ARRX - First Quarter 2019 by Arkansas Pharmacists Association

First Quarter 2019 Award-Winning Quarterly Publication of the Arkansas Pharmacists Association

WHERE THERE'S SMOKE... THE EPIDEMIC OF TEENAGERS AND E-CIGARETTES

PASSE 101

ARâ&#x20AC;¢Rx

THE ARKANSAS PHARMACIST

Dear Colleagues, The Arkansas Pharmacists Ass ociation (APA) is your professiona l statewide organization and for we have been looking after the the past 136 years, interests of Arkansas pharma cists. Today, I want to personally your professional future by join invite you to invest in ing APA as a member in 2019. 2018 was a challenging year for Arkansas pharmacists, but every step of the way APA has advocate for our profession. been there to fight and The community pharmacy mar ketplace was broken in 2018 all practice settings stood side and pharmacists from by side to fight for tax payers, patients, and our profession that successful year despite the imm we love. We had a ense challenges and we learned more than ever that it would be you. The key to success is you impossible without r continued membership in APA , financial support of our politica and professional engagement l action committee, through your valuable time and presence. A few of our succes ses include: • The APA worked with the Ark ansas legislature and Governo r to pass and sign pharmacy ben legislation during a special legi efit manager licensure slative session called by Gov ernor Hutchinson. This legislat Representative Michelle Gray ion, sponsored by and Senator Ron Caldwell, is leading the nation by creating pharmacy benefits market in fully oversight for the insured health plans. • APA supported Arkansas com munity pharmacists in their effo rts to report potential Decepti Act violations by Arkansas PBM ve Trade Practice s to Attorney General Leslie Rutledge. The attorney general investigation into CVS Carema announced an rk in February 2018 and this inve stigation remains open. • APA supported the attorney general’s office as they fought for the 2015 MAC pricing law court at the 8th Circuit of App , Act 900, in federal eals. The law was upheld for fully insured plans and overturned D. The federal court also ruled for Medicare Part that ERISA self-insured plans were not required to follow ACT general has filed for a petition 900. The attorney to the Supreme Court of the Uni ted States to overturn the app on self-insured plans preemp eals court decision ted by ERISA. • APA staff and members par ticipated in nearly 30 live tele vision interviews. APA staff was published news articles in Ark also interviewed for ansas Business, the Arkansas Democrat-Gazette, the Los Ang Street Journal, and Bloomberg eles Times, the Wall Law. • APA staff continues to sup port the development of the Arkansas CPESN (Communit Services Network), which offic y Pharmacy Enhanced ially launched as a clinical integrat ed network with CPESN USA. community pharmacies are par Over 112 Arkansas ticipating in the network and they were the first network in the cou 95% geographic network ade ntry to achieve quacy and 90% population netw ork adequacy. • APA continues to support its partnerships with the Ark ansas Association of Health Consultant Pharmacist Academ Systems Pharmacists, y, and Compounding Pharma cist Academy. • APA provides expertise and facilitates conversations with health plans about attributing and paying for professional pha patients to a pharmacy rmacist enhanced services. • APA offers networking and relationship building opportunitie s for its members at educationa regional meetings in 11 different l conferences and cities across Arkansas.

We appreciate the opportunity to serve the pharmacists of Ark ansas. We are one of the stro associations in the nation but ngest state pharmacist will only remain that way with you r active membership and eng not hesitate to contact our tale agement. Please do nted staff at 501-372-5250 if we can do anything to serve you joining the APA! you. We look forward to Sincerely,

John Vinson, Pharm.D. Chief Operating Officer 417 South Victory Street | Littl

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e Rock, AR 72201-2923 | p 501

-372-5250 | f 501-372-0546

| www.arrx.org

Pharmacy Insurance

Tomorrow. Imagine That.

phmic.com

All products may not be available in all states and territories.

APA Staff John Vinson, Pharm.D. Chief Operating Officer John@arrx.org Jordan Foster Director of Communications Jordan@arrx.org

Susannah Fuquay Director of Membership & Meetings Susannah@arrx.org Lauren Jimerson, Pharm.D. Executive Fellow Lauren@arrx.org Celeste Reid Director of Administrative Services Celeste@arrx.org Debra Wolfe Director of Government Affairs Debra@arrx.org Office E-mail Address Support@arrx.org Publisher: John Vinson Editor: Jordan Foster Design: Gwen Canfield - Creative Instinct Arkansas Pharmacists Association 417 South Victory Street Little Rock, AR 72201-2923 Phone 501-372-5250 Fax 501-372-0546 AR•Rx The Arkansas Pharmacist © (ISSN 0199-3763) is published quarterly by the Arkansas Pharmacists Association, Inc. It is distributed to members as a regular service paid for through allocation of membership dues ($5.00). Non-members subscription rate is $30.00 annually. Periodical rate postage paid at Little Rock, AR 72201. Current edition issue number 85. © 2016 Arkansas Pharmacists Association.

POSTMASTER: Send address changes to AR•Rx The Arkansas Pharmacist 417 South Victory Little Rock, AR 72201 Opinions and statements made by contributors, cartoonists or columnists do not necessarily reflect the attitude of the Association, nor is it responsible for them. All advertisements placed in this publication are subject to the approval of the APA Executive Committee. Visit us on the web at www.arrx.org.

CONTENTS 6 Inside APA: Setting the Stage for 2019

25 AAHP: Membership and Advocacy

7 From the President: A New Year

26 Compounding Academy: Changes

9 Member Spotlight: Joshua Bright

Pharm.D. - Director of Pharmacy Services, North Arkansas Regional Medical Center

10 FEATURE: PASSE 101 14 Rx and the Law: Pharmacy Benefit

to Cleaning in the Non-Sterile Compounding Lab

27 2019 Calendar of Events 28 2019 APA Awards Solicitation 30 Call for Board Nominations 2019-2020

Manager Regulation

15 Safety Nets: Zithromax 17 New Drugs: A First Class Quarter at the

FDA

18 UAMS: Farewells and Opportunities 19 Harding University: New Strategic Plan

Offers a Look Ahead

20 FEATURE: Where There's Smoke -

The Problem with Electronic Cigarettes

ADVERTISERS 4 Pharmacists Mutual 8 Retail Designs, Incorporated 8 Arkansas Pharmacy Support Group 13 Save the Date: 2019 APA Convention 16 EPIC Pharmacies 16 UAMS College of Pharmacy 23 Biotech Pharmacal, Inc. 26 The Law Offices of Darren O'Quinn 31 Pharmacy Quality Commitment Back Cover: Amerisource Bergen

24 Legislator Profile: Representative Mark

Lowery - Maumelle

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APA Board of Directors 2018 - 2019 Officers President – Stephen Carroll, Pharm.D. President-Elect - Dean Watts, P.D., DeWitt Vice President – Kristen Riddle, Pharm.D., Greenbrier Past President – Lynn Crouse, Pharm.D., Lake Village

Regional Representatives Region 1 Representatives Dylan Jones, Pharm.D., Fayetteville Spencer Mabry, Pharm.D., Berryville Lacey Parker, Pharm.D., Charleston Region 2 Representatives Greta Ishmael, Pharm.D., Cherokee Village Region 3 Representatives Brandon Achor, Pharm.D., Sherwood Clint Boone, Pharm.D., Little Rock Lanita White, Pharm.D., Little Rock Region 4 Representative Betsy Tuberville, Pharm.D., Camden Region 5 Representative James Bethea, Pharm.D., Stuttgart At Large Representatives Yanci Walker, Pharm.D., Russellville Stacy Boeckmann, Pharm.D., Wynne Academy of Consultant Pharmacists Larry McGinnis, Pharm.D., Searcy Academy of Compounding Pharmacists Tyler Shinabery, Pharm.D., Sherwood Arkansas Association of Health-System Pharmacists David Fortner, Pharm.D., Rogers

Ex-Officio APA Chief Operating Officer John Vinson, Pharm.D., Benton AR State Board of Pharmacy Representative John Kirtley, Pharm.D., Little Rock UAMS College of Pharmacy Representative (Interim Dean) Schwanda Flowers, Pharm.D., Little Rock Harding College of Pharmacy Representative (Dean) Jeff Mercer, Pharm.D., Searcy Legal Counsel Harold Simpson, J.D., Little Rock Treasurer Richard Hanry, P.D., El Dorado UAMS COP Student Cortni Hicks, Little Rock Harding COP Student Jacilyn 6 McNulty, Searcy

INSIDE APA

Setting the Stage for 2019

n 2019, Arkansas is the first state in the nation to John Vinson, Pharm.D. license pharmAPA Chief Operating Officer acy benefit managers (PBMs) and define a robust set of specific prohibited acts. At the time of this article, the state has awarded licenses, including those operating in the fully insured commercial insurance space. Having a referee on the playing field is a great first step to encourage the possibility of a fairer marketplace, but it is not a perfect law or a fair marketplace yet. The Arkansas Pharmacists Association team plans to work harder than ever to look for needed tweaks in the law, advocate for enforcement of the laws, and seek innovations in the market. Self-insured insurance provided by larger employers is, for the most part, not subject to oversight by the Arkansas Insurance Commissioner through the PBM licensure act. This type of health insurance is preempted from state law. Pharmacists need to be willing to talk to the CEO, COO, VP for Benefits, and the human resources director about plans that treat you unfairly in an anticompetitive fashion. Spread pricing, clawbacks, mandatory mail order, repackaging by mail order pharmacies, and below cost reimbursement are all threats to patient care, access, and quality. Often, these employers do not understand health benefits and they hire a benefits consultant that gives them bad advice. You must be willing to challenge that bad advice and encourage employers to invest in value-based care rather than treating prescription drugs like a simple commodity. This all starts with a conversation and a relationship. Employers in Batesville (Steve Bryant) and Jonesboro (Arkansas State) have been listening and are implementing transparent models that treat pharmacists like healthcare providers. State employees and public-school teachers (EBD) has 155,000 lives and is also continuing to use a transparent evidence-based model. We are also likely to see new self-insured models emerge called Association Health Plans that President Donald Trump authorized last year.

