverse effects, as well as general expectations for the therapy, along with recommendations for actions to take if an event occurs. Education about each of these components can reduce patient risks. When working at the in- and out-windows of busy community pharmacies, it is easy to allow patients to simply decline counseling with the pharmacist. With injectable diabetes therapies, there are a number of effects that can be managed with quick education. It is important for the technician to help the patient understand the problem of not knowing the questions that should be asked rather than asking if the patient has questions. By simply modifying the communication at the out-window to alert the patient of the needed discussion with the pharmacist, the technician can impact patient outcomes and overall safety. The pharmacist needs to discuss the risk of bruising, bleeding, discomfort, inflammation and infection with patients using these therapies. It also is important for the pharmacist to check in with the patient about routinely inspecting any injectable diabetes medication prior to administration. As over time, bad habits can develop with even the most knowledgeable patient. Perhaps the most important discussion that the pharmacist will want to have with a patient beginning insulin treatment is about the potential for hypoglycemia. The SEPTEMBER

5 discussion should include a review of the most common signs, symptoms and advice for a specific action plan for how to handle the low blood sugar. Table 1 lists common symptoms of hypoglycemia. Patients who are at risk will need a plan that includes monitoring their blood sugar, consuming fast-acting carbohydrates, monitoring and repeating steps as necessary. Table 2 provides examples of recommended fastacting carbohydrates that can be used by patients experiencing low blood sugar. Some patients using insulin may experience extremely low blood sugar that can cause unconsciousness. In these patients, a caregiver must administer glucagon for the patient. The pharmacist needs an opportunity with the patient to assess the patient s risk and to consider a glucagon kit for the patient s safety. By not letting these patients simply decline counseling, the technician can greatly impact patient care. INJECTABLE THERAPY OVERVIEW The next section of the lesson will review the available injectable diabetes medications to allow the technician the opportunity to review the detailed instructions that the pharmacist must provide to ensure the patient is well managed. Reviewing Insulin There are several types of insulin available. Insulins are stored in the refrigerator before their first use. 18 Unopened insulins that are properly refrigerated are good until the expiration date printed on the label. Once opened, refrigeration is not necessary. Expiration dates for in-use products vary by manufacturer and device. Consult individual product-package inserts to advise patients about appropriate use. 18 This is particularly important for patients using small insulin doses from a multidose vial. A 10 ml vial of U-100 insulin contains 1,000 units of insulin. If the manufacturer recommends discarding unused insulin 31 days after opening, patients using less than 32 units of that insulin per day will have left over insulin that should be discarded. Insulin pens should not be stored in the refrigerator once they are opened. Insulins are categorized by the duration of action as ultra-long-acting, long-acting, intermediate- acting, short-acting or rapidacting. 18 Additionally, there are multiple concentrations available. Concentrated insulins have more than 100 units per ml. Table 3 contains a summary of the various types of available insulins. Concentrated Insulins U-500 regular insulin was the first form of concentrated insulin marketed in the United States. It was developed for those with insulin resistance. 19 When patients require large doses of insulin, the volume of medication needed of the U-100 product can prevent full insulin absorption within the subcutaneous space, thus limiting its ability to control blood glucose. 