Florida Pharmacy Today April 2020

The Official Publication Of The Florida Pharmacy Association APRIL 2020

COVID-19 MEDICATIONS

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

WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization.

Our Pharmacy Quality Commitment (PQC) program: • • • •

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

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

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

7 Executive Insight

13 News & Notes

VOL. 83 | NO. 4 APRIL 2020 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

14 15 20 22 25

Open Letter to Gov. DeSantis

COVID-19 Medications

New Leave Provisions Under The Families First Coronavirus Response Act As the Future of Pharmacy Marches On, Pharmacists Must Embrace IT’s Intelligence Risk Management Alert: Drug Shortages

APRIL 2020

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Mission Statements:

FPA Calendar 2020

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APRIL 20

Last day for Region 6 Runoff Election

30

Board of Pharmacy Rules Committee Conference Call MAY

8

Last day to submit resolutions to the House of Delegates

13

House of Delegates Board of Directors Virtual Meeting

16 - 17 FPA CE Conference Jacksonville, Florida 19

NASPA Virtual Leadership Retreat

25

Memorial Day, FPA Office Closed

FPA Leadership Retreat Virtual retreat JUNE

2-3

Florida Board of Pharmacy Meeting Jacksonville

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

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House of Delegates registration deadline JULY

3

Independence Day 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 two-hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists and pharmacy technicians must also complete a one-hour Florida Board approved continuing education on human trafficking

by Jan. 1, 2021.

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

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

For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org CONTACTS 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 EPIC..................................................................... 12 KAHAN & ASSOCIATES................................. 12 PQC........................................................................ 2 PHARMACISTS MUTUAL.............................. 32

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

I

Pharmacy and the COVID-19 Connection

had every intention of writing this month’s article on a completely different subject, but this past month or so nothing else has been in everyone’s thoughts and prayers as much as the coronavirus, nor should it be.

It’s so hard to believe that this is actually a reality and not some movie out of Hollywood or that we won’t wake up tomorrow to find out it was all just a bad dream. Unfortunately it’s not, and the number of cases and the death toll keep rising. We pray that the curve begins to flatten and we turn the corner towards recovery soon.

Before I go any further, I want to sincerely thank each and every one of you (and your families) for everything that you have done. We all are health care providers, risking our health and safety each day working at the front line taking care of our patients. Yes, I know and totally agree that doctors, nurses and first responders have a higher risk factor. But our risk factor is very high with very little discussion or publicity regarding our personal health. It concerns me that pharmacy personnel and our profession always seem to be forgotten, eliminated or last on the list of importance when we deserve so much more. I know so many of our patients love and respect us immensely and appreciate all that we do, but when you’re done reading this article, I believe you will understand the true meaning I hope to make here.

First, we all have learned so much from this pandemic and have so much more to learn. As the highly educated health care providers we are, we know that something like this was possible.

But we never thought it would ever occur, at least not in the United States

of America. One major lesson learned is to not underestimate or ignore the possibilities of epidemics or pandemics, no matter how small the odds seem.

As we hear now, some experts had predicted something like this would occur but didn’t know specifically when, where or how. We must all learn

It’s so hard to believe that this is actually a reality and not some movie out of Hollywood or that we won’t wake up tomorrow to find out it was all just a bad dream. and teach future generations to never let their guard down so we prevent this from occurring again. Pharmacy philosophy has always been to support and advocate for prevention first and treat when necessary.

Secondly, I want to thank all of the pharmacy workers who stayed late or worked extra shifts to help compound hand sanitizers and distribute it to local hospitals, nursing homes and sheriff’s offices. Your devotion and passion is greatly appreciated by so many and will not be forgotten. Having personally participated in the effort to help fight this horrible disease, I realized the pharmacy profession has

David Mackeray, RPh

areas that need some improvements during a crisis. Many pharmacists in the Palm Beach County area worked endlessly on the difficult task of ordering bulk quantities of essential items, compounding it, safely storing the materials and then getting the message out to those who needed some of these items, including our patients.

We didn’t have a proper means of formal communication to know who had what items and who needed what products- making this a major challenge to overcome.

Florida Pharmacy Association CEO/EVP Michael Jackson and staff have done an excellent job posting so much vital information on our website. However, not everyone is a member of FPA (this is a really good reason to become one) to have access to this site. Also, there are other health care providers who would have loved to have access to this information, APRIL 2020

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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

but didn’t have the capability. This knowledge is vital to so many and could have been helpful to those in need.

With today’s technology and social media, the pharmacy profession needs to and should have a much better form of real time communication established that covers all of us, in all areas of pharmacy, throughout all counties and all the states. A major missed opportunity for the pharmacy.

Here’s one example I noticed during this crisis. National news reporters went to distilleries where the owners and their staff were making hand sanitizers in the vats where days earlier they were making alcohol. The story painted a well-deserving group of people doing a wonderful act of kindness beyond the normal call of duty. However, what difference is there between this story and the stories of pharmacies and their staff professionally and safely compounding hand sanitizers and delivering it when needed? Where were the reporters talking to pharmacists to tell their stories nationally of how they serviced all their patients in addition to still taking care of dispensing maintenance medications?

I called a national reputable office supply company that I’ve been to place a regular order and noticed that limited supplies of hand sanitizers and disinfecting products were available to “health care professionals, health care clinics/ facilities and first responders.” I placed my order that included a limited supply of those items to my account name that included “pharmacy,” and was rejected because I wasn’t on their list of qualified health care personnel.

I called to speak to an agent to explain that I’m a pharmacist, which most definitely is a health care professional by all definitions, and intend to use those items for use inside my pharmacy to protect myself, my staff, and most importantly, my patients to help stop the spread of this terrible virus. She said she wasn’t able to override that block.

I then spoke to her supervisor who said the exact same thing, apologized and said that she didn’t agree with the company rule but had to strictly follow it. She promised me that she See President's Viewpoint, continued on Page 13

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FLORIDA PHARMACY TODAY

Executive Insight

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

T

2020 Was a Blockbuster Session

o describe the results of the policy making during the 2020 legislative session as remarkable is an understatement.

This year will be remembered for some of t he most a ma zi ng accomplishments of your professional orga n i zat ion. O ne of t he ma i n purposes and missions of professional organizations is to monitor changes in public policy that affect our industry.

We concentrate on the Florida House and Senate and also work with our national association partners on issues discussed within the halls of Congress in Washington, D.C. Something special has happened here in Florida, and this message to you in this month’s journal will help you understand what it will mean to your practice.

Prior to t he begin n ing of each legislative session, the FPA’s governmental affairs team – officers of the FPA, five at-large members (including one student) appointed by the president, a representative of FSHP and the chairperson of the Florida Pharmacist Political Committee – build an advocacy plan. That plan was presented to and approved by the FPA Board of Directors.

The FPA’s resources are not unlimited. and as such, this committee is charged with establishing a priority of the policies that need to be on the table for our advocacy team. We are pleased to continue to work with Claudia Davant and her team at Adams Street Advocates who have been at our side tirelessly working the issues that are important to pharmacy. Ideally, we would love to take on all issues that are out there, but bandwidth is limited.

Also, some policy changes may take place within Florida’s House and Senate while others may require action at state agencies. The approved advocacy plan for 2020 included:

TIER ONE – PUBLIC POLICY TO ADVOCATE FOR: ■ ■

■ ■

Collaborative practice legislation.

Require a pharmacy technician to be on duty with a pharmacist during pharmacy hours.

PBM legislation addressing transaction fees and anti-steering.

Test and treat legislation.

This year will be remembered for some of the most amazing accomplishments of your professional organization.

■

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Opposition of automated dispensing systems allowing for mitigation of issues and protection of patient safety.

Metrics in pharmacies.

Michael Jackson, B.Pharm

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TIER TWO – ADVOCATE FOR IF OPPORTUNITY IS PRESENTED ■

■

DEA and law enforcement opioid overreach advocacy to the Governor’s Office; Drugs, Devices and Cosmetics; and Opioid Task Force.

Revise laws allowing for ACPE providers to offer the three-hour vaccine safety continuing education available exclusively through the Florida Medical Association. It is recommended to collect evidence of

■

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issues with the existing law.

Advocate through Board of Pharmacy rulemaking for call centers to properly identify themselves to prescribing practitioners and to patients.

Advocate for changes in Florida laws that would allow for pharmacists to prescribe oral contraceptives.

Advocate before the DEA; the Governor’s Office; Florida Division of Drugs, Devices and Cosmetics; and the Florida Opioid Task Force to address unclear regulatory policies on wholesaler supply restrictions and red flags diversion.

Advocate for changes in Florida laws that allow pharmacists to initiate prescriptions for drug delivery aids.

Advocate for changes in Florida laws that would require pharmacist patient screening services in medical marijuana dispensaries.

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

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

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.

TIER THREE – MONITOR: ■ ■ ■ ■

Continue working with AHCA on network restrictions.