Medicare D prescription drug plans are also preempted from state law. The PBMs operating in these plans are subject to oversight by CMS (Centers for Medicare & Medicaid Services). Pharmacists in January have been aggressively providing written comments to CMS for a proposed rule change for DIR fees and quality payments for prescription drugs. This outreach from pharmacists is needed to advocate for simplicity and transparency rather than complexity. The current complexity is driving rural pharmacists out of business, raising out of pocket costs for seniors and the disabled, and is lining the pockets of insurance companies and PBMs. The Wall Street Journal estimated in January 2019 that the current complicated system led to PBMs and carriers overcharging tax payers by an estimated $9.1 billion dollars. It is very important to continue to speak out to CMS about changing the broken market, including the ridiculous, anti-quality preferred-pharmacy networks. The Arkansas General Assembly kicked off a full legislative session on Monday, January 14, 2019. We have 100 state House of Representative members and 35 state Senators. The time around, there are two Arkansas Pharmacists Association members and pharmacists serving in the House. There are several others in both the Senate and House who also deeply understand our great profession. We appreciate their service and their unique understanding of our complicated issues. The legislative session will be dominated by state government transformation legislation guided by Governor Asa Hutchinson and the legislative leadership. There will also be several potential scope of practice legislative bills considered for optometrists, physicians, pharmacists, and nurse practitioners. Leading up to session, legislators filed three Interim Study Proposals (ISPs) for three possible opportunities for pharmacists to work at the top of their license in collaboration with physicians to address top public health issues in Arkansas. I am hopeful that the session will bring positive and new opportunities for pharmacists to better utilize their skills and training for improved patient care.

AR•Rx

THE ARKANSAS PHARMACIST

SETTING THE STAGE FOR 2019

Telepharmacy, advancing automation, expanding 340B opportunities, and new value-based payment programs are expected to grow in 2019. I also expect to see drug pricing and prescription drug rebates to continue to be under the microscope at both the state and the national level. Mergers and vertical integration will continue to bring both opportunities and threats to our profession and patients. We also will finally see the new managed care Medicaid program, provider-led care operated PASSEs, fully launch for 45,000+ complicated patients with behavioral health and developmental disabilities. Pharmacy will be part of these programs and will be administered by pharmacy benefit managers who will either design value-based programs that treat pharmacists as healthcare professionals or resort to broken market business tactics that pay pharmacists below cost. The decision of these plan designs will be made by a board that has healthcare provider majority ownership. Time will tell. We will be having ongoing discussions with

the Arkansas Medicaid Fee for Service program about the possibility for modernizing immunization policy, slot limits on prescriptions, and prescription expiration dates. Finally, we will continue to monitor the ongoing Attorney General’s role in enforcing the Arkansas Deceptive Trade Act. We are anxiously awaiting to see if the United States Supreme Court will choose to hear the Act 900 MAC law case based on the 2018 petition for writ of certiorari from the Arkansas Attorney General with support from 38 other state attorney generals. Thank you for your membership and engagement in our profession. We need your continued involvement, support, and ideas. Finally, we also need your financial support for our political action committee as it is vital for Arkansas pharmacists to support political candidates that recognize the value that local Arkansas pharmacists bring to our state. I look forward to serving each of you and our great profession in 2019. §

FROM THE PRESIDENT

A New Year

he 2019 calendar year is off to a fast start. Drug manufacturers took widespread price increases. Pharmacies are having to monitor reimbursement changes to ensure updated pricing is loaded at third party payors. APA COO John Vinson did an excellent video on social media explaining price increases and what to watch for with third party payors to help ensure pharmacies receive correct reimbursement. In addition, the Arkansas Insurance Commissioner issued licenses to several PBMs as part of the PBM Licensure Act which was passed during the special legislative session in 2018. I feel that it is very important for us to use this new law to ensure that PBMs are complying with the law’s provisions. The law offers multiple issues for pharmacists and pharmacies to report to the Arkansas Insurance Commissioner’s office. I encourage you to look at this as an opportunity to expose bad actors and ensure that patients in Arkansas have the access they need to their local pharmacy. The PBM Licensure Act of 2018 was a major step, but it was not perfect. We must identify methods that are being used by PBMs to circumvent the law so that they can be addressed with the legislature. The Arkansas legislature began the 2019 legislative session in January. Dr. Vinson and our legislative affairs team have been working diligently to ensure that APA is at the table focusing on issues that affect pharmacy. It is important for us as APA members to continue engaging our legislators to ensure that they know where we stand on issues that affect pharmacy. There are several issues that the APA staff have been receiving questions on and I ask each member to be prepared to help if staff calls upon us. APA efforts are making a difference. DIR fees have been wreaking havoc on patients and pharmacies across Arkansas.

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On January 31st, the Arkansas United States congressional delegation sent a letter to the Secretary Alex Azar with the Stephen Carroll, Pharm.D. Department of Health and Human President Services voicing support of CMS’s proposed reform to DIR fees. I urge you to thank your congressman for their support of this proposed rule change that is imposing a greater financial burden to our patients. We must continue to ensure Arkansas patients have adequate access to healthcare. I am proud that Arkansas pharmacies have started programs to provide CLIA waived tests to patients and are working with local physicians to use test results to refer patients that need to see their physician. We must continue to look for opportunities to improve access for patients and be prepared to expand our scope of practice to provide better care for patients. If you are performing a healthcare service for your community, be sure to tell your legislators about the value of the service for patient and how you are collaborating with other healthcare professionals to ensure prompt access to care for your patients. I am also excited to see the results from the smoking cessation program developed by Harding University in coordination with APA and the Arkansas Department of Health. This provides an opportunity for pharmacists to prove that we are continuously working to improve public health. As a reminder, please be on the lookout for the weekly APA Interactions email that is sent out each Friday. It is a short and effective way for APA staff to communicate with us and ensure we are up to date with the issues facing APA and pharmacy in Arkansas. §

ARâ&#x20AC;¢Rx

THE ARKANSAS PHARMACIST

MEMBER SPOTLIGHT

Joshua Bright Pharm.D. Director of Pharmacy Services North Arkansas Regional Medical Center

Pharmacy School & Graduation Year: UAMS, 2008 Years in business/years teaching: I’ve been in a pharmacy

since I was 17 years old. I was hired as a clerk in a community pharmacist by my brother David, who is also a practicing pharmacist.

Favorite part of the job and why: I like the variety of work

that I get to do as a pharmacist. I’ve been fortunate to work in several roles and work in an institution that appreciates innovative thinking. I like interacting with my staff, and solving problems as a team.

Least favorite part of the job and why: The breadth

of regulation surrounding pharmacy poses an incredible challenge. It is difficult to feel competent in any one area without feeling neglectful in others. With numerous changes in the USP compounding standards, 340B rules, DSCSA, payer updates, and others, keeping up is daunting. I think my least favorite thing is the monotonous daily work that goes into keeping up with the regulatory requirements.

What do you think will be the biggest challenges for pharmacists in the next 5 years? I feel that the biggest

challenge in pharmacy will be obtaining provider status to ensure payment for cognitive services. Though our biggest opportunity may be innovation and improving quality in population health models, the biggest challenge will be proving that those services should be properly reimbursed. Reimbursement for these cognitive services, while showing improvement in quality versus standard care, will help offset overall payer pressure.

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Oddest request from a patient/customer: The first time

a physician ordered a whiskey in the hospital, I thought it was some kind of prank. It wasn’t until getting hired in the hospital that I’d ever seen alcohol ordered like a medication. I thought, “What kind of place are we running?” A few years down the road, I still chuckle about my first reaction when the occasional order comes over.

