August 2020 Florida Pharmacy Today

The Official Publication Of The Florida Pharmacy Association AUGUST 2020

New Pharmacological Options for Sickle Cell Pain Crises

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florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 Executive Insight 23 FPA Officer and Director Nominations 26 FPA House of Delegates: Speaker’s Report

VOL. 83 | NO. 8 AUGUST 2020 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

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Vaccines: A Brief History 2020 Florida Pharmacy Association Cyberspace Adventure in Education and Networking FPA Names Pharmacist of the Year and Technician of the Year Medications in a Natural Disaster New Pharmacological Options for Sickle Cell Pain Crises FDA Issues Warnings on COVID-19 Products

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FPA Calendar 2020

SEPTEMBER 1

Deadline for officer and director nominations to be received in the FPA office

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Labor Day, FPA office closed

12-13 FPA Infections Disease Conference Webinar OCTOBER 1-2

Midyear Nuclear Conference Webinar.

3-4

Midyear Clinical Conference Webinar.

NOVEMBER 11

Veterans Day, FPA office closed

14 - 15 FPA Council, Committee and Board meeting 26 - 27 Thanksgiving - FPA Office Closed DECEMBER 5-6

Regulatory and Law Conference Sarasota

17-21 NCPA Annual Meeting Virtual meeting

FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW.FLORIDAPHARMACY.ORG

Events calendar subject to change

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. Pharmacists and pharmacy technicians must also complete a one-hour Florida Board approved continuing education on human trafficking

by Jan. 1, 2021.

Pharmacists should have satisfied all continuing education requirements for this biennial period by Sept. 30, 2021, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec. 31, 2020.

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 FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169

FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300

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

13-14 Florida Board of Pharmacy meeting Miami

FPA — Michael Jackson (850) 222-2400

Mission Statements:

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..................................................................... 7 EPIC....................................................................... 6 MICRO MERCHANTS........................................ 2 PQC...................................................................... 22 PHARMACISTS MUTUAL.............................. 28

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.

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

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Executive Insight

BY MICHAEL JACKSON, RPH MICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION

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Pharmacists Will Save Health Care

e are more than half a year into an extensive global pandemic never seen before in our lifetime. It is a health care crisis that is likely to change our way of life and create a new definition of normal.

Some have suggested that we are in the first stages of some kind of apocalypse or resetting of humanity that you only see in science fiction movies. It is clear that Congress is not going to be able to fix this issue by printing more money.

States will begin making very painful decisions on their operating budgets.

Gov. Ron DeSantis signed a $92.2 billion operating budget for Florida. Forty-eight percent of that budget goes to social services, with about $30 billion supporting Florida Medicaid. Education gets $27 billion, which means that whatever is left over will cover the cost of other state-provided services. Health care spending is without a doubt the biggest cost to state taxpayers. What this also means is that the budget approved by the 2020 Florida Legislature is not going to be sustainable given the shrinking of our state’s economic engine. In English, this means that anticipating deep and painful reductions in governmental spending is going to be an expectation for the years ahead of us.

It is my belief that this is an opportunity for pharmacy to save health care in Florida. The Florida Legislature quickly realized this as we were coming to the close of the 2020 session. A number of bills made significant changes to the pharmacy practice in this state. Changes to Florida Statute 465 now allow pharmacists to therapeutically interchange prescription medications. Consultant pharmacists can modify and discontinue prescription drug therapy

in institutional settings. They can also administer medications and order laboratory tests as defined by law.

Other changes in pharmacy laws allow pharmacists to initiate, modify or discontinue prescription drug therapy for patients with chronic diseases approved by the Board of Pharmacy, as well as testing and treating patients with board-defined non-chronic diseas-

It is my belief that this is an opportunity for pharmacy to save health care in Florida.

Michael Jackson, B.Pharm

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es. These major changes to FS 465 clearly are an attempt to bring our profession into focus in the management of patient care services. So why make all these changes to the practice?

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Here are a couple of reasons.

Growth of Florida’s population: In July 2019, Florida’s population was estimated to be about 21,477,000.

That is an increase of a little over 12 percent from our 2010 population of 18,804,000. With Florida growing like it is, the need and demand

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for health care services will not decline. Everything that we are seeing is suggesting that there will be significant health care provider shortages ahead of us.

Access to health care services: Our state is littered with health care deserts where access to primary care providers is either limited or nonexistent. In many communities, the pharmacist is the only health provider available. Even in urban areas, the pharmacist is available and on duty to help patients with many of their clinical issues. This provides a cost-effective alternative to using the emergency room as a primary care provider.

Training of today’s pharmacists: The curriculum of study that can be found in today’s colleges of pharmacy is vastly different than what we saw even 10 years ago. Our graduAUGUST 2020

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FPA STAFF Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200

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

Executive Insight, from Page 7

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Continuing Education Coordinator Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110

FLORIDA PHARMACY TODAY BOARD Chair............................... Carol Motycka, St. Augustine Vice Chair.........................Cristina Medina, Hollywood Treasurer.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member.............David Mackarey, Boynton Beach Member....................................... Matt Schneller, Tampa 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. . ©2020 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.

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ates are prepared to take on more of primary care roles in assisting patients with their medication needs.

Managing costs: Research has proven that coordinated care costs less than uncoordinated care. The model driven by the changes to the pharmacy practice act this past session creates a health care model where physician and pharmacy services become better connected. Patients who know their pharmacists are going to have better outcomes than patients who don’t. Better health care outcomes improve quality measures that may have an impact on reimbursement for both collaborating physicians and pharmacists.

Pandemic barriers: Many institutions and facilities had to limit their services to help contain the spread of COVID-19. This means that patients had to delay routine health services or procedures. Some of these services could be obtained through pharmacies that were willing to step up. This includes those that began offering testing and screening services for the coronavirus. In time when scientists develop an effective vaccine, the pharmacist can be available to provide that service.

With all of the above, it is clear why Florida made these significant changes.

Over the years, we have worked to educate members of the Florida House and Senate on how pharmacy can make a difference. Now we have been given the opportunity to save society with what we have been trained to do in the health care marketplace. n

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Learn more at www.medicationsafety.org or call us at (866) 365-7472.

The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

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VACCINES: A Brief History

By William Garst

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FLORIDA PHARMACY TODAY

Va c c i n e s h a v e been in the news lately with the COVID-19 pandemic, therefore I thought a column about this topic would be timely, especially since we have known William Garst for a long time about the immunity conferred by exposing a person to the disease that we are trying to avoid.

A vaccine is defined as “a substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease.”

The practice of inoculation – a term synonymous with vaccination and sometimes called variolation – has been practiced in different forms since the 10th century. Edward Jenner of England is credited with being the father of Vaccines. In 1796, Jenner inoculated a boy with matter from a young dairymaid’s cowpox. The boy became mildly ill but recovered in a few days. He then inoculated the boy with material from smallpox and the boy showed no ill effects. By the way, the reason the disease was called smallpox was to differentiate it from the great pox, now commonly called syphilis. All of this occurred from the observation that dairymaids who were exposed to cowpox never seemed to catch smallpox, which was quite common in England and Europe.

In addition, dairymaids were known to have nice complexions. Up to 25 percent of the people who contracted smallpox died, and the ones who survived were disfigured by the deep-seated pustules.

However, a little-known story about inoculation is told about Lady Montagu, an English aristocrat whose husband was appointed to be ambassador to Turkey in 1717. She was an inquisitive woman and wanted to learn as much as she could about the Ottoman culture.

She quickly came to realize that smallpox was rare in that part of the world, when she learned that most of the children were engrafted with pus material from a person who had a mild case

of smallpox. The children would receive a scratch on their arms then have the smallpox material rubbed into the scratch. They would fall ill for a few days and have a small number of mild pox but would recover quickly, their complexions would clear and they would acquire immunity from smallpox. Lady Montagu was so convinced of this procedure she had her son undergo the treatment with no ill effects.

When she returned to England, she convinced Caroline, princess of Wales,

EDWARD JENNER OF ENGLAND IS CREDITED WITH BEING THE FATHER OF VACCINES. IN 1796, JENNER INOCULATED A BOY WITH MATTER FROM A YOUNG DAIRYMAID’S COWPOX. the wife of the future King George II to have her children similarly engrafted. George II would allow only the female children to be engrafted, not the males. The procedure was successful, and the female children recovered from a short illness. To test the procedure further, some prisoners and orphans were recruited for the procedure. They were all observed to recover fully and seemed to have protection from smallpox. This was the first recorded clinical trial, crude as it was.

Initially, there was resistance to this procedure in the medical profession in England, but soon it caught on and became more common. The reason Jen-

ner’s cowpox inoculation became the preferred method was that it was much safer. Sometimes patients would fall extremely ill with the engrafting and die, while Jenner’s inoculation could be transferred from arm to arm and not directly from cowpox material, making it more reliable. In addition, there were rarely any serious reactions to Jenner’s method, and smallpox immunity was conferred.

