November 2022 Florida Pharmacy Today

DECEMBER

2 APhA Immunization Certificate Training program Sarasota

3-4 FPA Regulatory and Law Zoom Conference via Zoom

14-15 Florida Board of Pharmacy Meeting Orlando

26-27 Christmas HolidayFPA Office Closed

JANUARY

2 New Years - FPA Office Closed

16 MLK holiday

22 Board of Directors Meeting Orlando

CE CREDITS (CE cycle)

FEBRUARY

4-5 FPA Clinical Meeting via ZOOM

8-9 Florida Board of Pharmacy Meeting

Mission Statements:

Florida Pharmacy Today Journal

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

Florida Pharmacy Today Board of Directors

The Florida Board of Pharmacy requires 10 hours’ LIVE continuing education as part of the required 30 hours’ general education needed every license renewal period. There is a two-hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. The Reducing Medication Errors course is needed for pharmacists and technicians.

Pharmacists should have satisfied all continuing education requirements for this biennial period by Sept. 30, 2023, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec. 31, 2022.

For the Pharmacy Technician Certification Board application, exam information and study materials, please contact the FPA office.

For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org

CONTACTS

FPA — Tian Merren-Owens (850) 222-2400

FSHP — Tamekia Bennett (850) 906-9333

UF — Emely McKitrick (352) 273-5169

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

NSU — Carsten Evans (954) 262-1300

DISCLAIMER

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

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 Jour nal 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 ap propriate advertising to assist the Journal in its goal of self-support.

Articles in this publication are designed to provide accurate and authoritative infor mation 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.

The President’s Viewpoint

CAROL MOTYCKA, PHARM.D., CHSE

Do You Hear What I Hear?

We have been working hard at the FPA to help pro mote pharmacy and to reach out to as many phar macists, technicians and students in the state as possible. We realize that Southwest Florida is still facing many challenges following Hurricane Ian, and Helen Saira ny and Dan Buffington made a special trip to visit with local pharmacists in the area to provide support.

If your pharmacy has needs in which the organization may be of assistance, please reach out to our office so we can work with you to help if possible. This past month, Helen and I met with local pharmacists and pharmacy owners to dis cuss their challenges and listen to ways in which our orga nization can better serve members. We also met with stu dents around the state to hear what excites them about being a member and to find out how we can continue to grow our student membership.

We will continue to plan more visits, so please follow our social media to find out when your “CEO is on the Go!” We also enjoy speaking at regional meetings and are happy to set up a date with your region, so please reach out to us.

I am also very excited to announce our recently launched podcast titled Florida RxPerts! The podcast can be found on Spotify or Apple Podcasts and can also be streamed from our website. Just click on the link in the banner at the top of the page.

The podcast was developed as a way to meet with pharma cy guests from a broad range of practice settings and discuss important pharmacy issues, with topics ranging from leg islation to workplace challeng es. Our first few episodes have featured Michael Jackson, a new pharmacist legislator Gal lop Franklin, APhA President Theresa Tolle, Helen Sairany, and pharmacists from multiple practice settings. Upcoming guests include our other new pharmacist legislator, Shane Abbott, independent pharma cy owners including Kevin Duane, and Claudia Davant from Adams St. Advocates. We always welcome new ideas and suggested guests.

Pharm.D., CHSE

As we reflect after the Thanksgiving holiday, I want to say THANK YOU to all our members who have supported our organization and the profession over the years. I also look back on a year with many challenges, including storms, ill nesses and busy work conditions, and recognize the hard work and sacrifices made to continue caring for patients while pushing our profession ever forward. It is because of the dedication of pharmacists, through the toughest of times, that we are able to provide the best care for our community.

Finally, I wish everyone a safe and healthy time with fam ily and friends during the upcoming holidays and hope you will continue to engage with and enlighten us into the new year. n

Carol Motycka,

Executive Vice President, CEO Helen Sairany, ext.200

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

Continuing Education Coordinator Stacey Brooks, ext. 210

Coordinator of Membership Ranada Howard, ext. 110

FLORIDA PHARMACY TODAY BOARD

Chair David Mackarey, Boynton Beach

Vice Chair Matt Schneller, Tampa

Treasurer Eric Jakab, Gainesville

Secretary Julie Burger, Pensacola

Member Aiya Almogaber, Tampa

Member Michael Finnick, Jacksonville

Member Carol Motycka, Jacksonville

Member Teresa Tomerlin, Rockledge

Member Greta Pelegrin, Hialeah

Technician Member Julie Burger, Pensacola

Executive Editor Helen Sairany, Tallahassee

Managing Editor Dave Fiore, Tallahassee

Journal Reviewer Dr. Melissa Ruble

Journal Reviewer Dr. Angela Hill

This is a peer-reviewed publication.