Recent reads: I’ve recently re-read several books by Patrick

Lencioni, including “The Five Dysfunctions of a Team,” which is now part of the curriculum for our APPE Management students. I like his practical and engaging style. I’ve also recently finished “Around the World in 50 Years” by Albert Podell.

Favorite activities/hobbies: I like to do some small

woodworking projects like cutting boards. I also love to garden- particularly roses and a small vegetable garden.

Why should a pharmacist in Arkansas be a member of the Arkansas Pharmacists Association? I recently

heard a colleague say that participating in our professional association is the rent we pay for the room we take up in the profession. This cannot be more true right now. The profession is changing rapidly, and we must continually redefine our role in healthcare to stay relevant. With an onslaught of new regulations and pressure from payers, there has never been a better time for Arkansas pharmacists from all practice settings to have a united voice. This voice comes through your membership in the APA and its academies. Supporting, engaging, and participating in the Association ensures that pharmacists continue to reinvent and empower the profession. § 9

PASSE

101

By Jordan Foster APA Director of Communications

ASSE – Provider-Led Arkansas Shared Savings Entity system – a managed care model created by Act 775 of 2017 - each PASSE consists of a partnership of healthcare providers and a traditional organization that performs administrative healthcare functions such as claims processing, member enrollment, and appeals, similar to the role of an insurance company. The “Provider-Led” part of the PASSE acronym denotes that the healthcare provider partners must own at least 51% of the PASSE and the governing body of the PASSE must include several types of providers licensed to practice in Arkansas, including a developmentally disabled specialty provider, a behavioral health specialty provider, a hospital, a physician, and a pharmacist. The PASSE system was designed to improve the health of Medicaid patients in the behavioral health (BH) and 10

developmental disability (DD) populations who need more intensive care and allow them to take a more active role in their treatment by connecting them with services in their community, as well as services from their doctors. In addition, the PASSE system aims to increase the number of providers available to the DD/BH populations while reducing costs of care by coordinating and providing appropriate and preventative care. Organizing the full range of services for individuals in the PASSE system is expected to lower costs and improve health outcomes by appropriately utilizing services – decreasing gaps in care, lowering the rates of crisis and acute care, decreasing duplication of services, and improving medication management. Further savings are expected through lower rates of emergency room visits, reduction in hospital admissions for ambulatory sensitive conditions, and reductions in hospital readmissions. AR•Rx

THE ARKANSAS PHARMACIST

Phase 1

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The PASSE system aims to increase the number of providers available to the developmentally disabled and behavioral health populations while reducing costs of care by coordinating and providing appropriate and preventative care.

PATIENT PROCESS During Phase 1 of the PASSE implementation (February 2018 – February 2019), the Arkansas Department of Human Services hired Optum to independently assess Medicaid recipients that receive behavioral health or developmental disability services, determine their needs, and establish a level of service for the patient by assigning them to one of three tier levels.

Behavioral Health: Tier 1 – The patient can receive counseling services and medication management but is not assigned to a PASSE. Their needs will be met through the Outpatient Behavioral Health system. Tier 2 – The patient is eligible for targeted services provided in home and community settings in addition to counseling Tier 3 – The patient is eligible for all of Tier 2 services and may need services provided in residential settings

Developmental Disability: Tier 2 – The patient is eligible for paid services and support. Tier 3 – The patient is eligible for the most intensive level of services, including 24 hours a day/7 days a week paid supports and services. After the initial assessment, patients were assigned to one of three PASSEs (Arkansas Total Care, Empower Healthcare Solutions, Summit Community Care) and a care coordinator contacted each patient to guide them through this new process.

Phase 2

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PHARMACISTS INFORMATION During Phase 2 of the PASSE process (March 2019), each PASSE receives a global payment from Arkansas DHS to cover the cost of care of all services provided to their members, including pharmacy services. The payment will also cover care management, care coordination, and administrative expenses. Pharmacies bill the PASSEs, not Medicaid, for patients who are participating in the PASSE program. During Phase 2 and beyond, if a pharmacist tries to submit a fee-for-service claim for a PASSE recipient, the claim will be rejected with a message that the patient is in a PASSE network and you can either log into the DXC Eligibility Portal to locate the patient’s PASSE network or you can contact the PASSE directly if you know the patient’s assigned network. Fortunately, similar to an insurance company, each PASSE provides patients with an ID card they can present at the pharmacy with information on the PASSE to which they’ve been assigned. DXC Provider Portal – https://portal.mmis.arkansas.gov/ armedicaid/provider/Home/tabid/135/Default.aspx (continued)

cut out & post

PASSE CONTACT INFORMATON Arkansas Total Care www.ArkansasTotalCare.com 1-866-282-6280 John Ryan JRyan@centene.com

Empower Healthcare Solutions www.GetEmpowerHealth.com 1-866-261-1286 Nicole May

Summit Community Care www.SummitCommunityCare.com 1-844-405-4295 Jason Miller

Care Coordination Contact: Amber Baker 501-478-2597

Care Coordination Contact: Jamie Ables 501-707-0961

Care Coordination Contact: Tiffany Parkhurst – 501-773-6273

PBM: Envolve Pharmacy Solutions

PBM: CVS Caremark

Amber.Baker@ArkansasTotalCare.com

Nicole.May@BeaconHealthOptions.com

Jamie.Ables@BeaconHealthOptions.com

Jason.Miller@SummitCommunityCare.com

Tiffany.Parkhurst@SummitCommunityCare.com

PBM: Express Scripts, Inc.

*Note: In January 2019, Gateway Health, the managed care organization that would have been the managed care partner for ForeverCare, the APAbacked PASSE, decided not to move forward with the program.

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PASSE 101

APA is continually watching the PASSE rollout and we know that there may be bumps along the way with the implementation of this new program. However, if reimbursement rates become unsustainable, APA and your local legislators need to know. Please contact us if you start to see rates dip low enough to threaten your sustainability in the PASSE program. §

Sources: https://www.macpac.gov/medicaid-101/ provider-payment-and-delivery-systems/ https://access.arkansas.gov/pdf/acafaqs. pdf https://afmc.org/health-careprofessionals/arkansas-medicaidproviders/policy-and-education/webinars/ https://medicaidsaveslives.files. wordpress.com/2017/02/arkansasorganized-care-model-information-final-1. pdf

Types of Medicaid Medicaid Fee-for-service (FFS) – Under the fee for service model, the state uses federal Medicaid dollars to pay providers directly for each covered service received by a Medicaid beneficiary. Section 1902(a)(30)(A) of the Social Security Act requires that such payments be consistent with efficiency, economy, and quality of care, and are sufficient to provide access equivalent to the general population. Medicaid FFS payment rates for providers are often much lower than those paid by other payers, raising concerns that low fees affect participation in Medicaid. Medicaid Managed Care - Under managed care, the state uses federal Medicaid dollars to pay a fee to a managed care plan for each person enrolled in the plan. In turn, the plan pays providers for all of the Medicaid services a beneficiary may require that are included in the plan’s contract with the state. In 2013, 72 percent of all Medicaid beneficiaries were enrolled in some form of managed care. Managed care provides states with some control and predictability over future costs. Compared with FFS, managed care can allow for greater accountability for outcomes and can better support systematic efforts to measure, report, and monitor performance, access, and quality. In addition, managed care programs may provide an opportunity for improved care management and care coordination. Arkansas Works – Under the Arkansas Works program, the state uses federal Medicaid dollars to buy private insurance or Employer Sponsored Insurance (ESI) for beneficiaries. Medicaid will pay most or all of the premiums for the plan while the individual may be responsible for copays and a small part of the premium.

AAHP Board

Arkansas State Board of Pharmacy

Executive Director............Susan Newton, Pharm.D., Russellville

President.................................Lenora Newsome, P.D., Smackover

President-Elect............Erin Beth Hays, Pharm.D., Pleasant Plains

Member..........................................Steve Bryant, P.D., Batesville

President..................................David Fortner, Pharm.D., Rogers Immediate Past President.........Brandy Owen, Pharm.D., Conway

Treasurer...........................Kendrea Jones, Pharm.D., Little Rock Secretary..................................Melissa Shipp, Pharm.D., Searcy Board Member at Large.....Kimberly Young, Pharm.D., Little Rock

Board Member at Large........Chad Krebs, Pharm.D., Little Rock Board Member at Large...........Joy Brock, Pharm.D., Little Rock

Vice President/Secretary................Debbie Mack, P.D., Bentonville

Member...........................Rebecca Mitchell, Pharm.D., Greenbrier Member....................................Ken Lancaster, P.D., Arkadelphia Member................................Lynn Crouse, Pharm.D., Lake Village

Public Member........................................Carol Rader, Fort Smith Public Member............................................Amy Fore, Fort Smith

Technician Representative.....BeeLinda Temple, CPhT, Pine Bluff

AR•Rx

THE ARKANSAS PHARMACIST

SAVE the

DATE! 2019 APA Convention June 6-8, 2019 Little Rock DoubleTree Hotel Little Rock, Arkansas