Today, pharmacists are on the leading edge of providing immunizations to the public. Many pharmacies provide a variety of vaccines without a person having to go to the physician’s office. Check with your local pharmacy regarding availability and procedures for obtaining vaccinations because not all pharmacies offer vaccinations.

The final part of this column may be the most important: the reporting of adverse reactions to vaccines. The CDC and FDA co-administer a reporting program called the Vaccine Adverse Event Reporting System (VAERS). This is much like the MedWatch program in which individuals, as well as pharmacists and physicians, report any adverse reaction that may be related to the administration of a vaccine. If you should experience an adverse reaction to a vaccine you can reach out to https://vaers. hhs.gov/.

Vaccines are not without their risks, but the benefits usually outweigh those risks. In fact, vaccines have eliminated or greatly reduced more than 14 preventable infectious diseases including, measles, polio and smallpox. However, it is still an individual decision and should not be made without due consideration.

References

1. https://vaers.hhs.gov/index.html 2. https://www.honorhealth.com/ healthy-living/benefits-outweighrisks-when-it-comes-vaccination 3. “Ten Drugs” by Thomas Hager

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2020 Florida Pharmacy Association Cyberspace Adventure in Education and Networking Here is a list of those James Wright received the R.Q. Richards Public Relations Award. The Florida pharmacist is a graduate of the University of Florida. He worked in a hospital before starting Five Points Pharmacy and Wellness in 2012. He’s been a member of FPA since 2012 and served on the Government Affairs Council in 2016, 2017 and 2018.

After exhaustive review and analysis, the FPA Board of Directors suspended all planning for a live meeting in May, and for the first time in 130 years, the FPA held a virtual annual meeting.

The convention was completely digital using the Zoom webinar platform. The staff transitioned six months of conference planning to a computer-based live application. Essentially, this new way of stakeholder engagement was an opportunity for members who have not had the opportunity to attend an FPA conference to experience an annual meeting for the first time.

While we were not in person, we still delivered important training, conducted association business and recognized the best of our membership with the usual slate of awards and recognitions.

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William Garst received the Frank Toback Consultant Pharmacist Award.

He is a graduate of the University of Colorado in Denver and has been an FPA member since 1984. Garst is the owner of Reliable Consulting Pharmacy Services LLC and the chair of the board of the Alachua County Health Care Advisory Board. He also serves the homeless at Grace Pharmacy in Gainesville.

recognized at our virtual awards ceremony: The Distinguished Young Pharmacist Award was presented to Jeff Consaul. This award was presented

by Pharmacists Mutual Insurance Company to Consaul after he was nominated by a committee of his peers for exceeding the criteria required for this prestigious award.

The NASPA/APhA Bowl of Hygeia Award recipient was Humberto Martinez. In 1992, when Hurricane Andrew hit South Florida, he volunteered to distribute medications to people and ran a mini-pharmacy out of a trailer. He is a member of the Medical Reserve Corps and provided vaccinations in Miami during the H1N1 flu outbreak and collected urine samples during the Zika virus outbreak. He served as team captain, battalion chief and logistics chief of the Community Emergency Response Team. He’s researching how to help the community during the COVID-19 pandemic.

Neil Barnett, a Duval County pharmacist, received the DCPA Sidney Simkowitz Pharmacy Involvement Award. He is a graduate of Nova Southeastern University and served as the past president, vice president, officer and board member of the Duval County Pharmacy Association. He’s the county association’s chairman of the board and the FPA Region 2 Director since 2015.

Charlie Brown was the recipient of the Jean Lamberti Mentorship Award.

Brown is a Gainesville pharmacist who graduated from the University of Florida and is a veteran of the U.S. Army. He’s been a member of the Alachua County Association of Pharmacists for more than 20 years, serving on the board of directors, president, corresponding secretary and treasurer. He established the Alachua County Association of Pharmacists Student Engagement Fund, encouraging students to be more involved in local and state pharmacy associations.

The Interamerican Pharmacist Association’s Roman Maximo Corrons Inspiration and Motivation Award recipient was Kathy Pestos. She’s a University of Florida graduate who has been an FPA member since 1985.

Pestos has been involved in local, state and national associations and is a past recipient of the R.Q. Richards Award, the Sidney Simkowitz Pharmacy Involvement Award, the Bowl of Hygeia and was named FPA Pharmacist of the Year in 20017. She is a Fellow of the American Pharmacists Association and sponsors students at APhA and FPA political committee events.

Students also racked up awards at the convention. They include: ■

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Thomas Howell, Florida Agricultural and Mechanical University, won the Terry Gubbins Leadership Award.

Jahan Balyshova, Nova Southeastern University, won the James A. Mincy Scholarship.

Matthew Haas, Lake Erie College of Osteopathic Medicine, won the Norman Tomaka Family Scholarship.

Breana Caturano, Nova Southeaster, won the Hamilton, Harris and Hobbs Student Presidential Award.

Mahiul Reza, University of South Florida Health Taneja College of Pharmacy, won the Volusia Flagler County Pharmacy Association Scholarship.

Vivian Nguyen, University of Florida, won the James B. and Patsy Powers Scholarship.

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FPA Names Pharmacist of the Year and Technician of the Year The Florida Pharmacy Association named Tallahassee pharmacist James L. Mincy Pharmacist of the Year and Brian Willever as Technician of the Year.

James L. Mincy

Brian Willever

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Mincy, vice president for government affairs and business development for Pharmacy Provider Services Corp, received the award, which is named for James Hartley Beal, who was a pharmacist from Ohio and was the first recipient of the prestigious Remington Medal for Distinguished Service to American Pharmacy. Beal was president of the American Pharmacist Association and eventually made Okaloosa County.

Mincy served on the FPA’s Governmental Affairs Committee and is a member of the National Community Pharmacy Association, American Pharmacists Association and the Florida Independent Pharmacy Network. He is a 1976 graduate of the University of Florida College of Pharmacy.

Willever, an FPA member since 2012, has been a licensed pharmacy technician since 2004. He received his bachelor of arts in communication from Florida Atlantic University in 1992 and is the owner and treasurer of Royal Wellington Pharmacy.

Medications in a Natural Disaster Source: Centers for Disease Control and Prevention It’s hurricane season in Florida. Residents are stocking up on bottled water, nonperishable foods, batteries and flashlights. But what to do about their medications? Here are some reminders from the Centers for Disease Control and Prevention for your patients and customers.

Before Disaster Strikes Having a plan is particularly important if you have health conditions. You should take precautions for storing medications and being prepared for a disaster, the CDC says. Counsel your patients to: ■ Keep an up-to-date list of medications, including dose and indicated use.

■ Know how much medication they have on hand.

■ Obtain early refills if they anticipate poor access to a pharmacy.

■ Place medication bottles or packages in a water-tight container if there’s a possibility of flooding.

■ Have ice available for medications that need refrigeration.

After a Disaster Often, a disaster includes different kinds of disasters. A hurricane can bring strong winds, flooding, tornadoes and even fires. Here’s how different drugs could react to those exposures.

Fire or excessive heat: These can decrease the effectiveness of drugs. If your pharmacy was exposed to fire or excessive heat, consider replacing your stock. Tell your patients the same.

Unsafe water: Municipal water supplies can become contaminated during natural disasters, making them unsafe to drink or use. Flood water can be contaminated by chemicals and debris. Drugs, even those in their original containers with screw-top caps, snap lids or droppers, should be discarded if they come into contact with flood or contaminated water, the CDC says. Medicines placed in other storage containers should be discarded if water managed to infiltrate that container.

In a Life-Threatening Situation If a drug is needed to treat a life-threatening condition, it should be replaced as soon as possible if there’s a chance it was contaminated. However, if no replacement is available and the drug seems unchanged, for instance if the bottle is wet but the pills are dry, it may be taken until a replacement is available.

Drugs that Need to be Reconstituted Drugs that have to be reconstituted should only be mixed with purified or bottled water. Tell your patients to count this water in their emergency supplies before a storm hits. Liquids other than purified or bottled water should not be used to reconstitute medications.

Drugs that Need Refrigeration Hurricanes usually mean a loss of power. If a drug that needs refrigeration can’t be refrigerated because electrical power has been off for a long time, the drug needs to be discarded and replaced. Temperature-sensitive drugs can lose potency if not refrigerated. However, if it is necessary to sustain life, such as insulin, it may be used until a new supply is available.

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New Pharmacological Options for Sickle Cell Pain Crises Tamara Richards, Pharm.D., BCPS College of Pharmacy, Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences, Tallahassee Jamal A. Brown, Pharm.D, BCGP College of Pharmacy, Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences, Tallahassee Charlie Colquitt, Pharm.D. College of Pharmacy, Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences, Tallahassee Address correspondence to Dr. Brown (jamal.brown@famu.edu)

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Abstract PURPOSE

This article provides a summary of current therapies used to reduce the incidence of vaso-occlusive crises in sickle cell disease.