©2022 FLORIDA PHARMACY JOURNAL, INC.

ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association as sumes 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.

FPA STAFF JOIN TODAY!

FLORIDA PHARMACY ASSOCIATION

610 N. Adams St.

• Tallahassee, FL 32301 850/222-2400

• FAX 850/561-6758

Web address: www.floridapharmacy.org

Executive Insight

HELEN SAIRANY, BA, PHARMD, MBA, RPH, BCACP EXECUTIVE VICE PRESIDENT & CEO

Stress, Trauma and Substance Use Disorder During the Pandemic

This month’s executive summa ry focuses on the alarming rise we have seen in substance use in Florida as well as the nation, a top ic that could not be timelier. Accord ing to a recent report by the U.S. Cen ters for Disease Control and Prevention, more than 93,000 people died of a drug overdose in the United States in 2021 –the highest number of overdose deaths the country has ever recorded. Of these numbers, 7,579 people died from a drug overdose in Florida, making Florida No. 2 in the nation for overdose deaths behind only California. This number is a 37% increase from 2019.

According to the National Survey on Drug Use and Health, 17 million U.S. adults experienced both mental health and substance use disorder in 2020. In 2019 alone, there were 49,860 opioid-re lated deaths. Though Florida has strug gled with a substance misuse crisis for years, the pandemic only exacerbated these effects.

Many studies have shown that the pandemic contributed to increased al cohol and drug abuse, suicide attempts, and calls to mental health hotlines be cause of the isolation, disruption to rou tines, economic uncertainty, and the anxiety it created.

As a result, both alcohol and drug use are up. Approximately 8% of Flori da citizens are using illicit drugs at any given point in time, which comes out to be approximately 1.5 million Florid ians. The Pasco Sheriff’s Office reported a total of 1,491 overdoses in 2020, which was a 71% increase from 2019.

Former Governor Rick Scott de clared a state of emergency to autho

rize the state to draw the funding from the State Targeted Response to the Opi oid Crisis Grants, a program that was established by the U.S. Department of Health and Human Services in April of 2017 and was administered by the Sub stance Abuse and Mental Health Ser vice Agency.

According to a recent report by the U.S. Centers for Disease Control and Prevention, more than 93,000 people died of a drug overdose in the United States in 2021 –

surpassing the totals for either fire arm or vehicle traffic deaths. Shock ingly enough, sustaining this death toll is the equivalent of experienc ing an event like 9/11 every three weeks.

Unfortunately, many of these prob lems were reaching epidemic propor tions even before COVID-19. Consider that, pre-pandemic, President Trump declared the opioid epidemic a nation al emergency, relying on the following statistics:

n Each day, 140 Americans die of an opioid-related overdose.

n Drug overdoses are the leading causes of injury deaths in America,

n In 2015, 27 million people reported current use of illegal drugs or abuse of prescription drugs. The stagger ing number of opioids prescribed in the U.S. in 2015 was enough for ev ery American to be on medication around the clock for three weeks.

Americans are apparently in more pain than any other population in the world. At least, that is the conclusion that can be drawn from the startling findings from recent years. Approxi mately 80% of the global opioid supply is consumed in the United States, which accounts for only 5% of the world pop ulation. In the words of Vikesh Singh,

Helen Sairany, BA, PharmD, MBA, RPh, BCACP

the highest number of overdose deaths the country has ever recorded.

assistant professor of medicine and di rector of the Pancreatitis Center at John Hopkins University, “If you include Canada and Western Europe [consump tion of global opioid supply] increases to 95%, so the remaining countries only have access to about 5% of the opioid supply.”

The harsh reality that at least 140 people die from overdoses every day in the U.S. – two thirds of which are from opioids - isn’t new information, accord ing to Dr. Gabor Maté, addiction expert and author of the book, “The Myth of Normal.” Dr. Maté says, “We need to change the conversation to provide an effective response to the crisis. Dissuad ing people from taking drugs and treat ing addictive behavior isn’t the answer. Understanding and addressing the emotional pain and adverse conditions

at the root of addiction would be signif icantly more effective.”