STAFF SPOTLIGHT: ELISABETH MATHEWS

Join us in the heart of the capital cityâ&#x20AC;&#x2122;s downtown district for the 2019 APA Annual Convention, to be held June 6-8 at the Little Rock DoubleTree. APA will offer up to 15 hours of continuing pharmacy education (CPE) relating to pharmacy practices. Members and guests will be able to learn about the latest product trends in pharmacy from more than 40 exhibitors who will showcase new products to potential customers while working to maintain and strengthen relationships with existing customers. Social events to mingle with fellow pharmacists, colleagues, and friends are planned as well as the annual golf tournament on Wednesday afternoon, June 5. Convention registration will open shortly so stay tuned for more information through InteRxActions and at www.arrx.org/annual-convention. WWW.ARRX.ORG

Pharmacy Benefit Manager Regulation This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and the Arkansas Pharmacists Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

first step in the regulation of Pharmacy Benefit Managers (PBMs) occurred at the quarterly meeting of the National Council of Insurance Legislators (NCOIL) in December 2018. That group’s Health, Long Term Care and Health Retirement Issues Committee passed a Model Act providing for the regulation of PBMs by state insurance commissioners. National Community Pharmacists Association’s (NCPA) regulatory affairs Vice President Ronna Hauser said, "We believe the act is a robust chassis that will put state insurance commissioners in a better position to regulate PBMs." Many pharmacists may not have heard of NCOIL nor are they aware of how insurance is regulated in the United States. In 1944, Congress passed the McCarran Ferguson Act which provided for the regulation of the insurance industry by the states rather than the Federal Government. As part of this regulatory design, Congress mandated that states must adopt an Unfair Trade Practices Act by 1948. The states did this through the adoption of a Model Act. Model Acts provide a template for state legislatures to review and adopt in their state. This eases the drafting burden on the legislatures while provided some uniformity across the several states. The National Association of Boards of Pharmacy provides the same service with its Model State Pharmacy Act. To facilitate the state regulation of insurance, there are two groups that provide assistance to the state legislatures and departments of insurance. The National Association of Insurance Commissioners (NAIC) was founded in 1871 and establishes standards, best practices, and coordination of regulatory oversight. NAIC also drafts and proposes Model Acts. NCOIL was founded in 1969 and brings together legislators from the states. NCOIL functions to educate legislators on insurance issues and to create Model Acts for states to adopt. So what does the adoption of this Model Act mean for pharmacy? There have been attempts by a few states to regulate PBMs. These attempts have not been consistent in their approach and some have not survived judicial scrutiny. The Model Act provides a consistent approach to PBM regulation. The Model Act specifically grants the state insurance commissioner the authority to regulate PBMs and to promulgate rules covering items such as network adequacy requirements, pharmacy compensation, and prohibited market conduct practices.

Aside from the legal technicalities, the Model Act facilitates the passage of the law in the various states. The fact that a Model Act has been drafted highlights to state legislators the severity of the issue. The absence of a Model Act can sometimes be used by opponents to advocate that the issue isn’t that important simply because there is no Model Act addressing it. The drafting of a law takes a lot of research time and drafting effort. As mentioned earlier, the Model Act relieves the state legislators of this burden and makes it easier for them to pass the law. The passage of the Pharmacy Benefits Manager Licensure and Regulation Model Act is a positive step in the right direction for the profession of pharmacy. However, advances like this are not easy and are not free. NCPA worked with NCOIL members for more than nine months on the language of the Model Act to make sure that it addressed pharmacy owners’ concerns. This highlights again the need for pharmacists to be involved in the legislative process. As a previous article in this series said, “Even if we don’t get involved in the making of laws, we will be subject to them nonetheless. Pharmacists can ill afford to be impacted by laws drafted by those who know nothing about pharmacy.” The Model Act is available, but that is not the end of the story. Now the scene shifts to the state legislatures. The Model Act will likely face stiff opposition in each state where it is introduced. Pharmacists need to be prepared to get involved and advocate for passage of the Model Act. If you don’t, who will? § ________________________________________________________________ © Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company. This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

AR•Rx

THE ARKANSAS PHARMACIST

UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES COLLEGE OF PHARMACY

Melanie Reinhardt, Pharm.D. Eddie Dunn, Pharm.D.

Zithromax This issue of Safety Nets illustrates the potential hazards associated with poorly handwritten prescriptions. Thank you for your continued support of this column.

pharmacy technician in Central Arkansas received the original, handwritten prescription illustrated in Figure One. The technician entered the information into the computer as “Zithromax Z-PAK®, 250 mg tablets, quantity six, with directions of, “Take two tablets, by mouth today, then one tablet daily for 5 days.” The prescription was filled by the same technician who then placed the filled order in line for pharmacist verification and counseling. During the counseling session, the pharmacist instructed the patient to take two Zithromax® 250 mg tablets immediately, then take one tablet daily thereafter. The patient seemed confused for a moment and then said, “I’m pretty sure the doctor told me to take one a day. I’m almost positive he did.” The pharmacist said, “That’s right. You take one tablet daily after you take two tablets today.” The patient responded, “The doctor just said take one daily. He never said anything about taking two”. After this, the pharmacist re-examined the prescription and realized the handwritten “Z” in Z-PAK® could also be interpreted as the number “3”. If interpreted this way, the prescriber could have actually intended for the patient to receive a Zithromax TRI-PAK® 500 mg tablets which is, in fact, dosed one tablet daily. A telephone call to the prescriber confirmed the patient was to receive Zithromax TRI-PAK®. After this, the prescription was correctly filled and the patient counseled to take one tablet daily for three days. Figure 1

Dispensing a Zithromax Z-PAK® instead of a Zithromax TRIPAK® would not have harmed this patient. That is not the point. One point of this Safety Net is to stress the importance of writing the exact name for the medication prescribed. When taking medication orders from prescribers over the telephone – or transcribing orders from prescriber message lines - all pharmacists should write legible, accurate, complete prescriptions. Illegible scrawls, shorthand notations, and abbreviations that are meaningful to the writer, might be completely meaningless to a relief pharmacist on duty after the pharmacist who wrote the order has left for the day. The second point of this Safety Net is to stress the importance of patient counseling and its important role in patient safety. Question: How would you – a pharmacist - have detected this error other than through patient counseling? The majority of Arkansas pharmacists and technicians would have initially misfilled this prescription by misinterpreting the prescriber’s handwritten “3” as a cursive “Z.” We see handwritten orders for Z-PAK® on a regular basis and rarely, if ever, interpret the letter “Z” for the number “3”. In this case, however, that is exactly WWW.ARRX.ORG

what the prescriber intended. Without patient counseling, this medication error would have most certainly reached the patient. We cannot control what prescriptions come into our pharmacy. We can, however, legibly and correctly transcribe medication orders that can be easily interpreted by other pharmacists and technicians. We must continually strive to create pharmacy environments that maximize patient safety. § STUDENT SPOTLIGHT

Immunizations from a Mother’s Perspective - Chassidy Seward It can be easy to disregard the reasons parents have for refusing to vaccinate their children. When weighing the minimal risk of adverse effects against the overwhelming benefits, it can be hard to imagine why anyone would refuse to vaccinate their child. However, as a mother I am keenly aware of the power of fear. My oldest child was born more than ten years ago, at what felt like the height of vaccination misinformation. I will never forget the fear that washed over me as I listened to Jenny McCarthy spew anti-vaccination propaganda on television. The thought of injecting my baby with anything was terrifying. After researching the claims, I realized much of my fear was unfounded and quickly realized my children needed to become fully vaccinated. I also understand why this decision might not be as easy for others. Parents are bombarded with conflicting information leaving them unable to reconcile their fears, while others may not be able to differentiate accurate information. Additionally, vaccination discussions often become a contentious debate which further complicates reversing the misconceptions surrounding the topic. As pharmacy administered immunizations continue to increase, I believe pharmacists are in a unique position to dispel persistent fears. It is important to recognize that parents choosing anti-vaccination are doing so out of protective instinct. By exploring and correcting lines of reasoning, we can promote open evidence-based discussions that clarify fallacies. Whether their stance is embedded in fear or misguided direction, it will likely remain unchanged when approached with firm advocacy.