19 When this occurs, it is appropriate to consider the use of a concentrated insulin. There are four concentrated insulins currently marketed in the United States: U-500 regular insulin (a short-acting insulin) marketed under the brand name Humulin R U-500; Insulin glargine 300units/mL (a longacting insulin) marketed under the brand name Toujeo Insulin degludec 200 units/ml (an ultra long-acting insulin) marketed under the brand name Tresiba Insulin lispro 200 units/ml (a rapidacting insulin) marketed under the brand name Humalog U-200. U-500 regular insulin is available in a vial and a prefilled pen. When injecting U-500 regular insulin via syringe, many professionals recommend the use of a tuberculin syringe with the dose specified in ml. 19 The concentration difference presents a patient safety risk if U-100 syringes are dispensed without proper dosing conversion instruction. If used incorrectly, a standard insulin syringe could deliver five times the recommended dose. Should an insulin syringe be used, it is vital to educate the patient on how to properly draw up the reduced volume of insulin. The availability of the prefilled U-500 pen reduces this risk for patients as the volume calculation is removed. It is important that those patients who are converting from U-100 insulin to U-500 insulin speak to the pharmacist as there are differences in the clicks of the pen, and there could be a need to reduce the patient s total dose depending upon his or her A1c. 19 Long-acting/ ultra long-acting insulins Long-acting insulins include insulin Table 2 15 gm servings of carbohydrates EXAMPLES Three-to-five glucose tablets (check the nutrition facts label) One tube of glucose gel Three packets of table sugar glargine under the brand names Lantus, Basaglar and Toujeo. Basaglar was recently approved as a follow on drug. This is a new abbreviated path to Food and Drug Administration approval. 21 Drugs that are approved as follow on drugs are required to prove their similarity to a drug that has already been approved by the FDA. Basaglar proved its similarity to Lantus, and based on Lantus prior evidence of safety and efficacy, Basaglar was approved. 21 Lantus and Basaglar contain insulin glargine 100 units/ml. Toujeo is a concentrated form of insulin glargine at 300 units/ml. Each prefilled pen of Toujeo contains a total of 450 units of insulin. Patients injecting Toujeo should dial to the dose prescribed by their provider. When converting from Lantus or Basaglar to Toujeo, a one-to-one conversion should be used.21 If a patient was injecting 40 units of Lantus, they should inject 40 units of TYPE Severe Severe Severe 4 oz. (1/2 cup) of soda, fruit juice or other non-low calorie beverage One tbsp. honey One mini juice box Two tablespoons of raisins Table 1 Common symptoms of hypoglycemia DESCRIPTION Shakiness Sweaty Hungry Headaches Blurred vision Sleepiness Dizziness Lack of coordination Combative Weakness Unconsciousness Seizures Unable to eat or drink 5 SEPTEMBER

6 Toujeo by dialing to 40. All three brands of insulin glargine are to be injected once daily to cover the patients basal insulin needs. Glargine formulations should not be mixed with other insulins Insulin detemir, sold under the brand name Levemir, is another long-acting insulin that comes in both vials and prefilled pens. Insulin detemir is dosed once or twice daily. It may require twice-daily dosing to sustain a long- acting duration. 25 It should not be mixed with other insulins. 25 Insulin degludec, under the brand name Tresiba, is an ultra long-acting insulin. It comes as 100 units/ml or 200 units/ml. 28 When using the concentrated 200 units/ ml pen, patients should dial to the dose prescribed by their provider. The duration of insulin degludec is greater than 42 hours. This allows the drug to work more like the body s basal release of insulin at steady state. Intermediate-acting insulin Insulin NPH is an intermediate-acting insulin that is generally dosed up to twice a day to cover for basal glycemic control. One benefit to the use of NPH is that it can be mixed with rapid-acting or short-acting insulins, allowing patients to achieve basal and mealtime insulin coverage with a single injection. There are a number of counseling considerations for patients using NPH, including the need to gently roll the NPH vial between the hands to mix the suspension rather than shaking the vial, and a number of steps if the patient will be mixing insulins in a syringe.30 Premixed insulins Insulins also come as premixed formulations, containing both basal and bolus insulin in one premixed injection. These insulins are cloudy and should be mixed prior to injection by gently rolling the pen or vial between the palms of the hands. Humalog Mix 50/50TM, Humalog Mix 75/25TM and Novolog Mix 70/30 contain rapid-acting bolus insulin, along with the basal insulin, and should be injected 15 minutes prior to eating Humulin Mix 70/30 and Novolin Mix 70/30 contain short-acting insulin and should be injected 30-to-60 minutes prior to eating.34 Insulin degludec/insulin aspart injection marketed as Ryzodeg 70/30, a rapid-acting and long-acting formulation, is recommended to be injected prior to eating. 