Kaiser Permanente Internal Medi cine Specialist, Dr. Vincent Felitte, in partnership with the CDC’s Dr. Bob Anda, led an investigation of the nowfamous Adverse Childhood Experi ences study. In this study, they looked at the impact of early exposure to trau ma and life adversity on the likelihood of substance use disorder. This curios ity emerged in Dr. Felitte after count less numbers of trauma stories he heard from his patients at an obesity clinic. The ACE study was conducted on 17,000 middle class Americans in 1990 at the Kaiser Permanente health care network. They found that the more adversity the child was exposed to, the greater the risk of addiction, mental health issues and other medical problems they faced

in adulthood. Their definition of adver sity was categorized under three head ings: abuse (psychological, physical, sexual); neglect (physical, emotional); and household dysfunctionality (alco holism or drug use by a loved one in the household, divorce or loss of a biologi cal parent, depression or mental health disorder by a loved one in the house hold, mother or a loved one treated vi olently in front of someone, imprisoned household member). To their surprise, the impact of early exposure to these events did not simply add up; they mul tiplied each other. For example, an adult reporting an ACE score of six was 46 times more at risk of intravenous drug use than a child with none of the adver sities listed above.

What do these scary statistics and findings mean for pharmacists, who are the most accessible providers in the country? It means we have a role to play, and as an association, we are ob ligated to provide our frontline heroes the tools and resources to fight this worthy fight. Here is what we have to share so far.

For the very first time, FPA’s Annu al Convention will have an opening and closing keynote session, and both will be dedicated to addressing this timely topic. The first keynote will be Dr. Mon ty Burks, a pioneer and SUD advocate who will address pharmacists’ role in standing up to substance use disorder. For the closing keynote, we are honored to have Kevin Hines, a filmmaker and an advocate for suicide prevention, to share his wisdom with our audience. The sessions will be moderated by FPA’s president, Dr. Carol Motycka, and FPA’s board chair, Dr. Dan Buffington. In ad dition, FPA plans to bring national ex perts in both substance use as well as mental health to tackle the issues relat ed to the opioid epidemic, trauma, and mental health.

Make sure you mark your calen dar and join us in Marco Island from July 5 - 9. Registration for FPA’s Annu al Convention will go live soon. Be on the lookout for early bird registration as well as other future initiatives by FPA to tackle this timely topic. I look for ward to seeing you soon. n

NSU College of Pharmacy

Dean’s Message

Defining Our Identity and Looking to the Future with a New Strategic Plan

As we enter a new era following the recent pandemic, NSU College of Pharmacy continues to be an agent of change in the community, the profession, and in research. Our revised vision and mission state ments led to the development of a new Strategic Plan which will guide the college into the future of health care.

The strategic planning process was collaborative and took almost two years to complete as it included many drafts, discussions, incorporation of stakeholder feedback, and ultimately a faculty vote to finalize a strategic plan that would meet the goals and priorities of the newly defined vision and mission. Small er sub-committees are assigned to track key performance indicators within each of the strategic priorities within each pillar.

A. Clark, Ph.D., Dean

Vision Statement: To be a preeminent College of Pharmacy that cultivates leadership, innovation, and diversity in education, practice, research, and service to advance the health and well-being of our com munities.

Mission Statement: To educate and devel op inclusive leaders in the science and practice of pharmacy who will improve health through discovery, innovation, advocacy, and the deliv ery of optimal patient care.

This plan allows us to commit to the devel opment of future leaders in health care and provide a safe learning environment where students can pursue dreams and achieve per sonal and professional goals. We look forward to sharing details in the future.

Michelle

College Launches Community Leadership Council

NSU College of Pharmacy launched its first community relations and strategic planning board, the NSU College of Pharmacy Community Leadership Council. The mission of the CLC is to fully support and promote the College of Phar macy through outstanding community engagement and stra tegic planning to meet the critical, ongoing philanthropic and educational needs of the College. The CLC consists of com munity leaders and alumni who subscribe to the mission of the College and meet the responsibilities and duties of Coun cil membership. The founding chair of the CLC is Richard K. Brook, President & CEO of Richard Klein Brook & Asso ciates Inc.

The CLC had a very successful first year, raising $35,000 to support student scholarships and College of Pharmacy ex cellence. Council members are engaged within one of four subcommittees: strategic planning, concentration implemen tation, admissions and development, where their talents and skills can be best utilized. We are looking forward to anoth er successful year!

