March 2020 Florida Pharmacy Today by Florida Pharmacy Today

The Official Publication Of The Florida Pharmacy Association MARCH 2020

(EVALI)uating

E-Cigarette or Vaping Product Use-Associated Lung Injury

florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 President's Viewpoint

7 Executive Insight

8 News & Notes

VOL. 83 | NO. 3 MARCH 2020 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

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(EVALI)uating E-Cigarette or Vaping Product Use-Associated Lung Injury COVID-19: Frequently Asked Questions from Health Care Professionals

Board of Pharmacy Passes Emergency Rules The Florida Board of Pharmacy added an emergency rule regarding the inspection requirements of consultant pharmacists in order to help with restricted access because of the COVID-19 pandemic. Passed March 19, the emergency rule addresses challenges with 64B16-28.501, 64B16-28.702(2) (b), (c) and (d); 64B16-28.850(16); and 64B16-28.870(3)(c) and (d). The emergency rule, 64B16ER20-21, adds section 5 to rule 64B16-28.501, which reads as follows: (5) Off-site consultant pharmacists of record shall not be required to perform inspections and on-site consultations at permitted institutional pharmacies as referenced in Rules 64B16-28.501 F.A.C., Rules 64B16-28.702 (2)(b), (c) and (d) F.A.C., Rules 64B16-28.850(16) F.A.C., and Rules 64B1628.870(3)(c) and (d) F.A.C., when the consultant pharmacist of record is not regularly present at the location. This rule shall in no way modify any obligations stemming from state or federal laws regarding drug regimen reviews. This emergency rule becomes active no later than March 20 and will be in effect for 90 days. The FPA is working closely with state and federal agencies and with the national association to battle COVID-19. There is a special page at www.floridapharmacy.org/page/COVID19 to help you keep informed on the latest developments.

MARCH 2020

Mission Statements:

FPA Calendar 2020

APRIL 8

Florida Board of Pharmacy Meeting Conference Call

Good Friday, FPA Office Closed

Memorial Day, FPA Office Closed

30:

FPA Leadership Retreat TBD JUNE

18-19 Mental Health Conference Webinar

2-3

Florida Board of Pharmacy Meeting Jacksonville, Florida

Last day to submit items of new business to the House of Delegates

House of Delegates registration deadline

Board of Pharmacy Rules Committee Conference Call MAY

Last day to submit resolutions to the House of Delegates

16 - 17 FPA CE Conference Jacksonville, Florida

JULY 3

FPA office closed

8-12

130th FPA Meeting and Convention Marco Island, Florida

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

Events calendar subject to change

CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE continuing education as part of the required 30 hours’ general education needed every license renewal period. There is a 2 hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists and pharmacy technicians must also complete a 1 hour Florida Board approved continuing education on human trafficking by Jan. 1, 2021. Pharmacists should have satisfied all continuing education requirements for this biennial period by Sept. 30, 2021, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec.31, 2020. For the Pharmacy Technician Certification Board application, exam information and study materials, please contact the FPA office. For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org CONTACTS FPA — Michael Jackson (850) 222-2400

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

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

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

Florida Pharmacy Today Board of Directors 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 KAHAN & ASSOCIATES................................. 13 PQC........................................................................ 9 PARTNERSHIP FOR SAFE MEDICINES......... 2 PHARMACISTS MUTUAL.............................. 24

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

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

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FLORIDA PHARMACY TODAY

EMAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com

The President’s Viewpoint DAVID "CHACHI" MACKERAY, RPH

t’s hard to believe that it’s already March and the annual Florida Pharmacy Association convention in Marco Island July 9-12 will be here in less than 100 days. It’s even harder to believe that it was almost a year ago that I was sworn into office as FPA president, as it seems like it was just last week that we all gathered in Ft. Lauderdale, having our usual fantastic time, catching up with old friends, making new friendships, seeing the excitement from first-time attendees (especially the students), and having serious and intense discussions during our House of Delegates as we passionately voiced our opinions on how to protect our beloved pharmacy profession. I must also mention and give thanks to all the excellent CE lectures presented by experts in their respective fields, which were greatly appreciated by those who attended. I can promise you even better choices of lectures and topics will be offered at this year’s convention. Another wonderful event that occurs annually at the convention, usually on Sunday morning, is the installation of officers. It truly has been important to me the past seven years as I was installed as on the FPA Board of Directors. Each year had its own special kind of meaning to me, from president, president-elect, speaker of the House of Delegates, speaker-elect or regional director, and each having its own excitement. I have had the honor and privilege of working with so many wonderful people that I couldn’t even begin to mention them all without taking up the entire journal. I thanked them all previously and so will thank them again now, and respectfully, even more times in the future. I am so blessed and fortunate for all that we accomplished, the

Who's Next? time spent working together and the experiences we shared, mostly good, but always making us better individuals, and advancing our profession forward. So, this leads me to the great unknown. Who’s turn is it next? Yes, a few positions are already known such as President-Elect Joe Scuro, and recently

We have plenty of different positions to fill, that I’m sure you will find something that matches your interests as well as your level of time commitment. I can promise you one thing for sure — a gratifying experience during your time volunteering at the FPA. elected President-Elect Dan Buffington. I have the utmost confidence in their leadership, knowledge and experience to advance the FPA. However, speaking from first-hand experience, they cannot do this alone. They need the participation from so many others, those who have the passion and desire to help the

