Call for Resolutions

in the provision of opioid antagonists, has passed both the Florida House and Senate and is headed to the governor’s desk for his signature.

What does this change mean for pharmacy?

Before adoption of SB544, a pharmacist could provide opioid antagonists by prescription or provide opioid antagonists administer by auto-injection or intranasally by a standing order. SB544 provides the ability for pharmacies to order or dispense emergency opioid antagonists by auto-injection or intranasally with or without a standing order. The bill grants personnel of law enforcement agencies and includes correctional probation officers and child protective investigators acting within the scope of their employment and who come in contact with a controlled substance or persons experiencing an opioid overdose to possess opioid antagonists.

Emergency departments of hospitals or urgent care centers will be required to report to the Department of Health incidents where patients are treated for suspected controlled substance overdoes and released. The hospital or urgent care center must use its best efforts to report these incidents within five days.

The bill also allows school systems to purchase a supply of naloxone from a wholesale distributor and grants immunity for a school district employee who administers an approved opioid antagonist to a student.

This is just a small sampling of the various issues monitored by your Florida Pharmacy Association. A full report will be provided during the FPA’s annual convention at the Marriott Harbor Beach Resort in Ft. Lauderdale, July 6-10, 2022. Please mark your calendar and plan to attend.

CALL FOR RESOLUTIONS TO THE 2022 HOUSE OF DELEGATES

The House of Delegates is now accepting resolutions for 2022. The last day to submit resolutions is May 11, 2022.

The following information will be needed when submitting resolutions:

1. Name of organization: The name of the organization submitting the resolutions(s); 2. Name and telephone number of individuals: A contact in the event clarification or further information is needed; 3. Problem: A statement of the problem addressed by the resolution; 4. Intent: A statement of what passage of the resolution will accomplish; 5. Resolution Format: Please type and use double spacing.

TITLE OF RESOLUTION

NAME OF ORGANIZATION

WHEREAS , AND

WHEREAS :

THEREFORE BE IT

RESOLVED (THAT THE FPA OR SUBDIVISION OF FPA)

CONTACT NAME AND PHONE #:

PROBLEM:

INTENT:

Return this form to: Membership Coordinator, Florida Pharmacy Association, 610 North Adams Street, Tallahassee, Florida 32301 or fax (850) 561-6758

A Review on Smart Insulin Pens

AUTHORS:

Arthur Beckett

PharmD Candidate, 2022 Florida Agricultural and Mechanical University, Tallahassee, FL 32307

Morgan Carter

PharmD Candidate, 2022 Florida Agricultural and Mechanical University, Tallahassee, FL 32307

Kasey Odom

PharmD Candidate, 2022 Florida Agricultural and Mechanical University, Tallahassee, FL 32307

Alex Vega

PharmD Candidate, 2022 Florida Agricultural and Mechanical University, Tallahassee, FL 32307

Lauren Woody

PharmD Candidate, 2022 Florida Agricultural and Mechanical University, Tallahassee, FL 32307

PRIMARY AUTHOR Cameron Javanmardi, PharmD

Assistant Professor, Pharmacy Practice Florida Agricultural and Mechanical University, Tallahassee, FL 32307

CORRESPONDING AUTHOR Nicole Cheung, PharmD, BCPS

Assistant Professor, Pharmacy Practice Florida Agricultural and Mechanical University, College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health, 1415 S Martin Luther King Jr Blvd, New Pharmacy Building, Suite #344, Tallahassee, FL 32307, USA 850-599-8656, Nicole.cheung@famu.edu

Soheyla Mahdavian-Matthews, PharmD, BCGP

Professor, Pharmacy Practice Florida Agricultural and Mechanical University, Tallahassee, FL 32307 Introduction

Diabetes is a chronic, debilitating disease affecting over 34 million people in the United States and over 108 million people worldwide.1 This condition occurs when the pancreas either inadequately utilizes insulin produced by the body or when the body cannot produce enough insulin. Unfortunately, in 2019, diabetes was responsible for approximately 1.5 million deaths worldwide.1 This chronic disease is the seventh leading cause of death in the U.S. and is associated with increased medical expenses due to frequent visits to the emergency department and physician’s offices.2