SUMMARY

Acute vaso-occlusive pain crisis is the most common complication of sickle cell disease and is responsible for most hospitalizations among sickle cell patients. Sickle cell patients experience an average of three pain crises yearly. Hydroxyurea has been the standard in the management of sickle cell disease and is indicated to reduce the frequency of pain crises and the requirement of blood transfusions in sickle cell patients. Although effective, hydroxyurea has a toxic side effect profile and a high rate of nonadherence with use. Until 2017, hydroxyurea had been the mainstay of therapy in sickle cell disease. Thereafter, three novel agents have since been approved to reduce the incidence of pain crises in sickle cell patients. L-glutamine, an essential amino acid, reduces the frequency of pain crises by decreasing the sickling of hemoglobin which thereby prevents its adhesion to blood cells.

Voxelotor is a hemoglobin S inhibitor which reduces anemia and hemolysis by reversibly binding to hemoglobin to prevent sickling of hemoglobin. Crizanlizumab, the first parenteral agent, is a p-selectin inhibitor which works by preventing the adhesion of sickled hemoglobin and leukocytes to endothelium. All of the aforementioned novel agents had favorable outcomes and noble side effect profiles when compared to hydroxyurea.

CONCLUSION

Novel agents such as L-glutamine, voxelotor and crizanlizumab have shown efficacy in reducing the incidence of pain crises.

Introduction Sickle cell disease is an inherited hematologic disorder that causes a genetic mutation in the beta hemoglobin gene. As a result, patients express a reduced oxygenated form of hemoglobin, hemoglobin-S (Hgb S), which causes the sickling of normal red blood cells and can lead to complications such as hemolysis and vascular occlusion (vaso-occlusion). Acute vaso-occlusive crisis is the most common complication of sickle cell disease.1 Vaso-occlusive crisis (VOC) is defined as pain resulting from tissue ischemia caused by vaso-occlusion of blood vessels.

Patients who experience vaso-occlusive crisis present with acute, severe pain commonly in the extremities, chest or back.1 Sickle cell disease affects approximately 100,000 Americans and is responsible for an average of three vaso-occlusive crises a year in sickle cell patients.2,3,4 Due to potential life-threatening complications such as stroke, acute chest syndrome and multiorgan failure that may occur as a result of vaso-occlusive crisis, prevention is imperative. Prophylactic treatment of vaso-occlusive pain crisis has been limited to

hydroxyurea and blood transfusions. For more than two decades, hydroxyurea has been the gold standard for the management of sickle cell patients.

Despite clinical efficacy of hydroxyurea, 96 percent of hospitalizations of sickle cell patients are due to vaso-occlusive pain crisis.5 In 2016, the average length of stay for a sickle cell patient was 5 days and resulted in an annual cost of $811 million.5 Data supported the notion of underutilization of hydroxyurea among sickle cell patients and an inverse proportion of hospitalizations to hydroxyurea use.6,7 Until 2017, hydroxyurea had been the only FDA-approved medication to reduce the incidence of vaso-occlusive crises in sickle cell patients. Three novel agents have since been approved to aid in the prevention of vaso-occlusive crises in sickle cell patients.

This article aims to provide a summary of current therapies used to reduce the incidence of vaso-occlusive crises in sickle cell disease with emphasis on general principles, clinical efficacy, safety and place in therapy.

Hydroxyurea Hydroxyurea is a ribonucleotide reductase inhibitor used in sickle cell patients to reduce the frequency of painful crises and the need for blood transfusions.8 Hydroxyurea works on a key pathway in sickled hemoglobin synthesis by inhibiting polymerization of sickled hemoglobin, which increases fetal hemoglobin (HbF).9 An increase in fetal hemoglobin aids in the reduction of vaso-occlusive crises.

Hydroxyurea also prevents the adhesion of blood cells, increases mean corpuscular volume in red blood cells, and can reduce the deformity of red blood cells which, in turn, decreases the incidence of anemia and vaso-occlusive crises in sickle cell patients.1 Hydroxyurea is indicated in all adult sickle cell patients who have experienced three or more pain crises within a year and all infants less than 6 months, children and adolescents with sickle cell disease regardless of incidence of pain crises.8 DOSAGE

Hydroxyurea is dosed at 15 mg/kg once daily based on actual or ideal body weight, whichever is lower, and may be titrated up to the maximum tolerated dose of 35 mg/kg/day in two divided doses.8 Dose titrations of 5 mg/kg/day every 12 weeks is required to monitor for hematological toxicity. Once a patient’s blood count is within normal limits and if the patient is not experiencing toxicity, hydroxyurea is no longer titrated. Renal adjustments are required for patients with a creatinine clearance (CrCl) less than 60 mL/min. It is recommended to reduce the dose of hydroxyurea by 50 percent once the CrCl falls less than 60 mL/min. There are no recommended dose adjustments in patients with hepatic impairment.

CLINICAL TRIALS

Hydroxyurea was first approved in 1998 following the multicenter study of hydroxyurea in patients with sickle cell anemia trial (MSH).10 The MSH trial proved hydroxyurea efficacy in reducing the rate of pain crises by 44 percent (2.5 versus 4.5 crises per year, p<0.001) when compared to placeAUGUST 2020

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bo. Hydroxyurea also increased the time between the first (3 versus 1.5 months, p=0.01) and second occurrence (8.8 versus 4.6 months, p<0.001) of pain crises in sickle cell patients who had experienced three or more vaso-occlusive pain crisis within a year when compared to placebo. Patients who received hydroxyurea also had a lower incidence of acute chest syndrome (25 versus 51 patients, p<0.001), required less blood transfusions (48 versus 73 patients, p=0.001), experienced an average increase in hemoglobin by 0.6 gram per deciliter (g/ dL), and an average increase in fetal hemoglobin by 3.6 percent when compared to placebo. A 17-year follow-up to the initial MSH trial reported a 40 percent reduction in mortality in sickle cell patients who used hydroxyurea.11 Safety. Hydroxyurea is a human carcinogen and may cause severe myelosuppression, vasculitic toxicity and macrocytosis with use. Although more than 30 percent of adverse reactions are hematological and gastrointestinal related, hydroxyurea may also cause bacterial infections, headache, leg ulcers, vitamin D deficiency and weight gain.8 Hydroxyurea should not be used with live vaccines and may cause pancreatitis, hepatotoxicity and neuropathy when used concomitantly with antiretrovirals. Hydroxyurea can cause embryofetal toxicity and should not be used in pregnant women or in men and women who plan to become pregnant. It is recommended that women use effective contraception for at least 6 months after stopping hydroxyurea. It is also recommended for men with female partners of reproductive age to use effective contraception for at least 12 months after stopping hydroxyurea. Hydroxyurea is also excreted in breast milk and should not be used during lactation.

PLACE IN THERAPY

Despite clinical benefits with use of hydroxyurea, there is an alarming rate of nonadherence among sickle cell patients. A cross sectional survey was completed in adolescent and young adult sickle cell patients to identify barriers to hydroxyurea adherence, assess adherence rates and quality of life.12 Thirty-two percent of the patients reported nonadherence with hydroxyurea use due to its negative side effect profile and a presumed lack of efficacy.12,13 Unfortunately, hydroxyurea has a delayed clinical response rate of 3 to 6 months and patients may experience pain crisis during this induction phase.10 This may provide insight into a patientâ&#x20AC;&#x2122;s perception of ineffectiveness of hydroxyurea. The potential for twice daily dose administration, an unfavorable side effect profile and frequent monitoring for myelosuppression may also adversely impact adherence. Prior to 2017, hydroxyurea was the only drug approved to reduce the incidence of pain crises in sickle cell patients. Thereafter three novel agents have been approved to ameliorate outcomes among sickle cell patients and to address issues associated with use of hydroxyurea.

Endari (L-glutamine) L-glutamine is an essential amino acid that was approved in 2017 to reduce the frequency of pain crises in sickle cell patients who have had two or more vaso-occlusive events with16

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in a year. L-glutamine is indicated in patients less than 5 years of age and may be used as an adjunct to hydroxyurea or as an alternative in patients who are intolerable to hydroxyurea.14 L-glutamine reduces oxidative stress in sickled red blood cells through the synthesis of nicotinamide adenine dinucleotide (NAD). NAD is an oxidation-reduction cofactor in red blood cells. NAD and its reduced form, NADH, play a key role in maintaining redox balance in red blood cells to prevent cell damage.15 Unfortunately, in sickled red blood cells this balance is reduced. Sickled red blood cells consume three times the amount of L-glutamine than normal red blood cells to maintain intracellular levels of NAD.16 The use of L-glutamine in sickle cell patients results in an increase in the NAD redox ratio which thereby reduces sickling of hemoglobin and adhesion of blood cells to vasculature.

DOSAGE

L-glutamine dosing is weight-based and administered twice daily. A recommended dose of 5 g by mouth twice daily should be administered to patients with a weight < 30 kg, 10 g by mouth twice daily in patients with a weight between 30 kg and 65 kg, and 15 g by mouth twice daily in patients with a weight > 65 kg.14 L-glutamine is commercially available as a 5-gram oral powder packet that must be dissolved in 8 ounces of a beverage or eaten with 4 to 6 ounces of foods such as applesauce or yogurt. There are no reported contraindications with use. There are also no dose adjustments with use, however caution should be used in patients with renal and hepatic impairment. L-glutamine may reduce the effects of lactulose, therefore patients should be monitored if lactulose is used concomitantly with L-glutamine.