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A First Class Quarter at the FDA By guest author Mary Ann McAllen, Pharm.D. Candidate

This quarter saw the approval of 29 new drugs and biologicals, including the first new drug approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs. Many of the approved entities were first-in-class, targeting a wide variety of disease states. This quarter caps off a first class year of more than 60 new drug approvals. Infectious Disease: Xofluza™ (baloxavir marboxil), the first new antiviral influenza treatment in 20 years with a novel mechanism of action, was approved for acute uncomplicated influenza in patients who have not been symptomatic more than 48 hours. Aemcolo™ (rifamycin) got the green light for treating travelers’ diarrhea caused by noninvasive strains of E coli. Tetracycline derivatives made a resurgence this quarter in the infectious disease world. Nuzyra™ (omadacycline), a modernized broad-spectrum tetracycline designed to overcome tetracycline resistance was priority approved to treat community-acquired bacterial pneumonia and acute skin and skin structure infections. Seysara™ (sarecycline), a first-in-class tetracycline derivative, was approved to treat inflammatory lesions associated with non-nodular moderate-to-severe acne vulgaris. Xerava™ (eravacycline) is the first fully synthetic fluorocycline (tetracycline class) for treating resistant pathogens in complicated intra-abdominal infections. Finally, emergency use of the DPP Ebola Antigen System rapid fingerstick test was granted to detect the Ebola virus. Oncology: The industry really took the fight to cancer with a staggering number of oncology approvals this quarter, including one of the first approvals to emerge from the FDA’s new RealTime Oncology Review program which only took only 2 weeks from submission-to-approval for the new indication. Copiktra™ (duvelisib), a phosphoinositide 3-kinase inhibitor, received priority orphan drug endorsement to treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma who have received at least two prior therapies. Daurismo™ (glasdegib), from the oral smoothened inhibitors drug class, was given priority orphan approval for newly diagnosed acute myeloid leukemia in select patients over 75 years old. Libtayo™ (cemiplimab-rwlc), a PD-1 blocker, became the first drug approved for advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery. Lorbrena™ (loriatinib) was approved to treat ALK-positive metastatic nonsmall cell lung cancer. Lumoxiti™ (moxetumomab pasudotox) became a first-in-class treatment for the rare hairy cell leukemia who have received at least two prior lines of treatment. Talzenna™ (talazoparib), a PARP inhibitor, gained priority drug status for the treatment of patients with BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Vitrakvi™ (larotrectinib) is the second tissue agnostic (biomarkers define the cancer rather than the organ where the disease originated) drug approved for solid tumors that have a rare NTRK gene fusion. Vizimpro™ (dacomitinib) gained priority orphan status for metastatic nonWWW.ARRX.ORG

small cell lung cancer. Xospata™ (gliterirtinib) received orphan approval for treating FLT3 mutation-positive AML, along with the LeukoStrat CDx FLT3 Mutation Assay used to detect the mutation. Specialty: Firdapse™ (amifampridine) became the first drug to treat the rare Lambert-Eaton myasthenic syndrome, an autoimmune disorder that affects the connection between nerves and muscles. Gamifant™ (emapalumab), an interferon gamma-blocking antibody, became the first treatment designed for patients with the ultra-rare, rapidly progressing, often fatal primary hemophagocytic lymphohistiocytosis. Revcovi™ (elapegademase-lvlr) earned orphan status to treat adenosine deaminase severe combined immune deficiency by replacing the missing ADA enzyme. Tegsedi™ (inotersen) received priority orphan status to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis due to the abnormal buildup of amyloid in body tissue. Chronic Care: Drugs for chronic conditions were a short list including Ajovy™ (fremanezumab-vfrm) and Emgality™ (galcanezumab– gnlm), as injectable drugs, became the first calcitonin-gene-related peptide antagonists for the prevention of migraine. Dsuvia™ (sufentanil, SL), a synthetic opioid that is 1,000 times more potent than morphine, was to treat severe acute pain in adults amid significant controversy. Yupelri™ (revefenacin) is the first oncedaily nebulized long-acting muscarinic antagonist bronchodilator for COPD. New Dosage Forms: Significant new dosage forms approved this quarter include: Arikayce™ (amikacin liposome, inhalation suspension), for Mycobacterium avium complex lung disease, became the first orphan drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs. Dextenza™ (dexamethasone, intracanalicular) for post-operative ocular pain. GamaSTAN® (human immune globulin, IM) for hepatitis A or measles post-exposure. Jivi® (antihemophilic factor recombinant PEGylated-aucl) for management of bleeding. Primatene® MIST (epinephrine, OTC) was reintroduced to the market for mild intermittent asthma. Symjepi™ (epinephrine, autoinjector) lowdose for children between 33-65 pounds. Xelpros™ (latanoprost, ophthalmic) as the first benzalkonium chloride-free product. Xyosted™ (estosterone enanethate, autoinjector) as the first product for once-weekly self-administration using a disposable autoinjector. §

UAMS SCHOOL OF PHARMACY

Farewells and Opportunities Keith M. Olsen, Pharm.D. and Schwanda Flowers, Pharm.D.

Keith M. Olsen, Pharm.D.

Schwanda Flowers, Pharm.D.

ust under four years ago I was contacted by a search firm recruiting for the dean at the University of Arkansas for Medical Sciences (UAMS) College of Pharmacy. As I look back at that time and the present, the same things keep coming to mind; why I Keith Olsen came back to Arkansas and what I Pharm.D., FCCP, FCCM will miss about Arkansas pharmacy. Former Dean and Professor The passion of pharmacists in Arkansas for the profession is the primary reason for me returning to the College. This passion starts at the grass roots pharmacist level, but the role the Arkansas Pharmacy Association (APA) occupies cannot be understated. The APA is truly a gem among state pharmacy associations that would be difficult to duplicate or find in any other state in this country. The leadership provided by the APA Board, Scott Pace, and John Vinson was amazing, especially this past year as they pulled Arkansas pharmacists together to speak as one voice. Equally important is the close relationship the College and I had with the APA and State Board of Pharmacy. Representatives from each organization met on a quarterly basis for discussions on important pharmacy issues that impact Arkansas Pharmacy. The profession of pharmacy in all practice settings is undergoing a transitional phase as we redefine roles in the patient care process. What the new norm in pharmacy will look like in 5-10 years is unknown; what I do know is the College is committed to produce the best students that will have a lasting impact on the profession in Arkansas and nationally. The faculty at the College have done a tremendous job keeping a positive attitude despite the financial situation at UAMS. The can-do spirit of the faculty has a trickledown effect on our students and trickle up effect as students enter the profession as pharmacists. The entrepreneurial attitude of faculty, students, and Arkansas pharmacists have driven the profession forward and that is difficult to reproduce in most colleges and states. With that being said, leaving Arkansas is bittersweet for me. I will definitely miss the passion for pharmacy that permeates throughout this state as well as many new and old friends. At the same time, the sweet part is to return to my alma mater and to be close to family and grandkids. Therefore, I thank you for all of your support and friendship and bid you farewell, wishing you success, not only in pharmacy, but in your personal lives as well.

s our profession is undergoing a period of transition, so is our College. We are nearing the end of the College’s 66th year and my 14th year on faculty and I am honored to continue to serve our profession and our institution in a new role as Interim Dean. As a native Arkansan and UAMS College of Pharmacy alum, I could not be prouder to have this opportunity to serve and to lead.

Schwanda Flowers Pharm.D. Interim Dean and Professor

I am excited about this spring semester as our faculty and students continue to excel and accomplish great things. A few highlights of some upcoming events are the student mass immunization trainings and the preparations for the Pharmacy Ownership and Leadership Academy. We will be certifying all P1, P2 and P3 students to immunize later this month. By the time you read this, these students will be ready to provide immunizations to patients across the state as student interns or students on experiential rotations. The impact our student pharmacists will have on population health and patient care is tremendous and I am excited for this opportunity and the many others to come. We will also be preparing to offer a weeklong summer academy focused on ownership and leadership. Our Pharmacy Ownership and Leadership Academy (POLA) will bring students from across the country together with UAMS students to develop innovative ideas in community pharmacy. The academy will allow future pharmacy owners the opportunity to interact with current pharmacy owners from Arkansas and develop a network of life-long mentors. Faculty are continuing their work on Curriculum 2025 and beginning work on our SelfStudy planning for our accreditation visit in 2021. Exciting times are ahead and with big changes come even greater opportunities. I hope to have the opportunity to visit with many of you in person as I travel across the state in the coming months. I sincerely thank each of you for your support and for being a friend of the UAMS College of Pharmacy. §

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HARDING UNIVERSITY REPORT

New Strategic Plan Offers a Look Ahead Jeff Mercer, Pharm.D. Dean

uring my time at Harding University College of Pharmacy, I have experienced a number of important occasions. Many have been firsts, like the first time I entered the Farrar Center for Health Sciences, or the day I followed in the footsteps of my mentor and was named Dean in 2016. Other occasions are more routine, yet no less thrilling, like the beginning of each new semester, reciting the Oath of a Pharmacist at each year’s White Coat Ceremony, or the smiles of each new graduate as they cross the stage. I love important occasions and the recognition they receive as we continuously celebrate new beginnings. Thus, it should come as no surprise that 2019 has offered a number of new opportunities for our program. The most significant of which was the implementation of the College’s third strategic plan. This new five-year plan encompasses 2019- 2023 and reflects the feedback and priorities identified by a broad cross-section of our constituents that will be used to guide our strategic steps going forward. True to Harding’s culture, this new plan was formed in accordance with the mission, vision, and core values that have long defined the heart of our program. As stated above, this is Harding College of Pharmacy’s third strategic plan. That is fitting, because each five-year plan has mirrored our mission and guided our work as we have matured over the years. The first plan was formed in 2007 and focused heavily on the foundational development of our program. The second plan was implemented in 2013 and guided the refinement of our program that has brought us to where we are today. This new strategic plan builds upon the work that underpins our accomplishments over the last twelve years and sets a rational and assertive course for our future. With the changing landscape of the pharmacy profession, developing a strategic vision for the future is inherently challenging. Fortunately, the College is rooted in a strong sense of self that

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corresponds well with the strategic plan set forth by Harding University in 2018. This shared vision helped us identify the following statement as the impetus for our strategic planning work: “At Harding University College of Pharmacy, we are a Caring, Committed, and Connected Community of Mission.” With this simple statement as our guide, three strategic priorities were then formed:

Caring – We value relationships. Committed – We value our commitment to purpose-driven education.