Monitor the Board of Pharmacy for the development of telepharmacy services.

Work with the Florida ASCP Chapter on changes to Florida laws that require consultant pharmacists in ALF and other facilities.

Foreign drug importation.

We will focus this month’s issue on the outcome of the 2020 legislative session.

It is no secret that the passing of legislation in Florida is extremely difficult. There are 120 members of the Florida House and 40 members of the Florida Senate that have to be convinced to support an issue. Even if successful, the next step is to convince the governor that an approved bill is a good idea and get his signature.

Below are the metrics for the legislative session for the previous three years. The chart below tells a story that any organization reporting adoption of legislation is a major accomplishment.

2018 Legislative Session

Total Bills Filed

Total Bills Passed

Percentage Passed

2019 Legislative Session

3,192 Total Bills Filed 200 6%

Total Bills Passed

Percentage Passed

2020 Legislative Session

3,491 Total Bills Filed 194 5.5%

Total Bills Passed

Percentage Passed

3,517 210 5.9%

MAJOR ISSUES OF INTEREST PBM Legislation (supported by the FPA): Through the relationships that the FPA had with members of the House and Senate, we were able to get some fairly strong bills filed to correct ongoing PBM abuses of the pharmacy marketplace.

Rep. Jackie Toledo, Sen. Jose Rodriguez, Sen. Gail Harrell and Sen. Tom Wright were strong supporters of our campaign to regulate PBMs, however it was clear that the House would take the lead on choosing a single conservative bill to move forward with. The House version (HB961), sponsored by Rep. Toledo, that we preferred did not get a hearing, however HB7045, sponsored by Rep. Andrade, ultimately passed off of the House floor. This bill essentially focused on transparency and reporting requirements while the Senate version dealt with fair auditing practices and added enforcement for noncompliant PBM practices. The Senate version passed two of three committees and never made it to the Senate floor. The Senate did not take up the House version that passed, and as a result, there were no policy changes in Florida on PBM practices for this year. The FPA did, however, secure a grant from the National Alliance of State Pharmacy Associations and launched a massive public relations campaign on PBM practices. The message was delivered throughout Florida in print, radio and television media as well as broad outreach in social media. It triggered a lot of healthy debate within the Florida House and Senate. This work on PBM public awareness will set us up for a more informed discussion and advocacy for the 2021 legislative session. The Association also worked closely with NASPA and the American Pharmacy Cooperative (APCI) on a comprehensive study looking at 350 million prescription drug claims data from Florida Medicaid. This study demonstrated the predatory practices of PBMs in the Medicaid market.

Testing and Treating for Streptococcus and Influenza (HB389, supported by the FPA): We are pleased to report that the Florida House and Senate passed and the Governor signed significant legislation related to the practice of pharmacy.

Our initial efforts were to change Florida laws allowing pharmacists to test for and treat streptococcus and influenza. What the legislature gave us was much more See Executive Insight, continued on Page 10

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 APRIL 2020

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Executive Insight, from Page 8

than that. I call it collaborative practice on steroids.

What are the major issues in this bill?

■ Adds 465.1895, allowing for testing or screening for and treatment of minor nonchronic health conditions.

■ Adds 465.1865, allowing for collaborative practice of certain chronic health conditions.

■ Adds pharmacists certified under the above two new sections to the list of health care providers under F.S. 381.0031 that report to the Department of Health evidence of diseases of public health importance.

■ Adds to the definition of the practice of pharmacy the ability to initiate, modify or discontinue drug therapy for a chronic health condition under a collaborative pharmacy practice agreement.

■ Adds to the definition of the practice of pharmacy the ability to test or screen for and treatment of minor, nonchronic health conditions if qualified under 465.1895.

■ Both new sections of Florida law require a pharmacist to successfully complete of a 20-hour certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and Board of Osteopathic Medicine.

■ Pharmacists that are testing and screening under 465.1895 must complete a three-hour CE program each biennial renewal period to maintain their credential.

■ Pharmacists that are providing collaborative practice services under 465.1865 must complete an eighthour CE program each biennial renewal period to maintain their credential ■ The eight-hour and the three-hour programs mentioned above are in addition to the 30 hours that a pharmacist must complete each biennial renewal period.

■ Pharmacists working under a collaborative practice agreement must maintain $250,000 of professional liability insurance.

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FLORIDA PHARMACY TODAY

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There is no authority to initiate prescription drug therapy for controlled substances to patients under either of these two new sections of Florida law.

Pharmacists who are providing collaborative practices under 465.1865 must be either a PharmD or have five years of practice experience as a licensed pharmacist.

What will this change in law do for the profession and for public health?

The passage of this legislation will open the door for pharmacy by creating new practice models. It is a method of bringing pharmacy and physician practices closer together with better coordinated care for patients. It also creates a way for pharmacist to practice at the top of their professional training and experience. This legislation would allow for qualified pharmacists to manage chronic and nonchronic diseased patients in any practice setting.

This legislation expanded greatly from the initial bill advocated for by the Florida Pharmacy Association primarily due to our efforts in working with House leadership. Within an 8 hour period of March 11th of the 2020 session this bill was passed by the Senate, messaged to the House where it passed there and then sent to the desk of Govern DeSantis where he signed the bill before the sun went down. It is extremely rare to see activity like this on a bill and for it to get to the Governor and signed that same day is nothing less that spectacular advocacy work.

Collaborative Practice for Consultant Pharmacists (HB599, supported by the FPA) – Similar to HB389 as reported above, this legislation was considered a priority of the House Speaker’s efforts to expand health care provider’s scope of practice. This legislation makes substantial changes to Florida consultant practices under F.S. 465.0125. It defines collaborative practices in defined institutional settings by Florida licensed consultant pharmacists. This legislation passed the House on Feb. 26 and was sent to the Senate, where it passed March 11 and was approved by the governor the same day.

What are the major issues in this bill?

■ Allows for Florida licensed consultant pharmacists to order and evaluate laboratory or clinical testing, conduct patient assessments, modify, discontinue or administer medicinal drugs.

■ Allows for consultant pharmacists to provide medication management services in licensed institutions pursuant to a written collaborative practice agreement.

■ Collaborative practice agreements could be with either a medical director or a Florida licensed medical doctor, osteopathic physician, podiatric physician or dentist authorized to prescribe medications.

■ Consultant pharmacist can provide these collaborative practice services and clinical testing only with the patients of the health care practitioner that the consultant pharmacist has a written agreement with.

■ Does not authorize a consultant pharmacist to diagnose any disease or condition.

■ Expands the ability for consultant pharmacists to order laboratory tests beyond nursing homes.

What will this change in law do for the profession and for public health?

This legislation will open the door for pharmacy by creating new practice models for the consultant pharmacist.

It also codifies what practices are going on in institutional pharmacy practices. This change in Florida law does not appear to add any additional educational requirements on consultant pharmacists, however the Board of Pharmacy may examine their rules on consultant pharmacist educational programs.

Instit utional For mular ies for Nursing Homes (HB559, supported by the FPA): Current Florida laws allow for pharmacists to interchange prescription medications that are generically equivalent (465.025). There is also a pathway for pharmacists to interchange biological and biosimilar medications

as defined under 465.0252. Florida laws did not allow for pharmacists to make a therapeutic interchange of prescription medications which would require getting a new order from the prescribing practitioner. House Bill 559 changed that for pharmacists in a nursing home practice.

What are the major issues in this bill?

■ Adds a new section to F.S. 465.025 related to substitution of drugs.

■ Creates a way for pharmacists to therapeutically substitute medicinal drugs in a nursing home that is operating under a formulary.

■ The prescriber must agree to the use of the institutional formulary for his or her patient.

■ Pharmacist is restricted from therapeutically substituting a medication if the prescriber notes “NO THERAPEUTIC SUBSTITUTION” on the prescription or overtly indicates that therapeutic substitution is prohibited.

■ Bill has passed the House and Senate but not yet signed as of the presentation of this article to the Journal.

What does this change in law do for the profession and for public health?

For the first time in Florida, laws have changed that now recognize the ability for pharmacists to be a part of patient care therapeutic decision making. It is also a way for nursing home institutions to manage their costs through a formulary program.

Removal of Discipline for Failure to Replay Student Loans (HB1193, suppor ted by t he F PA): Deeply embedded in the general profession’s laws is a provision that requires the Department of Health to take disciplinary action against a licensee who fails to comply with their student loans that are issued or guaranteed by the state or federal government. This legislation also repeals a requirement for the Department of Health to get a monthly list of practitioners who fail to repay their loans from the Department

of Health and Human Services. The disciplinary action would require the department to suspend the license of a health care provider. By doing so, this creates a cascading problem for pharmacists and other health professionals licensed in Florida. If the license were suspended, then the individual could not work. If the individual could not work in their trained field, there would be no income to pay back their student loans.

What are the major issues in this bill?

