October 2021 Florida Pharmacy Today by Florida Pharmacy Today

OCT. 2021

ROLES OF PHARMACISTS, STUDENT PHARMACISTS AND PHARMACY TECHNICIANS IN COVID-19 TESTING AND VACCINATION

Protect your patients. Protect your pharmacy. ERRORS CAN INJURE PATI E NTS AND PUT YOUR PHARMACY IN FI NA NCIAL JE O PARDY.

The PQC+ QA program can improve efficiency and increase patient safety as well as help you meet accreditation, credentialing, PBM and state Quality Assurance requirements. • Training, Quality Assurance CE, and resources • Patient Safety Organization protection for your QA work • Practical tools to collect and analyze patient safety data

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).

florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 Executive Insight 18 Call for Nominations

VOL. 84 | NO. 10 OCTOBER 2021 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

8 10

Tamiflu: The Story of a Prodrug

Roles of Pharmacists, Student Pharmacists and Pharmacy Technicians in COVID-19 Testing and Vaccination

OCTOBER 2021

FPA Calendar 2021-2022

Mission Statements: Florida Pharmacy Today Journal

NOVEMBER 11

Veterans Day - FPA office closed

FPA Board of Directors Meeting

25-26 Thanksgiving - FPA Office Closed DECEMBER 4-5

FPA Law and Regulatory Conference Via Zoom

JANUARY 1

New Year Holiday observed FPA Office Closed

Florida Legislative Session begins

MLK Holiday - FPA Office Closed

18-19 Legislative Days 22-23 FPA Clinical Consultant Conference 31

15-16 Florida Board of Pharmacy Meeting 16

Pharmacists and Patient Center Diabetes Care Webinar

24 - 27 Christmas Holiday FPA Office Closed 31

FPA Office Closed

FPA Election Ballots due FEBRUARY

FPA Awards Nominations Due MARCH

Last Day of Legislative Session

FPA Board of Directors Meeting

18 - 21 APhA Annual Meeting San Antonio, Texas

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 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 — Michael Jackson (850) 222-2400

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..................................................................... 2 PQC...................................................................... 20 PHARMACISTS MUTUAL.......................... 6, 11

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

Note: The views of the authors do not necessarily represent the views or NSU — Carsten Evans (954) 262-1300 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. FAMU — Dr. Selika Sampson (850) 599-3301

4 |

FLORIDA PHARMACY TODAY

EMAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com

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

Pharmacy Stakeholders Unite and Engage

or the month of October, we have an opportunity to take on several important projects related to our profession. We can begin by first acknowledging this month as American Pharmacist Month. You may have already been aware of it through your years of membership in our organization. Historically, we have been able to get the Governor of Florida and elected local officials throughout our state to acknowledge what we do within the health care industry. This includes the issuing of proclamations and public events praising what we do every day to care for patients. With fighting the pandemic added to our basic job descriptions, we have become an important piece of the health care management team. If you have not had an opportunity to get involved, now is the time ask the question, “What can I do this year?" Here are some answers to your question. ■ Everyone reading this has a mayor, county commissioner or similar local governmental official responsible for public health policy. Make an appointment and meet them. Tell them the story of our profession and ask that they issue a simple declaration proclaiming October as American Pharmacist Month. Take a picture with your elected or appointed official and send it to us. We will put it into our social media space. ■ It is very likely that you have your own favorite social media platform such as Facebook, Twitter, Instagram, TikTok or another tool on your digital device that you use to communicate with the world. Recall your best health care pharmacy sto-

■

ry and share it with your network. Make sure that you leave out any confidential health information. Make a note that the official hashtags for American Pharmacists Month are #APhM2021 and #phar-

With fighting the pandemic added to our basic job descriptions, we have become an important piece of the health care management team.

■

macistsmonth. Use them at every chance, including all of your emails. Let’s get this celebration trending like never before. Write an editorial and submit it to your local newspaper about what you do as a pharmacist or pharmacy technician. There is no one on this earth that can tell your story better than you.

Michael Jackson, B.Pharm

Another project that we can take on is our continued efforts to get those in our profession recognized as health care providers. Many of us may recall our time spent in pharmacy school. The course work was intense, and the study time included many hours of preparation. Then there was the competencyexamination and law tests necessary to become a licensed practitioner. As pharmacists, we spend a lot of time working through the health care problems that patients bring to us. The majority of visits to the doctor’s office are for things that easily can and are being done by pharmacists. Recent changes to Florida laws created and clarified advanced practices for pharmacists. While state laws are catching up with the contemporary training of pharmacists, the federal social security laws have not recognized pharmacists as health care providers similar to other professions. In April of this OCTOBER 2021

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

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

Continuing Education Coordinator Stacey Brooks, ext. 210 Coordinator of Membership TBD

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. . ©2021 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.

year, H.R. 2759 and S. 1362, entitled the Pharmacy and Medically Underserved Areas Enhancement Act, were introduced in Congress. These bills would recognize our profession as health care providers for a designated portion of medically underserved patients in the Medicare Part B program. For several years now we have been fighting for this legislation with our national partners. Congress is not well known for getting things done, especially in the current political environment. This particular issue has bipartisan consensus given the historical support we have been able to muster during previous administrations. So, what can you do during the month of October? ■ Learn and understand what H.R. 2759 and S. 1362 are and how important this legislation is for the medically underserved Part B patients. ■ Reconnect with the member of Congress that you elected to represent your community in Washington, D.C. Describe this legislation and ask for their support of the bill. ■ Ask that your member of Congress sign on to these bills as a cosponsor. ■ Offer your expertise as a pharmacist should your member of Congress have a question about your profession and be adamant that correcting the omission of pharmacy as a recognizedhealth care provider is a task long overdue. ■ Invite your member of Congress to your pharmacy and demonstrate the many services that you provide that are not solely related to the dispensing of prescription medications. Help them to understand that this bill being considered by Congress is not adding anything new to the practice of pharmacy, but simply acknowledging what we have been doing for years. Finally, here in Florida, we are beginning our 2021-2022 legislative campaign. Our Governmental Affairs Committee has met to begin hashing out our priority list, and it appears that our PBM campaign from the 2021 legislative session will continue.