Student Spotlight

Annual Preceptor/Site Experiential Expo

The NSU College of Pharmacy Annual Preceptor/Site Ex periential Expo was held in August at the Fort Lauderdale/ Davie campus. The event was sponsored in partnership with Janssen Pharmaceuticals. The night was electric, full of con versation, networking, education, and the excitement of peo ple seeing each other again after quite some time apart. Over 200 students attended the event, gaining insight into IPPE/ APPE rotations, residency/job opportunities, and learning about different career options for pharmacists.

The event was strategically planned prior to IPPE and APPE ranking and the ASHP Midyear Clinical Meeting & Exhibition to give students the opportunity to engage with preceptors, residency directors, and residents. We are grateful for the support and participation from every health system in the South Florida area, independent and compounding phar macies, and some nontraditional sites. Over 150 pharmacists attended the event, and we look forward to growing this op portunity for our community and college year after year.

Gabriela Marrero (‘24) participated in the Junior Commis sioned Officer Student Training and Externship Program with the United States Public Health Service during the summer months in Sisseton, South Dakota. During this ex perience, she trained alongside Commander Lori Braaten, Pharm.D., BCPS, BCACP and other active-duty officers at Woodrow Wilson Keeble Memorial Health Center. Marrero shared that time spent in the JRCOSTEP program has been an amazing experience and one that has confirmed her de sire to pursue a career in public health in order to provide pa tients with the best health care possible.

Vivek Patel (‘24) completed a summer internship in Regulatory Affairs at Dr. Reddy’s Laboratories in Princeton, New Jersey. During this experience, he main tained regulatory databases, assisted with submissions and correspondence with agencies, reviewed ptublications, and revised controls for labeling and lifecycle management of over-the-coun ter products. Patel shared that time spent at Dr. Reddy’s Laboratories has been a rewarding experience, as it has helped him focus on the pharmaceutical industry as a career choice in hopes of making a significant impact at a global level.

Congratulations to Alecia Muwonge (‘23), Nedra GeddesMcCarthy (‘23), and Uzair Ali (‘23), for winning the Quiz Bowl at the 2022 FSHP Annual Meeting, held in Orlando, Florida. This year, a total of six pharmacy schools across Flor ida participated.

In February 2022, students at the Puerto Rico Campus par ticipated in “Pharm Arts - A Night with Our Stars.” This an nual event allows students to exhibit their artistic abilities in singing, photography, painting, drawing, poetry, and craft ing. Funds raised are donated to a person in need from the local community. This year, a 17-year-old patient diagnosed with Mandibular Osteosarcoma received all the funds ob tained from Pharm Arts to be used toward her care.

Students from the Palm Beach campus participated in lo cal community and philanthropic activities. The Class of 2024 visited Loggerhead Park in Juno Beach for a beach clean-up event, and students from the Psi Chapter of Alpha Zeta Ome ga (AZO) pharmaceutical fraternity held a pie-in-the-face fundraiser to support the Lustgarten Foundation (Pancreatic Cancer Research).

Thandeka Bissasor

Faculty Accomplishments

In keeping with the college vision and mission, our faculty continue to be highlighted for their achievements. Below are some of our recent accomplishments:

Dmitriy Minond, Ph.D., Associate Pro fessor, Pharmaceutical Sciences, was re cently awarded the US Patent #11,149,028 entitled “Methods for treating melano ma using small molecules.” This pat ent presents a fundamentally unique approach for the treatment of melano ma. In addition, novel targets and ap proaches for melanoma treatment are disclosed. Most importantly, this ap proach is specific for non-malignant cell types suggesting the potential for low toxicity for melanoma patients. Notably, pre-clinical studies, funded by NIH, are underway to eval uate the efficacy of Minond’s approach to treat melanoma. Read more about Dr. Minond’s research.

Elizabeth Sherman, Pharm.D. (‘07), As sociate Professor, Pharmacy Practice, was elected to serve on the board of directors of the HIV Medicine Association. Housed within the Infectious Disease Sovciety of America, HIVMA represents medical providers and researchers working on the front lines of HIV. HIVMA is a lead er on issues of importance to HIV med ical professionals, including education and training, policy and advocacy, setting guidelines for pa tient care, and developing resources for clinical practice. More than 12,000 IDSA and HIVMA members work across the Unit ed States and in nearly 100 other countries on six different con tinents. Dr. Sherman is the sole pharmacist on the board and will begin her term following IDWeek 2022 in October.