CLINICAL TRIALS

Efficacy of L-glutamine was initially evaluated in a multicenter, randomized, double-blinded, placebo-controlled, parallel group phase II study that evaluated the safety and efficacy of L-glutamine use in sickle cell patients.15 The investigators assessed the frequency of pain crises in sickle cell patients who received L-glutamine versus those in placebo. Although L-glutamine was shown to reduce the incidence of pain crises versus placebo at 24 weeks (2.5 versus 5.5 events), the study was underpowered due to sample size (n=62), reported statistically insignificant results, and there was a high withdrawal rate among participants (49 percent versus 62 percent).15 As a result, a landmark phase III trial was completed to increase power (n=230), control for compliance in an effort to reduce the rate of withdrawal, and to evaluate the incidence of pain crises in sickle cell patients who received 48 weeks of therapy.17 Eligible patients were between the ages of 5 and 58 years of age, with a diagnosis of sickle cell disease or sickle beta thalassemia, and who had experienced at least two pain crises within the past year. Patients on hydroxyurea were included if they were stable on therapy for at least 3 months. At baseline, 66 percent of the patients received hydroxyurea. Patients were randomized 2:1 to receive weightbased L-glutamine or placebo. The primacy efficacy endpoint was the reported number of pain crises by week 48. Investi-

gators also evaluated the incidence of hospitalization as a secondary endpoint.

At 48 weeks, there was a reported mean reduction in the frequency of crises by 3.2 versus 3.9 events per year with Lglutamine use compared to placebo (p=0.005).17 L-glutamine also reduced the number of hospitalizations with a mean frequency of two versus three hospitalizations per year compared to placebo (p=0.005). L-glutamine prolonged the time to first occurrence of a pain crisis, which was a reported 84 days versus 54 days (hazard ratio, 0.69; p=0.02) when compared with use of placebo. The amount of time for a second recurrence of crises was 212 days versus 133 days (hazard ratio, 0.68; p=0.03) with L-glutamine versus placebo, respectively.

L-glutamine was also found to substantially reduce the number of pain crises in patients who previously experienced frequent crises. At baseline 84.2 percent of the patients enrolled had two to five reported sickle cell related pain crises within a year, however only 8.6 percent of the patients receiving L-glutamine experienced at least one pain crisis within the year following use. Patients also experienced less acute chest syndrome with L-glutamine (8.6 percent versus 23.1 percent, p=0.03) when compared to placebo. At week 48, only 63.8 percent versus 75.6 percent of the patients enrolled were compliant with L-glutamine and placebo, respectively.

SAFETY

Patients experienced more adverse effects with use of Lglutamine than that of placebo. The most common adverse effects reported were constipation, headache, and nausea which occurred in more than 15 percent compared to 13 percent of the patients who received L-glutamine and placebo, respectively.17 Non-cardiac chest pain, fatigue, UTI, nasal congestion and pain in the back and extremities were also reported.17 There is no reported data with use of L-glutamine in pregnant women and L-glutamine can be found in breast milk.14 Therefore caution is advised with use of L-glutamine in pregnant women and women who breastfeed.

PLACE IN THERAPY

Although L-glutamine was shown to be effective in reducing the incidence of pain crises there was a relatively high rate of noncompliance with use which is already a major issue in the management of sickle cell patients. This could in part be due to the number of packets administered per dose coupled with the fact that L-glutamine must be administered twice daily. Also, L-glutamine caused more adverse effects than that of placebo. Unfortunately, sickle cell patients cite unwarranted side effects and forgetfulness as common reasons of nonadherence with hydroxyurea use.12 The rate of discontinuation due to side effects with L-glutamine use was 3.3 percent versus zero with placebo use.17 Although L-glutamine may be a viable agent used to reduce the incidence of vaso-occlusive events in sickle cell patients, its side effect profile coupled with a twice daily administration dosing with dietary requirements may continue to negatively impact a population burdened with nonadherence.

ACUTE VASO-OCCLUSIVE PAIN CRISIS IS THE MOST COMMON COMPLICATION OF SICKLE CELL DISEASE AND IS RESPONSIBLE FOR MOST HOSPITALIZATIONS AMONG SICKLE CELL PATIENTS. Oxbryta (voxelotor) Polymerization of hemoglobin S is the initial step in the development of deoxygenated sickled hemoglobin. The polymerization of hemoglobin S leads to complications associated with hemolysis, anemia, vaso-occlusive events and chronic organ dysfunction. Voxelotor is a hemoglobin S polymerization inhibitor that works by reversibly binding to hemoglobin to stabilize hemoglobin’s oxygenation to reduce sickling.18 Voxelotor is indicated in adult and pediatric patients less than 12 years of age to reduce anemia and hemolysis in sickle cell patients.

DOSAGE

Voxelotor is recommended at a dose of 1500 mg by mouth, once daily. Dose adjustments of 1000 mg by mouth, once daily, are required for patients with severe hepatic impairment since the AUC was shown to be 90 percent higher in patients with severe hepatic disease.18 Caution is advised when voxelotor is used concomitantly with 3A4 substrates. Coadministration with moderate or strong 3A4 inhibitors or inducers should be avoided, specifically with fluconazole. If coadministration is unavoidable, a recommended dose of 1000 mg by mouth once daily should be used with strong inhibitors and AUGUST 2020

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2500 mg by mouth once daily should be used with moderate or strong inducers.

CLINICAL TRIALS

Voxelotor gained an accelerated FDA approval in 2019 following the landmark HOPE trial. The HOPE trial was a multicenter, randomized, double-blind, placebo-controlled phase III study completed in sickle cell patients to compare the efficacy of voxelotor 1500 mg and 900 mg with placebo for 24 weeks.19 Eligible patients were 12 to 65 years of age, had a hemoglobin level between 5.5 and 10.5 g/dL, and who had experienced 1 to 10 pain crises within the year. Patients previously on stable doses of hydroxyurea for at least three months were included in the study. Patients with recent blood transfusions within 60 days and erythropoietin use within 28 days of randomization were excluded. In the HOPE trial, 274 patients were randomized 1:1:1 to receive voxelotor 1500 mg, voxelotor 900 mg, and placebo for 24 weeks.19 The primary endpoint was the percentage of patients with an increase in hemoglobin from baseline of more than 1 g/dL at week 24. Investigators also evaluated change in hemoglobin from baseline to week 24, incidence of hemolysis, and the annual incidence of pain crises as secondary endpoints.

An increase in hemoglobin by at least 1 g/dL at week 24 was achieved in 51 percent of the patients who received voxelotor 1500 mg, 33 percent of the patient who received voxelotor 900 mg, and in 7 percent of the patient who received placebo (p<0.001). A mean change in hemoglobin from baseline of 1.1 g/dL, 0.6 g/dL, and - 0.1 g/dL occurred with use of voxelotor 1500 mg, voxelotor 900 mg, and placebo, respectively (p<0.001). At week 24, 41 percent of the patients who received voxelotor 1500 mg, 20 percent of the patients who received voxelotor, and 9 percent of the patients who received placebo achieved a hemoglobin level of at least 10 g/ dL. Voxelotor was also shown to significantly reduce the incidence of worsening anemia and hemolysis in patients. Indirect bilirubin (-29.1percent, -20.3 percent, and -3.2 percent, p<0.001) and percentage of reticulocytes (-19.9 percent, -1.3

NOVEL AGENTS SUCH AS L-GLUTAMINE, VOXELOTOR AND CRIZANLIZUMAB HAVE SHOWN EFFICACY IN REDUCING THE INCIDENCE OF PAIN CRISES. 18

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percent, and4.5 percent, p<0.001) had a significant reduction from baseline with voxelotor 1500 mg and 900 mg versus placebo use. Blood transfusions were permitted during the study, 33 percent and 32 percent of the patients who received voxelotor 1500 mg and 900 mg received blood transfusions versus 25 percent of the patients who receivedplacebo.

Voxelotor also had a greater impact on reducing the annual incidence of vaso-occlusive events (2.77 versus 2.76 versus 3.19 events). Although 65 percent of the patients enrolled previously received hydroxyurea, marginal improved outcomes were observed in patients who had not previously received hydroxyurea (1.2g/dL versus 0.7 g/dL versus 0 g/dL change in hemoglobin from baseline).19 SAFETY

The most common adverse effects with use of voxelotor include headache and diarrhea, which occurred in > 20 percent of patients.19 Other common side effects include abdominal pain, nausea, fatigue, rash and pyrexia. Forty-one percent of patients experienced a dose reduction or dose interruption as a result of an adverse reaction to voxelotor.19 However, only 5 percent of patients who received voxelotor 1500 mg discontinued use due to an adverse reaction.19 It is known that sickle cell patients have a high blood viscosity, therefore in theory an increase in hemoglobin may pose additional risk for thrombosis. Fortunately, there were no reported thrombotic events with the use of voxelotor. It is advised to avoid use of voxelotor in pregnant women and women who breastfeed since there is no reported data of its use in either population of patients.

