March 2022 Florida Pharmacy Today

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MAR. 2022

A REVIEW ON

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florida PHARMACY TODAY

Features

Departments 4 Calendar 4 Advertisers 5 Presidential Viewpoint 7 Executive Insight 9 Call for Resolutions 20 Call for Abstracts

IN MEMORIAM

VOL. 85 | NO. 3 MARCH 2022 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

10 22

A Review on Smart Insulin Pens

132nd FPA Annual Meeting and Convention Registration

FPA Mourns Passing of Former President Eric Alvarez FPA joins its members in mourning the loss of Dr. Eric Alvarez, friend, colleague and past president of the FPA. A graduate of Florida A&M University of 1975, Eric earned his Pharm.D. from NOVA Southeastern University in 1994. He was an independent pharmacy owner for 20 years and a Hospital Pharmacy Director for McKesson Medication Management Division. Eric was credentialed to serve on the Florida Board of Pharmacy and chaired that body in 2006. He received many awards, including the James H. Beal "Pharmacist of the Year" in 1994 and the coveted "Bowl of Hygeia" in 2010. No details on services are available at this time.

FPA Board of Directors

Daniel Buffington......................................... President and Interim Board Chair Carol Motycka...................................................................................President Elect Elias Chahine................................................................................... FSHP President Alexander Pytlarz.................................................................Speaker of the House Verender Brown........................................................................Technician Director William Mincy............................................................................................ Treasurer Kimberly Jones...................................................................................... Vice Speaker Joyanna Wright.............................................................................Region 1 Director Tejas Patel.......................................................................................Region 2 Director Matt Schneller..............................................................Region 3 Director (Interim) Cheryl Rouse.................................................................................Region 4 Director Bob Parrado...................................................................................Region 5 Director Katherine Petsos...........................................................................Region 6 Director Paul Delisser..................................................................................Region 7 Director Carmen Aceves Gordon..............................................................Region 8 Director Goar Alvarez.................................................................................Region 9 Director Michael Jackson......................................................................................EVP & CEO MARCH 2022

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Mission Statements:

FPA Calendar 2022

APRIL 1

Point-of-Care Test and Treat Certificate Program Grand Hyatt Tampa

2-3

Geriatric Conference (Hybrid meeting) Grand Hyatt Tampa

13-14

FL BOP Meeting

15

Good Friday, FPA Office Closed

24-26

NASPA Leadership Retreat San Antonio, Texas MAY

11

Last day to submit Resolutions for the House of Delegates

18

House of Delegates Board of Directors Zoom Meeting

21-22

FPA Virtual Consultant Conference

JUNE 8

Last day for delegate registration FPA House of Delegates

8

Last day to submit items of new business

15-16

Florida Board of Pharmacy Meetings (Subject to approval) JULY

6-10

132nd Annual Meeting and Convention Ft. Lauderdale

4

Independence Day, FPA Office Closed

31-3

39th Annual SE Gatherin' Destin

CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE continuing education as part of the required 30 hours’ general education needed every license renewal period. There is a two-hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. The Reducing Medication Errors course is needed for pharmacists and technicians. Pharmacists should have satisfied all continuing education requirements for this biennial period by Sept. 30, 2023, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec. 31, 2022. For the Pharmacy Technician Certification Board application, exam information and study materials, please contact the FPA office. For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org CONTACTS FPA — Tian Merren-Owens (850) 222-2400 FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169

FAMU — Dr. Selika Sampson (850) 599-3301

Note: The views of the authors do not necessarily represent the views or opinions of the Florida Pharmacy Association, Florida Pharmacy Today or any related entities.

Florida Pharmacy Today Journal The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.

Florida Pharmacy Today Board of Directors The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.

Advertisers APMS................................................................... 21 EPIC..................................................................... 13 MyRx Pro............................................................... 2 PQC...................................................................... 24 PHARMACISTS MUTUAL.............................. 19

NSU — Carsten Evans (954) 262-1300

DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association is engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by the maker of the product should always be consulted before use.

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FLORIDA PHARMACY TODAY

EMAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com


Presidential Viewpoint BY MICHAEL JACKSON, RPH DANIEL E. BUFFINGTON, PHARMD, MBA, FAPHA ALYSON LOZICKI NELSON, PHARMD ALEX PYTLARZ, PHARMD

T

FDA Retreated from Their Attempts to Overregulate Compounding Pharmacies

he US Food and Drug Administration’s mission and purpose are to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and to ensure the safety of our nation's food supply, cosmetics, and products that emit radiation. They are not responsible for regulating health care practice standards or the pharmacy marketplace. However, for the past few years, they have attempted to regulate pharmacy business practices in states and dictate changes to their respective boards of pharmacy. This is most apparent with their attempt to force a “memorandum of understanding” or MOU that exerts limits and tracking of interstate sales of compounded medications.

