First Quarter 2018 Award-Winning Quarterly Publication of the Arkansas Pharmacists Association
Pharmacists
STORM ARKANSAS CAPITOL Over Pharmacy Reimbursements p. 4
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THE ARKANSAS PHARMACIST
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Dear Colleague, As the first few months of a new year arrive, it brings with it refle ction on the past and focus on back at 2017, the pharmacy pro the future. Looking fession saw several successes and a few setbacks, yet APA step of the way. has been there every We started 2017 with a hard-fou ght victory in court as United State Circuit Judge Brian Mill filed by the PBM organization er ruled on a lawsuit Pharmaceutical Care Manageme nt Association in regard to Ark which established an appeals ansas Act 900 of 2015, process for Arkansas pharmacies that were paid below the pharma cost. APA worked closely with cy’s drug acquisition the Attorney General’s office on this case and its appeal in Jan forward to a ruling in the next uary 2018 and we look few months. 2017 also brought with it a legi slative session that saw several victories for pharmacy. APA wor bring about changes to the Ark ked with legislators to ansas Pharmacy Practice Act, including expanding a pharma medication, allowing pharma cist’s ability to administer cists to dispense the life-sav ing drug naloxone without a definition of an emergency refil prescription, changing the l, and changing the act to defi ne pharmacists as healthcare In addition to political efforts, providers. the APA continues to advoca te for pharmacists through a expanded in 2017. Through range of services that the formation of the Commu nity Pharmacy Enhanced Ser launched a quality improvemen vices Network, APA has t initiative focused on integrating community pharmacy enhanc coordination of health care serv ed services to optimize ices to patients and populations in our state and communities all pharmacists, no matter thei – an effort that affects r practice setting. APA continues to advocate for pharmacists through our exp anded media presence, continu exposure of an estimated 20+ ing our television appearances in 2018. We’ve also promoted pharmacy through publications, all urging Arkans features in state-wide ans to take advantage of their local medication expert. We continue to offer and broade n our clinical programming. The award-winning Pharmacists Imm provides immunization and CPR unization Program training for APA members as well as free promotional pos pharmacists are becoming com ters. More Arkansas fortable with Medication Therap y Management as we expand MTM certificate training progra the accessibility of our m. The APA corresponds with our members regularly through Inte RxActions, a weekly e-newslette changes and trends, and the r on industry award-winning AR∙Rx The Ark ansas Pharmacist, a quarterly features on topics affecting the journal with in-depth pharmacy world, in addition to up to 25 hours annually of Education with numerous netw Continuing Pharmacy orking opportunities. Although we celebrate last yea r's successes of APA and pha rmacy in Arkansas, 2018 has alre a trying time for our profession. ady shown it will be The continual fight for fair reim bursement rates escalated to dan anything we’ve ever seen bef gerous territory unlike ore. Pharmacies across the stat e are threatened with unsusta models and patient access to inable reimbursement care is in danger. More than eve r before, APA needs your suppor Membership in the APA connec t and your membership. ts you to a network of pharma cy leaders, practice innovato visionaries who not only want rs, and professional to see you thrive, but actively help you succeed. Buying into investment that will yield a gre this network is a small at return for your professional future and the future of the pro I know I speak for everyone in fession. our office when I say it is an hon or to serve on your behalf. We you have placed in us to be you appreciate the trust r voice in Arkansas. Moving forw ard, I hope you continue to sup in the APA, beginning by joining port and participate or renewing your membership for 2018. The easiest way to rene arrx.org/join or over the phone w is online at www. at (501) 372-5250. Please do not hesitate to con tact us if we can ever do anythin g to assist you in your practic e. Sincerely,
Scott Pace, Pharm.D., JD Executive Vice President & CEO 417 South Victory Street | Littl
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e Rock, AR 72201-2923 | p 501
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APA Staff Scott Pace, Pharm.D., J.D. Executive Vice President and CEO Scott@arrx.org
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John Vinson, Pharm.D. Vice President of Practice Innovation John@arrx.org Jordan Foster Director of Communications Jordan@arrx.org Susannah Fuquay Director of Membership & Meetings Susannah@arrx.org Elisabeth Mathews, Pharm.D. Executive Fellow Elisabeth@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: Scott Pace 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 82. © 2018 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: As Insurers and PBMs
Slash Reimbursements, Arkansas Pharmacists Storm the Capitol
7 From the President: Nuts...This
Business Is Nuts!
9 Member Spotlight: Nicki Hilliard
Pharm.D., MHSA, BCNP, FAPhA UAMS College of Pharmacy Professor Little Rock
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Affects Us All
28 Compounding Academy: Why H.R.
2871 is a Bad Idea for Patient Care
29 2018 Calendar of Events 30 Compliance Corner: 2017 Brings
Expanded Role for Pharmacists in Opioid Abuse Battle
10 FEATURE: Rising UP to the Challenge
32 2018 APA Awards Solicitation
15 Safety Nets: Required Patient
34 Call for Board Nominations
Counseling Does Not Equal Effective Patient Counseling
17 New Drugs: The FDA Closes Out the
Year with Vigor
18 FEATURE: New Hypertension Guidelines
Published
22 UAMS: Student Leadership in
Community Pharmacy
24 Harding University: Harding College of
Pharmacy Celebrates First 10 Years
26 Legislator Profile: Senator Larry Teague WWW.ARRX.ORG
27 AAHP: What Affects One Pharmacist,
Cover Photo: Michael Hibblen
ADVERTISERS 4 Pharmacists Mutual 8 Retail Designs, Incorporated 8 Arkansas Pharmacy Support Group 13 EPN 14 Pace Alliance 16 Wright, Lindsey, Jennings 23 UAMS College of Pharmacy 23 Save the Date: 2018 APA Convention 25 Smith Drug Company 28 Law Offices of Darren O'Quinn 31 EPIC Pharmacies 36 Pharmacy Quality Commitment Back Cover: Pharmacy Partners of America /
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APA Board of Directors
INSIDE APA
2017 - 2018 Officers President - Lynn Crouse, Pharm.D., Lake Village President-Elect – Stephen Carroll, Pharm.D., Benton Vice President – Dean Watts, P.D., DeWitt Past President – Eddie Glover, P.D., Conway
Regional Representatives Region 1 Representatives - Dylan Jones, Pharm.D., Fayetteville - Spencer Mabry, Pharm.D., Berryville - Lacey Parker, Pharm.D., Centerton Region 2 Representatives - Max Caldwell, P.D., Wynne - Darla York, P.D., Salem Region 3 Representatives - Brandon Achor, Pharm.D., Sherwood - Clint Boone, Pharm.D., Little Rock - Lanita White, Pharm.D., Little Rock Region 4 Representatives - Betsy Tuberville, Pharm.D., Camden Region 5 Representatives - James Bethea, Pharm.D., Stuttgart At Large Representatives - Amber Bynum, Pharm.D., Little Rock - Yanci Walker, Pharm.D., Russellville Academy of Compounding Pharmacists Becca Mitchell, Pharm.D., Greenbrier Arkansas Association of Health-System Pharmacists Brandy Owen, Pharm.D., Conway
Ex-Officio APA Executive Vice President & CEO Scott Pace, Pharm.D., J.D., Little Rock Board of Health Member Gary Bass, Pharm.D., Little Rock AR State Board of Pharmacy Representative John Kirtley, Pharm.D., Little Rock UAMS College of Pharmacy Representative (Dean) Keith Olsen, 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 Meghan Petersen Harding COP Student Chithien Le 6
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Scott Pace, Pharm.D., J.D. Executive Vice President & CEO
As Insurers and PBMs Slash Reimbursements, Arkansas Pharmacists Storm the Capitol
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ednesday, January 31st, was an important day for Arkansas pharmacists. It was a day that pharmacists from all practice settings and from all corners of the state gathered at the Arkansas State Capitol to let their voices be heard that the insurance companies, and the pharmacy benefits managers (PBM) that they hire to outsource their pharmacy benefits to, have made draconian cuts to reimbursements that threaten patients and pharmacies all across Arkansas.
their cost, and they did it because their competitors did it first.
Over 300 pharmacists and pharmacy students packed the committee room, causing the Capitol Police to ask a great number of attendees to stand in the halls to listen to the testimony of pharmacists, insurance executives, and pharmacy benefits managers.