PLACE IN THERAPY

A common goal of therapy for patients with sickle cell disease is to reduce the incidence of vaso-occlusive crisis and to slow or prevent chronic organ dysfunction. Although a marginal benefit in the incidence of vaso-occlusive events was proven, voxelotor was shown to significantly reduce hemolysis and anemia in patients with sickle cell disease without increasing the risk of thrombosis. It should be noted that more patients did receive blood transfusions within the voxelotor cohort than placebo. Voxelotor proved to increase the hemoglobin by at least 1 g/dL in most patients which is an advantage over that of hydroxyurea which yields an average increase of 0.6 g/dL. 1,19 Voxelotor may be beneficial in sickle cell patients with persistent anemia. Voxelotor’s once daily formulation, low rate of study drop out and mild side effect profile makes it an attractive option in patients who may have adherence issues, who are reluctant to use hydroxyurea or who are intolerable to hydroxyurea. The long-term effects of voxelotor have not been evaluated. There is currently a phase III trial to evaluate the use of voxelotor in patients who receives at least 72 weeks of voxelotor.20 Adakveo (crizanlizumab) P-selectin is a human protein that functions as a cell adhesion molecule.21 P-selectin plays a key role in the cascade of events which leads to vaso-occlusion in sickle cell patients.

Initiated by the expression of p-selectin, vaso-occlusion is caused by the bonding of sickled red blood cells and leukocytes to endothelium.22 Crizanlizumab is a p-selectin inhibitor which was recently approved to reduce the incidence of pain crises in adult and pediatric sickle cell patients less than 16 years of age.

zanlizumab should be discontinued. Crizanlizumab may also interfere with automated platelet counts resulting in pseudothrombocytopenia due to platelet clumping. Crizanlizumab is not recommended for use in pregnant women and should be used with caution during lactation.

DOSAGE

In comparison to other novel agents, crizanlizumab proved efficacy in patients with a higher incidence of pain crises at baseline, reduced the annual rate of hospitalized days, and prolonged the interval time between the recurrence of pain crises. Although, efficacy was proven in patients on hydroxyurea, the astounding results observed in patients who were not on hydroxyurea may make it a judicious option as initial therapy in patients who are intolerant to hydroxyurea or who are concerned with the toxicities associated with its use. There is currently a phase III trial underway to evaluate the safety and efficacy of a higher dose of crizanlizumab (5 mg/kg and 7.5 mg/kg) versus placebo.22

Crizanlizumab is dosed at 5 mg/kg via intravenous infusion using the patient’s actual body weight on week zero, week two and every four weeks thereafter. Crizanlizumab must be prepared and administered by a health care professional. There are no contraindications with use.

CLINICAL TRIALS

A multicenter, randomized, double-blind, placebo-controlled phase II study (SUSTAIN) was completed in sickle cell patients with or without concomitant use of hydroxyurea.21 Eligible patients were 16-65 years of age who had experienced two to 10 pain crises within a year. Patients who used hydroxyurea for at least six months and were compliant for at least three months prior to randomization were included.

Patients who were not on hydroxyurea were not permitted to initiate use during the trial period. Patients who required long-term blood transfusions were excluded. In the SUSTAIN trial, 198 patients were randomized 1:1:1 to low-dose (2.5 mg/ kg) crizanlizumab, high-dose (5 mg/kg) crizanlizumab, and placebo. The primary endpoint was to determine the annual incidence of pain crises with use of crizanlizumab for 52 weeks.

High-dose and low-dose crizanlizumab was shown to reduce the incidence of pain crises by 45.3 percent and 32.6 percent in sickle cell patients when compared to placebo (p=0.01), respectively. Thirty-six percent of the patients who received high dose crizanlizumab had no reported pain crises within the treatment period when compared to the 17 percent of the patients who reported events with placebo. Patients who did not use hydroxyurea at baseline had a 50 percent reduction in pain crises compared with a 32.1 percent reduction in patients who concomitantly used hydroxyurea. A profound reduction in pain crises by 63 percent was shown in patients who reported 5 to 10 pain crises within a year at baseline, with a median rate of 1.97 crises per year with use of crizanlizumab. High dose crizanlizumab prolonged the median time to the first and second crises versus that of placebo, 4.07 versus 1.38 months (p=0.001) and 10.32 versus 5.09 months (p=0.02), respectively. Crizanlizumab was also shown to reduce the number of days hospitalized by 41.8 percent when compared to placebo (four days per year versus 6.87 days per year, p=0.45). At 52 weeks, only 65 percent of the patients enrolled completed the study protocol.

SAFETY

The most common adverse reactions with the use of crizanlizumab are nausea, arthralgia, back pain and pyrexia.21 Patients should be monitored for severe infusion related reactions. In the event of a severe infusion related reaction, cri-

PLACE IN THERAPY

CONCLUSION

Hydroxyurea has been the gold standard for the reduction of pain crises in sickle cell patients, however sickle cell patients still experience an average of three pain crises yearly.3 In 2016, the annual cost for sickle cell related hospitalizations was $811 milion.5 Sickle cell patients are also four times more likely to leave against medical advice and have a 33 percent 30-day readmission rate.5 Within the clinical trials of all three novel agents, at least 30 percent of the patients enrolled reported chronic use of hydroxyurea and more than 58 percent of patients enrolled experienced at least two pain crises at baseline. Although hydroxyurea is effective and has proven to reduce mortality in sickle cell patients, a negative side effect profile and confounding factors such as adherence, patient perception and access may negatively impact outcomes associated with hydroxyurea use.11,12,13 L-glutamine, voxelotor and crizanlizumab have been approved to improve outcomes such as anemia, hospitalizations and pain crises among sickle cell patients in hopes of bridging the gaps found with hydroxyurea use.

In a population burdened with non-adherence to an effective agent that mitigates severe, chronic complications associated with sickle cell disease, each novel agent may specifically and distinctly improve adherence and overall patient outcomes. Although, L-glutamine failed to show a profound difference in reducing pain crises and hospitalizations, it still may be a viable option to be used as adjunct to hydroxyurea to improve outcomes. Voxelotor may also be best suited for use as adjunct to hydroxyurea to aid in combating the incidence of anemia associated with sickle cell disease. Of the three, crizanlizumab may be the only novel agent that could potentially be used in place of hydroxyurea due to its positive outcomes reported in clinical trials. Although further evaluation is needed to evaluate the long-term effects of use of such novel agents, there are now more options that may be used to improve outcomes in sickle cell patients.

AUGUST 2020

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Table 1 Comparison of current therapies for the prevention of vaso-occlusive crises8,14,17,18,21,22,24,25,26,27

HYDROXYUREA

L- GLUTAMINE

VOXELOTOR

CRIZANLIZUMAB

Increases fetal hemoglobin, prevents adhesion of blood cells, increases MCV and improves RBC deformity

Increase synthesis of NAD to reduce oxidative stress in hemoglobin S

Inhibits polymerization of hemoglobin S

Inhibits P-selectin (molecule responsible for cell adhesion)

Reduces frequency of VOC

Reduces VOC pain in patients with at least two VOC events within a year

Reduces anemia and hemolysis in patients with one or more VOCs

Reduces the frequency of VOC

Mainstay

Alternative to (in intolerant patients) or adjunct to hydroxyurea

Alternative to (in intolerant patients) or adjunct to hydroxyurea

Initial therapy or adjunct to hydroxyurea

Starting Age of Initiation

Pediatrics and adults

5 years of age

12 years of age

16 years of age

Route of Administration

Oral

Oral

Oral

IV Infusion

Frequency of Administration

Once, up to twice daily

Twice daily

Once daily

Every four weeks

Time to Clinical Efficacy

3-6 months

2 weeks

4 weeks

6 weeks

N/A

66%

65%

62%

100%

98%

58%

100%

Yes

Yes

Yes

No

Myelosuppression, malignancy, bacterial infections, headache, weight gain, and leg ulcers

Constipation, headache, and nausea (> 10%)

Headache and diarrhea

Arthralgia, back pain, nausea, and pyrexia

CBC

None

None

Infusion reactions

$1.64 per 500 mg tablet

$22.20 per 5 g packet

$138.89 per 500 mg tablet

$282.96 per 100 mg/10 mL vial

Mechanism of Action

Indication

Place in Therapy

Hydroxyurea Use at Baseline in Clinical Trial (%) Patients with > 2 Pain Crises at Baseline in Clinical Trial (%) Blood Infusions with Use in Clinical Trial

Common Adverse Effects

Monitoring

Price

Reduces anemia and need for blood transfusions

MCV – mean corpuscular volume 20

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References 1. Evidence-Based Management of Sickle Cell Disease: Expert Panel. Heart N, Institute B (2014) 2. Center for Disease Control (CDC). Data and Statistics on Sickle Cell Disease. https://www.cdc.gov/ncbddd/ sicklecell/data.html. Accessed 2020-04-01 3. Neumayr L, Hoppe C, Brown C. Sickle Cell Disease: Current Treatment and Emerging Therapies. Am J Manag Care.