Connected – We value community.

These overarching priorities formed a central point of focus in the development of strategic initiatives, action steps for execution, and measurable outcomes for assessment for each step of the plan. Alignment with the core tenants of the Harding University Strategic Plan was also threaded throughout the plan and included important consideration for demonstrating our commitment to a Christ-focused, affordable, successful, diverse, and collaborative community of mission. I am excited about our new strategic plan and look forward to sharing it in more detail as we visit with you throughout the year at APA meetings and other special events. To our alumni, students, and preceptors who provided influence and direction for our planning, I am deeply grateful for your support. If you would like more information about our strategic plan or about our program, please visit us at www.harding.edu/ pharmacy. §

Where There's Smoke

THE PROBLEM WITH ELECTRONIC CIGARETTES

By Morgan Crews, Harding University College of Pharmacy Pharm.D. Candidate, Chad Dawson, UAMS College of Pharmacy Pharm.D. Candidate and Lauren Jimerson, Pharm.D., Executive Fellow Arkansas Pharmacists Association

According to a recent poll by INSIDER, 80 out of 1,102 people stated that their New Year’s resolution for 2019 was to quit smoking. Of those 80 people, 23.8% said that they planned on using e-cigarettes or “vaping” as a means to help them quit, even though the use of e-cigarettes is not an FDA-approved method to help someone quit smoking.

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WHERE THERE'S SMOKE

ccording to a July 2018 study from the University of California, San Francisco, people who use e-cigarettes as a method to quit smoking often end up becoming dual users, meaning that they smoke cigarettes and e-cigarettes simultaneously. Even when successfully quitting with the use of e-cigarettes, there are other health related risks to consider, such as recent findings that e-cigarettes contain high amounts of toxins like nicotine, lead, cadmium, and pyrene, according to a new study from The Journal of the American Medical Association (JAMA).

Prevention and the Food and Drug Administration’s National Youth Tobacco Survey, the percentage of high school aged children reporting use of e-cigarettes in the past 30 days rose by more than 75 percent between 2017 and 2018 and use among middle-school aged children rose by about 50 percent. Manufacturers don’t have to report e-cigarette ingredients, so users don’t know what is in them. According to the National Institute of Drug Abuse study, 66 percent of adolescents think that “just flavoring” is in their e-cigarettes, 13.2 percent know that they contain nicotine, 5.8 percent believe that the electronic cigarettes contain marijuana, 1.3 percent don’t know what they contain, while the other 13 percent believe they contain other substances.

Electronic cigarettes are cigarette-shaped devices containing a nicotine-based liquid (“vape juice”, “e-juice”, “e-liquid”) that is vaporized or inhaled. Electronic cigarettes deliver aerosols of nicotine and other Product design, flavors, perception of substances to the lungs which simulates safety and acceptability have increased the same experience as smoking tobacco. the appeal of electronic cigarettes to There is a common misconception that the young people leading to new generations exhaled vapor is harmless, but the aerosol who are addicted to nicotine. E-cigarette exhaled by the user can involuntarily expose advertising on social media, internet bystanders to the same nicotine, toxins, sites, retail stores, movies, and other or irritants that the user is inhaling. There sources of media are associated with are currently no mandatory regulations the growing use among the adolescent Many e-cigarettes, like this Juul, are or standards on content or labeling for chosen by teens because they are population. Greater exposure to these these liquids, but they usually contain at easy to conceal and don't look like marketing ads has been associated with least a vehicle, nicotine, and a flavoring traditional e-cigarettes. higher odds of use. Another reason why agent in non-standardized concentrations. adolescents are so keen to use electronic The liquids can contain many cigarettes worth of nicotine cigarettes is because of the flavoring or taste that it provides. in each vial, doses high enough to be toxic or potentially In a large cohort study, 81 percent of youth users of electronic fatal if ingested by a child. Also, nicotine is readily absorbed cigarettes reported that their starter product was flavored through the skin and could lead to the same result. Nausea compared to 61 percent and 46 percent of young and all and vomiting are typical side effects of over-ingestion and if adults, respectively. More than 7,500 flavored electronic you suspect that someone has overdosed, please contact cigarette products and solutions were available in 2014 and the Poison Control Center at 1-800-222-1222. that number has only gotten larger within the last several years. In contrast, some countries have banned or limited E-cigarette use among teenagers has drastically increased flavorings in combustible cigarettes. Data from the Population over the past year. One of the substances contained in Assessment of Tobacco Youth Survey revealed that 63-70 e-cigarettes, nicotine, is a highly addictive substance and can percent of adolescent users of tobacco products preferred be harmful to adolescent brain development. After repeated products that were flavored. exposure to nicotine, the central nervous system undergoes structural and functional changes, such as the brain requiring COMMUNITY PHARMACISTS COACHING ARKANSANS TO nicotine to function, resulting in dependence. Signs of nicotine NICOTINE INDEPENDENCE dependence can occur very quickly, within days to weeks of occasional nicotine use and often before onset of daily use. Although e-cigarettes have become a dangerous trend In addition, using nicotine in adolescent years can harm the for teenagers, quitting should be a focus at any age. The parts of the brain that control attention, learning, mood, and Community Pharmacists Coaching Arkansans to Nicotine impulse control. The adolescent brain isn’t fully developed Independence is a collaborative effort between the Arkansas until a person is around the age of twenty-five and for this Pharmacists Association and Harding University College reason e-cigarettes are especially unsafe for use in kids, of Pharmacy to help Arkansans quit smoking by utilizing teens, and young adults. There is evidence suggesting that pharmacists in rural Arkansas. The pilot program currently the use of e-cigarettes in adolescents can also increase the has thirty pharmacies in Arkansas that are participating in risk of future use of other tobacco products. the program and will allow pharmacies to be paid for their services. For patients to participate in the program, they According to data from the Centers for Disease Control and must be a citizen of Arkansas and eighteen years or older. WWW.ARRX.ORG

When a patient comes into one of the thirty participating pharmacies and says that they would like to participate in the smoking cessation program, the patient will be asked to fill out a packet of forms. The packet of forms will include demographics, insurance information, medical history, quit history, questionnaires to determine a baseline for nicotine dependence and depression, and social modifiers. Once that packet of information is filled out and an initial intake session is performed with the patient by the pharmacist, the pharmacist will then determine if that patient is a good candidate for the program. If the patient is determined to be a candidate, the patient will have four more additional sessions with the pharmacist, unless the patient is pregnant then the patient will have an addition nine sessions. The patient will be given two weeks of nicotine replacement therapy; this therapy will include either the patch, gum, or lozenges. Depending on which therapy is chosen, the patient will get a packet on how to use that product correctly. Educational information will also be given to the patient that will include the quitting process, coping with quitting, and information about the process of withdrawal. More information can be found by contacting the Arkansas Pharmacists Association.

https://erj.ersjournals.com/content/51/5/1800278 https://www.drugabuse.gov/related-topics/trends-statistics/ infographics/teens-e-cigarettes

_____________________________________________________ Graphic Source: https://www.drugabuse.gov/related-topics/trends-statistics/ infographics/teens-e-cigarettes

Sources: https://www.businessinsider.com/popular-new-years-resolutionshealth-2018-12?r=UK&IR=T https://www.cdc.gov/tobacco/basic_information/e-cigarettes/Quick-Factson-the-Risks-of-E-cigar ettes-for-Kids-Teens-and-Young-Adults.html https://www.cdc.gov/tobacco/basic_information/e-cigarettes/pdfs/ Electronic-Cigarettes-Infograph ic-508.pdf

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THE ARKANSAS PHARMACIST

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LEGISLATOR PROFILE

Representative Mark Lowery

District: 39

Most admired politician: President Ronald Reagan

Represents (Counties): Communities of Maumelle, Morgan

Advice for pharmacists about the political process and working with the Arkansas Legislature: Politics is about

Marche, Oak Grove and Amboy in Pulaski County

Years in Office: 6

relationships so getting to personally know your area legislator is the most critical part of being able to be an influence.