The legislators were able to see first-hand that the PBM middleman hired by the health insurers were driving up the cost of care for their own financial gain and at the expense of patients and pharmacists.
The turnout was absolutely overwhelming. As your association leader, I was astounded by the terrific turnout and the undeniable passion that you showed for your patients and the profession that you love dearly. Cissy Clark of Earle and Randy Kassissiah of North Little Rock did an outstanding job of testifying and educating the Health Insurance Marketplace Committee members of the dire situation facing both rural and urban communities throughout Arkansas. When Cissy finished, I’m not sure there was a dry eye in the room. Their testimony was followed by representatives from Arkansas Blue Cross Blue Shield, Ambetter, and CVS/ Caremark who provided their perspective on the reimbursement crisis they have created. One of the most powerful moments of the entire committee hearing was when the representative from Blue Cross Blue Shield testified that they knew they were paying pharmacists below
Sen. Ron Caldwell and Rep. Deborah Ferguson chaired the meeting, which featured spirited questions from legislators. I was able to provide testimony on behalf of pharmacists and patients that illustrated the disruption to patients and the access issues that were created when the pharmacists were not paid enough to cover the cost of the medications or operate their businesses.
I was pleased to ask the legislators for three specific things: 1. Set a reimbursement floor of the National Average Drug Acquisition Cost (NADAC) plus $10.50 for medications in the healthcare exchange; 2. Aggressively enforce the current laws that require transparency in state-funded health plans and the laws that govern maximum allowable costs (MAC), and; 3. Arkansas should lead the nation in placing comprehensive oversight on Pharmacy Benefits Managers.
These common-sense steps can help correct many of the problems that currently exist in our healthcare system. We must keep pushing for these reforms. We have to have immediate relief and a long-term change in how these business practices work.
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ARKANSAS PHARMACISTS STORM THE CAPITOL
I want to recognize Gov. Hutchinson for the work he and his executive agencies have done to address this issue. The Governor and his staff have spent countless hours working towards a solution and I want to thank them.
this cause. Their work has been simply amazing. There are simply too many legislators to mention that have stepped up to support you and your patients and I am thankful for each and every one. Please reach out to them and thank them.
Finally, I want to thank Rep. Michelle Gray and Sen. Ron Caldwell for taking a leading role in helping to shepherd
We continue to work hard to find a solution to this current crisis. I am confident we will achieve some positive change. §
FROM THE PRESIDENT
Nuts...This Business Is Nuts!
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mployers provide what is commonly called health insurance for their employees. Now, this is where the misdirection begins. It is NOT insurance. Insurance is not something one purchases hoping to use. It is something purchased to be used as a safety net. Examples of this would be car insurance, but life insurance and home owners would also apply. Ultimately, the number of insured and the frequency of claims regulates the costs, (premiums, deductibles, etc.) Within the PBM model for “insurance,” the employer pays the PBM though an insurance carrier. The employer in this case may be a private company, a state Medicaid plan, or CMS. In each case there is tax payer backing it all. The PBM pays the pharmacy. Unfortunately for all, the PBM keeps so much more than the employer intends and the pharmacist sees. Simply put drug costs continue to increase insulated from their true competitive cost, the price of insurance continues to rise, and pharmacist reimbursement is so low it is threatening patient access in irreconcilable manner. The winners in this scenario seem to be the insurance companies and, of course, the PBM's now the darling, “former payer, now regulator,” and reigning champion of the pharmacy world. Even the drug companies kowtow to some of their practices by inflating the cost of their drug to afford rebates to plans. A 2015 study analyzing the cost of brand name prescription drugs performed by the Berkley Research Group suggested this inflation to a drugs market cost was as much as 30% to state Medicaid plans and Tricare to be on their formularies so as to have a market to sell their product. More recent numbers suggest that with the inclusion of all PBM's, that number could be closer to a 50% addition. However, the real loser is the tax payer, which includes the employer, the beneficiary of the policy, and provider of the service. Most taxes are paid for these services as soda taxes, employee taxes, and the like. The pharmacist is taxed by being reimbursed less than the drug costs to buy and by giving away service as free labor or going out of business. In this manner, pharmacists and pharmacies are funding plans in
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the state by working for free or below their cost. Many are doing this because they still can, but the contrived, limited access fostered by the PBM model is growing.
Lynn Crouse, Pharm.D. President
As I compose this article, I am interrupted by calls and texts of different pharmacists bemoaning reimbursements below costs and evaluating different business strategies to adjust to the coming year. We discuss how to continually help our patients and neighbors, all the while watching the growing shadow of denied patient access to our services and our own insolvency. We have faith that our system of government and our leaders will stop assuming the system is understood and learn it. Lives are dependent on it. However, there are positives in the present and in the future. I am still humbled and amazed at what pharmacists do for their patients daily. Most of the time it is played down, it is always preyed upon, and often times expected and overlooked. We see our patients on average 35 times a year. We have a legislature and political leaders that want to know from you what they can do to make our home great. We have an Attorney General and staff that has gained valuable knowledge combatting law breaking PBM practices, as well as an engaged Governor and his staff committed to the wellbeing of Arkansans. We also may have an answer. We have a much maligned NADAC model of reimbursement based on real costs that may relegate the PBM to its original duty as a claims processor and remove the graft kept in the middle. It can prove to be the model that gives true cost of ingredients and services to the patient, thereby solidifying access to products and services and separating the pharmacist patient services from the cost of dispensing. Only then can our leaders and employers negotiate the cost of health care in a truly educated transparent manner. §
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MEMBER SPOTLIGHT
Nicki Hilliard Pharm.D., MHSA, BCNP, FAPhA UAMS College of Pharmacy Professor Little Rock
Nicki holds a print of the founding of the American Pharmaceutical Association in 1852 showing the founders of the group signing their names into an official book. As incoming president, Nicki signed her own name into the very same book represented in the print.
Pharmacy school:
Graduated from the UAMS College of Pharmacy with a BS in 1983, a Masters of Health Services Administration in 1990, and a PharmD in 1996.
Years in business/years teaching:
I spent a year doing relief work in community pharmacy and going to grad school before starting a career as a nuclear pharmacist. After managing the nuclear pharmacy for seven years I started a nuclear pharmacy education program at UAMS, where I’ve been for almost 27 years.
Favorite part of the job and why:
Working with student pharmacists is rewarding and inspiring. I love their passion for patient care projects and the profession. My work with APhA also allows me to learn about the wonderful job pharmacists are doing across the country to impact patient and public health.
Least favorite part of the job and why:
I love my job, but I wish someone else could write the reports.
What do you think will be the biggest challenges for pharmacists in the next 5 years? Inadequate reimbursement models threaten the sustainability of community pharmacies. I am hopeful that provider status will bring about a more patient-centered practice. Change is always difficult, but it will be necessary to providing more cognitive services.
I had a veterinarian that needed training to treat hyperthyroid cats with radioactive iodine.
Recent reads:
Fierce Conversations, The Power of the Other, Being Mortal, TED Talks: The Official TED Guide to Public Speaking
Fun activities/hobbies:
Time with family and friends, traveling, golf, and videography
Ideal dinner guests:
Leaders of pharmacy, CMS, Congressional Budget Office, and third-party payers talking and agreeing to pay for pharmacist care! (I think I am beginning to have a one track mind!)
If not a pharmacist then‌
an Apple Professional Learning Specialist.
You will be sworn in this March as the 2018 APhA President at the APhA Annual Meeting in Nashville. What do you hope to accomplish during your presidency? I am very proud of the work APhA and other organizations are doing to achieve provider status for pharmacists. It is my goal to help get pharmacists ready to provide and receive payments for patient care services. APhA is the only organization that represents the entire profession and together we can be stronger to magnify the voice of pharmacists across all areas of pharmacy practice.