2019;25-S0 4. Shah N, Bhor M et al. Sickle cell disease complications: Prevalence and resource utilization. PLoS One. 2019 Jul 5;14(7):e0214355 5. Statistical Brief #251. Healthcare Cost and Utilization Project (HCUP). August 2019. Agency for Healthcare Research and Quality, Rockville, MD. www.hcup-us.ahrq.gov/ reports/statbriefs/sb251-Sickle-Cell-Disease-Stays-2016.jspv Accessed 2020-05-02 6. Nottage K, Hankins J et al. Hydroxyurea Use and Hospitalizations Trends in a Comprehensive Pediatric Sickle Cell Program. PLoS One. 2013;9(8):e72077 7. Lanzkron S, Haywood C et al. Examining the Effectiveness of Hydroxyurea in People with Sickle Cell Disease. Journal of Health Care for the Poor and Underserved 21(1),277-286 8. Droxia (hydroxyurea) prescribing information. Princeton, New Jersey: Bristol-Myers Squibb Company; 2019 9. Bunn HF. Pathogenesis and treatment of sickle cell disease.

N Engl J Med 1997; 337:762-9 10. Charache S, Terrin M, et al. Effect of Hydroxyurea on the frequency of painful crises in sickle cell anemia.

Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med. 1995 May 18;332(20):131722.

11. Steinberg MH, McCarthy WF, Castro O, Ballas SK, Armstrong FD, Smith W, et al. The risks and benefits of longterm use of hydroxyurea in sickle cell anemia: A 17.5 year follow-up. Am J Hematol. 2010;85(6):403-8.

12. Badawy S, Thompson A et al. Adherence of hydroxyurea, health related quality of life domains, and patients’ perceptions of sickle cell disease and hydroxyurea: A cross sectional study in adolescents and young adults. Health Qual Life Outcomes. 2017;15:136 13. Badawy S Thompson A et al. Barriers to hydroxyurea adherence and health related quality of life in adolescents and young adults with sickle cell disease. Eur J Haemetol.

2017;98:608-614

14. Endari (L-glutamine) prescribing information. Torrance, CA: Emmaus Medical, Inc; 2017.

15. Niihara Y, Macan H, Eckman JR et al. L-glutamine Therapy Reduces Hospitalization for Sickle Cell Anemia and Sickle B-Thalassemia Patients at Six Months- A phase II Randomized Trial. Clin Pharmacol Biopharm 2014. 3(1);116.

16. Niihara Y, Zerez CR, Akiyama DS, Tanaka KR (1997) Increased red cell glutamine availability in sickle cell anemia: demonstration of increased active transport, affinity, and increased glutamate level in intact red cells. J Lab Clin Med 130: 83-90[Package Insert] L-glutamine 17. Niihara Y, Miller S, Kanter J et al. A Phase III Trial of L-glutamine in Sickle Cell Disease. N Engl J Med 2018.

379;3:226-235 18. Oxbryta (voxelotor) prescribing information. South San Francisco, CA: Therapeutics, Inc; 2019 19. Vichinsky E et al. A Phase III Randomized trial of Voxelotor in Sickle Cell Disease. N Engl J Med 2019; 381(6):509-519.

20. Study to Assess the Effect of Long-term Treatment with Voxelotor in Participants who have completed treatment in Study GBT440-031-Full Text View-ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03573882 .

Accessed 2020-04-01 21. Ataga K, Kanter J et al. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. N Engl J Med 2017;365(5):429-439 22. Adakveo (crizanlizumab) prescribing information. East Hanover, New Jersey: Novartis; 2019 23. Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients (STAND)Full Text View- ClinicalTrials.gov. https://clinicaltrials.gov/ ct2/show/NCT03814746 . Accessed 2020-4-29 24. Hydroxyurea. In: Lexi-Drugs [Lexi-Comp Database].

Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; 2020 [Updated 2020, cited 2020 Oct 2] 25. L-glutamine. In: Lexi-Drugs [Lexi-Comp Database]. Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; 2020 [Updated 2020, cited 2020 Oct 2] 26. Voxelotor. In: Lexi-Drugs [Lexi-Comp Database]. Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; 2020 [Updated 2020, cited 2020 Oct 2] 27. Crizanlizumab. In: Lexi-Drugs [Lexi-Comp Database].

Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; 2020 [Updated 2020, cited 2020 Oct 2]

AUGUST 2020

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FPA Officer and Director Nominations FPA Officer Officer and and Director Director Nominations Nominations FPA FPA Officer and Director Nominations

Although we have just finished the election for a President-Elect and Directors for the odd-numAlthough we the a president-elect directors forthinking the Although we have have justfinished finished the election for a President-Elect and Directors foreventheabout odd-numbered regions who just were installed atelection the 2019forannual meeting, itand is time to start nomnumbered regions who were installed at the 2020 annual meeting, it is time to start thinking about Although we have just finished the election for a President-Elect and Directors for the odd-numbered regions whoelection, were installed at nomination the 2019 annual meeting, it is time to start aboutAs nominees for the 2020 since the deadline is September 1 of thisthinking year (9/1/19). the nominees for the 2021 election, since the nomination deadline is Sept.

1.

As the form below indicates, bered regions who were installed at the 2019 annual meeting, it is time to start thinking about nomAlthough we have just finished the election for a President-Elect and Directors for the odd-numinees for the indicates, 2020 election, the will nomination deadline for is September 1 of this year (9/1/19). the form below this since year we need candidates President-Elect, Technician and As Directhis year we 2020 will need candidates for president-elect, treasurer and directors for the odd-numbered inees for the election, since the nomination deadline is September 1 of this year (9/1/19).

As the bered regions who were installed at the 2019 annual meeting, it is time to start thinking about nomform below indicates, this year we will need candidates President-Elect, Technician and Directors for the even-numbered regions.

Please note that youfor may nominate yourself. regions.

Please note that you may nominate yourself. form below indicates, this year we will need candidates for President-Elect, Technician and Direcinees for the 2020 election, since the nomination deadline is September 1 of this year (9/1/19).

As the tors for the even-numbered regions. Please note that you may nominate yourself. tors forbelow the FPA even-numbered regions.

Please note that you may nominate yourself. form indicates, thisAND year we will need candidates for President-Elect, Technician and DirecCALL FOR OFFICER CALL FOR FPA OFFICER AND tors for theFPA even-numbered regions. Please note that you may nominate yourself.

DIRECTOR NOMINATIONS for CALL FOR OFFICER AND DIRECTOR NOMINATIONS for

2020FOR Elections DIRECTOR NOMINATIONS for CALL FPA OFFICER AND 2021 Elections 2020 Elections DIRECTOR NOMINATIONS for CALL FOR FPA OFFICER AND or The FPA bylaws specify that any subdivision 2020 Elections DIRECTOR NOMINATIONS for one anyThe member in good standing nominate FPA bylaws specify that may any subdivision or The FPA bylaws specify that any subdivision or person forElections theinoffice ofstanding President-Elect and one per2020 any member good nominate one The FPA bylaws specify that may any subdivision or

anyfor member in good standingAmay nominate one son the office of Treasurer.

President-Elect shall person for President-Elect andone oneperperperson for the theinoffice office ofstanding president-elect and any member goodof may nominate one be elected every year and shall assume the duties of The FPA bylaws specify that any subdivision or son the office ofofTreasurer.

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A President-Elect president-elect person office of President-Elect and one shall perthe President on the last day of the annual meeting any member in good standing may nominate one be elected every year and shall assume the duties of be elected everyof year and shall the duties of son for the office Treasurer.

A assume President-Elect shall of the year following election as the President-Elect.

The person forevery theon office of President-Elect andmeeting one perthe President the last day of annual meeting the president day of the annual be elected year and shall assume the duties of Treasurer serve a two-year term and may shall sucson foryear theshall office of Treasurer.

Athe President-Elect of following election as President-Elect.

The ofthe the year following election as president-elect. the President on the last day of annual meeting ceed to one consecutive term of assume office in that capacibe elected every year and shall the duties Treasurer shall a two-year term and may sucTreasurer serve a two-year term and may sucof the year following election as President-Elect. Theof ty.

Nominees must belast Florida registered the President on the day of ofoffice the meeting ceed to consecutive term in that capaciceed toone one consecutive term of office inpharmacists Treasurer shall serve a two-year termannual and may sucin good standing with the Florida Pharmacy Associof the year following election as President-Elect.

The ty.

Nominees must be Florida registered pharmacists ty.

Nominees must be Florida registered pharmacists ceed to one consecutive term of office in that capaciation and the Florida of Pharmacy.

Nominees ingood good standing withBoard the Florida Pharmacy AssociTreasurer shall serve a two-year term and may sucin standing with the Florida Pharmacy Associty. Nominees must be Florida registered pharmacists for President-Elect should have aoffice goodinunderstandation and the Florida Board ofof Pharmacy.