Diabetes mellitus is separated into two subcategories known as type 1 and type 2. Type 1 diabetes is characterized by a deficiency in the overall production of insulin. Risk factors include family history of type 1 diabetes, less than 20 years of age, and certain genetic predispositions.3 According to the American Diabetes Association (ADA), about 1.6 million Americans have type 1 diabetes, which includes over 180,000 children and adolescents.4 Type 2 diabetes, sometimes referred to as non-insulin-dependent diabetes, is due to the inadequate production of insulin within the body. This is the most common type of diabetes, accounting for about 95 percent of all diabetes mellitus cases. Several predisposing risk

factors for type 2 diabetes includes obesity, family history, increasing age, and ethnicity including African Americans, Hispanics, Native Americans, or Alaska Natives.3

There are many dangerous and life-threatening microvascular and macrovascular complications from uncontrolled diabetes mellitus. Microvascular complications affect small blood vessels and include diabetic retinopathy, nephropathy, and neuropathy. Diabetic retinopathy occurs due to high blood glucose levels and increased blood pressure that causes damage to the blood vessels of the eyes, with a prevalence of 10,000 cases annually.5 Diabetic nephropathy is caused by vasodilation within the afferent and efferent arterioles within the kidneys.6 This results in an increase in thickness of the glomerular basement membrane and the formation of mesangial nodules, contributing to decreased glomerular filtration and an increase in intraglomerular capillary pressure, and eventually progressing to diabetes-related renal failure.5,7

Lastly, diabetic neuropathy is quite common and can cause diabetics to be unaware of cuts which may lead to infections and amputations of the lower extremities. There are about 230 amputations that occur daily in the U.S. due to diabetes, with African Americans being four times more likely to undergo amputations than whites.8 Macrovascular complications of diabetes affects large blood vessels such as those in the aorta, brain, and extremities. Some examples include coronary artery disease, myocardial infarction, cerebrovascular accident, and peripheral vascular disease. Macrovascular complications are due to atherosclerosis, defined as a buildup of plaques within the arterial walls due to fat and cholesterol deposits. These plaques restrict blood flow to the organs and tissues, leading to blockages and ischemia.8

Diabetes continues to be an increasing concern both in the U.S. and worldwide. Making a prompt and adequate diagnosis along with individualized treatment is crucial to prevent diabetes-related complications and cardiovascular events in developed and underdeveloped countries. According to the ADA, diagnosis of diabetes includes a fasting plasma glucose of 126 mg/dL or greater, a random plasma glucose of 200 mg/ dL or greater with symptoms of polyuria, polydipsia, or polyphagia, and hemoglobin A1C readings of 6.5% or greater.8 Insulin and pramlintide are the only agents currently approved for use in type 1 diabetics who require treatment with prandial and basal insulin, or a continuous insulin infusion.9 Similarly, insulin is recommended to be initiated in type 2 diabetics presenting with symptoms of hyperglycemia, ongoing weight loss, hemoglobin A1C levels greater than 10% and/or blood glucose levels greater than or equal to 300 mg/dL.8

There are a variety of therapeutic options available for the treatment of type 2 diabetes. Patient-specific factors such as past medical history, health status, renal and hepatic function, and socioeconomic status must be taken into consideration. The recommended initial oral therapy in type 2 diabetes is the biguanide, metformin; however, this agent should be avoided in patients with renal insufficiency due to the increased risk of lactic acidosis. Furthermore, other non-insulin agents such as glipizide, semaglutide, and linagliptin may be suitable for patients with renal or hepatic insufficiency, but the costs of these agents should still be considered for patients who may not be able to afford them.

Insulin is commonly used for patients experiencing severe hyperglycemia despite appropriate treatment with other antidiabetic agents. In the United States, the percentage of patients using insulin therapy over the past decade has remained relatively stable at about 30 percent.10 The average out-of-pocket cost for one vial of insulin ranges from $90 to $200, while the cost of non-insulin injectable therapy such as the glucagon-like peptide 1 agonists range from $700 to over $1,000.11 It is also important that physicians remain aware of the additional supplies needed for insulin injections such as alcohol swabs, lancets, and test strips. The cost of these supplies may become a financial burden for some patients.