■ HB1193 makes changes to the grounds for disciplinary action under 456.072(1)(k) that removes a requirement that a license to be suspended if there is a finding of default on the repayment of a student loan issued or guaranteed by the state or federal government.

■ Removes a requirement that a fine be assessed on a licensee in the amount of 10 percent of the defaulted loan amount ■ Removes a requirement for the state to gather evidence of failure to repay the loan from the Department of Health and Human Services and also removes a requirement to report such findings to the legislature.

■ Bill has passed the House and Senate but not yet signed as of the presentation of this article to the Journal What does this change in law do for the profession and for public health?

Student debt has become a major topic of discussion among our young practitioners. In pharmacy, we are seeing a tightened job market with depressed salaries. The law, before the passage of this bill, could have created an impossible scenario for our newly licensed graduates. This bill removes a tremendous public policy liability from our graduates who have hit speed bumps starting their professional careers.

Automated Pharmacy Systems (HB59, opposed by the FPA): This legislation was introduced during the 2019 legislative session and returned for

a second try this year. We were able to stop it from moving last year, however this year was a little different. The FPA worked tirelessly to try to prevent passage of this bill, including urging pharmacists to contact their legislators.

The intent of this legislation is to create a way for consumers to get access to their medications when discharged from hospitals or their emergency departments and local community pharmacy services are not available. An FPA-supported amendment was added to the Senate version that restricted the deployment of these systems to either within a pharmacy or in the establishment where the pharmacy is located. However, that amendment was removed. FPA has transmitted a letter to the governor’s office asking for a veto of this legislation.

What are the major issues in this bill?

■ Authorizes a community pharmacy to provide outpatient dispensing through the use of an automated pharmacy system.

■ An automated pharmacy system employed by a community pharmacy does not need to be located at the same location as the community pharmacy.

■ A community pharmacy must notify the Board of Pharmacy of the location of the system and any time the location of such system changes.

■ The pharmacy must maintain a record of the medicinal drugs dispensed by the automated pharmacy system, including the identity of the pharmacist responsible for verifying the accuracy of the dosage and instructions for the prescription.

■ A community pharmacy must also maintain and annually review written policies and procedures that ensure the safety and security of the automated pharmacy system.

■ Authorized, rather than required, the Board of Pharmacy to adopt rules.

■ The automated dispensing system cannot contain any controlled substances.

■ The community pharmacy APRIL 2020 |

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maintains written policies and procedures to ensure the proper, safe and secure functioning of the automated pharmacy system.

The automated pharmacy system must have a mechanism that provides live, real-time patient counseling by a pharmacist licensed in this state before the dispensing of any medicinal drug.

Bill has passed the House and Senate but not yet signed as of the presentation of this article to the Journal.

What does this change in law do for the profession and for public health?

FPA advocates were concerned over the safety of such systems that are remotely located from the supervising ph a r mac y. Wh i le t he FPA i s a proponent of automated systems we are unable to endorse such system that is remotely managed as this legislation is allowing. Technology is best deployed to support the services provided by a pharmacist and not as a replacement.

The bill also makes it optional for the Board of Pharmacy to write rules rather than require rulemaking.

Electronic Prescribing (HB1103, opposed by the FPA): This issue presented itself during the session and was unexpected. During the 2019 legislative session, a bill passed that created a requirement for Floridalicensed practitioners to electronically prescribe medications. There were a number of exceptions to the law. In HB1103, the House sponsor’s interest was to remove many of those exceptions in an attempt to revert HB1103 to the original version of last year’s bill. FPA met with the sponsor on the Senate side and expressed our concerns such as unrecovered costs that community pharmacies bear with prescriptions are electronically transmitted. The House version passed all of its committees and passed the floor of the House, but the Senate version was never heard in committee. The Senate never took up the House version.

What are the major issues in this bill?

■ Removes the requirement for written prescriptions to be legible.

■ Would require all prescriptions to be either issued by telephone or electronic means.

■ Would have allowed for written prescriptions only when there is an electronic or technical failure beyond the control of the prescriber.

■ Would have allowed for written prescriptions for patients in defined free clinics.

■ Would have allowed for written prescriptions for patients from emergency rooms.

■ E-prescribing software could not be used to influence prescribing decisions.

What would this change in law have done for the profession and for public health?

If passed into law, Florida would see a considerable drop in written prescrip-

See Executive Insight, continued on Page 13

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Brian A. Kahan, R.Ph., J.D.

LICENSED Florida Pharmacist and Attorney STAT EW I DE R EPR E SEN TAT ION 561-392-9000 bkahan@kahanlaw.com 7000 W. Palmetto Park Rd., Suite 210 Boca Raton, FL 33433 The hiring of a lawyer is an important decision that should not be based upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience.

FPA News & Notes Miller named Field Representative of the Year Brian Miller, a Florida field representative for Pharmacists Mutual Insurance Co., was named the company’s 2019 Field Representative of the Year.

The award recognizes the field representative with the best overall ratings in the categories of territory growth, new business, life insurance and retention of business.

Miller received his award at the 2020 Annual Sales Meeting.

Executive Insight, from Page 12

President’s Viewpoint, from Page 6

tions. Data from the Agency for Health Care Administration shows a large increase in prescriber adoption of electronic health records and electronic prescribing.

Proponents claim that e-prescribing will reduce transcription errors and increase operational efficiencies.

Pharmacy advocates note that the costs of electronic prescribing is mostly a burden of community pharmacy providers.

would relay my sincere dissatisfaction with the company and its policy. We all must work hard to change people’s opinion and the perception of the pharmacy profession so that people respect us as health care providers that we are and recognize us as a very integral part of the health care team.

We in the pharmacy profession need to shine whenever we can. We can’t expect the general population to fully know and understand all that we are capable of professionally. During this time of a horrible health crisis, we need to take the lead, be proud and be loud. So many groups have been recognized and applauded for all their efforts during this pandemic (and 100 percent justified) but we weren’t discussed by the media for all the fantastic things that we accomplished.

I know that many of us do what we do from the goodness of our hearts and not for the glory, which is admirable and selfless. However, the pharmacy profession needs the recognition and respect it deserves because our future depends on it. The general public and politicians need to know and understand what we can do not only every day, but especially during a crisis. We know that we are highly educated health care professions that can offer so much during a crisis like COVID-19. Unfortunately, so many others don’t know or recognize all the important life-saving services that we can offer, and nowadays, the pharmacy profession needs all the proper publicity available.

I know how hard everyone has worked recently under such terrible conditions while risking their safety as well as their family’s safety. You all can’t be thanked enough and your patients are forever grateful. God will bless us all for our kindheartedness in his own special way. As FPA president and a member of the Board of Directors for the past 7 years, I’ve come to realize it would be so much easier for us as pharmacists when we travel to our state and national capitols to advocate to advance our profession if we didn’t have to tell the politicians what we could do and instead could tell them what we actually did do. We need to be proud and be loud so they have no option but to hear us, see us and respect us!! Thank you for all you do, stay safe and God bless you all. n

Summary of the 2020 Legislative Session This year we witnessed a remarkable campaign with amazing policies favorable to pharmacy. While we are disappointed with the legislature’s failure to act on the growing PBM issues, our public relations campaign has changed the minds and hearts of members of the House and Senate. We need to use this time between now and the beginning of session next year to keep this on the front page of those who write public policy. Under the leadership of President David Mackarey and the hard work and many hours of the Legislative Committee and the countless volunteers, we made a big difference this session. Our colleagues across the U.S. are talking about what we did here in Florida. Our many thanks again to Adams Street Advocates.

Above are a few of the major bills we worked on. There are many more that are included in the legislative report that is published on the FPA web site. We will also include discussions at our conference in May and also a report will be available at the FPA annual convention this summer. For the full session report select the sub menu item “FPA Legislative Session Report” under “Advocacy & Legislation” and “Legislative Action Center.” See you in Marco Island. n

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March 27, 2020 The Honorable Ron DeSantis, Office of the Governor 400 S. Monroe St. Tallahassee, Florida 32399

Re: Concerns on the Unlabeled Use of Medications in the Management of COVID-19 Patients Dear Gov. DeSantis: This correspondence is provided on behalf of the Florida Pharmacy Association, Inc. (“FPA”), a not-for-profit corporation organized under the laws of this state which seeks to preserve and advance the practice of pharmacy and serves the professional needs of all pharmacists, pharmacy students, and pharmacy technicians in Florida. The FPA is the state’s largest and oldest professional society representing Florida pharmacists and pharmacies with over 3,500 members. The FPA is committed to improving public health and patient care, enhancing professional development, and advocating for the interests of the profession. The purpose of this letter is to bring to your attention certain prescribing practices that are endangering the health of Floridians and to request that you issue an emergency order, or direct the Board of Pharmacy in collaboration with the Board of Medicine to issue an emergency rule, limiting such practices.