years of dialogue and stakeholder input. The MOU was finally published disseminated to states in October of 2020 and boards of pharmacy were given 365 days to decide to enter. This document is directed specifically at 503A compounding pharmacies. Each state board of pharmacy or governing body was given the option to sign the MOU, which was designed to track the compounding pharmacies that shipped high volumes of compounded medications across state lines. The purpose of the MOU was to establish an agreement between a state’s board of pharmacy, or other appropriate state agencies, and the FDA to monitor the interstate distribution of inordinate amounts of compounded human drug products. It also aimed to opti-

Daniel E. Buffington, PharmD, MBA, FAPhA

This process started with an article originally drafted in 1997 and was initially named the “Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the US FDA”, currently referred to as the FDA Memorandum of Understanding (MOU). The MOU was created with consultation from the National Association of Boards of Pharmacy (NABP), Food, Drug, and Cosmetic Act, and nearly 20 MARCH 2022

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mize patient safety and reduce risks. Compounded medications distributed across state lines are easily tracked and monitored, and adverse event reporting becomes important and makes it imperative to be able to track an issue back to a single pharmacy or provider. In an effort to strongarm states into signing on, the FDA created penalties for pharmacies in those states that refused to sign the MOU, including limiting the interstate distribution of compounded products to 5% of a pharmacy’s total volume. Conditions of the MOU would also subject the pharmacies to an investigation, pharmacies that ship 50% of compounded products out-of-state would be under much more rigorous documentation standards and regulatory burdens, and the financial impact on the state board of pharmacy to enforce these regulations would be substantial. This FDA’s attempt at regulating interstate distribution was not well received. As of the date of this article, few states had signed the MOU and the others are hesitant. Their resistance is primarily due to the excessive administrative burden needed for states to hire additional staff and develop new procedures simply to comply with the MOU as well as the potential for ongoing legal challenges from healthcare providers. After the MOU was issued, the FDA was sued by several compounding pharmacies in the US district court. The court remanded the MOU back to the FDA with instruction to ensure small businesses would not be significantly impacted or to prepare a regulatory flexibility analysis to ensure the agency has researched all regulatory alternatives in order to curtail the rule’s economic burdens and provide the opportunity for the smaller entities impacted to still have a fair opportunity to succeed. Pharmacies that executed the lawsuit felt that the FDA was exceeding their authority without considering the potential consequences of the MOU. The pharmacies claimed the FDA was failing to consider the administrative burden of the MOU under the Paperwork Reduction Act. In addition, they believe the FDA did not retain enough in6 |

FLORIDA PHARMACY TODAY

put from the state boards of pharmacy before drafting the MOU. Pharmacies are also debating the FDA’s position on dispensing and distribution, which according to the FDA are not distinct acts. The FDA may have taken advantage of congress establishing the inclusion of dispensing to a patient and distribution to healthcare practitioners, hospitals, or other entities as a single act in the Drug Quality Security Act (DQSA). In response to the MOU, and as a market-driven alternative to strict regulations, NABP in conjunction with pharmacy owners, boards of pharmacy, and the FDA began the development of an electronic tracking program that would align with the sentiment of the MOU and help protect patient safety. With the assistance of an FDA grant, the NABP aims to create a system using e-Profiles that provides the state boards of pharmacy with information on each individual pharmacist, technician, student/intern, and facility that is participating. This will allow for information exchange between pharmacists, facilities, regulatory boards, and the FDA. Information such as that which is outlined in the MOU, complaints, inspection forms, and reports among other supporting data will be tracked. Benefits of this program would include reduced administrative burden for the boards of pharmacy and would streamline the documentation and reporting process and providing a more efficient

method for protecting patient safety. The FDA may have issued the MOU with good intentions of increasing the tracking and monitoring of compounded medication across state lines, it rapidly became apparent that they drifted out of their lane of statutory mission and jurisdiction over pharmaceutical manufacturers and into an attempt to regulate medical and pharmacy practice in the healthcare marketplace. The FDA has now retreated from the MOU in response to the overarching backlash and lawsuits and is expected to work together with stakeholders in a more collaborative nature to encourage the development and utilization of health information technology systems to improve product tracking from compounding pharmacy to the point-ofcare in order to identify and rapidly respond to patient safety risk factors. n


Executive Insight MICHAEL JACKSON, BPHARM, RETIRED EVP & CEO, FLORIDA PHARMACY ASSOCIATION

E

The Florida Legislature Has Gone Home – What Did They do?

ven as I transition into retirement, it is hard not to notice when the Florida House and Senate meet to discuss policy issues. After all, our profession exists because the Florida Legislature said it could by sustaining Florida laws under F.S. 465. Whenever there is tinkering under that code, there needs to be 35,000 Florida pharmacists and 56,000 Florida registered technicians who are interested. Any changes under that Florida law affects each of us directly. One task that the Legislature must do each year is to review and pass the operating budget for the state. We are talking in excess of $110 billion in government funding. Health care is a very large piece of that dollar pie. For the 2022 legislative session, reports from the Capitol are showing that 3,685 bills were filed. There were 992 in the Senate and 2,693 in the House. Of those 3,685 bills, only 285 or slightly more than 7.7% of bills passing both chambers have been sent to the governor’s desk for signature. Many of those bills that passed were adopted within the final week or so of the session. In this message to the membership, I am going to tease you with a preliminary report of what happened and why you should be interested. Detailed reports will be provided at the FPA convention where you will be able to talk directly with leadership and our lobbyists from Adams Street Advocates. You may even get a chance to talk with members of the Legislature who volunteered to marshal our issues through this maze of sausage making.