While there are disadvantages and advantages to insulin therapy, patients typically require multiple daily injections which comes with an increased risk of experiencing hypoglycemia. Especially if diabetics are older, have long-standing diabetes, or have erratic eating patterns. Multiple injections may also be an inconvenience to some patients and decrease patient adherence to complicated regimens. Despite complications such as hypoglycemia and the burden of daily insulin injections, insulin smart pens have become available on the market as an aid to these issues. Insulin smart pens offer patients a wide range of advantages such as ease of use, dose reminders, and glucose monitoring that may assist patients in the management of their diabetes.

Treatment Overview

Insulin therapy is one of the most effective ways to reduce a patient’s hemoglobin A1C with no exclusivity in the type of diabetes it is used to treat. The indications for insulin use in a type 2 diabetic may include severe hyperglycemia with ketonuria on presentation, difficulty distinguishing an accurate diagnosis, pancreatic insufficiency, and persistent hyperglycemia with oral agents.12-14 Insulin can be administered to a diabetic patient in three ways: a basal dose with an intermediate-acting or long-acting insulin, a prandial bolus dose of short-acting or rapid-acting insulin, or a combination of intermediate-acting and a short-acting or rapid-acting insulin injected at the same time.

For type 1 diabetes, basal-bolus regimens are the preferred option for optimal glycemic control, with 50% of the calculated total daily dose of insulin being the basal dose, and the other 50% being the bolus dose divided among patient’s meals. Type 1 diabetics require both basal and bolus insulin throughout the day to meet their insulin requirements and achieve euglycemia. If cost and nonadherence are patient barriers to care, clinicians may consider initiating mixed formulations of insulin, such as a combination of Neutral Protamine Hagedorn (NPH) with short-acting insulin, or rapid-acting insulin with its respective protamine formulation.

Rapid-acting insulins include insulin lispro, aspart, glulisine, and short-acting insulins include insulin regular. Intermediate-acting and long-acting insulins simulate the pancreas’s fasting mechanism by slowly releasing doses of insulin throughout the day to help keep serum glucose levels with-

Table 1 Different Insulin Types and Their Onset of Action, Peak Effect, and Duration of Action23

INSULIN FORMULATION ONSET OF ACTION PEAK EFFECT DURATION OF ACTION

Rapid-Acting

Lispro (HumaLOG®) <15 minutes 60-90 minutes 3-5 hours Aspart (NovoLOG®, Fiasp®) <15 minutes 60-90 minutes 3-5 hours

Glulisine (Apidra®) <15 minutes 60-90 minutes 1-2.5 hours

Short-Acting

Regular (HumuLIN R®; NovoLIN R®) 30-60 minutes 2-5 hours 6-8 hours

Intermediate-Acting

Neutral Protamine Hagedorn (NPH) (HumuLIN N®; NovoLIN N®) 4-12 hours 4-12 hours 18-24 hours

Long-Acting

Glargine (Lantus®; Toujeo®) 1-1.5 hours No peak 20-36 hours Detemir (Levemir®) 1-2 hours 6-8 hours 20-24 hours Degludec (Tresiba®) 30-90 minutes No peak >24 hours

Pre-Mixed

HumuLIN® 70/30; HumuLIN® 50/50

NovoLIN® 70/30

NovoLOG® Mix 70/30; HumaLOG® Mix 50/50

HumaLOG® Mix 75/25 30 minutes 2-4 hours 14-24 hours

30 minutes 2-12 hours Up to 24 hours

10-20 minutes 1-4 hours Up to 24 hours

15 minutes 30 minutes2.5 hours 16-20 hours

in normal range. Intermediate-acting insulin contains NPH which does have a peak effect, whereas long-acting insulin such as insulin glargine, detemir, and degludec have a longer duration and do not have a peak effect.

Most type 1 patients are started on 0.2-0.5 units/kg/day to account for their “honeymoon phase,” but most will eventually require 0.6-0.7 units/kg/day when phase has ended. Typical doses range from 0.4-0.11 units/kg/day, with most clinicians dosing at 0.5 units/kg/day.13 The “honeymoon phase” is a temporary period right after the diagnosis of type 1 diabetes, in which patients may require less insulin because there is still some retained pancreatic function. Adjustments of daily insulin requirements should be based on daily fasting and prandial blood glucose measurements along with threemonth hemoglobin A1C measurements.