So how would you be involved in a project like this? ■ The first thing, and likely most important, is to understand what a PBM is and what do they do. ■ Gain knowledge on why a regulatory framework for PBMs is necessary and what the benefits are to consumers and payers. ■ Know the role of transparency within the PBM marketplace. ■ Have a basic understanding and knowledge of several comprehensive studies performed in the Medicaid managed care program and what those findings mean. ■ Contact your state legislator and get to know them. Also, help your legislator know you and make sure that they have your contact information if there are any questions that need to be answered. ■ Don’t allow your state legislator to come to Tallahassee to make decisions without your input. ■ Band together with colleagues in your community and mobilize your efforts as a group project. Your legislator will listen to you. They will take you seriously if they know you have an army of professionals behind you with the same concerns that you have. We are all interested in getting our profession recognized for the things that we do, and we have gotten proficient at making that happen. We are good at telling our story, and with our profession united and engaged, we can be great in getting our message out to the general public. Your community needs to know who you are and what you are doing. Now is the time to take advantage of the many services that we have provided during this pandemic. n

2022

COMMUNITY PHARMACY

SCHOLARSHIP

APPLY NOW!

APPLY OCTOBER 1 - DECEMBER 1, 2021 Recipients selected will each be awarded $3,000. Up to $60,000 in scholarships may be awarded for this academic year. TO BE ELIGIBLE TO APPLY for the Pharmacists Mutual Community Pharmacy Scholarship, students must meet the following criteria: • Current students must be a P3 or P4 pharmacy student in the 2022-2023 academic year • Eligible students must plan to practice in one of the following settings: • an independent or small chain community pharmacy, or • an underserved geographic or cultural community, preferably in an independent or small chain community pharmacy

Pharmacists Mutual Insurance Company Algona, Iowa

phmic.com

FOR ELIGIBILITY REQUIREMENTS AND TO APPLY: phmic.com/scholarship

OCTOBER 2021 |

Tamiflu: The Story of a Prodrug By William Garst

Symptoms of an influenza viral infection were described by Hippocrates 2400 years ago. In recent recorded history there have been pandemics such as the 1918-1920 Spanish Flu and the more recent 2009 Swine Flu. In modern medical times, there were only two medications indicated to treat an influenza infection: amantadine, and rimantaWilliam Garst, dine. This changed in 1999 with the introPharm.D. duction of Tamiflu (oseltamivir): an antiviral Consultant drug used to treat influenza A and B. It is Pharmacist usually used within the first 48 hours of influenza symptoms in the general popultion. For people who are at high risk it is sometimes used as a preventative treatment if a high-risk person has been exposed to influenza A or B and has not been vaccinated. Recommendations like these are initiated to lessen the development of resistance to the medication. The story of the prodrug Tamiflu began when virologists (scientists who study viruses) identified a viral enzyme called neuraminidase, which is produced by many strains of viruses. An enzyme is a chemical that organisms make to speed up chemical reactions. In this case, the enzyme helped the virus to be released from human cells that it had infected, therefore, if this enzyme could be blocked it would lessen the impact of viral infections by inhibiting replication. The virus uses neuraminidase to break open cell walls thus releasing viral particles that have replicated inside the host cell. The first neuraminidase inhibitor to reach the market was Relenza (zanamivir). Ironically, this drug was not recommended for approval by the FDA advisory committee. However, the FDA leadership overruled the committee’s disapproval and approved it anyway, based on the results of a single clinical trial that showed positive results. Other clinical trials had shown no significant effectiveness over a placebo. However, Relenza did validate that neuraminidase was a viable target for antiviral medications. The problem with Relenza was its method of administration. It was inhaled as a powder, which proved to be inconvenient and cumbersome and had very poor oral absorption properties. The scientists at the Gilead Sciences Inc., a pharmaceutical company, became interested in neuraminidase inhibitors and soon developed GS-4701, a neuraminidase inhibitor that has a 3700-fold increase in neuraminidase inhibition. This molecule had a different enough structure to be eligible for a separate patent. However, GS-4701 did not show much greater oral absorption than Relenza. What finally occurred at Gilead was the creation of Tamiflu (oseltamivir), which is a prodrug. A prodrug is a drug that is metabolized in the body to release the active compound. A prodrug is better absorbed in the body. When Tamiflu is ingested orally it is metabolized 8 |

FLORIDA PHARMACY TODAY

THE FIRST SYNTHETIC ANTIMICROBIAL DRUG, ARSPHENAMINE, USED TO TREAT SYPHILIS, WAS A PRODRUG, AS WAS THE FIRST “SULFA” ANTIBIOTIC PRONTOSIL. IT IS ESTIMATED THAT 10% OF THE DRUGS CURRENTLY MARKETED WORLDWIDE ARE PRODRUGS. to the GS-4701 molecule that has the neuraminidase inhibition activity. This is a particularly good example of using prodrugs to bring to market important pharmaceuticals that can be administered more conveniently, thus creating more compliance and effectiveness. Other examples of familiar prodrugs are aspirin and codeine. The first synthetic antimicrobial drug, arsphenamine, used to treat syphilis, was a prodrug, as was the first “sulfa” antibiotic Prontosil. It is estimated that 10% of the drugs currently marketed worldwide are prodrugs. In the near future Tamiflu may be one of the drugs that can be dispensed by a pharmacist who has obtained Test and Treat Certification in the State of Florida. In the past year, the Florida Legislature passed legislation that will allow patients to be treated for influenza and streptococcus infections at a community pharmacy without having to go to a physician's office, in order to make treatment for influenza and streptococcus infections more available to the public where timeliness is important. Currently Tamiflu is not indicated for the treatment of the Sars-Cov-2 (Covid-19) virus. Stay informed and stay healthy. William Garst is a consultant pharmacist who resides in Alachua, Florida. He received his bachelor’s degree in pharmacy from Auburn University in 1975. He earned a master’s degree in pharmacy from the University of Florida in 2001. In 2007, he received his doctor of pharmacy from the University of Colorado. Dr. Garst is a member of many national professional associations as well as the local Alachua County Association of Pharmacists. He serves on the Alachua County Health Care Advisory Board. He works part-time at the UF Health Psychiatric Hospital and retired from the VA in 2016. Dr. Garst enjoys golf, reading (especially history) and family. He writes a blog called The Pharmacy Newsletter (https://thepharmacy newsletter.com). He can be contacted at communitypharmacynewsletter@gmail.com .