PBM Reform A common discussion in pharmacy meetings throughout Florida and the U.S. involve the subject of the PBM marketplace and what it means to pharmacy businesses. For the past several years the FPA has shared data with the state on the prescription drug benefit within the Medicaid Managed Care Program. Our findings have shown some very

Many of those bills that passed were adopted within the final week or so of the session. In this message to the membership, I am going to tease you with a preliminary report of what happened and why you should be interested. revealing and troublesome issues, including patient steering and preferential pricing to affiliated pharmacies. There were laws within the pharmacy practice act that created some basic auditing standards, however there was no enforcement mechanism to address PBM auditing abuses. The Board of Pharmacy had no jurisdiction to

Michael Jackson, B.Pharm, FPA CEO (Ret)

sanction PBMs for any violations of F.S. 465.188 (Medicaid Audits of Pharmacies) or F.S. 465.1885 (Pharmacy Audits; Rights). In House Bill 357 sponsored by Rep. Jackie Toledo of Hillsborough County, we successfully advocated for a change that moves these auditing standards under the umbrella of the Office of Insurance Regulations. The FPA worked with a coalition called “Empower Patients.” This group focused its efforts on PBM education and reform and took to social media the message that something needed to be done. It was fascinating to see that members of the Florida House and Senate grow interest in this area. HB357 picked up 28 cosponsors in the House. This legislation passed with no objection in the House as well as the Senate and at the production of this article is headed to the governor’s desk for signature. There was an additional issue includMARCH 2022 |

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Executive Insight, from Page 7

FPA STAFF Director of Continuing Education Tian Merren-Owens, ext. 120

Continuing Education Coordinator Stacey Brooks, ext. 210 Coordinator of Membership Ranada Howard, ext. 110

FLORIDA PHARMACY TODAY BOARD Chair....................David Mackarey, Boynton Beach Vice Chair................................... Matt Schneller, Tampa Treasurer.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member....................... Carol Motycka, Jacksonville Member............................Teresa Tomerlin, Rockledge Member...................................... Greta Pelegrin, Hialeah Technician Member..........Julie Burger, Pensacola Executive Editor.......Michael Jackson, Tallahassee Managing Editor...................Dave Fiore, Tallahassee Journal Reviewer........................... Dr. Melissa Ruble Journal Reviewer....................................Dr. Angela Hill This is a peer-reviewed publication. . ©2022 FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board.

FLORIDA PHARMACY ASSOCIATION

610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web address: www.floridapharmacy.org.

ed in the Senate version of the bill that would have required a review of PBM market conduct, however we were running out of time during this year’s session and did not get that included in the bill headed to the governor. What does this change mean for pharmacy? The bill transfers the audit provisions in the Florida Pharmacy Practice Act to the Florida Insurance Code. It gives the Office of Insurance Regulation the authority to enforce these provisions as well as potential violations. HB357 also adds in the ability for pharmacies to appeal audit findings using dispute resolution programs through the Agency for Health Care Administration. There is also a $10,000 financial penalty for PBMs that fail to register with the Office of Insurance Regulation. Insurance plans and HMOs become accountable to PBM behavior. Vaccinations by Pharmacy Technicians During the current pandemic, emergency orders were issued by the Department of Health and Human Services granting authority for pharmacy technicians to administer COVID vaccinations. While these emergency orders superseded state laws, their duration is limited. For the 2022 legislative session, HB1209 was filed to take the provisions of the Public Readiness and Emergency Preparedness Act (PREP Act) granted to the Secretary of the Department of Health and Human Services and code them into Florida laws. HB1209 and SB1892 were filed to begin making those changes. The bills were not identical and as such the FPA preferred the Senate version. We also advocated for changes to the pharmacist-to-intern ratio when administering vaccines, which currently is limited to 1:1. Ultimately, HB1209 passed both the Florida House and Senate with FPA preferred changes and is waiting to be signed into law by Governor DeSantis.