Nominees ceed to one consecutive that capaciation and the Florida of Pharmacy. in good standing withBoard theterm Florida Pharmacy Associing of how themust Association functions and should be forNominees president-elect should have aa good understandty. be Florida registered pharmacists for President-Elect should have good understandation and the Florida Board of Pharmacy. Nominees current on the impacting pharmacy.

Nominees inggood of how how theissues Association functions and should be in standing with thehave Florida Pharmacy Associing of the Association functions and should be for President-Elect should a good understandfor Treasurer have good analytical skills and current onthe theshould issuesimpacting impacting pharmacy.Nominees Nominees ation and Florida Board of Pharmacy.

Nominees current on issues pharmacy. ing of how the Association functions and should be forTreasurer treasurer should have good analytical skills experience and ability in financial management and for President-Elect should have a good understandfor should have good analytical skillsand and current on the issues impacting pharmacy.

Nominees experience and ability in financial management and budget preparation. ing of how the Association functions and should be experience and ability in financial management and for Treasurer should have good analytical skills and budget preparation.

There are nine regional Boardpharmacy.

Directors Nominees who shall current on the issues impacting budget preparation. experience andnine ability in financial management and There are regional Board directors who shall serve two-year terms.

A nominee must bewho a Florida forThere Treasurer should have good analytical skills and are nine regional Board Directors shall budget preparation. serve two-year terms.

A nominee must be a Florida registered pharmacist in good standing with the Florexperience and ability in financial management and serve two-year terms.

A nominee must bewho a Florida There are nine regional Board Directors shall registered pharmacist in good standing withBoard the of ida Pharmacy Association and the Florida budget preparation. registered pharmacist in good standing with the Florserve two-year terms.

A nominee must be a Florida Florida Pharmacy Association and theDirector Florida Board Pharmacy.

Additionally, each Board must There pharmacist are nine regional Board Directors who shall ida Pharmacy Association and the Florida Board of registered in good standing with the Florof Pharmacy.

Additionally, each Board Director must be a member ofterms. at least one the FPA Unit Associaserve two-year A nominee must be a Florida Pharmacy.

Additionally, each Board Director must ida Association Board of be Pharmacy a member of at least oneand thethe FPAFlorida Unit Associations within their Board Directors’ terms are registered pharmacist in good standing with themust Florbe a member of atregion. least one the FPADirector Unit Associations within their region.

Board Directors’ terms are Pharmacy.

Additionally, each Board staggered such that even-numbered regions shall be ida Pharmacy Association and the Florida Board of tions within their Board staggered such even-numbered shallare be be a member of that atregion. least one the Directors’ FPAregions Unit terms Associaelected in such even-numbered yearsBoard andregions odd-numbered Pharmacy.

Additionally, each Director must staggered that even-numbered shall be elected in even-numbered yearsDirectors’ and odd-numbered tions within their region. Board terms are regions shall be elected inone odd-numbered years.

All be a member of at even-numbered leastin theand FPA Unityears.

Associaelected in even-numbered years odd-numbered regions shall be elected odd-numbered staggered such that regions shallAll be newly elected Board of Directors Regional Directors tions within their region.

Board Directors’ terms are regions shall beBoard elected in years odd-numbered years. All newly in elected of Directors regional directors elected even-numbered and odd-numbered shall take office on the last day of the annual meeting, staggered such that even-numbered regions shall be newly elected Board of Directors Regional Directors shall take office on the last day of the annual meeting, regions shall be elected in odd-numbered years. All and shall continue in office until the last day ofofannuelected in even-numbered years and odd-numbered and shall continue in office until the last day annushall take office on the last day of the annual meeting, newly elected Board of Directors Regional Directors al of second ensuing year. al meeting meeting ofthe the second ensuing year. regions be odd-numbered All and shall continue in office until last dayyears. of annushall takeshall office onelected the lastin day of the the annual meeting, newly elected Board of Directors Regional Directors al meeting of the second ensuing year. and shall continue in office until the last day of annutake office the last day ofyear. the annual meeting, alshall meeting of theon second ensuing and shall continue in office until the last day of annual meeting of the second ensuing year.

FPA Candidate Candidate Nomination Nomination Form Form FPA FPA Candidate Nomination Form FPA Candidate Nomination Form I AM PLEASED TO SUBMIT THE FOLLOWING INOMINATION: AM PLEASED TO SUBMIT THE FOLLOWING INOMINATION: AM PLEASED TO SUBMIT THE FOLLOWING NOMINATION: I AM PLEASED TO SUBMIT THE FOLLOWING NAME: NOMINATION: NAME: NAME: ADDRESS: ADDRESS: NAME:

FOR THE FOLLOWING OFFICE: ADDRESS: (Nomination deadline: September 1, 2019) FOR THE FOLLOWING OFFICE: (Nomination deadline: Sept.

1, 2020) (Nomination deadline: September 1, 2019) FOR THE FOLLOWING OFFICE:  President-Elect (Nomination deadline: September 1, 2019)  President-Elect FOR THEDirector FOLLOWING OFFICE:  President-Elect Board  Region (Nomination  President-Elect  Board RegionDirector 21deadline: September 1, 2019)  Region  Director  Region 243  Board President-Elect   2465  Region  Region Board Director    Region  Region Region46872  Region    Region Region6894 Technician   Technician  Region Region86  Treasurer   Technician RegionBY:8 NOMINATED NOMINATED BY:  Technician ADDRESS:

NOMINATED BY: NAME:

NAME: NOMINATED BY: NAME: DATE SUBMITTED: DATE SUBMITTED: NAME: DATE SUBMITTED: SIGNATURE: SIGNATURE: DATE SUBMITTED: SIGNATURE:

MAIL NOMINATIONS TO: Election Nominations, Florida Pharmacy SIGNATURE: Association, 610TO: N. Adams Tallahassee,Florida FL 32301 MAIL NOMINATIONS ElectionSt., Nominations, Pharmacy (850) 222-2400 FAX (850) 561-6758 Association, 610 N. Adams St., Tallahassee, FL 32301 MAIL NOMINATIONS TO: Election Nominations, Florida Pharmacy (850) 222-2400 FAX 561-6758 FL 32301 Association, 610 N. Adams St.,(850) Tallahassee, MAILDEADLINE NOMINATIONS TO: Election Nominations, Florida FOR NOMINATIONS IS SEPTEMBER 1, Pharmacy 2019 (850) 222-2400 FAX (850) 561-6758 Association, 610 N. Adams St., Tallahassee, FL 32301 DEADLINE FOR NOMINATIONS IS SEPTEMBER 1, 2019 (850) 222-2400 FAX (850) 561-6758 DEADLINE FOR NOMINATIONS IS SEPTEMBER 2019 DEADLINE FOR NOMINATIONS IS SEPT. 1,1,2020 DEADLINE FOR NOMINATIONS IS SEPTEMBER 1, 2019 JULY 2019

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JULY 2019 | AUGUST 2020 | JULY 2019 |

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JULY 2019

FDA Issues Warnings on COVID-19 Products Source: U.S. Food and Drug Administration

Several products recently drew the ire of the U.S. Food and Drug Administration with claims to stop or test for COVID-19. Warning letters have been sent to many companies since the outbreak of the coronavirus pandemic. These letters are regarding remedies, products that promise to stave off infection and test kits. Some of the warned companies include: Canadian Chaga, Barry’s Bay, Ontario, Canada Canadian Chaga was warned over its tablets, tea and tinctures, which it claimed were full of one of the “highest antioxidants you can get,” and may prevent coronavirus and cancer. The FDA determined the tablets were unapproved new drugs and misbranded.

Vapore LLC dba Mypurmist, Concord, California Mypurmist is a steam inhaler that the FDA says claimed to manage symptoms of pneumonia and coronavirus, and could kill coronavirus in the sinuses. The FDA says the product includes sterile water as an unapproved new drug and is misbranded.

Oxford Medical Instruments USA Inc., Carlsbad, California On Aug. 11, the FDA warned that the salt inhaler products sold at www.oxfordmedicals.com were intended to mitigate, prevent, treat, diagnose or cure COVID-19. The salt inhalers claimed to boost the immunity of the lungs and respiratory tracts by breathing micro salt particles.

Fair Price Labs Inc., Winchester, Tennessee Fair Price Labs, the FDA alleges, sold COVID-19 home testing kits that were not approved by the agency. The testing kits were made by Missouri company CoreMedica and violated several statutes and regulations, the FDA says. Samples taken at home can be improperly collected and unstable, the FDA says.

Holistic Health International LLC, Bethel, Maryland Similarly to the Fair Price allegations, the FDA says the at-home stool sample COVID-19 testing kits sold by this company were not approved by the agency.

H-Lab Life, Melbourne, Florida The FDA warned H-Lab Life over its multi-use spray that claimed to kill coronavirus germs on hands and surfaces without approval or authorization by the agency.

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21st Century LaserMed Pain Institute dba Create Wellness Clinics, Garden Grove, California The FDA says this company marketed an umbilical cordderived stem cell product to treat or prevent COVID-19.