Faculty members from the Sociobe havioral and Admin istrative Pharmacy Department, Alexandra Perez Rivera, Pharm.D. and Jesús Sánchez, Ph.D., are a part of the team studying “Hispanic, black and pacific islander perspectives on COVID-19 outreach strategies and patient centered outcomes.” They are working in collaboration with faculty from Queen’s Medical Center in Hawaii and have been awarded $968,834 from the Food and Drug Administration (FDA) to support their research.

The research article “What Is Nuclear Factor Kappa B (NF-κB) Doing in and to the Mitochondrion?” by Benedict C. Albensi, Ph.D., BCMAS, CRQM, Chair, Pharmaceutical Sciences, Professor, has gone viral. The paper has key informa tion and important ramifications for Al zheimer’s disease, memory, and process es of aging and inflammation. So far, it has been viewed 115,000 times and has been cited 149 times - as of September 2022. The article has more views than 99% of all of Frontiers articles (publisher of the journal). It has also been downloaded 7,493 times.

Pre-Exposure Prophylaxis (PrEP): An Update

Authors: Shane Artiles, Pharm.D. Candidate 2023, Chardae Whitner, Pharm.D., Eric F. Egelund, Pharm.D., Ph.D.

Introduction

PAYMENT FOR PREP

WHAT IS PREP?

Pre-Exposure Prophylaxis (PrEP) is a relatively new effec tive method for preventing HIV infection in persons at risk of exposure (e.g., those who engage in behaviors that may lead to HIV exposure, either unprotected sex or injection drug use with the use of antiretroviral medications).2 Three pharma ceutical options are available when deciding which PrEP op tion is best. Truvada® (emtricitabine/tenofovir disoproxil fu marate) and Descovy® (emtricitabine/tenofovir alafenamide), are oral tablets that you can take once daily. A significant dif ference between both therapies is that Descovy® is the pro drug version of Truvada® and requires a smaller dose, lead ing to fewer side effects. Truvada® was the sole option since its approval by the FDA for HIV prevention in 2012. However, Descovy® was approved in 2019 as an alternative therapy. In addition, in December 2021, the FDA approved Apretude®, a once every two months injectable PrEP alternative. This new revolutionary PrEP option provides an immense amount of hope for the future of HIV prevention.

PATIENT EDUCATION

For patients wanting to initiate PrEP, an HIV blood test is required prior to PrEP initiation. Patients must test negative to be eligible for PrEP, as these therapies would only offer par tial treatment (i.e., two active drugs versus three active drugs), potentially causing the virus to show resistance patterns to the PrEP components of HIV therapy.

PrEP does not prevent other sexually transmitted infec tions (STIs), and patients should still be advised to practice safe sex when possible. Before prescribing PrEP, an STI panel should be ordered, consisting of hepatitis A, B, and C, syph ilis, gonorrhea, and chlamydia. Kidney function should also be assessed before initiating PrEP and every three months during therapy since the tenofovir component can lead to re nal toxicity in some patients.3

Social determinants of health should also be assessed to ensure that the patient has no additional barriers to access ing PrEP therapies. One of the most common issues patients face %is the expensive drug cost without extensive health in surance coverage. Transportation to and from the clinic and pharmacy and timely completion of blood work may also be barriers to accessing care. Lastly, a negative stigma exists re garding HIV and PrEP. Continued patient education and re inforcement of normalcy are essential for patients to feel com fortable talking to their providers about starting PrEP.

A government assistance program called Ready Set PrEP can provide PrEP at no cost for eligible patients. This program is provided by the Department of Health and Human Servic es (HHS). Eligibility criteria for this program include:

1. Patients cannot currently have health insurance cov erage for prescription drugs,

2. Must have taken an HIV test and received a nega tive result,

3. Currently have a prescription for PrEP in hand, and 4. Live within the United States.10

Patients can enroll online through the website (https:// readysetprep.hiv.gov) once they have obtained the proper lab work and prescription from their prescriber. Healthcare pro fessionals can also create an account with Ready Set Prep to assist with the enrollment of patients. If a patient is current ly uninsured and seeking payment assistance for PrEP, an other viable option is to utilize GoodRx. At the time of this writing, up to 98 percent off the average retail price of gener ic Truvada® can be attained.12 Additionally, county health de partments are vital for local PrEP resources.