What does this change mean for pharmacy? HB1209 allows registered Florida pharmacy technicians to administer all vaccines listed under F.S. 465.189 after having completed a certification training program approved by the Board of Pharmacy after consultation with the Board of Medicine and Board of Osteopathic Medicine. Pharmacy technicians must also complete a two-hour continuing education program approved by the Board of Pharmacy. The bill also amends the vaccines allowed to be administered by pharmacists and pharmacy technicians by referencing the CDC list published as of March 21, 2022, and removing the reference to April 30, 2022. The bill also limits the ratio of pharmacists to technicians AND interns to 5:1 when there are vaccines being administered. This means that at no time could there be more than five pharmacy interns, five technicians or a combination of both interns and technicians up to five under the supervision of a pharmacist. The bill further clarifies that the pharmacist entering into a protocol with a Florida licensed physician must maintain professional liability insurance. Drug-Related Overdose Prevention Under current Florida laws (F.S. 381.887) pharmacists can provide emergency opioid antagonists to patients or patient caregivers pursuant to a prescription or pursuant to a nonpatient specific standing order for auto-injection deliver or intranasal application. These provisions were placed into Florida law to assist with the growing opioid epidemic. According to the Florida Attorney General’s Opioid Working Group, drug overdose is now the leading cause of non-injury related death in the United States. With the current pandemic, it has been found that opioid use disorders have begun to rise. Senate Bill 544 revised what pharmacists can do


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

MARCH 2022

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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

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FLORIDA PHARMACY TODAY

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 withMARCH 2022 |

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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

30-60 minutes

2-5 hours

6-8 hours

4-12 hours

4-12 hours

18-24 hours

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

HumuLIN® 70/30; HumuLIN® 50/50

30 minutes

2-4 hours

14-24 hours

NovoLIN® 70/30

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

Short-Acting Regular (HumuLIN R®; NovoLIN R®) Intermediate-Acting Neutral Protamine Hagedorn (NPH) (HumuLIN N®; NovoLIN N®) Long-Acting   Glargine (Lantus®; Toujeo®)

>24 hours

Pre-Mixed

NovoLOG® Mix 70/30; HumaLOG® Mix 50/50 HumaLOG® Mix 75/25

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 12

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FLORIDA PHARMACY TODAY

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 14

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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.


Table 2: Comparison of Smart insulin pens32,34,45-49

InPen™

NovoPen Echo Plus®

HumaPen Memoir™

June 2020

November 2018

April 2006

Patients aged 7 and up

Patients aged 7 and up

Patients aged 18 and up

Companion Medical/Medtronic

NovoPen Nordisk Global

Eli Lilly

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

Dose Calculator

Yes

Yes, through 3rd party app

Yes

Dose Reminder

Yes

Yes, through 3rd party app

No

1 year

5 years

3 years

Both IOS and Android

IOS and Android to be launched

Both IOS and Android

Bluetooth

NFC (Near Field Communications)

Bluetooth

Yes

Yes

No

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

Insulin Pen

Food and Drug Administration (FDA) approval date Approved age range Manufacturer Cost

Battery Life Apps for IOS/Android Connectivity CGM (Continuous Glucose Monitoring) Compatible Insulins

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 MARCH 2022

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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, 16

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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.


References

1. Diabetes. World Health Organization. https://www.who.int/ news-room/fact-sheets/detail/diabetes. Accessed July 23, 2021. 2. FastStats - Diabetes. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/fastats/diabetes.htm. Published March 30, 2021. Accessed July 23, 2021. 3. Diabetes Risk Factors. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/riskfactors.html. Published April 23, 2021. Accessed July 23, 2021. 4. Statistics About Diabetes. Statistics About Diabetes | ADA. https://www.diabetes.org/resources/statistics/statisticsabout-diabetes. Accessed July 23, 2021. 5. Fowler MJ. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes. 2008;26(2):77-82. doi:10.2337/ diaclin.26.2.77. 6. Giunti S, Barit D, Cooper ME. Mechanisms of Diabetic Nephropathy. Hypertension. 2006;48(4):519-526. doi: 10.1161/01.hyp.0000240331.32352.0c. 7. Cheng H-T, Xu X, Lim PS, Hung K-Y. Worldwide epidemiology of diabetes-related end-stage renal disease, 2000–2015. Diabetes Care. 2020;44(1):89-97. doi:10.2337/dc201913. 8. Foluso A. Fakorede MD. Increasing awareness this national diabetes month can save limbs and lives. AJMC. https:// www.ajmc.com/view/increasing-awareness-this-nationaldiabetes-month-can-save-limbs-and-lives. Published July 30, 2020. Accessed November 14, 2021. 9. American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers [published correction appears in Diabetes Care. 2022 Jan;40(1):10-38]. Diabetes Care. doi:10.2337/cd22-as01. 10. Selvin E, Parrinello CM, Daya N, Bergenstal RM. Trends in insulin use and diabetes control in the U.S.: 1988–1994 and 1999–2012. Diabetes Care. 2015;39(3). doi:10.2337/dc15-2229. 11. Luo J, Feldman R, Rothernberger SD, Hernandez I, Gellad WF. Coverage formulary restrictions, and out-of-pocket costs for sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists in the medicare part D program. JAMA Network Open. 2020;3(10). doi:10.1001/ jamanetworkopen.2020.20969. 12. Wallia A, Molitch ME. Insulin therapy for type 2 diabetes mellitus. JAMA. 2014;311(22):2315. doi:10.1001/ jama.2014.5951. 13. 9. pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes—2021. Diabetes Care. 2020;44(Supplement 1). doi:10.2337/dc21-s009. 14. Thomas NJ, Jones SE, Weedon MN, Shields BM, Oram RA, Hattersley AT. Frequency and phenotype of type 1 diabetes in the first six decades of life: A cross-sectional, genetically stratified survival analysis from UK Biobank. The Lancet Diabetes & Endocrinology. 2018;6(2):122-129. doi:10.1016/ s2213-8587(17)30362-5. 15. Bretzel RG, Nuber U, Landgraf W, Owens DR, Bradley C, Linn T. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (Apollo): An open randomised controlled trial. The Lancet. 2008;371(9618):1073-1084. doi:10.1016/s0140-6736(08)60485-7. 16. Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2007. doi: 10.1002/14651858.cd005613.pub3. 17. Monami M, Marchionni N, Mannucci E. Long-acting insulin