35 When using premixed insulins, providers are unable to individualize the basal and bolus doses based on the premixed nature of the preparation. This format allows for a reduction in the total number of injections a patient receives, but also increases the risk of hypoglycemia if patients are not able to maintain consistent food schedules. Rapid-acting insulins Rapid-acting insulins including insulin lispro, insulin glulisine and insulin aspart, are designed to target prandial peaks in blood glucose and should be injected just before eating, within 5-to-15 minutes Insulin lispro also comes as a concentrated insulin of 200 units/ml. 37 These rapid-acting insulins are clear and colorless and can be mixed with the intermediate-acting insulin, NPH. 37,39-40 Insulin lispro 200 units/ml should not be mixed with any other insulins. 40 GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGO- NISTS Glucagon-like peptide-1 receptor agonists, or GLP-1 RA, are one of the newer classes of diabetes drugs. Glucagon-like peptide-1 regulates glucose control in the body by binding to glucagon-like peptide-1 receptors in response to ingestion of fat and carbohydrates. The glucose-dependent binding of these receptors leads to an increase in insulin release from the beta cells of the pancreas, an inhibition of the glucagon release from the alpha cells of the pancreas, which delays gastric emptying and promotes beta cell proliferation. 41 There currently are four GLP-1 RAs approved by the FDA exenatide, liraglutide, dulaglutide and albiglutide. The most commonly seen side effects within this class of medications are nausea, vomiting and injection site reactions.41 As a favorable side effect, these drugs also have been reported to lead to weight loss of 0.2 kg to more than 3 kg When these products are dispensed, there are a number of important counseling points that must be covered as the set up and delivery of the medications is quite complex. The technician must advocate for the patient by raising the patient s awareness of the unknown questions. Dulaglutide Dulaglutide comes as a prefilled pen that is used once weekly. The product must be dispensed with a med guide and patients should be advised of the box warning concerning the risk of thyroid C-cell tumors. Each pen is used once and then discarded. It may be administered directly from the refrigerator without allowing the product to come to room temperature. It may be kept out of the refrigerator for up to 14 days. The pen has glass parts and thus should be discarded if it is dropped. Counseling with the pharmacist is necessary to ensure that the patient can safely use dulaglutide. 44 Albiglutide Albiglutide comes as a prefilled pen that is stored in the refrigerator. It is administered once weekly and may be stored at room temperature for up to four weeks. The product must be dispensed with a med guide and patients should be advised of the box warning concerning the risk of thyroid C-cell tumors. It must be reconstituted prior to administration. The powder and water are in separate compartments in the pen. Counseling with the pharmacist is necessary to ensure that the patient can safely use abliglutide. 45 Weekly Exenatide Exenatide comes in two different preparations, a once-weekly injection and a twicedaily injection. Both formulations must be dispensed with a med guide and patients should be monitored concerning the risk of thyroid C-cell tumors. The package insert for the once-weekly formulation contains a box warning, while the twice-daily formulation does not contain a box warning, but does contain labeling concerning the risk of thyroid C-cell tumors. The once-weekly formulation is stored in the refrigerator and should be protected from light. The preparation must sit out at room temperature for 15 minutes prior to administration and must be reconstituted prior to administration. It comes in both a prefilled pen and a single-dose tray. Counseling with the pharmacist is necessary to ensure that the patient can safely use exenatide. 