David Mackeray, RPh

pharmacy profession, to dedicate their time and energy in protecting the future of pharmacy. New people with new ideas are especially needed or those with years of knowledge with some extra free time to give to FPA. We have plenty of different positions to fill, that I’m sure you will find something that matches your interests as well as your level of time commitment. I can promise you one thing for sure — a gratifying experience during your time volunteering at the FPA. I believe that everyone should be involved in one capacity or another, in not only being a member of either your local, state or national professional organization, but even in a more active role in some form or another. I also believe that higher levels of leadership and the time required isn’t possible for everyone, so find what works best for you and go for it. As I begin my transition period as outgoing president with incoming President-Elect Scuro, I plan to help make MARCH 2020

2019-2020 FPA Board of Directors The Florida Pharmacy Association gratefully acknowledges the hard work and dedication of the following members of the FPA leadership who work diligently all year long on behalf of our members.

Angela Garcia.....................................................................................................Board Chair David Mackarey..........................................................................................FPA President Kimberly Jones.......................................................................................... FPA Treasurer Joseph Scuro............................................................................................ President Elect Gary Koesten..............................................................................Speaker of the House Eric Larson.......................................................................Vice Speaker of the House Bill Kernan................................................................................................... FSHP President Preston McDonald............................................................................. Region 1 Director Neil Barnett............................................................................................Region 2 Director Larry Alaimo..........................................................................................Region 3 Director Cheryl Rouse.........................................................................................Region 4 Director James Alcorn.......................................................................................Region 5 Director Barbara Beadle...................................................................................Region 6 Director Paul Delisser.......................................................................................... Region 7 Director Carmen Gordon...................................................................................Region 8 Director Mitchell Levinson...............................................................................Region 9 Director Julie Burger.......................................................................................Technician Director

Florida Pharmacy Today Journal Board Chair.............................................................. Carol Motycka, motycka@cop.ufl.edu Vice Chair....................................................Cristina Medina, cmmedina@cvs.com Treasurer.........................................................Eric Jakab, ericjakab@hotmail.com Secretary............................................. Julie Burger, julieburger133@gmail.com Member.................................................. Michael Finnick, michaelfinnick@ufl.edu Member.....................................................David Mackarey, dmackarey@aol.com Member.......................................................Matt Schneller, schnem18@gmail.com Member..........................................Teresa Tomerlin, teresapharmd@cfl.rr.com Member............................................Greta Pelegrin, gretapelegrin@yahoo.com Technician Member........................Julie Burger, julieburger133@gmail.com Executive Editor................Michael Jackson, mjackson@pharmview.com Managing Editor...................Dave Fiore, dave@fiorecommunications.com Journal Reviewer....................... Dr. Melissa Ruble, mruble@health.usf.edu Journal Reviewer....................................Dr. Angela Hill, ahill2@health.usf.edu

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FLORIDA PHARMACY TODAY

this time as easy and painless as possible, and share with him my recommendations and suggestions to help him make the best decisions for the FPA.I ask those of you reading this article, if you or someone you know is interested or would be a good choice to join our new team, please reach out to myself, any other board member, any FPA member or even just contact the FPA office directly.

I ask those of you reading this article, if you or someone you know is interested or would be a good choice to join our new team, please reach out to myself, any other board member, any FPA member or even just contact the FPA office directly.

If I even just sparked a tiny little interest and you would like some more information, or share with someone, please go to our wonderful new website, floridapharmacy.org, to explore all the many opportunities that are available to everyone, especially students. Yes students, who are the future of our profession, who need to become involved in the direction and protection of the future of pharmacy. I know that academics are your priority now, as it should be, but participation in your professional association is just as important to your future, so any time offered, you will get back back ten-fold. Take care, stay well and I look forward to seeing everyone in Marco Island in July at the annual FPA convention. n

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

FPA Out Front in the Media

s we go to press with this issue of Florida Pharmacy Today, we are pleased to report to the members an extremely successful outreach campaign. Over the years, we struggled to get our message on the top of public policy makers’ inbox. The year 2020 found us in new and exciting territory with a funded study on predatory pharmacy benefits manager practices. We also received a special grant from the National Alliance of State Pharmacy Associations, of which the FPA is a member. Rewinding to the beginning of the session, we armed ourselves with a comprehensive analysis of the Medicaid prescription drug program by the Ohio company, 3Axis Advisors. Their analysis of more than 350 million Medicaid claims as reported in last month’s issue of Florida Pharmacy Today (See “Turning the Light on PBMs”) exposed some troubling trends in the pharmacy market place. We had this blockbuster report, but no mechanism to let the world know about it. FPA’s public relations information budget is very limited with few resources to help us perform well in this area. With the grant from NASPA, we were able to enter into a contract with one of the nation’s premier public relations firms and initiated a massive campaign in social media, the press, television and radio broadcast shows. This effort was instrumental in triggering favorable conversations within the Florida House and Senate. We are convinced that this campaign — along with several visits to the office of the Florida Attorney General by FPA advocates — was instrumental in getting our state added to the list of 38 other states supporting the Supreme Court case involving the state of Arkansas and PCMA.

Here is just a small sampling of the media outreach and the article subject matter that we were involved with in addition to our standard messaging to our members:

With the grant from NASPA, we were able to enter into a contract with one of the nation’s premier public relations firms and initiated a massive campaign in social media, the press, television and radio broadcast shows.