Late last week, President Trump announced the promise of hydroxychloroquine as a potential treatment for COVID-19. This has resulted in a run on the medication. Several of our member pharmacies have reported that their supply of the medication is gone and they are unable to order more. We are gravely concerned that patients who rely on this medication for the treatment of lupus or rheumatoid arthritis will be unable to obtain the medication in the near future. Even more troubling, our members report that nearly all of the new prescriptions for hydroxychloroquine are being issued for the prescribing practitioners themselves or family members of the prescribing practitioners. We are very concerned with this practice of stockpiling of medications and believe that this type of practice behavior needs to be redirected.

Many of the medications for the treatment of lupus are immunosuppressive medications. These medications place individuals at a higher risk for infections, including the coronavirus. Hydroxychloroquine is one of the most widely-prescribed medications for the treatment of lupus because it is effective while having very little immunosuppressive effect. If lupus patients are unable to obtain hydroxychloroquine, they may be forced to make the difficult decision of taking a stronger immunosuppressive medication – placing them at higher risk of becoming infected with coronavirus – or not treating lupus at all.

I would like to bring to your attention a joint statement just released by the American Medical Association, American Pharmacists Association and the American Society of Health-System Pharmacists. In that statement there is an acknowledgement of the important role that physicians, pharmacists and health systems play in being stewards of health care resources. We hope that this joint message will assist you with an understanding of what we are bringing to your attention with this letter.

As of Monday, March 23, 2020, at least six states have taken action to prevent prescribing practitioners from unnecessarily prescribing the medication. We ask that Florida follow suit. Specifically, we request the issuance of an emergency order or rule stating the following.

No prescription for chloroquine or hydroxychloroquine may be dispensed unless all the following apply: 1. The prescription bears a written diagnosis from the prescriber consistent with the evidence for its use; 2. The prescription is limited to no more than thirty (30) tablets, unless the patient was previously established on the medication prior to the effective date of this order/rule; and 3. No refills may be permitted unless a new prescription is issued. This requirement does not apply to a patient previously established on the medication prior to the effective date of this order/rule.

We believe the above language implemented as a temporary rule ensures continued access to the medication while preventing unnecessary stockpiling.

Thank you for taking the time to consider this important matter and thank you for your continued leadership in navigating Florida through these challenging times. As always, please do not hesitate to contact me should have any questions or need any additional information.

With kindest regards, Michael A. Jackson, BPharm, CPh Executive vice president and CEO

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COVID-19 MEDICATIONS

Authors: Emilie Collongette, Pharm.D. candidate Carol Motycka, Pharm.D. Eric F. Egelund, Pharm.D., Ph.D. Emilie Collongette, Pharm.D. candidate

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COVID-19 Emergence COVID-19 (SARS-CoV-2) is a new strain of corona virus and was first identified in Wuhan, China in 2019. Originally coined in 1968, the coronavirus (CoVs) name originates from their “corona” or crown-like morphology observed under an electron microscope. Coronaviruses are enveloped viruses with positive-stranded RNA.1 Coronaviruses can be subcategorized into four genera: alpha, beta, delta and gamma. Alpha- and beta-CoVs are the two that are known to infect humans. Previously, the 2002 severe acute respiratory syndrome, or SARS, outbreak was associated with beta-HCoV and then in 2012 another pathogenic beta-CoV species was responsible for the Middle East respiratory syndrome (MERS).2 On Dec. 31, Chinese authorities reported several pneumonia cases in Wuhan, China. Most cases were associated with patients who had reported exposure to a large seafood market, suggesting another pathogenic zoonotic CoV, similar to the origins of SARS and MERS. In addition, human-to-human transmission was confirmed by the infection of health care professionals in Wuhan and outside of the Hubei district.2,3 Human-to-human transmission is thought to occur via respiratory droplets among close contacts. The Centers for Disease Control and Prevention defines close contact for risking transmission as being within six feet of an individual with COVID-19 for a prolonged period of time or having direct contact with infectious secretions (sputum, serum, blood and respiratory droplets) from an individual with COVID-19.3 COVID-19 Pandemic The World Health Organization characterized COVID-19 as a pandemic on March 11.3 At the time, more than 118,000 cases in 144 countries, and 4,291 deaths had been confirmed.

The classification of COVID-19 as a pandemic is due to the “alarming levels of spread and severity.”4 The WHO urged all countries to search for a balance between protecting health, minimizing economic and social disruptions, and respecting human rights. Four key areas of strategy were provided: 1) Preparation and readiness.

2) Detection, protection and treatment.

3) Reduction of transmission.

4) Innovation and learning.4 COVID-19 Florida As of April 21, the Florida Department of Health confirmed more than 25,000 total positive cases of COVID-19 in the state with a majority of counties affected. Miami-Dade, Broward, West Palm Beach, Hillsborough and Orange counties had the overall highest rates of infection.5 COVID-19 Essential Personnel The CDC has drafted an Interim Infection Prevention and Control Recommendations with the intention of assisting in the assessment of risk monitoring and work restrictions for health care providers with potential exposure to COVID-19.

High-risk exposures are considered for health care providers who have prolonged contact with COVID-19 patients NOT wearing a facemask while the HCP’s nose and mouth were 16

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exposed to material potentially infectious with the virus. Medium-risk exposure includes any HCP who had prolonged close contact with COVID-19 patients while they were wearing a face mask. Low-risk included brief interactions with patients with COVID-19 or prolonged close contact with patients who are wearing a facemask while the HCP also wears a facemask.6 COVID-19 Clinical Presentation The estimated incubation period of COVID-19 ranges from two to 14 days following exposure, with most cases occurring within four to five days of exposure.7-9 A review of publicly reported cases in China revealed that 97.5 percent of the cases experienced symptoms within 11.5 days. The most common clinical features/symptoms include fever (88-97 percent), dry cough (57-76 percent), fatigue and myalgia (44 percent), anorexia, and dyspnea (22-45 percent). Less common symptoms include GI upset, headaches, sore throat and rhinorrhea.7-9 Clinical complications associated with progression of COVID-19 are acute respiratory distress syndrome, arrythmias, acute cardiac injury and shock.10 Based on an overview of 44,500 COVID-19 cases from the Chinese Center for Disease Control and Prevention, 81 percent were classified as mild and had no pneumonia. Critical disease with respiratory failure, shock, or multiorgan dysfunction was 5 percent and the overall fatality rate was 2.3 percent.10 COVID-19 Home versus Hospital Management The CDC and WHO justify that home management is appropriate for patients with mild infection who can be appropriately isolated.10,11 The main focus of home management is isolation and prevention of remission while monitoring for clinical deterioration. Patients with mild infections should wear facemasks when in the same room, vehicle or setting as other individuals. The CDC recommends discontinuing home isolation after at least seven days from the initial presentation of symptoms and three days since symptoms have resolved.12 The CDC reports approximately 20-30 percent of hospitalized patients with COVID-19 have pneumonia requiring intensive care for respiratory support. Ultimately, decisions to monitor a patient in the outpatient or inpatient setting should be made on a case-by-case basis and no specific treatment for COVID-19 was available at press time.

COVID- 19 Pharmacotherapy options A standard of care has not been established for the management of COVID-19. The American Society of Health-System Pharmacists has published an assessment of evidence for COVID-19 Related Treatment which is updated frequently.13 Chloroquine Phosphate and hydroxychloroquine are antimalarial agents which have been shown to have in vitro activity against some coronaviruses. In addition, both drugs have immunomodulatory activity that could potentially have an ant-inflammatory like response in patients with viral infections. Clinical experience has shown possible benefit in decreasing viral load and duration of illness in COVID-19, but data is limited, and more data is needed to support safety and

efficacy. ASHP suggests chloroquine phosphate and hydroxychloroquine as potential options for COVID- 19 treatment: DOSING: ■ ■ ■ ■

■ ■ ■

Chloroquine phosphate: 500 mg PO BID X 10 days15 Chloroquine phosphate: 500 mg PO BID X 7 days (18-65 years old weighing > 50 kg)11 500 mg PO BID days 1 &2, then 500 mg days 3-7 (wt. < 50 kg)11 Chloroquine phosphate: Initial dose (600 mg PO X 1 dose), followed by 300 mg PO 12 hours following first dose, then 300 mg PO BID days 2-515 Hydroxychloroquine: 400 mg PO BID on day 1, then 200 mg BID days 2-5 Hydroxychloroquine: 100-200 mg PO BID for 5-14 days15 Hydroxychloroquine: 200 mg PO TID for 10 days17

Hydroxychloroquine with azithromycin has shown to be effective in a preliminary studies in France in hospitalized patients with confirmed COVID-19.18 The objective was to assess the efficacy of hydroxychloroquine used alone or with azithromycin with the primary end point being a negative PCR result in nasopharyngeal sample at day six. On day six, 100 percent of patients receiving hydroxychloroquine 200 mg PO TID x 10 days WITH azithromycin 500 mg PO daily on day 1 and 250 mg PO daily days 2-5 versus 57 percent of patients receiving hydroxychloroquine 200 mg PO TID x 10 days had a negative PCR result.