Served in: House of Representatives 2013, 2015, 2017

Your fantasy political gathering would be: Any political

Occupation: Adjunct instructor/consultant Your Hometown Pharmacist: Brent Bradley

policy meeting in Washington DC

Hobbies: Golf, graphic design, grilling ยง

What do you like most about being a legislator? I like getting to be involved in so many different policy areas to help the people of Arkansas.

What do you like least about being a legislator? The pressure of voting on thousands of bills in a concentrated timeframe of a legislative session.

Most important lesson learned as a legislator: I've enjoyed learning that most policy differences are not issues of the right way versus the wrong way but instead a difference in perspective. 24

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THE ARKANSAS PHARMACIST

ARKANSAS ACADEMY OF HEALTH-SYSTEM PHARMACISTS

Membership and Advocacy

any of you know about the benefits that come with David Fortner, Pharm.D., being a member of state and President national organizations. APA and AAHP continually work to serve pharmacists in all practice sites across Arkansas. Through advocacy efforts, networking opportunities, conferences and seminars, and a variety of other methods, association membership and involvement will benefit you as a pharmacist in our great state. Additionally, AAHP is a state affiliate of ASHP, the American Society of Health-System Pharmacists. ASHP is our voice at a national level and continues to focus efforts on an agenda that directly attacks many of the issues we face in hospitals and health-systems in Arkansas. Many of you heard the keynote speaker at AAHP Fall Seminar last October, Jillanne Shulte Wall, who serves as Director of Regulatory Affairs for ASHP, discuss the organization’s current initiatives. Additionally, during the ASHP Midyear Clinical Meeting in Anaheim, CA, this same topic was presented to ensure members are informed of how the organization is working to positively impact our profession. A few of the key initiatives for ASHP are outlined below:

Drug Shortages: ASHP participated in a summit in Fall 2018 to begin working through ways to handle shortages nationwide. These efforts continue and ASHP is hopeful for bipartisan legislation that would make positive impacts on the drug supply chain to protect against future shortages.

Compounding: ASHP continues to work with legislators to

seek compounding guidance for hospitals/health-systems, as the lack of information is a concern. At this point those conversations are in a “holding pattern,” but the organization expects to turn up the volume this summer if nothing is provided from a federal perspective.

340B Reimbursement: ASHP is closely involved in this

debate. The recent news of an injunction from the U.S. District court was a positive turn of events. ASHP is closely monitoring the response from CMS and subsequent downstream effects on hospitals.

Provider Status: With a new Congress, ASHP is focusing on

more education efforts in hopes of continuing this ongoing discussion and working with groups at the agency level to seek legislative change. In 2018, we saw first-hand what coming together as a profession can accomplish. Hopefully the same will continue in the months and years ahead here in Arkansas and at the national level through the collective effort of our professional organizations. Supporting state and national organizations is of the utmost importance considering the current environment surrounding pharmacy practice. If you are not already a member of APA and/or AAHP, I would encourage you to join today! §

In 2018, we saw firsthand what coming together as a profession can accomplish. Hopefully the same will continue in the months and years ahead here in Arkansas and at the national level through the collective effort of our professional organizations.

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COMPOUNDING ACADEMY REPORT

Changes to Cleaning in the Non-Sterile Compounding Lab

wanted to take some time talking about some changes to USP 795 that would affect the compounding of non-sterile products in the next few articles. There are a few sections that are quite a bit different from the current version of USP 795 that has been published in the USP 795: Proposed Revision. Keep in mind, all of the ideas discussed in this USP 795 Revision are still in draft mode, but most people in industry expect the final version to be published and enforceable around the same time that USP 800 is finalized, which is December of 2019. Tyler Shinabery, Pharm.D. Compounding Academy President

The first difference I wanted to discuss from the USP 795: Proposed Revision is the updates to cleaning and sanitation of the non-sterile compounding lab. After looking through the current version of USP 795, there is very little guidance on how often and with what supplies to clean the compounding lab. The current document says “the areas used for compounding shall be maintained in clean, orderly, and sanitary conditions and shall be maintained in a good state of repair.” The USP 795: Proposed Revision not only mirrors the language above, but also adds a distinct section that defines the minimum frequency of cleaning & sanitizing various surfaces in the compounding lab. Floors must be cleaned daily, after spills, and when surface contamination is known or suspected. Walls, ceilings, & storage shelving must be cleaned every three months, after spills, and when surface contamination is known or suspected.

mop or microfiber dry-mop daily to clean the floors. This would then be followed by a wet-mopping with a properly selected disinfectant that is designed to kill bacteria, thus sanitizing the lab by reducing the number of bacteria on the surface. Other factors to consider when disinfecting a room include following the manufacturers instructions with regard to contact times and proper application of a disinfectant to a surface. Many of these disinfectants can also leave a residue on your compounding lab, requiring a second wet mop to rinse the disinfectant off with water or isopropyl alcohol. Updating SOPs in your facility with regard to training, scheduling, and documentation of cleaning & sanitizing are also required in the revised document. In closing, please keep in mind that this is just one man’s interpretation of a fairly vague set of instructions in the USP revision. I think variations in how the task of cleaning and sanitizing the compounding lab could easily be developed and still be appropriate. Yet I would caution all compounders that, when preparing medications, over-cleaning will always be preferred to under-cleaning by various regulatory agencies. As Nobel Prize winner Bob Dylan once said, “the times, they are a changin’.” §

Along with the clearly defined frequency of cleaning in the USP 795: Proposed Revision the heading of the section and all subsequent wording refers to cleaning & sanitizing the compounding lab. Although these words may sound innocuous to the casual reader, the terms “cleaning” and “sanitizing” hold very distinct meaning in such an environment. According to the CDC, “Cleaning” refers to the physical action of removing dirt, germs, and other impurities from an area. This is accomplished by physically scrubbing or wiping the area with appropriate tools with the use of a soap or other appropriate detergent. “Sanitizing” refers to the lowering of the number of germs on a surface to an acceptable level. Sanitizing occurs by either “cleaning” or “disinfecting” an area. Those of you involved in sterile compounding will know that “disinfecting” an area also carries a distinct meaning: the use of chemicals on a surface to kill bacteria or vegetative spores. Confused yet??? So what does this mean for the everyday non-sterile compounder? Although it is not clearly defined what the USP 795: Proposed Revision requires for sanitizing the compounding lab, I would contend that in order to properly sanitize the area you would need a combination of cleaning and disinfecting to occur in your lab on the defined schedule noted above. An example of this may be pushing a tacky-roller 26

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THE ARKANSAS PHARMACIST

2019 Calendar of Events

MARCH ———————————

JUNE ———————————

APRIL ———————————

June 6-8, 2019 APA 137th Annual Convention DoubleTree by Hilton Little Rock, AR

March 22-25, 2019 American Pharmacists Association Annual Meeting Seattle, WA

April 10-11, 2019 National Community Pharmacists Association Congressional Pharmacy Fly-In Hilton Alexandria Old Town Arlington, VA April 18, 2019 Arkansas Pharmacy Foundation Golf Tournament Tannenbaum

MAY ——————————— May 3, 2019 Harding P3 Pinning Ceremony Harding Campus Searcy, AR May 10, 2019 Harding Class of 2019 Senior Meeting Searcy, AR May 11, 2019 Harding College of Pharmacy Commencement Searcy, AR May 17, 2019 UAMS Class of 2019 Senior Meeting Little Rock, AR May 18, 2019 UAMS College of Pharmacy Commencement Little Rock, AR

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June 5, 2019 APA Board Meeting DoubleTree by Hilton Little Rock, AR

June 8-12, 2019 American Society of Health-System Pharmacists Summer Meeting Boston, MA

JULY ———————————

July 31- August 2, 2019* APA Board Retreat and Committee Chair Orientation TBA

AUGUST —————————— August 27-31, 2019 APA District Meetings Around the State

SEPTEMBER ———————— September 5-26, 2019 APA District Meetings Around the State

October 26-29,2019 National Community Pharmacists Association Annual Convention San Diego, CA October 31, 2019* APA Golden CPE Hosto Center Little Rock, AR

NOVEMBER ————————— November 7-10, 2019 American Society of Consultant Pharmacists Annual Meeting and Exhibition Gaylord Texan Resort Grapevine, TX

DECEMBER ————————— December 1, 2019* APA Committee Forum TBA December 1, 2019* APA Board Meeting TBA December 8-12, 2019 American Society of Health-System Pharmacists Midyear Clinical Meeting Las Vegas, NV

OCTOBER ————————— October 3-4, 2019* AAHP Fall Seminar Little Rock, AR

October 20, 2019* APA Board Meeting Conference Call

2019 APA Awards Solicitation AWARD NOMINATIONS Each year APA encourages members to submit the names of individuals who are deserving of special recognition for their professional activities during the past year. Any active APA member is eligible to nominate a person for the awards. Award recipients are chosen by an APA committee following a review of all nominees. Nominations are now being accepted for the following annual awards to be presented by the Association. Nominations will close at is 4:30pm Friday, April 19, 2019. Please mark your nomination with an X. If you have more than one nomination, please feel free to copy this form.