Congratulations 2021 Scholarship Winners Pharmacists Mutual is proud to support students who are interested in serving in an independent or small chain community pharmacy or an underserved geographic or cultural community. Each student listed received a $2,500 scholarship. Brianna O’Gary North Dakota State University

Madison Yoakum Ohio Northern University

Catherine Hayes University of Illinois at Chicago

Olivia Denny University at Buffalo,

Colin Collery University of Illinois at Chicago

The State University of New York

Ganiat Asuni Philadelphia College

Matthew Brock Medical University of South Carolina

of Osteopathic Medicine

Megan Breier Ohio Northern University

Hayden Wooldridge University of Mississippi

Marlee Clements Mercer University

Hassan Khatib Wayne State University

Megan Hardy South Dakota State University

Kristian Tan Keck Graduate Institute

Morgan Rambo Samford University

Kayla Lucas Virginia Commonwealth University

Sarah Erlingheuser University of Connecticut

Kensey Hunt St. Louis College of Pharmacy

Steven Kramer St. Louis College of Pharmacy

Kinsey McClure University of South Carolina

Sarah Lankford Presbyterian College

ROLES of Pharmacists,

Student Pharmacists and Pharmacy Technicians in COVID-19 Testing and Vaccination Margareth Larose-Pierre, BS, PharmD; Madison Como, PharmD, BCPS; Phyllisa Best, BS, MPH, PharmD Candidate; Chenita Carter, PharmD, MS; Kayla Jackson, PharmD Candidate; Natalya Butsikov, PharmD Candidate

FLORIDA PHARMACY TODAY

Margareth Larose-Pierre, BS, PharmD, is Founding Campus Dean and Professor of Pharmacy Practice of the Florida Agriculture & Mechanical University College of Pharmacy Durell Peaden, Jr. Rural Pharmacy Education Campus. In addition to teaching and training Doctor of Pharmacy students, Dr. Larose-Pierre has been an active member of multiple professional organizations. In her professional affiliations and in academia, Dr. Larose-Pierre remains a strong advocate for pharmacy students’ involvement in community activities and research in areas including pharmacy practice, critical care, infectious disease, immunization, medication therapy management, and screening of patients for chronic diseases (i.e hypertension, diabetes mellitus, coagulopathies).

Chenita Carter, PharmD, MS is an Assistant Professor of Pharmacy Practice at Florida Agricultural and Mechanical University (Florida A&M University), College of Pharmacy and Pharmaceutical Sciences (COPPS) located in Tallahassee, Florida. Dr. Carter received her Doctor of Pharmacy degree from Florida A&M University and completed PGY1 residency at Sacred Heart Hospital in Pensacola, Florida. She earned a Master of Science degree in Pharmaceutical Outcomes and Policy with a specialty track in Pharmaceutical Regulations from the University of Florida in Gainesville, Florida in 2015. Her research interests include asthma, COPD, medication therapy management, pediatrics, and benzodiazepine use/ abuse.

Madison Como, PharmD, BCPS (Corresponding Author) is an Assistant Professor of Pharmacy Practice at Florida A&M University College of Pharmacy and Pharmaceutical Sciences located in Tallahassee, Florida. Dr. Como received her Doctor of Pharmacy degree from Florida A&M University and completed a PGY1 residency at Saint Thomas West Hospital in Nashville, Tennessee. She obtained her Board Certified Pharmacotherapy Specialist certification in November 2020. Her research interests include diabetes, hypertension, infectious disease, and medication therapy management.

Kayla Jackson is a fourth-year Doctor of Pharmacy candidate at Florida A&M University’s College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health. She is a licensed pharmacy intern and immunizer. Kayla holds membership in Rho Chi Pharmacy Student Honor Society and the Florida Pharmacy Association. She also volunteers with the Emerald Coast Children’s Advocacy Center. Upon graduation, Kayla’s areas of interest include retail pharmacy, compounding, consulting pharmacy, and ambulatory care. Her areas of research interest include diabetes, neurological diseases, women’s health, and autoimmune disorders.

Phyllisa Best, BS, MPH, is currently enrolled at Florida A&M University College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health as a fourth-year Doctor of Pharmacy Candidate. Her passion is to help the underserved population and to give back to her hometown community. She is currently a member of the Alpha Xi Chapter of Kappa Epsilon Fraternity, Inc. and the Beta Sigma Chapter of Phi Lambda Sigma Leadership Society. She is also a pharmacy intern member of the Ambulatory Care Council for the Florida Society of Health-System Pharmacists, Inc. She wishes to continue to work part time as a retail pharmacist after graduation and pursue additional research in pediatric pharmacy with a specialty in hematology and oncology.

Natalya S. Butsikov is a fourth-year Pharm.D. candidate at Florida A&M University’s College of Pharmacy and Pharmaceutical Sciences. Natalya is originally from Ukraine and moved to the United States in 2004. Since that time, she obtained her Associate in Arts degree from Broward College, received her Emergency Medical Technicians license and obtained over nine years of experience as a certified pharmacy technician. She is a member of Rho Chi Beta Kappa National Honor Society and has been on the honor list since the beginning of pharmacy school. She is also certified as an immunizer in the state of Florida and has a true passion for helping people.

OCTOBER 2021 |

Introduction The novel coronavirus SARS-CoV-2 (COVID-19) pandemic has required many adjustments across all professions and walks of life. As members of the healthcare community, pharmacists have been significantly affected by this time of change and crisis. As most Americans live only a few miles from the nearest community pharmacy, pharmacists are some of the most accessible and trusted medical professionals.1 In addition to their important typical roles in medication dispensing and counseling, responsibilities of pharmacists have expanded to include participation in COVID-19 testing and vaccination. In April 2020, pharmacists received the first guidance from the office of the Assistant Secretary of Health authorizing them to order and administer COVID-19 tests. Mass vaccinations started in January 2021, beginning with frontline healthcare workers. This review will seek to educate pharmacists, student pharmacists and pharmacy technicians on their participation in these new opportunities and provide updates regarding the coronavirus vaccines. Status of COVID-19 Vaccines As early as January 2020, scientists began racing to produce a safe and effective vaccine against COVID-19. Various companies entered the race by developing vaccine candidates with the assistance of U.S. government funding as part of Operation Warp Speed.1 As of March 2021, 44 vaccines were in phase 1 trials, 32 vaccines were in phase 2 testing for expand-

ed safety, while 22 were in phase 3 trials for large scale efficacy.2 The leaders in the race to develop a vaccine against COVID-19 are Moderna in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and Pfizer in combination with BioNTech. The reports on these vaccines show that they demonstrated high efficacy against COVID-19. Johnson & Johnson also released promising clinical trial results showing some efficacy against the virus and its variants. Pfizer and BioNTech recently announced their two-dose vaccine to be 95 percent effective. Moderna demonstrated similar results, as their vaccine has been found to be 94.5 percent effective in phase 3 clinical trials. Studies post distribution and vaccination show that both Pfizer’s and Moderna’s vaccines are safe and effective. However, more clinical studies in vaccinated patients will help determine the long-term effects related to safety and efficacy of these vaccines. Both companies submitted their vaccines in late 2020 to the U.S. Food and Drug Administration (FDA) and were approved for emergency use authorization (EUA). This expedited process allowed the vaccines to be available for administration as soon as possible when compared to standard FDA approval.2,3 There are unique benefits and drawbacks related to storage, number of doses, and efficacy with each potential vaccine candidate.2,3 Johnson and Johnson announced that their onedose vaccine has demonstrated efficacy in 60-70 percent of their subjects and has obtained approval from the FDA for an