The study was a small nonrandomized trial with 20 patients during which data on disease severity was unclear and information on disease progression and clinical outcomes were not reported. Therefore, additional data is needed before conclusions regarding the effects of hydroxychloroquine and azithromycin in COVID-19 patients. Hydroxychloroquine and azithromycin are associated with QT prolongation. Caution is advised for use in patients with chronic medical conditions such arrythmia, renal failure and hepatic disease. 18 Tocilizumab (Actemra®) is a disease modifying anti-rheumatic drug thought to potentially combat cytokine release syndrome featured in severely ill patients.19 While a randomized, multicenter, controlled clinical trial evaluating the efficacy and safety of COVID-19 is still underway in China, the preliminary data has shown rapid fever reduction and a decreased need for supplemental oxygen after receiving tocilizumab 400 mg via IV infusion.19-21 In China, it has been used in severely or critically ill COVID-19 patients with extensive lung lesion and high IL-6 levels.

DOSING:

Tocilizumab: initial dose 4-8 mg/kg IV over more than 60 minutes. If initial dose is not effective, may administer a second dose (same dosing) after 12 hours. No more than two doses should be given; max dose 800 mg/dose. (Recommendation in China)20 Inhaled Nitric Oxide (INOpulse®) is a selective pulmonary vasodilator thought to be useful in the treatment of acute respiratory distress syndrome, a common complication of COVID-19. On March 20, the FDA granted emergency expanded access allowing INOpulse® to be immediately used for the treat-

ment of COVID-19.21 Inhaled nitric oxide reversed pulmonary hypertension, improved severe hypoxia, and shortened the duration of ventilator support amongst SARS-CoV patients in a small pilot study in China during the 2003 outbreak.21 Clinical trials are evaluating the role of inhaled nitric oxide in COVID-19 treatment or prevention.

DOSING:

Inhaled nitric oxide therapy was given for > three days (30 ppm on day one, followed by 20 ppm on day two and 10 ppm on days 3, then weaned on day four; therapy was resumed at 10 ppm if deteriorating oxygenation occurred (SARS-CoV patients)22 COVID- 19 Investigational Therapeutics Several clinical trials are ongoing for the treatment of COVID-19, some of which involve non-commercially available or FDA approved agents. Remdesivir is a broad-spectrum antiviral with activity against coronaviruses, previously tested in SARS, MERS and Ebola. Remdesivir is given via IV infusion.

A Phase 3 open-label trial and a Phase 2 randomized placebocontrol trial are underway for hospitalized patients with COVID-19.24,25 Gilead, the manufacturer, is transitioning to an expanded access program for emergency access to the drug for those severely ill patients with COVID-19.26 Colchicine is being assessed in a phase 3 randomized double-blind trial to determine if short term treatment will reduce mortality and lung complications due to COVID-19.27

CORONAVIRUSES (COVS) NAME ORIGINATES FROM THEIR “CORONA” OR CROWN-LIKE MORPHOLOGY OBSERVED UNDER AN ELECTRON MICROSCOPE.

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THE INCREASE DEMAND OF HYDROXYCHLOROQUINE AND CHLOROQUINE DURING THE PANDEMIC HAS LED TO INAPPROPRIATE PRESCRIBING. Numerous other medications are being examined as well: statins, high dose vitamin C, zinc, among many others. For further information, The American Society of Health System Pharmacists is maintaining a table listing the various agents used in treatment as well as an assessment of those agents’ efficacy in treating COIVD-19.

COVID-19 Therapeutic Agents to Avoid The WHO and CDC recommend to not use corticosteroids routinely in patients with COVID-19 who have developed pneumonia or acute respiratory distress syndrome unless otherwise indicated. There is no evidence to show the survival benefit of corticosteroids in patients with SARS and MERS. Delayed viral clearance, avascular necrosis, psychosis and diabetes have been shown to be potential effects associated with the use of corticosteroids in COVID-19 patients.28,29 However, some endocrinologists recommend “a stress dose” of glucocorticoids in patients who use them on a routine basis for inflammatory conditions (e.g., asthma, arthritis).30 COVID-19 and Fish Antibiotics Fish medications are not FDA-approved to treat humans and, therefore, do not have the labeling information for human dosing, administration or side effects.31 Chloroquine phosphate and hydroxychloroquine are anti-viral medications available under the care/orders of a supervising provider that have shown efficacy in the treatment of COVID-19.

Chloroquine phosphate is also available over the counter as an additive used to clean fish tanks.

An Arizona couple in their 60s found the formulation used in aquariums of chloroquine phosphate on their shelf and decided to self-medicate after hearing on a media outlet that it was a treatment for COVID-19.32 After ingesting the product, the husband could not be resuscitated when he arrived at the hospital, however, the wife was able to throw up most of the chemical.

Following the incident, Banner Health, the manufacturers of the prescription formulation of chloroquine, urged individuals that self-medicating is not appropriate and dangerous. The formulations differ between the aquarium cleaning additive and the prescription drug used to treat viruses and should not be recommended for self-treatment.

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COVID-19 Prescribing Patterns The increase demand of hydroxychloroquine and chloroquine during the pandemic has led to inappropriate prescribing. Brian Brito, president of SMP Pharmacy Solutions, shared with ProPublica that the pharmacy has experienced individuals attempting to stockpile the medications for prophylactic use. SMP Pharmacy solutions had 800 tablets on a Monday and were nearly sold out in about an hour. Brito explained a doctor called and asked for 200 tablets, after the pharmacy refused to dispense such a high quantity, the doctor asked for 42 tablets, the treatment amount for two people.33 Experiences like these have led state boards of pharmacy to take action to help prevent inappropriate prescribing and potential shortages. State boards of pharmacy in Nevada, Ohio, Texas, West Virginia, Louisiana and Idaho have developed policies to manage the supply and dispensing of rules of hydroxychloroquine, requiring a diagnosis for an indicated disease be written on the prescription. If diagnosis indicates COVID- 19, restrictions such as a 14-day supply limit and no refills apply.34 The goal is to combat hoarding and maintain an adequate supply for patients who have been taking the hydroxychloroquine as a maintenance medication.

Conclusion The COVID-19 pandemic is an evolving situation, placing pharmacists at the forefront of the pandemic. Pharmacists play a critical role in supporting our fellow health-care providers and patients. As the most accessible health care providers, pharmacists can help educate the public and disseminate accurate information. Aside from filling prescriptions and managing inventories, pharmacists can also counsel individuals on proper hygiene, preventative measures and symptom management. Pharmacists may encourage and refer individual with symptoms or who may have been in contact with infected persons to self-quarantine or seek medical care.

As the medication experts, pharmacists work along-side physicians, nurses, researchers and other providers in understanding the virus and establishing treatments. The world has seen a rapid increase in confirmed COVID-19 cases as testing has become more readily available. It is essential all personnel: members of the community, health care providers, essential workers, government leaders etc play a role in the global pandemic and make strides towards healing.

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2. Paules Cl, Marston HD, Fauci AS. Coronavirus Infections-More Than Just the Common Cold. JAMA. Jan 23. DOI:10.1001/jama.2020.0757.

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4. WHO Director-General’s opening remarks at the media briefing on COVID-19. World Health Organization. Accessed at: https://www.who. int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-mediabriefing-on-covid-19---11-march-2020 5. What you need to know about COVID-19 in Florida. Florida Health.

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6. Centers for Disease Control and Prevention. Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19). Accessed at: https://www. cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html 7. Huang et al. Clinical features of patients with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223).

8. Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, et al. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis 2020. doi: 10.1016/j.tmaid.2020.101623.

9. Li P, Fu JB, Li KF, et al. Transmission of COVID-19 in the terminal stage of incubation period: a familial cluster. Int J Infect Dis 2020 Mar 16; s1201-9712(20)30146-6..

10. Centers for Disease Control and Prevention. Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ clinical-guidance-management-patients.html Accessed April 4, 2020.

11. World Health Organization. Home care for patients with suspected novel coronavirus (nCoV) infection presenting with mild symptoms and management of contacts. Updated February 4, 2020. https:// www.who.int/publications-detail/home-care-for-patients-with-suspectednovel-coronavirus-(ncov)-infection-presenting-with-mild-symptoms-andmanagement-of-contacts.html. Accessed February 14, 2020.

12. United States Centers for Disease Control and Prevention.

Discontinuation of home isolation for persons with COVID-19 (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-inhome-patients.html Accessed March 27, 2020.

13. American Society of Health-System Pharmacist. Assessment of evidence for COVID-19-related treatments: https://www.ashp.org/-/ media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHPCOVID-19-Evidence%20Table.ashx?la=en&hash=B414CC64FD64E1AE8C A47AD753BA744EDF4FFB8C. Accessed on March 24,2020.