When insulin therapy is warranted, initial therapy for a type 2 diabetic patient includes a single daily dose of Neutral Protamine Hagedorn (NPH) or insulin detemir given at night, or insulin glargine or degludec given either in the morning or at night.15-20 Benefits for using premixed insulin include less injections throughout the day and reduced costs compared to basal-bolus regimens However, intermediate-acting insulin is associated with more nocturnal hypoglycemia than long-acting insulin due to the peak effects.16,17,20

As stated previously, insulin may be recommended initially for type 2 diabetic patients with severe hyperglycemia and/ or symptoms. Unlike type 1 diabetes mellitus where it is critical to mimic the natural insulin secretion with basal-bolus regimen, type 2 diabetes can initially start off with a basal insulin at 10 units or 0.1-0.2 units/kg/day subcutaneously (10 units minimum; up to 15-20 units daily); if still not at the desired glycemic goal, an increase in the basal insulin dose is indicated, and the addition of prandial insulin may be needed for overbasalization.13,15-20 If fasting blood glucose levels are high after dose initiation (>250 mg/dL), hemoglobin A1C is greater than 8%, or if a patient is known to be insulin resistant, then 0.3 units/kg/day (maximum 15-20 units/day) can be used.19 Another benefit of only using basal insulin is that there is less occurrence of hypoglycemia when compared to a regimen that includes prandial insulin.15-18

True basal insulins do not have a peak in their effect like rapid and short-acting insulins, leading to a reduction in hypoglycemic episodes. If the average fasting blood glucose is above target, an increase of 2-4 units of basal insulin approximately every 3 days allows for slow titration and prevention of hypoglycemia; titration can be more aggressive if needed in resistant patients.19 When a patient experiences basal insulin doses exceeding 0.5 units/kg/day, elevated bedtime-morning, elevated post-pre-prandial differential, and/or episodes of hypoglycemia, over basalization, and the addition of rapidacting insulin before meals at 4 units/day or 10% of the basal dose may be required to achieve euglycemia.13,15-20

If insulin is not needed, typically a glucagon-like peptide-1 receptor antagonist (GLP-1 RA) is preferred and should be considered first before starting insulin due to weight loss and cardiovascular benefits.21,22

In patients with persistent fasting blood glucose within range but an uncontrolled A1C, exercise, diet, and weight loss needs should be further evaluated.24-26 It is recommended to check pre-lunch and pre-dinner/bedtime glucose levels to determine if prandial insulin is required for certain meals.13 The choice of prandial insulin should be based upon availability, patient preference, cost, and insurance coverage. The newer, rapid-acting insulins have an advantage in glycemic control in both types of diabetes compared to short-acting insulin due to their shorter duration of action and benefit in hypoglycemia reduction. An additional benefit of newer agents is the ease of use for pre-meal injections, which may help improve patient adherence.27,28

Essentially, the goal of a diabetic patient on prandial insulin is to adjust the required dose of short-acting or rapid-acting insulin before the meal,( based on the patient’s blood glucose) in an attempt to achieve euglycemia and avoid hypoglycemia.29,30 Simple calculations involve consideration of the carbohydrate content in a meal, along with the patient’s blood glucose level will help guide the patient on the required dose for that specific meal at that specific glucose level.29,30 If blood glucose levels are above range two hours after a meal, a correction dose

may be given using the patient’s glucose goal range following a simple calculation to determine the amount of insulin needed to decrease their blood glucose by a specific number.31

Patient education is important in diabetes management. Correctional dose calculations can be taught to patients to help them achieve their glycemic goals. These calculations are based off the total daily dose of insulin a patient receives; doses of additional prandial insulin can be given on the next scheduled prandial dose to correct the high blood glucose levels.29-31 Titration of prandial insulin should be done after observation of consistently high blood glucose levels after certain meals.13 Consulting with an endocrinologist about the patient education required for this disease state is something every patient should consider to achieve optimal glycemic control.

Given the requirements of maintenance and upkeep for a daily insulin regimen, adjustment to this lifestyle may be aided by advancing technologies regarding diabetes care. Adherence is one of the most prevalent issues when dealing with diabetic patients who require insulin, so anything that can improve this area of self-care, should always be considered. With the technology of automated insulin pens advancing more and more, assistive tools such as continuous glucose monitoring, insulin pen caps, and smart pens may not only improve patient adherence, but may potentially prolong lives, and improve the quality of life in diabetic patients. As more studies are assessing benefits of this technology, health care professionals should consider its use in patients with adherence issues and uncontrolled diabetes.