analogues versus NPH human insulin in type 2 diabetes. Diabetes Research and Clinical Practice. 2008;81(2):184-189. doi: 10.1016/j.diabres.2008.04.007. 18. Taylor R, Davies R, Fox C, Sampson M, Weaver JU, Wood L. Appropriate insulin regimes for type 2 diabetes: A multicenter randomized crossover study. Diabetes Care. 2000;23(11):16121618. doi:10.2337/diacare.23.11.1612. 19. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29(8):1963-1972. doi:10.2337/dc06-9912. 20. Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: A meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005;28(4):950-955. doi:10.2337/diacare.28.4.950. 21. Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2011. doi: 10.1002/14651858.cd006423.pub2. 22. Singh S, Wright EE, Kwan AY, et al. Glucagon-like peptide-1 receptor agonists compared with basal insulins for the treatment of type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes, Obesity and Metabolism. 2016;19(2):228-238. doi:10.1111/dom.12805. 23. Injectable insulin (chart). Cleveland Clinic. https:// my.clevelandclinic.org/health/drugs/13902-injectable-insulinmedications. Accessed November 16, 2021. 24. Henry RR, Schaeffer L, Olefsky JM.Glycemic effects of intensive caloric restriction and isocaloric refeeding in noninsulin-dependent diabetes mellitus*. The Journal of Clinical Endocrinology & Metabolism. 1985;61(5): 917-925. doi:10.1210/jcem-61-5-917. 25. Wing RR, Blair EH, Bononi P, Marcus MD, Watanabe R, Bergman RN. Caloric restriction per se is a significant factor in improvements in glycemic control and insulin sensitivity during weight loss in obese NIDDM patients. Diabetes Care. 1994;17(1):30 36. doi:10.2337/diacare.17.1.30. 26. Lean MEJ, Leslie WS, Barnes AC, et al. Primary careled weight management for remission of type 2 diabetes (direct): An open-label, cluster-randomised trial. The Lancet. 2018;391(10120):541-551. doi:10.1016/s0140-6736(17)33102-1. 27. Mannucci E, Monami M, Marchionni N. Short-acting insulin analogues vs. regular human insulin in type 2 diabetes: A meta-analysis. Diabetes, Obesity and Metabolism. 2009;11(1):53-59. doi:10.1111/j.1463-1326.2008.00934.x. 28. Melo KF, Bahia LR, Pasinato B, et al. Short-acting insulin analogues versus regular human insulin on postprandial glucose and hypoglycemia in type 1 diabetes mellitus: A systematic review and meta-analysis. Diabetology & Metabolic Syndrome. 2019;11(1). doi:10.1186/s13098-018-0397-3. 29. Bell KJ, Barclay AW, Petocz P, Colagiuri S, Brand-Miller JC. Efficacy of carbohydrate counting in type 1 diabetes: A systematic review and meta-analysis. The Lancet Diabetes & Endocrinology. 2014;2(2):133-140. doi:10.1016/s22138587(13)70144-x. 30. Vaz EC, Porfírio GJ, Nunes HR, Nunes-Nogueira Vdos. Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: A systematic review and meta-analysis. Archives of Endocrinology and Metabolism. 2018. doi:10.20945/23593997000000045. 31. Davidson PC, Hebblewhite HR, Steed RD, Bode BW. Analysis MARCH 2022