Oddest request from a patient/customer: WWW.ARRX.ORG
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UP RISING
TO THE CHALLENGE By Jordan Foster
“Let us not seek the Republican answer or the Democratic answer, but the right answer. Let us not seek to fix the blame for the past. Let us accept our own responsibility for the future.” -John F. Kennedy
F
rom city clerk to governor, each elected position in Arkansas has an important role to play. Elected officials must make difficult decisions, guide their communities through times of turmoil, and balance the needs of the people with the realities of financial responsibility. It sounds like a daunting task to even the most prepared, but doing it well makes you an effective leader in your community who’s capable of making lasting change. In addition to their official duties, elected officials are often approached with disputes that have arisen and are affecting their constituents. Since the beginning of the year, and long 10
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before for that matter, community pharmacists have been faced with a reimbursement crisis that threatens to destroy an integral part of the healthcare system. With PBMs looking to snatch more and more money from pharmacists and insurance companies in a race to lower rates to compete with each other, the pharmacy profession reached a breaking point on January 31 at the Arkansas State Capitol. An estimated 300 pharmacists stood before state elected officials and asked for help. Because of the pharmacy profession’s reputation of selflessness, professionalism, and knowledge, APA has AR•Rx
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made friends in the state legislature, but having additional voices fighting for pharmacists can help the profession when challenges like PBMs threaten to destroy our patients’ access to healthcare. Staying engaged politically doesn’t just make you a member of the well-informed electorate, it can make you a powerful ally that can topple injustice.
Running for Office
If you’re interested in running for office in Arkansas, consider starting with the Secretary of State’s office website (www.sos.arkansas.gov/elections). The office is responsible for helping county officials conduct federal, state, and district elections and for maintaining all election records for the state. In addition, they have a comprehensive guide for candidates to know the requirements to run for any office from city clerk to President of the United States, as well as important information about campaign finances, terms and qualifications, and how to file for office.
The new year feels like it’s just begun, but pharmacy has already faced a crisis that threatens to close stores throughout the state. Getting involved with the legislative process is a proactive way to become a decision-maker and to fight for the future of the profession in Arkansas.
Once you’ve decided to run for office, you may need some direction in this uncharted territory. According to Ron Faucheux of WinningCampaigns.org1, there are a few key things to remember when you’re shaking hands and kissing babies. First, always keep your cool. There will be tough days when your campaign experiences chaos and unexpected events but remembering why you decided to run and staying focused on that instead of all the noise will pull you through.
Second, you won’t get every vote and not everyone will like you, but you should still ask every voter for help. Waiters, janitors, neighbors, teachers, almost everyone you meet could be a potential vote. Share your story and why you’re running and ask them to consider voting for you. Finally, don’t let defeat stop you. If you’re unsuccessful in your bid for an elected position, you still have a voice as a concerned citizen. Speak up and share your concerns; don’t let a loss extinguish your passion. Abraham Lincoln, Franklin Roosevelt, Ronald Reagan, Bill Clinton, and George W. Bush all lost races early in their political careers but went on to the highest level of political success.
Maintaining Relationships
If you prefer making a difference on a more local level and running for office doesn’t interest you, you can still make an impact by having a good relationship with your representatives. According to research by the Center for Community Health and Development at the University of Kansas2, “all politics, almost no matter how you define the term, comes down in the end to personal relationships.” Growing, nurturing, and maintaining those relationships provide access to the
people who will be making big decisions, especially when there are issues close to you that you would like to be addressed. However, don’t expect a relationship to bloom overnight. Reach out to your elected official and try to find some common ground; you could even consider offering your knowledge or expertise on a subject unrelated to pharmacy to help them make a decision. The more helpful you are as a constituent, the better position you’re in when you need help from your representative. According to the University of Kansas’s research, “the relationship doesn't have to be highly personal, or a friendship — although it may develop in those directions, depending on the personalities involved — but it needs to be one of mutual trust and respect, and to be based on mutual interest in a particular set of issues and on mutual benefit.” In addition, there are a number of goals you should aim for in establishing a relationship: • The official’s staff people — and the official herself — should recognize your name and be willing to take or return your calls promptly. • You should be the first person the official’s office thinks of to call when he needs information about your issue. • The official should be willing to visit your organization or community, or support you in other ways speaking at an organizational function, explaining the legislative process to participants, etc. (continued)
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• You should be willing to help the official and her staff when they need it, including acting as a resource or information finder, speaking positively about them in conversation, giving them awards, thanking them publicly for support, and/or contributing money to their campaigns.
Contributing to Campaigns
The final way you can make a difference is by donating to a candidate or a cause that you support. There is an individual limit of $2,700 per candidate per election, so make those decisions wisely. These direct-tocandidate donations must be individual contributions, not business. You can also contribute to the Arkansas Pharmacists Political Action Committee, the APA’s official PAC that supports candidates who support pharmacy. Donating to the PAC is a great way to help pharmacists be heard in elections throughout the state. There is a limit of $5,000 per year to a PAC. However, PAC donations can be business or corporate contributions, so please consider donating to the APA’s PAC when you’re deciding how best to donate. You can find more information at www.arrx. org/arkansas-pharmacists-pac about APA’s political action committee.
Representative Michelle Gray and APA Board member Darla York discuss pharmacy issues in Arkansas.
Staying engaged politically doesn’t just make you a member of the well-informed electorate, it can make you a powerful ally that can topple injustice.
Get Involved
The new year feels like it’s just begun, but pharmacy has already faced a crisis that threatens to close stores throughout the state. Here at APA, we’ve heard from pharmacists across Arkansas that want to know how to make a lasting impact that can reverse some of the dire consequences we’ve seen so far in 2018. Getting involved with the legislative process is a proactive way to become a decision-maker and to fight for the future of the profession in Arkansas. §
http://www.winningcampaigns.org/Winning-Campaigns-ArchiveArticles/Winning-Tips-For-Political-Candidates.html 1
https://ctb.ku.edu/en/table-of-contents/advocacy/direct-action/ relationships-with-legislators-aides/main 2
AAHP Board
Arkansas State Board of Pharmacy
Executive Director............Susan Newton, Pharm.D., Russellville
President.......................................Tom Warmack, P.D., Sheridan
President................................Brandy Owen, Pharm.D., Conway
Vice President/Secretary..................Steve Bryant, P.D., Batesville
President-Elect.....................David Fortner, Pharm.D., Sherwood
Member..........................................Debbie Mack, P.D., Bentonville
Past President...................Kendrea Jones, Pharm.D., Little Rock
Member...................................Lenora Newsome, P.D., Smackover
Treasurer...........................Kendrea Jones, Pharm.D., Little Rock
Member...........................Rebecca Mitchell, Pharm.D., Greenbrier
Secretary..................................Melissa Shipp, Pharm.D., Searcy
Member....................................Ken Lancaster, P.D., Arkadelphia
Member-at-Large........Erin Beth Hays, Pharm.D., Pleasant Plains
Public Member........................................Carol Rader, Fort Smith
Member-at-Large.....................Joy Brock, Pharm.D., Little Rock
Public Member............................................Amy Fore, Fort Smith
Technician Representative.....BeeLinda Temple, CPhT, Pine Bluff
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UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES COLLEGE OF PHARMACY
Melanie Reinhardt, Pharm.D. Eddie Dunn, Pharm.D.
Required Patient Counseling Does Not Equal Effective Patient Counseling This issue of Safety Nets once again examines the potential hazards associated with electronic prescriptions. Thank you for your continued support of this column.