Table 1: Comparison of leading COVID-19 vaccine candidates5,6,7

Developer

Pfizer/BioNTech

Moderna/NIAID

Johnson & Johnson

Novavax

Technology

mRNA

Viral Vector

Recombinant protein nanoparticle

95 %

94%

66%

90-95%

3 (Global)

3 (United States)

3 (Global)

3 (US, Mexico, and Europe)

≥ 12*

≥ 18

FDA EUA approval Press Release

EUA approval December 11, 2020

EUA approval December 18, 2020

EUA Approval February 27, 2021

Pending EUA Approval

FDA Approval

Yes August 23, 2021

Pending

Pending EUA Approval

IM 21 days apart

IM 28 days apart

21 days apart

-94 °C

-4 °C for 30 days

2-8 °C

-70°C

≈ $19.50

≈ $25-$37

≈ $10

Efficacy Phase of Clinical Trial Age Range

Number of Doses Route & Timing Storage Price/Dose

*children as young as 12 were part of the Pfizer studies starting October 2020

FLORIDA PHARMACY TODAY

EUA. The Johnson and Johnson vaccine is also being distributed throughout the US. The Pfizer and Moderna COVID-19 vaccines are mRNA biologics that contain genetic instruction to mimic viral proteins in the body. The Johnson and Johnson vaccine is a viral vector vaccine.3,4 All three vaccines are currently being used in the US, with the Pfizer BioNTech vaccine being the only one with current FDA approval. Importance of Vaccination While progress has clearly been made in developing a safe and effective vaccine, many Americans question the safety of a vaccine produced in such a short time frame. There are many important messages pharmacists can deliver to help encourage patients to be vaccinated against COVID-19. The ongoing clinical trials to evaluate the COVID-19 vaccine candidates are being monitored closely to ensure products are both safe and effective prior to approval. Additionally, patients should be educated on the importance of getting a vaccine to protect both themselves and others. While some groups may have a lower risk of having serious complications from a coronavirus infection, they can unknowingly transmit the virus to others. The virus may also have significant impacts on previously young and healthy patients in certain cases. If a patient does contract COVID-19, they are also less likely to experience a severe illness from the disease if they have been vaccinated. Vaccination allows patients to develop immunity without the risk of complications from infection with the virus itself. Pharmacists can utilize their existing patient education strategies regarding the importance of annual influenza vaccines to assist with this new transition.8 While administering the vaccine and providing information about vaccines to patients is an important role for pharmacists, it will also be essential to encourage patients to continue utilizing masks and social distancing to reduce risk of infection. On March 8, 2021, the CDC released information regarding lifting the social distancing precautions for patients who have received their second dose of the Pfizer and Moderna vaccines and those who have received their single dose of Johnson and Johnson vaccine four weeks after vaccination. This new update allows vaccinated individuals to visit with other vaccinated loved ones without wearing a mask. Since many of the approved vaccines require two doses for maximum efficacy, it will be necessary to encourage patience and adherence as the vaccines are administered to millions of Americans.3 Cost is another important issue that many patients may also be concerned about. Pharmacists should make patients aware that the goal is for everyone to be able to receive the vaccines at no charge to them. Pharmacists will be able to receive payment for immunization services through insurance programs or government funding.3

Expanding Roles of Pharmacists in COVID-19 Vaccination and Testing The dynamic nature of the coronavirus pandemic has prompted many legislative changes that have affected the roles of pharmacists. For example, the Public Readiness and Emergency Preparedness (PREP) Act in April 2020 enabled licensed pharmacists to order and administer FDA-authorized COVID-19 tests. Locations where tests are administered must meet specific requirements, including compliance certifications.9 Many states have implemented policies providing guidance for pharmacists stepping into this new role of pointof-care testing. For example, Florida Emergency Order 20-006 suspended restrictions that would prevent Florida pharmacists from administering authorized COVID-19 tests.10 Pharmacists have also been provided guidance concerning daily reporting of COVID-19 tests they administer to the Department of Health and Human Services. This allows pharmacists to play a role in public health on a broader scale.11 Additionally, the COVID-19 pandemic has led to expanded vaccination services that may be provided by pharmacists. In August 2020, the U.S. Department of Health and Human Services authorized licensed pharmacists and interns in all states, regardless of individual state laws, to administer approved vaccines to patients ages 3 and older. This allows for children to be immunized at pharmacies as well as assisting with the implementation of a COVID-19 vaccination program. It will also help families keep children up to date with routine childhood vaccines during the pandemic.12 Per this federal guidance, states, including Florida, have implemented this adjustment into the authorized practice of pharmacy.13 In November 2020, the U.S. Department of Health and Human Services announced the U.S. government’s partnership with large chain pharmacies to maximize access to COVID-19 vaccines for all Americans. This program includes about 60 percent of pharmacies across all 50 states as well as U.S. territories. The goal of the partnership is to provide better access to vaccines at no cost to patients. Initially, only approximately 60 percent of pharmacies had signed up to participate in the federal allocation program for COVID-19 vaccines. However, with the rollout, others were encouraged to join these efforts in coordination with their jurisdiction’s health department.14 The National Association of Chain Drug Stores (NACDS) strongly supports the partnership of pharmacies with the U.S. government to assist with implementation of a COVID-19 vaccination program.15 Incremental implementation of the program will lead to approximately 40,000+ pharmacies as vaccine availability increases.16 Currently, all retail pharmacies that can meet the requirements for storage and administration of vaccines can seek such partnership with the government. An extensive list of Federal Retail Pharmacy Program Partners can be found on the CDC website at www.cdc.gov/ vaccines/covid-19/retail-pharmacy-program/participating-pharmacies.html. Based on these expanding roles, it is apparent that pharmacists are key players in the public health response to the COVID-19 pandemic. Participation in additional forms of counseling, vaccination and testing will allow pharmacists to OCTOBER 2021