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of guidelines for basal-bolus insulin dosing: Basal insulin, correction factor, and carbohydrate-to-insulin ratio. Endocrine Practice. 2008;14(9):1095-1101. doi:10.4158/ep.14.9.1095 32. What is a smart insulin pen? ADA. https://www.diabetes. org/healthy-living/devices-technology/smart-insulin-pen. Accessed July 22, 2021. 33. Eli Lilly HumaPen Memoir Insulin Pen. Diabetes. https:// www.diabetes.co.uk/diabetic-products/pens/eli-lillyhumapen.html. Published March 9, 2020. Accessed August 17, 2021.   34. Venekamp WJ, Kerr L, Dowsett SA, et al. Functionality and acceptability of a new electronic insulin injection pen with a memory feature. Curr Med Res Opin. 2006;22(2):315-325. doi:10.1185/030079906X80477. 35. Medtronic Integrates Guardian Connect CGM with InPen Smart Insulin Pen. diaTribe. https://diatribe.org/ medtronic-integrates-guardian-connect-cgm-inpen-smartinsulin-pen. Published June 29, 2021. Accessed July 22, 2021.   36. Hyllested-Winge J, Sparre T, Pedersen LK. NovoPen Echo® insulin delivery device. Med Devices (Auckl). 2016;9:11-18. Published 2016 Jan 7. doi:10.2147/MDER.S59229. 37. Eli Lilly launches insulin pen with memory. FDAnews. https://www.fdanews.com/articles/90655-eli-lilly-launchesinsulin-pen-with-memory. Accessed August 13, 2021. 38. Danne T, Forst T, Deinhard J, Rose L, Moennig E, Haupt A. No effect of insulin pen with memory function on glycemic control in a patient cohort with poorly controlled type 1 diabetes: A randomized open-label study. Journal of Diabetes Science and Technology. 2012;6(6):1392-1397. doi:10.1177/1932 29681200600619. 39. Medtronic announces real-world data On InPen™ and Extended Infusion SET* Pivotal trial data at the American Diabetes Association 81st Scientific Sessions. Medtronic News. https://news.medtronic.com/2021-06-23-MedtronicAnnounces-Real-World-Data-on-InPen-TM-and-ExtendedInfusion-Set-Pivotal-Trial-Data-at-the-American-DiabetesAssociation-81st-Scientific-Sessions. Accessed August 14, 2021. 40. Vigersky RA, McMahon C. The relationship of hemoglobin a1c to time-in-range in patients with diabetes. Diabetes Technology & Therapeutics. 2019;21(2):81-85.doi:10,1089/ dia.2018.0310. 41. Wright EE, Morgan K, Fu DK, Wilkins N, Guffey WJ. Time in range: How to measure it, how to report it, and its practical application in clinical decision-making. Clinical Diabetes. 2020;38(5):439-448. doi:10.2337/cd20-0042. 42. Use of THE guardian™ Connect system with smart connected devices. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/ show/NCT04809285. Accessed September 12, 2021. 43. Observational study of NovoPen ECHO® on Safety and Treatment Satisfaction in Children and Adolescents with Type 1 Diabetes. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/ show/NCT01180530. Accessed August 14, 2021. 44. Adolfsson P, Veijola R, Huot C, et al. Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study. Curr Med Res Opin. 2012;28(9):1455-63. 45. Eli Lilly HumaPen memoir is an insulin pen with a MEMORY, recording the date, time, and amount of your last 16 DOSES (INCLUDING priming doses). Diabetes. https://www. diabetes.co.uk/diabetic-products/pens/eli-lilly-humapen. html. Published March 9, 2020. Accessed August 17, 2021. 46. Medtronic Integrates Guardian Connect CGM with InPen Smart Insulin Pen. diaTribe. https://diatribe.org/medtronicintegrates-guardian-connect-cgm-inpen-smart-insulin-pen. Published June 29, 2021. Accessed July 22, 2021. 18