T
he prescription illustrated in Figure One was faxed from a prescriber's office to a community pharmacy in Western Arkansas. The pharmacy technician entered the prescription information into the computer as hydrocodone 7.5 mg/ acetaminophen 325 mg, quantity 90, with directions to the patient of "take one tablet every eight hours as needed.” The pharmacist verified the prescription information entered by the technician. After this, the technician filled the prescription and placed it in line for final verification by the pharmacist and patient counseling. At the end of the counseling session, the patient opened the prescription vial, looked at the tablets, and said, "These don't look the same". [Note: the patient was currently taking hydrocodone 7.5 mg/ibuprofen 200 mg tablets for lower back pain. This prescription was intended to be a continuation of that same medication]. The pharmacist replied, "It's okay. They look different because they are from a different manufacturer". After this "reassurance" by the pharmacist, the patient paid for the prescription and left. Figure 1
One week later, the patient returned to the pharmacy to refill a maintenance medication. She told the pharmacist she had been suffering from nausea, anorexia and fatigue. She then asked, "Remember I told you my pills looked different? Are you sure I got the right medicine"? This time the pharmacist double checked the tablet appearance and realized the patient had received hydrocodone 7.5 mg/acetaminophen 325 mg tablets instead of the prescribed hydrocodone 7.5 mg/ibuprofen 200 mg tablets. When informed of the mistake, the patient said "My doctor told me to never take Tylenol because of my liver." After this, the pharmacist apologized for the error and instructed the patient to call her prescriber as soon as possible. The pharmacist also took the appropriate (legal) steps to provide the patient with the correct medication. Patient counseling is an important part of community pharmacy practice. It is required by the State Board of Pharmacy. Required patient counseling does not equal effective patient counseling. In this case, the pharmacist performed Board required patient counseling. However, when the patient questioned the tablet appearance during the counseling session, the pharmacist brushed aside her concern with an assumption (i.e. different manufacturer) instead of verifying the tablets dispensed were correct. This assumption resulted in a patient with "liver problems" ingesting the one medication she was specifically told to avoid - acetaminophen. WWW.ARRX.ORG
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Do you view patient counseling as "one more thing I have to do" or as an opportunity to ensure your patients achieve the best possible outcome from their medication therapy? § STUDENT SPOTLIGHT
Elder Abuse - Emma Matherne
Elder abuse is any type of exploitation of an elderly person by a family member or care giver. It occurs in approximately 1 in 10 people over the age of 60 and can vary from physical abuse to passive neglect. I would like to present a case of drug diversion involving elder abuse. A man in Southern Arkansas was his mother’s only caregiver, he rarely allowed her to leave the house other than for doctor’s visits, and was responsible for picking up her prescriptions. She was in the late stages of cancer and was taking tramadol for breakthrough pain. Five refills were authorized for the tramadol on her last visit to her prescriber. After she died, the son continued refilling her tramadol until the pharmacist learned the patient had died. There was evidence he had been taking his mother’s tramadol since before her death leading some to believe she had been deprived of her pain medication. One of the most important responsibilities of a pharmacist is ensuring patient safety. In community pharmacy, pharmacists can learn details about a patient’s personal life and therefore have the ability to identify situations that may be harmful to a patient. There are warning signs. Bruises, pressure marks, broken bones, withdrawal from normal activities, depression, unattended medical needs, and weight loss can be signs of emotional abuse and neglect. Alzheimer’s patients or those with dementia are at particularly high risk. With the percentage of Americans over 60 growing, pharmacists must stay alert for these situations. Preventing abuse is easier than repairing the damage.
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The FDA Closes Out the Year with Vigor This column, presented by the Harding University College of Pharmacy, aims to briefly highlight information on new molecular or biological entities, new indications, or significant new dosage forms recently approved by the FDA.
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he FDA wrapped up the last quarter of 2017 with more drug, biological and new dosage form approvals than any corresponding quarter over the past 3-years, including drugs for a variety of chronic care conditions as well as in oncology, infectious disease, and specialty areas.
Chronic Care: Lonhala™ Magnair™ (glycopyrrolate) as
the first nebulized long-acting muscarinic antagonist for COPD using a proprietary eFlow technology; Fasenra™ (benralizumab) as adjunct maintenance therapy for severe eosinophilic asthma; Ozempic® (semaglutide) as the seventh GLP-1 receptor agonist (and third dosed once-weekly) approved for type 2 diabetes; Vyzulta™ (latanoprostene), an ophthalmic solution to reduce intraocular pressure in ocular hypertension or open-angle glaucoma; Eskata™ (hydrogen peroxide 40%) as the first topical, non-invasive treatment for raised seborrheic keratoses; and the NSS-2 Bridge®, approved through the de novo premarket review pathway, an electrical nerve stimulator placed behind the ear as the first device to curb opioid cravings.
Oncology: Calquence® (acalabrutinib) by accelerated approval for mantle cell lymphoma; Yescarta™ (axicabtagene) which is just the second chimeric antigen receptor (CAR) T-cell technology approved to treat relapsed/ refractory B-cell non-Hodgkin lymphoma; Tagrisso® (osimertinib) is designated as a breakthrough therapy as a 3rd-generation EGFR-TKI inhibitor for non-small cell lung cancer; Zelboraf® (vemurafenib) Is a kinase inhibitor used in patients with Erdheim-Chester Disease with the BRAF V600 mutation; Verzenio™ (abemaciclib) for HR-positive/ HER2-negative advanced breast cancer; and Gazyva® (obinutuzumab) was granted priority review for previously untreated follicular lymphoma. Infectious Disease: New antiinfectives receiving approval included: Solosec™ (secnidazole) as the first single-dose therapy for bacterial vaginosis; Xepi™ (ozenoxacin) is a quinolone cream to be used for impetigo; Prevymis™ (letermovir) became the first drug approved to prevent CMV infection after bone marrow transplant. New vaccines include Heplisav-B™ as the first two-dose vaccine for all hepatitis B subtypes, and Shingrix™ as a recombinant, nonlive, two-dose vaccine to prevent herpes zoster (shingles) in adults >50 years.
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Biologicals: New biologicals include: Hemlibra®
(emicizumab-kxwh) received priority review as a breakthrough orphan drug aimed at preventing or reducing the frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors; Luxturna™ (voretigene neparvovec-rzyl) is a novel gene therapy targeted at the rare biallelic RPE65 mutation-associated retinal dystrophy that leads to vision loss; Kevzara® (sarilumab) is the second IL-6 receptor blocker DMARD to treat rheumatoid arthritis; and Mepsevii™ (vestronidase alfa-vjnk) received fast-track priority review as the first drug to treat the rare genetic Sly Syndrome (mucopolysaccharidosis type VII). New biosimilars getting the nod include: Ixifi™(infliximab-qbtx) the third biosimilar to Remicade®; Ogivri™ (trastuzumab-dkst) the first biosimilar to Herceptin®; Mvasi™ (bevacizumabawwb) which is biosimilar to Avastin®; Fiasp® (insulin aspart) which is a new formulation of NovoLog® in which niacinamide has been added to help increase the rate of insulin absorption; and Admelog® (insulin lispro) as the first “follow-on” to Humalog® under an abbreviated approval pathway.
New Dosage Forms: Significant new dosage forms
approved this quarter include: Abilify MyCite® (aripiprazole, ingestible sensor) to ensure ingestion; Bydureon® BCise™ (exenatide, pen device) for hyperglycemia; Adzenys ER™ (amphetamine, extended-release oral suspension) and Cotempla XR-ODT™ (methylphenidate, oral disintegrating tablet) for ADHD; Auvi-Q® (epinephrine 0.1mg, autoinjector) for anaphylaxis in infants and children; Carospir® (spironolactone, oral suspension) diuretic; Cinvanti™ (aprepitant, injectable emulsion) and Varubi® (rolapitant, IV) for nausea/vomiting; Clenpiq™ (sodium picosulfate, magnesium oxide, citric acid) combination stimulant/osmotic laxative for colonoscopy; Impoyz™ (clobetasol propionate 0.025%) lower-strength cream for plaque psoriasis; Juluca® (dolutegravir/rilpivirine) first two-drug regimen for certain HIV-1 infections; Lynparza® (olaparib, tablet) for certain cancers; Lyrica® CR (pregabalin, extended-release tablets) for neuropathies; Nikita™ (pitavastatin, sodium salt) for hyperlipidemia; Sublocade™ (buprenorphine, SQ injection) first oncemonthly formulation for opioid use disorder; Xhance™ (fluticasone propionate, nasal spray) for polyps; Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol) new combination for COPD; and Zilretta™ (triamcinolone acetonide, extended-release injectable suspension) for osteoarthritis of the knee. § 17