46 Twice-daily Exenatide The twice-daily exenatide formulation comes in a prefilled pen and offers one appeal over its once-weekly counterpart it does not need to be reconstituted prior to injection. It is taken twice daily 60 minutes before morning and evening meals. Twicedaily exenatide does not come packaged with a pen needle and requires a separate prescription. Before initial use, exenatide is stored in the refrigerator, but may be stored at room temperature after first use. It should be discarded in 30 days, even if there is medicine remaining in the pen. Counseling with the pharmacist is necessary to ensure that the patient can safely use exenatide. 46 Liraglutide Liraglutide is stored in the refrigerator. It is FDA approved both for the treatment of diabetes under the brand name Victoza and for weight loss under the brand name Saxenda. The product has an FDArequired Risk Evaluation and Mitigation Strategy, or REMS requirement, due to the potential risk of medullary thyroid C-Cell cancer (a boxed warning). as well as an increased risk of acute pancreatitis. Pen needles do not come with liraglutide and thus require a separate prescription. Liraglutide SEPTEMBER

7 Table 3 Summary of insulins BRAND NAME GENERIC NAME CONCENTRATION LONG-ACTING INSULINS MAX UNITS DELIVERED PER DOSE BY PEN FREQUENCY STORAGE Lantus, Lantus SoloSTAR Insulin glargine 100 units/ml 80 units Daily Store unopened pens and vials in the refrigerator before use or at room temperature After initial use, vials can be stored at room temperature or refrigerated Basaglar KwikPen Insulin glargine 100 units/ml 80 units Daily Store unopened pens in the refrigerator before use. Store at room temperature for up to 28 days after use. Toujeo SoloSTAR Insulin glargine 300 units/ml 80 units Daily Store unopened pens in the refrigerator. After opening, store pens at room temperature for up to 42 days. Do not refrigerate once opened. Levemir, Levemir FlexTouch Insulin detemir 100 units/ml 80 units Daily-BID Store unopened pens in the refrigerator or at room temperature for up to 42 days. After use, store vials at room temperature or in the refrigerator for up to 42 days. Pens must be stored at room temperature after initial use for up to 42 days. Do not store opened pen in the refrigerator. Tresiba FlexTouch Insulin degludec 100 units/ml 200 units/ml INTERMEDIATE-ACTING INSULIN Humulin N, Humulin N KwikPen Novolin N 80 units 160 units (Continued on page 8) 7 SEPTEMBER Daily Store unopened pens under refrigeration or at room temperature for up to 56 days. Once opened, store at room temperature for up to 56 days. Do not store opened pens in the refrigerator. Insulin NPH 100 units/ml 60 units BID Humulin N vial: Store unopened vials in the refrigerator. Once opened, vials may be stored at room temperature or in refrigerator for up to 31 days. SHORT-ACTING INSULIN Humulin R U-500 Humulin R U-500 KwikPen Insulin regular 500 units/ml 300 units BID-QID depending on total daily dose Humulin R Novolin R Humulin N KwikPen TM : Store unopened pens in the refrigerator. Once opened, store pens at room temperature for up to 14 days. Do not store open pens in the refrigerator. Novolin N: Store unopened vials in the refrigerator or at room temperature for up to 42 days. Once opened, store vials at room temperature for up to 42 days. Do not store opened open vials in the refrigerator. Store unopened vials in the refrigerator. Once opened, vials may be stored at room temperature or in the refrigerator for up to 40 days. Store unopened pens in the refrigerator. Once opened, store pens at room temperature Do not store open pens in the refrigerator. Insulin regular 100 units/ml Not available in pen BID Humulin R: Store unopened vials in the refrigerator. Once opened, vials may be stored at room temperature or in the refrigerator for up to 31 days. Novolin R: Store unopened vials in a refrigerator for up to 42 days. Once opened, store vials at room temperature for up to 42 days. Do not store open vials in the refrigerator. RAPID-ACTING INSULIN Novolog, Novolog FlexPen Insulin aspart 100 units/ml 60 units TID Store unopened vials in the refrigerator. Opened vials should be stored at room temperature