14. Cortegiani A, Ingoglia G, Ippolito M et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020; DOI:10.1016/j.jcrc.2020.03.005.

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16. 16. Gautret P, Lagier JC, Parola P et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agnts. 2020; In Press.

DOI:10.1016/jantimicag.2020.105949.

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18. 18. Genentech, Inc, South San Francisco, CA. Actemra use in Coronavirus Disease 2019 (COVID-19) standard reply letter. March 6, 2020.

19. 19. National Health Commission and State Administration of Traditional Chinese Medicine. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). (Mandarin; English translation.).

20. 20. Xu X, Han M, Li T et al. Effective treatment of severe COVID-19 patients with Tocilizumab. Available on chinaXiv website. Accessed Mar 29, 2020.

21. 21. Chen L, Liu P, Gao H et al. Inhalation of nitric oxide in the treatment of severely acute respiratory syndrome: a rescue trial in Beijing. Clin Infect Dis. 2004; 39(10):1531-5. PMID:15546092 DOI: 10.1086/425357.

22. 22. FDA Grants Bellerophon Emergency Expanded Access for INOpulse® for the Treatment of COVID-19 Virus [press release].

Warren, NJ; Bellerophon Therapeutics, Inc: 2020 Mar 20. http://investors. bellerophon.com/news-releases/news-release-details/fda-grants-bellerophonemergency-expanded-access-inopulser. Accessed 2020 Mar 24.

23. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734) in participants with severe coronavirus disease (COVID-19). NCT04292899. https://clinicaltrials.gov/ct2/ show/NCT04292899. Accessed April 4, 2020.

24. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734) in participants with moderate coronavirus disease (COVID-19) compared to standard of care treatment. NCT04292730. https://www.clinicaltrials.gov/ct2/show/ NCT04292730. Accessed April 4, 2020.

25. Gilead Sciences. Company statement on access to remdesivir outside of clinical trials. Accessed 2020 Mar 23. https://www. gilead.com/news-and-press/company-statements/gilead-sciencesstatement-on-access-to-remdesivir-outside-of-clinical-trials

26. Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/ NCT04322682. Accessed April 1, 2020.

27. World Health Organization. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected.

Interim guidance. World Health Organization (WHO). https://www. who.int/publications-detail/clinical-management-of-severe-acute-respiratoryinfection-when-novel-coronavirus-(ncov)-infection-is-suspected 28. Centers for Disease Control. Healthcare professionals: Frequently asked questions and answers. Accessed at: https://www.cdc.gov/ coronavirus/2019-ncov/hcp/faq.html 29. Gautret P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐ randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 17. DOI : 10.1016/j. ijantimicag.2020.105949.

30. Kaiser UB, Mirmira RG, Stewart PM. Our response to Covid-19 as Endocrinologists and Diabetologists. J Clin Endocrinol Metab. 2020 May 1; 105(5).

31. Egelund EF, Casapao AC. “Pet Nemo’s Pills”: The Last Loophole in Antimicrobial Stewardship? Clin Infect Dis. 2020 Jan;70(1)177-179.

32. Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019 (COVID-19). Centers for Disease Control. Accessed at: https:// emergency.cdc.gov/han/2020/han00431.asp 33. Sanders T, Armstrong D, Kofman A. Doctors are Hoarding Unproven Coronavirus Medicine by Writing Prescriptions for Themselves and Their Families. ProPublica. 2020 March 24. Accessed at: https://www. propublica.org/article/doctors-are-hoarding-unproven-coronavirus-medicineby-writing-prescriptions-for-themselves-and-their-families 34. Hydroxychloroquine (Plaquenil) Shortage Causing Concern. Arthritis Foundation. 2020 Mar 24. Accessed at: https://www.arthritis.org/drugguide/medication-topics/plaquenil-shortage

Emilie Collongette is a fourth-year student pharmacist at the University of Florida College of Pharmacy Jacksonville. As an Advanced Pharmacy Practice Experience student amidst the COVID-19 pandemic, she has experienced first-hand the role pharmacist have played. During her academia rotation, Emilie was tasked with supporting the UFCOP’s faculty and staff in transitioning to 100 percent virtual learning. In addition, Emilie has had experience providing care for patients during this time as an intern for Publix Pharmacy and APPE community student. Emilie’s focus has been to support her pharmacist and provide up-to-date information to her colleagues and patients.

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New Leave Provisions Under The Families First Coronavirus Response Act

By TJ Morton | FPA General Counsel, The Lockwood Law Firm

On March 18, President Trump signed into law the Families First Coronavirus Response Act (FFCRA)1. The FFCRA, which took effect April 1, is the second major legislative initiative passed by Congress to address the challenges arising from the spread of the novel coronavirus (the first was signed into law on March 6, and provides emergency funding for federal agencies to respond to the outbreak).

2 The FFCRA provides for a variety of benefits including paid leave, expanded unemployment benefits, and free COVID-19 testing. This article will discuss the expanded family and medical leave, paid sick leave, and tax credit provisions of the FFCRA. The FFCRA expands the Family and Medical Leave Act to allow eligible employees to take up to 12 weeks of leave to care for a child younger than 18 whose school is closed or whose child care provider is unavailable due to COVID-19. Employees who unable to work or telework for these reasons are entitled to receive two-thirds of their regular pay, but not more than $200 per day or $10,000 in the aggregate over the course of the 12-week period. Employees are not entitled to receive paid family and medical leave for the first 10 days of the 12-week period; however, employees may elect to use accrued existing vacation, personal, or sick leave to receive payment for the first 10 days. Alternatively, employees may use the paid sick leave provided under the FFCRA (discussed below) for the first 10 20

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days. Generally, employees who claim expanded family and medical leave are entitled to be restored back to their prior position at the conclusion of the leave. However, an exception applies for employers who employ less than 25 employees if the position held by the employee no longer exists due to economic conditions resulting from COVID-19.

Only employers with fewer than 500 employees are required to provide the expanded family and medical leave. Employers with fewer than 50 employees are not required to provide expanded family and medical leave if such benefits would jeopardize the viability of the business.3 An employee is eligible for the leave if the employee has worked for the employer for at least 30 calendar days. The FFCRA allows an employer of an employee who is a health care provider or emergency responder to elect to exclude such employee from receiving expanded family and medical leave. According to the Department of Labor, a health care provider is anyone employed at the following facilities: Any doctorâ&#x20AC;&#x2122;s office, hospital, health care center, clinic, postsecondary educational institution offering health care instruction, medical school, local health department or agency, nursing facility, retirement facility, nursing home, home health care provider, any

facility that performs laboratory or medical testing, pharmacy, or any similar institution, employer, or entity.4 Based on this guidance, pharmacists and pharmacy technicians, along with non-licensed pharmacy employees, can be excluded by their employer from receiving expanded family and medical leave on a case-by-case basis. The Department of Labor encourages employers to be judicious when excluding health care providers so as to minimize the spread of the novel coronavirus.

The FFCRA also allows employees to receive paid sick leave if the employee is unable to work or telework because the employee: 1. Is subject to a COVID-19 quarantine or isolation order.

2. Has been advised by a heath care provider to selfquarantine due to COVID-19.

3. Is experiencing symptoms of COVID-19 and seeking a medical diagnosis.

4. Is caring for an individual who is subject to COVID-19 quarantine or isolation order or has been advised by a health care provider to self-quarantine.

5. Is caring for a child whose school is closed or child care provider is unavailable due to COVID-19.

6. Is experiencing any other substantially similar condition specified by the Secretary of Health and Human Services in consultation with the Secretary of the Treasury and the Secretary of Labor.

FULL-TIME EMPLOYEES ARE ENTITLED TO UP TO 80 HOURS OF PAID SICK LEAVE. PARTTIME EMPLOYEES ARE ENTITLED TO THE NUMBER OF HOURS EQUAL TO THE NUMBER OF HOURS THAT SUCH EMPLOYEE WORKS ON AVERAGE OVER A TWO-WEEK PERIOD. Full-time employees are entitled to up to 80 hours of paid sick leave. Part-time employees are entitled to the number of hours equal to the number of hours that such employee works on average over a two-week period. Employees who claim paid sick leave for reason one, two or three above, are entitled to receive their regular pay, but not more than $511 per day or $5,110 in the aggregate over the benefit period. Employees who claim paid sick leave for reason four, five or six above, are entitled to receive two-thirds of their regular pay, but not more than $200 per day, or $2,000 in the aggregate over the benefit period.

Many of the same requirements that apply to the expanded family and medical leave also apply to paid sick leave. For example, only employers with fewer than 500 employees are required to provide paid sick leave and employers of employees who are health care providers or emergency responders may elect to exclude such employees from receiving paid sick leave. This means pharmacists and pharmacy technicians may be ineligible for paid sick leave if

the employer elects to exclude those employees from eligibility.