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New Hypertension Guidelines Published Article by John Vinson, Pharm.D. and Elisabeth Mathews, Pharm.D. Graphic by Meghan Petersen, UAMS Pharm.D. Candidate 2019, UAMS APhA-ASP President and Hope Quattlebaum, UAMS Pharm.D. Candidate 2019, UAMS APhA-ASP, Vice Chair of Patient Care
H
eart disease remains the number one killer in America and in Arkansas. Strokes remain the 5th leading cause of death in America and in Arkansas. Combined, they kill 1 in 3 people. One of the most effective preventive strategies to prevent the morbidity and mortality from these diseases is to screen for and effectively treat high blood pressure. The most effective strategies include regular physical activity, healthy eating and adherence to effective blood pressure medications. The American College of Cardiology (ACC) and the American Heart Association (AHA) published updated hypertension guidelines in November 2017.1 For those of you familiar with Joint National Committee (JNC 7 and 8) hypertension guidelines, the National Heart, Lung, and Blood Institute (NHBLI) and JNC announced in 2013 that they would stop publishing new guidelines. The new ACC/AHA hypertension guidelines are expected to be a trusted replacement for healthcare professionals to utilize in their clinical practices. The writing committee consisted of clinicians including a pharmacist, cardiologists, epidemiologists, internists, an endocrinologist, a geriatrician, a nephrologist, a neurologist, a nurse, a physician assistant, and two lay/patient representatives. It included representatives from the ACC, AHA, American Pharmacists Association (APhA), American Academy of Physician Assistants
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(AAPA), Association of Black Cardiologists (ABC), American College of Preventive Medicine (ACPM), American Geriatrics Society (AGS), American Society of Hypertension (ASH), American Society for Preventive Cardiology (ASPC), National Medical Association (NMA), and Preventive Cardiovascular Nurses Association (PCNA). There is some controversy associated with these guidelines as The American Academy of Family Physicians (AAFP) announced in December 2017 that they did not endorse the new guidelines and would continue to endorse the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults developed by panel members appointed to the Eighth Joint National Committee (JNC8).3 There were a number of reasons the AAFP decided to not endorse the AHA/ACC guideline, including that the bulk of the guideline wasn't based on a systematic evidence review, harms of treating a patient to a lower blood pressure were not assessed in the systematic review, and AAFP was not one the of the many organizations involved in the development of the new hypertension guidelines.2 You can read the Full and the Executive Summary for the 2017 ACC/AHA hypertension guidelines1 here: http://professional.heart.org/professional/ GuidelinesStatements/UCM_316885_Guidelines-Statements.jsp
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NEW HYPERTENSION GUIDELINES
Top 10 things to know from the new 2017 ACC/ AHA hypertension guidelines 1. Change in Classification for Defining High Blood Pressure: Instead of > 140/90 being the threshold, these guidelines define an average of > 130/80 as the definition of stage 1 hypertension. 2. Prevalence of High Blood Pressure: With > 130/80 being the new defined definition of hypertension, the prevalence of high blood pressure in adults is expected to increase from 32% to 46%. This is seen most dramatically in adults age 20 to 45 where the prevalence is expected to triple in men (11% to 30%) and double in women (10% to 19%). The good news is that nonpharmacological management is recommended for most adults who would be newly classified as having hypertension. Blood pressure lowering medication, in addition to nonpharmacological therapy, is only recommended for the small fraction of those newly diagnosed who have the highest risk for cardiovascular events. 3. Emphasis on Accurate Measurement of Blood Pressure: The guidelines outline strategies to avoid errors in clinic / pharmacy based blood pressure measurement. They also make recommendations on when and how to use ambulatory BP monitoring measurements and home BP monitoring measurements and how they can be used as an adjunct to clinic / pharmacy readings to recognize “white coat” and “masked” hypertension. 4. Secondary Cause of High Blood Pressure: 10% of patients with high blood pressure have a secondary cause. The guidelines provide advice on how to screen for and diagnose these causes. One of the causes is drug induced high blood pressure and may include substances like caffeine, corticosteroids, and oral contraception. 5. Nonpharmacological Management of High Blood Pressure: The most important nonpharmacological interventions to both prevent and treat high blood pressure include weight loss, a heart healthy diet such as the DASH Diet, reduced dietary sodium intake, increased intake of potassium (preferably by dietary modification), increased physical activity, and moderation or avoidance of alcohol intake. 6. Drug Management of High Blood Pressure: Decisions to treat with drug therapy are impacted by both the level of blood pressure and the underlying risk for atherosclerotic cardiovascular disease (ASCVD). The ACC/AHA 10year ASCVD risk calculator can be found at http://www. cvriskcalculator.com/. 7. Choice of Antihypertensive Medication: In adults who do not have a compelling need for a specific BP lowering medication to manage another illness, first line treatment can be selected from four classes of medications: thiazide diuretics (chlorthalidone preferred), calcium channel blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers. In most adults with hypertension, pharmacotherapy requires more than one agent.
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8. Management of Hypertension in Adults with Comorbidities and in Special Patient Groups: Recommendations are made for comorbidities such as heart failure, chronic kidney disease or renal transplantation, peripheral vascular disease, diabetes mellitus or metabolic syndrome, atrial fibrillation, and valvular heart disease or aortic disease. Recommendations by patient population, include specific racial/ethnic groups, women (including those who are pregnant), older adults, and children or adolescents. 9. Other Special Recommendations: Recommendations are made for treatment of resistant hypertension and hypertensive crisis or emergency. Resistant hypertension is defined as those patients who are not well controlled despite taking three antihypertensive medications, including a diuretic. Effective treatment strategies may include adherence interventions, weight loss, physical activity, lifestyle changes, and diagnosis/modification of secondary causes. If necessary, spironolactone, eplerenone, and loop diuretics are typically considered next as the 4th or 5th drug depending on patient characteristics. 10. Improving Treatment and Control in Adults with Hypertension: Evidence based recommendations for improving adherence include once daily dosing for blood pressure medications and use of combination pills rather than individual components. The creation of an encouraging, blame-free environment in which patients are recognized for achieving treatment goals and given “permission” to answer questions related to their treatment honestly is essential to identify and address nonadherence. The guidelines did not give a recommendation for community pharmacist medication synchronization or special adherence packaging interventions.
See following two pages for
Hypertension Thresholds and Treatment Recommendations Key References: 1. Whelton, PK, Carey, RM, et. al. 2017 ACC/AHA/AAPA/ABC/ACPM/ AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. https://doi. org/10.1161/HYP.0000000000000065. Hypertension. 2017; Originally published November 13, 2017, accessed on Jan 22, 2018. 2. AAFP Decides to Not Endorse AHA/ACC Hypertension Guideline Academy Continues to Endorse JNC8 Guideline. https://www.aafp. org/news/health-of-the-public/20171212notendorseaha-accgdlne. html. Accessed on Jan 22, 2018. 3. Armstrong C; Joint National Committee. JNC 8 Guidelines for the Management of Hypertension in Adults. Am Fam Physician. 2014 Oct 1;90(7):503-4. https://www.aafp.org/afp/2014/1001/p503.html. Accessed on Jan 22, 2018.