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FLORIDA PHARMACY TODAY

47. NovoPen 6 and NovoPen Echo Plus: Connected Insulin Pens to Launch in Early 2019. diaTribe. Published November 3, 2018. Accessed August 13, 2021. 48. Lilly E, Luxura H, Mumford O. 510(K) Summary Z 1. Submitter’s Name.; 2006. Accessed September 16, 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf6/K063151. pdf. 49. Medtronic. Diabetes Digest. Medtronic.com. Published 2021. Accessed August 17, 2021. https://www.medtronic.com/ us-en/healthcare-professionals/therapies-procedures/ diabetes/education/diabetes-digest/inpen-smart-insulinpen.html#:~:text=InPen%20TM%20offers%20decision%20 support%20to%20patients%20who,with%20rapid-. 50. InPenTM User Access Program. Medtronic Diabetes. Published June 18, 2021. Accessed February 8, 2022. https:// www.medtronicdiabetes.com/inpen-access-program. 51. NovoPen Echo savings | NovoCare®. Novocare.com. Published 2021. Accessed February 8,2022. https://www. novocare.com/diabetes-overview/let-us-help/novopenechosavings.html. 52. Umbehr J. HumaPen Memoir, a Digital Insulin Pen | Medgadget. Medgadget.com. Published 2022. Accessed February 8, 2022.https://www.medgadget.com/2007/02/ huma-pen_memoir.html#:~:text=The%20device%2C%20 called%20the%20Huma-Pen%20Memoir%2C%20uses%20 insulin,Doug%20Boyd%2C%20who%20led%20the%20 Battelle%20development%20team. 53. Insulin Pens | ADA. Diabetes.org. Published 2021. Accessed September 13, 2021. https://www.diabetes.org/healthyliving/devices-technology/insulin-pens. 54. Injection technique in insulin therapy | Nursing Times. Nursing Times. Published March 2, 2012. Accessed September 14, 2021. https://www.nursingtimes.net/clinical-archive /diabetes-clinical-archive/injection-technique-in-insulintherapy-02-03-2012/. 55. Norliza. Insulin Injection Technique - PORTAL MyHEALTH. PORTAL MyHEALTH. Published October 4, 2011. Accessed August 17, 2021. 56. Spero D. Insulin Injection Technique: Tips and Tricks. Diabetes Self-Management. Published March 3, 2020. Accessed August 17, 2021. 57. National Health and Nutrition Examination Survey. Centers for Disease Control and Prevention. https://wwwn.cdc.gov/ Nchs/Nhanes/2017-2018/DIQ_J.htm. Published February 2020. Accessed August 16, 2021. 58. Farsaei S, Radfar M, Heydari Z, Abbasi F, Qorbani M. Insulin adherence in patients with diabetes: risk factors for injection omission. Prim Care Diabetes. 2014;8(4):338-345. doi: 10.1016/j.pcd.2014.03.001. 59. Kenney J. Smart insulin pen cleared for kids. diaTribe. https:// diatribe.org/smart-insulin-pen-cleared-kids. Published July 13, 2020. Accessed September 16, 2021. 60. Benedict AW, Spence MM, Sie JL, et al. Evaluation of a pharmacist-managed diabetes program in a primary care setting within an integrated health care system. Journal of Managed Care & Specialty Pharmacy. 2018; 24(2):114-122. doi:10.18553/jmcp.2018.24.2.114.


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COMPETITOR

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$1MM per occurrence / $3MM aggregate $2MM per occurrence / $4MM aggregate

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Sterile Compounding

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?

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$250,000 per occurrence / $250,000 aggregate

$25,000

Board of Pharmacy Imposed Fees

$2,500 sublimit

?

HIPAA Claim Defense Coverage

$50,000

$25,000

Assault Coverage

$25,000

$25,000

Sexual and Physical Abuse Coverage

$50,000

$25,000 sublimit

$1,500 per day / $50,000 per occurrence

1,000 per day / $25,000 aggregate

$50,000 limit

$10,000 aggregate

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CALL FOR ABSTRACTS FOR POSTER PRESENTATIONS FLORIDA PHARMACY ASSOCIATION 132nd ANNUAL MEETING AND CONVENTION

July 6-10, 2022 Marriott Harbor Beach Resort ♦ Ft. Lauderdale, Florida Poster Session: Friday, July 8, 2022 ♦ 11:00AM-1:00PM COST ONE DAY REGISTRATION The FPA Poster Presentations are open to PHARMACISTS, RESIDENTS, STUDENTS, AND TECHNICIANS. Complete and submit this COVERSHEET for each abstract submission. Submissions must be received no later than Friday, May 6, 2022. Abstracts will NOT be accepted after this date. Mail or E-mail this application along with the abstract submission to:

PLEASE TYPE

Tian Merren Owens, MS, PharmD, Director of Continuing Education Florida Pharmacy Association 610 N. Adams Street Tallahassee, FL 32301 tmerren@pharmview.com

Contact Information: Presenter's Name: _______________________________________________________________________________ □ Pharmacist

□ Resident

□Student

□ Technician

Address: ________________________________________________________________________________________ City, State, Zip: ___________________________________________________________________________________ Telephone No: _____________________E-Mail Address: _________________________________________________ College of Pharmacy: _____________________________________________________________________________ Abstract Title: ____________________________________________________________________________________ Poster Type:

□ Basic Science Research □ Best Practice □ Clinical Research □ Literature Review □ Translational Research (Basic Science and Clinical Research)

Primary Author: __________________________________________________________________________________ (Presenter will be notified by mail of acceptance). Co-Author(s): ____________________________________________________________________________________ Awards:

Posters will be eligible for 1st, 2nd, and 3rd place prizes to be presented at Convention. (Only one prize is given for each winning poster)

ABSTRACT FORMAT The abstract form submitted should be the equivalent of one page. The abstract should include: Title (Include authors’ names and name of College of Pharmacy), Purpose, Methods, Results, and Conclusions. Abstracts will not be accepted if they are not in this format. Do not include figures or graphs.