TRUVADA®

Truvada® is the brand name for the popular PrEP option, emtricitabine 200 mg combined with tenofovir disoproxil fu marate (TDF) 300 mg taken once daily. Even though it has been commercially available for HIV treatment since 2004, Truvada® has been the mainstay option for PrEP ever since the FDA approved its use for HIV prevention in 2012. Since this PrEP formulation contains TDF, it is essential for pre scribers to continually assess renal function while patients are taking this medication, along with the HIV/STI panels that must also be conducted regularly.11

An off-label indication for Truvada® is known as the 2-1-1 “on-demand” PrEP option.3 This regimen was explicitly stud ied for men who have sex with men (MSM). This intermittent regimen first involves taking two tablets by mouth 2-24 hours before sex (closer to the 24 hours preferred). Next, the patient takes one tablet by mouth 24 hours after the initial dose, fol lowed by one tablet by mouth 48 hours after the initial dose. If the patient has another sexual encounter after the initial en counter, they may take an additional one tablet dose up to 48 hours after the last encounter as long as there was a gap of fewer than seven days since the last encounter. If it has been longer than seven days since the last encounter, the patient would need to restart with the 2-1-1 dosing regimen. It is im

portant to note that the FDA and CDC do not initially recom mend this as a mainstay option to advise patients. The main reason some patients may benefit from this alternate regimen is the strict importance of adherence to once-daily PrEP. If the patient has adherence issues, this alternative regimen may be a better option. Additionally, this is also good for patients that have sexual encounters rarely or on occasion.

DESCOVY®

Descovy® is the brand name for emtricitabine 200 mg com bined with tenofovir alafenamide (TAF) 25 mg taken once daily. Descovy ® was approved by the FDA as a new HIV treatment option in 2016 but has only been available as a PrEP option since it was approved in late 2019. Since it contains the prodrug version of tenofovir (TAF), this medication is a much safer alternative to Truvada®, especially concerning kidney function. It is essential to be mindful that Descovy® is not ap proved for use in all patients needing HIV prevention. Desco vy® was not studied in people assigned to the female sex at birth who were at risk of receiving HIV infection through vaginal sex.4

Notes on Individual Antivirals Used in Current Oral PrEP Therapies

EMTRICITABINE

Emtricitabine is a nucleoside reverse transcriptase inhib itor (NRTI). This class of medications is commonly used to treat and prevent HIV infections due to its high efficacy and safety profile. Emtricitabine works by binding to the DNA chains of the virus with a 3’-5’-phosphodiester bond, which

prevents viral replication by stopping positive and negative strands of DNA from being synthesized.9 Emtricitabine is generally a safe drug. Some common side effects include diz ziness, headache, insomnia, skin rash, and diarrhea. Lastly, emtricitabine may need to be renally adjusted if the patient has a creatinine clearance of less than 50 mL/minute.9

TDF

Tenofovir disoproxil fumarate (TDF), also an NRTI, is the active parent form of tenofovir that has been commonly used in combination with emtricitabine as a highly effective PrEP option. This drug acts as a nucleotide analog that helps to block reverse transcriptase for HIV. Proper kidney function is essential for this medication to be taken safely. Tenofovir can cause new-onset or worsening renal impairment; thus, creat inine clearance needs to be monitored. The exact mechanism of toxicity is unknown, but it is most likely due to mitochon drial toxicity in the proximal tubule. This toxicity could po tentially lead to hypophosphatemia and a possible reduction of bone mineral density.14

TAF

Tenofovir alafenamide (TAF) is the inactive prodrug of TDF. TAF is metabolized and activated intracellularly, vast ly reducing the drug’s concentration in the blood. The ben efit of this reduction as compared to TDF is a potential re duction in renal toxicity and bone mineral loss, since there is less circulating TAF. Due to this improved targeted therapy, TAF has been formulated as one-tenth the dose compared to TDF.14 TAF has the exact mechanism of action as TDF in that it blocks the viral DNA from replicating and infecting the pa

tient. One major downside to TAF is cost, as it is a relative ly new therapy, entering the pharmaceutical market in 2015. Nevertheless, most prescribers still choose TDF PrEP over TAF PrEP because of the increased likelihood of being cov ered by insurance and lower cost, especially for uninsured and underserved patient populations in the LGBTQ+ com munity.