Device Overview

According to the American Diabetes Association, the biggest challenge with the management of diabetes care is adherence to medication therapies, especially insulin dosing. The incorporation of smart insulin pens into diabetes management will aid in clinical decision-making and enhance the user’s quality of life. As an added benefit, endocrinologists are more aware of their patients’ individual needs. A smart insulin pen is a reusable pen that can be connected to various smartphone apps and aid in insulin dose calculations, prevent missed doses, and depending on the specific pen, track the expiration dates of insulin vials.32 Inspired by the HumaPen Memoir® manufactured by Eli Lilly and Company in 2007, there are several U.S. Food and Drug Administration (FDA) approved smart pens on the market manufactured by Companion Medical, Novo Nordisk, and Abbott.

The HumaPen Memoir® was the first insulin pen with a digital memory designed for diabetic patients using more than one dose of insulin. The pen is equipped with a digital display to enable accurate dose selections allowing patients to track their last 16 insulin doses, including priming doses.33 To minimize wasted units of insulin, the Memoir® pen doses are dialed one unit at a time and can be corrected at any time, a feature unavailable with previous administration techniques with a vial and syringe. The pen has a battery life of up to three years and patients will be notified with a flashing battery icon on the display when it is time to replace the device.

A clinical trial focusing on efficacy and tolerance in the target patient population was conducted despite regulatory authorities not requiring clinical trials to approve smart pen devices. This 6 to 10-week open-label trial of 300 patients revealed that 81.4% of the tested population preferred the HumaPen Memoir® device compared to their previous devices due to ease of use and control of blood glucose levels.34 In a questionnaire conducted by researchers, the most beneficial feature of the Memoir pen was its unique memory function.

The first FDA approved smart insulin pen was the InPen® which was manufactured by Companion Medical. The InPen® can be used by individuals seven years of age and older for up to one year and has a continuous glucose monitor embedded into the pen, which allows individuals to monitor glucose levels via a mobile device.35 This innovative pen may be used with HumaLOG®, NovoLOG®, and Fiasp® insulins. The InPen® is compatible with Dexcom G5® technology, which enables the device to perform insulin dose calculations, send reminders, and allow users to view real-time glucose levels and trends through the InPen® app. Continuous automated glucose monitoring will help all patients, and may be especially useful for individuals with difficulty manually monitoring their blood sugar levels.

NovoNordisk and Abbott partnered to manufacture the NovoPen 6® and NovoPen Echo Plus®. The NovoPen® has similar capabilities to most smart insulin pens on the market; however, this pen differs due to its five-year battery life, as well as an audible click at the end of each dose administered. These additions have increased patient satisfaction in

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the pediatric and elderly populations.36 Despite the many advantages of incorporating smart pens in insulin dosing, some resistance may arise when considering patients on multiple insulins. Smart insulin pens are only compatible with one type of insulin so patients receiving both prandial and basal insulins will need multiple injections, potentially decreasing adherence in this population.

Clinical Efficacy

Insulin smart pens offer several advantages for diabetic patients including specific features that improve convenience for insulin dosing and blood glucose monitoring. The smart pens that will be discussed are Eli Lilly’s HumaPen®, MemoirTM Medtronic’s InPen®, Novo Nordisk’s NovoPen 6®, and NovoPen® Echo TM. It is important to note that Eli Lilly produced its first insulin pen, the HumaPen Luxura TM, in 2007. HumaPen Luxura TM allows patients to inject smaller doses of HumaLog®, from 1 to 30 units in half-unit increments.37 One major difference between the Eli Lilly pens is that the MemoirTM is a mechanical insulin pen that incorporates memory function with the ability to track the last 16 insulin injections, including the dose, date, and time of the injections. This feature is not available with HumaPen Luxura TM .38

A randomized, open-label, 24-week multi-center study compared HumaPen® MemoirTM and HumaPen® LuxuraTM. The dose-tracking feature of the pen has several implications in those with uncontrolled diabetes. This study evaluated patients with inadequately controlled type 1 diabetes to determine if using the HumaPen® MemoirTM achieved superior glycemic control compared to patients using the conventional device, HumaPen® LuxuraTM.38 Patients were randomized to use the HumaPen® MemoirTM for their mealtime insulin injections to determine if this device achieved superior glycemic control, defined as the change in hemoglobin A1C from baseline compared to those using the HumaPen® LuxuraTM .