Pharmacist of the Year _______

The Pharmacist of the Year Award was established in 1959 to honor an individual who “should possess professional standards beyond reproach, a record of outstanding civic service in the community, and as a member of the APA, who has contributed efforts toward the progress of the association.” Previous recipients include: 2018 David Smith, Conway 2017 Laura Lumsden, Little Rock 2016 Keith Larkin, Fort Smith 2015 Wayne Padgett, Glenwood 2014 Michelle Crouse, Lake Village 2013 Carl Collier, Fayetteville 2012 Charles Born, Little Rock 2011 Don Johnson, Little Rock

Bowl of Hygeia Community Service Award _______

In 1958 E. Claiborne Robbins of the A.H. Robbins Company established the Bowl of Hygeia Award. The purpose of the award is to encourage pharmacists to take active roles in the affairs of their respective communities. Previous recipients include: 2018 Cissy Clark, Earle 2017 Sue Frank, Little Rock 2016 Jon Wolfe, Little Rock 2015 Nicki Hilliard, Little Rock 2014 Eric Shoffner, Newport 2013 Vicki and Karrol Fowlkes, Little Rock 2012 Sparky Hedden, Sheridan 2011 Tom Warmack, Sheridan

Distinguished Young Pharmacist of the Year _______

The nominee must have an entry degree in Pharmacy, received nine or fewer years ago, and be a member of the APA. Nominee must be in the active practice of pharmacy in the year selected, and actively involved in the profession of pharmacy, displaying an interest in the future of the profession. Previous recipients include: 2018 Greta Ishmael, Cherokee Village 2017 Joshua Bright, Harrison 2016 Kevin Barton, Centerton 2015 Rachel Stafford, North Little Rock 2014 Stephen Carroll, Arkadelphia 2013 Zach Holderfield, Fayetteville 2012 Clint Recktenwald, Gassville 2011 Cheryl Bryant, Little Rock

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THE ARKANSAS PHARMACIST

2019 APA Awards Solicitation (continued) Excellence in Innovation Pharmacy Practice Award _______

This award was established in 1993 by the APA in cooperation with the National Council of State Pharmacy Associations and DuPont Pharmaceuticals to recognize, annually, a pharmacist who has demonstrated a prominent spirit of innovation and entrepreneurship in the practice of pharmacy. Previous recipients include: 2018 Whitney Bussell, Little Rock 2017 Jody Smotherman, Batesville 2016 Nikki Scott, Russellville 2015 Taylor Franklin, Fort Smith 2014 Marcus Costner, Fayetteville 2013 Lanita White, Little Rock 2012 Melissa Brown, Fayetteville 2011 Eric Crumbaugh, Benton

Guy Newcomb Award _______

The APA Board of Directors created this award in 1997 to recognize individuals who, by their legislative influence and leadership, have distinguished themselves as political friends of Arkansas pharmacy. This award is named in memory of Dr. Guy Newcomb of Osceola. Dr. Newcomb was a pharmacy leader who understood, appreciated, and enthusiastically participated in the political process. Previous recipients include: 2018 Governor Asa Hutchinson, Little Rock 2017 Senator Jason Rapert, Conway & Representative Clint Penzo, Springdale 2016 Senator Ron Caldwell, Wynne & Representative Michelle Gray, Melbourne 2011 Johnny Key, State Senator, Mountain Home 2009 Allen Maxwell, State Representative, Monticello 1999 Larry Teague, State Representative, Nashville 1998 Tim Hutchinson, U.S. Senator, Bentonville

Percy Malone Public Service Award _______

This award was established in 2009 by the Arkansas Pharmacists Association in honor of former state senator Percy Malone, P.D. The recipient must have made a contribution to public service by being elected to any public office and by displaying an interest in the people of Arkansas. Previous recipients include: 2017 Representative Justin Boyd, Fort Smith 2016 Representative Justin Boyd, Fort Smith 2015 Lenora Newsome, Smackover 2011 Gene Boeckmann, Wynne 2009 Percy Malone, Arkadelphia

Friend of Pharmacy Award _______

This new award honors someone that does not serve as a pharmacist but is a champion to the pharmacist community. Name of Nominee_____________________________________________________________________________________________ Address______________________________________________________________________________________________________ City/State/Zip ________________________________________________________________________________________________ Phone________________________________________________________________________________________________________ Reasons for selecting nominee: Attach one page with description of reasons and/or the individual nomineeâ&#x20AC;&#x2122;s resume. Nominatorâ&#x20AC;&#x2122;s Name: _____________________________________ Phone____________________________

Date______________

Fax or email written nomination form and material to: Awards Committee, Arkansas Pharmacists Association; jordan@arrx.org; Fax 501-372-0546. Please submit by 4:30pm Friday, April 19, 2019.

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Call for Board Nominations 2019-2020 Take advantage of the opportunity to give back by serving on the Arkansas State Board of Pharmacy or the APA Board of Directors. We are seeking nominations for enthusiastic and energetic individuals who want to make an important contribution to the pharmacy profession. APA’s Board of Directors is made up of 12 representatives spread out over five regions, including two at-large representatives. Each regional representative will serve a three-year term. For questions about term lengths, please contact Susannah Fuquay at 501372-5250. APA Board membership requires the flexibility to meet in Little Rock during the week and on two Sundays during the year.

APA Board of Directors Call for Nominations

Nominations are invited for each of the following positions on the Arkansas Pharmacists Association Board of Directors. Brief job descriptions follow.

Vice President of APA

Statewide (Serves four one-year terms as Vice President, President-Elect, President, and Past President, four total years as Board Member) • Attends all board and executive committee meetings • Serves on the executive committee • Assumes responsibilities of the chair in the absence of the board president or president-elect • Participates as a vital part of the board leadership

Regional Representatives

• Attends all board meetings and conducts the affairs of the association • Maintains knowledge of the organization and personal commitment to its goals and objectives • Appoints an executive committee and other committees and delegates to the executive committee power and authority of the board of directors in the management of the affairs of the association • Recruits new members; participates in APA membership drives

Region 1 – Northwest Arkansas: One Open Seat Northwest Counties: Benton, Boone, Carroll, Conway, Crawford, Faulkner, Franklin, Johnson, Logan, Madison, Marion, Newton, Pope, Searcy, Sebastian, Van Buren, Washington

Region 4 – Southwest Arkansas: One Open Seat Southwest Counties: Clark, Columbia, Garland, Hempstead, Hot Spring, Howard, Lafayette, Little River, Miller, Montgomery, Nevada, Ouachita, Perry, Pike, Polk, Scott, Sevier, Yell

Region 2 – Northeast Arkansas: No Open Seats Northeast Counties: Baxter, Clay, Cleburne, Craighead, Crittenden, Cross, Fulton, Greene, Independence, Izard, Jackson, Lawrence, Mississippi, Poinsett, Randolph, Sharp, Stone, White, Woodruff

Region 5 – Southeast Arkansas: No Open Seats Southwest Counties: Clark, Columbia, Garland, Hempstead, Hot Spring, Howard, Lafayette, Little River, Miller, Montgomery, Nevada, Ouachita, Perry, Pike, Polk, Scott, Sevier, Yell

Region 3 – Central Arkansas: Open One Seat Central Counties: Pulaski, Saline

At-Large Representatives: One Open Seat

APA Officers and Board of Directors

The requirements for nominees of the APA Officers are as follows: Arkansas licensed pharmacist who has been a member of this Association in good standing for the past three (3) consecutive years. Board Members shall be limited to six (6) consecutive years as a Regional Representative, or six (6) consecutive years as an At-Large Representative. No member of the Board of Directors shall serve more than nine (9) years on the Board of Directors in any non-Executive Committee capacity. Reimbursement- Members of the Board of Directors don’t receive compensation but can be reimbursed for reasonable direct and indirect expenses related to attending meetings such as mileage and/or hotel costs. Board members receive a discount on annual convention registration. Board members who are on the program at Regional Meetings (president, regional representative) do not pay registration fees. Removal from office- Directors may be removed for being absent without reasonable cause from any two consecutive meetings or any three meetings during a 12-month period. Meeting dates for 2019-2020 are likely to be: • • • •

July 31 - August 2, 2019 (Thursday afternoon, all day Friday, Saturday 8 a.m. to 12 p.m.) December 7, 2019 (Saturday 9 a.m. to 6 p.m.) in Little Rock March 2020 (Sunday 9 a.m. to 4 p.m.) in Little Rock APA Annual Convention Board Meeting, June 2020 (Wednesday a.m.)

If interested in nominating yourself or another individual, please fill out this form www.arrx.org/2018-board-nominations. Nominations will close at 4:30 p.m., April 19, 2019.

AR•Rx

THE ARKANSAS PHARMACIST