have a significant impact in the continued fight against the coronavirus. The modifications in legislation have already expanded the roles of pharmacists to provide vaccination in long-term care facilities. This notable new development started in December 2020 with the first wave of distribution of the COVID-19 vaccines from Pfizer and Moderna. CVS Health and Walgreens have formed partnerships with the CDC and the Centers for Medicare and Medicaid Services (CMS) to serve as designated providers of COVID-19 vaccines to residents of long-term care facilities. Therefore, many pharmacists have taken on new roles in administering coronavirus vaccines within nursing homes and long-term care facilities.17 Expanding Roles of Pharmacists in COVID-19 Vaccination and Testing In another attempt to increase access to vaccinations in pharmacies, pharmacy technicians have now been authorized to begin administering vaccinations. The Public Readiness and Emergency Preparedness (PREP) Act, issued by the Department of Health and Human Services, addresses this responsibility. This declaration also identifies pharmacy interns and technicians, under supervision of a pharmacist, as qualified administrators of vaccines to patients aged 3 and above. Any technicians, interns or pharmacists involved in administering immunizations must possess all necessary certifications and be licensed or registered by the state board of pharmacy.18 Vaccines administered by interns or technicians must be FDA-approved, ordered by a supervising pharmacist and administered in accordance with the Advisory Committee on Immunization Practices (ACIP) schedules and recommendations. The pharmacist must be readily available for supervision, assistance and patient questions. Like pharmacists, pharmacy technicians involved in administering immunizations must complete a practical training program approved by the Accreditation Council for Pharmacy Education (ACPE) covering injection technique and emergency reactions. Pharmacists, interns and technicians involved in administering immunizations must also possess certification in basic cardiopulmonary resuscitation (CPR) and complete continuing education on immunizations.18,19 This new development is both concerning to some and potentially beneficial to most pharmacists. Some pharmacists may view this legislation as an unwelcome expansion of the role of the technician. If pharmacy technicians become immunizers, this will reduce potential roles and job opportunities for pharmacists while disregarding their more extensive educational training. However, authorizing technicians to administer vaccines could free up pharmacists’ time to allow them to perform more clinical roles, expand medication therapy management encounters and increase patient counseling and education. Regardless of the benefits and drawbacks, pharmacy staff members need to prepare for continued implementation of this legislation. It is essential for pharmacists, pharmacy interns and pharmacy technicians who are eligible to administer COVID-19 vaccines to begin completing training and requirements now in order to fulfill their new 14

FLORIDA PHARMACY TODAY

responsibilities. The American Pharmacists Association provides an ACPE-accredited certificate course in immunization for pharmacists, pharmacy interns and technicians.20 Technicians can also obtain their immunization administration certificate and credentials through the Pharmacy Technician Certification Board (PTCB) training program at www.ptcb.org/ credentials/immunization-administration-certificate.21 Future Directions During the Operation Warp Speed, a tiered approach of vaccine distribution was successfully implemented.20 Figure 1 shows the tiered phase of COVID-19 vaccination rollout. Phases 1, 2 and 3 involving the vaccination of health care providers and first responders (5 percent), people with underlying health conditions and essential workers at high risk of severe COVID-19 disease or death (45 percent), appear to be going steadily. Phases 4, 5 and 6, which will include young adults, children, and essential workers at increased risk of exposure (40-45 percent), followed by the remaining population (5-15 percent). Figure 1: Proposed order for COVID-19 vaccine administration22

While there are still questions regarding the safety and length of immunization supplied by the vaccines, all three vaccines in current distribution in the U.S. appear to have minimal adverse reactions.23 These adverse events can be local, such as pain, redness, and swelling at the site of injection, and/or generalized, manifested as headache, tiredness, muscle pain chills, fever and nausea. According to clinical trials by Pfizer, younger and healthier patients appear to experience these side effects at a higher rate than those older than 55 years of age.24,25 This is likely due to younger patients having more robust immune systems and immune response. Se-

vere allergic reactions reported during the mass rollout outside of the Pfizer vaccine clinical trials appear to be the most significant side effects so far and more likely to occur after the second dose.23 The CDC recommends that all patients who receive the COVID-19 vaccine be observed for a period of 15 minutes after vaccination or a period of 30 minutes if they have a history of serious allergies.26 Concerns are also arising with the level of immunity in the general population if a patient does not receive the second dose, refuses to receive the vaccine at all, and/or how long the immunity will last after a complete vaccination series.27 How much will this impact the level of mutation of the virus and the population immunity remains to be determined.28 Additional testing may be required to determine extent of immunity. These concerns raise the stakes for needed education and counseling by pharmacists to their patients and the local community they serve. In September 2021, the FDA amended the EUA for the Pfizer BioNTech Vaccine to include a booster shot recommended in selected individuals previously fully vaccinated.29 Other concerns revolve around the storage of the vaccines in pharmacies where they are distributed. Retail pharmacies must meet certain requirements for storage to ensure viability of the vaccine, in addition to other requirements needed to develop partnership with the Federal government. Both vaccines require an initial dose and a booster dose 21 or 28 days apart, depending on whether the patient receives the Pfizer vaccine or the Moderna vaccine, respectively. Patients can receive the second dose up to 42 days after the first inoculation, according to the CDC.26 It is also recommended that patients receive the same brand for both vaccines. The Johnson and Johnson vaccine requires a one-time dose only. Although there are discussions around whether patients should receive an additional dose of that vaccine, the current recommendation from the CDC is to administer a booster shot to special populations to reinforce prevention against the virus.29 While there are still concerns about the scarcity of the COVID-19 vaccine studies in pregnant and lactating women, there is strong evidence that the vaccines are safe in pregnancy and breast feeding. At least one case of COVID-19 mutating in a newborn has been identified. Blood tests and throat swabs showed that both baby and mother were infected with COVID-19 with the possibility that the baby had been infected while in the womb. This finding suggests that COVID-19 can be transmitted through the placenta.30The goal of vaccination in pregnancy is to reduce risk of exposure to the virus if at all possible with data showing that the benefits of the vaccine outweigh the risks. The CDC recommends that pregnant women and those who are breastfeeding be vaccinated. The COVID-19 vaccine studies performed in animals by Pfizer, Moderna and Johnson & Johnson reported no safety concerns regarding reproduction, fetal and/or postnatal development.31The CDC also provides guidance for precaution and prevention for lactating women and newborns. There is mounting evidence that the vaccines are safe and effective and do not cause any fertility problems in men or women.