Eligible study participants were eight years or older, previously received intensified insulin regiments for at least two months, and had a hemoglobin A1C of 8% or greater at screening.38 The average age of the study participants was 39 years; 43% were female, 99% were Caucasian, and the average body mass index (BMI) was about 27 kg/m2. The primary endpoint was the change in hemoglobin A1C from baseline after 24 weeks. The difference in the change of hemoglobin A1C from baseline was analyzed using a mixed model for repeated measures. The change in hemoglobin A1C from baseline to week 24 did not result in statistically significant findings. The mean hemoglobin A1C decreased in both groups, with changes in baseline of -0.43% [95% CI, (-0.59 to -0.28%)] with HumaPen® MemoirTM and -0.48% [95% CI, (-0.64% to -0.32%; p = 0.669)] points with the HumaPen® Luxura TM.38

Also of note, the proportion of patients who reported episodes of hypoglycemia did not differ significantly between groups. At least one episode of hypoglycemia was reported in 81 patients using HumaPen® MemoirTM and in 79 patients using HumaPen® LuxuraTM.38 The most common adverse reaction in both groups was nasopharyngitis, which occurred in 9.2% of patients in the HumaPen® MemoirTM group and 1.5% in the HumaPen® LuxuraTM group.38 In conclusion, the use of memory function with HumaPen® MemoirTM did not result in superior glycemic control in patients with inadequately controlled type 1 diabetes as compared to the conventional device, HumaPen® LuxuraTM. While memory function features benefit some patients, especially adolescents, further studies should be conducted to determine the significance.

Medtronic announced early real-world data on its InPen® at the American Diabetes Association’s 81st Scientific Sessions.39 This data showed that the InPen® improves glycemic control in individuals with inadequately managed type 1 and type 2 diabetes. Continuous glucose monitoring data was obtained from 1,736 patients before and up to 90 days after initiating InPen® use between January 2018 and October 2020 with analysis of glycemic outcomes based on the mean sensor glucose, glucose management indicators, and the time in range (the percentage of time the patient spent at glucose levels of 70 to 180 mg/dL) consistent with the ADA guidelines.40 The outcome measures were analyzed using the Wilcoxon signed-rank test. Compared to pre-InPen® use, 423 individuals with inadequate glycemic control had increased time in range with an addition of roughly 0.6 hours per day within glucose range. In addition, patients experienced a decrease in the time spent above range (blood glucose greater than 180 mg/dL) of about 2.3%.

Amongst the patients included, there were 106 patients deemed to have the most inadequate glycemic control. Compared to pre-InPen® use, these individuals had an increased time in range by 5%, equating to 1.2 hours per day. These results were determined to be statistically significant with a pvalue of < 0.05. Although the results may not be of clinical significance, any increase time in range is favorable to avoid prolonged hyperglycemia or hypoglycemia.41 To conclude, this early real-world data shows the InPen® is associated with improved glycemic control in individuals with inadequately controlled diabetes.

Additionally, there is a study sponsored by Medtronic that is currently recruiting patients with type 1 or type 2 diabetes between the ages of 2 to 80 years.42 Additional inclusion criteria include subjects who are on multiple daily doses (MDI) of insulin who can afford insulin pens and pen cartridges. This is a multi-center, prospective, single-arm study without a control group. Phase 1 of the study will be a duration of 90 days and phase 2 involves the participation of subjects aged 18 years or older for a duration of 9 months. Each of the subjects enrolled in the study will wear the MedtronicTM Guardian Connect® system, a real-time continuous glucose monitoring device, along with the use of smart insulin pens incorporating smart caps for MDI. Subjects within the study will also continue their standard therapy throughout the study duration to control for as many extraneous factors as possible. Data will be obtained through applications requiring manual entry and include insulin delivery, sleep, physical activity, food intake, and medication. The primary outcome measure is the percentage of time in glucose range, including glucose levels less than 70 mg/dL, 70 – 180 mg/dL, and greater than 180 mg/dL for the duration of the study.