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The Capitolist: Study finds millions in Medicaid unfairly pocketed by pharmacy benefit managers. POLITICO Florida: Pharmacy lobby releases PBM report during legislative fight. News Service of Florida: Pharmacists say they take hit in Medicaid. Florida Politics: Pharmacists say they take hit in Medicaid. WUSF News: Pharmacists Say They Take Hit In Medicaid. News Break: Pharmacists say they take hit in Medicaid. STAT News: PBMs favor their own pharmacies in the Florida Medicaid program. Takeaways from Tallahassee (Florida Politics): PBMs pocket savings. Florida Channel: PBMs to blame for rising prescription drug costs (21:00). Capital Soup: New study highlights

Michael Jackson, B.Pharm

predatory practices by pharmacy benefit managers that drive up costs for patients, taxpayers. A full report has been provided to the FPA Board of Directors, including some amazing metrics on the effectiveness of our public relations campaign. It is clear that we need to find a way to sustain campaigns like this without raising member dues or doing member assessments. Grants cannot always be relied upon as a source of revenue. We see the opportunity for member growth as the fuel to sustain efforts like this. With less than 10 percent of Florida’s licensed pharmacists holding FPA membership, we have a wonderful opportunity ahead of us to sustain future campaigns. We can continue to make pharmacy issues an important topic of discussion on Florida’s Capitol Hill. All it takes is for each of us to convince our colleagues to join and be involved.

MARCH 2020 |

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

FPA News & Notes

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

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

FLORIDA PHARMACY TODAY BOARD Chair............................... Carol Motycka, St. Augustine Vice Chair.........................Cristina Medina, Hollywood Treasurer.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member.............David Mackarey, Boynton Beach Member....................................... Matt Schneller, Tampa Member............................Teresa Tomerlin, Rockledge Member...................................... Greta Pelegrin, Hialeah Technician Member..........Julie Burger, Pensacola Executive Editor.......Michael Jackson, Tallahassee Managing Editor...................Dave Fiore, Tallahassee Journal Reviewer........................... Dr. Melissa Ruble Journal Reviewer....................................Dr. Angela Hill This is a peer-reviewed publication. ©2020 FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. FLORIDA PHARMACY ASSOCIATION

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

Test and Treat Signed into Law House Bill 389, which allowed pharmacists to test and treat patients for illnesses such as influenza and streptococcus, was debated by the Senate, House and then signed into law by Gov. Ron DeSantis. The bill: ■ Adds pharmacists working under a protocol to the list of health care providers under F.S. 381.0031 who must report discovery of the existence of a disease of public health importance to the state Department of Health. ■ Adds to the definition of the practice of pharmacy the ability to initiate, modify or discontinue drug therapy as part of a collaborative practice agreement for patients with chronic illnesses. ■ Allows pharmacists within a collaborative practice to test or screen for and treat certain nonchronic health conditions. ■ Includes the testing and treating of conditions such as lice, skin conditions and minor uncomplicated infections to the original language in the bill that allowed for testing and treating of the flu and strep, if done under a protocol. Pharmacists must complete education, training and other requirements before performing these functions. The new law takes effect July 1. Consultant Pharmacists Get More Authority Another new law signed by Gov. Ron DeSantis gives consultant pharmacists working in licensed facilities more authority. F.S. 465.0125 will allow consultant pharmacists to: ■ Provide medication management services in licensed facilities under a collaborative agreement. ■ Order and evaluate laboratory tests beyond just nursing homes and licensed home health agencies, which now includes ambulatory surgery centers, hospitals, chemical dependency centers, licensed hospices or a licensed continuing care facility. ■ Administer medicinal drugs. ■ Modify or discontinue medications under a patient-specific order or preapproved protocol. ■ Conduct patient assessments. Look for a full legislative report in next month's Florida Pharmacy Today.

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Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION MARCH 2020

(EVALI)uating E-Cigarette or Vaping Product Use-Associated Lung Injury Carol Motycka, Pharm.D., Melissa Catalano, Pharm.D. Candidate 2020, and Kathryn Kettler, Pharm.D. Candidate 2020

Carol Motycka, Pharm.D.

Kathryn Kettler, Pharm.D. candidate

Melissa Catalano, Pharm.D. candidate

The first electronic cigarette development dates back to 1930 when a patent was approved for Joseph Robinson’s design. While Robinson’s product was never commercialized, Phil Ray and Norman Jacobson successfully introduced a type of electronic cigarette (e-cigarette) to the market in 1979. Ray’s and Jacobson’s product was not technically electronic, but it did contribute to the adoption of the term “vape.” The 1990s brought another wave of activity for nicotine inhaler devices. Since the FDA did not regulate tobacco products at the time, but rather regulated delivery systems, the 10

FLORIDA PHARMACY TODAY

device requested for marketing was denied by the FDA. The FDA deemed the device unapproved and the e-cigarette frenzy soon died again. However, the devices returned in 2006 when electronic cigarettes were successfully introduced to the United States. Within two years, the World Health Organization deemed e-cigarettes an unsuccessful smoking cessation aid and demanded any markets to remove any claims that the WHO supports the safe and effective use of e-cigarettes as such. Over the next few years, the debate regarding nicotine concentrations, added toxic chemicals and the overall safety of e-cigarettes continued. Tobacco use is the single largest preventable cause of death and disease in the United States, with more than 480,000 people dying prematurely from diseases caused by smoking and exposure. The United States spends nearly $170 billion per year for direct medical care and more than $156 billion in lost productivity, ultimately spending more than $300 billion per year on smoking-related illnesses. Consequently, in 2009, the FDA was authorized to oversee the manufacturing, marketing, distribution, and sale of tobacco products when the Federal Food, Drug, and Cosmetic Act was amended. This effec-