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UAMS SCHOOL OF PHARMACY
Student Leadership in Community Pharmacy Keith Olsen Pharm.D., FCCP, FCCM Dean and Professor
Y
new pharmacy.” The team of students excelled due to their ou may or may not realize that rigid preparation for a 20 minute live presentation, and their the state of Arkansas is highly ranked compared to other states in 70 page written business plan encompassing innovative technology, finance and marketing. “Colleagues started our percentage of independently owned pharmacies. A huge contributing factor to this statistic is the support from our contacting us as they noticed our consistent top placement state association. The Arkansas Pharmacists Association and multiple winning teams,” reported Dr. Schwanda Heldenbrand, “so we decided it would be beneficial to (APA) strongly advocates for laws and policies favorable, not only to independent pharmacists but all pharmacists. extend our model where students beyond our own campus Having recently moved from a state could access our leadership and with a very different political and entrepreneurial training.” professional climate, it is easy to see the influence this provides for Together with the CPESN (ComThe National Community pharmacy owners in our state. We munity Pharmacy Enhanced Pharmacists Association Good realize the vast percentage of our Service Network) program “a quality Neighbor Pharmacy Pruitt UAMS graduates will be entering improvement initiative focused on Schutte student business plan community pharmacy practice. As integrating community pharmacy competition competition’s goal enhanced services to optimize we strategize to prepare our students is “to encourage ownership by with the highest and best education coordination of health care services motivating students to create opportunity to launch their careers, to patients and populations in our a business model for buying state and communities” (led by Dr. we want to address this statistic by an existing independent equipping potential entrepreneurs Rachel Stafford, Assistant Professor community pharmacy or with the tools to be successful. and Dr. Megan Smith, Assistant opening a new pharmacy.” Professor), UAMS is committed to the evolution and development An entrepreneur is defined as “a of community pharmacy services person who sets up a business, in Arkansas, and to “the uptake, taking on financial risk, in the hope of profit”, which involves much more detail than securing a sustainability, and impact of these services on patient care payroll job. Typically, P1 to P2, or P2 to P3 students begin and pharmacoeconomic indicators”. In addition, our PGY1 thinking about their future careers; some about independent Residency Program, community partners and Preceptors ownership. Though the decision to become a pharmacy (at rotation sites throughout the state) help educate future entrepreneur (a.k.a. pharma preneur) is similar to any other community pharmacists through their loyal contributions. business launch, specific industry considerations must be included in order to create a sustainable model. We want We seriously understand the need for aging owners’ our entrepreneurial-minded students to understand viable succession plans, as well as the need for patient healthcare accessibility in our underserved rural areas. Given that the reimbursement so they know what they’re getting into. As business owners, they will need to engage their skill set with State of Arkansas is an attractive place for independent a well thought out business plan. pharmacy ownership, we would like to see the number of UAMS graduates who indicate a desire toward community Although the study of entrepreneurship may not be a strength in pharmacy ownership double over the next few years. In most pharmacy curriculums, this is not a new arena for UAMS. any industry, successful entrepreneurial plans include Our Business Plan Teams have won the National Community understanding your market, understanding the metrics, and Pharmacists Association Good Neighbor Pharmacy Pruitt being adaptable to industry changes, while bringing personal Schutte student business plan competition award three innovation and passion to the mix. We currently have a team that can teach this to students. We are taking steps towards out of the past six years, and received high placement the other years. Led by advisors Dr. Schwanda Heldenbrand, an endowed leadership and pharmacy ownership summer Associate Professor and Associate Dean for Student Affairs symposium open to all pharmacy students nationwide. & Faculty Development and Dr. Seth Heldenbrand, Associate If this is a legacy program that you would like to see you Professor and Associate Dean of Experiential Education, or your family’s name on, we’d like to talk with you about the competition’s goal is “to encourage ownership by endowment and sharing your training success with these motivating students to create a business model for buying student-pharmacists. § an existing independent community pharmacy or opening a
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SAVE the
STAFF SPOTLIGHT: ELISABETH MATHEWS
DATE! JUNE 7-9, 2018
2018 APA Convention Embassy Suites Northwest Arkansas Rogers, Arkansas Join us in the rolling hills of Northwest Arkansas for the 2018 APA Annual Convention, to be held June 7-9 at the Embassy Suites Northwest Arkansas in Rogers, Arkansas. APA will offer up to 16 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 6. Convention registration will open shortly so stay tuned for more information through InteRxActions and at www.arrx.org/annual-convention. WWW.ARRX.ORG
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HARDING UNIVERSITY REPORT
Harding College of Pharmacy Celebrates First 10 Years Jeff Mercer, Pharm.D. Dean
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t’s hard to believe, but 2018 marks the tenth anniversary of the first entering class at Harding University College of Pharmacy. We recently celebrated this milestone with family and friends at a reception held at the Robbins Sanford Grand Hall in downtown Searcy. During this well-attended event, current faculty, staff, and students joined preceptors, alumni and others for an evening of food and fellowship. Former University President and current Chancellor, David B. Burks, was in attendance, as was Dr. Julie Hixson-Wallace, who served as the founding Dean of the College and now holds the positions of Vice Provost and Vice President for Institutional Effectiveness for Harding University. Together with so many friends of the College, the anniversary celebration was a great way to start off the New Year and served as the first of several tenyear anniversary activities planned for 2018. Ten years is a relatively short span, but so much has happened for the College during that time. What began as the dream of a few university administrators is now the professional home for over 35 faculty and staff as well as the pharmacy education center for over 500 collective students and alumni. Even the footprint of Harding’s campus has changed dramatically with the construction of the Farrar Center for Health Sciences building in 2008 and more recently the Swaid Center for Health Sciences. Today, the College of Pharmacy is part of Harding’s larger Center for Health Sciences, which includes the Colleges of Nursing and Allied Health. As Harding’s commitment to the health sciences matures, pharmacy students are training more interprofessionally with students from related programs, including nursing, physician assistant, and physical therapy among others. To date, the College has graduated six cohorts of pharmacy students and has four additional classes of students currently 24 24
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progressing through the program. While we don’t necessarily seek to limit our classes, Harding’s focus has never really been about large student numbers. Instead, our class sizes are among the smallest in the nation, typically ranging anywhere from 40 to 60 students per year. At Harding, we emphasize the importance of interpersonal relationships and mentoring between faculty and students. We were designed early on as a small Christian College of Pharmacy firmly rooted in the longstanding mission of graduating pharmacists who accept the responsibility of providing spiritual and physical wellness to the world. With this clear vision, the College continues to mature and establish its unique place in the world of pharmacy education. Among the various aspects that define our College, I am most pleased and encouraged by the service that our students and faculty provide to communities in need. I’ve written in this space at times about the number of health fairs, immunizations, medical missions and other direct patient care interventions our program is responsible for each year. You may recall the numbers are quite substantial, but it’s much more than just the volume of activities that occur. Each act of service reinforces Harding’s overarching goal of being a “Community of Mission” and illustrates the College’s adherence to our stated mission. For all of you that have contributed in some way to the success of Harding University College of Pharmacy, please know that we are most grateful and blessed by you. It has been a wonderful first ten years, and we are already looking toward the next decade and beyond. We will continue to celebrate throughout 2018, so be on the watch for additional celebration activities. We would love to have you join us or stop by for a visit the next time you are near campus. Happy 2018! §
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LEGISLATOR PROFILE
Senator Larry Teague NASHVILLE
My grandfather, Brice Carlton, was a local pharmacist in Nashville, Arkansas. He owned and ran the Owl Drugstore. Hardly a day goes by that my mom doesn’t regale me with some story from the drugstore. It was an important part of her life - she worked the soda fountain and has great memories from that experience. She remembers that when someone made an after-hours call to her dad, that she would load up and go to the drugstore with him and go on deliveries with him after his day at the store was finished.
District: Senate District 10 Represents (Counties): Parts of Clark, Hempstead, Nevada, and Sevier and all of Howard, Montgomery, Pike & Polk
Years in Office: 15 Occupation: Independent Insurance Agent Your hometown pharmacist: Mike Pinegar is my
pharmacist. He sold his business and works part-time now but I trust him and value his health advice.
What do you like most about being a legislator: Helping
people - hands down that is what makes the job worth doing. When someone has a problem - often with a state agency and I can call and help them work it out - that is what makes me happy.
What do you like least about being a legislator: During a Session, when things get a little tense and we sometimes forget that we are on the same team, that we work for the same people - the residents of our great state.
Most important lesson learned as a legislator: That we
don’t always agree but we need to work together to do what
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is best for the people of Arkansas and that I can’t always fix everything.
Most admired politician: Other than my wife, Debbie,
Howard County Assessor, I don’t know that I have a favorite. I do value and appreciate politicians that care about their constituents and their well-being and love our country and our state.
Advice for pharmacists about the political process and working with the AR Legislature: I think that the
pharmacists are pretty astute in their understanding of the political process. You have a good team that represents you. With hometown, locally owned pharmacies seemingly disappearing, I worry you will lose your personal relationships.
Your fantasy political gathering would be: A gathering
of those I have served with over the years. I have many good friends that I have served with - it would be good to see some of those who no longer serve in the Legislature.
Toughest issue of the session: The Fiscal Session should
be fairly easy and not particularly contentious. There is always a legislator or two who might be mad at an agency and try to get their attention, but I am hopeful everything will run smoothly.
Hobbies: I ride a bicycle a lot and I am a ham radio enthusiast. I also enjoy shooting and collecting guns.
What should Arkansans know about the fiscal session? I believe my job is to keep Arkansas from spending
more money than we have. It is not a hard job and I have the help of my colleagues and Governor Hutchinson as we all work toward keeping our spending within our means. §
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ARKANSAS ACADEMY OF HEALTH-SYSTEM PHARMACISTS
What Affects One Pharmacist, Affects Us All Brandy M. Owen Pharm.D., BCPS President
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hope the holiday season and end of 2017 found you surrounded by family and friends, a bit of a reprieve from normal stress of everyday job and life, and a time to give thanks for all we have been given.
of the exciting work we are doing with pharmacy education, advocacy, and technician advancement. We may be a small state, but we are mighty! What a great way to cap off 2017!