Insulin Pen

Food and Drug Administration (FDA) approval date

Approved age range

Manufacturer

Cost

Dose Calculator

Dose Reminder

Battery Life

Apps for IOS/Android

Connectivity

CGM (Continuous Glucose Monitoring) Compatible

Insulins InPen™

June 2020

Patients aged 7 and up

Companion Medical/Medtronic

As low as $35/month through InPen access program via Medtronic50 No cost if eligible for NovoPen Echo Savings Card51 As low as $45/month via WellRx52

Yes

Yes

1 year

Both IOS and Android

Bluetooth

Yes

Eli Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges needles Long-acting basal insulin (Levemir®, Tresiba®) and short-acting mealtime insulin (NovoLog®, Fiasp®) Humalog® and Humulin® U-100 3ml insulin cartridges

NovoPen Echo Plus®

November 2018

Patients aged 7 and up

NovoPen Nordisk Global

Yes, through 3rd party app

Yes, through 3rd party app

5 years

IOS and Android to be launched

NFC (Near Field Communications)

Yes

HumaPen Memoir™

April 2006

Patients aged 18 and up

Eli Lilly

Yes

No

3 years

Both IOS and Android

Bluetooth

No

As previously stated, adherence and ease of use are significant factors in effectively managing diabetes. The Rating the Effects of Memory Function in Pediatric Insulin Devices (REMIND) study was used to examine the safety and memory function capabilities of NovoPen Echo® . 43 This study was a multi-center observational study that included 354 children and adolescents with type 1 diabetes from ages 2 to 18 years old. The study’s primary outcome was the incidence of technical complaints related to the use of the NovoPen Echo® after 12 to 18 weeks with no severe adverse reactions reported.36 This patient-reported study showed that the majority (95 – 99%) of patients found it "easy" or "somewhat easy" to access information regarding their last injection and the hours elapsed since their previous dose when utilizing the device's memory function.44 Additionally, the proportion of children who completed self-injections was 71% compared to those on the previous device, which was 66% (p-value < 0.006).

Although the REMIND study was based on questionnaires and case reports, the NovoPen Echo® may offer benefits with its use and adherence in patients with diabetes, especially in children and adolescents. Further studies should be conducted to determine the overall benefit of the memory function with NovoPen Echo® on glycemic control and to assess hypoglycemia risks. Another consideration for the memory function is its potential use in the older adult population with conditions such as dementia or other forms of cognitive impairment.

As technology advances, there are many ways for patients to monitor their blood glucose levels and improve their time in range more easily. As seen with the clinical data regarding the InPen®, there was a statistically significant decrease in the time spent above glucose range, while the time in range improved in patients with inadequately controlled diabetes. Not only do smart insulin pens offer potential advantages for adult patients with diabetes but are also beneficial options for children and adolescents. The REMIND study highlights the efficacy and ease of use for this specific population. Clinical data supporting the NovoPen Echo® resulted in most patients finding it either “easy” or “somewhat easy” to access their recorded blood glucose levels utilizing the memory function. As mentioned, it is vital for diabetic patients to adequately check their blood glucose levels and remain within the appropriate glucose range while minimizing the incidence of hypoglycemia. With smart insulin pens and the features offered by these devices, patients may be able to achieve glycemic goals.

Safety

Most individuals are familiar with the normal disposable insulin pens, which are preloaded with insulin and thrown away after the insulin cartridge is empty. On the other hand, smart insulin pens are reusable and work with insulin cartridges that can be loaded into the pen and then disposed of once the insulin is used, leaving the pen ready for the next cartridge.53 Learning to self-inject insulin can be one of the toughest tasks for new insulin users. Each pen only works

with certain types of insulin, so individuals should keep that in mind when selecting the pen most suitable for them. It is particularly important to teach proper use of insulin pens, storage considerations, and signs of defects in the insulin pen itself. Regarding proper injection techniques for insulin, there are some key points and tips to remember when using an injection pen.

Before using the insulin pen, it is advised to make sure it is the correct type of insulin, correct dose, and that it has not expired yet.54 Individuals must change the pen needle before every use because not doing so can lead to inadequate penetration of the skin and pain upon administration. Since this is a subcutaneous injection, it is recommended to get under the fatty tissues but not too deep to where the injection goes into the muscle tissues.