Please direct all questions and concerns to: Tian Merren Owens ♦ (850) 222-2400 ext. 120 ♦ tmerren@pharmview.com DEADLINE DATE: FRIDAY, MAY 6, 2022


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132nd 132nd Annual Meeting and Convention an

General Education Track You You Don't Don't Consultant Education Track Want Want to Miss Student & Technician to Track Mis Social Distanced Special Events This! This! Networking Opportunities

Exhibits • Poster Presentations Exh • Receptions i b i t•s Awards •

Po

Room Rates: Room $195 plus tax based on Rates: single/double occupancy.$195 The room reservation room deadline is Friday, reservation June 17, 2022 or when room d block is full. block is full. Thereafter, reservations may be taken on a space Ther available or available rate available basis. There is an optional or resort rate fee. Selfav parking is parking discounted to $12 per day. Please is be sure discoun to ask for the Florida Pharmacy Florida Association group rate. Pharmacy All reservations must be accompanied accompanied by a first night room deposit guaranteed with a major by a credit card. credit The check-in time is 4:00 card. p.m. and the checkout The time is ch 11:00 a.m. 11:00 a.m.

132nd and July 6 -10, 2022

Room reservations Marriot Marriot Harbor Beach ResortHarbor Beach Reso M can be made by calling && Spa, Ft. Spa, Lauderdale, FL, Ft. Lauderdale, FL 33316 33316 (800) 222-6543 22

|

Venue

FLORIDA PHARMACY TODAY


1

FPA 132nd Annual Meeting and Convention July 6-10, 2022v Ft. Lauderdale, FL

,

55Daily Education Registration

Participant Information Participant Information

Daily registration does not include admittance to functions or handbooks. Handouts will be posted on our website July 5.

Name: _____________________________________________________ Name _______________________________________________ Address______________________________________________ Badge Name: _______________________________________________ City, State, Zip_________________________________________ Mailing Address: ____________________________________________ Phone___ ________________________ City, State, Zip: _____________________________________________ Email________________________________________________ Phone: (W) (H)_______________________ Practice Setting________________________________________ License: PS______________ PU _____________RPT_________ Fax: ______________________________________________________ NABP Date of Birth___________ License:e-profile#__________________ PS________________ PU_________ Other State________ Emergency Contact Name/Number_________________________

2

Full Package Registration

Full package registration includes Educational Programs Thursday-Sunday, House of Delegates on Thursday, Exhibit Hall Friday and Saturday, Receptions, and Awards Event on Saturday. Handbooks are not included in full package registration. Handouts will be available the week of the convention on our website, www.floridapharmacy.org. Onsite

Amount_

2FPA Member

$345

$430

$_______

Non-Member

$525

$610

$_______

Pharmacist BEST Value

$540

$625

$_______

Member Technician

$155

$185

$_______

Non-Member Technician

$175

$210

$_______

Technician BEST Value

$185

$220

$_______

$150

$170

$_______

$40

$40

$_______

3Student

Handbooks

(BEST Value includes Registration & Membership)

3

Onsite

Amount

FPA Member

$165

$185

$_______

Non-Member

$215

$235

$_______

Member Technician

$65

$85

$_______

Non-Member Technician

$90

$110

$_______

Handbooks

$40

$40

$_______

Please select the day(s) you will attend: ¨Thursday

Before June 17

3

Before

June 17

6

¨Friday

¨Sunday

Additional Tickets

The following events are included in the Full Registration Package, if requested. However, you must purchase additional tickets for guests who are NOT registered. Quantity

Price

Amount

Exhibit Hall

$30

$______

Awards Event

$80

$______

7

Special Events Registration

The Poster Event is available to all pharmacy professionals and included in full and daily registrations. The Student Awards Event is not included in any registration packages. Quantity

Price

Amount

Poster Presenter One Day Registration $______ (Registration fee is based upon membership and professional status for non-convention registrants.) Student Awards Event

Please indicate below which functions you will attend. If no boxes are selected, we will assume you will not attend any of the events listed below. Please see box 6 for additional tickets.

¨Saturday

8

_______

$50

$______

FPA Polo Shirt (Deadline is June 3) Quantity Price ¨

Yes

______

$35

M/F ______

Size ______

Amount $_______

¨

House of Delegates (Thursday)

¨

FPPC Reception (Thursday)

¨

Exhibit Hall (Friday and/or Saturday)

¨

Awards Event (Saturday)

¨

Christian Fellowship (Sunday)

¨Check (To: FPA) ¨AMEX ¨Discover ¨MasterCard ¨Visa

¨

I will not attend any of these functions.

Account # ____________________________________________

4

House of Delegates

House of Delegates (Non-convention registrants)

9

Payment

Total Enclosed: $______

Security Code _________________ Expiration Date __________ Before June 8 $165

Amount ______

Billing Address ________________________________________ Signature ____________________________________________

Four Ways to Register

Mail: FPA, 610 North Adams Street, Tallahassee, FL 32301 Phone: 850-222-2400 Fax: 850-561-6758 Web: www.floridapharmacy.org

Schedule and Fees Subject to Change

MARCH 2022

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23


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