Unlike expanded family and medical leave, however, employees are not required to have worked for the employer for 30 calendar days to be eligible for paid sick leave.

The expanded family and medical leave and paid sick leave provisions of the FFCRA became effective on April 1 and apply to leave taken between April 1 to Dec. 31. After Dec. 31, the FFCRA’s leave provisions are no longer applicable.

In order to assist employers in paying for the expanded family and medical leave and paid sick leave, the FFCRA allows employers to receive payroll tax credits equal to 100 percent of the amounts paid to employees for expanded family and medical leave and paid sick leave for each calendar quarter. To the extent the amounts paid to employees for expanded family and medical leave and paid sick leave exceed the employer’s payroll tax obligation for the quarter, the employer is entitled to a refund of the excess credit. Employers are not eligible for tax credits for leave benefits paid to employees that are not in accordance with the provisions of the FFCRA. In conclusion, the FFCRA requires employers of fewer than 500 employees to provide expanded family and medical leave and paid sick leave to employees who are unable to work or telework for COVID-19 related reasons. The FFCRA authorizes employers to receive fully refundable tax credits equal to the amount paid to employees for expanded family and medical leave and paid sick leave.

Due to a provision that authorizes employers to exempt for health care providers from these benefits, pharmacists and pharmacy technicians may not be eligible to receive expanded family and medical leave or paid sick leave.

Pharmacies, pharmacists, and pharmacy technicians should work together to ensure that pharmacies have sufficient staffing to safely operate while allowing employees to utilize the FFCRA’s leave benefits when necessary to minimize the spread of the novel coronavirus.

References

1. The full text of the FFCRA is available at https://www. congress.gov/bill/116th-congress/house-bill/6201/text.

2. On March 27, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), the third, and so far the largest, legislative relief package in response to the coronavirus crisis.

3. The Department of Labor has issued guidance on when an employer with fewer than 50 employees is eligible for this exemption. See FAQs 57 and 58 at https://www.dol.gov/ agencies/whd/pandemic/ffcra-questions#5 4. See FAQ 56. at https://www.dol.gov/agencies/whd/ pandemic/ffcra-questions#5

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As the Future of Pharmacy Marches On, Pharmacists Must Embrace ITâ&#x20AC;&#x2122;s Intelligence Guest Columnist: Travis C. A. Brooks, Pharm.D. candidate

Pharmacy is being revolutionized by the fruits of its labor. The godfather of technology, information technology and its poster child artificial intelligence has forever changed our future in the practice of pharmacy. When we think about where we are at this moment in time, we have to first remember to thank and pay homage to our forerunners in pharmacy practice.

Travis C.A. Brooks, Without the efforts of our predecessors adPharm.D. candidate vancing the field of pharmacy, the industry would not be at the level it has grown to today.

Advancements in both IT and AI paved the way for the field of pharmacy to continue to grow.1 When IT was first introduced, most of the pharmacists couldnâ&#x20AC;&#x2122;t even fathom the idea of technology helping them. As the years passed, technology advanced and now there are numerous technological trajectories in the modern practice of pharmacy. It is up upand-coming pharmacists new to the field to embrace ever22

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changing technology. So, what is our role in being a pharmacist? Is our primary role and professional title more than just filling a prescription? The answer is yes in a huge way! Our role and scope of practice more than meets the public eye. A pharmacist must provide: health assessments and screenings, immunizations and vaccines, medication therapy management services, patient education and counseling, and patient care plans in collaboration with a physician to ensure that each patient is receiving the utmost quality care.2 Now, with all that being said, a pharmacist cannot do all this alone.

We must have help and we must work together.

It is worth noting that pharmacy technicians play a critical role assisting pharmacists. Pharmacy techs are much appreciated by pharmacists and patients alike. Information technology has given pharmacists a whole new outlook and new methods to provide the absolute highest quality of patient care. The role of information technology in pharmacy practice is dynamic and not likely to lose any relevance. I believe we will see an increase in efficiency as we are able to

execute our daily tasks while improving our access to vital information necessary to complete our mission.

Pharmacists undoubtedly faced daunting tasks along the way. New technology means there’s a learning curve, but those learning curves have been to our benefit and prepared pharmacists for the future. Information technology is now a staple, entrenched into the lives of all human beings. Today, we can use two new technological advancements that provide a way for pharmacies to work with greater confidence and efficiency.3 These innovations ensure that each patient is receiving the correct medication in their prescribed dosages. Digital imaging allows the display label of a medication to be digitized on screen as part of a multistep process by a pharmacist, streamlining the verification process during dispensing procedures.4 Machines assist the pharmacist in the dosage count for certain medication dispenses. IT/AI advancements also ensure our patients will be receiving an enhanced form of accuracy in lieu of the more antiquated pill counting, which provides a comfort shared by and beneficial for both the patient and pharmacist.

Innovation in AI can create more effective pharmaceutical medications. This has been a hot trend in modern pharmacy. Throughout thousands of combined hours of research, I feel that most people do not comprehend the fantastic implications of all the new pharmaceutical IT/AI advances.

The greatest positive implication is that we can rely successfully upon a computer system to interpret millions of pages of scientific data, facts and literature. AI can help researchers and pharmaceutical companies speed up the entire process of developing new medications during the required drug clearance process.5 The particular computer system leading the race is the IBM® Watson, which has a platform known as IBM® Clinical Development that covers an entire study from start to finish. IBM’s broadly innovative IT/AI platform features solutions that can gather, organize, analyze and report data for any type, size or phase of a clinical trial from any place in the world.6 As such, artificial intelligence will be used in drug development and enhancements. We can only expect even greater positive professional outcomes.

Another major advancement is 3D printable medications.

This innovation paved the way for pharmaceutical companies to lower the cost of manufacturing medications. The first company to do this was Aprecia Pharmaceuticals, which created the first-ever FDA approved, 3D-printed medication — Spritam. This process allows for the pill to be porous enough to dissolve quickly while still delivering an efficient amount of dosage to each patient. This advancement led to an extraordinary and fresh prescription drug landscape, as well as creating a path for a bright future ahead in the pharmaceutical industry.

It is worth noting that, besides the use of AI for the creation of medications or use during sequencing, we can now also utilize AI to gather data. Gathering data can lead to a much safer and smoother process, and help patients gain access to much needed prescription-based health care. It is the willingness to fathom what capabilities we have yet to create and eventually access at our fingertips. AI has given us an avenue

that so many medical professionals at one point in time never believed to totally transform our mobile devices for a patient’s health care, such as with our various new mobile heath applications and an introduction to virtual health care systems.

Mobile health applications are providing more ways than ever before to gather relevant data for the use of clinical trials. These apps are now being recommended to patients nationwide to provide precise information on a patient’s health in real time! This is why newly developed medical apps have been used to study diseases like Parkinson’s disease, diabetes, breast cancer, asthma and cardiovascular disease.7 Pharmaceutical companies and others are finally recognizing this advancement as a helpful and crucial necessity across clinical research models, especially as the threat of harmful diseases become more pervasive. Prescription apps help facilitate the development of new medications and use data in a way that studies each in order to guide researchers down a shorter, more direct path of creating the most beneficial medicine for patients who have any of the pervasively advancing viral and bacterial pathologically life-threatening diseases.8 We must gain clinical knowledge so that pharmacists, researchers and health care professionals can provide a more effective preventative care treatment plan or be able to depend upon better management of our patients for them to enjoy a much-improved quality of life. The more that can be discovered from tracking a patient’s disease, the more doors are opened up in more ways than ever before imagined. AI/IT production and advancement gives pharmacists an increased opportunity to more swiftly access more and better knowledge to improve our necessary treatments with more highly advanced modalities to be used in improved patient health care outcomes. Some of these applications include the Cardiogram’s Deep Heart app known to aid in the detection of diabetes and other medical conditions.9 The MyStudies app is FDA-approved to facilitate the collection of real-world evidence through mobile devices, and it is becoming widely known for aiding in increasing the interpretation of and diversity of new information research for clinical trials.10 Another app is Sensely, an avatar-based mobile phone chatbot app linked with patient self-monitoring to enhance access to health knowledge while building trust, which has decreased hospitalization, readmissions and monitoring costs.11 This is hugely beneficial preventative health care news.

Across America and the globe, IT/AI usage has shifted the spectrum of our profession. More and more, we are relying on digital and virtual technology. IT/AI is expected to balloon across e-commerce and mobile channels for marketing, which will produce stiff competition across the pharmaceutical industry. The transcendence of virtual health care will be seen in uses such as apps, online prescription forms, patient portals and delivery services. These all are sure to be the future of procuring medications for manufacturing, refill requests and automated patient deliveries. Even technology such as telemedicine (defined as the remote diagnosis and treatment of patients by means of telecommunications technology) has now expanded pharmacy services across the internet. Individual patients who are willing and able can ultiAPRIL 2020

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mately utilize this model for point-of-care access to add the convenience of quickly having a pharmacist be immediately accessible at any time. This is especially accommodating to the patient when they need help, medical/medication advice and personalized, specific treatments in the most desperate of times.