8 Table 3 Summary of insulins BRAND NAME GENERIC NAME CONCENTRATION RAPID-ACTING INSULIN Humalog, Humalog KwikPen Insulin lispro 100 units/ml Insulin lispro 200units/mL 100 units/ml 200 units/ml MAX UNITS DELIVERED PER DOSE BY PEN FREQUENCY STORAGE 60 units TID Store unopened vials in the refrigerator. Opened vials should be stored at room temperature Apidra, Apidra SoloSTAR Insulin glulisine 100 units/ml 80 units TID Store unopened vials in the refrigerator. Opened vials PREMIXED INSULINS *mix prior to administration Humalog Mix50/50 TM, Humalog Mix50/50 TM Kwikpen Humalog Mix 75/25 TM, Humalog Mix 75/25 TM Kwikpen Novolog Mix 70/30, Novolog Mix 70/30 FlexPen Ryzodeg 70/30 Humulin 70/30, Humulin 70/30, KwikPen, Novolin 70/30 Insulin lispro protamine and insulin lispro Insulin lispro protamine and insulin lispro Insulin aspart protamine and insulin aspart Insulin degludec and insulin aspart Insulin NPH and insulin regular should be stored at room temperature 100 units/ml 60 units BID Store unopened vials in the refrigerator. Opened vials should be stored at room temperature for up to 10 days. 100 units/ml 60 units BID Store unopened vials in the refrigerator. Opened vials should be stored at room temperature for up to 10 days. 100 units/ml 60 units BID Store unopened vials in the refrigerator. Opened vials should be stored at room temperature for up to 14 days. 100 units/ml *Not yet available Daily or BID should be stored at room temperature 100 units/ml 60 units BID Humulin 70/30 vial: Store unopened vials in the refrigerator. Opened vials may be stored in the refrigerator or at room temperature for up to 31 days. Novolin 70/30 vial: Store unopened vials in the refrigerator. Opened vials must be stored at room temperature for up to 42 days. Do not store opened vials in the refrigerator. Humulin 70/30 KwikPen : Store unopened pens in the refrigerator. Opened pens should be stored at room temperature for up to 10 days. Do not store opened pens in the refrigerator. pens can be stored at room temperature for up to 30 days. Pen needles must be discarded in 30 days even if the drug is remaining in the package. Counseling with the pharmacist is necessary to ensure that the patient can safely use liraglutide. 47 CONCLUSION The number of available diabetes therapies continues to grow. With the new therapies, prescribers have more alternatives to help patients in achieving clinical targets for glucose control and reducing the incidence of costly complications. With the growing sophistication of available thera- SEPTEMBER

9 Table 4 Summary of GLP1-RA BRAND NAME GENERIC NAME FREQUENCY WEIGHT LOSS Trulicity Dulaglutide Weekly 1.34 kg to 1.44 kg Tanzeum Albiglutide Weekly 0.64 kg to 1.7 kg REDUCTION IN A1C STORAGE CLINICAL PEARLS 1.32% to 1.38% 0.79% to 0.82% Store in the refrigerator. May be kept out of the refrigerator for up to 14 days. Store in refrigerator. May be stored at room temperature for up to four weeks. Must wait 15 minutes prior to reconstituting the drug if it s been stored in the refrigerator. Bydureon Exenatide Weekly 2 kg to 3 kg 1.3% to 1.9% Store in the refrigerator. Let the pen warm outside the fridge for 15 minutes prior to injection. Protect the pen from light. Byetta Exenatide BID 2 kg to 3 kg 0.8% to 1.2% Store in the refrigerator. Protect from light. Victoza Liraglutide Daily 0.2 kg to 3.3 kg 1% to 1.5% Store in the refrigerator. May be stored at room temperature after initial use. Discard after 30 days. Has glass parts throw out if dropped Must be reconstituted before administration Must be reconstituted prior to administration Requires separate prescription for pen needle Also FDA-approved for weight loss under the brand name Saxenda Requires separate prescription for pen needles pies, patients and prescribers need additional educational resources to ensure that patients receive the necessary education and training to safely and effectively use recommended treatments. The community pharmacy is well-positioned to ensure that all staff members are knowledgeable about the needs of the patients and prescribers, and are prepared to meet the needs and ultimately improve patient adherence, clinical outcomes and quality of life. PRACTICE POINTS The number of people living with diabetes is expected to continue to increase, creating a strain on the healthcare system. Patients with Type 2 diabetes are being managed in primary care settings, where available resources for training and education can be limited. Community pharmacies have opportunities to provide services that meet patient and prescriber needs. Technicians have an important role in advocating for patients with diabetes to ensure that appropriate counseling sessions with the pharmacist are completed. 1 Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, Atlanta, GA: U.S. Department of Health and Human Services; Centers for Disease Control and Prevention. Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; White, J. R. A Brief History of the Development of Diabetes Medications. Diabetes Spectrum 27.2 (2014): Print. 4 American Diabetes Association. Approaches to glycemic treatment. Sec. 7. In Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S52 S59. 