In contrast, coming into 2018 has almost felt like a tidal wave of insurmountable problems. While we have long known the ills of PBMs, the current reimbursement issues have To finish out 2017, all while representing this great association, I was able to attend the ASHP Officers’ Retreat in Dallas, TX reached crisis levels for our retail brethren. For hospitals of in early November. This meeting brings the leaders of ASHP’s all sizes, 340b programs are still under attack. ASHP strongly state affiliates to the same table to discuss association opposes the proposed changes to the Medicare payment achievements and struggles, to share innovative ideas, and rates for drugs that hospitals acquire under the 340B Drug to network with those in similar roles Pricing Program. AAHP stands in for their state as well as leaders the same position, and we will be from our national organization. We working hard to get out information I will be calling on our current learned about the important plans and ways to communicate to our coming out of ASHP, such as the legislation as soon as we can. We leadership, as well as past new Pharmacy Technician Forum are also working closely with APA presidents and leaders, to to support their grassroots efforts they are developing and their new come together (hopefully Strategic Plan. The technician forum on the reimbursement issues. What in late March or early April) is their answer to addressing what affects one pharmacist affects us membership has been asking about all. Natural disasters from last year to refresh our organization’s for years: how to retain quality have continued to plague us with goals and plans, realign with technicians, how to develop a mounting drug shortages. All this the national plan, and craft career ladder at your facility, how to in addition to continuing matters of ideas to better respond to our technician retention, the pharmacist approach technician certification, etc. We are not yet certain what the job field, job satisfaction vs burnout, members’ needs. state affiliate role will be within this and many others. While it feels like forum, but we will certainly keep you a lot, please know that we are all in this together and that AAHP is posted. working for you. We will overcome these issues. Through it As for the ASHP strategic plan, it stays mostly in line with all, it has brought (and will continue to bring) our profession what they’ve strived for in the past. Their vision statement together as never before. Please search out our section and mission are the same. VISION: that medication use will of the APA website, our social media sites, and the ASHP be optimal, safe, and effective for all people all of the time. website for more information dealing with 340b and national MISSION: to help people achieve optimal health outcome. drug and fluid shortages. I think those are ideas we can all get behind. Announcing the update strategic plan led me to understand that it is time Finally, I’m excited to leave you with the announcement of a to update AAHP’s strategic plan as well. In order to do this, newly elected Technician Representative on the AAHP board. I will be calling on our current leadership, as well as past BeeLinda Temple, CPhT was elected in December to replace presidents and leaders, to come together (hopefully in late Holly Katayama. BeeLinda is the Pharmacy Automation and March or early April) to refresh our organization’s goals and Informatics Specialist at Jefferson Regional Medical Center plans, realign with the national plan, and craft ideas to better in Pine Bluff. She has been a past speaker at Fall Seminar respond to our members’ needs. If you fall in this group, and a longtime member of the association. AAHP would please be on the lookout for future correspondence. like to give a big thank you and much appreciation to Holly for her work on the board. As we transition to working with BeeLinda, please be on the lookout for more information for In December, I attended the 2017 ASHP Midyear Clinical Meeting in Orlando, FL. Again, it was an exciting time to membership and association opportunities for our health network with other state affiliate leaders, as well as other system technicians in Arkansas. § Arkansas pharmacists, residents, and students. In hearing from other states, I was proud to represent Arkansas and talk
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` COMPOUNDING ACADEMY REPORT
Why H.R. 2871 is a Bad Idea for Patient Care By Guest Contributor Kevin Robertson, Pharm.D.
A
lthough almost every pharmacist is familiar with the deadly Becca Mitchell, PharmD compounding disaster of the New FIACP England Compounding Center (NECC), numerous examples existed before and have occurred since the 2012 NECC case. Several were recently addressed within New England Journal of Medicine “perspective,” written by Julie Dohm, JD, PhD and Janet Woodcock MD from the Center for Drug Evaluation and Research division of the Food and Drug Administration.1,2 Due to the NECC tragedy Congress created a new category of compounder (i.e., outsourcing facility, often called “503B facilities”) with the passage of the Drug Quality and Security Act. Registered outsourcing facilities are subject to FDA inspections and required to comply with Current Good Manufacturing Practice (CGMP). CGMP compliance, if followed appropriately, significantly increases the likelihood of a patient receiving a properly compounded, labeled, and sterile product, as compared to a product prepared within a less rigorous practice environment. As clarified within the recent release of two FDA guidance documents,3,4 whenever possible, commercially available products must be utilized. For pharmacies practicing as 503A compounders, this will require a conversation between pharmacists and prescribers who may not be knowledgeable of suitable commercially available products or alternative sources.
outsourcing facilities) aids in ensuring this occurs, if they are understood, followed, and enforced. § ______________________________________________________
Special thanks to Dr. Robertson for guest writing this article for the Compounding Academy. References: 1. Food and Drug Administration. Insanitary conditions at compounding facilities – Guidance for Industry (August 2016). https://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm514666.pdf (accessed 2018 Jan 19). 2. Woodcock J, Dohn J. Toward better-quality compounded drugs – an update from the FDA. New England Journal of Medicine. 2018; 377(26):2509-2510. 3. Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the federal food, drug and cosmetic act – Guidance for industry (January 2018). https:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM510154.pdf (accessed 2018 Jan 19). 4. Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503B of the federal food, drug and cosmetic act – Guidance for industry (January 2018). https:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM510153.pdf (accessed 2018 Jan 19). 5. MedScape. Struggle to Improve Quality of Compounded Drugs Continue. https:// www.medscape.com/viewarticle/891019 (accessed 2018 Jan 19). 6. BiopharmDIVE.com. FDA aims to strengthen oversight of compounding drug manufacturing. https://www.biopharmadive.com/news/fda-strengthen-oversightcompounded-drug-manufacturing-nejm/514097/ (accessed 2018 Jan 19).
Traditionally, 503A compounders are regulated by their state Boards of Pharmacy. However, Boards of Pharmacy inspector training and skill-set vary widely amongst these regulatory bodies. Recent national standardized training through NABP has occurred, but adequate oversight is lacking in most states, and large opportunities for self-education/regulation and compliance with existing standards (e.g., USP797 – last updated in 2008) is observed on a regular basis. Traditional compounding pharmacies (503A) are important in that, pursuant to an individual patient prescription, they are able to compound unique formulas that are not available either through traditional manufacturers or 503B facilities (e.g., patient allergic to inactive ingredients, etc). However, there is a congressional move to alter the Food Drug and Cosmetic Act again may jeopardize the slow progress that has been made since 2012 to increase the probability of receiving a high quality sterile product. HR 2871 would reduce patient protection that currently exits by allowing traditional compounding pharmacies to distribute product without the requirement for an individual prescription or compliance with CGMP standards. In other words, they would be allowed to act as an outsourcing facility (503B) without registering with the FDA, report adverse events to the FDA, and would not be required to comply with CGMP, as outsourcing facilities must do. 5,6 We should all want to deliver the safest possible product to our patients, and the current required minimum practice standards (i.e., USP797 for 503A sterile compounders and CGMP for 503B 28
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2018 Calendar of Events
MARCH ———————————
JUNE ———————————
APRIL ———————————
June 6, 2018 APA Board Meeting NWA Embassy Suites Rogers, AR
March 16-19, 2018 American Pharmacists Association Annual Meeting Nashville, TN
April 11-12, 2018 National Community Pharmacists Association Congressional Pharmacy Fly-In Hilton Alexandria Old Town Arlington, VA April 19, 2018* Arkansas Pharmacy Foundation Golf Tournament TBA April 27, 2018 Harding P3 Pinning Ceremony Harding Campus Searcy, AR
MAY ———————————— May 4, 2018 Harding Class of 2018 Senior Meeting Searcy, AR
June 2-6, 2018 American society of Health-System Pharmacists Summer Meeting Denver, CO
June 7-9, 2018 APA 136th Annual Convention NWA Embassy Suites Rogers, AR
JULY ———————————— July 26-28, 2018* APA Board Retreat and Committee Chair Orientation TBA
AUGUST —————————— UAMS P1 White Coat Ceremony Little Rock, AR
August 17, 2018 Harding P1 White Coat Ceremony Searcy, AR
May 5, 2018 Harding College of Pharmacy Commencement Searcy, AR
August 23-31, 2018 APA District Meetings Around the State
May 18, 2018 UAMS Class of 2018 Senior Meeting Little Rock, AR
September 6-27, 2018 APA District Meetings Around the State
May 19, 2018 UAMS College of Pharmacy Commencement Little Rock, AR
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SEPTEMBER —————————
OCTOBER —————————— October 4-5, 2018* AAHP Fall Seminar TBA
October 6-10,2018 National Community Pharmacists Association Annual Convention Boston, MA October 23, 2018 APA Board Meeting Conference Call October 25, 2018* APA Golden CPE Hosto Center Little Rock, AR
NOVEMBER ————————— November 1-4, 2018 American Society of Consultant Pharmacists Annual Meeting and Exhibition Gaylord National Harbor National Harbor, MD November 30, 2018* APA Committee Forum TBA November 30, 2018* APA Board Meeting TBA
DECEMBER ————————— December 2-6, 2018 American Society of Health-System Pharmacists Midyear Clinical Meeting Anaheim, CA
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2017 Brought Expanded Role for Pharmacists in Opioid Abuse Battle
E
arly last year, Governor Hutchinson signed Act 284 into law, which will improve access to the life-saving opioid antagonist naloxone. The new law authorizes pharmacists to dispense and/or administer naloxone to individuals without a prescription. A companion bill was also passed in the 2017 Regular Session that imposes a legal duty on prescribers to monitor their patients’ opioid and benzodiazepine prescription history. These laws are the latest in an ongoing effort to address the opioid epidemic in Arkansas. These laws are necessary due to the increasing number of deaths caused by opioid overdose in Arkansas. • The CDC recently released statistics revealing that Arkansas has a prescription rate of 114.6 per 100 people, whereas the national average is 66.5 prescriptions per 100 people. • The Arkansas Attorney General reports that more than 40 percent of teenagers have tried prescription drugs and more than half report that prescription drugs are easy to obtain from their family’s medicine cabinet. • The Kaiser Family Foundation found a 14% increase in the opioid overdose death rate from 2014 to 2015. • The National Bureau of Economic Research recently published a study in which states that adopted naloxone access laws saw a 9 to 11 percent decrease in the opioid-related deaths.