There are four injection sites to use when injecting insulin. These include the abdomen (fastest rate of absorption), back of the upper arms, upper buttocks, and outer thighs.55 It is imperative to make sure to rotate injection sites to avoid lipodystrophy, or loss of fat. If premixed or intermediate-acting insulin is being used, the pen must be gently rolled between the palms of the hands for 15-30 seconds prior to injection to reach room temperature.56 It is not necessary to clean the injection area with an alcohol swab unless the patient is at considerable risk for infections.

Patients should make sure to clean the pen needle with an alcohol swab before using it every time. It is ideal to push the pen needle in at a 90-degree angle into one of the four sites previously mentioned. If administered to a child or in an area with little fat, holding some skin together with the opposite hand can yield better results.54 Once the button is released, hold the pen for about 10 seconds in the injection site before removing the needle and discarding it into a designated sharps container.

Lastly, storage of the insulin pen is especially important to prevent the expiration of the medication. Refrigeration is required whenever the pen is not being used since it is sensitive to changes in light, heat, and pH. These changes could lead to degradation of the product inside. Any insulin pens not in use should be kept refrigerated to avoid those issues. It is acceptable to leave pens that are in use at room temperature to avoid injecting a cold fluid which can be uncomfortable for some patients.

Place in Therapy

A significant impediment for patients with diabetes mellitus is the ongoing issue of achieving optimal blood glucose control and the management of insulin dosing, which is essential for disease management.32 Despite insulin’s proven efficacy in those with diabetes, there is still an unwavering number of patients not achieving glycemic goals who are utilizing insulin therapies. This is seen in data collected by the National Health and Nutrition Examination Survey in 2017 which showed that 45% patients in the United States on insulin therapy were not achieving target glycemic levels of less than 7 percent.57 Uncontrolled glycemic levels may be due to a lack of patient education, adverse events, and in some cases, delivery formulations.

A study conducted in 2014, included over 500 patients with type 1 and 2 diabetes mellitus discovered that significant barriers to insulin adherence were fear of hypoglycemia (87.4%), injections being time-consuming (63.2%), and lack of injection education (59.6%).55 The inclusion of insulin dosing smart pens will make it easier for patients to ensure they are receiving accurate and timely doses of their medication, as well as documenting patient data for their endocrinologist to aid in further treatment recommendations. Insulin smart pens are recommended for use in all patients requiring multiple daily injections of insulin to improve medication adherence and hopefully reduce the morbidity associated with diabetes.58

Role of the Pharmacist

The pharmacist's primary role in the management of diabetes is to aid and minimize the gap between patients and primary care providers. Pharmacists can help identify patients who may have diabetes, provide patient-education, and collaborate with primary care physicians and endocrinologists regarding regimen changes based on patient monitoring in real time. Educating patients on managing their diabetes effectively and providing the knowledge of all available options for glycemic control is potentially the pharmacist’s most important job. Patient identification and education for integral elements of the pharmacist’s role in patient care, and smart pens could be one of the tools that help pharmacist’s manage diabetes in the future. Accessibility to smart pens may be difficult for some depending on coverage by insurance companies. Pharmacists can work with prescribers to obtain prior authorizations and identify co-pay assistance programs like those associated with the InPen® to help with coverage gaps associated with smart pens.59 Any patient diagnosed with diabetes should undergo drug therapy counseling that reinforces proper administration techniques, drug interactions, adverse events, and dosing frequencies. Pharmacists also play a crucial role in monitoring patients' disease progression and recommending patients to see specialists if treatment goals, and disease management are not achieved.

In a study published in the Journal of Managed Care, it was reported that the incorporation of pharmacists in the treatment of type 2 diabetes led to a greater percentage of patients achieving target A1c levels faster at 3 and 6 months. This was represented by a 27% and 37% success rate respectively compared to the control group which only achieved target A1c levels at 14% and 31%.60 The introduction of smart pens and other technologies involved in the treatment of diabetes will make pharmacists' roles in patient management more critical and improve the quality of care a patient receives. As the diabetes population continues to grow and become more complex, the pharmacist's role in management is becoming more evident in the management of this disease.

EDITORIAL NOTE: This article represents the viewpoints of its authors and not necessarily the Florida Pharmacy Association.

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$50,000

$25,000 $25,000

$25,000

$50,000 $25,000 sublimit

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$50,000 limit $10,000 aggregate

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