5 Alan J. Garber, Martin J. Abrahamson et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm 2016 Executive Summary. Endocrine Practice 2016; 22-1: Peyrot M, Rubin RR, Lauritzen T, et al, the International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes and Needs study. Diabetes Care. 2005;28: Christopher Sorli, Michael K Heile. Identifying and meeting the challenges of insulin therapy in type 2 diabetes. J Multidiscip Healthc. 2014; 7: Published online 2014 Jul 2. doi: /jmdh.s Funnell MM. Overcoming barriers to the initiation of insulin therapy. Clin Diabetes. 2007;25: Yap K, et al Barriers to insulin initiation in type 2 diabetes mellitus: A single institution study among the physicians AACE 2013; Abstract Kunt, T, Snoek, FJ. Barriers to insulin initiation and intensification and how to overcome them. Int J Clin Pract Suppl Oct ;(164): Hayes, R. P., Fitzgerald, J. T. and Jacober, S. J. (2008), Primary care physician beliefs about insulin initiation in patients with type 2 diabetes. International Journal of Clinical Practice, 62: doi: /j x 12 Fera T., Bluml BM, and Ellis WM. Diabetes Ten City Challenge: Final Economic and Clinical Results. Journal of the American Pharmacists Association: JAPhA 49.3 (2009): Print. 13 Brennan, Troyen A., et al. An Integrated Pharmacy-Based Program Improved Medication Prescription and Adherence Rates in Diabetes Patients. Health Affairs 31.1 (2012): Print. 14 Kreugel G, Keers JC, Kerstens MN, Wolffenbuttel BHR. Randomized Trial on the Influence of the Length of Two Insulin Pen Needles on Glycemic Control and Patient Preference in Obese Patients with Diabetes. Diabetes Technology & Therapeutics. 2011;13(7): McCarthy JA, Covarrubias B, Sink P. Is the traditional alcohol wipe necessary before an insulin injection? Dogma disputed. Diabetes Care. 1993;16(1): Teaching Injection Technique to People with Diabetes. American Association of Diabetes Educators. Resources. June Inzucchi SE, Bergenstal RM, Buse JB, et. al. Management of Hyperglycemia in Type 2 Diabetes, 2015: A Patient Centered Approach. Diabetes Care 2015;38: Lexicomp. Insulins General Statement (AHFS DI (Adult and Pediatric)). Available at Accessed July 7, Lane WS, Cochran EK, Jackson JA, et. al. High-dose insulin therapy: is it time for u-500 insulin? endocr pract. 2009;15: U.S. Food and Drug Administration. FDA News Release. FDA approves Basaglar, the first follow-on insulin glargine product to treat diabetes. Available at PressAnnouncements/ucm htm. Accessed July 1, Toujeo Package Insert. Available at Accessed July 7, Basaglar Product Monograph. Available at Accessed July 7, Lantus Package Insert. Available at Accessed July 7, Johannes P, Bodenlenz M, Sinner F, et. al. A Double-Blind, Randomized, Dose-Response Study Investigating the Pharmacodynamic and Pharmacokinetic Properties of the Long-Acting Insulin Analog Detemir. Diabetes Care 2005 May; 28(5): Levemir Package Insert. Available at Accessed July 7, Haahr H, Heise T. A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance. Clin Pharmacokinet. 2014; 53(9): Zinman B, Philis-Tsimikas A, Cariou, B, et. al. Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes. Diabetes Care Dec;35(12): Tresiba package insert. Available at Accessed July 7, Meneghini L, Atkin SL, Gough, SCL, et. al. The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily. Diabetes Care 2013 Apr; 36(4): Humulin N Package Insert. Available at Accessed July 7, Humalog Mix50/50TM package insert. Available at Accessed July 7, Humalog Mix 75/25TM Package Insert. Available at com/us/humalog7525-pi.pdf. Accessed July 7, Novolog Mix 70/30 Package Insert. Available at Accessed July 7, SEPTEMBER

10 Clinical Pharmacology. Regular Insulin; Isophane Insulin (NPH). Available at m=3356&sec=monindi&t=0. Revised July 22, Accessed July 7, Ryzodeg 70/30 package insert. Available at label/2015/203313lbl.pdf. Accessed July 7, Yki-Jarvinen H, Kotronen A. Is There Evidence to Support Use of Premixed or Prandial Insulin Regimens in Insulin-Naive or Previously InsulinTreated Type 2 Diabetic Patients? Diabetes Care. 2013; 36 (suppl 2): Humalog Package Insert. Available at pdf. Accessed July 7, NovoLog. What is NovoLog? Available at Accessed July 7, Apidra package Insert. Available at Accessed July 7, NovoLog Package Insert. Available at Accessed July 7, Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context. 