Pharmacists in remote locations can fill prescriptions that can then be mailed to the patient’s location. This specialized modality for care is especially advantageous for both the pharmacist and patient alike in places like Alaska, due to its sparsely populated demographic areas. Looking forward, a futuristic model of telemedicine will be automated dispensing systems which will be remotely located with a pharmacist only one telecommunications link away from being connected with a patient. This will enable more direct access of care for a patient whose pharmacy might be closed after hours or which may provide access for those in rural areas without a pharmacy located for miles.

Moreover, (if not all) pharmacy experts say that data tracking and the management of the data is one of the single most daunting tasks regarding all health systems’ pharmacies.

Pharmacies must ensure they are conforming to the use of fundamental methods and facets of acquiring data as it is an intrinsic part of the health care system. Pharmacies should be able to use their data to make sharper, quicker and smarter decisions for patients. Data must be made more efficient. Elevating our use of data will resolve problems in pharmacies such as slashing the cost of managing numerous IT systems and expanding research and the ability to accurately design treatment plans for the best patient outcomes. An idea would be to entirely integrate all the health systems into a single platform. This could save time in performing day-to-day activities because it would assist in optimizing inventories, generating more accurate reports and managing individualized consumer/customer loyalty programs.

Pharmacies will progressively increase the use of analytics such as electronic health records systems for the benefit of the overall health of the patient and results in a chance to provide better services to its customers. Additionally, pharmacies will use business analytics to help identify a patient’s course of action or status and be able to actively improve outcomes. There is definitely a multifaceted, scientifically sound approach needed in order to move forward like researchers are hoping to. Pharmacies will be positively impacted as patients continue to embrace technologies that give them a tremendous sense of control with more access to pertinent information.

For instance, technologies that provide patient awareness of drug-pricing disparities between retail pharmacies will influence a patient’s decision on where to get a prescription filled.

So, if our patients are already embracing this shift in technological advancements, then nothing should prevent us within the pharmacy world from recognizing IT/AI as tools to reach for excellence.

What is holding us back from riding this wave? If we do not adapt to these exciting, but daunting advances, then we will choose to be suspended in time when compared to the more courageous adventurous few seeing the positive ele24

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ments of IT and AI. Perhaps we all might consider choosing what is best for our patients. IT/AI is proving to be the future of the pharmacy profession — and for the health care industry as a whole. It is important to not forget our humanitarian reasons for choosing a career in health care in the first place.

From those reasons comes a technological system of advancements. The key to unlocking our potential is to recognize IT/ AI and to begin to fully embrace its benefits. It is to our advantage as pharmacists — so we can continue our oath to provide the best quality of care to our patients.

Travis C. A. Brooks is a doctor of pharmacy candidate at Florida A&M University. At the time of submission, he was an advanced pharmacy practice intern at the Florida Pharmacy Association. He aspires to help contribute to pharmacy practice, his community and the patients in society that will need harmacists to uphold the standard of excellence to be suitable for all mankind. He says, “You have got to carry a vision in pharmacy and deliver the kind of leadership that is empowering towards others. Ensure this is done with full integrity and compassion so that others reach for excellence.”

References

1. Abubakar A, Sinclair J. Federal Initiatives Promoting HIT Health Information Technology in Practice. Vol 24.; 2018. doi:10.1016/j. ptdy.2018.04.036 2. Artificial Intelligence in Pharmacy: Are You Ready? | Clinical Drug Information. https://www.wolterskluwercdi.com/blog/ artificial-intelligence-pharmacy-are-you-ready/. Accessed March 16, 2020.

3. Flynn A. Using artificial intelligence in health-system pharmacy practice: Finding new patterns that matter. Am J Heal Pharm. 2019;76(9):622-627. doi:10.1093/ajhp/zxz018 4. Ghafur S, Schneider E. Why Are Health Care Organizations Slow To Adopt Patient-Facing Digital Technologies? Health Affairs. doi:10.1377/hblog20190301.476734 5. The Ten Pharmacy Trends to Watch Out For in 2020 - APPA. https://joinappa.com/the-ten-pharmacy-trends-to-watch-outfor-in-2020/. Accessed March 16, 2020.

6. IBM Clinical Development - Overview | IBM. https://www. ibm.com/products/clinical-development. Accessed March 9, 2020.

7. Chronic Disease Mobile Health Apps Need Better Value Propositions and Evidence | Avalere Health. https://avalere. com/insights/chronic-disease-mobile-health-apps-needbetter-value-propositions-and-evidence. Accessed March 9, 2020.

8. Wilhide Iii CC, Peeples MM, Anthony Kouyaté RC. EvidenceBased mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework. JMIR Res Protoc.

2016;5(1):e25. doi:10.2196/resprot.4838 9. Study: Cardiogram’s DeepHeart detects diabetes through smartwatches | MobiHealthNews. https://www. mobihealthnews.com/content/study-cardiograms-deepheartdetects-diabetes-through-smartwatches. Accessed March 9, 2020.

10. FDA Launches App to Support Clinical Trials, Real-World Evidence Collection. https://www.healthitanalytics.com/ news/fda-launches-app-to-support-clinical-trials-real-worldevidence-collection. Accessed March 9, 2020.

11. Homepage - Sensely. https://www.sensely.com/. Accessed March 9, 2020.

Risk Management Alert: Drug Shortages From Pharmacists Mutual

medications to patients with clear indications and needs.

Over-dispensing of any one medication for a patient can unintentionally harm several others. The unapproved medications being touted against this virus serve a select group of patients with serious diseases in which these drugs are their only option.

Pharmacies across the nation have implemented policies to prevent over-prescribing and over-dispensing. States have gotten involved to try to limit or regulate certain medications. As the pandemic unfolds, we encourage members to plan ahead for drug shortages and issues they may encounter while providing patient care.

Drug shortages – including human, animal and biological products – have been an ongoing issue for the past several years. Many shortages were a result of market changes and supply challenges. However, the COVID-19 pandemic has created an acute demand for certain products and a disruption in the supply chain.

The FDA is working with manufacturers so that they may have accurate data on drug supplies, and the FDA and ASHP maintain a list of drug shortages. As you view each list, you may find discrepancies based on how each entity defines and categorizes the shortage. Both lists are an excellent resource when trying to gain information about what medications are available and the approximate availability of drugs in shortage.

On the front lines of this pandemic, pharmacists have the opportunity to provide information, testing to suspected COVID-19 patients, education about over-the-counter options for symptoms and be stewards of good dispensing practices. The temptation for patients to hoard medications and even for prescribers to order medications without an indication has already been apparent.

As pharmacists, we have the opport unit y and responsibility to dispense appropriate amounts of

UNFORTUNATELY, WE ARE UNABLE TO PREDICT HOW LONG THIS PANDEMIC AND RESULTING FALLOUT WILL LAST. PLEASE REMEMBER, IF YOU CANNOT PROVIDE THE NEEDED MEDICATION TO YOUR PATIENT, DO NOT LEAVE THEM WITHOUT TREATMENT.

Members are advised to: ■ Stay abreast of drug shortages, supply chain issues and therapies being utilized. This can help you anticipate the needs of your patients and limits you may encounter with their care.

■ Research options for different dosage forms, delivery methods or medications for items that are in shortage.

■ Keep providers up to date on supply issues so they can be involved and ready to make therapeutic substitutions for patients.

■ Communicate with patients and their family members so they understand limitations on prescriptions, changes to therapy or changes to dosing that may occur due to differences in strength or actual medication. Patients may also need information about the new ways they interact remotely or through drive-thru windows with pharmacy staff.

Unfortunately, we are unable to predict how long this pandemic and resulting fallout will last. Please remember, if you cannot provide the needed medication to your patient, do not leave them without treatment. It is imperative that you find a pharmacy with the needed medication or contact the provider for a therapeutic substitution or further evaluation of the patient. Pharmacists are well-positioned to assist patients in navigating the health care landscape during this difficult time.

To learn more about COVID-19 and what you can do to protect yourself and your business, visit the Risk Management Center and enter “COVID-19” in the search box. The RMC is available at no cost to Pharmacists Mutual commercial insurance customers at www.phmic.com. Click “My Accounts” in the upper right corner to access or enroll.

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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

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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.

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130th Annual Meeting and Convention

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

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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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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.

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FLORIDA PHARMACY TODAY

1

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_________________________

2

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

$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

6

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

$______

7

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

$40

$_______

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

3Student

Handbooks

(BEST Value includes Registration & Membership)

3

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.

4

House of Delegates

House of Delegates (Non-convention registrants)

Quantity

8

_______

Amount $______

$50

$______

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

9

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

APRIL 2020

|

31

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