APRETUDE® (CABOTEGRAVIR)

Cabotegravir (Apretude®) is part of the class of medica tions known as HIV-1 integrase strand transfer inhibitors (IN STI). This type of medication is indicated for pre-exposure prophylaxis to reduce the risk of HIV-1 infection in adults and adolescents who weigh at least 77 pounds (35 kg). The first and only long-acting, injectable PrEP is designed to be taken every eight weeks for improved adherence. 600 mg must be administered into the gluteal muscle by a healthcare profes sional. Upon initiation, the injection is given one month apart for the first two months. After the first two months, cabote gravir can be given every eight weeks (six times yearly). The most common side effects of cabotegravir are local injection site reactions. Cabotegravir has not been studied for pregnant and breastfeeding patients. No dose adjustments are needed for patients with kidney impairment, unlike the oral PrEP op tions.1

Future PrEP Therapies

DAPIVIRINE VAGINAL RING

A new drug application (NDA) was in progress for a vagi nal ring containing dapivirine. The pursuant of this NDA was the non-profit organization, International Partnership for Mi crobicides (IPM). They are dedicated to developing new HIV prevention tools and strategies for women. This ring is de signed to be inserted vaginally every month to help prevent new HIV infections in cisgender female patients. The vaginal ring contains 25 mg of dapivirine. It showed a favorable 31% HIV infection risk reduction in The Ring Study (phase 3 trial). The advantage to this new vaginal ring dosage form is that women can use this as a discreet, female-initiated, long-act ing prevention that does not require taking a pill daily. Dapi virine is an HIV-1 non-nucleoside reverse transcriptase inhib itor (NNRTI).

Last year, the DREAM study was conducted.8 This was an open-label extension of The Ring Study, done at five research centers in South Africa and one in Uganda. This study gave eligible patients the dapivirine vaginal ring (DVR) for inser tion at the enrollment visit. Participants had to follow up with the program for testing and examinations. The DREAM study used the placebo group from the previously conducted Ring Study to compare with the DVR patients. The data from the DREAM study showed that the DVR treatment was well tol erated and had a similar safety profile to that in The Ring Study.

Unfortunately, in December 2021, IPM voluntarily with drew its application from FDA consideration as a result of feedback provided by the FDA stating the ring did not yield similar efficacy to the current mainstay therapies of Truvada® and Descovy®, which show 99% protection against HIV, and the new long-acting (every two months) injectable, Apretude. For now, the World Health Organization (WHO) recommends that the DVR be used as an additional preventative choice for women at high risk for HIV infection through vaginal sex for member nations.13 However, this is currently not available to patients of the United States.

ISLATRAVIR

In early 2021, there was an investigational new drug appli cation (IND) for the oral, implant, and injectable formulations of the Nucleoside Reverse Transcriptase Translocation Inhib itor (NRTTI) islatravir. In November 2021, the FDA placed clinical holds on all formulations with islatravir. Preliminary data revealed decreases in total lymphocyte and CD4+ T-cell counts in some patients receiving islatravir in clinical stud ies.6 Whether clinical studies will ever continue for this new drug is something to look for in the future.

LENACAPAVIR

In early 2019, the FDA allowed Gilead Sciences, Inc. a Breakthrough Therapy Designation to develop a new HIV treatment and prevention option, lenacapavir. This new agent is a first-in-class HIV-1 capsid inhibitor with a multi-stage mechanism of action that inhibits HIV-1 at multiple stages in its lifecycle.5 Lenacapavir is also a long-acting option that only needs to be administered every six months. However, it is still in the clinical trials to ensure the efficacy and safety of the drug before it becomes a mainstay option. Previously, the FDA issued a clinical hold due to concerns about the vials’ compatibility. However, following changes in the vial com posite, the FDA resumed all clinical studies evaluating lena capavir. More to come about this intriguing new HIV medi cation.

MODERNA HIV VACCINE

Since the massive success of the mRNA vaccine efforts with COVID-19, Moderna has been working on a vaccine for HIV-1 using this innovative new technology, including the lipid nanoparticle formulation to help with efficacy.7 This forthcoming innovation lends the idea of HIV vaccines being commonplace, and we could help prevent new HIV infections worldwide!

Role of the Pharmacist

Pharmacists are one of the most accessible healthcare pro viders that patients can depend on in every setting. Advocat ing for legislative changes promoting the pharmacist’s ability to test for HIV in a point-of-care setting and potentially pre scribing PrEP to interested patients by consulting pharmacists in the community would be a step in the right direction for the future of pharmacy.

Recognizing when patients are at high risk for HIV infec tion and taking the appropriate steps to help them reduce their risk is the biggest takeaway from this discussion. It is en couraged that all healthcare providers learn more about PrEP and its efficiency in preventing HIV infections and saving pa tient lives.