2015; 4: Victoza. Weight Change. Available at Accessed July 9, Victoza. A1c Reduction Across Studies. Available at Accessed July 8, Clinical Pharmacology. Dulaglutide. Available at Accessed July 9, Clinical Pharmacology. Albiglutide. Available at Accessed July 9, Clinical Pharmacology. Exenatide. Available at =0&enh=1. Accessed July 9, Clinical Pharmacology. Liraglutide. Available at =3496&n=Liraglutide&t=0. Accessed July 9, Which statement concerning the DAWN study is correct? a. DAWN was a study involving patients using basal insulin therapies that examined the effect of the 2 a.m. blood sugar result as an indicator for morning fasting blood sugar. b. DAWN was a large, global study that focused a portion of research on the reasons that primary care health providers delayed initiating insulin. c. DAWN was a large global study that examined how injectable insulin could be used in therapy for people with Type 2 diabetes. d. None of these statements are correct concerning the DAWN study. 2. Steven is a patient with Type 2 diabetes who has been using the pharmacy for several weeks. As he arrived, he mentioned that he was referred to the pharmacy for an insulin training session with the pharmacist. His prescriber has chosen to add a rapid-acting prandial insulin to be taken at lunchtime. Which of the following products is the most likely choice? a. NPH insulin b. Regular U-100 insulin c. Insulin lispro d. Insulin detemir 3. Mary arrives at the out window to pick up a refill of her medications that includes her basal insulin prescription that she has been successfully injecting for the past few months. As she looks for her credit card, she steps away to sit down, commenting that she is feeling dizzy and light headed. As she sits in the waiting area, she removes a bag of lifesavers from her purse and eats several of them. After a few minutes she returns to the out-window, ready to pick up her prescriptions. Which of the following statements is the best action for the technician to take? Learning Assessment a. The technician should advise the patient that sugar-free lifesavers are available near the front check stands, and she should choose those as a snack due to her diabetes. b. The technician should ask the pharmacist for a counseling session with a patient and share the information about the suspected low blood sugar reaction that just occurred. c. The technician should advise the patient to reduce her insulin dose since she just obviously had a low blood sugar reaction. d. The technician should ask the patient if she has questions for the pharmacist and document the response. 4. Which of the following products has these storage recommendations: Once opened, store at room temperature for up to 56 days. Do not store opened pens in the refrigerator. a. Humulin N KwikPen b. Humulin R U-500 KwikPen c. Levemir FlexTouch Tresiba FlexTouch 5. A patient is using insulin glargine (Basaglar KwikPen ), how many total units of insulin can be injected at a time by the pen? a. 100 units b. 1,000 units c. 80 units d. 300 units 6. Tim is a 55-year-old Caucasian male with insulin resistance. He would like to use a pen device to deliver his evening meal dose of rapid-acting insulin as he is frequently out with clients. His usual evening meal dose is 64 units. Which of the following products would allow him to deliver the dose in a single shot? a. Insulin glargine pen b. Insulin glulisine pen c. Insulin aspart pen d. Insulin lispro pen 7. When recommending options for patients needing a sharps disposal method, which of the following statements is true? a. All patients must purchase a mail-back for- incineration sharps container to be compliant. b. All patients may use a rigid household container, such as a coffee can, to dispose of sharps in noninstitutional settings. c. Requirements for sharps disposal vary across the country, and local ordinances should be checked before making a recommendation. d. None of the above. 8. True or false: Healthcare professionals in the DAWN study delayed insulin for patients due to a shortage of available products. a.. True b. False 9. When considering the medications in the GLP-1RA category, which of the following are reasons a prescriber may choose a drug from this class? a. Previous therapy is not allowing the patient to achieve clinical goals. b. The patient could benefit from the weight reduction side effects. c. The prescriber wants to avoid increasing the risk of low blood sugar reactions. d. All of the above. 10. True or false: A patient has been routinely injecting 10 units of long-acting insulin for six months and is well controlled. The most appropriate syringe is a 3/10 cc U-100 Insulin syringe. a. True b. False SEPTEMBER