Currently, the CDC recommends COVID-19 vaccines for all adults and for children who are at least 12 years old. The Pfizer vaccine has recently been approved by the FDA for teens 16 years of age and older, and received FDA-amended EUA for children 12 to 15 years old. Pfizer, Moderna and Johnson and Johnson continue to test their vaccines in children as young as 12 years old.32-33 Pfizer plans to apply for FDA approval of its vaccine use in children five to 11 years old in September 2021 while the company continues to test its vaccine in children two to five years old. Clinical trials by Moderna reveal that its vaccine is 100 percent effective in teens 12 to 17 years of age and the company has filed for an expansion of the EUA in that population. As of July 2021, Johnson and Johnson has started performing trials in children 6 months and older in the US and Europe.33 Figure 2: CDC COVID-19 Vaccination recommendation Timeline33

Vaccine Timeline COVID-19 Vaccination Updates Recommendations December 1, 2020

ACIP recommendation for all healthcare personnel and long-term care residents be vaccinated

December 11, 2020

FDA issued EUA for the Pfizer BioNtech COVID-19 Vaccine Use

December 18, 2020 FDA issued EUA for the Moderna COVID-19 Vaccine Use December 20, 2020 ACIP recommendations are updated as in the proposed order in Figure 1 February 27, 2021

FDA issued EUA for the Johnson & Johnson’s Janssen COVID-19 Vaccine Use in people who are 18 and older

April 30, 2021

ACIP issued recommendation on J&J based reports of thrombosis and thrombocytopenia

May 10-12, 2021

FDA issued expansion of EUA for the Pfizer BioNtech COVID-19 Vaccine Use in children 12-15 years old. ACIP recommends use of the Pfizer vaccine in the same population

August 23, 2021

FDA approved the Pfizer BioNtech COVID-19 Vaccine Use in people aged 16 years and older

September 22, 2021

FDA amended EUA for the Pfizer BioNtech COVID-19 Vaccine Use to include a booster shot in selected populations

September 24, 2021

CDC recommends booster shots for selected individuals 6 months after receiving the second dose of the Pfizer vaccines OCTOBER 2021

As of October 1, 2021, 393 million doses of vaccines have been administered in the U.S., accounting for 56 percent of the population being fully vaccinated. The end goal is for enough Americans to be vaccinated so that the herd immunity threshold can be reached. While Americans are still dying from COVID-19 daily, totaling over 698,000 to date, the incidence of daily death is currently declining in the U.S.33 In addition, the COVID-19 Delta variant is reportedly more virulent, more transmissible and accounts for the current mortality rate when compared to the initial breakout of the pandemic and other variants.33 There will continue to be many unanswered questions about COVID-19, vaccines and emerging variant strains. Several variants to COVID-19 have already been identified, notably the B.1.1.7 (Alpha), B.1.617.2 (Delta), B.1.351 (Beta), B.1.427 (Epsilon) and P.1 (Gamma).33-37 These emerging variants are cause for serious concern in the U.S. The COVID-19 variant B.1.525 (Eta) is especially concerning because of its multiple mutations, which may potentially allow the virus to evade the immune system. The COVID-19 variant B.1.1.7 is also concerning due to how quickly it appears to be spreading in the U.S.29,35 Currently, the Delta variant accounts for 99 percent of all new COVID-19 cases in the U.S. and is the only one classified as a variant of concern, while Alpha, Beta, Eta and Iota variants have been downgraded from variants of concern to either variants that are being monitored or variants of interest.36 The three available vaccines appear to have some effectiveness against these new variants. Both the Pfizer and Moderna vaccines appear to have some effectiveness against the Delta variant but not as much as they did against the initial strains of the virus.28 However, more studies need to be performed regarding these variants to arrive to any conclusion as to the extent and duration of the vaccine effectiveness against them. In February 2021, both Pfizer and Moderna announced that they have begun trials on modified versions of their vaccines to target new variants.37 Conclusion Pharmacists, student pharmacists and technicians are clearly equipped to take on many roles related to testing and vaccination during the COVID-19 pandemic. New legislation and emergency orders have expanded opportunities for pharmacists to provide testing services and administer vaccines to both adults and children. As new changes continue, additional opportunities for all pharmacy staff members are sure to follow. Pharmacists will need to demonstrate adaptability, perseverance and commitment to integrate these new tasks and responsibilities into their current practice roles. In addition, these new opportunities also open doors for lasting legislative changes, recognition of pharmacist services through reimbursement and new ways to elevate the level of patient care. Pharmacists across the U.S. will play a key role in moving our nation out of this pandemic and into a brighter future.

FLORIDA PHARMACY TODAY

References

1. Hughes R IV, Nam D, Diamond N, et al. The Pharmacist’s Role In COVID-19 Response Efforts. Health Affairs. https://www. healthaffairs.org/do/10.1377/hblog20200721.162747/full/. Published July 23, 2020. Accessed November 11, 2020. 2. Zimmer C, Corum J, Wee S. Coronavirus Vaccine Tracker. The New York Times. https://www.nytimes.com/ interactive/2020/science/coronavirus-vaccine-tracker.html. Updated March 16, 2021. Accessed March 18, 2021. 3. Nania R, Ianzito C, Bunis D. What to Know About the Coronavirus Vaccines? AARP. https://www.aarp.org/health/ conditions-treatments/info-2020/coronavirus-vaccineresearch.html. Published May 1, 2020. Updated March 16, 2021. Accessed March 18, 2021. 4. mRNA Vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/ different-vaccines/mrna.html. Updated March 4, 2021. Accessed March 16, 2021. 5. COVID-19 Vaccine Candidates. American Society of Health System Pharmacists. https://www.ashp.org/-/media/assets/ pharmacy-practice/resource-centers/Coronavirus/docs/ Vaccine-candidate-tracking-table.ashx?la=en&hash=445ED31 EC216D4F4E33C920AE151530C986F9255. Updated March 5, 2021. Accessed March 16, 2021. 6. COVID-19 Vaccine Development Tracker. Vizient. https://www.vizientinc.com/-/media/documents/ sitecorepublishingdocuments/public/vizient_covid_19_ vaccine_tracker.pd. Updated March 15, 2021. Accessed March 16, 2021. 7. U.S. clinical trial results show Novavax vaccine safe and prevents COVID-19. www.nih.gov/news-events/newsreleases/us-clinical-tril-results-show-nvavax-vaccine-safeprevents-covid-10. Published June 14,2021. Accessed October 3, 2021 8. Benefits of Getting Vaccinated. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019ncov/vaccines/about-vaccines/vaccine-benefits.html. Updated January 5, 2021. Accessed March 16, 2021. 9. Pharmacists’ Authority to Test for COVID-19. American Pharmacists Association. https://nabp.pharmacy/wpcontent/uploads/2020/04/APhA-Pharmacists-Ability-to-TestCOVID19-April-2020-1.pdf. Published April 20, 2020. Accessed November 22, 2020. 10. Pharmacists May Order and Administer COVID-19 Tests. Florida Board of Pharmacy. https://floridaspharmacy.gov/ latest-news/pharmacists-may-order-and-administer-covid-19tests/. Accessed November 10, 2020. 11. Community Pharmacists Need to Report COVID-19 Test Results. U.S. Pharmacist. https://www.uspharmacist.com/ article/community-pharmacists-need-to-report-covid19-testresults. Published June 20, 2020. Accessed November 12, 2020. 12. HHS Expands Access to Childhood Vaccines during COVID-19 Pandemic. U.S. Department of Health & Human Services. https://www.hhs.gov/about/news/2020/08/19/ hhs-expands-access-childhood-vaccines-during-covid19-pandemic.html. Published August 19, 2020. Accessed November 10, 2020. 13. Pharmacists and Interns May Administer Childhood and COVID-19 Vaccines. Florida Board of Pharmacy. https:// floridaspharmacy.gov/latest-news/pharmacists-andregistered-pharmacy-interns-may-administer-childhood-andcovid-19-vaccines/. Accessed November 10, 2020. 14. Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccines. U.S. Department of Health & Human