The agency says it was an unapproved new drug and an unlicensed biological product. Dr. Phillip Yoo, on several websites, claimed that the donated cells would boost immunity, the FDA said.

Kegan Wellness, Gujarat, India Kegan Wellness sold a variety of tablets under the names She+, She-Vitamin C and Giloe+ that all claimed to boost immunity and possibly prevent COVID-19, the FDA says.

The tablets were not approved by the agency.

Pharmaboosters.com, United States The company sold a variety of drugs, the FDA says, including Arbidol and amitriptyline, which it claimed to cure, mitigate, prevent or treat COVID-19, major depressive and anxiety disorders, early-stage Parkinson’s disease and opioid dependence.

Center for Wellness and Integrative Medicine, Soquel, California The FDA warned this company over a sale of a COVID protection package or value package that included capsules that claimed to improve immunity and mitigate coronavirus

symptoms. The FDA asked the company to cease the sale of unapproved and unauthorized products related to COVID-19.

Shen Clinic LLC, Albany, California Shen Clinic sold Chinese herbs that it claimed to “remove heat” from the lungs and successfully treat COVID-19. The FDA claimed these products were unapproved new drugs and misbranded drugs.

Butterfly Expressions LLC, Clifton, Idaho The FDA warned this company over the sale of essential oils, blessed waters, hand sanitizers, tinctures and other homeopathic products that claimed to mitigate, prevent, treat, diagnose or cure COVID-19.

Nuance Health LLC, Ponte Vedra Beach, Florida This company sold a nasal gel called Swype Shield that the FDA alleges was intended to mitigate, prevent, treat, diagnose or cure COVID-19 and other viral upper respiratory viruses. The FDA says this product was not approved for use and also is prohibited, like many of the other products here, from entering into interstate commerce.

Curativa Bay Corp., Clearwater, Florida The FDA alleges this company’s Advanced Hypochlorous Skin Spray, a topical hypochlorous acid-containing product, is an unapproved drug intended to mitigate, prevent, treat, diagnose or cure COVID-19.

Project 1600 Inc., Amagansett, New York The FDA warned this company over cannabidiol products that were intended to mitigate, treat, prevent, diagnose or cure COVID-19. The agency said their products boosted a person’s immune system to defend against COVID-19.

Dr. Jason Korkus, Sonrisa Family Dental, mycovidtest19. com, Chicago Dr. Korkus’ websites offered test kits to consumers for athome use, the FDA says. The kits included 15-minute tests for the whole family, the FDA says, including 20 individual test kits that were good for up to a year.

FRS International LLC, Boston, Massachusetts FRS offered a quercetin-containing soft chew and liquid products for sale that claimed to defend against coronavirus.

The FDA said their drugs, Q-Force and FRS Health Energy, claimed to decrease upper respiratory tract infections. They were also not approved for sale.

Dr. Sherrill Sellman, Burlington, Massachusetts Dr. Sellman and his websites were warned over selling several products, including HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges with Vitamin C and Silver Biotics Silver Gel Ultimate Skin & Body Care, that proclaimed to enhance the immune system and kill or prevent virus infection. The FDA says the products are unapproved new drugs.

Quadrant Sales & Marketing Inc., Clearwater, Florida Quadrant’s non-alcohol hand sanitizer, Purifi, was labeled a new drug that is not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested. Quadrant claimed Purifi killed bacteria, viruses, mold, mildew, fungi and algae on contact.

It also, their website says, formed a barrier that lasted for hours.

North Coast Biologics, Seattle The FDA warned North Coast and Johnny T. Stine over a purported vaccine Stine created that he called the “nCoV19 spike protein vaccine.” The agency say Stine’s claims that the vaccine is effective or safe for the prevention of COVID-19 are misleading, and that his vaccine is an unapproved drug and an unlicensed biologic product.

Santiste Labs LLC, Doylestown, Pennsylvania Santiste offered a transdermal patch, called the Defend Patch, that contained botanical oils that was alleged to protect against or treat COVID-19. The FDA called Defend an unapproved drug and demanded Santiste stop the sale of the product.

Alive by Nature Inc., Fleming Island, Florida The FDA warned Alive by Nature over the NAD+ and NMN sublingual gels that the agency called unapproved new drugs. The agency says Alive by Nature claimed the gels could reverse COVID-19 and improve the immune system.

The FDA demanded Alive by Nature stop selling the gels.

The Art of Cure, Vancouver, Washington The Art of Cure offered homeopathic remedies for coronavirus, which they said were made of actual coronavirus, that would alleviate symptoms and boost immunity. The FDA called these drugs unapproved and misbranded, and demanded the company stop selling the products and making these claims.

AUGUST 2020

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House of Delegates: Speaker’s Report Eric Larson, PharmD Speaker of the House of Delegates

PROPOSED RESOLUTIONS Greetings FPA members.

This summer, the House of Delegates met to consider various policy statements. Your House of Delegates was created to establish policy positions for the Florida Pharmacy Association through participation by member pharmacy interest groups from local unit organizations and specialty groups. The House is a forum where ideas and concepts can be exchanged among interested stakeholders.

As you are aware, we are in very extraordinary times and, for the first time, the House had to convert its meeting to a virtual format. This was quite a challenge to prepare for as we only had a little over one month to transition to a webinar plan. The House Board of Directors met to review the plan and process, and prepare for the House to conduct its business. Our thanks to Speaker Gary Koesten for working through a difficult process with the FPA House. If you ever participated in a House of Delegates, you know how active the debate can be.

During this meeting, we also received updated information on the resolutions adopted over the previous three years. At convention, we entertained five resolutions and four items of new business the FPA is being asked to address. Included in this article are the results of our discussions that will be presented to the FPA Board of Directors for implementation.

NOMINATION OF HOUSE OFFICERS 2020-1A Nominations for Vice Speaker We are pleased to announce that Alexander Pytlarz was elected vice speaker for the FPA House of Delegates.

2020-1B Nomination for House Board Director We are also pleased to announce that Jeanette Connelly was elected to serve a three-year term as a member of the House Board of Directors.

Resolutions Presented to the House

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FLORIDA PHARMACY TODAY

2020-2 Membership Bonus THEREFORE BE IT RESOLVED THAT THE FPA (OR SUBDIVISON OF THE FPA) allow active members only of the FPA to acquire the two mandatory continuing education programs of “Validation and Counseling of Prescriptions for Controlled Substances and Opioids” and “Reducing Medication Errors Through Implementing Continuous Quality Improvement Program” who have registered and attends an FPA sponsored C.E. conference or convention at no additional fee.

Resolution Adopted 2020-3 Access to Virtual Meeting Platform THEREFORE BE IT RESOLVED THAT THE FPA provide access to a virtual meeting platform for local unit associations leveraging the scale of FPA and develop a pool of virtual accredited training programs and/or speakers.

Resolution Adopted 2020-4 Defining Telehealth, Telepharmacy and Telemedicine THEREFORE BE IT RESOLVED THAT THE FPA shall support the research endeavor of the University of South Florida Taneja College of Pharmacy APhA-ASP chapter to stratify common definitions amongst the health professions for future regulatory and legislative action.

Resolution Adopted Items of New Business Presented to the House 2020-5 Immunizing Pharmacists Continuing Education Opportunities THEREFORE BE IT RESOLVED THAT THE FPA seek legislation that would allow for Florida pharmacists to seek immunization continuing education credit for recertification from any ACPE approved program.

Rules of the House Suspended Resolution Adopted 2020-6 Eliminating Live Continuing Education Requirements for 2020 Renewals THEREFORE BE RESOLVED THAT THE FPA promote to the Board of Pharmacy the elimination of live continuing education requirements for licenses that renew in 2020.

Rules of the House Suspended Resolution Adopted

2020-7 Pharmacy Resilience Strategy THEREFORE BE IT RESOLVED THAT THE FPA adopt a policy that any establishment that includes a pharmacy must provide enough PPE for every staff member for at least one month during an emergency situation to prevent reusing PPE, and to provide proper education on donning and doffing procedures.

Rules of the House Suspended Resolution Not Adopted 2020-8 Order for a Report on Pharmacy Workplace Condition Concerns THEREFORE BE IT RESOLVED THAT THE PROFESSIONAL AFFAIRS COUNCIL shall issue a report on pharmacy workplace condition concerns by 5 p.m. on Feb. 12, 2021 (approximately 12 weeks prior to May 9, 2021, the last day to submit resolutions to the House of Delegates). At a minimum, the report shall contain both statistical data quanti-

fying the prevalence of concerns and first-hand accounts of events that led to the development of workplace condition concerns.

Rules suspended Resolution Adopted From the above policy statements, the FPA has work to do.

We will be monitoring the progress of each of the adopted issues and have a final report of their progress at next yearâ&#x20AC;&#x2122;s convention. Add to your calendar the date May 9, 2021. That is the last date to submit resolutions to be considered by the 2021 House of Delegates. We hope that you will be able to be with us at next yearâ&#x20AC;&#x2122;s convention.

AUGUST 2020

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