Pharmacists can play an active role in reducing deaths from opioid overdose, but there are a few legal considerations to keep in mind to ensure compliance and immunity.
Dispensing and Administering Naloxone
The cost for naloxone will be $45-$150, depending on insurance. It will be available in the following forms: Narcan, Naloxone HCl Solution in a 2 mL prefilled Luer-Lock Syringe, and Evzio. The first step to compliance for pharmacists in dispensing and administering these drugs is the Arkansas Naloxone Protocol (“Protocol”) approved by the Arkansas State Board of Pharmacy and the Arkansas State Medical Board, which is available on the Board of Pharmacy website.
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The Board of Pharmacy has issued a statewide standing order with the following dispensing guidelines: “An Arkansas Licensed Pharmacist may initiate therapy to an individual who is at increased risk of an opioid overdose or who is a family member, friend, or other person who is in a position to assist an individual with an increased risk of an opioid overdose . . . .” The law (Ark. Code Ann. § 17-92-101 et seq.) provides further requirements for administering and dispensing under a statewide protocol. First, the pharmacist must notify the primary care provider (“PCP”) of the patient or “enter the appropriate information in a patient record system shared with the PCP, as permitted by the PCP.” If the patient does not have a PCP, the pharmacist must “provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician.” Second, the pharmacist must make a standardized fact sheet available to the recipient. This fact sheet must include the following: (1) indications and contraindications for the use of the drug; (2) the appropriate method for the use of the drug; (3) the need for medical follow-up; and (4) other appropriate information. The State Board of Pharmacy will allow the Protocol to serve as the required fact sheet.
Liability
With this new authorization, pharmacists can play a more active role in reducing deaths resulting from opioid overdose. This new capability may be perceived as creating a greater risk of liability for pharmacists. However, under the 2015 Naloxone Access Act, pharmacists are immune from criminal, civil, and disciplinary action when dispensing or administering naloxone “in good faith and in compliance with the standard of care.” The law simply requires adherence to the Protocol. There are no training requirements or additional recording requirements provided in the Protocol. Yet, the general standard of care would require pharmacists to make reasonable efforts to obtain patient information, provide counseling, and warn the patient of possible side effects. Fortunately, there are several free resources that provide training on administering naloxone, such as http://www.getnaloxonenow.org, the NARCAN Now App, and additional educational resources available on the Board of Pharmacy website.
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COMPLIANCE CORNER
The Protocol contains the important precautions that must be provided to the patient and/or individual intending to administer the drug. Perhaps the most important thing to emphasize when dispensing or administering naloxone is the fact that naloxone wears off quickly and the individual can go back into an opioid overdose. The temporary nature of this drug makes it essential that EMS be contacted immediately. Individuals purchasing naloxone may also be advised that naloxone is not a controlled substance so anyone can carry it. Additionally, the Joshua Ashley-Pauley Act of 2015 provides immunity from charges for possession of a controlled substance when the individual is seeking medical assistance for a drug overdose for himself, herself, or another.
Conclusion
The expanded ability to provide life-saving naloxone to patients and their family members is an important step which will help the pharmacy community continue its leadership role in the fight against needless opioid deaths. To ensure appropriate patient care and immunity from potential claims, pharmacies should adopt written policies for how their pharmacists will comply with the Protocol, ensure
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that pharmacists and other staff are trained on appropriate administration and dispensing and create a record of all training or other compliance activities. § ________________________________________________________________
Erika Gee is a partner at Wright Lindsey Jennings, a member of the firm’s Government Relations Practice and a former Chief of Staff and
Chief Deputy in the Arkansas Attorney General’s Office. She focuses her
practice on administrative and regulatory law, government investigations, legislative drafting and lobbying.
1. https://www.cdc.gov/drugoverdose/maps/rxstate2016.html
2. https://arkansasag.gov/media-center/news-releases/rutledgeannounces-first-in-the-nation-initiative-aimed-at-preventingprescription-drug-abuse/
3. https://www.kff.org/other/state-indicator/opioid-overdose-deathrates/?currentTimeframe=0&sortModel=%7B%22colId%22:
%22Percent%20Change%20in%20Opioid%20Overdose%20
Death%20Rate%20from%20Prior%20Year%22,%22sort%22:%22desc%22%7D
4. http://www.nber.org/papers/w23171
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2018 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 4:30pm Friday, April 13, 2018. 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: 2017 Laura Lumsden, Little Rock 2016 Keith Larkin, Fort Smith 2015 Wayne Padgett, Glenwood 2014 Michelle Crouse, Lake Village 2013 Carl Collier, Fayetteville
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: 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
Cardinal Health Generation Rx Award _______
This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community. The award is also intended to encourage educational prevention efforts aimed at patients, youth, and other members of the community. Previous recipients include: 2017 Rob Christian, Little Rock 2016 John Kirtley, Little Rock 2015 Aduston Spivey, Hot Springs 2014 Denise Robertson, Little Rock
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: 2017 Joshua Bright, Harrison 2016 Kevin Barton, Centerton 2015 Rachel Stafford, North Little Rock 2014 Stephen Carroll, Arkadelphia 2013 Zach Holderfield, Fayetteville
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2018 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: 2017 Jody Smotherman, Batesville 2016 Nikki Scott, Russellville 2015 Taylor Franklin, Fort Smith 2014 Marcus Costner, Fayetteville 2013 Lanita White, Little Rock
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: 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
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: 2016 Representative Justin Boyd, Fort Smith 2015 Lenora Newsome, Smackover 2011 Gene Boeckmann, Wynne 2009 Percy Malone, Arkadelphia
(New) 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 nominee’s resume. Nominator’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 13, 2018.
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Call for Board Nominations 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. However, due to the map conversion from area representatives and district presidents to regional representatives last year, some elected members may serve a one or two-year term until the election cycle is fully synced. For questions about term lengths, please contact Susannah Fuquay at 501-372-5250. APA Board membership requires the flexibility to meet in Little Rock during the week and on two weekends 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: 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 2 – Northeast Arkansas: One Open Seat 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 Southeast Counties: Arkansas, Ashley, Bradley, Calhoun, Chicot, Cleveland, Dallas, Desha, Drew, Grant, Jefferson, Lee, Lincoln, Lonoke, Monroe, Phillips, Prairie, St Francis, Union
Region 3 – Central Arkansas: One Open 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 relating 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 2018-2019 are likely to be: • • • •
July 26-28, 2018 (Thursday afternoon, all day Friday, Saturday 8 a.m. to 12 p.m.) December 1, 2018 (Saturday 9 a.m. to 6 p.m.) in Little Rock March 10, 2019 (Sunday 9 a.m. to 4 p.m.) in Little Rock APA Annual Convention Board Meeting, June 2019 (Wednesday a.m.) in Little Rock
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 13, 2018. 34
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