Services. https://www.hhs.gov/about/news/2020/11/12/ trump-administration-partners-chain-independentcommunity-pharmacies-increase-access-future-covid-19vaccines.html#. Published November 12, 2020. Accessed November 21, 2020. 15. NACDS Lauds Preparedness and Dedication of Diverse Pharmacies, Pharmacists and Pharmacy Teams Upon HHS’ Announcement about Their Role in COVID-19 Vaccinations. National Association of Chain Drug Stores. https://www. nacds.org/news/nacds-lauds-preparedness-and-dedicationof-diverse-pharmacies-pharmacists-and-pharmacy-teamsupon-hhs-announcement-about-their-role-in-covid19-vaccinations/. Published November 13, 2020. Accessed November 21, 2020. 16. Understanding the Federal Retail Pharmacy Program for COVID-19 Vaccination. https://www.cdc.gov/vaccines/ covid-19/retail-pharmacy-program/index.html. Accessed October 3, 2021 17. Pharmacy Partnership for Long-Term Care Program. COVID-19 Vaccination. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/covid-19/longterm-care/pharmacy-partnerships.html. Accessed November 10, 2020. 18. Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing. U.S. Department of Health and Human Services. https://www.hhs.gov/sites/default/files/prep-act-guidance. pdf. Published October 20, 2020. Accessed November 12, 2020. 19. Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing. Department of Health and Human Services. https:// www.hhs.gov/sites/default/files/prep-act-guidance.pdf. Published October 20, 2020. Accessed March 16, 2021. 20. APhA 2021. Pharmacy-Based Immunization Delivery. APhA. www.pharmacist.com). 21. PTCB 2021. Immunization Administration AssessmentBased Certificate Program. www.ptcb.org/credentials/ immunization-administration-certificate. 22. Subbaraman N. Who gets a COVID vaccine first? Access plans are taking shape. https://www.nature.com/articles/ d41586-020-02684-9. Published September 17, 2020. Accessed December 6, 2020. 23. Possible Side Effects. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/ vaccines/expect/after.html. Updated September 30, 2021. Accessed October 3, 2021. 24. Pfizer-BioNTech COVID-19 Vaccine. Pfizer. https://www. pfizermedicalinformation.com/en-us/pfizer-biontech-covid19-vaccine?section=adverse-reactions. Accessed March 13, 2021. 25. Real-World Evidence Confirms High Effectiveness of PfizerBioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared. Pfizer. https://www.pfizer.com/news/press-release/ press-release-detail/real-world-evidence-confirms-higheffectiveness-pfizer. Published March 11, 2021. Accessed March 13, 2021. 26. Vaccine Safety and Monitoring. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019ncov/vaccines/safety.html. Updated September 28, 2021. Accessed October 3, 2021. 27. Myths and Facts. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/

facts.html. Updated September 7, 2021. Accessed October 3, 2021. 28. Rubin R.COVID-19 Vaccines vs Variants – Determining How Much Immunity Is Enough. JAMA. 2021;325:1241-1243. Doi:10.1001/jama.2021.3370. 29. Vaccines & Immunizations, COVID-19 Vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/ vaccines/covid-19/info-by-product/clinical-considerations. html. Updated September 9, 2021. Accessed October 3, 2021. 30. Zaigham, M, Holmberg A, Karlberg M, et al. Intrauterine vertical SARS—CoV-2 infection: a case confirming transplacental transmission followed by divergence of the viral genome. BJOG. 2021 Feb 27. doi: 10.1111/1471-0528.16682. 31. COVID-19 and Pregnancy. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/ need-extra-precautions/pregnant-people.html. Updated August 11, 2021. Accessed October 2, 2021. 32. Cunningham A. COVID-19 vaccines may be ready for teens this summer. Science News. https://www.sciencenews.org/ article/coronavirus-covid-19-vaccines-children-kids-teensready-summer. Published February 25, 2021. Accessed March 9, 2021. 33. COVID Data Tracker. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-datatracker/#datatracker-home. Accessed October 1, 2021. 34. US COVID-19 Cases Caused by Variants. Centers for Disease Control and Prevention. https://www.cdc.gov/ coronavirus/2019-ncov/transmission/variant-cases.html. Updated September 25, 2021. Accessed October 3, 2021. 35. There’s another new variant of SARS-CoV-2 spreading fast. Here’s what we know so far. ScienceAlert Latest. https:// www.mdlinx.com/news/theres-another-new-variant-ofsars-cov-2-spreading-fast-heres-what-we-know-so-far/2os 79RQa929hHBWqFOKC4G?publish_dt=03-02-2021&news_ id=673&newsdt=030321&subspec_id=282&utm_ source=DailyNL&utm_med. Published March 2, 2021. Accessed March 9, 2021. 36. Bernal JL, Andrew N, Gower C, et al. Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. N Engl J Med. 2021 Jul 21;doi:10.1056/NEJMoa2108891 37. Mahase E. Covid-19: Where are we on vaccines and variants? BMJ. 2021 Mar 2;372:n597. doi: 10.1136/bmj.n597.