Author Bio

Shane Artiles is a fourth-year pharmacy student at the University of Florida College of Pharmacy on the Gainesville campus. He grew up in West Palm Beach, FL and stud ied chemistry and anthropology at the Uni versity of Florida during his undergraduate studies. LGBTQ+ healthcare has been a large passion of his, not only because he is a mem ber of this community, but due to the trials and tribulations that he has seen first-hand among friends that he made in this community. HIV is very prev alent in this community of patients and it is a very serious disease that we as healthcare professionals need to work together to prevent from spreading.

References

1. Apretude® (cabotegravir extended-release injectable suspension) package insert. Research Triangle Park, NC: GlaxoSmithKline. December 2021

2. Centers for Disease Control (CDC). Preexposure prophylaxis for the prevention of HIV infection in the United States–2017 update: a clinical practice guideline. www.cdc.gov/hiv/pdf/ risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Accessed August 21, 2022.

3. Centers for Disease Control and Prevention. (2022, June 1). On-demand prep. Centers for Disease Control and Prevention. Retrieved August 21, 2022, from https://www.cdc.gov/hiv/ basics/prep/on-demand-prep.html#:~:text=The%20type%20 of%20%E2%80%9Con%2Ddemand,hours%20after%20the%20 second%20dose.

4. Descovy (EMTRICITABINE 200 mg and tenofovir alafenamide

25 mg) package insert. Foster City, CA: Gilead Sciences, Inc. April 2016

5. FDA lifts clinical hold on investigational lenacapavir for the treatment and prevention of HIV. FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV. (2022, May 16). Retrieved August 21, 2022, from https://www.gilead.com/news-and-press/press-room/pressreleases/2022/5/fda-lifts-clinical-hold-on-investigationallenacapavir-for-the-treatment-and-prevention-of-hiv

6. Merck announces clinical holds on studies evaluating islatravir for the treatment and prevention of HIV-1 infection. Merck. com. (2021, December 13). Retrieved August 21, 2022, from https://www.merck.com/news/merck-announces-clinicalholds-on-studies-evaluating-islatravir-for-the-treatment-andprevention-of-hiv-1-infection/

7. Moderna launch clinical trial of mrna HIV vaccine. IAVI. (2022, May 18). Retrieved August 21, 2022, from https://www.iavi. org/news-resources/press-releases/2022/iavi-and-modernalaunch-first-in-africa-clinical-trial-of-mrna-hiv-vaccinedevelopment-program#:~:text=Recent%20findings%20 from%20the%20Phase,recipients%20(healthy%20U.S.%20 adults).

8. Nel, A., van Niekerk, N., Van Baelen, B., Malherbe, M., Mans, W., Carter, A., Steytler, J., van der Ryst, E., Craig, C., Louw, C., Gwetu, T., Mabude, Z., Kotze, P., Moraba, R., Tempelman, H., Gill, K., Kusemererwa, S., Bekker, L.-G., Devlin, B., & Rosenberg, Z. (2021). Safety, adherence, and HIV-1 seroconversion among women using the Dapivirine Vaginal Ring (Dream): An open-label, extension study. The Lancet HIV, 8(2). https://doi.org/10.1016/s2352-3018(20)30300-3

9. Patel PH, Zulfiqar H. Reverse Transcriptase Inhibitors. [Updated 2022 May 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https:// www.ncbi.nlm.nih.gov/books/NBK551504/

10. Ready, Set, PrEP. (n.d.). Retrieved August 21, 2022, from https://readysetprep.hiv.gov/

11. Truvada (emtricitabine and tenofovir disoproxil fumarate) package insert. Foster City, CA: Gilead Sciences, Inc. June 2013

12. Truvada prices, Coupons & savings tips - goodrx. (n.d.). Retrieved August 22, 2022, from https://www.goodrx.com/truvada

13. Vázquez, E. (2022, May 24). Virtual Croi 2022: The Dapivirine Ring vs. the FDA. Positively Aware. Retrieved August 21, 2022, from https://www.positivelyaware.com/articles/virtual-croi2022-dapivirine-ring-vs-fda

14. What every pharmacist should know about tenofovir alafenamide Pharmacy Times. (2016, October 5). Retrieved September 21, 2022, from https://www.pharmacytimes.com/view/whatevery-pharmacist-should-know-about-tenofovir-alafenamide