The FDA issued a “deeming rule” to further regulate tobacco products. ■

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Registering domestic establishments and submitting lists of products manufactured at those establishments, including all labeling and representative samples of advertisements. Submitting tobacco health documents. Submitting ingredient listings. Marketing new tobacco products only after FDA review. Marketing products with direct or implied claims of reduced risk only if FDA confirms that scientific evidence supports the claim and determines that providing a marketing authorization for the product will benefit the health of the population as a whole. Minimum age restriction and identification requirement to prevent sales to underage youth. Requirements to bear certain health warnings on packages and advertisements (including certain ENDS components, such as e-liquids) such as, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Prohibition of vending machine sales, unless in a facility that never admits youth.

When the deeming rule took effect in August 2016, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, cigarette tobacco and roll-yourown tobacco since 2009, as well as several new requirements specific to deemed products, became applicable to makers of e-cigarettes and other ENDS products.

tively gave the FDA the tools necessary to protect the public from harmful effects of tobacco through science-based product regulation. In 2016, the FDA issued a “deeming rule” to further regulate tobacco products. This ruling deemed additional products meeting the statutory definition of “tobacco product” to be subject to the FDA’s regulatory authority. These additional products included electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, nicotine gels, waterpipe tobacco (hookah) and any future tobacco products, but excluded accessories. Later, in July 2017, the FDA released a comprehensive plan that would serve as a multiyear roadmap for tobacco and nicotine regulation, with the ultimate goal of significantly reducing tobacco-related death and disease. The purpose of this comprehensive plan was to make combustible tobacco products less toxic, less appealing and less addictive. In July 2019, the court ordered applications deemed new tobacco products (e-cigarettes, cigars, pipe tobacco and hookah to-

bacco) on the market prior to August 2016 must be filed with the FDA no later than May 12, 2020. For a tobacco product to be legally marketed, it would need to undergo FDA scientific review and be found to have marketing appropriate for the protection of the public health. Alternatively, an ENDS product marketed for therapeutic purposes as a drug would need to be reviewed under FDA’s drug authorities and approved for such marketing. As such, no ENDS product is on the market legally in the U.S. since no products have been FDA-authorized or FDA-approved. Moreover, the FDA has taken aggressive actions against the increasing use of ENDS products by minors. Much of this is attributed to additional reports which continued to show the very rapid increases in use of e-cigarettes by adolescents. The 2018 data from the National Youth Tobacco Survey discovered that between 2017 and 2018, e-cigarette use by high schoolers increased 78 percent, from 11.7 percent to 20.8 percent. During the same period, use among middle schoolers increased by 48 percent, from 3.3 percent to 4.9 percent. The numbers are thought to potentially be much higher given the fact that often adolescents underreport with these types of surveys. Additionally, evidence shows that youth are especially attracted to flavored ENDS products. In September 2019, the Trump administration announced a plan to remove flavored e-cigarette products from all stores. The FDA then prioritized enforcement actions requiring products to exit the market unless manufacturers meet their burden under the Tobacco Control Act to show scientific evidence demonstrating marketing is appropriate for the protection of public health. Most recently, on Jan. 2, the FDA announced a compromise between the Trump administration and small businesses with a plan to ban all sweet and fruit-flavored pods from e-cigarette cartridges, though the ban would not apply to the tank systems commonly found in vape shops. Acute lung injuries due to vaping have brought to light some of the potential dangers of vaping, but it is important to also note the many concerns regarding both use and accidental exposures in children and adolescents. The National Institute of Drug Abuse published a Monitoring the Future report in December 2019 in which 8th, 10th, and 12th graders

TOBACCO USE IS THE SINGLE LARGEST PREVENTABLE CAUSE OF DEATH AND DISEASE IN THE UNITED STATES, WITH MORE THAN 480,000 PEOPLE DYING PREMATURELY FROM DISEASES CAUSED BY SMOKING AND EXPOSURE. MARCH 2020 |

reported past-year and past-month use of certain substances. NIDA found the second largest one-year jump in reported substance use among 12th graders reporting past-month use of vaping marijuana, which was reported at 14.0 percent in 2019 up from 7.5 percent in 2018. This 2019 report also showed that 20.8 percent of 12th graders, 19.4 percent of 10th graders, and 7.0 percent of 8th graders reported vaping marijuana within the past year. For the first time, the MTF report displayed data on daily vaping use and it was found that 3.5 percent, 3.0 percent and 0.8 percent of 12th, 10th, and eighth graders respectively reported daily marijuana vaping. The 2019 MTF report on nicotine vaping showed climbing results as well. In the report, 25 percent, 20 percent, and 9 percent of 12th, 10th, and 8th graders, respectively, reported nicotine vaping in the past-month survey making it difficult to ignore the public health crisis unfolding among teens. Another entity, the Action on Smoking and Health , published data highlighting the rise in 11- to 18-year-olds in Great Britain trying e-cigarettes for the first time without having smoked a cigarette in the past. Those adolescents that had never tried a cigarette before their first use of an e-cigarette rose from 18 percent to 29 percent between 2014 and 2016, while those that tried a cigarette first, dropped from 70 percent to 57 percent. Furthermore, the American Association of Poison Control Centers reported data from the 55 poison control centers in the United States showing a marked increase in e-cigarette and liquid nicotine cases reported. A total of 3,139 vapingrelated calls were documented in 2018, while vaping-related calls to the poison control centers reached an all-time high of 5,328 in 2019. The recent spike in acute lung injuries, known as e-cigarette or vaping product use-associated lung injury (EVALI), has led to wide media coverage and concern for e-cigarette use. Understanding the potential causes and issues surrounding these injuries has been a top concern among health practitioners. Various signs and symptoms have been reported with e-cigarette use, which has led to the increased interest in the subject. Signs and symptoms of electronic cigarette use appear to include cough, phlegm, chronic bronchitis and

THE UNITED STATES SPENDS NEARLY $170 BILLION PER YEAR FOR DIRECT MEDICAL CARE AND MORE THAN $156 BILLION IN LOST PRODUCTIVITY, ULTIMATELY SPENDING MORE THAN $300 BILLION PER YEAR ON SMOKINGRELATED ILLNESSES. 12

FLORIDA PHARMACY TODAY

pulmonary toxicity. One study in particular investigated the association between self-reported e-cigarette use and chronic bronchitic symptoms including chronic phlegm, bronchitis or wheezing in adolescents and found that symptoms were associated with both past and current e-cigarette use. The study also found a positive correlation between the number of days of e-cigarette use in the previous 30 days and severity of symptoms. Another study that looked at 12 cases treated for suspected EVALI found that patients reported with dyspnea, fever and emesis (83 percent), cough (75 percent), and required admission to the ICU for hypoxemic respiratory failure (67 percent).11 Most patients seemed to improve within one to two weeks of initial presentation after vaping cessation and treatment with corticosteroids. Although suspected signs and symptoms for EVALI have been identified, the exact cause continues to be debated. Finding the culprit for the abundance of acute lung injuries being seen in e-cigarette users is being widely studied. Vitamin E seems to be a common denominator in many EVALI cases, however it cannot be deemed solely responsible until further studies are conducted and vitamin E is isolated as the toxic substance at fault. The New England Journal of Medicine published a study by Blount and colleagues on the chemical contents of bronchoalveolar lavage fluid in 25 patients with EVALI, 26 patients with probable EVALI, and 99 healthy participants. Vitamin E was found in the BAL fluid of 48 of the 51 patients (94 percent) with suspected or diagnosed EVALI.

Of the three patients without detectable vitamin E, an assignment of probable EVALI was made by their respective health departments. Limonene and coconut oil were also found in the samples, however, their toxicological effect is still not clear. Of the 99 healthy participants, 18 of which were e-cigarette users, vitamin E was not found in any of the BAL fluid collections. In addition to vitamin E findings, tetrahydrocannabinol (THC) or its metabolites were also found in the BAL of 47 of 50 cases for which laboratory data was available. This poses uncertainty surrounding vitamin E, THC, or the synergy of the two having a causal relationship with EVALI cases. While vitamin E has been associated with EVALI cases, other additive products may contribute to the development of EVALI. Furthermore, heating certain additives can alter the original chemical structure to something more harmful when inhaled. So while the FDA may find certain additives to be relatively safe, the way in which these chemicals are being used within the e-cigarette system may transform these additives into harmful substances. For example, heating propylene glycol can result in a final inhaled product of formaldehyde, a known carcinogen and respiratory irritant. For patients experiencing symptoms of respiratory illness and concurrently using e-cigarette or vaping products, it is advised that outpatient management of EVALI may be reasonable if no respiratory distress is present and is oxygen saturation on room air exceeds 94 percent. The CDC published interim guidelines in November 2019 on the treatment

of EVALI. In these guidelines, case reports have suggested the potential for corticosteroids to be warranted due to its effects on the inflammation process in EVALI. In one study, 46 patients from Illinois and Wisconsin were given glucocorticoids and 65 percent had noted respiratory improvement. Of the 140 cases reported to the CDC, 82 percent had improved respiratory status after corticosteroid treatment. Although corticosteroids look promising for the treatment of EVALI, outpatient management with corticosteroids has not been adequately studied. The addition of antimicrobial and antiviral therapy may be warranted based on individual guideline recommended therapy. Assessment for pulmonary infections is advised as EVALI can occur along with other respiratory illnesses. Follow-up x-rays and pulse-oximetry are also recommended within one to two weeks post-treatment for EVALI. In conclusion, the debate regarding e-cigarette use as a healthier alternative to smoking cigarettes is ongoing, though data disputing this thought is now being more widely accepted. Additionally, the growing concern for e-cigarette or vaping acute lung injury is causing public concern to the dangers associated with the use of e-cigarettes or vaping products. It is important for health care providers to keep up with the data surrounding the causes and treatment for these cases of EVALI and to update the public on the emerging data.

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MARCH 2020

COVID-19: Frequently Asked Questions from Health Care Professionals Source: Centers for Disease Control and Prevention

What are the clinical features of COVID-19? The clinical spectrum of COVID-19 ranges from mild disease with nonspecific signs and symptoms of acute respiratory illness to severe pneumonia with respiratory failure and septic shock. There have also been reports of asymptomatic infection with COVID-19. Who is at risk for COVID-19? Those at greatest risk of infection are people who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19 and those who live in or have recently been to areas with sustained transmission. Who is at risk for severe disease with COVID-19? With the data available now, the CDC is unable to identify risk factors for severe clinical outcomes. What we know from other coronaviruses such as SARS and MERS, it is possible that older adults and people with underlying chronic medical conditions, such as immunocompromising conditions, may be at risk for more severe outcomes. When is someone infectious? The onset and duration of viral shedding and period of infectiousness for COVID-19 are not yet known. It is possible that RNA from SARS-CoV-2, the virus that causes COVID-19, may be detectable in the upper and lower respiratory tract for weeks after illness onset, similar to infection with MERS and SARS. However, detection of viral RNA does not necessarily mean that infections virus is present. Asymptomatic infection with SARS-CoV-2 has been reported, but it is not yet known what role asymptomatic infection plays in transmission. Similarly, the role of pre-symptomatic transmission, or infection detection during the incubation period prior to illness onset, is unknown. Existing literature from SARS-CoV-2 and other coronaviruses suggest that the incubation period may range from 2-14 days. Which body fluids can spread infection? Data is limited, but SARS-CoV-2 RNA has been detected in upper and lower respiratory tract specimens and SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid. SARS-CoV-2 has been detected in blood and stool specimens, but whether infectious virus is present in extrapulmonary specimens is unknown. The duration of SARS-CoV-2 RNA detection in upper and lower respiratory tract specimens and in extrapulmonary specimens 14

FLORIDA PHARMACY TODAY

is not yet known, but may be several weeks or longer. While viable, infections SARS-CoV has been isolated from respiratory, blood, urine and stool specimens. In contrast, viable infectious MERS-CoV has only been isolated from respiratory tract specimens. It is not yet known whether other non-respiratory fluids from an infected person â&#x20AC;&#x201C; including vomit, urine, breast milk or semen can contain viable, infectious SARSCoV-2. Can people who recover from COVID-19 be infected again? The immune response to COVID-19 is not yet understood. Patients with MERS are unlikely to be re-infected shortly after they recover, but it is not yet known whether similar immune protection will be observed for patients with COVID-19. How should health care personnel protect themselves when evaluating a patient who may have COVID-19? Although the transmission dynamics have yet to be determined, the CDC recommends a cautious approach to people under investigation for COVID-19. Health care personnel evaluating people under investigation or providing care for patients with confirmed COVID-19 should use standard transmission-based precautions. Are pregnant health care personnel at increased risk for adverse outcomes if they care for patients with COVID-19? Pregnant health care personnel should follow risk assessment and infection control guidelines for health care personnel exposed to patients with suspected or confirmed COVID-19. Adherence to recommended infection prevention and control practices is an important part of protecting all health care personnel in health care settings. Information on COVID-19 in pregnancy is very limited; facilities may want to consider limiting exposure of pregnant health care personnel to patients with confirmed or suspected COVID-19, especially during higher risk procedures, such as aerosol-generating procedures, if feasible based on staffing availability. Should any diagnostic or therapeutic interventions be withheld due to concerns about transmission of COVID-19? Patients should receive any interventions they would normally receive as a standard of care. Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed.

How is COVID-19 treated? Not all patients will require medical supportive care. Clinical management for hospitalized patients with COVID-19 focused on supportive care of complications, including advanced organ support for respiratory failure, septic shock and multi-organ failure. Empiric testing and treatment for other viral or bacterial etiologies may be warranted. Corticosteriods are not routinely recommended for viral pneumonia or ARDS and should be avoided unless they are indicated for another reason. As of press time, there were no antiviral drugs licensed by the FDA to treat COVID-19. Some in-vitro or in-vivo studies suggest potential therapeutic activity of some agents against related coronaviruses, but there are no available data from observational studies or randomized controlled trials in humans to support recommending any investigational therapeutics for patients with confirmed or suspected COVID-19. Remdesivir, an investigational antiviral drug, was reported to have in-vitro activity against COVID-19. A small number of patients with COVID-19 have received intravenous remdesivir for compassionate use outside of a clinical trial setting. Also, a randomized open label trial of combination lopinavir-ritonavir treatment has been also conducted in patients with COVID-19 in China, but no results are available as of press time. Who should health care providers notify if they suspect a patient has COVID-19? Health care providers should consult with local or state health departments to determine whether patients meet criteria for a person under investigation. Providers should immediately notify infection control personnel at their facility if they suspect COVID-19 in a patient. Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital? Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants in-patient clinical management for supportive medical care should be admitted under appropriate isolation precautions. Some patients with an initial mild clinical presentation may worsen in the second week of illness. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis. This decision will depend not only on the clinical presentation, but also on the patientâ&#x20AC;&#x2122;s ability to engage in monitoring, the ability for safe isolation at home, and the risk of transmission in the patientâ&#x20AC;&#x2122;s home environment.

Will existing respiratory virus panels, such as those manufactured by Biofire or Genmark, detect SARS-CoV-2? No. These multi-pathogen molecular assays can detect a number of human respiratory viruses, including other coronaviruses that can cause acute respiratory illness, but they do not detect COVID-19. MARCH 2020

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CALL FOR ABSTRACTS FOR POSTER PRESENTATIONS FLORIDA PHARMACY ASSOCIATION 130th ANNUAL MEETING AND CONVENTION

July 8-12, 2020 JW Marriott Beach Resort ♦ Marco Island, Florida Poster Session: Friday, July 10, 2020 ♦ 11:00AM-1:00PM COST $ONE COST: ONE DAY DAY REGISTRATION REGISTRATION The FPA Poster Presentations are open to PHARMACISTS, RESIDENTS, STUDENTS, AND TECHNICIANS. Complete and submit this COVERSHEET for each abstract submission. Submissions must be received no later than Friday, May 1, 2020. Abstracts will NOT be accepted after this date. Mail or E-mail this application along with the abstract submission to:

PLEASE TYPE

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

Contact Information: Presenter's Name: _______________________________________________________________________________

□ Pharmacist □ Resident

□Student

□ Technician

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

□Clinical Research □Basic Science Research □Translational Research (Basic Science and Clinical Research)

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

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

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

Please direct all questions and concerns to: Tian Merren Owens ♦ (850) 222-2400 ext. 120 ♦ tmerren@pharmview.com DEADLINE DATE: FRIDAY, MAY 1, 2020 MARCH 2020

CALL FOR RESOLUTIONS TO THE 2020 HOUSE OF DELEGATES The House of Delegates Board of Directors will meet in May 2020 to review and approve resolutions for the Annual Meeting. The deadline for submitting resolutions is May 8, 2020! PLEASE NOTE THIS DEADLINE. The last day to submit items of new business is June 5, 2020. The following information will be needed when submitting resolutions: 1. Name of organization: The name of the organization submitting the resolutions(s); 2. Name and telephone number of individuals: A contact in the event clarification or further information is needed; 3. Problem: A statement of the problem addressed by the resolution; 4. Intent: A statement of what passage of the resolution will accomplish; 5. Resolution Format: Please type and use double spacing. TITLE OF RESOLUTION NAME OF ORGANIZATION WHEREAS , AND

WHEREAS :

THEREFORE BE IT RESOLVED (THAT THE FPA OR SUBDIVISION OF FPA)

CONTACT NAME AND PHONE #: PROBLEM: INTENT:

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

FLORIDA PHARMACY TODAY

HELP SUPPORT THE ADOPT-A-STUDENT PROGRAM Florida Pharmacy Association (FPA) 130th Annual Meeting & Convention July 8-12, 2020 JW Marriott Resort – Marco Island, Florida

Again this year, students from Florida Colleges of Pharmacy will be “Adopted” for the FPA Annual Meeting and Convention. Pharmacy students will benefit from the interaction with practicing pharmacists, learn first hand how FPA actually operates and how they can become involved in their chosen profession. As you remember, college students are on a tight budget and most of them cannot afford to attend convention. Here is how you can help! Be a Bronze, Silver or Gold Sponsor! The donation amounts are Bronze ($150), Silver ($250), and Gold ($500) Level Mentor Sponsors and will help offset the costs of the AAS program. You also have the option to give any amount you prefer. The FPA offer Adopted students complimentary registration, which includes admission to the AAS Mentor Social, Exhibit Hall and Student Awards Event. FPA’s programs and services are keys to our success in advocating for our profession, supporting our pharmacy students and promoting quality patient care services. Thank you for giving back to your profession. Make a contribution yourself, ask your local unit association or get together with friends to Adopt-A-Student. Remember…..these are the future leaders of pharmacy! Mentor Program. Each of the adopted students will be assigned a pharmacist who may invite them to attend meetings, CE programs, and share their knowledge and pharmacy experience with them. If you plan to attend the convention and would like to be a mentor, please contact the FPA office. Please donate online at the Foundation’s website, www.flpharmfound.org, or complete the form below and fax or mail with your check to: Florida Pharmacy Foundation PO BOX 266977 Weston, FL 33326 Please make your check payable to the Florida Pharmacy Foundation Sponsor Name: _________________________________________________________________________ Address: ______________________________________________________________________________ City: _______________________________________ State: __________ Zip: _______________________ Phone: ____________________________________ Amount of Contribution: _______________________ Charge to the following:

* AMEX

* DISCOVER

* MASTERCARD

* VISA

Account #:_____________________________________Security Code: ________ Exp. Date: __________ Signature: _____________________________________________________________________________ o Yes, I would like to serve as a Mentor. o Contact me with more information on Mentoring. Contributions to the Florida Pharmacy Foundation are tax deductible as a charitable contribution for federal income tax purposes. Consult your CPA for complete details.

MARCH 2020

OTE CTING

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130th Annual Meeting and Convention

July 8 – 12, 2020 JW Marriott Resort Marco Island, FL

FLORIDA PHARMACY TODAY

Keynote Speaker Christopher Jerry lost his beautiful two-year-old daughter, Emily, after a fatal medication error in March of 2006. After the tragic loss, he created the Emily Jerry Foundation to increase awareness of key patient safety related issues associated with preventable medical error, which by recent estimates, have been identified as being the third leading cause of death in the United States. Over the past decade, Mr. Jerry has had the privilege of collaborating with many of the experts in the various modalities in medicine, to focus on the modification of underlying core systems, processes, and protocols, to help keep patients safe and assure the best possible outcome for each and every patient. In doing so, he has worked tirelessly with some of the brightest minds in healthcare, to identify technology and best practices, that are proven to minimize the inherent “human error component” associated with patient care in the clinical setting. Through what Mr. Jerry considers his life’s work, his primary objective going forward, will always be to help stop tragedies BEFORE they happen…ultimately saving as many lives as possible from preventable medical error. He is a relentless patient safety and clinician advocate who spreads a message of hope, forgiveness, compassion, and collaboration, by turning an unimaginable tragedy, into inspiring positive change, globally in healthcare, in honor of his daughter Emily.

Accommodations

ROOM RATES: $229 plus tax based on single/double occupancy. The room reservation deadline is Friday, June 19, 2020 or when room block is full. Thereafter, reservations may be taken on a space available or rate available basis. There is an optional resort fee. Self-parking is discounted $10 per day. Please be sure to ask for the Florida Pharmacy Association group rate. All reservations must be accompanied by a first night room deposit or guaranteed with a major credit card. The check-in time is 4:00pm and the checkout time is 11:00 am. Room reservations can be made by calling (800) 438-4373 or (239) 394-2511.

LE PEOP E AT N O I “P A S S

The general education track will offer courses designed to educate pharmacists on a wide variety of important topics pertaining to the profession of pharmacy practice. Specific required Florida Board Approved courses being offered are Reducing Medication Errors, HIV/AIDS, Human Trafficking, Validation of Controlled Substances and the Ordering and Evaluating Laboratory Tests. There will also be courses on Pharmacy Burnout and Resiliency, Vaccines & Myth Busters, and Legislative Update!

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MARCH 2020

Consultant Education Track FRIDAY - SATURDAY

The consultant education track will provide pharmacists with the most current information available on various topics that pharmacists encounter in the profession of pharmacy. The consultant track will focus on Nutrition, Autoimmune Disorders and and Specialty Pharmacy. The specific topics being offered include Vitamins and Herbals, Arthritis, Multiple Sclerosis, Pain Management, Marijuana and Hemp, Oncology and Pharmacogenomics. There are 12 hours available for consultant pharmacists.

Student and Technician Track THURSDAY - SUNDAY

Students and Technicians will benefit from interacting with practicing pharmacists and attending student and technician focused continuing education programs. The technician track offers several hours of continuing education on Medication Safety, Roles for Technicians, and the required courses for Florida registration and PTCB renewal: Medication Errors, HIV/AIDS, and Law. The student track consists of several hours of fun and exciting continuing education, such as The Career Forum, the NASPA/NMA Game Show and a Leadership Course. Students will also have an opportunity to participate in the Patient Counseling Competition and showcase their Poster Presentations.

Special Events FPPC RECEPTION: Attend this reception to support your Political Action Committee. HOUSE OF DELEGATES: Be a delegate or observer and see how important member participation is to the direction of the Association. PRESIDENT’S 250 CLUB: Contribute to the president’s club and be invited to a private reception. EXHIBITS: Participate in the grand opening reception in the exhibit hall! Visit with exhibitors, introduce yourself, shake their hands, tell them you appreciate them and invite them back next year! The exhibitors are a very important part of FPA’s convention. Companies send their representatives to educate you about their products and services at great expense. Please show them your appreciation! POSTER PRESENTATIONS: Browse submissions from all pharmacy professionals. Contact the FPA office for more information if you would like to submit a poster presentation. RECEPTIONS: Enjoy catching up with your colleagues as the Universities entertain their alumni and friends followed by a night of Karaoke Fun! STUDENT EVENTS: Participate in the Adopt-A-Student Mentor Social. Students will benefit from interacting with practicing pharmacists, attending student focused continuing education programs and learning firsthand about the FPA and how involvement can improve their chosen profession. Call the FPA office and offer to mentor or sponsor a student. FUN RUN WALK: Exercise is good for the soul. Incorporate health and fitness while at the FPA convention. Please register early to reserve your space. AWARDS EVENT: Honor outstanding practitioners during the awards presentation. INSTALLATION OF OFFICERS: Attend the installation of NEW officers on Sunday morning!

For More Information Call (850) 222-2400. 22

FLORIDA PHARMACY TODAY

FPA 130th Annual Meeting and Convention July 8-12, 2020 Marco Island, FL

55Daily Education Registration

Participant Information Participant Information

Daily registration does not include admittance to functions or handbooks. Handouts will be posted on our website July 6.

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

Before

June 19

Full Package Registration

2FPA Member

Before June 19

Onsite

Amount_

$430

$_______

$345

Amount

FPA Member

$165

$185

$_______

Non Member

$215

$235

$_______

Member Technician

$65

$85

$_______

Non Member Technician

$90

$110

$_______

Handbooks

$40

$_______

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

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

Onsite

Friday

Saturday

Sunday

Additional Tickets

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

Price

Amount

Exhibit Hall

$30

$______

Awards Event

$80

$______

Non Member

$525

$610

$_______

Pharmacist BEST Value

$540

$625

$_______

Member Technician

$155

$185

$_______

Non Member Technician

$175

$210

$_______

Technician BEST Value

$185

$220

$_______

$150

$170

$_______

Poster Presenter

$40

$_______

(Registration fee is based upon membership and professional status for Non-convention registrants.)

3Student

Handbooks

(BEST Value includes Registration & Membership)

House of Delegates (Thursday)



FPPC Reception (Thursday)



Exhibit Hall (Friday and/or Saturday)



Awards Event (Saturday)



Christian Fellowship (Sunday)



I will not attend any of these functions.

House of Delegates

House of Delegates (Non-convention registrants)

Quantity

_______

Amount $______

$50

$______

FPA Polo Shirt (Deadline is June 5) Quantity Price 

Price

One Day Registration

Student Awards Event

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



Special Events Registration

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

Yes

______

Payment

$35

M/F ______

Size ______

Amount $_______

Total Enclosed: $______

Check (To: FPA) AMEX Discover MasterCard Visa Account # ____________________________________________ Security Code _________________ Expiration Date __________

Before June 11

Amount

$165

______

Billing Address ________________________________________ Signature ____________________________________________

Four Ways to Register

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

Schedule and Fee Subject to Change

MARCH 2020

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