OCTOBER 2021

C A L L

F O R

APhA Foundation and NASPA Bowl of Hygeia Awarded to a pharmacist for outstanding community service above and beyond professional duties. The use of the following selection criteria is required: ■ The recipient must be a Florida licensed pharmacist and member of the FPA. ■ The recipient must be living. Awards are not presented posthumously. ■ The recipient has not previously received the award. ■ The recipient is not currently serving nor has he/she served within the immediate past 2 years on its award committee or an officer of the association in other than an ex officio capacity. ■ The recipient has compiled an outstanding record of community service, which, apart from his/her specific identification as a pharmacist reflects well on the profession. James H. Beal Award Awarded to the “Pharmacist of the Year”. The criteria established for this award is that the recipient be a Florida licensed pharmacist and a member of FPA, who has rendered outstanding service to pharmacy within the past five years. Criteria: ■ The recipient must be a Florida licensed pharmacist and a member of the FPA. ■ The recipient has rendered outstanding service to pharmacy within the past five years. Technician of the Year Award Awarded annually to a Florida pharmacy technician who is recognized for his/her outstanding performance and achievement during his/ her career. Criteria:

FLORIDA PHARMACY TODAY

N O M I N A T I O N S ■

■

Candidate must be a member of the Florida Pharmacy Association for at least 2 years. Candidate must have demonstrated contributions and dedication to the advancement of pharmacy technician practice. Candidate must have demonstrated contributions to the Florida Pharmacy Association and/or other pharmacy organizations. Candidate must have demonstrated commitment to community service. Candidate is not a past recipient of this award.

R. Q. Richards Award This award is based on outstanding achievement in the field of pharmaceutical public relations in Florida. Criteria: ■ The recipient must be a Florida registered pharmacist and a member of the FPA. ■ The recipient has displayed outstanding achievement in the field of pharmaceutical public relations in Florida. Frank Toback/AZO Consultant Pharmacist Award Criteria: ■ Candidate must be an FPA member, licensed with the Florida Board of Pharmacy as a consultant pharmacist in good standing. ■ Candidate should be selected based on their outstanding achievements in the field of consultant pharmacy. DCPA Sidney Simkowitz Pharmacy Involvement Award Presented annually to a Florida pharmacist who has been active at the local and state pharmacy association level in advancement of the profession of pharmacy in Florida. Criteria:

■

■ ■

■

F P A

A minimum of five years of active involvement in and contributions to the local association and FPA. Candidate must have held office at local level pharmacy association. Member in good standing for a period of at least five years in the FPA and must have served as a member or chairman of a committee of the association. Candidate must have been actively involved in a project that has or could potentially be of benefit to members of the profession.

Pharmacist Mutual Companies Distinguished Young Pharmacist Award Awarded to a young pharmacist for their involvement and dedication to the practice of pharmacy: Criteria: ■ Licensed to practice for nine (9) years or less. ■ Licensed to practice in the state which selected. ■ Participation in national pharmacy association, professional programs and/or community service. IPA Roman Maximo Corrons Inspiration & Motivation Award Interamerican Pharmacists Association created this award to honor the memory of Roman M. Corrons who inspired and motivated countless pharmacists to participate actively and aspire to take on leadership roles in their profession. Roman was always there with guidance and support that motivated pharmacists and encouraged visionary leadership, approachable active membership and succession planning. This award recognizes the motivators among us who inspire others to continue to advance the profession. Criteria: ■ The recipient must be a Florida li-

A W A R D S

■

censed pharmacist and a member of the FPA. Candidate should motivate others to excel within the profession by encouraging them to be leaders. Candidate is not necessarily an association officer, but guides, supports and/or inspires others. A brief description on the candidate’s motivational/inspirational skills must accompany the nomination.

2 0 2 1 - 2 0 2 2 The Jean Lamberti Mentorship Award The Jean Lamberti mentorship Award was established in 1998 to honor those pharmacists who have taken time to share their knowledge and experience with pharmacist candidates. The award is named in honor of long time FPA member Jean Lamberti for her effort in working with pharmacy students. Criteria: ■ The recipient must be an FPA member. ■ The recipient must serve as a role model for the profession of pharmacy.

Upsher Smith Excellence in Innovation Award Awarded to honor practicing pharmacists who have demonstrated innovation in pharmacy practice that has resulted in improved patient care. Criteria: ■ The recipient has demonstrated innovative pharmacy practice resulting in improved patient care. ■ The recipient should be a practicing pharmacist within the geographic area represented by the presenting Association. ■ Qualified Nominee: A pharmacist practicing within the geographic area represented by the Association.

DEADLINE FOR NOMINATIONS: FEBRUARY 28, 2022 FPA AWARDS NOMINATION FORM I AM PLEASED TO SUBMIT THE FOLLOWING NOMINATION:

NOMINATED BY:

Name:

Address:

Date Submitted: Signature:

FOR THE FOLLOWING AWARD:  Bowl of Hygeia  Beal and Powers Award  R. Q. Richards Award

Please describe briefly the nominee’s accomplishments, including why you feel he or she should receive this award. (Attach additional sheets if necessary.)

 Frank Tobak/AZO Consultant Pharmacist Award  DCPA Sydney Simkowitz Award  Pharmacist Mutual Distinguished Young Pharmacist Award  Jean Lamberti Mentorship Award  IPA Roman Corrons Inspiration & Motivation Award  Upshur Smith Innovation Pharmacy Practice Award  Technician of the Year Award

SUBMIT NOMINATONS TO: Annual Awards, Florida Pharmacy Association, 610 N. Adams St., Tallahassee, FL 32301 (850) 222-2400 FAX (850) 561-6758 FOR A LISTING OF PAST AWARD RECIPIENTS GO TO WWW.FLORIDAPHARMACY.ORG AND SELECT THE “AWARD” MENU ITEM DEADLINE FOR NOMINATIONS IS FEBRUARY 28.

OCTOBER 2021

“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”

WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program: • • • •

Helps you implement and maintain a continuous quality improvement program Offers federal protection for your patient safety data and your quality improvement work Assists with quality assurance requirements found in network contracts, Medicare Part D, and state regulations Provides tools, training and support to keep your pharmacy running efficiently and your patients safe

Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION